(189 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. It describes a device for qualitative snoring measurement, which is typically a sensor-based technology.
No
The device provides a qualitative measure of snoring for recording, which is diagnostic, not therapeutic.
Yes
The device provides a qualitative measure for recording, which suggests its use in assessing a condition (snoring) potentially for diagnosis or monitoring.
Unknown
The provided summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, the Ultima Snoring Mike is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a qualitative measure of snoring for recording. This involves measuring a physiological sound (snoring), not analyzing a biological sample (like blood, urine, or tissue) outside of the body.
- Device Description: While the description is "Not Found," the intended use clearly points to a device that interacts with the patient externally to capture sound.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, chemical reactions, or any other typical characteristics of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Ultima Snoring Mike does not fit this definition. It's a device for recording a physiological sound.
N/A
Intended Use / Indications for Use
The Ultima Snoring Mike provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system.
Product codes
MNR
Device Description
Not Found
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
Children and adult patients
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 of |
| snoring for recording onto an FDA-cleared data acquisition | |
| system. | |
| Target Population: | Children and adult patients who are screened during sleep |
| 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