(189 days)
The Ultima Snoring Mike provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system.
Not Found
The provided document is an FDA 510(k) clearance letter for the "Ultima Snoring Mike, Model 0540." This type of document declares substantial equivalence to a predicate device and permits marketing. It does not contain specific details about acceptance criteria or a dedicated study proving the device meets those criteria, as typically found in clinical study reports or detailed technical documentation.
Therefore, I cannot provide the requested information from the given text.
The document primarily states:
- The device name and model.
- Its classification (Class II, Product Code MNR).
- Its intended use: "provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system."
- Target population and environment of use.
- Concurrence of the FDA's Office of Device Evaluation.
This document serves as an authorization to market the device, not a detailed technical report of its performance against specific acceptance criteria.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem consisting of a stylized representation of a human face in profile, with three parallel lines extending from the head, resembling an abstract bird or wing.
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.
{1}------------------------------------------------
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
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 ofsnoring for recording onto an FDA-cleared data acquisitionsystem. |
| Target Population: | Children and adult patients who are screened during sleepdisorder 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_________
§ 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).