(28 days)
The Respironics SleepEasy CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.
The Respironics SleepEasy CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The SleepEasy CPAP System also includes the flex therapy feature cleared in K021861 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its device predicates, the SleepEasy CPAP System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.
The Respironics SleepEasy CPAP System (K091112) is a modified device, and its acceptance criteria and the study proving it meets these criteria are described as follows:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document states: "Design verification tests were performed on the Respironics SleepEasy CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
However, the specific acceptance criteria (e.g., precise pressure ranges, flow rates, noise levels, reliability metrics) and the detailed results of these tests are not provided within the given text. The document only states that the tests were performed and met the criteria.
Without the specific details, a table cannot be fully constructed. Based on the provided information, the table would appear as follows:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Specific criteria not detailed in the provided document | Stated to have met all required acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). The verification tests are described as "design verification tests," which typically involve testing a representative sample of the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document. The verification tests described are likely engineering design tests rather than clinical studies requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the given document. Given that the tests are described as "design verification tests," adjudication in the context of clinical or diagnostic performance assessment is unlikely to be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided in the document. The Respironics SleepEasy CPAP System is a positive airway pressure delivery device for Obstructive Sleep Apnea, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not provided in the document. As this is not an AI-based or algorithm-driven diagnostic device in the sense of image interpretation or complex data analysis, the concept of a "standalone" algorithm performance study is not relevant. The device operates mechanistically to deliver positive airway pressure.
7. The Type of Ground Truth Used
The document does not explicitly state the "type of ground truth" used. For "design verification tests" of a mechanical device like a CPAP system, the "ground truth" would likely refer to established engineering and medical device standards, specifications, and performance targets (e.g., accuracy of pressure delivery, stability of flow, noise levels within acceptable limits, safety features functioning correctly). These are typically verified against calibrated measurement equipment and established protocols.
8. The Sample Size for the Training Set
This information is not provided in the document. The Respironics SleepEasy CPAP System is not an AI/machine learning device that requires a "training set" in the conventional sense. Its functionality is based on predefined engineering principles and control algorithms, not learned from data.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. As noted above, the concept of a "training set" and associated "ground truth" is not applicable to this type of device.
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Respironics SleepEasy CPAP System
Premarket Notification – Special 510(k)
MAY 15 2009
品 年度 网 SEMATION ને છે
Official Contact
Zita A. Yurko Director, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
724-387-4120 724-387-7490 (fax) Email: Zita. Yurko@Respironics.com
Classification Reference
Product Code
Common/Usual Name
Proprietary Name
Predicate Device(s)
Reason for submission
21 CFR 868.5905
BZD - Non-Continuous ventilator
CPAP System
Respironics SleepEasy CPAP System
Respironics REMstar Plus CPAP System (K010263)
Respironics REMstar Pro with C-Flex CPAP System (K021861)
Modified design.
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Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate devices:
- Same intended use. 0
- Same operating principle. aj
- O Same technology.
- Same manufacturing process.
Design verification tests were performed on the Respironics SleepEasy CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.
The modified device complies with the applicable standards referenced in the Guidance for FDA. Reviewers and Industry "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 2005.
Intended Use
The Respironics SleepEasy CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.
Device Description
The Respironics SleepEasy CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The SleepEasy CPAP System also includes the flex therapy feature cleared in K021861 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its device predicates, the SleepEasy CPAP System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.
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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 with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 15 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Zita A. Yurko Director, Regulatory Affairs Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K091112
Trade/Device Name: Respironics SleepEasy CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 16, 2009 Received: April 17, 2009
Dear Ms. Yurko:
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.
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
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Page 2- Ms. Yurko
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Susan Kunne
Susan Runner, D.D.S., MA Acting 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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Page _ 1 of 1
510(k) Number (if known):
Device Name: Respironics SleepEasy CPAP System
Intended UseAndications for Use
The Respironics SleepEasy CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).
Prescription Use _ XX (Per 21 CFR 801.109)
OB
Over-The-Counter Use (Optional Format 1-2-96)
Susan Quinn
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion) Dentel Devices Division of Ancolnest - 37
Infection Control, Dental Devices
510(k) Number: Ka1112
§ 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).