BIOTHANE PATIENT RESTRAINT

• K Number: K991591
• Device Name: BIOTHANE PATIENT RESTRAINT
• Manufacturer: BIOPLASTICS
• Date Cleared: 1999-07-29 ( 83 days)
• Product Code: FMQ , FMO
• Regulation Number: 880.6760
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

BioThane Patient Restraints are intended for medical purposes only. They are intended to limit the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the BioThane™ Patient Restraint. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for diagnostic or AI-driven medical devices.

The letter is the outcome of a regulatory review stating that the device is "substantially equivalent" to legally marketed predicate devices. This means that, based on the information provided in the 510(k) submission (which is not included here), the FDA determined the device is as safe and effective as a predicate device.

Therefore, I cannot extract the requested information from the provided text. This document is a regulatory clearance, not a performance study report.

Specifically, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This document doesn't define specific performance metrics or acceptance criteria for the restraint device itself. It's a regulatory approval.
2. Sample size used for the test set and the data provenance: No test set information is present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic test set.
4. Adjudication method for the test set: 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: Not applicable. This device is a physical patient restraint, not an AI or diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1999

Ms. Claire Boron Marketing Assistant BioPlastics 34655 Mills Road North Ridgeville, Ohio 44039 USA

Re : K991591 BioThane™ Patient Restraint Trade Name: Requlatory Class: I Product Code: FMO May 5, 1999 Dated: Received: May 7, 1999

Dear Ms. Boron:

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 wit h the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market the device, subject to the (Act). 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 (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. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Boron

this response to your premarket notification Please note: 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to ene regaracion Choroson" (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 [phone] or [phone] or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

V A. Ulatowski 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): K991591 Device Name: BigThane Patient Restraint

Indications For Use:

BioThane Patient Restraints are intended for medical purposes only. They are intended to limit the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODF)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Fabrica Cascente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .

Regulation Number and Section

§ 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.