STARDUST II

K052573 · Respironics, Inc. · MNR · Dec 13, 2005 · Anesthesiology

Device Facts

• Record ID: K052573
• Device Name: STARDUST II
• Applicant: Respironics, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Dec 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

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 Story

Stardust II is a multi-function recording device for sleep disorder diagnosis. It acquires physiological signals including airflow (via pressure cannula or thermistor), effort, SpO2, and pulse rate. Device processes these inputs using proprietary algorithms to detect and report respiratory events: apnea, hypopnea, desaturation, and snore. Used in home or clinical settings under supervision of physician, technologist, or clinician. Device also interfaces with Respironics pressure therapy devices to stream real-time data and event flags, serving as a portable recorder to assess titration quality and therapeutic benefit for diagnosed OSA patients. Healthcare providers review recorded data to inform clinical decision-making regarding sleep disorder diagnosis and therapy management.

Clinical Evidence

Bench testing only. Design verification tests were performed based on risk analysis and product requirements; all tests met acceptance criteria.

Technological Characteristics

Multi-function physiological signal recorder. Inputs: airflow (cannula/thermistor), effort, SpO2, pulse rate. Proprietary algorithms for respiratory event detection. Interfaces with Respironics pressure therapy devices for data streaming. Complies with FDA software guidance (May 2005).

Indications for Use

Indicated for patients requiring collection and storage of physiological signals to aid in the diagnosis of respiratory sleep disorders. Used under the direction of a physician, technologist, or clinician.

Regulatory Classification

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.

Predicate Devices

• Respironics Stardust (K021845/K973920)
• Compumedics Somte System (K021176)

Submission Summary (Full Text)

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Traditional 510(k) Tab 5 – 510(k) summary DEC 1 3 2005

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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: [phone] Fax: [phone] Zita. [e-mail]

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

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### 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

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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 [phone]. 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 [phone] or [phone] 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

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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

K052573