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).

AI/ML Overview

This document is a 510(k) Premarket Notification for the S8 ADVANCE system, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a dedicated study report comparing its performance against predefined criteria in the same way a novel device might.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test/training sets, expert adjudication methods, and MRMC studies are not typically found in a 510(k) submission of this nature. This submission asserts that the new device performs similarly to existing, already cleared devices.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of "acceptance criteria" with corresponding "reported device performance" in the way one might expect for a de novo device or a clinical trial report. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. The "performance" is considered equivalent to the predicate devices.

The document states:

"Design and Verification activities were performed on the S8 ADVANCE System as a result of the risk... and confirmed the product met the predetermined acceptance criteria." (Section 1)
The device generates "Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an 'air splint' for effective treatment of OSA." (Section 0)
"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)." (Section 0)

Thus, the acceptance criteria are implicitly that the S8 ADVANCE must perform comparably to the S8 Escape II (for CPAP features) and the S8 Pioneer (for auto-titrating APAP features) within the specified pressure range and for its intended use. No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a novel function are provided, as the core functionality is claimed to be similar to legally marketed devices.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices through engineering design, verification, and comparison of technical specifications, rather than a clinical study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. As there is no specific "test set" of patient data described with a ground truth established by experts, this information is not relevant to this type of submission.

4. Adjudication method for the test set

Not applicable/Not provided. Same reasoning as above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This is a device for treating sleep apnea, not an imaging diagnostic device that would involve "human readers" or "AI assistance" in the sense of image interpretation. Therefore, an MRMC study is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided in this context. The S8 ADVANCE is a therapeutic device that delivers pressure based on internal algorithms for CPAP and APAP modes. Its performance is evaluated on its ability to deliver pressure and respond to physiological signals in a manner similar to predicate devices, not as a standalone diagnostic algorithm for human interpretation. The "algorithm only" performance refers to the device's internal control logic, which is part of the "Design and Verification activities" mentioned but not detailed in this summary.

7. The type of ground truth used

Not applicable in the context of diagnostic performance. For a therapeutic device like this, "ground truth" would relate to the accuracy of its pressure delivery, response to patient needs (e.g., auto-titration), and safety, as compared to established engineering and medical standards, and the performance of predicate devices. This is achieved through engineering verification and validation against known standards and predicate device performance, not typically against a "ground truth" derived from patient outcomes or pathology in a clinical study for a 510(k).

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device that would require a "training set" of data in the typical sense. Its functionality is based on established control systems and algorithms.

9. How the ground truth for the training set was established

Not applicable/Not provided. Same reasoning as above.

Summary of Study (Based on 510(k) Submission):

The "study" in this context refers to the design and verification activities undertaken to demonstrate substantial equivalence of the S8 ADVANCE system to the predicate devices, S8 Escape II (K080079) and S8 Pioneer (K041209).

Objective: To demonstrate that the S8 ADVANCE is substantially equivalent to the predicate devices for the treatment of Obstructive Sleep Apnea (OSA) in adult patients, suitable for home and hospital use.
Methodology: The submission states that "Design and Verification activities were performed on the S8 ADVANCE System... and confirmed the product met the predetermined acceptance criteria." These activities likely included:
- Comparison of Intended Use: Shown to be similar.
- Comparison of Operating Principle: Shown to be similar (micro-processor controlled blower system generating CPAP).
- Comparison of Technologies: Claimed to be similar.
- Comparison of Manufacturing Process: Claimed to be the same.
- Performance and Functional Characteristics Analysis: The S8 ADVANCE "includes all the clinician and user friendly features of the S8 Escape II... with the addition of the auto-titrating mode equivalent to the S8 Pioneer." This implies testing against the specifications and performance characteristics of the predicate devices.
- Compliance with Guidance Documents: The device complies with 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), and FDA Off-the-Shelf Software Use in Medical Devices (September 9, 1999).
Data Provenance: The nature of the "Design and Verification activities" suggests internal engineering and testing data without specific mention of external clinical data or patient cohorts.
Conclusion: ResMed determined, and the FDA concurred, that the S8 ADVANCE System is substantially equivalent to the S8 Escape II and S8 Pioneer. This means the device met the "acceptance criteria" of being comparable in safety and effectiveness to the predicate devices already on the market.

Summary

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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 KingV.P., Global Quality Assurance & Regulatory AffairsResMed Ltd1 Elizabeth Macarthur DriveBella Vista NSW 2153 AustraliaAustralia
	Tel: +61 (2) 8884 2243Fax: +61 (2) 8884 2000
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)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

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black and white, and the text is in a simple sans-serif font. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

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).