(85 days)
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Not Found
No
The description focuses on mechanical functions (motors, wheels) and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device description and intended use indicate it is a hospital bed with adjustable contours and mobility, which assists patient care but does not directly treat a disease or condition.
No
Explanation: The device description states its purpose is to adjust the bed's surface contour and move it, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it includes "bed using built-in electric motors and wheels," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to adjust the surface contour of a bed and move it. This is a physical manipulation of a medical device for patient comfort and mobility, not for examining specimens from the human body to provide diagnostic information.
- Device Description: The description focuses on the physical components of the bed (motors, wheels).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic results.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
This device is intended for medical purposes in hospitals or nursing homes for use by the staff or caregivers to adjust the sleeping surface contour of the patients. The device includes a bed using built-in electronic motors and wheels for movement of the bed to different locations. Intended patients for this bed is not limited in age; however, it is not for infants 0-12 years of age.
Product codes
FNL
Device Description
Volker Hospital Bed, Model K-960
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not limited in age; however, it is not for infants 0-12 years of age.
Intended User / Care Setting
Staff or caregivers in hospitals or nursing homes.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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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
1
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
2
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON AND THERE PAGE IF HEEDED)
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)