(146 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No.
The device is intended for acquiring, displaying, transmitting, displaying, and analyzing vital signs, as well as providing follow-up and response, which are diagnostic and monitoring functions, not therapeutic.
Yes
The device is used for "medical testing of patients' vital signs, display and analysis" and for patients to "acquire, display and transmit their vital signs... for analysis", which are actions directly related to diagnosing a patient's health status.
Unknown
The provided summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. The intended use mentions acquiring vital signs, which could imply a hardware component is needed for data acquisition.
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 acquiring, displaying, and transmitting vital signs for analysis by a medical professional. This involves direct interaction with the patient and their physiological data, not the examination of specimens derived from the human body in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis.
The PMP4 Application appears to be a system for remote patient monitoring and communication of vital signs, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The PMP4 Application is intended for: a) Patients wishing to acquire, display and transmit their vital signs to a medical professional via Webbased Call Center for analysis and obtain response b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data
Product codes
MSX
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
Patients wishing to acquire, display and transmit their vital signs to a medical professional via Webbased Call Center for analysis and obtain response. Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data.
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 16 2006
Card Guard Scientific Survival LTD c/o Alex Gonorovsky 2 Perkins St. Rehovot, TX 76100
Re: K061428
Trade/Device Name: PMP4 Application Regulation Number: 21 CFR 870.2300 Regulation Name: Network and Communication Physiological System Regulatory Class: Class II Product Code: MSX Dated: August 10, 2006 Received: September 6, 2006
Dear Mr. Gonorovsky:
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 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) 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
1
Page 2 - Mr. Gonorovsky
or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bhimmar fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For and Intended Use PMP4 Application
510(k) Number (if known):
K061428 pg lofl
The PMP4 Application Device Name:
Indication for Use:
The PMP4 Application is intended for:
a) Patients wishing to acquire, display and transmit their vital signs to a medical professional via Webbased Call Center for analysis and obtain response
Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and b) response to patient's transmitted data
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✔ (Per 21 CFR 801.109) (Optional Format 1-2-96)
OR
Over-The-Counter Use V
B. Zimmerman