LogoFDA 510(k) Search
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
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

§ 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.