(50 days)
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.
Protective Restraint Models #302,440,750, 850, and 905
This prompt is about a 510(k) premarket notification for "Protective Restraint Models #302, 440, 750, 850, and 905" by Geriatric Products Incorporated.
The provided document is an FDA clearance letter and an Indications for Use statement. This type of document does not include information about acceptance criteria, study details, or performance data for a medical device. It primarily confirms that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in the 510(k) submission itself (e.g., in sections describing performance testing, clinical studies, or bench testing), which is not part of the provided text.
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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
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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
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.K 972123...
510(k) Number (if known):
Device Name: Protective Rostraint
Classification Panel: 880.6760, 80FMQ
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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.
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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
§ 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.