(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] §868.5250 Breathing circuit circulator. (a) Identification. A breathing circuit circulator is a turbine device that is attached to a closed breathing circuit and that is intended to circulate anesthetic gases continuously by maintaining the unidirectional valves in an open position and reducing mechanical dead space and resistance in the breathing circuit. (b) Classification. Class II (performance standards). §868.5260 Breathing circuit bacterial filter. (a) Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit. (b) Classification. Class II (performance standards). §868.5270 Breathing system heater. (a) Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller. (b) Classification. Class II (performance standards). § 868.5280 Breathing tube support. (a) Identification. A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s). (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 54 FR 25048, June 12, 1989] §868.5300 Carbon dioxide absorbent. (a) Identification. A carbon dioxide absorbent is a device intended for medical purposes that consists of an absorbent material (e.g., soda lime) that is intended to remove carbon dioxide from the gases in the breathing circuit. (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] §868.5310 Carbon dioxide absorber. (a) Identification. A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain. (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] §868.5320 Reservoir bag. (a) Identification. A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation. (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] §868.5330 Breathing gas mixer. (a) Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient. (b) Classification. Class II (performance standards). § 868.5340 Nasal oxygen cannula. (a) Identification. A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils. (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 59 FR 63007, Dec. 7, 1994] §868.5350 Nasal oxygen catheter. (a) Identification. A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen. (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 59 FR 63007, Dec. 7, 1994] $868.5365 Posture chair for cardiac or pulmonary treatment. (a) Identification. A posture chair for cardiac or pulmonary treatment is a device intended to assist in the rehabilitation and mobilization of patients with chronic heart or lung disease. (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 54 FR 25048, June 12, 1989] §868.5375 Heat and moisture condenser (artificial nose). (a) Identification. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient. (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] § 868.5420 Ether hook. (a) Identification. An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether. (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 exception 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] §868.5430 Gas-scavenging apparatus. (a) Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system. (b) Classification. Class II (performance standards). § 868.5440 Portable oxygen generator. (a) Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve). (b) Classification. Class II (performance standards). §868.5450 Respiratory gas humidifier. (a) Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device. (b) Classification. Class II (performance standards). § 868.5460 Therapeutic humidifier for home use. (a) Identification. A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes the vapor during normal respiration. (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; 47 FR 40410, Sept. 14, 1982, as amended at 61 FR 1120, Jan. 16, 1996] §868.5470 Hyperbaric chamber. (a) Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650). (b) Classification. Class II (performance standards). $868.5530 Flexible laryngoscope. (a) Identification. A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. (b) Classification. Class I. The device is exempt from the premarket notifica tion procedures in subpart E of part 807 of this chapter. [47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996] § 868.5540 Rigid laryngoscope. (a) Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996] § 868.5550 Anesthetic gas mask. (a) Identification. An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper 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 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996] $868.5560 Gas mask head strap. (a) Identification. A gas mask head strap is a device used to hold an anes thetic gas mask in position on a patient's face. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 41107, Sept. 17, 1982, as amended at 54 FR 25048, June 12, 1989] § 868.5570 Nonrebreathing mask. (a) Identification. A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases. (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] §868.5580 Oxygen mask. (a) Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. (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] §868.5590 Scavenging mask. (a) Identification. A scavenging mask is a device positioned over a patient's nose to deliver anesthetic or analgesic gases to the upper airway and to remove excess and exhaled gas. It is usually used during dentistry. (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] §868.5600 Venturi mask. (a) Identification. A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient. (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] §868.5610 Membrane lung for long term pulmonary support. (a) Identification. A membrane lung for long-term pulmonary support is a device used to provide to a patient extracorporeal blood oxygenation for longer than 24 hours. (b) 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. See § 868.3. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987] §868.5650 Esophageal obturator. (a) Identification. An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask. (b) Classification. Class II (performance standards). § 868.5655 Portable liquid oxygen unit. (a) Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug. (b) Classification. Class II (performance standards). 8868.5665 Powered percussor. (a) Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas. (b) Classification. Class II (performance standards). § 868.5675 Rebreathing device. (a) Identification. A rebreathing device is a device that enables a patient to rebreathe exhaled gases. It may be used in conjunction with pulmonary function testing or for increasing minute ventilation. (b) 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 § 868.9. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000] § 868.5690 Incentive spirometer. (a) Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation. (b) Classification. Class II (performance standards). § 868.5700 Nonpowered oxygen tent. (a) Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods. (b) 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 § 868.9. [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000] |