VPAP ADAPT

K051364 · Resmed, Ltd. · MNS · Aug 16, 2005 · Anesthesiology

Device Facts

• Record ID: K051364
• Device Name: VPAP ADAPT
• Applicant: Resmed, Ltd.
• Product Code: MNS · Anesthesiology
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VPAP ADAPT is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

Device Story

Non-invasive flow generator providing adaptive servo-ventilation (ASV) therapy; stabilizes patient ventilation. Device measures instantaneous ventilation; calculates target ventilation (90% of 100-second moving average); adjusts support to servo-control ventilation to meet target. Used in clinical or home settings by patients/clinicians. Includes graphic user interface for parameter adjustment and alarm monitoring (fixed and selectable). Output informs clinical management of respiratory insufficiency; benefits patients by stabilizing breathing patterns and reducing apnea/hypopnea events.

Clinical Evidence

Clinical study comparing VPAP ADAPT to VPAP III ST-A. Primary endpoints: Apnea/Hypopnea Index (AHI) and Respiratory-related Arousal Index (RAI). Results showed clinical equivalence in sleep/respiratory parameters; VPAP ADAPT showed statistically superior AHI reduction (p=0.001). Bench testing confirmed similar performance in minute ventilation and tidal volume under varying breathing efforts.

Technological Characteristics

Flow generator comprising blower (motor/fan assembly), flow/pressure sensors, and processing electronics. Delivers pressurized air via mask/tubing. Non-invasive. Software-controlled adaptive servo-ventilation. Complies with FDA guidance for ventilators and software in medical devices.

Indications for Use

Indicated for adult patients with OSA and respiratory insufficiency caused by central and/or mixed apneas and periodic breathing.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• VPAP III ST-A (K033276)

Submission Summary (Full Text)

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AUG 16 2005

Sponsor

1. 11

ResMed Ltd

K051364

Traditional 510(k) Premarket Notification

VPAP ADAPT

# 510(k) Summary – AutoSet CS2 [As required by §807.92 (c) ]

| Submitter Name: | ResMed Corp. |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 14040 Danielson Street, Poway CA 92064-6857, USA |
| Contact Person: | David D'Cruz, VP Requlatory & Clinical Affairs US |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | May 19, 2005 |
| Device Trade Name | VPAP ADAPT |
| Device Common Name/<br>Classification Reference | Bi level Positive Pressure Ventilator/ Continuous<br>Ventilator, Passive Exhalation Port, Non-Critical Care.<br>21 CFR868.5895 |
| Product Code | 73MNS |
| Predicate Devices: | VPAP III ST-A (K033276) |
| Reason for submission | New device |
| Intended Use: | The VPAP ADAPT is intended to provide non-invasive<br>ventilatory support to treat adult patients with OSA and<br>Respiratory Insufficiency caused by central and/or mixed<br>apneas and periodic breathing. |

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#### Device Description

The VPAP ADAPT is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventifation. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP ADAPT is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed) whereas others are clinically selectable. Also, a graphic user interface displays clinical data and enables the user (patient/clinician) to set and adjust certain parameters.

#### Performance Data

Design and verification activities were performed on the VPAP ADAPT as a result of the risk analysis and product requirements. All tests confirmed that the VPAP ADAPT met the acceptance criteria. The VPAP ADAPT complies with the applicable standards and requirements referenced in the following quidance documents:

- FDA Draft Reviewer Guidance for Ventilators (July 1995)
- FDA Reviewer Guidance for Premarket Notification Submissions (November ﺎ 1993)
- FDA Reviewer's and Industry, Guidance for the content of premarket submissions for software contained in medical devices, May 1998

## Substantial Equivalence

The VPAP ADAPT (new device) and the VPAP III ST-A (predicate device) are both positive pressure flow generators comprising of a blower (motor/fan assembly), flow and pressure sensors, and processing electronics. The blower supplies pressurized air to the patient via a mask and air tubing. The VPAP ADAPT has the same intended use as the VPAP III ST-A.

Predicate bench testing and clinical studies were used to show substantial equivalence between the VPAP ADAPT and VPAP III ST-A.

In the predicate bench testing, the minute ventilation and tidal volume produced by VPAP ADAPT and the VPAP 111 ST-A were measured under various patient breathing efforts. The results show the VPAP ADAPT behaves similar to the predicate device, the VPAP III ST-A.

The findings of the VPAP ADAPT equivalence study demonstrated that the VPAP ADAPT is effective for use in patients with central, mixed apnea or periodic breathing. The primary endpoints were achieved, showing clinically equivalent ApnealHypopnea (AHI) and Respiratory-related Arousal Index (RAI) sleep and respiratory parameters between the VPAP ADAPT and VPAP III ST-A devices. Furthermore, the non-equivalent AHI results indicated that the VPAP ADAPT device is superior (statistically significant p=0.001) to the VPAP III ST-A device for providing effective therapy. Additionally, all secondary endpoints provided further evidence of the equivalency of the devices.

## Conclusion

The VPAP ADAPT is substantially equivalent to the VPAP III ST-A.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

AUG 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David D'Cruz Vice President, Regulatory & Clinical Affairs ResMed Limited 14040 Danielson Street Poway, California 92064-6857

Re: K051364

Trade/Device Name: VPAP Adapt Regulation Number: 21 CFR 868.5895 Regulation Name: Bi-Level positive Pressure Ventilator/Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: May 20, 2005 Received: May 31, 2005

Dear D'Cruz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 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 controls provisions of the Act. The general controls provisions of the Act include requirements 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. D'Cruz

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice 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); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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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# Indications for Use

510(k) Number (if known):

VPAP ADAPT Device Name: ____________________

Indications For Use:

The VPAP ADAPT is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aun Sufeom

(Division Sign-Off) Division of Anesthasiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

.

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