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.

AI/ML Overview

The provided document, K974296, is a 510(k) summary for Invacare Corporation's Model 720 Series Full/Semi Electric and 1120 Full Electric Beds. It describes typical regulatory submission information for medical devices, focusing on substantial equivalence to predicate devices and adherence to relevant safety standards.

Based on the content of the document, here's a breakdown regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Meet U.L. 544 Standard for Safety for Medical and Dental Equipment	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.
Include a low voltage control system	The beds include a low voltage control system.
Include thermal protection on the motors	The beds include thermal protection on the motors.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of clinical or performance data for the device. The testing mentioned refers to compliance with safety standards. Therefore, information on sample size and data provenance for a test set in the sense of clinical evaluation is not applicable or provided.

3. Number of Experts and Their Qualifications for Ground Truth

This information is not applicable. The device is a hospital bed, and its compliance is assessed against engineering safety standards (U.L. 544), not through expert-derived clinical ground truth.

4. Adjudication Method

This information is not applicable. Adjudication methods are typically used in studies involving subjective assessments or disagreements among experts, which is not the nature of the testing described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or image interpretation devices where human performance with and without AI assistance is evaluated. The Invacare beds are mechanical devices.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was done. This device is a bed, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is defined by the requirements and standards outlined in the Underwriters Laboratories (U.L.) 544 Standard for Safety, for Medical and Dental Equipment. This is a set of objective engineering and safety criteria.

8. Sample Size for the Training Set

This information is not applicable. The product is a physical device, not an AI model that requires a training set.

9. How Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for an AI model. The "ground truth" for the device's safety and effectiveness is established by compliance with the U.L. 544 standard, which is determined through defined testing procedures.

Summary

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K974296

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).

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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

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.

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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

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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

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K974296

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)

Regulation Number and Section

§ 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.