(76 days)
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Not Found
No
The summary describes a physical restraint device and contains no mention of AI, ML, or any related computational technologies.
No
The device is described as a "Protective Restraint" intended for "gentle reminder to remain in the bed or wheelchair and for postural support." This function does not involve treating or diagnosing a medical condition, which are characteristics of a therapeutic device.
No
The "Intended Use / Indications for Use" states that the device is a "gentle reminder to remain in the bed or wheelchair and for postural support," which describes a physical restraint rather than a tool for diagnosis.
No
The device description "ProVest - Protective Restraint" strongly suggests a physical restraint device, not a software-only application. The intended use also describes a physical function ("gentle reminder to remain in the bed or wheelchair and for postural support").
Based on the provided information, the ProVest device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of ProVest is described as a "gentle reminder to remain in the bed or wheelchair and for postural support." This is a physical restraint device used on a patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description of ProVest does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes related to detecting or monitoring a disease or condition.
Therefore, ProVest falls under the category of a physical medical device used for patient restraint and support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support.
Product codes
FMQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
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
licensed medical practitioner
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
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angelita Kowalewsky 'President Jemm Medical Products 42909 Alep Street Lancaster, California 93536
JUL 1 4 1997
Re : K971561 Provest-Protective Restraint Trade Name: Requlatory Class: I Product Code: FMQ Dated: March 1, 1997 Received: April 29, 1997
Dear Ms. Kowalewsky:
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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements 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
1
Page 2 - Ms. Kowalewsky
through 542 of the Act for devices under the Electronic enroduct Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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/dsmamain.html".
sincerely yours,
Timo thy A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number: K971561
Device Name: ProVest - Protective Restraint
:
Indications for use:
ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | 971561 |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | --------------- |
OR
| Over - The - Counter Use | |
|---|---|
| (Optional Format 1, 2-96) |
(Optional Format 1 - 2 - 96)