(33 days)
Not Found
Not Found
No
The summary describes a basic hospital bed for support and comfort, with no mention of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.
No
Explanation: The device is described as a "HOSPITAL BED" intended to "PROVIDE SUPPORT & COMFORT" for residents. This function is for general comfort and support, not for treating or preventing a disease or condition.
No
The device is a hospital bed, intended to provide support and comfort to residents. There is no indication in the provided text that it performs any diagnostic function.
No
The device description explicitly states "HOSPITAL BED," which is a hardware device. The intended use also describes "SLEEPING SURFACES," further indicating a physical product. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "PROVIDE SUPPORT & COMFORT" to residents in nursing homes and long-term care facilities. This is a physical support function, not a diagnostic one.
- Device Description: The device is described as a "HOSPITAL BED." Beds are medical devices, but they are not typically used for in vitro diagnostic testing.
- 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 samples
- Providing information for diagnosis, monitoring, or screening
In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device's function is purely physical support and comfort.
N/A
Intended Use / Indications for Use
TO PROVIDE SUPPORT & COMFORT TO RESIDENTS OF NURSING HOMES OR LONG TERM CARE Facilities
Product codes
FNL
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
NURSING HOME + LOXE TORN CARE
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
§ 880.5100 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. R. N. Thompson M.C. Healthcare Products, Incorporated 4658 Ontario Street Beamsville, Ontario, Canada LOR 1B4
DEC I 8 K
Re : K974254 Benefit B3---Series Trade Name: Requlatory Class: II Product Code: FNL October 30, 1997 Dated: November 13, 1997 Received:
Dear Mr. Thompson:
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 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. ਸ 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Thompson
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 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 requlation (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,
Timothy A. Ulatowski
ı A latowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
a
Enclosure
2
Page ' of '
97425.4
KASHOT
510(k) Number (if known);
HOSPITAL BED. Device Name:
Indications For Use:
HURSING HOME + LOXE TORN CARE
SLEEPING SURFACES.
."
TO PROVIDE SUPPORT & COMFORT.
TO RESIDENTS OF NURSING HOMES
OR LONG TERM CARE Facilities
:
:
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF
: :
NEEDED) ----------------------------------------------------------------------------------------------------------------------------------------------------------------------
11
rence of CDRH, Office of Device Evaluation (ODE) · Concu
and Bach (Division Sign-Off) Division of Dental, Infection Control, and General Hor 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)