(88 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a micro-processor controlled blower system with auto-titrating and fixed-pressure modes, which are standard features for CPAP/APAP devices and do not inherently indicate AI/ML.
Yes
The device is indicated for the "treatment of Obstructive Sleep Apnea (OSA) in adult patients," which is a therapeutic purpose.
No.
The device's stated "Intended Use / Indications for Use" is for the "treatment of Obstructive Sleep Apnea (OSA)," and the "Device Description" explains it operates by generating "Continuous Positive Airway Pressure (CPAP) ... to maintain an 'air splint' for effective treatment of OSA." There is no mention of it being used to diagnose conditions.
No
The device description explicitly states the system comprises a flow generator, patient tubing, mask, and humidifier, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. IVDs are used for the diagnosis or monitoring of diseases or conditions by examining specimens from the human body (like blood, urine, tissue).
- Device Description: The device description focuses on generating positive airway pressure to treat OSA. It does not mention analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing specimens, using reagents, or providing diagnostic information based on biological samples.
This device is a therapeutic device used to manage a medical condition, not a diagnostic device used to identify or monitor a condition through in vitro testing.
N/A
Intended Use / Indications 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.
Product codes
73.BZD, BZD
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
The S8 ADVANCE system is intended for home and hospital use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
S8 Escape II (K080079), S8 Pioneer (K041209)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
· S8 ADVANCE Traditional 510(k) Premarket Notification
510(k) Summary - S8 ADVANCE System
| Date Prepared | 3 rd October, 2008 |
|---|---|
| Official Contact | Dr Lionel King |
| V.P., Global Quality Assurance & Regulatory Affairs | |
| ResMed Ltd | |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista NSW 2153 Australia | |
| Australia | |
| Tel: +61 (2) 8884 2243 | |
| Fax: +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
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
1
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).
2
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.
3
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
4
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