(131 days)
Not Found
No
The device description details a purely passive, analog sensor and filter system that converts physical motion into a voltage signal. There is no mention of any computational processing, algorithms, or learning capabilities.
No
The device is intended for measuring respiratory effort and frequency for monitoring or recording purposes in sleep studies, not for treating or preventing a disease or condition. It explicitly states it is "NOT intended for use as an Apnea Alarm," further indicating it's a diagnostic/monitoring tool rather than a therapeutic one.
Yes
The device is described as measuring respiratory effort for monitoring or recording in sleep disorders studies, which falls under the scope of diagnosing sleep-related breathing disorders. It measures physiological parameters to aid in medical assessment.
No
The device description explicitly details hardware components: a polyvinylidene fluoride plastic film sensor, a passive low pass electronic filter, and a strap system. It describes how these physical components interact to generate a voltage signal.
Based on the provided information, the Gereonics Ultra-Piezo Respiratory Effort Sensor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Gereonics Ultra-Piezo Respiratory Effort Sensor measures respiratory effort by detecting the physical motion of the abdomen or chest. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for measuring respiratory effort in sleep disorders studies, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
73 BZQ
Device Description
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. The sensor is usable with adults, children and babies since various length straps are available to suit the body size needs.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal (stomach) and thorax (chest)
Indicated Patient Age Range
adults, children and babies
Intended User / Care Setting
Sleep Disorders Testing
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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.
-
- 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.
-
- 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 | ||
| DIN 45-802 Safety Connectors | Yes | Yes |
| Connects to physiological recording system | Yes | Yes |
| Comparable voltage output | Yes | Yes |
| Completely passive system | ||
| 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 |
| & elastic |
2
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.
3
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 (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. 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
4
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)