(52 days)
Not Found
No
The description mentions a "micro-processor controlled blower system" and "self-adjusting" modes, but these are standard features for CPAP devices and do not explicitly indicate the use of AI or ML. There is no mention of AI, DNN, or ML in the provided text.
Yes
The device is indicated for the "treatment of Obstructive Sleep Apnea (OSA) in adult patients," which is a therapeutic purpose.
No
Explanation: The device is described as a "self-adjusting sleep apnea system" indicated for "treatment of Obstructive Sleep Apnea (OSA)". It generates "Continuous Positive Airway Pressure (CPAP)" to maintain an "air splint" for effective treatment. There is no mention of it being used to diagnose conditions, only to treat them.
No
The device description explicitly lists hardware components such as a flow generator, patient tubing, mask, and Smart Card Module or DB9 Adapter, indicating it is a physical system, not software-only.
Based on the provided text, 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 device generates Continuous Positive Airway Pressure (CPAP) to treat OSA. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions related to in vitro testing, such as reagents, analyzers, or the analysis of biological specimens.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to provide a physical therapy (air pressure) to treat a diagnosed condition.
N/A
Intended Use / Indications for Use
The S8 Pioneer self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Pioneer self-adjusting sleep apnea system has two treatment modes (AutoSet and fixed-pressure CPAP).
The S8 Pioneer system is intended for home and hospital use.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The S8 Pioneer CPAP System is similar to the predicate devices, (AutoSet Spirit, S8 Prime and VPAP III) it is smaller, with a new and improved micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of OSA. Treatment modes are self-adjusting, CPAP and CPAP with Expiratory Pressure Relief (EPR). CPAP with EPR provides a comfort to patients who experience difficulty in breathing out aqainst CPAP during the expiratory phase.
The system comprises the Flow Generator, patient tubing, mask (patient interface) and Smart Card (SC) Module or DB9 Adapter for receiving and sending data.
The performance and functional characteristics of the S8 Pioneer CPAP system includes all the clinician and user friendly features of the predicate devices, Autoset Spirit, S8 Prime and VPAP III.
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 Pioneer CPAP System as a result of the risk analysis and product requirements. All tests confirmed the product met the acceptance criteria. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment of OSA in adults. The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:
- FDA Reviewer Guidance for Premarket Notifications, November 1993
- FDA Draft Reviewer Guidance for Ventilators (July 1995) .
- FDA reviewer's and industry, Guidance for the content of premarket submissions for software . V contained in medical devices, May 1998
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AutoSet Spirit (K013843), S8 Prime (K033841), VPAP III (K030843)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 041209
510(k) Summary - S8 Pioneer CPAP System
| Date Prepared | Tuesday, May 4th, 2004 |
|---|---|
| Official Contact | Dr Lionel King |
| V.P., Quality Assurance & 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™ Pioneer CPAP System |
| Predicate Device(s) | AutoSet Spirit (K013843) |
| S8 Prime (K033841) | |
| VPAP III (K030843) | |
| Reason for submission | New Device |
| Indications for Use | The S8 Pioneer self-adjusting sleep apnea system is indicated for |
| the treatment of Obstructive Sleep Apnea (OSA) in adult patients. | |
| The S8 Pioneer self-adjusting sleep apnea system has two | |
| treatment modes (AutoSet and fixed-pressure CPAP). | |
| The S8 Pioneer 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 intended use ﺮ ﻣﻌ
- r Similar operating principle
- Similar technologies ﺮ ﻣﺤ
- -Same manufacturing process
Design and Verification activities were performed on the S8 Pioneer CPAP System as a result of the risk analysis and product requirements. All tests confirmed the product met the acceptance criteria. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment of OSA in adults. The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:
- FDA Reviewer Guidance for Premarket Notifications, November 1993 ﺮ
- FDA Draft Reviewer Guidance for Ventilators (July 1995) . ﺗ
- FDA reviewer's and industry, Guidance for the content of premarket submissions for software . V contained in medical devices, May 1998
Intended Use
The S8 Pioneer self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Pioneer self-adjusting sleep apnea system has two treatment modes (AutoSet and fixed-pressure CPAP).
The S8 Pioneer system is intended for home and hospital use.
Device Description
The S8 Pioneer CPAP System is similar to the predicate devices, (AutoSet Spirit, S8 Prime and VPAP III) it is smaller, with a new and improved micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of OSA. Treatment modes are self-adjusting, CPAP and CPAP with Expiratory Pressure Relief (EPR). CPAP with EPR provides a comfort to patients who experience difficulty in breathing out aqainst CPAP during the expiratory phase.
The system comprises the Flow Generator, patient tubing, mask (patient interface) and Smart Card (SC) Module or DB9 Adapter for receiving and sending data.
The performance and functional characteristics of the S8 Pioneer CPAP system includes all the clinician and user friendly features of the predicate devices, Autoset Spirit, S8 Prime and VPAP III.
Llfk
Dr Lionel King V.P., Quality Assurance & Regulatory Affairs ResMed.
Tuesday, May 04, 2004
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 1 2004
ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K041209
Trade/Device Name: ResMed S8 Pioneer CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 4, 2004 Received: May 10, 2004
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.
3
Page 2 – Mr. 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 (OS) 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,
Qiu Ls
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 Pioneer
Indications for Use:
The S8 Pioneer self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Pioneer self-adjusting sleep apnea system has two treatment modes (AutoSet and fixed-pressure CPAP).
The S8 Pioneer system is intended for home and hospital use.
Ciny Suliom
(Division Sign Division of Anesthesiology. General Hospital, Infection Control, Dental Device 510(k) Number:
Prescription Use X AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(Part 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)
Page 1 of _ 1
Tuesday, May 04, 2004