(147 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on respiratory effort sensing.
No.
The intended use describes the device as an amplifier for sensors, which is a measurement device, not a therapeutic intervention.
Yes
The "Intended Use" states "Pro-Tech G inchrony or the censure during steep directed ing, belancing, summing and an effort", which suggests it is used to measure and monitor physiological processes (respiratory effort). This type of measurement is fundamental to diagnostics.
No
The device description explicitly mentions an "amplifier" and "sensors," which are hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an amplifier for respiratory effort sensors used during sleep studies and other activities. This involves measuring physiological signals from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description confirms it's a system for respiratory effort sensing.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
The amplifier is intended for use with Pro-Tech Synchrony or the sensor during sleep, detecting, balancing, summing and an effort.
Product codes
MNR
Device Description
Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors)
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2002
Mr. Neil Sheller Pro-Tech Services, Inc. 4338 Harbour Pointe Blvd. SW Mukilteo, WA 98275
Re: K013905
Modification EZ-1 System Respiratory Sensors Regulation Number: 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: II (two) Product Code: MNR Dated: April 4, 2002 Received: April 5, 2002
Dear Mr. Sheller:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are cased in 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Neil Sheller
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loast be devilod that I bromination that your device complies with other requirements of the Act that I Dr Has Intacted and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fut 607), ideoming (21 CFR Part 820); and if applicable, the electronic forth in also quarty by by wisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms let notification. The FDA finding of substantial equivalence of your device to a legally premaince medicate 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Donna-Bea Tillman, Ph.D.
Acting Director
Division of Cardiovascular
and Respiratory Devices
and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page_l_of_
510(k) Number (if known): K013905
Device Name: Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors)
Indications For Use:
uplifier is intented for use with Pro-Tech G inchrony or । he censure during steep directed ing, belancing, summing and an effort 5%
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number R013905
Prescription Use (Per 21 CFR 801.109 OR
Over-The-Counter Use_
(Optional Format 1-2-96)