(33 days)
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No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing for analysis. The device description is also missing, which would be a key place to describe such technology.
No
The device is used for monitoring and recording respiratory effort in sleep disorder studies, not for treating or alleviating a medical condition. It explicitly states it is "NOT intended for use as an Apnea Alarm," further indicating it's for diagnostic/monitoring purposes, not therapeutic intervention.
Yes
The device is described as measuring "respiratory effort for monitoring or recording on a physiological recording system" in "sleep disorders studies," which indicates its use in assessing a physiological state relevant to diagnosing sleep disorders.
No
The device is described as a "Respiratory Effort Sensor," which strongly implies a physical hardware component is involved in sensing respiratory effort. The summary lacks information to suggest it's purely software processing data from another source.
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 description states the device "measure[s] respiratory effort". This is a measurement of a physiological process occurring within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for "sleep disorders studies to measure respiratory effort for monitoring or recording on a physiological recording system." This reinforces its role in monitoring a physiological function directly.
Therefore, the Gereonics Ultra-Piezo Respiratory Effort Sensor 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 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.
Product codes
73 BZQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles facing to the right, with flowing lines beneath them.
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
2
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)