Identification. An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 874.9.

Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory is exempt from the premarket notification procedures in subpart E of this part subject to the limitations in 876.9.

Identification. A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

Identification. A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 874.9.

Identification. A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.

Classification. Class II (performance standards).

Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

Classification. Class II (special controls). The special control is "Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers."

Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA." See 878.1(e) for the availability of this guidance document.

Identification. A nearpoint ruler is a device calibrated in centimeters intended to measure the nearpoint of convergence (the point to which the visual lines are directed when convergence is at its maximum).

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Classification. Class II (performance standards).

Identification. A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Classification. Class I (general controls). Except when used in donor screening tests, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Classification. Class II.

Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled "Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA."

Identification. A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 880.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Classification. Class II (performance standards).

Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Classification. Class II (performance standards).

Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.

Classification. Class II (performance standards).

Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Classification. Class I.

Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.

Classification. Class II (performance standards).

Identification. Immunonephelometer equipment for clinical use with its electrical power supply is a device that measures light scattering from antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light passed through a solution is scattered by the particles in suspension. The amount of light is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is called the light-scattering value and is used to measure the concentration of antigen-antibody complexes. This generic type of device includes devices with various kinds of light sources, such as laser equipment.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Classification. Class II (performance standards).

Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Classification. Class II (performance standards).

Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

Classification. Class II (performance standards).

Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).

Classification. Class II (performance standards).

Identification. Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:

Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.

Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

Classification. Class II.

Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Classification. Class II (performance standards).

Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Classification. Class II (performance standards).

Identification. A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

Classification. Class II (performance standards).

Identification. A neurosurgical chair is an operating room chair used to position and support a patient during neurosurgery.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.

Classification. Class II (performance standards).

Identification. A neurosurgical headrest is a device used to support the patient's head during a surgical procedure.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.