VPAP S-A

K122324 · Resmed, Ltd. · MNS · Nov 13, 2012 · Anesthesiology

Device Facts

• Record ID: K122324
• Device Name: VPAP S-A
• Applicant: Resmed, Ltd.
• Product Code: MNS · Anesthesiology
• Decision Date: Nov 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The VPAP S-A is indicated to provide noninvasive ventilation for patients weighing more than 30 lbs (13 kg) with respiratory insufficiency such as that associated with hypercapnic Chronic Obstructive Pulmonary Disease (COPD) or obstructive sleep apnea (OSA). The VPAP S-A is intended for home and hospital use.

Device Story

VPAP S-A is a noninvasive, microprocessor-controlled positive pressure ventilator for home and hospital use. It utilizes a blower system to deliver CPAP (4-20 cmH2O) or bilevel (3-30 cmH2O) therapy to maintain airway patency. The system includes an integrated heated humidifier and patient interface. It is operated by clinicians or patients to treat respiratory insufficiency and OSA. The device monitors flow and pressure to provide therapy, with output used by clinicians to manage patient ventilation. Benefits include noninvasive respiratory support for patients over 30 lbs.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including pressure, flow, pressure support, trigger and cycling, and apnea/hypopnea detection tests, alongside validation via patient simulation models.

Technological Characteristics

Microprocessor-controlled blower system; CPAP (4-20 cmH2O) and bilevel (3-30 cmH2O) modes; integrated heated humidifier; electromagnetic compatibility per IEC 60601-1-2:2007; safety per IEC 60601-1:2005; alarm systems per IEC 60601-1-8:2006.

Indications for Use

Indicated for patients >30 lbs (13 kg) with respiratory insufficiency, including hypercapnic COPD or obstructive sleep apnea (OSA).

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

• ResMed, VPAP ST-A with H5i (K113288)

Submission Summary (Full Text)

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# K122324

# 510(k) Summary - VPAP S-A

# NOV 1 3 2012

| Date Prepared | 30th July 2012 |
|------------------|------------------------------------------------------------|
| Submitter | Greg Dockar |
| | Senior Regulatory Affairs Manager |
| Official Contact | Mr Jim Cassi - Vice President - Quality Assurance Americas |
| | ResMed Corp. |
| | 9001 Spectrum Center Boulevard, |
| | San Diego, CA 92123 |
| | Tel: [phone] |

| Classification Reference | 21 CFR §868.5895 |
|--------------------------|---------------------------------------------|
| Product Code | 73 MNS |
| Common/Usual Name | Ventilator, continuous, non-life-supporting |
| Proprietary Name | VPAP S-A |
| Predicate Device(s) | ResMed, VPAP ST-A with H5i (K113288) |

Reason for submission

New Device

.

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## Indication for Use

The VPAP S-A is indicated to provide noninvasive ventilation for patients weighing more than 30 lbs (13 kg) with respiratory insufficiency such as that associated with hypercapnic Chronic Obstructive Pulmonary Disease (COPD) or obstructive sleep apnea (OSA).

The VPAP S-A is intended for home and hospital use.

## Substantial Equivalence

The new device has the following similarities to the previously cleared predicate devices.

- Similar intended use >
- Same operating principle A
- A Same technologies
- A Same manufacturing process

Design and Verification activities were performed on the VPAP S-A System as a result of the risk analysis and design requirements. All bench tests confirmed the product met the predetermined acceptance criteria, this included Pressure, Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests against the predicate devices using the same protocols for both devices. Clinical data for the VPAP S-A is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing activities. The new device complicable requirements referenced in the FDA guidance documents:

- FDA Draft Reviewer Guidance for Ventilators (July 1995) >
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices > (May 11, 2005)

# Non-Clinical Testing:

The VPAP S-A has been tested to appropriate standards and other applicable requirements. The VPAP S-A with and without the integrated heated humidifier (H5i) was designed and tested according to:

- IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and A essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- > IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance
- > IEC 60601-1-8:2006, Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

## Device Description

VPAP S-A System (VPAP S-A with H5i) is similar to the predicate device, using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is the Same as the S9 VPAP ST-A (K113288) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure (CPAP) between 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmHzO for the treatment respiratory insufficiency caused by COPD. The system comprises the flow generator, patient interface), alarm functions and integrated humidifier.

Therapy modes contained in the VPAP S-A are CPAP and Spontaneous. Therapy modes come from the S9 VPAP ST-A (K113288) and remain unchanged.

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The functional characteristics of the VPAP S-A system includes all the clinician and user friendly features of the predicate devices.

# Conclusion

The VPAP S-A is substantially equivalent to the Predicate device (VPAP ST-A, K113288).

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

# November 13, 2012

ResMed Limited C/O Mr. Jim Cassi Vice President, Quality Assurance Americas 9001 Spectrum Center Boulevard Kearny Mesa, California 92123

Re: K122324

Trade/Device Name: VPAP S-A Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: October 2, 2012 Received: October 5, 2012

Dear Mr. Cassi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Cassi

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner 2012.11.14 11:24:52 -05'00'

Anthony D. Watson, B.S., M.S., M.B.A. Director

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

Radiological Health

Enclosure

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#### Indication for Use

510(k) Number (if known):

Device Name: VPAP S-A

#### Indication for Use

The VPAP S-A is indicated to provide noninvasive ventilation for patients weighing more than 30 lbs (13 kg) with The VPAP S-A is nulcated to provide noninvasive vonilation to paronto Chronic Obstructive Pulmonary Disease (COPD) or obstructive sleep apnea (OSA).

The VPAP S-A is intended for home and hospital use.

Sharon Evans

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

510 (k) Number:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

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