(12 days)
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.
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
This 510(k) summary describes a device that is an accessory to an existing medical device, rather than a standalone diagnostic or therapeutic device. As such, it does not involve the typical clinical study or performance metrics that would require the detailed breakdown of acceptance criteria, sample sizes, and ground truth establishment you've requested.
The submission focuses on demonstrating substantial equivalence to existing devices, primarily by showing that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
Here's an analysis based on the provided text, addressing your points where applicable and explaining why others are not present:
Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
This submission is for a Class II medical device accessory, the Passy-Muir Oxygen (O2) Adapter. The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices, focusing on safety and functional characteristics typical for O2 delivery accessories. No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for device performance are explicitly stated in the document, nor would they be expected for this type of device. The "study" proving the device meets criteria is primarily a comparison to predicate devices and an assessment of its operational principles.
1. Table of Acceptance Criteria and the Reported Device Performance
As mentioned, explicit quantitative acceptance criteria are not provided for this type of accessory. The "reported device performance" is described through its functional design and how it operates similarly to existing devices.
| Acceptance Criteria (Implicit from Submission Nature) | Reported Device Performance |
|---|---|
| Safety: Device operates without introducing new safety risks. | "inherently open system, functioning in the manner of a Tracheostomy mask or an aerosol "T" piece" (implies established safety profile) |
| Effectiveness: Device can deliver supplemental oxygen effectively. | "allows for improved mobility of those patients requiring...low flow supplemental oxygen." "delivers O2 in front of speaking valve diaphragm, usually in an open system configuration where O2 delivery is continuous," |
| Compatibility: Device fits with intended Passy-Muir speaking valves. | "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)." |
| Oxygen Connection: Device provides a reliable connection for oxygen tubing. | "equipped with an integral, tapered tube fitting that provides a friction fit with the inside diameter of flexible, supplemental oxygen tubing" |
| Substantial Equivalence: Shares similar intended use and technological characteristics with predicate devices. | "same general intended use...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" |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for the Test Set: Not applicable. No clinical "test set" of patients or data was used in the assessment of this device, given its nature as an accessory relying on the established safety and effectiveness of its predicate devices and its simple mechanical function.
- Data Provenance: Not applicable. The submission relies on a comparison to existing, legally marketed devices and general knowledge about oxygen delivery systems. No specific patient data or clinical trial data is presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts & Qualifications: Not applicable. There was no "test set" requiring ground truth establishment by experts in a clinical context. The assessment is based on engineering principles and comparison to predicate devices, evaluated by the FDA's reviewers.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring clinical adjudication was involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. Such a study is completely irrelevant for an oxygen adapter. This type of study is typically used for diagnostic imaging devices to assess how AI impacts the performance of human interpreters.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: No. This device is a mechanical accessory, not an algorithm or an AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the clinical sense. The "ground truth" for this submission revolves around the known functional principles of oxygen delivery accessories and the established safety and effectiveness profiles of predicate devices. The truth is established through engineering design, material compatibility, and comparison to existing products.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a mechanical accessory, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.
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FEB | 2 |997
510(k) SUMMARY FOR PASSY-MUIR OXYGEN (02) ADAPTOR FOR USE WITH THE PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVES (PMV 2000 AND 2001)
| Contact: | Patricia E. PassyPassy-Muir, Inc.4521 Campus Drive, Suite 273Irvine, 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) AdapterProduct Number PMA 2000 | ||
| Common or Usual Name: | Oxygen (O2) Adapter; Accessory O2 Adapter; SupplementalO2 Adapter; Speaking Valve O2 Adapter; AirwayConnector; 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: 73BZA21 CFR 868.5810 - "An airway connector is a deviceintended to connect a breathing gas source to atracheal tube, Tracheostomy tube or mask."Formerly a Class II device. | |||
| 2. Oxygen Mask: Classification Number: 73BYG21 CFR 868.5680 - "An oxygen mask is a device placed overa patient's nose, mouth, or Tracheostomy toadminister oxygen or aerosols." Formerly a Class IIdevice. | |||
| Predicate Devices: | 1. Trach Ring Adapter (Marquest Medical): Product # 178548, 15mmI.D. x 22 mm OD with side port for supplemental oxygen supply totrach or ET tube | ||
| 2. Aerosol Tee Connector (Hudson RCI): Product # 1648, 22mm ODhorizontal ports with a 15mm ID vertical port | |||
| 3. Tracheostomy Mask (Hudson RCI): Product # 1075, Adult maskfor tracheostomy and laryngectomy aerosol therapy | |||
| Description of Device: | The Passy-Muir O2 Adapter is a one-piece, injection-molded plasticdevice designed to attach to the outer surface of either one of the Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valves (PMV2000 or PMV 2001) and provide a means for connecting a supplementaloxygen supply tube |
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| Intended Use: | The P-M O2 Adapter is designed for use with the companion PMV2000 (clear) and PMV 2001 (purple) Low Profile Tracheostomy andVentilator Speaking Valves. The P-M O2 Adapter allows for improvedmobility of those patients requiring a tracheostomy tube, speakingvalve, 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 mechanicalstrength of two gripper flanges, and the shape of the device (which hugsthe outer profile of the valve). The O2 Adapter is equipped with anintegral, tapered tube fitting that provides a friction fit with the insidediameter of flexible, supplemental oxygen tubing (not supplied byPassy-Muir). The low-pressure oxygen (flowing through the flexibleoxygen supply tubing) passes first through the tube fitting of the O2Adapter, then into a duct-like channel created by the juxtaposed walls ofthe Adapter and the outer surface of the Speaking Valve, exiting at thefront edge of the valve, where it is either inhaled (along with ambientair) or allowed to dissipate into the atmosphere. This is an inherentlyopen system, functioning in the manner of a Tracheostomy mask or anaerosol "T" piece, commonly used in weaning tracheostomized patientsof 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 dependents 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.
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
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.(b)
Classification. Class II.