(50 days)
Not Found
No
The device description and intended use focus on mechanical and electrical adjustments controlled by a pendant, with no mention of AI or ML capabilities.
No
The device is described as providing "added comfort" and allowing "adjustment of the surface contour of the bed," which are not typically considered therapeutic functions. While it meets "Standard for Safety, for Medical and Dental Equipment," its primary purpose is comfort and positioning rather than directly treating a medical condition.
No
The device is described as a nursing home bed designed for patient comfort and positional adjustment, not for diagnosing medical conditions.
No
The device description clearly states it includes a steel frame construction with motorized adjustments and a pendant control, 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 provide comfort and allow adjustment of the bed surface contour for individuals during bedrest. This is a physical support and positioning function.
- Device Description: The description details a nursing home bed with motorized adjustments, frame construction, and accessories like side rails and IV sockets. These are all related to patient support and care within a physical setting.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Use in a laboratory setting.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This bed does not perform any such function.
N/A
Intended Use / Indications for Use
To provide added comfort during periods of bedrest by permitting the user to adjust the surface contour of the bed to various positions.
Product codes (comma separated list FDA assigned to the subject device)
FNL
Device Description
The Model 720 Series Full/Semi Electric and 1120 Full Electric Beds are a series of nursing home beds with an intended function of providing added comfort during periods of bedrest. Additionally they permit the user to adjust the surface contour of the bed to various positions which best suit the specific needs of the bed user.
The 720 and 1120 product lines include a steel frame construction with motorized adjustments which are controlled through a pendant. The pendant controls are completely sealed and are available in four or six button configurations. Each series has variety of options and accessories which vary according to model number. Some options include floor locks, lock-out switches and perforated pans. Accessories include various side rails, IV sockets, IV rods and trapeze.
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
Not Found
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)
The 720 Series and 1120 Electric Beds have all been tested for and meet the requirements listed with Underwriters Laboratories (U.L.) under the 544 Standard for Safety, for Medical and Dental Equipment. They include a low voltage control system and thermal protection on the motors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
JA' - 0 1998
510(k) SUMMARY
JAN - 6 1998
Invacare Corporation's Model 720 Series Full/Semi Electric and 1120 Full Electric Beds
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person: Edward A. Kroll Director, TQM and Regulatory Affairs
August 1, 1997 Date Prepared:
Name of Device and Name/Address of Sponsor
Model 720 Series Full/Semi Electric Bed and 1120 Full Electric Bed
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Common or Usual Name
Nursing Home Bed
Classification Name
AC Powered Adjustable Hospital Bed
Predicate Devices
The Model 720 Series Full/Semi Electric Bed and 1120 Full Electric Bed are substantially equivalent to Invacare Corporation's 5110, 5210, 5310 and 5410 Series of Home Care Beds (K925534).
1
Intended Use
The intended use of the Model 720 Series Full/Semi Electric and 1120 Full Electric Beds is to provide added comfort during periods of bedrest by permitting the user to adjust the surface contour of the bed to various positions.
Technological Characteristics and Substantial Equivalence
A. Device Description
The Model 720 Series Full/Semi Electric and 1120 Full Electric Beds are a series of nursing home beds with an intended function of providing added comfort during periods of bedrest. Additionally they permit the user to adjust the surface contour of the bed to various positions which best suit the specific needs of the bed user.
The 720 and 1120 product lines include a steel frame construction with motorized adjustments which are controlled through a pendant. The pendant controls are completely sealed and are available in four or six button configurations. Each series has variety of options and accessories which vary according to model number. Some options include floor locks, lock-out switches and perforated pans. Accessories include various side rails, IV sockets, IV rods and trapeze.
B. Substantial Equivalence
Products which are substantially equivalent to the 720 Series and 1120 Electric Beds are; Invacare's Model 5110, 5210, 5310 and 5410 Series Home Care Beds (K925534).
Each of these products have motorized head and knee section adjustments, a pendant type push button controller and an optional motorized or manual bed height adjustment. Additional similarities are a screw type linear actuator for positioning adjustment and locking casters for maneuverability. Additionally, all provide a means for selecting and adjusting the type of surface contour and positioning which best suits the needs of the bed user. Finally, all of these devices have been granted marketing clearance by FDA under prior submissions.
None of the differences between the Model 720 Series and 1120 Electric Beds and their predicate devices alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness.
Performance Data
The 720 Series and 1120 Electric Beds have all been tested for and meet the requirements listed with Underwriters Laboratories (U.L.) under the 544 Standard for Safety, for Medical and Dental Equipment. They include a low voltage control system and thermal protection on the motors.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes extending from its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 1999
Mr. Edward A. Kroll Director, TQM and Regulatory Affairs Invacare Corporation 899 Cleveland Street Elyria, Ohio 440362-2125
K974296 Re : Model 720 Series Full/Semi Electric Bed 1120 Trade Name: Full Electric Beds Requlatory Class: II Product Code: FNL Dated: November 3, 1997 November 17, 1997 Received:
Dear Mr. Kroll:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations 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 Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you miqht have under sections 531
3
Page 2 - Mr. Kroll
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 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) Number (if known): Unknown
Device Name: Model 720 Series Full/Semi Electric and 1120 Full Electric Beds
Indications for Use:
To provide added comfort during periods of bedrest by permitting the user to adjust the surface contour of the bed to various positions.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | Patricia Cuenca |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974296 |
Prescription Use ______ OR Over-The Counter-Use ✓
(Optional Format 1-2-96)