(91 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on a microprocessor-controlled blower system and data transfer capabilities, not AI/ML algorithms.
Yes
The device is indicated for the treatment of Obstructive Sleep Apnea, which classifies it as a therapeutic device.
No
The device is indicated for the treatment of Obstructive Sleep Apnea, not for diagnosing it. It functions by providing an "air splint" to maintain an open airway.
No
The device description explicitly mentions hardware components such as a "micro-processor controlled blower system," "Flow Generator," "patient tubing," and "Smart Card (SC) Module or DB9 Adapter." This indicates it is a hardware device with integrated software, not a software-only medical device.
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. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of providing continuous positive airway pressure (CPAP) to maintain an "air splint." It does not describe any components or processes for examining specimens from the human body to provide diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic results based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to diagnose diseases or conditions. This device is a therapeutic device used to treat a diagnosed condition.
N/A
Intended Use / 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.
Product codes
BZD
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.
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
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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
| 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 of |
| Obstructive Sleep Apnea (OSA) in adult patients. The S8 Prime | |
| CPAP System is intended for home and hospital use. |
1
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
2
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
3
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
4
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