(74 days)
New to protect patient from injury or injury to others.
Full Body Restraint System
This looks like a 510(k) clearance letter for a "Full Body Restraint System" from the FDA, dated August 15, 1997. This document grants market clearance based on substantial equivalence to a predicate device, rather than a rigorous study proving specific performance metrics against acceptance criteria. Therefore, most of the requested information cannot be found in this document.
Here's a breakdown of what can be inferred or directly stated, and what is missing:
1. A table of acceptance criteria and the reported device performance
Missing. This document is a clearance letter, not a performance report. It states that the device is "substantially equivalent" to a predicate device, which implies that its performance is presumed to be similar and acceptable, but it does not specify quantitative acceptance criteria or reported performance figures.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The letter does not detail any specific test set data or its provenance. The clearance is based on a determination of substantial equivalence, which typically involves demonstrating that the device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device, often through bench testing and comparisons rather than clinical trials with large test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing. As there's no mention of a test set with established ground truth, this information is not applicable to this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Missing. This device is a "Full Body Restraint System," which is a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing. This is a physical restraint system, so the concept of "standalone performance" for an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing. Not applicable to this type of device and clearance document.
8. The sample size for the training set
Missing. As this is a physical device, the concept of a "training set" in the context of machine learning or AI is not applicable.
9. How the ground truth for the training set was established
Missing. Not applicable.
Summary based on the provided document:
The provided document is a 510(k) clearance letter. It indicates that the "Full Body Restraint System" by Gillen Industries (K972046) has been deemed "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This substantial equivalence determination means the FDA believes the device is as safe and effective as a legally marketed device that does not require premarket approval.
The primary "acceptance criterion" for this type of clearance is substantial equivalence to a predicate device for the stated "Indications For Use: To protect patient from injury or injury to others." The document does not provide specific quantitative performance metrics or details about clinical studies, test sets, or ground truth establishment, as these are typically not required for 510(k) clearances if substantial equivalence can be demonstrated through other means (e.g., bench testing, comparison of technological characteristics).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Gillen President Gillen Industries One Richmond Square Providence, Rhode Island 02906
AUG 1 5 1997
Re: K972046 Full Body Restraint System Trade Name: Regulatory Class: I Product Code: FMO Dated: May 27, 1997 Received: June 2, 1997
Dear Mr. Gillen:
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, Druq, 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 regulations 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 reguirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 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 miqht have under sections 531
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Page 2 - Mr. Gillen
through 542 of the Act for devices under the Electronic Product 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 regulation (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,
W. C. Lilatoush.
ky A. Ulatowski Time Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Full Body Restraint System Device Name: __
Indications For Use:
New to protect patient from injury or injury to others.
(PLEASE DO NOT WRITE BELOW THIS LINE -
CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Brenda Bolder for PC
Division of Dentel, Infection Control,
and General Hoepita! Devices
(k) Number K962046
Prescription Use (Per 21 CFR 801.109)
OK
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.