GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR

K991411 · Gereonics, Inc. · BZQ · Apr 28, 1999 · Anesthesiology

Device Facts

• Record ID: K991411
• Device Name: GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
• Applicant: Gereonics, Inc.
• Product Code: BZQ · Anesthesiology
• Decision Date: Apr 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended 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.

Device Story

The Ultra-Piezo Respiratory Effort Sensor is a transducer used in sleep disorder studies. It detects mechanical chest or abdominal wall movement associated with breathing; converts physical strain into electrical signals via piezoelectric technology. The device connects to a physiological recording system for data display and storage. It is operated by trained personnel in clinical or sleep lab settings. The output provides clinicians with respiratory effort waveforms to assist in the diagnosis and monitoring of sleep-related breathing disorders. It does not function as an apnea alarm.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Piezoelectric transducer technology; converts mechanical strain to electrical signals. Designed for integration with physiological recording systems. Form factor is a respiratory effort sensor belt/transducer.

Indications for Use

Indicated for use in sleep disorder studies to measure respiratory effort for monitoring or recording on a physiological recording system. Not indicated for use as an apnea alarm.

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

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 [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"(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 [phone] or [phone], 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)