(85 days)
This device is intended for medical purposes in hospitals or nursing homes for use by the staff to adjust the surface contour of the bed using built-in electric motors and wheels for movement of the bed to different locations.
The device includes bed using built-in electric motors and wheels for movement of the bed to different locations.
The provided text is a 510(k) premarket notification letter from the FDA regarding a hospital bed (Volker Hospital Bed, Model K-960). This type of document is an approval for a medical device to be marketed, based on its substantial equivalence to a legally marketed predicate device.
It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information from this document. The letter explicitly states that the device is approved "subject to the general controls provisions of the Act," confirming its substantial equivalence rather than providing detailed performance study results against specific acceptance criteria.
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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures representing health, services, and humanity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 1997
Mr. Milton N. Beneke Jr. Official Correspondent Volker Healthcare, Incorporated C/O MDI Consultants, Incorporated -55 Northern Boulevard, Suite 410 Great Neck, New York 11021
Re : K972115 Volker Hospital Bed, Model K960 Trade Name: Regulatory Class: II Product Code: FNL Dated: June 3, 1997 Received: June 5, 1997
Dear Mr. Beneke:
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, Druq, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manutacturing 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 Please note: concerning your device in the Federal Register. 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. Beneke
through 542 of the Act for devices under the Electronic emrough State not in the II 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 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 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 ene regulation Cherclea, "Meblanding "I "Sther 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,
Timothy A. Ulatowski
Timo Directpr 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):
Device Name: Volker Hospital Bed, Model K-960
This device is intended for medical purposes Indications For Use: in hospitals or nursing homes for use by the staff or in hospicals of nursing nomes rod surface contour of the patients to adjast one norgin and ors. The device includes bed using built-in crecorre motis and wheels for movement moveable and fatenably in this bed is not of the bed to dirrerent rocations. In a 12 years of age.
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cacurence of CDRH, Office of Device Evaluation (ODE)
Patricio Casanate
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Courter Use
(Optional Forced 1-2-96)
§ 880.5100 AC-powered adjustable hospital bed.
(a)
Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.