(80 days)
An indicator of respiratory effort for recording onto a data acquisition system.
Ultima Respiratory Effort Sensor, 0520 and 0522
This document is a 510(k) clearance letter from the FDA for the Ultima Respiratory Effort Sensor Models 0520 and 0522. It primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
While it mentions the device's intended use and target population, it lacks the detailed information required to answer your specific questions regarding acceptance criteria, study methodologies, and performance metrics.
Specifically, the document does not contain:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment for any test sets.
- Information on expert qualifications, adjudication methods, or MRMC studies.
- Data on standalone algorithm performance or training set details.
Therefore, I cannot provide the requested information based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEB I I 1998
Richard A. Bonato, Ph.D. Braebon Medical Corporation P.O. Box 72094 Kanata, ON, K2K 2P4 CANADA
Re: K982216 Ultima Respiratory Effort Sensor Models 0520 and 0522 Requlatory Class: II (two) Product Code: 73 BZQ Dated: June 15, 1998 Received: June 23, 1998
Dear Dr. Bonato:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Richard A. Bonato, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K9%2216__(To be assigned) 510 (k) Number__
| Device Name: | Ultima Respiratory Effort Sensor, 0520 and 0522 |
|---|---|
| Indications for Use: | An indicator of respiratory effort for recording onto a data acquisitionsystem. |
| Target Population: | Children and adult patients who are screened during sleep disorderstudies |
| Environment of Use: | Sleep disorder screenings occur at a sleep laboratory. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
name
Prescription Use_ V
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
§ 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).