(174 days)
The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
The REMstar Auto Continuous Positive Airway Pressure (CPAP) System is a microprocessorcontrolled, blower-based system that generates positive airway pressures from 4 to 20 cmH₂O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The Respironics Model 7410 Voyager has been modified to detect hypopneas and to add an interface to adjust the settings of the Remstar Heated Humidifier. The design implementation of the humidifier and the humidifier interface is the same as the Remstar Plus CPAP System (K010263). The basic functional and performance characteristic of the REMstar Auto CPAP System is unchanged from the predicate device (Model 7410 Voyager K974879).
This document is a 510(k) premarket notification for the Respironics REMstar Auto CPAP System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, performance studies, or clinical trial data as typically found in a comprehensive clinical study report. Therefore, I can only extract limited information based on the provided text.
Here's an attempt to answer your questions based on the available text:
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Table of acceptance criteria and the reported device performance
The document states: "Design verification tests were performed on the REMstar Auto CPAP System because of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
However, no specific acceptance criteria or detailed reported device performance metrics are provided in the text. The submission highlights that the device has the "Same operating principle," "Same technology," and "Same manufacturing process" as the predicate, and that its "basic functional and performance characteristic... is unchanged from the predicate device (Model 7410 Voyager K974879)." The key modification is the ability to "detect hypopneas."
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "design verification tests" but does not specify the sample size used for any test set or the data provenance. There is no indication of clinical trial data or patient data being used for these tests; "design verification tests" typically refer to engineering and bench testing.
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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 provided in the document. The submission focuses on substantial equivalence based on design and technical characteristics rather than a clinical evaluation requiring expert ground truth assessment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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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 MRMC comparative effectiveness study is mentioned. The device is a CPAP system, not an AI-assisted diagnostic tool that would typically involve human readers. The new feature is the automatic detection of hypopneas, which is an algorithmic function, but its comparative effectiveness in improving human reader performance is not discussed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions that the modified device "has been modified to detect hypopneas." This suggests an algorithm for detecting hypopneas is part of the device's functionality. The "design verification tests" would have evaluated the performance of this detection algorithm in a standalone manner (without a human in the loop for the detection itself), but details of these tests and their results are not provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document refers to "design verification tests" but does not specify the type of ground truth used for evaluating the hypopnea detection, or any other functional aspect. For a feature like hypopnea detection, ground truth would typically come from polysomnography data scored by sleep experts, but this is not mentioned.
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The sample size for the training set
The document does not mention any training set or machine learning development process, nor a sample size for it. While the device detects hypopneas, it doesn't explicitly state that this detection uses a modern machine learning model that would require a distinct training set. It could be based on rule-based algorithms.
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How the ground truth for the training set was established
Since no training set is mentioned, information on how its ground truth was established is not provided.
In summary, this 510(k) submission is a regulatory document focused on demonstrating substantial equivalence, not a detailed technical or clinical study report. It states that design verification tests were conducted and met acceptance criteria, but it does not provide the specifics of these tests, including sample sizes, ground truth establishment, or detailed performance metrics.
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| Official ContactJAN 2 9 2002 | David J. VanellaManager, Regulatory Affairs/Product AssuranceRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668K012554 |
|---|---|
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Non-Continuous ventilator |
| Common/Usual Name | CPAP System |
| Proprietary Name | Respironics REMstar Auto CPAP System |
| Predicate Device(s) | Model 7410 Voyager (K974879) |
| Respironics Remstar Plus CPAP System/Remstar Heated Humidifier(K010263) | |
| Respironics Virtuoso LX CPAP System (K993433) | |
| Reason for submission | Modified design, additional accessories. |
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- Same intended use. 0
- D Same operating principle.
- Same technology.
- O Same manufacturing process.
Design verification tests were performed on the REMstar Auto CPAP System because 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 device.
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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 1998.
Intended Use
The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. This device is intended for use in the home or hospital/institutional environment on adult patients.
Device Description
The REMstar Auto Continuous Positive Airway Pressure (CPAP) System is a microprocessorcontrolled, blower-based system that generates positive airway pressures from 4 to 20 cmH₂O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The Respironics Model 7410 Voyager has been modified to detect hypopneas and to add an interface to adjust the settings of the Remstar Heated Humidifier. The design implementation of the humidifier and the humidifier interface is the same as the Remstar Plus CPAP System (K010263). The basic functional and performance characteristic of the REMstar Auto CPAP System is unchanged from the predicate device (Model 7410 Voyager K974879).
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2002
Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
Re: K012554
Respironics® REMstar Auto CPAP System Regulation Number: 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: Class II (two) Product Code: BZD Dated: January 2, 2002 Received: January 3, 2002
Dear Mr. Vanella:
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. David J. Vanella
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a astad regulations administered by other Federal agencies. You must or any I catal statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 607); accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by some (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) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premails in the modicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 011 594-4646. Additionally, for questions on the promotion and advertising of Compination at (301) 591-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general 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/dsma/dsmamain.html
Sincerely yours,
Qo. V. Tille
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory 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): KOLZ554
Device Name: Respironics® REMstar Auto CPAP System
Intended UseAndications for Use
The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
Environment of Use/Patient Population
For use in the home or hospital/institutional environment on adult patients.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Over-The-Counter Use |
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| (Optional Format 1-2-96) |
Division of Cardiovascular & Respiratory Devices
510(k) Number K012559
§ 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).