RESMED S8 PRIME CPAP SYSTEM

K033841 · Resmed, Ltd. · BZD · Mar 10, 2004 · Anesthesiology

Device Facts

• Record ID: K033841
• Device Name: RESMED S8 PRIME CPAP SYSTEM
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The S8 Prime CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Prime CPAP System is intended for home and hospital use.

Device Story

S8 Prime CPAP System provides positive airway pressure therapy for Obstructive Sleep Apnea (OSA). Device inputs include ambient air; system delivers pressurized air (4-20 cmH2O) via patient tubing to maintain airway patency (air splint). System comprises flow generator, patient tubing, and data interface (Smart Card Module or DB9 Adapter). Operated in home or hospital settings; intended for adult patients. Micro-processor controlled blower system adjusts pressure delivery. Clinicians use data modules to retrieve therapy information. Device benefits patients by providing effective OSA treatment through automated pressure regulation.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified against product requirements and FDA guidance documents for ventilators and software in medical devices.

Technological Characteristics

Micro-processor controlled blower system; pressure range 4-20 cmH2O. Includes Smart Card (SC) Module or DB9 Adapter for data connectivity. Form factor is smaller and lighter than predicates. Software-controlled pressure delivery.

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

• ResMed, S7 Elite CPAP System with ResLink (K024191)
• ResMed, Sullivan III (K930656)

Submission Summary (Full Text)

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| 510(k) Summary - S8 Prime CPAP System | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | Dec 5th, 2003 |
| Official Contact | Dr Lionel King |
| | V.P., Regulatory Affairs |
| | ResMed Ltd |
| | 97 Waterloo Road |
| | North Ryde, NSW 2113 |
| | Australia |
| | Tel: [phone] |
| | Fax: [phone] |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Non-Continuous Ventilator |
| Common/Usual Name | CPAP System |
| Proprietary Name | S8™ Prime CPAP System |
| Predicate Device(s) | ResMed, S7™ Elite CPAP System with ResLink (K024191)<br>ResMed, Sullivan III (K930656) |
| Reason for submission | New Device |
| Indications for Use | The S8 Prime CPAP System is indicated for the treatment of<br>Obstructive Sleep Apnea (OSA) in adult patients. The S8 Prime<br>CPAP System is intended for home and hospital use. |

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## Substantial Equivalence

The new device has the following similarities to the previously cleared predicate device(s).

- Same intencled use ﺎﺯ
- Similar operating principle ﺘﺮ
- Similar technologies ﺘﺮ
- Same manufacturing process ﺗﺰ

Design and Verification activities were performed on the S8 PRIME CPAP System as a result of the risk Design and vehication activities wore performed the product met the acceptance criterial. ResMed allalysis and product requirements. In took altered the safety and effectiveness of CPAP treatment of has determined that the new device has not and on the standards and requirements referenced in the FDA guidance documents:

- FDA Reviewer Guidance for Premarket Notifications, November 1993 ﻨﺰ
- FDA Draft Reviewer Guidance for Ventilators (July 1995) ﺧﺮ
- FDA reviewer's and industry, Guidance for the content of premarket submissions for ﻨﺰ software contained in medical devices, May 1998

#### Intended Use

The S8 Prime CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Prime CPAP System is intended for home and hospital use.

### Device Description

The S8 Prime CPAP System is similar to the predicate devices, (Sullivan III and S7 Elite CPAP System) it is smaller and lighter, with a new and improved micro-processor controlled blower system that it is smaller and lighter, with a new and improved micro prom 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the Flow Generator, patient tubing, ail spline for enodires trouth Smart Card (SC) Module or DB9 Adapter for receiving and sending data.

The performance and functional characteristics of the S8 PRIME CPAP system includes all the clinician and user friendly features of the predicate devices, Sullivan III and S7 Elite CPAP System.

Leonil J.R.

Dr Lionel King V.P., Regulatory Affairs ResMed.

Friday, December 05, 2003

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). 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 of three overlapping lines, resembling an abstract representation of the human form or a bird in flight.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2004

ResMed Ltd. C/O Mr. David D'Cruz VP Regulatory & Clinical Affairs US ResMed Corp. 14040 Danielson Street Poway, CA 92064-6857

Re: K033841

Trade/Device Name: ResMed S8 Prime CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Ventilator, Non-Continuous (Respirator) Regulatory Class: Class II Product Code: BZD Dated: December 5, 2003 Received: December 10, 2003

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 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.

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

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Page 2 – Mr. David D'Cruz

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

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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# Indications for Use

510(k) Number (if known): K033841

Device Name: S8 Prime CPAP System

Indications For Use: The S8 Prime CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Prime CPAP System is intended for home and hospital use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Jahuh

sthesiology, General Hospital,

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510(k) Number: K033841