S8 ADVANCE

K082979 · Resmed, Ltd. · BZD · Jan 2, 2009 · Anesthesiology

Device Facts

• Record ID: K082979
• Device Name: S8 ADVANCE
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The S8 ADVANCE self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 ADVANCE system has two treatment modes: auto-titrating APAP and fixed-pressure CPAP. The S8 ADVANCE system is intended for home and hospital use.

Device Story

S8 ADVANCE is a microprocessor-controlled flow generator system for OSA treatment. It delivers Continuous Positive Airway Pressure (CPAP) between 4-20 cmH2O to maintain an airway splint. System components include flow generator, patient tubing, mask, and humidifier. Operates in two modes: auto-titrating APAP and fixed-pressure CPAP. Used in home and hospital settings; operated by patients or clinicians. Device monitors airflow/pressure to adjust therapy automatically in APAP mode. Output is pressurized air delivered to the patient via mask. Benefits include effective OSA treatment through pressure regulation.

Clinical Evidence

Bench testing only. Design and verification activities confirmed the product met predetermined acceptance criteria.

Technological Characteristics

Microprocessor-controlled blower system; CPAP pressure range 4-20 cmH2O. Includes flow generator, patient tubing, mask, and humidifier. Software-controlled operation. Complies with FDA guidance for ventilators and software in medical devices.

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea (OSA) in adult patients. 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

• S8 Escape II (K080079)
• S8 Pioneer (K041209)

Submission Summary (Full Text)

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· S8 ADVANCE Traditional 510(k) Premarket Notification

# 510(k) Summary - S8 ADVANCE System

| Date Prepared | 3 ^rd October, 2008 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Dr Lionel King<br>V.P., Global Quality Assurance & Regulatory Affairs<br>ResMed Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista NSW 2153 Australia<br>Australia |
| | Tel:   [phone]<br>Fax:   [phone] |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | 73.BZD |
| Common/Usual Name | Non continuous ventilator (IPPB): |
| Proprietary Name | S8 ADVANCE |
| Predicate Device(s) | S8 Escape II (K080079)<br>S8 Pioneer (K041209) |
| Reason for submission | New Device |

JAN - 2 2009## Indication for Use

The S8 ADVANCE self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients.

The S8 ADVANCE system has two treatment modes: auto-titrating APAP and fixed-pressure CPAP. The S8 ADVANCE system is intended for home and hospital use.

## Device Description

The S8 ADVANCE System is similar to the predicate devices, (S8 Escape II and S8 Pioneer) with a micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.

The performance and functional characteristics of the S8 ADVANCE system includes all the clinician and user friendly features of the S8 Escape II (K080079) with the addition of the auto-titrating mode equivalent to the S8 Pioneer (K041209).

#### Substantial Equivalence

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

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

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Design and Verification activities were performed on the S8 ADVANCE System as a result of the risk and Dough and Vennoution don't of nessonfirmed the product met the predetermined acceptance criteria. ·ResMed has · determined that the new device is Substantially Equivalent to the predicate devices. The new device complies with the applicable requirements referenced in the FDA guidance documents:

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

A STATISTIC CARADIA CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION

- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999) ಿಗ್ರಹ
#### Conclusion

The S8 ADVANCE System is substantially equivalent to the S8 Escape II (K080079) and the S8 Pioneer (K041209).

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN ~ 2 2009

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

Re: K082979

> Trade/Device Name: S8 Advance Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: October 3, 2008 Received: October 6, 2008

# Dear David D'Cruz:

ﻧﮯ

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. David 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,

Suste Y. Mckain Ows.

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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## Indication for Use

## 510(k) Number (if known):

Device Name: S8 ADVANCE

## Indication for Use

The S8 ADVANCE self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients.

The S8 ADVANCE system has two treatment modes; auto-titrating APAP and fixed-pressure CPAP. The S8 ADVANCE system is intended for home and hospital use.

Over-The-Counter Use_ AND/OR × Prescription Use _ (Part 21 CFR B07 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)

Page 1 of_ 1

Eugite Y. Mchail Dus

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

510(k) Number: ***_***

3d October, 2008