ULTIMA SNORING MIKE, MODEL 0540

K020312 · Braebon Medical Corp. · MNR · Aug 7, 2002 · Anesthesiology

Device Facts

• Record ID: K020312
• Device Name: ULTIMA SNORING MIKE, MODEL 0540
• Applicant: Braebon Medical Corp.
• Product Code: MNR · Anesthesiology
• Decision Date: Aug 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Ultima Snoring Mike provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system.

Device Story

Ultima Snoring Mike (Model 0540) is a sensor device used in sleep laboratories to detect snoring sounds. It captures acoustic signals and provides a qualitative measure of snoring, which is recorded onto an FDA-cleared data acquisition system. The device is operated by sleep laboratory personnel. The output allows clinicians to assess snoring activity during sleep disorder studies, aiding in the evaluation of patient sleep health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acoustic sensor for snoring detection; designed for integration with external data acquisition systems. Class II device under 21 CFR 868.2375.

Indications for Use

Indicated for children and adult patients screened during sleep disorder studies.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard A. Bonato, Ph.D. Vice President Braebon Medical Corporation 120 Walgreen Drive Suite 1, RR#3 Carp, Ontario Canada K0A 1L0

AUG 0 7 2002

Re: K020312

> Trade/Device Name: Ultima Snoring Mike, Model 0540 Regulation Number: 21 CFR 868.2375 Regulation Name: Snoring Mike Regulatory Class: II Product Code: MNR Dated: May 17, 2002 Received: May 20, 2002

Dear Dr. Bonato:

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 - Dr. Bonato

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. You must comply with all the Act's requirements, including, but not limited to: registration , and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely,

Timothy A. Ulatowski

Time 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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## Indications for Use Statement

K020317 (To be assigned) 510 (k) Number

| Device Name: | Ultima Snoring Mike, Model 0540 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Ultima Snoring Mike provides a qualitative measure of<br>snoring for recording onto an FDA-cleared data acquisition<br>system. |
| Target Population: | Children and adult patients who are screened during sleep<br>disorder studies |
| Environment of Use: | The majority of the screenings occur at a sleep laboratory. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.H. Westerhauser

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental D

510(k) Number: K020312

Prescription Use < (Per 21 CFR 801.109)

OR

Over-The-Counter Use_________