VPAP ST-A

K113288 · Resmed, Ltd. · MNS · Mar 29, 2012 · Anesthesiology

Device Facts

• Record ID: K113288
• Device Name: VPAP ST-A
• Applicant: Resmed, Ltd.
• Product Code: MNS · Anesthesiology
• Decision Date: Mar 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The VPAP ST-A is indicated to provide non-invasive ventilation for patients weighing more than 30 lbs (13kg) or more than 66 lbs (30kg) in iVAPS mode with respiratory insufficiency or obstructive sleep apnea (OSA). The VPAP ST-A is intended for use in the hospital or home.

Device Story

VPAP ST-A is a non-invasive, blower-based positive pressure ventilation system; includes integrated heated humidifier and heater controller. Device generates CPAP (4-20 cmH2O) for OSA treatment and bilevel pressures (3-30 cmH2O) for respiratory insufficiency. System comprises flow generator, patient tubing, mask, and alarm functions. Used in hospital or home settings by patients under clinician guidance. Micro-processor controlled blower maintains airway pressure. Therapy modes include CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC, and iVAPS. Clinicians use device output to manage respiratory support; benefits include effective treatment of OSA and respiratory insufficiency via non-invasive ventilation.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and reliance on clinical data/validated patient simulation models from predicate devices. Bench testing included pressure, flow, pressure support, trigger, cycling, hypopnea, and apnea protocols.

Technological Characteristics

Blower-based positive pressure system; integrated heated humidifier. CPAP range 4-20 cmH2O; Bilevel range 3-30 cmH2O. Micro-processor controlled. Standards: IEC 60601-1:2005 (safety), IEC 60601-1-2:2007 (EMC), IEC 60601-1-8:2006 (alarms).

Indications for Use

Indicated for patients >30 lbs (13kg) or >66 lbs (30kg) for iVAPS mode, diagnosed with respiratory insufficiency 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 with H5i (K102513)
• ResMed, Stellar 150 (K103167)
• ResMed, VPAP III ST-A (K033276)

Submission Summary (Full Text)

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# ResMed

#### KI13288 510(k) Summary - VPAP ST-A

MAR 2 9 2012

Date Prepared 31st Oct, 2011 Submitter Greg Dockar Senior Regulatory Affairs Manager Mr David D'Cruz – V.P., US Medical & Regulatory Affairs Official Contact ResMed Corp. 9001 Spectrum Center Boulevard,

San Diego, CA 92123

Tel: [phone]

21 CFR §868.5895 Classification Reference 73 MNS Product Code Common/Usual Name Ventilator, continuous, non-life-supporting Proprietary Name VPAP ST-A Predicate Device(s) ResMed, VPAP ST with H5i (K102513) ResMed, Stellar 150 (K103167) ResMed, VPAP III ST-A (K033276) Reason for submission New Device

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#### Indication for Use

The VPAP ST-A is indicated to provide non-invasive ventilation for patients weighing more than 30 lbs (13kg) or more than 66 lbs (30kg) in iVAPS mode with respiratory insufficiency or obstructive sleep apnea (OSA). The VPAP ST-A is intended for use in the hospital or home.

### Substantial Equivalence

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

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

Design and Verification activities were performed on the VPAP ST-A System as a result of the risk 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 common protocols for both devices. Clinical data for the VPAP ST-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 phases. The new device complicable requirements referenced in the FDA guidance documents:

- A 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 ST-A has been tested to apropriate FDA consensus standards and other applicable requirements passing all test protocols. The VPAP ST-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 quidance for alarm systems in medical electrical equipment and medical electrical systems

#### Device Description

VPAP ST-A System (VPAP ST-A with H5) is similar to the predicate device(s), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is similar to the S9 VPAP ST (K102513) 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. The system comprises the flow generator, patient tubing, mask (patient interface), alarm functions and integrated humidifier.

Therapy modes contained in the VPAP ST-A are CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. Therapy modes come from the S9 VPAP ST (K102513) and Stellar 150 (K103167).

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

### Conclusion

The VPAP ST-A is substantially equivalent to the Predicate devices.

31st Oct, 2011

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ResMed Limited C/O Mr. David D' Cruz Vice President Clinical & Regulatory Affairs ResMed Corporation 9001 Spectrum Center Boulevard Kearny Mesa, California 92123

MAR 2 9 2012

Re: K113288

Trade/Device Name: VPAP ST-A Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: II Product Code: MNS Dated: March 24, 2012 Received: March 28, 2012

Dear Mr. 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. 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. 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); 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.goy/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,

Anthony v. Anton

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indication for Use

510(k) Number (if known):

Device Name: VPAP ST-A

Indication for Use

The VPAP ST-A is indicated to provide non-invasive ventilation for patients weighing more than 30 lbs (13kg) or more than 66 lbs (30kg) in iVAPS mode with respiratory insufficiency or obstructive sleep apnea (OSA). The VPAP ST-A is intended for use in the hospital or home.

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________

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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| 510(k) Number: | K113288 |
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