S8 ASPEN WITH H4I PLUS

K091947 · Resmed, Ltd. · BZD · Sep 28, 2009 · Anesthesiology

Device Facts

• Record ID: K091947
• Device Name: S8 ASPEN WITH H4I PLUS
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Sep 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S8 Aspen self-adjusting system is intended for home and hospital use.

Device Story

S8 Aspen is a self-adjusting CPAP system for obstructive sleep apnea treatment; used in home and hospital settings. System components include flow generator, patient tubing, mask, and HumidAire 4i Plus humidifier. Device generates continuous positive airway pressure (4-20 cmH2O) via internal blower system controlled by a microprocessor. Microprocessor manages power supply and heater controller for humidifier. Clinicians/patients use device to deliver prescribed pressure therapy; output helps maintain airway patency during sleep. Device is substantially equivalent to predicate systems with improved power and heater control electronics.

Clinical Evidence

Bench testing only. Design and verification activities were performed to confirm the device meets predetermined acceptance criteria and design requirements, demonstrating safety and effectiveness equivalent to predicate devices.

Technological Characteristics

CPAP system; pressure range 4-20 cmH2O. Includes flow generator, tubing, mask, and humidifier. Features microprocessor-controlled power supply and heater controller. Operates as a non-continuous ventilator (IPPB).

Indications for Use

Indicated for treatment of obstructive sleep apnea (OSA) in patients weighing >30 kg (66 lb). Intended for home and hospital use.

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

• VPAP ST (K080131)
• VPAP Auto (K082605)

Submission Summary (Full Text)

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K691947

# 510(k) Summary ~ S8 Aspen

Date Prepared

25th June, 2009

Official Contact

Dr Lionel King V.P., Quality Assurance & Regulatory Affairs ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

Tel: [phone] [phone] Fax:

| Classification Reference | 21 CFR 868.5905 |
|--------------------------|----------------------------------------|
| Product Code | 73 BZD |
| Common/Usual Name | Non continuous ventilator (IPPB). |
| Proprietary Name | S8 Aspen |
| Predicate Device(s) | VPAP ST (K080131) VPAP Auto (K082605) |

Reason for submission

New Device

25th June, 2009

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### ResMed

### Indication for Use

The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg).

The S8 Aspen self-adjusting system is intended for home and hospital use.

#### Substantial Equivalence

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

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

Design and Verification activities were performed on the S8 Aspen System as a result of the risk and vis and Design and VChildullion activities were performed the predetermined acceptance critieria. Resided has design requirements. An ests commod the probably and effectiveness of CPAP treatment for patients with delething that the new device has not not allor of the new device complies with the applicable 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)

### Device Description

The S8 Aspen System (S8 Aspen with HumidAire 4i Plus) is similar to the predicate device(s), with a new and The So Aspen Oyellen (OO Aspon Min HumidAire 4) Plus. The S8 Aspen contains a Micro-processor
improved power supply and heater controller for the HumidAire 4i Plus. The S8 As illiproved power supply and neater of the Pressure (CPAP) from 4-20 cmHz as required commond blover system that goneration of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.

The functional characteristics of the S8 Aspen system includes all the clinician and user friendly features of the predicate devices.

### Conclusion

The S8 Aspen is substantially equivalent to the Predicate devices.

25th June, 2009

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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## SEP 2 8 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 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

Re: K091947

Trade/Dévice Name: S8 Aspen Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 25, 2009 Received: June 30, 2009

### Dear Mr. 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.

for

Susan Runner, D.D.S., M.A. Acting Division 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: S8 Aspen

Indication for Use

The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 Ib (>30 kg).

The S8 Aspen self-adjusting system is intended for home and hospital use.

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)

Page 1 of 1

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

510(k) Number: K091947

25th June, 2009

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