(73 days)
Not Found
No
The device description and intended use clearly describe a physical restraint vest made of fabric and straps, with no mention of software, data processing, or any technology that would incorporate AI or ML.
No
The device is a physical restraint used to limit body movement, not to treat a medical condition or restore health.
No
The device description indicates it is a physical restraint for limiting body movement and providing support, not for diagnosing medical conditions.
No
The device description clearly states it is a physical vest constructed from polyester mesh fabric with straps, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for limiting body movement and providing support for patients in chairs, wheelchairs, and beds. This is a physical restraint and support device, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of a vest made from fabric and straps. This is consistent with a physical restraint device, not an IVD which would involve reagents, instruments for analyzing samples, etc.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status based on laboratory testing.
Therefore, the DePuy OrthoTech Heavy Duty Vest Restraint falls under the category of a physical medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy OrthoTech Heavy Duty Vest Restraint is intended to limit body movement and provide support for patients in chairs, wheelchairs and beds who (a) may be susceptible to lifethreatening falls, (b) may be suicidal, or (c) are aggressive.
Product codes (comma separated list FDA assigned to the subject device)
80 FMQ
Device Description
The body of the vest restraint is constructed from three main pattern pieces, two front panels and a back panel which are cut from polyester mesh fabric. The vest comes equipped with four pairs of long straps which are used for securing the patient to the chair, wheelchair or bed. The subject vest restraint is supplied in five sizes from X-small to X-large to fit chests from 28" to 56". It may be hand washed in warm water and air dried.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SAFETY AND EFFECTIVENESS SUMMARY
JUL 2 4 1997
| NAME OF FIRM: | DePuy, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
FDA Registration No.: 1818910 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FIRM CONTACT: | Arlene Saull, RAC
Manager, Medical Device Submissions
DePuy Orthopaedics, Inc. (a subsidiary of DePuy, Inc.)
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
| TRADE NAME: | DePuy OrthoTech Heavy Duty Vest Restraint |
| COMMON NAME: | Protective Restraints |
| CLASSIFICATION: | Class I per 21 CFR, 880.6760 Protective Restraint |
| DEVICE PRODUCT CODE: | 80 FMQ Restraint, Protective |
| SUBSTANTIALLY EQUIVALENT DEVICES: | |
SUBSTANTIALLY EQUIVALENT DEVICES
Zimmer Heavy Duty Vest Restraint, and DePuy Vest Restraint with Sleeves (K963393)
DEVICE DESCRIPTION AND INTENDED USE:
The body of the vest restraint is constructed from three main pattern pieces, two front panels and a back panel which are cut from polyester mesh fabric. The vest comes equipped with four pairs of long straps which are used for securing the patient to the chair, wheelchair or bed. The subject vest restraint is supplied in five sizes from X-small to X-large to fit chests from 28" to 56". It may be hand washed in warm water and air dried.
The DePuy OrthoTech Heavy Duty Vest Restraint is intended to limit body movement and provide support for patients in chairs, wheelchairs and beds who (a) may be susceptible to lifethreatening falls, (b) may be suicidal, or (c) are aggressive ..
BASIS OF SUBSTANTIAL EQUIVALENCE:
Based on their similarities in design, construction, materials, and intended uses, DePuy, Inc. considers the subject DePuy OrthoTech Heavy Duty Vest Restraint as substantially equivalent to the DePuy Mesh Vest Restraint with Sleeves which was cleared by FDA in 510(k) K963393 and the Zimmer Inc. Heavy Duty Vest Restraint.
Heavy Duty Vest Restraints
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines beneath them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Arlene C. Saull Manager, Medical Device Submission DePuy, Incorporated_______ 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
JUL 2 4 1997
K971742 Re : DePuy Orthotech Heavy Duty Vest Restraint Trade Name: Regulatory Class: I Product Code: FMQ Dated: May 9, 1997 Received: May 12, 1997
Dear Ms. Saull:
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 regulations affecting your device can be found in the Code of Federal Regulations, 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 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 regulation may result in regulatory 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 might have under sections 531
2
Page 2 - Ms. Saull
through 542 of the Act for devices under the Electronic enroagle 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. JThe 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,
A. Ulatowski Time Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
INDICATIONS
510(k) Number (if known)_K971742
Device Name_DePuy OrthoTech Heavy Duty Vest Restraint
Indications for Use:
ﻤﺴﺘﻤ
The DePuy OrthoTech Heavy Duty Vest Restraint is intended to limit body movement and provide support for patients in chairs, wheelchairs and beds who (a) may be susceptible to lifethreatening falls, (b) may be suicidal, or (c) are aggressive.
============================================================================================================================================================================== Concurrence of CDRH, Office of Device Evaluation (Division Sign-Off) Division of Dental. and General Hospit 510(k) Number Prescription Use_ OR Over-the-Counter Use -------(Per 21 CFR 801.109)
Heavy Duty Vest Restraints