(77 days)
The Respironics REMstar Pro M Series CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg.
The Respironics REMstar Pro M Series CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Pro M Series 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 predicate, the REMstar Pro M Series 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.
This document describes the 510(k) summary for the Respironics REMstar Pro M Series CPAP System. It is a premarket notification to the FDA to demonstrate substantial equivalence to a previously cleared predicate device.
Based on the provided text, a formal study to prove the device meets acceptance criteria, in the sense of a clinical trial with specific performance metrics and statistical analysis, was not performed or reported in this 510(k) summary.
Here's an analysis of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "Design verification tests were performed on the Respironics REMstar Pro M Series CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
However, the document does not provide a table of specific acceptance criteria or the reported device performance metrics from these design verification tests. It only generally states that the tests met the criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide any information regarding the sample size used for the design verification tests (e.g., number of devices tested), the country of origin of the data, or whether it was retrospective or prospective.
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)
This information is not applicable as the document describes design verification tests for a medical device (CPAP system) and not an AI or diagnostic imaging device that would require expert-established ground truth for a test set. The "ground truth" for a CPAP system's performance would typically be based on engineering specifications and physical measurements, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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
An MRMC study was not done and is not applicable for this type of device (CPAP system). This is not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical CPAP system, not an algorithm, and its performance is inherently "standalone" in that it performs its function (delivering positive airway pressure) without direct continuous human interpretation loops.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As indicated in point 3, the concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For design verification of a CPAP system, the "ground truth" or reference for meeting acceptance criteria would be based on:
- Engineering specifications: The device is expected to deliver specific pressure, flow, and other parameters within defined tolerances.
- Performance standards: Compliance with relevant national and international standards for medical devices.
- Risk analysis requirements: Addressing identified risks through specific design and testing.
8. The sample size for the training set
This information is not applicable as the device is not an AI system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
Summary from the provided text:
The 510(k) summary for the Respironics REMstar Pro M Series CPAP System indicates that "Design verification tests were performed... All tests were verified to meet the required acceptance criteria." However, it does not provide details about these tests, such as:
- Specific acceptance criteria values (e.g., pressure output range, noise levels, temperature control).
- The results of these tests (e.g., actual measured pressure output, actual noise levels).
- The number of units tested (sample size).
- The methodology of these tests.
The submission focuses on demonstrating substantial equivalence to a predicate device (Respironics REMstar Pro with C-Flex CPAP System K021861) based on shared intended use, operating principles, technology, and manufacturing processes, and the general statement that design modifications had "no impact on the safety and effectiveness" as evidenced by meeting acceptance criteria in internal design verification. This is typical for a 510(k) clearance, which is not a full clinical trial.
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OCT 2005
100 million in the state
TAB 3
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
| Official Contact | Zita A. YurkoManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668 |
|---|---|
| 724-387-4120724-387-4206 (fax)Email: Zita.Yurko@Respironics.com | |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Non-Continuous ventilator |
| Common/Usual Name | CPAP System |
| Proprietary Name | Respironics REMstar Pro M Series CPAP System |
| Predicate Device(s) | Respironics REMstar Pro with C-Flex CPAP System (K021861) |
| Reason for submission | Modified design. |
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Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- Same intended use ra
- D Same operating principle.
- Same technology.
- □ Same manufacturing process.
Design verification tests were performed on the Respironics REMstar Pro M Series 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 Pre-market Submissions for Software Contained in Medical Devices," May 2005.
Intended Use
The Respironics REMstar Pro M Series CPAP System delivers positive ainway 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 REMstar Pro M Series CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Pro M Series 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 predicate, the REMstar Pro M Series 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 a circular logo for the Department of Health and Human Services, Inc. The logo features the department's seal, which includes an abstract image of an eagle or bird in flight. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, INC." is arranged around the top half of the circle.
Public Health Service
OCT 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Zita A. Yurko Manager, Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1001 Murry Ridge Lanc Murrysville, Pennsylvania 15668
Re: K052110
Trade/Device Name: M-SERIRES PRO CPAP SYSTEM Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 20, 2005 Received: September 21, 2005
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 referenced above antend 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 approvisions 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 cither class II (Special Controls) or class III if your device to such additional controls. Existing major regulations affecting (1 Nr.), it har or be subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Ecderal Register.
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Page 2 - Ms. Yurko
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 mean that 1 Dr. I has made statutes and regulations administered by other Federal agencies. or the Hot of all , I outh all the Act's requirements, including, but not limited to: registration 1 od intelse comply Trail and (21 CFR Part 801); good manufacturing practice and fisting (21 OF R Party of ), eguality systems (QS) regulation (21 CFR Part 820); and if requirements as bet forms in adiation control provisions (Sections 531-542 of the Act); appreadio, the elections of the will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA linding of substantial equivalence m 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), rr you desire specific at the Office of Compliance at (240) 276-0120. 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 may obtain 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,
Smite Y. Michael D.M.D.
Chiu Lin, Ph.D. Director Division of Ancsthesiology, General Hospital, Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1
510(k) Number (if known): ___
Device Name: Respironics REMstar Pro M Series CPAP System
Intended Use/Indications for Use
The Respironics REMstar Pro M Series CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg.
Environment of Use/Patient Population
For use in the home or hospital/institutional environment.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription UseXXXXX_________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
on of Anesthesiolor General Hospital. Infection Control. Der 510(k) Number
§ 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).