(12 days)
178548, 1648, 1075
Not Found
No
The description focuses on a simple mechanical adapter for oxygen delivery with speaking valves and makes no mention of AI or ML.
Yes
The device is designed to improve mobility for patients with tracheostomy tubes, speaking valves, and low flow supplemental oxygen, which directly addresses a health condition.
No
The device is described as an adapter for tracheostomy and ventilator speaking valves, allowing for supplemental oxygen supply. Its intended use is to improve mobility for patients, not to diagnose any condition or disease.
No
The device description explicitly states it is a "one-piece, injection-molded plastic device," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is designed for use with speaking valves for patients with tracheostomy tubes and requiring supplemental oxygen. This is a therapeutic and assistive device, not a diagnostic one.
- Device Description: The description details a plastic adapter for connecting an oxygen supply tube to a speaking valve. This is a physical accessory, not a device that performs in vitro testing on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device's function is to facilitate the delivery of supplemental oxygen in conjunction with a speaking valve, which is a direct patient care activity, not an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes
TBD: Accessory O2 Adapter for the Tracheostomy Speaking Valves, 73BZA, 73BYG
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
- 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
- Aerosol Tee Connector (Hudson RCI): Product # 1648, 22mm OD horizontal ports with a 15mm ID vertical port
- Tracheostomy Mask (Hudson RCI): Product # 1075, Adult mask for tracheostomy and laryngectomy aerosol therapy
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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. Passy
Passy-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
| 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 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.