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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria for specific performance metrics of the S8 Prime CPAP system, nor does it include a study that quantitatively proves the device meets such criteria with numerical results or statistical analysis.

However, based on the information provided, we can infer the general acceptance criteria and the nature of the "study" (design and verification activities) conducted.

Here's a breakdown based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Intended Use Equivalence	Device is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients for home and hospital use.	The S8 Prime CPAP System meets this.
Operating Principle	Similar operating principle to predicate devices.	The S8 Prime CPAP System uses a micro-processor controlled blower system to maintain an "air splint" for OSA, similar to predicates.
Technology	Similar technologies to predicate devices.	The S8 Prime CPAP System incorporates a new and improved micro-processor controlled blower system.
Manufacturing Process	Same manufacturing process as predicate devices.	The S8 Prime CPAP System uses the same manufacturing process as predicate devices.
Risk Analysis / Safety	Meet safety and effectiveness requirements based on risk analysis.	"Design and Verification activities... resulted in the product met the acceptance criteria." "ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment."
Performance Range	Deliver therapeutic pressure range (e.g., 4-20 cmH2O).	The S8 Prime CPAP System delivers a pressure range from 4-20 cmH2O.
Functional Equivalence	Possess similar clinician and user-friendly features as predicate devices.	The S8 Prime CPAP system includes all the clinician and user friendly features of the predicate devices.
Regulatory Compliance	Complies with relevant FDA guidance documents and regulations.	Design and Verification performed with reference to FDA guidance documents (e.g., FDA Reviewer Guidance for Premarket Notifications, FDA Draft Reviewer Guidance for Ventilators, Guidance for software in medical devices).

2. Sample Size and Data Provenance for Test Set

Sample Size: The document does not specify a numerical sample size for a "test set" in the context of clinical performance. The "Design and Verification activities" mentioned likely refer to engineering and functional testing rather than a clinical trial with a statistically defined patient sample.
Data Provenance: Not applicable in the context of a clinical test set. The activities were performed by ResMed, presumably at their facilities.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This information is not provided. The phrase "ground truth" typically refers to an authoritative diagnostic determination in clinical studies. Given the nature of the submission (510(k) for substantial equivalence based on engineering and functional testing), a formal "ground truth" established by experts in a clinical setting for a test set is not discussed.

4. Adjudication Method for Test Set

Not applicable/Not mentioned. There is no indication of a clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical and functional similarity to predicate devices, not on a clinical comparison of human reader performance with or without AI assistance.

6. Standalone Algorithm Performance

Not applicable. This device is a hardware CPAP system, not an AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this specific product.

7. Type of Ground Truth Used

For the "Design and Verification activities," the "ground truth" would be engineering specifications, performance standards, and the functional characteristics of the predicate devices. There is no indication of a clinical "ground truth" derived from pathology or patient outcomes data in this submission.

8. Sample Size for the Training Set

Not applicable. This document describes a physical medical device (CPAP machine), not a machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for a machine learning algorithm.

Summary

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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: +61 (2) 9886 5000
	Fax: +61 (2) 9878 5517
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)ResMed, Sullivan III (K930656)
Reason for submission	New Device
Indications for Use	The S8 Prime CPAP System is indicated for the treatment ofObstructive Sleep Apnea (OSA) in adult patients. The S8 PrimeCPAP 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 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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,

Page 1 of

510(k) Number: K033841

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
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.(b)
Classification. Class II (performance standards).