(88 days)
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.
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.
The provided text is a 510(k) summary for the ResMed S8 Escape II CPAP System. It states that "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." However, it does not explicitly detail the specific acceptance criteria or the study that proves the device meets those criteria.
The document focuses on demonstrating substantial equivalence to predicate devices (S8 Prime, S8 Pioneer, and S7 Elite) based on similarities in intended use, operating principles, technologies, and manufacturing processes. It confirms that the new device has not altered the safety and effectiveness of CPAP treatment.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's an analysis of what can be derived:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | All tests confirmed the product met the acceptance criteria (specific criteria and performance not detailed). The device generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions "Design and Verification activities" and "All tests," but does not provide details of specific studies, test set sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis by radiologists). For a device like a CPAP machine, "ground truth" during verification would likely refer to objective measurements against engineering specifications or established standards, rather than expert consensus on a test set in the way it applies to diagnostic algorithms. The document does not mention any expert involvement in establishing ground truth for testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in clinical studies or studies where subjective assessments by multiple readers need to be reconciled. This document does not describe such a study for the device's verification.
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
- No. This is not an AI-assisted diagnostic device, but a therapeutic device (CPAP system). Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical CPAP system, not an algorithm. Performance tests would relate to the physical function of the device, such as pressure delivery, flow rate, and safety features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified, but inferred to be engineering specifications and standards. For a CPAP device, "ground truth" for verification typically refers to established engineering specifications, performance standards (e.g., for pressure accuracy, flow stability, noise levels), and safety requirements. The document does not explicitly state the type of ground truth, but implies adherence to product requirements and applicable FDA guidance documents related to ventilators.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device (CPAP machine), not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not an AI/ML device requiring a training set.
In summary:
The 510(k) summary for the S8 Escape II CPAP System declares that "All tests confirmed the product met the acceptance criteria" as part of Design and Verification activities. However, it does not provide the specifics of those acceptance criteria, the methodology of the tests, sample sizes, or details typically found in a clinical study report. The document's primary purpose is to establish substantial equivalence to previously cleared predicate devices, thereby leveraging their established safety and effectiveness.
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510(k) Summary - S8 EscAPE II CPAP System
| Date Prepared | 4th January, 2008 | APR - 8 2008 |
|---|---|---|
| Official Contact | Dr Lionel KingV.P., Quality Assurance & Regulatory AffairsResMed Ltd1 Elizabeth Macarthur DriveBella Vista NSW 2153 AustraliaAustraliaTel: +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 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)
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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.
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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.
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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
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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)
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Mhththth
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K0800
§ 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).