(50 days)
Not Found
NOT_APPLICABLE
No
The summary describes physical restraints and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as "Protective Restraint Models" used to "limit patient movement to the extent necessary for treatment, examination, protection of patient and others, or postural control," which indicates a functional and protective role rather than a direct therapeutic effect on a medical condition.
No
The device description indicates it is a "Protective Restraint" used to "limit patient movement." There is no mention of diagnosing conditions, analyzing biological samples, or producing any diagnostic information. Its purpose is purely for physical restraint during treatment, examination, or for safety.
No
The device description explicitly lists "Protective Restraint Models #302,440,750, 850, and 905," which are physical restraint products, 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 used to "limit patient movement to the extent necessary for treatment, examination, protection of patient and others, or postural control." This describes a physical restraint used on a patient, not a test performed on a sample from the body to diagnose a condition.
- Device Description: The device is described as "Protective Restraint Models". This further reinforces that it is a physical device applied to a patient.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Geriatric Products Restraints are for use by a responsible licensed healthcare professional to limit patient movement to the extent necessary for treatment, examination, protection of patient and others, or postural control.
Product codes
FMQ
Device Description
Not Found
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
responsible licensed healthcare professional
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.
Not Found
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
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of flowing lines. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. E.J. Smith Geriatric Products Incorporated C/O Smith Associates P.O. Box 4341 Crofton, Maryland 21114
JUI 25 1997
Re : K972123 Protective Restraint Models #302,440,750, Trade Name: 850, and 905 Requlatory Class: I Product Code: FMQ June 3, 1997 Dated: Received: June 5, 1997
Dear Mr. Smith:
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 aqainst 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 requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Smith
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 FDAfinding 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,
K. Olstad
Timo A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
.K 972123...
510(k) Number (if known):
Device Name: Protective Rostraint
Classification Panel: 880.6760, 80FMQ
・・・・・・・・
Indications for Use:
The Geriatric Products Restraints are for use by a responsible licensed healthcare professional to limit patient movement to the extent necessary for treatment, examination, protection of patient and others, or postural control.
Foderal (U.S.A.) law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, f and General Hospital I 510(k) Number 2 3
Proscription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use