GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR

K983449 · Gereonics, Inc. · BZQ · Feb 8, 1999 · Anesthesiology

Device Facts

• Record ID: K983449
• Device Name: GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
• Applicant: Gereonics, Inc.
• Product Code: BZQ · Anesthesiology
• Decision Date: Feb 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Gereonics Ultra-Piezo Respiratory 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

Device is a passive respiratory effort sensor for sleep disorder studies. Input: physical breathing motion (chest/abdomen expansion) detected by a polyvinylidene fluoride (PVDF) piezoelectric film sensor. Operation: sensor converts mechanical motion directly into electrical voltage (no external power required); signal passes through a passive low-pass electronic filter (15 Hz cutoff) to minimize noise; output is a low-voltage signal (+/- 200-300 microvolts at 0.1 Hz). Device is secured to the patient via Velcro/elastic straps. Output is connected to a bioamplifier in a physiological recording system. Used in clinical sleep study settings; operated by trained personnel. Healthcare providers use the amplified signal to monitor/record respiratory effort and frequency to assist in sleep disorder diagnosis. Benefits include non-invasive, passive monitoring of respiratory patterns.

Clinical Evidence

No clinical data provided; bench testing only. Device equivalence established through comparative design analysis and technical specifications against predicate devices.

Technological Characteristics

Passive piezoelectric sensor using polyvinylidene fluoride (PVDF) plastic film. Includes passive low-pass electronic filter (15 Hz cutoff). Output: +/- 200-300 microvolts at 0.1 Hz. Connectivity: 8-foot cable with DIN 45-802 safety connectors. Form factor: strap-mounted sensor (1-inch Velcro/elastic). No internal power source or batteries. Non-invasive.

Indications for Use

Indicated for use in sleep disorders studies to measure respiratory effort and frequency in adults, children, and infants. Not intended 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.

Predicate Devices

• Crystal Trace Respiratory Effort Sensor (K923402)
• EPMS, Inc. respiratory effort sensor (K903300)

Submission Summary (Full Text)

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8 1999 FEB

9g3449

### Executive Summary:

The Gereonics, Inc. Ultra-Piezo Respiratory Effort Sensor is a device intended to be used in Sleep Disorders Testing for monitoring or recording abdominal (stomach) and thorax (chest) respiratory effort. It consists of a piezo sensor that converts breathing motion into an electrical output. The output goes into a passive low pass (15 Hz) electronic filter before the signal is then connected to a physiological recorder where the signal is amplified for monitoring or recording. This device is not intended for use as an Apnea Alarm.

The sensor is secured to the body using a one inch wide strap system of Velcro hook and elastic loop material. See Figure 1-2. The sensor is usable with adults, children and babies since various length straps are available to suit the body size needs.

This device is very similar to a respiratory effort sensor manufactured and sold by Pro-Tech, Inc., Woodinville, Washington. The essential differences are the strap width and the location of the passive electronic filter.

### Intended Use:

The Gereonics Ultra-Piezo Respiratory Sensor is intended for use in sleep disorders studies to measure respiratory effort for monitoring or recording on a physiological recording system.

#### Description of Gereonics Ultra-Piezo Respiratory Effort Sensor:

The Gereonics Ultra-Piezo Respiratory Effort Sensor is intended for use in Sleep Disorders Testing for the measurement of respiratory effort and frequency. It is designed for use with a bioamplifier attached to a physiological recording system.

The Respiratory Effort Strap Sensor utilizes a processed polyvinylidene fluoride plastic film sensor as the detector for breathing motion. The small breathing deflection of the human body, typically measured on the stomach (abdomen) or chest (thorax), creates a small voltage in the piezoelectric plastic film sensor. There is no external voltage supply -- the sensor stressed by inhalation and exhalation directly converts motion to voltage.

A passive low pass electronic filter is connected directly to the sensor and filters out frequencies above 15 Hertz to minimize noise and allow breathing frequencies to be monitored.

The output from the passive filter, typically +/- 200 to 300 microvolts at 0.1 Hz, is connected to a bioamplifier in the physiological recording system where the signal is amplified for monitoring or recording.

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## Substantial Equivalence to Devices Already in Commercial Distribution:

The Gereonics Ultra-Piezo Respiratory Effort Sensor (Strap System) is similar in design, composition and function to at least two devices currently on the market.

- 1. The system is most similar to a device manufactured and sold by Pro-Tech, Inc. The 510(k) Number is K923402, Decision Date 12/30/92.
- 2. Another firm marketing a similar product is:

EPMS, Inc. 5212 Highberry Woods Road Midlothian, Virginia 23112 The 510(k) Number is K903300, Decision Date 12/28/90.

### Identification of Substantially Equivalent Device:

Device Name: Crystal Trace Respiratory Effort Sensor Manufacturer: Pro-Tech, Inc. P.O. Box 2165 17710 134th Avenue N.E. Woodinville, WA 98072 510(k) Number: K923402

### Table of Comparison to a Legally Marketed Device:

| Features | Gereonics | Pro-Tech |
|------------------------------------------------------------------------|-------------|--------------------------|
| Velcro hook and loop elastic straps | Yes | Yes |
| Various strap sizes for adult and pediatric use | Yes | Yes |
| Plastic film piezo sensor | Yes | Yes |
| Built-in passive electronic filter | (at sensor) | (molded in cable) |
| Termination of about 8 foot cable with<br>DIN 45-802 Safety Connectors | Yes | Yes |
| Connects to physiological recording system | Yes | Yes |
| Comparable voltage output | Yes | Yes |
| Completely passive system<br>No batteries or power supply | Yes | Yes |
| Velcro, Inc. strap width | 1 inch | 1.5 inches |
| Materials in contact with body | Velcro loop | Velcro loop<br>& elastic |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 FEB

Mr. Gerald Rost Gereonics, Inc. 4650-143 Dulin Road Fallbrook, CA 92028

Re: K983449 Gereonics Ultra-Piezo Respiratory Effort Sensor Requlatory Class: II (two) Product Code: 73 BZQ Dated: January 22, 1999 Received: January 25, 1999

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 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 aqainst 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. In addition, FDA may publish further announcements requlatorv action. 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 requlations.

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Page 2 - Mr. Gerald Rost

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 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Thomas J. Callehan

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:

510(k) Number: K983449

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.

Chali i.ho. In DK.

Division Sion-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)