§ 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989] § 868.1975 Water vapor analyzer. (a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996] Subpart C-Monitoring Devices § 868.2025 Ultrasonic air embolism monitor. (a) Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles. (b) Classification. Class II (performance standards). § 868.2300 Bourdon gauge flowmeter. (a) Identification. A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996] § 868.2320 Uncompensated thorpe tube flowmeter. (a) Identification. An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flow rate accurately. The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter is open to the atmosphere. § 868.2450 Lung water monitor. (a) Identification. A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by measuring changes in thoracic electrical impedance (resistance to alternating current) by means of electrodes placed on the patient's chest. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP for a device is required to be filed with the Food and Drug Administration on or before July 12, 2000, for any lung water monitor that was in commercial distribution before May 28, 1976, or that has, on or before July 12, 2000, been found to be substantially equivalent to a lung water monitor that was in commercial distribution before May 28, 1976. Any other lung water monitor device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 65 FR 19834, Apr. 13. 2000] § 868.2480 Cutaneous carbon dioxide (PCCO2) monitor. (a) Identification. A cutaneous carbon dioxide (PCCO2) monitor is a noninvasive heated sensor and a pHsensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement. (b) Classification. Class II (performance standards). [54 FR 27160, June 28, 1989] § 868.2500 Cutaneous oxygen monitor. (a) Cutaneous oxygen monitor for an infant patient who is not under gas anesthesia (1) Identification. A cutaneous oxygen monitor for an infant patient who is not under gas anesthesia is a device that uses a noninvasive sensor (e.g., a Clark-type polarographic electrode) placed on the patient's skin and that is intended to monitor relative changes in the cutaneous oxygen tension in an infant patient who is not under gas anesthesia. (2) Classification. Class II (performance standards). (b) Cutaneous oxygen monitor for all other uses (1) Identification. A cutaneous oxygen monitor for all other uses is a device that uses a noninvasive sensor (e.g., a Clark-type polarographic electrode) placed on the patient's skin and that is intended to monitor relative changes in the cutaneous oxygen tension in a noninfant patient or in any patient, including an infant, who is under gas anesthesia. (2) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 868.3. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987] $868.2550 Pneumotachometer. (a) Identification. A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. § 868.2700 Pressure regulator. (a) Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996] § 868.2775 Electrical peripheral nerve stimulator. (a) Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases. (b) Classification. Class II (performance standards). § 868.2875 Differential pressure transducer. (a) Identification. A differential pressure transducer is a two-chambered device intended for medical purposes that is often used during pulmonary function testing. It generates an electrical signal for subsequent display or processing that is proportional to the difference in gas pressures in the two chambers. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996] § 868.2885 Gas flow transducer. (a) Identification. A gas flow transducer is a device intended for medical purposes that is used to convert gas flow rate into an electrical signal for subsequent display or processing. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996] § 868.2900 Gas pressure transducer. (a) Identification. A gas pressure transducer is a device intended for medical purposes that is used to convert gas pressure into an electrical signal for subsequent display or processing. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996] Subparts D-E [Reserved] Subpart F-Therapeutic Devices § 868.5090 Emergency airway needle. (a) Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction. (b) Classification. Class II (performance standards). § 868.5100 Nasopharyngeal airway. (a) 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. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996] § 868.5110 Oropharyngeal airway. (a) Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996] §868.5115 Device to relieve acute upper airway obstruction. (a) Identification. The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction. (b) Classification. Class II (special controls) ("Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices"). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to § 868.9. [65 FR 39099, June 23, 2000; 65 FR 47669, Aug. 3, 2000] § 868.5120 Anesthesia conduction catheter. (a) Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia. (b) Classification. Class II (performance standards). § 868.5130 Anesthesia conduction filter. (a) Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid. (b) Classification. Class II (performance standards). § 868.5140 Anesthesia conduction kit. (a) 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. (b) Classification. Class II (performance standards). § 868.5150 Anesthesia conduction needle. (a) Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia. (b) Classification. Class II (performance standards). § 868.5160 Gas machine for anesthesia or analgesia. (a) Gas machine for anesthesia—(1) Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. (2) Classification. Class II (performance standards). (b) Gas machine for analgesia (1) Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a § 868.5180 Rocking bed. (a) Identification. A rocking bed is a device intended for temporary use to help patient ventilation (breathing) by repeatedly tilting the patient, thereby using the weight of the abdominal contents to move the diaphragm. (b) Classification. Class II (performance standards). § 868.5220 Blow bottle. (a) Identification. A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a patient. The patient blows into the device to move a column of water from one bottle to another. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the excep tion of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989] § 868.5240 Anesthesia breathing circuit. (a) Identification. An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996] 194-069 D-01--10 |