BIOTHANE PATIENT RESTRAINT

K991591 · Bioplastics · FMQ · Jul 29, 1999 · General Hospital

Device Facts

• Record ID: K991591
• Device Name: BIOTHANE PATIENT RESTRAINT
• Applicant: Bioplastics
• Product Code: FMQ · General Hospital
• Decision Date: Jul 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

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 Story

BioThane Patient Restraint is a medical device designed to restrict patient movement. Used in clinical settings to facilitate treatment, examination, or ensure safety of patients and staff. Operated by healthcare professionals. Device functions as a physical restraint mechanism. Benefits include prevention of patient self-injury or interference with medical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Physical patient restraint device. Materials and specific technical dimensions not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring movement limitation for medical treatment, examination, or safety/protection of the patient or others.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human figures or profiles arranged in a row, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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 .