(33 days)
The Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in sleep disorders studies to measure respiratory effort for monitoring or recording on a physiological recording system. The Ultra-Piezo Respiratory Effort Sensor is NOT intended for use as an Apnea Alarm.
Not Found
This document is a 510(k) clearance letter from the FDA for the Gereonics Ultra-Piezo Respiratory Effort Sensor. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, number/qualifications of experts, or adjudication methods for a test set.
- Information about MRMC studies, standalone algorithm performance, or the type of ground truth used.
- Information about the training set size or how its ground truth was established.
This type of information would typically be found in the 510(k) submission itself, which is a much more extensive document than this clearance letter. The letter is merely the FDA's formal response indicating approval.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 1999
Mr. Gerald A. Rost Gereonics, Inc. 4650-143 Dulin Road Fallbrook, CA 92028
Re: K991411 Gereonics Ultra-Piezo Respiratory Effort Sensor Regulatory Class: II (two) Product Code: 73 BZQ Dated: March 23, 1999 March 26, 1999 Received:
Dear Mr. Rost:
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 the general controls provisions of the Act. 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 Failure to comply with the GMP regulation may result in assumptions. 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 - Mr. Gerald A. Rost
This letter will allow you to beqin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callhan, 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:
510(k) Number: K983442 × 1 4 1 1 4 1 1 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Device Name: Ultra-Piezo Respiratory Effort Sensor
INDICATIONS FOR USE:
The Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in sleep disorders studies to measure respiratory effort for monitoring or recording on a physiological recording system.
The Ultra-Piezo Respiratory Effort Sensor is NOT intended for use as an Apnea Alarm.
Arth. A. Ciarkowski
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
§ 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).