← Product Code [JOH](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH) · K970365 # PASSY-MUIR O2 ADAPTER; PMA2000 (K970365) _Passy-Muir, Inc. · JOH · Feb 12, 1997 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH/K970365 ## Device Facts - **Applicant:** Passy-Muir, Inc. - **Product Code:** [JOH](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH.md) - **Decision Date:** Feb 12, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5800 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Indications for Use The P-M O₂ Adapter is designed for use with the companion PMV 2000 (clear) and PMV 2001 (purple) Low Profile Tracheostomy and Ventilator Speaking Valves. The P-M O₂ Adapter allows for improved mobility of those patients requiring a tracheostomy tube, speaking valve, and low flow supplemental oxygen. ## Device Story Passy-Muir O₂ Adapter is a one-piece, injection-molded plastic accessory for PMV 2000/2001 speaking valves. Device snaps onto valve exterior via friction and gripper flanges. Features integral tapered tube fitting for connection to standard flexible oxygen supply tubing. Low-pressure oxygen flows through adapter channel, exiting at valve front for patient inhalation or atmospheric dissipation. Functions as an open system, similar to tracheostomy masks or aerosol 'T' pieces. Used in clinical or home settings by tracheostomized/ventilator-dependent patients. Enables supplemental oxygen delivery while maintaining speaking valve function, supporting patient mobility and weaning processes. ## Clinical Evidence No clinical data. Substantial equivalence is based on the long history of use of supplemental oxygen delivery systems and the similarity in design and function to established predicate devices. ## Technological Characteristics One-piece, injection-molded plastic construction. Mechanical attachment via friction fit and gripper flanges. Tapered tube fitting for standard oxygen tubing. Open-system design for continuous low-flow oxygen delivery. No electronic components, software, or energy source. ## Regulatory Identification A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic. ## Predicate Devices - Trach Ring Adapter (Marquest Medical) (Product # 178548) - Aerosol Tee Connector (Hudson RCI) (Product # 1648) - Tracheostomy Mask (Hudson RCI) (Product # 1075) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FEB 12 1997 K970365 # 510(k) SUMMARY FOR PASSY-MUIR OXYGEN (O₂) ADAPTOR FOR USE WITH THE PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVES (PMV 2000 AND 2001) Contact: Patricia E. Passy Passey-Muir, Inc. 4521 Campus Drive, Suite 273 Irvine, CA 92715 Phone: (714) 833-8255 Facsimile: (714) 833-8299 Establishment Registration Number: 2024841 Date Summary Prepared: 1/29/97 Name of the Device: Passy-Muir Oxygen (O₂) Adapter Product Number PMA 2000 Common or Usual Name: Oxygen (O₂) Adapter; Accessory O₂ Adapter; Supplemental O₂ Adapter; Speaking Valve O₂ Adapter; Airway Connector; O₂ Port; Supplemental O₂ Port Classification Name: TBD: Accessory O₂ Adapter for the Tracheostomy Speaking Valves Possible Product Classification Codes: 1. Airway Connector (Extension): Classification Number: 73BZA 21 CFR 868.5810 - "An airway connector is a device intended to connect a breathing gas source to a tracheal tube, Tracheostomy tube or mask." Formerly a Class II device. 2. Oxygen Mask: Classification Number: 73BYG 21 CFR 868.5680 - "An oxygen mask is a device placed over a patient's nose, mouth, or Tracheostomy to administer oxygen or aerosols." Formerly a Class II device. ## Predicate Devices: 1. Trach Ring Adapter (Marquest Medical): Product # 178548, 15mm I.D. x 22 mm OD with side port for supplemental oxygen supply to trach or ET tube 2. Aerosol Tee Connector (Hudson RCI): Product # 1648, 22mm OD horizontal ports with a 15mm ID vertical port 3. Tracheostomy Mask (Hudson RCI): Product # 1075, Adult mask for tracheostomy and laryngectomy aerosol therapy ## Description of Device: The Passy-Muir O₂ Adapter is a one-piece, injection-molded plastic device designed to attach to the outer surface of either one of the Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valves (PMV 2000 or PMV 2001) and provide a means for connecting a supplemental oxygen supply tube. {1} 11 ## Intended Use: The P-M O₂ Adapter is designed for use with the companion PMV 2000 (clear) and PMV 2001 (purple) Low Profile Tracheostomy and Ventilator Speaking Valves. The P-M O₂ Adapter allows for improved mobility of those patients requiring a tracheostomy tube, speaking valve, and low flow supplemental oxygen. ## Principles of Operation: The P-M O₂ Adapter is designed to snap around the body of the low-profile speaking valve, held in place by friction, the mechanical strength of two gripper flanges, and the shape of the device (which hugs the outer profile of the valve). The O₂ Adapter is equipped with an integral, tapered tube fitting that provides a friction fit with the inside diameter of flexible, supplemental oxygen tubing (not supplied by Passy-Muir). The low-pressure oxygen (flowing through the flexible oxygen supply tubing) passes first through the tube fitting of the O₂ Adapter, then into a duct-like channel created by the juxtaposed walls of the Adapter and the outer surface of the Speaking Valve, exiting at the front edge of the valve, where it is either inhaled (along with ambient air) or allowed to dissipate into the atmosphere. This is an inherently open system, functioning in the manner of a Tracheostomy mask or an aerosol "T" piece, commonly used in weaning tracheostomized patients of off ventilators. ## Summary of the Basis for the Finding of Substantial Equivalence: The safety and effectiveness of supplemental oxygen devices is based on a long history of O₂ delivery systems. Supplemental O₂ delivery systems have been used with tracheostomized and ventilator dependent patients since before the passage of the Medical Device Amendments of 1976. The Passy-Muir Oxygen (O₂) Adapter and the predicate devices have the same general intended use as a delivery system for low levels of supplemental oxygen. It is similar to the predicate devices as it attaches directly to (or in immediate proximity of) the tracheostomy speaking valve and delivers O₂ in front of speaking valve diaphragm, usually in an open system configuration where O₂ delivery is continuous. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH/K970365](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH/K970365) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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