(715 days)
The Stardust II is indicated for use by Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders in adult patients weighing more than 30kg in the home, hospital or other clinical setting.
The Stardust II is intended for use during sleep disorder studies to detect up to 5 physiological signals: percent SpO2 (functional), pulse rate, oral/nasal airflow, respiratory effort and body position (i.e., supine or non-supine).
The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events:
Airflow* Effort SpO2 Pulse rate Apnea Hypopnea Desaturation
*Nasal airflow can be acquired with a pressure cannula or thermistor sensor.
The Stardust II can also interface with various Respironics pressure therapy devices to report available device/patient information (i.e., event flags and real time streamed data). When used with these devices, the Stardust II is not intended to be a diagnostic application, but rather a portable recorder to assess the quality of the at home titration of an auto-titrating device and determine if there are still events occurring and to assess the therapeutic benefit of the already diagnosed OSA patient.
The provided document for the Respironics Stardust II (K021845) does not contain detailed information about specific acceptance criteria or the study that proves the device meets these criteria in the format requested. The document is a 510(k) summary, which primarily focuses on demonstrating substantial equivalence to a predicate device.
Here's what can be extracted and what is missing, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Design verification tests were performed on the Respironics Stardust II as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
However, it does not provide a table with specific acceptance criteria (e.g., accuracy thresholds for SpO2, airflow, etc.) nor the reported device performance measurements against those criteria.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. The document mentions "design verification tests," but does not specify the sample size of patients or data samples used for these tests, nor the country of origin of the data, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The document refers to the device aiding "Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders," implying clinical validation, but it doesn't detail how ground truth was established for any test sets.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided in the document. The filing is for a device to aid in diagnosis, but it does not detail any studies comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
The document states: "The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events: Airflow, Effort, SpO2, Pulse rate, Apnea, Hypopnea, Desaturation."
This indicates that the device has an algorithmic component that processes signals and determines events, suggesting a standalone algorithmic function. However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are not provided for these algorithms.
7. Type of Ground Truth Used:
This information is not explicitly stated in the document for any test sets. Given the device's intended use for diagnosing sleep-related breathing disorders, ground truth would typically be established by polysomnography (PSG) scored by a sleep expert, or clinical diagnosis. However, this is not described as part of the "design verification tests."
8. Sample Size for the Training Set:
This information is not provided in the document. The document mentions "proprietary algorithms" but does not detail their development or any training data used.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document.
Summary of available information regarding acceptance criteria and studies:
The provided 510(k) summary indicates that design verification tests were conducted, and "All tests were verified to meet the required acceptance criteria." However, the document does not disclose the specific acceptance criteria themselves, nor the detailed results of these tests, nor the methodologies, sample sizes, or ground truth establishment relevant to those tests.
The focus of this 510(k) is demonstrating substantial equivalence to predicate devices (Respironics Stardust and Respironics REMstar Auto) based on similar operating principles, technology, and manufacturing processes, rather than providing detailed clinical performance data from new studies.
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Respironics Stardust II
MAY 20 2004
Premarket Notification
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 868.2375 |
| Product Code | MNR - Ventilatory Effort Recorder |
| Proprietary Name | Respironics Stardust II |
| Predicate Device(s) | Respironics Stardust (K973920)Respironics REMstar Auto (K012554/K031460) |
| Reason for submission | Modified design/intended use. |
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- D Same operating principle.
- Same technology.
- □ Same manufacturing process.
Design verification tests were performed on the Respironics Stardust II 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.
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Premarket Notification
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 1998.
Intended Use
The Stardust II is indicated for use by Health Care Professionals to aid in the diagnosis of sleeprelated breathing disorders in adult patients weighing more than 30kg in the home, hospital or other clinical setting.
The Stardust II is intended for use during sleep disorder studies to detect up to 5 physiological signals: percent SpO2 (functional), pulse rate, oral/nasal airflow, respiratory effort and body position (i.e., supine or non-supine).
Device Description
The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events:
Airflow* Effort SpO2 Pulse rate Apnea Hypopnea Desaturation
*Nasal airflow can be acquired with a pressure cannula or thermistor sensor.
The Stardust II can also interface with various Respironics pressure therapy devices to report available device/patient information (i.e., event flags and real time streamed data). When used with these devices, the Stardust II is not intended to be a diagnostic application, but rather a portable recorder to assess the quality of the at home titration of an auto-titrating device and determine if there are still events occurring and to assess the therapeutic benefit of the already diagnosed OSA patient.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2004
Ms. Zita A. Yurko Regulatory Affairs Manager Respironics, Incorporated 1001 Murry Ridge Lanc Murrysville, PA 15668
Re: K021845
Trade Name: Stardust II Regulation Number: 21 CFR 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: II Product Code: MNR Dated: May 4, 2004 Received: May 5, 2004
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 dcvices 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 gencral 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 Codc 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 docs 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
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Page 2 - Ms. Zita A. Yurko
CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of 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), please contact the Office of Compliance at (301) 594-4646. 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 Division 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/dsma/dsmamain.html.
Sincerely yours,
Chiu Lin, Ph.D.
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): K021845
Device Name: Respironics Stardust II
Intended Use/Indications for Use
The Stardust II is indicated for use by Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders in adult patients weighing more than 30kg in the home, hospital or other clinical setting.
The Stardust II is intended for use during sleep disorder studies to detect up to 5 physiological signals: percent SpO2 (functional), pulse rate, oral/nasal airflow, respiratory effort and body position (i.e., supine or non-supine).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ XXX (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Hunaht Pinto
1248 1196 0101 Jonnol, Den
510(k,
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).