(179 days)
The Model 300157 CPAP System is a single patient reusable device. The Model 300157 CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with Obstructive Sleep Apnea.
The CPAP System provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. When interfaced with a CPAP Mask or CPAP Patient Interface the CPAP System provides a constant pressure of 4 to 20 cmHzO above the ambient atmospheric pressure to patient's nasal airway. This constant pressure, when set to a therapeutic level as prescribed by a physician, supports retaining an open airway during sleep. The CPAP System has primary components: 1) CPAP main unit, 2) Removable headgear, 3) External power supply/optional mobile power adaptor, and 4) Patient Interface.
This document is a 510(k) summary for a CPAP system, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and a study that proves the device meets those criteria.
A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device, which often relies on performance testing to show that the new device performs as safely and effectively as the predicate. However, the provided text only states that "Laboratory and standards compliance were provided to support the CPAP System performance," without detailing what those specific tests were, what the acceptance criteria for those tests were, or the results of those tests.
Therefore, I cannot provide most of the requested information based on the input text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not define specific acceptance criteria (e.g., pressure accuracy, flow rates, noise levels) or report specific performance metrics against such criteria. It only generally states "Laboratory and standards compliance were provided to support the CPAP System performance."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No information about sample sizes for any test set or data provenance is mentioned.
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):
- Cannot be provided. This type of information is relevant for studies involving human interpretation (e.g., medical imaging AI), which is not the nature of this device or document. The CPAP system's performance would primarily be evaluated through engineering and clinical performance tests, not ground truth established by experts in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. Not applicable to this type of device submission.
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:
- Cannot be provided. Not applicable to a standalone CPAP device. MRMC studies are typically for AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- While the device itself is "standalone" in its operation, the document doesn't detail performance studies. It states "Laboratory and standards compliance were provided," implying technical performance testing rather than a specific "standalone study" report in the context of an algorithm. However, its intended function is continuous positive airway pressure delivery, which is an "algorithm only" type of function in terms of consistent pressure delivery. No performance data is given.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Cannot be provided. The concept of "ground truth" as typically used in this context (e.g., for AI model training or evaluation in diagnostics) is not directly applicable here. Performance would be assessed against established engineering standards and clinical efficacy, not an expert-derived ground truth.
8. The sample size for the training set:
- Cannot be provided. This device is a hardware system, not typically an AI/ML algorithm that requires a "training set" in the conventional sense. Its design and manufacturing would adhere to engineering principles and standards.
9. How the ground truth for the training set was established:
- Cannot be provided. See point 8.
In summary, the provided text is a regulatory summary (510(k)) for a medical device and not a detailed study report. It focuses on the device's description, intended use, technology, and claim of substantial equivalence, rather than providing the granular data from performance studies.
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K(OO12|
JUL 1 8 2010
AEIOMed
1313 5" St. SE Suite 205 Minneapolis, MN 55414 Ph: 612-455-0550 Fax: 612-455-0551
510(k) Summary
Company Name: AEIOMed, Inc. 1313 5th Street SE, Suite 205 Minneapolis, MN 55414
Contact: Bruce Bowman, CTO
Phone: (612) 455-0550
Fax: (612) 455-0551
Summary Date: May xx, 2010
Trade Name: Model 300157 CPAP System
Common Name: CPAP Device
Classification Name: 21 CFR 868.5905, Non-Continuous (Respirator) Ventilator
Predicate Devices:
510(k) Number: K042945 Manufacture: AEIOMed, Inc Trade Name: Aura
510(k) Number: K042130 Manufacture: AEIOMed, Inc Trade Name: Aura Interface
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510(k) Number: K052597 Manufacture: Hoffman Trade Name: BreatheX
1.0 Description of Device
The CPAP System provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. During obstructive sleep apnea, the airway collapses. When interfaced with a CPAP Mask or CPAP Patient Interface the CPAP System provides a constant pressure of 4 to 20 cmHzO above the ambient atmospheric pressure to patient's nasal airway. This constant pressure, when set to a therapeutic level as prescribed by a physician, supports retaining an open airway during sleep.
The CPAP System is initially used under the direct supervision of a trained medical professional. The CPAP System function and applications may be reviewed in a clinical setting when the patient is treated for obstructive sleep apnea by the application of CPAP therapy.
2.0 Intended Use
The Model 300157 CPAP System is a single patient reusable device. The Model 300157 CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with Obstructive Sleep Apnea.
3.0 Technology
The CPAP System has primary components:
-
- CPAP main unit,
-
- Removable headgear.
-
- External power supply/optional mobile power adaptor, and
-
- Patient Interface.
4.0 Conclusions
The CPAP System is substantially equivalent to the predicate devices. Laboratory and standards compliance were provided to support the CPAP System performance. No new questions of safety or effectiveness were raised.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Bruce Bowman Chief Technology Officer AEIOMed, Incorporated 1313 5th Street SE, Suite 205 Minneapolis, Minnesota 55414
JUL 1 8 2010
Re: K100121
Trade/Device Name: Model 300157 CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: June 2, 2010 Received: June 16, 2010
Dear Mr. Bowman:
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 1 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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. Bowman
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 (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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use Form
Indications for Use
510(k) Number (if known): K100121
Device Name: Model 300157 CPAP System
Indications for Use:
The Model 300157 CPAP System is a single patient reusable device. The Model 300157 CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with Obstructive Sleep Apnea.
Prescription Use X (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)
(Division Ston-Lin) vision ന. Anestnesiology General Hospital nection Control, Dental Devices
2/13/10
510(k) Number: K100121
§ 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).