(90 days)
The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S8 Aspen self-adjusting system is intended for home and hospital use.
The S8 Aspen System (S8 Aspen with HumidAire 4i Plus) is similar to the predicate device(s), with a new and improved power supply and heater controller for the HumidAire 4i Plus. The S8 Aspen contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHz as required for the treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
This 510(k) summary (K691947) describes the S8 Aspen, a non-continuous ventilator (IPPB) intended for the treatment of obstructive sleep apnea (OSA).
1. Table of Acceptance Criteria and Reported Device Performance & Study Details
Unfortunately, the provided 510(k) summary does not contain a specific table of acceptance criteria or reported device performance metrics in the format requested. It states that "Design and Verification activities were performed on the S8 Aspen System as a result of the risk and vis and Design and VChildullion activities were performed the predetermined acceptance critieria. Resided has design requirements." This implies that internal design requirements and acceptance criteria were established and met, but these specific criteria and their corresponding results are not detailed in this public summary.
The summary focuses on demonstrating substantial equivalence to predicate devices (VPAP ST (K080131) and VPAP Auto (K082605)) rather than providing a detailed performance study with quantifiable acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. The statement "Design and Verification activities were performed on the S8 Aspen System" suggests internal testing was conducted, but details regarding the nature of this testing (e.g., clinical trials, bench testing, specific datasets) are not provided. Therefore, data provenance (country of origin, retrospective/prospective) is also not available from this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this 510(k) summary primarily focuses on substantial equivalence based on design and verification activities, and does not describe a clinical study with a "test set" in the context of expert-adjudicated ground truth (e.g., for image analysis or diagnostic accuracy), this information is not applicable and not provided.
4. Adjudication Method for the Test Set
As no specific clinical test set requiring expert adjudication for ground truth is described, this information is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The submission aims for substantial equivalence based on device design and functional characteristics, not comparative clinical outcomes with human readers. Therefore, an effect size of AI assistance for human readers is not discussed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a "self-adjusting system" for treating OSA, implying an inherent automated function. However, the summary does not explicitly detail a standalone algorithm performance study without human interaction in the context of a diagnostic or assistive AI system. The focus is on the device's overall functionality and safety, not on the isolated performance of an "algorithm" in the way it might be for a purely diagnostic AI tool.
7. The Type of Ground Truth Used
As no specific clinical test set requiring expert ground truth or diagnostic evaluation is detailed, the document does not specify the type of ground truth used. The "Design and Verification activities" would likely involve engineering specifications, functional testing against expected outputs, and potentially limited human factor evaluations, but not a "ground truth" for a diagnostic accuracy claim.
8. The Sample Size for the Training Set
The provided summary does not mention a training set sample size. This type of information is typically relevant for machine learning-based devices or algorithms that are "trained" on data. While the device is "self-adjusting," the description does not indicate a machine learning component that would require a distinct training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described in the summary, this information is not applicable and not provided.
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510(k) Summary ~ S8 Aspen
Date Prepared
25th June, 2009
Official Contact
Dr Lionel King V.P., Quality Assurance & Regulatory Affairs ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
Tel: +61 (2) 8884 2243 +61 (2) 8884 2000 Fax:
| Classification Reference | 21 CFR 868.5905 |
|---|---|
| Product Code | 73 BZD |
| Common/Usual Name | Non continuous ventilator (IPPB). |
| Proprietary Name | S8 Aspen |
| Predicate Device(s) | VPAP ST (K080131) VPAP Auto (K082605) |
Reason for submission
New Device
25th June, 2009
Page 17
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ResMed
Indication for Use
The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg).
The S8 Aspen self-adjusting system is intended for home and hospital use.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- Same intended use >
- Similar operating principle A
- Similar technologies >
- Same manufacturing process >
Design and Verification activities were performed on the S8 Aspen System as a result of the risk and vis and Design and VChildullion activities were performed the predetermined acceptance critieria. Resided has design requirements. An ests commod the probably and effectiveness of CPAP treatment for patients with delething that the new device has not not allor of the new device complies with the applicable requirements referenced in the FDA guidance documents:
- FDA Draft Reviewer Guidance for Ventilators (July 1995) >
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May * 11, 2005)
Device Description
The S8 Aspen System (S8 Aspen with HumidAire 4i Plus) is similar to the predicate device(s), with a new and The So Aspen Oyellen (OO Aspon Min HumidAire 4) Plus. The S8 Aspen contains a Micro-processor
improved power supply and heater controller for the HumidAire 4i Plus. The S8 As illiproved power supply and neater of the Pressure (CPAP) from 4-20 cmHz as required commond blover system that goneration of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.
The functional characteristics of the S8 Aspen system includes all the clinician and user friendly features of the predicate devices.
Conclusion
The S8 Aspen is substantially equivalent to the Predicate devices.
25th June, 2009
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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SEP 2 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 9001 Spectrum Center Boulevard Kearny Mesa, California 92123
Re: K091947
Trade/Dévice Name: S8 Aspen Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 25, 2009 Received: June 30, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Susan Runner, D.D.S., M.A. Acting Division 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 Aspen
Indication for Use
The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 Ib (>30 kg).
The S8 Aspen self-adjusting system is intended for home and hospital use.
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
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K091947
25th June, 2009
Page 14
§ 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).