(70 days)
Not Found
Not Found
No
The document describes physical restraints and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for descriptions of training/test sets and performance studies typically associated with AI/ML devices.
No.
The device is described as a medical restraint to prevent patients from disrupting other medical devices, rather than directly treating a disease or condition.
No
Explanation: The device is described as a medical restraint used to prevent patients from disconnecting other medical devices, not for diagnosing medical conditions.
No
The device description clearly states "LIMB HOLDERS, MITTS & ELBOW SPLINTS," which are physical restraints, not software. The summary contains no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically restrain patients to prevent them from interfering with other medical devices. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "LIMB HOLDERS, MITTS & ELBOW SPLINTS," which are physical restraint devices.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
Therefore, this device falls under the category of a physical medical device used for patient management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indicated use of these Limb Holders, Mitts and Elbow Splints are to be used as a medical restraint to help prevent patient from pulling and disconnecting other medical devices that are being used in their treatment.
These Limb Holders, Mitts and Elbow Splints are intended to be used on hospital beds, wheel chairs, and geriatric chairs. These devices should not be used on extremely violent patients.
Product codes
FMQ
Device Description
LIMB HOLDERS, MITTS & ELBOW SPLINTS
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
hospital beds, wheel chairs, and geriatric chairs.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard K. Donahue E.M. Adams Company, Incorporated 7496 Commercial Circle Ft. Pierce, Florida 34951
AUG - 6 1997
Re : K971948 Trade Name: Patient Restraint Regulatory Class: I Product Code: FMQ Dated: May 16, 1997 Received: May 28, 1997
Dear Mr. Donahue:
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 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 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug
1
Page 2 - Mr. Donahue
Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 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 beqin marketing your device as described in your 510 k) premarket notification. The 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 regulation (21 CFR Part 801 and additionally 809.10 for in yitro 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/lgov/cdrh/dsmamain.html".
Sincerely yours,
K. Gilchrist
Timothy A Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
2
K971948 510(k) Number (if known):
LIMB HOLDERS, MITTS & ELBOW SPLINTS Device Name:
Indications For Use:
The indicated use of these Limb Holders, Mitts and Elbow Splints are to be used as a medical restraint to help prevent patient from pulling and disconnecting other medical devices that are being used in their treatment.
These Limb Holders, Mitts and Elbow Splints are intended to be used on hospital beds, wheel chairs, and geriatric chairs. These devices should not be used on extremely violent patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Padua Crescente
(Division Sign-Off I wision of Dental, Inte a d General Hospita ್, 1 ೧(k) Number
Prescription Use y (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)