(715 days)
No
The summary mentions "proprietary algorithms" but provides no indication or keywords suggesting the use of AI or ML. The focus is on recording physiological signals and using these algorithms to determine and report events, which is typical of traditional signal processing and rule-based algorithms.
No
The device is described as an aid in diagnosis and a recorder to assess the quality of at-home titration, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states that "The Stardust II is indicated for use by Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders".
No
The device description explicitly mentions acquiring physiological signals and interfacing with pressure therapy devices, implying hardware components beyond just software.
Based on the provided information, the Stardust II is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Stardust II records physiological signals from the patient's body (SpO2, pulse rate, airflow, respiratory effort, body position) using external sensors. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is to aid in the diagnosis of sleep-related breathing disorders. While it aids in diagnosis, it does so by monitoring physiological responses in vivo, not by analyzing samples in vitro.
- The device description focuses on recording and analyzing physiological signals. It describes the acquisition and processing of signals like airflow, effort, SpO2, and pulse rate, which are all measured directly from the patient.
Therefore, the Stardust II falls under the category of a medical device used for physiological monitoring and diagnostic aid, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
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).
Product codes
MNR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients weighing more than 30kg
Intended User / Care Setting
Health Care Professionals, home, hospital or other clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Respironics Stardust II
MAY 20 2004
Premarket Notification
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
| Official Contact | Zita A. Yurko
Manager, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------|
| | 724-387-4120
724-387-4206 (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.
1
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.
2
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
3
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
4
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,