(88 days)
Not Found
No
The summary describes a standard CPAP system with a microprocessor-controlled blower, similar to predicate devices. There is no mention of AI, ML, or related concepts.
Yes
The device is indicated for the treatment of obstructive sleep apnea (OSA).
No
The device is indicated for the treatment of obstructive sleep apnea (OSA) and generates continuous positive airway pressure for treatment, not for diagnosis.
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 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) by providing continuous positive airway pressure (CPAP). This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on generating airflow and maintaining pressure, which are mechanical functions for therapy. It does not mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances within the body for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely therapeutic.
N/A
Intended Use / Indications for Use
The S8 Escare II CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S8 ESCAPE II is intended for hospital and home use.
Product codes (comma separated list FDA assigned to the subject device)
73 BZD
Device Description
The S8 EscAPE II CPAP System is similar to the predicate devices, (S8 Prime, S8 Pioneer and S7 Elite CPAP System with H2i) with a new and improved 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 EscAPE II CPAP system includes all the clinician and user friendly features of the predicate devices.
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
Not Found
Intended User / Care Setting
hospital and home 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 EscAPE II 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 for patients with Obstructive Sleep Apnoea (OSA) who weighing more than 66 lb (>30 kg).
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.
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
510(k) Summary - S8 EscAPE II CPAP System
| Date Prepared | 4th January, 2008 | APR - 8 2008 |
|---|---|---|
| Official Contact | Dr Lionel King | |
| V.P., 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 ESCAPE II CPAP System | |
| Predicate Device(s) | S8 Prime (K033841) | |
| S8 Pioneer (K041209) | ||
| S7 Elite (K010909) | ||
| Reason for submission | New Device |
Indication for Use
The S8 Escare II CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S8 ESCAPE II is intended for hospital and home use.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
-
Similar intended use
- A Similar operating principle
- 入 Similar technologies
- 大 Same manufacturing process
Design and Verification activities were performed on the S8 EscAPE II 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 for patients with Obstructive Sleep Apnoea (OSA) who weighing more than 66 lb (>30 kg). The new device complies with the applicable requirements referenced in the FDA guidance documents:
- 大 FDA Draft Reviewer Guidance for Ventilators (July 1995)
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May A 11, 2005)
- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)
1
Device Description
The S8 EscAPE II CPAP System is similar to the predicate devices, (S8 Prime, S8 Pioneer and S7 Elite CPAP System with H2i) with a new and improved 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 EscAPE II CPAP system includes all the clinician and user friendly features of the predicate devices.
Conclusion
The S8 EscAPE II CPAP System is substantially equivalent to the Predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2008
ResMed Limited C/O Mr. David D' Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K080079
Trade/Device Name: S8 Escape II Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 4, 2008 Received: January 11, 2008
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 (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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Snytte Y. Mohan Curs
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 Escape II
Indication for Use
The S8 EscAPE II CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S8 EscAPE II is intended for hospital and home use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × AND/OR Over-The-Counter Use_ (Part 21 CFR 807 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
Mhththth
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K0800