(85 days)
The Stardust II is a multi-function recording device intended to be used to collect and store physiological signals related to sleep disorders and to aid in the diagnosis of related respiratory sleep disorders. The Stardust II is only to be used under the direction and supervision of a physician, technologist or clinician.
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 (acquired with a pressure cannula or thermistor sensor) .
- Effort .
- SpO2 .
- . Pulse rate
- Apnea ●
- Hypopnea ♥
- Desaturation .
- Snore .
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.
This looks like a medical device submission, specifically a 510(k) summary for the Stardust II device. The provided text does not contain specific acceptance criteria or the details of a study demonstrating the device meets those criteria, nor does it provide performance data, sample sizes, ground truth establishment, or information on reader studies.
The submission focuses on establishing substantial equivalence to a predicate device and describing the intended use and device functionality. It states that "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 elaborate on what those criteria were, what the "reported device performance" was, or the details of the study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods for test sets.
- Information on MRMC comparative effectiveness studies or standalone studies.
- Details on the type of ground truth used or how it was established for training and test sets.
The provided text only contains the following relevant information regarding your request:
- Device Name: Stardust II Ventilatory Effort Recorder
- Intended Use: To collect and store physiological signals related to sleep disorders and to aid in the diagnosis of related respiratory sleep disorders.
- Key Functionality: Records physiological signals and uses proprietary algorithms to determine and report respiratory waveforms and events (Airflow, Effort, SpO2, Pulse rate, Apnea, Hypopnea, Desaturation, Snore).
- Statement on Testing: "Design verification tests were performed on the Respironics Stardust II... All tests were verified to meet the required acceptance criteria."
Without additional documentation (e.g., from an appendix or supporting study report that would typically be part of a full 510(k) submission but are not included in this summary), I cannot provide the specific details you've requested.
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Traditional 510(k) Tab 5 – 510(k) summary DEC 1 3 2005
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letters 'K' and 'O', followed by the numbers '52573'. The characters are written in black ink on a white background and appear to be part of a code or identification number.
Stardust II
TAB 5
510(K) SUN
Date of Submission
16 September 2005
Official Contact / Address of Manufacturing facility
Zita A. Yurko Manager, Regulatory Affairs Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
Phone: 724-387-4120 Fax: 724-387-4216 Zita. Yurko@Respironics.com
21 CFR 868.2375
Anesthesiology
Modified design
Respironics Stardust (K021845/K973920)
Compumedics Somte System (K021176)
Class II
MNR
- Stardust II Proprietary Name
Ventilatory Effort Recorder Common/Usual Name
Ventilatory Effort Recorder Device Classification Name
Classification Reference
Classification
Appropriate Classification Panel
Product Code
Predicate Devices
Reason for submission
{1}------------------------------------------------
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- O Same operating principle.
- 0 Same technology.
- O 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.
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 Stardust II is a multi-function recording device intended to be used to collect and store physiological signals related to sleep disorders and to aid in the diagnosis of related respiratory sleep disorders. The Stardust II is only to be used under the direction and supervision of a physician, technologist or clinician.
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 (acquired with a pressure cannula or thermistor sensor) .
- Effort .
- SpO2 .
- . Pulse rate
- Apnea ●
- Hypopnea ♥
- Desaturation .
- Snore .
000016
{2}------------------------------------------------
Traditional 510(k)
Tab 5 – 510(k) summary
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.
(End of Tab.)
:
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2005
Ms. Zita A. Yurko Manager, Regulatory Affairs Respironices, Incorporated Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668-8550
Re: K052573
Trade/Device Name: Stardust II Sleep Event Recorder Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: November 8, 2005 Received: November 14, 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 cquivalent (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 mendments, 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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 WAY, it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be fourther announcements concerning your device in the federal Register.
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Page 2 - Mr. 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. or the 7tet of ally I oderal business and and and limited to: registration 1 ou intilet compty to the mart 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 er rate in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as bet 1011 from in ontrol 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) I mo reter wrification. The FDA finding of substantial equivalence of your device to a premits receivement on 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), rryou desire specifice 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
C
Shia-Linn, Ph.D.
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
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K052573
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Stardust II is a multi-function recording device intended to be used to collect and store physiological signals related to sleep disorders and to aid in the diagnosis of related respiratory sleep disorders. The Stardust II is only to be used under the direction and supervision of a physician, technologist or clinician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aunfalion
ology, General Hospi
cal, Dental Devices
§ 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).