S9 VPAP TX

K123511 · Resmed, Ltd. · MNS · Mar 21, 2013 · Anesthesiology

Device Facts

• Record ID: K123511
• Device Name: S9 VPAP TX
• Applicant: Resmed, Ltd.
• Product Code: MNS · Anesthesiology
• Decision Date: Mar 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment.

Device Story

S9 VPAP Tx is a non-life-supporting continuous ventilator for clinical use. System includes flow generator, patient tubing, mask, and optional H5i humidifier. Device uses microprocessor-controlled blower to generate airway pressures, creating an 'air splint' to treat OSA and respiratory insufficiency. Supports CPAP, Auto-titrating, Bilevel, VAuto, and ASV modes. Clinicians operate device to titrate and treat patients. Output consists of regulated airway pressure delivered to patient. Benefits include effective management of sleep-disordered breathing and respiratory insufficiency. Device design and functional features are consistent with predicate ResMed VPAP and S8 series devices.

Clinical Evidence

No clinical data was required for this submission. Substantial equivalence was supported by bench testing, design verification, and validation activities. The device was tested against FDA consensus standards including IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-1-8 (alarms). Biocompatibility was assessed per ISO 10993 for external communicating devices with tissue/bone/dentin contact (duration C). Predicate devices have previously established clinical performance.

Technological Characteristics

Microprocessor-controlled blower system; CPAP, Auto-titrating, Bilevel, VAuto, and ASV modes. Materials tested per ISO 10993 (external communicating, contact duration C). Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-8. System includes flow generator, tubing, mask, and optional H5i humidifier.

Indications for Use

Indicated for patients with OSA, respiratory insufficiency, central/mixed apneas, or periodic breathing. CPAP, S, ST, T, and PAC modes for patients >30lb (13kg); other modes for patients >66lb (30kg). Intended for clinical environment use.

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 (K113288)
• ResMed, VPAP ST (K102513)
• ResMed, S9 VPAP Adapt (K113801)
• ResMed, S8 Aspen (K091947)

Submission Summary (Full Text)

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ResMed

KIZ3SI | S9 VPAP Tx Traditional 510(k) Submission | Nov 2012

## 510(k) Summary - S9 VPAP Tx

# MAR 2 1 2013

| Date Prepared | 16 March 2013 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Nicole Gaddi<br>Regulatory Affairs Manager<br>ResMed Ltd, Australia |
| Official Contact | Mr. Jim Cassi<br>V.P., Quality Assurance Americas<br>ResMed Corp<br>9001 Spectrum Center Boulevard<br>San Diego, CA 92123<br>USA<br>Tel: [phone]<br>Fax: [phone] |
| Classification Reference | 21 CFR 868.5895 |
| Product Code | 73 MNS |
| Common/Usual Name | Ventilator, continuous, non-life-supporting |
| Proprietary Name | S9 VPAP Tx |
| Predicate Device(s) | ResMed, VPAP ST-A (K113288) - Primary<br>ResMed, VPAP ST (K102513) - Secondary<br>ResMed, S9 VPAP Adapt (K113801) - Secondary<br>ResMed, S8 Aspen (K091947) - Secondary |
| Reason for submission | New Device |

Page 21

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## Indication for Use

The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg).

The S9 VPAP Tx is intended to be used in a clinical environment.

### Substantial Equivalence

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

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

Design and Verification activities were performed on the S9 VPAP Tx as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria. Clinical data for the S9 VPAP Tx 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 complies with the applicable requirements referenced in the FDA guidance documents:

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

#### Non-Clinical Testing:

The S9 VPAP Tx has been tested to appropriate FDA consensus standards and other applicable requirements passing all test protocols. The S9 VPAP Tx without the optional heated humidifier (H5) was designed and tested according to:

- > IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and 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

Materials have been tested in accordance with FDA Guidance documents (G95-1), and ISO 10993 series as defined for "external communicating device", Tissue/Bone/Dentin, contact duration "C"."

## Device Description

The S9 VPAP Tx is similar to the predicate devices VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947).

The S9 VPAP Tx provides CPAP, Auto-titrating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing. This is achieved through the use of a micro-processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency.

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The S9 VPAP Tx system comprises the flow generator, patient tubing, mask (patient interface) and optional H5i humidifier.

The performance and functional characteristics of the S9 VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947).

## Conclusion

The S9 VPAP Tx is substantially equivalent to the previously cleared predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and support.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002

## March 21, 2013

Mr. Jim Cassi Vice President, Quality Assurance Americas ResMed Corporation 9001 Spectrum Center Boulevard SAN DIEGO CA 92123

Re: K123511

Trade/Device Name: S9 VPAP Tx Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: February 15, 2013 Received: February 19, 2013

## 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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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 devicerelated 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,

Image /page/4/Picture/7 description: The image contains the words "Kwame Ulmer" in bold, black font on the left side of the image. To the right of the names is a logo that contains the letters "EDA". The letters in the logo are outlined in black.

for

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

માટડ કા 510(k) Number (if known):

Device Name: S9 VPAP Tx

Indication for Use

The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg).

The S9 VPAP Tx is intended to be used in a clinical environment.

| Prescription Use | X | 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) | Albert E. Moyal | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------|--------|
| | S | for LS |
| Page 1 of 1 | (Division Sign-Off) | |
| | Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | |
| 510(k) Number: | K123511 | |