OXYGEN DIVERTER VALVE

K033914 · Resmed, Ltd. · BZD · Apr 22, 2004 · Anesthesiology

Device Facts

• Record ID: K033914
• Device Name: OXYGEN DIVERTER VALVE
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Apr 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2

Intended Use

The Oxygen Diverter Valve is an accessory to a CPAP or Bilevel Flow Generator intended to prevent the backflow of oxygen or water when the unit is not operating.

Device Story

Oxygen Diverter Valve is an in-line one-way valve accessory for CPAP or Bilevel Flow Generators; prevents backflow of oxygen or water into the generator when the unit is inactive. Device incorporates a silicone membrane that seals against an outer housing; vents backflow to atmosphere when pressure drops below 2.0 cm H2O. Used in combination with an existing T-piece for supplemental oxygen delivery. Device is a modification of the Anti-Asphyxia Valve (K982530) with reversed connector genders to allow insertion between the flow generator and air tube. Benefits include protection of the flow generator from moisture or oxygen accumulation during non-operational periods.

Clinical Evidence

Bench testing only. Performance studies included: effectiveness of oxygen backflow prevention, activation/deactivation pressure thresholds, deactivation pressure during therapy, pneumatic impedance, leak rate, pressure range, effectiveness of water diversion, oxygen diversion after wetting, lifetime testing, environmental testing, and system compatibility.

Technological Characteristics

In-line one-way valve; silicone membrane sealing mechanism; plastic housing. Connectors modified from Anti-Asphyxia Valve (K982530) to allow insertion between flow generator and air tube. Passive mechanical operation; no energy source. Standalone accessory.

Indications for Use

Indicated for use as an accessory to CPAP or Bilevel Flow Generators to prevent backflow of oxygen or water into the generator when the unit is not operating. No specific patient population or contraindications defined.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Pressure Valve (K963250)
• Mirage Full Face Mask (K982530)

Submission Summary (Full Text)

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K033914

## APR 2 2 2004

Sponsor:

ResMed Ltd

## Oxygen Diverter Valve

Traditional 510(k) Premarket Notification

## 510(k) SUMMARY—Oxygen Diverter Valve

| Submitter Name: | ResMed Corporation |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 14040 Danielson Street<br>Poway, CA 92064-6857 |
| Contact Person: | David D'Cruz<br>Vice President, Regulatory and Clinical Affairs for the<br>Americas |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | December 16, 2003 |
| Device Trade Name: | Oxygen Diverter Valve |
| Device Common Name: | Oxygen Diverter Valve |
| Classification Name: | Accessory for Ventilator,<br>Passive exhaust port |
| Predicate Devices: | 1: K963250 Pressure Valve<br>2: K982530 Mirage Full Face Mask |
| Device Description: | The Oxygen Diverter Valve is an in-line one-way valve<br>that is intended to prevent oxygen or water in the patient<br>circuit from back flowing into a CPAP or Bilevel Flow |
| Sponsor: | Oxygen Diverter Valve |
| ResMed Ltd | Traditional 510(k) Premarket Notification |
| | Generator when the unit is not operating. The Oxygen<br>Diverter Valve incorporates a silicone membrane that<br>seals against the outer housing to vent any backflow to<br>the atmosphere when the pressure drops of the CPAP<br>or Bilevel Flow Generator drops below 2.0cm H20. |
| | The principle of operation is the same as used in the Full<br>Face Mask Anti-asphyxia valve (510(k) number<br>K982530), the difference being in application - in the<br>Full Face Mask, the valve is used to vent CO2 to<br>atmosphere to prevent patient rebreathing. |
| Intended Use: | The Oxygen Diverter Valve is an accessory to a CPAP<br>or Bilevel Flow Generator intended to prevent the<br>backflow of oxygen or water when the unit is not<br>operating |
| Device Technological | The device function is the same as the Pressure Valve<br>(K963250), which is to prevent the backflow of oxygen<br>or water when the unit is not operating. The Oxygen |
| Characteristics and | |
| Comparison to | Diverter Valve (ODV) is a simple modification of the |
| Predicate Device(s): | Anti-Asphyxia Valve (AAV) that was FDA cleared as part<br>of the Mirage Full Face Mask 510(k) submission<br>(K982530). The modification is to reverse the genders of<br>patient side and flow-generator side connectors to allow<br>the Oxygen Diverter Valve to be connected, inserted<br>between the flow generator and the air tube. This valve<br>is not a medical device in and of itself, but an accessory<br>to the flow generator system. The Oxygen Diverter<br>Valve will be used in combination with an existing T-<br>piece for introduction of supplemental oxygen. |
| Performance Data: | Performance testing has been conducted to ensure the<br>safety and effectiveness of the Oxygen Diverter Valve.<br>Tests performed include: |
| | • Effectiveness of intended use to prevent oxygen<br>backflow |
| | • Activation and Deactivation Pressure |
| | • Deactivation Pressure during Therapy |
| | • Pneumatic performance characteristics: Impedance<br>added during therapy |
| | • Leak rate and pressure range |
| Sponsor: | Oxygen Diverter Valve |
| ResMed Ltd | Traditional 510(k) Premarket Notification |
| | • Effectiveness of its intended use to divert water |
| | • Effectiveness of oxygen diversion after wetting |
| | • Lifetime testing |
| | • Environmental testing, and |
| | • System Compatibility |
| Conclusion: | Based upon the discussions above, performance<br>studies, documentation in the appendices, and the<br>proposed device labeling, the Oxygen Diverter Valve is<br>substantially equivalent to the identified predicate<br>devices in terms of intended use, safety, and<br>effectiveness |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2004

Mr. David D'Cruz Resmed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K033914

Trade/Device Name: Oxygen diverter valve, CPAP accessory Regulation Number: 21 CFR 868.5905 Regulation Name: Ventilator, non-continuous Regulatory Class: II Product Code: BZD Dated: March 12, 2004 Received: March 15, 2004

Dear Mr. D'Cruz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we mare reveal above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to active and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr.), it may of backed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device carroe rounder announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements Incan that I Dr nas made statutes and regulations administered by other Federal agencies. of the Act of any I ederal statues and Agenements, including, but not limited to: registration I ou must compry with an all rieves ing (21 CFR Part 801); good manufacturing practice

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Page 2 – Mr. David D'Cruz

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); applicable, the electionic product factation vou to begin marketing your device as described 21 CFR 1000-1030. This letter will affication. The FDA finding of substantial equivalence in your Seculon 510(k) promatics novelicate device results in a classification for your of your device to a conits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific atvice for your do not on the case note the regulation
please contact the Office of Compliance at [phone]. Also, please note the Vegalation V prease contact the Other of Ochiphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Birman [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Kein Muling

lyon Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Sponsor:

Oxygen Diverter Valve

ResMed Ltd

Traditional 510(k) Premarket Notification

510(k) Number (if known):

K033914

Device Name: Oxygen Diverter Valve

Indications for Use:

The Oxygen Diverter Valve is an accessory to a CPAP or Bilevel Flow Generator intended to prevent the backflow of oxygen or water when the unit is not operating.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Alma M. Puito

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

KO33914 510(k) Number:

Prescription Use

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Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)