The contOR® Table Surface is intended to be used on existing operating room table in all surgical procedures to greatly reduce the likelihood of complications as a result of placement on the operating table surface, such as:

pressure ulcers (pressure relief)
tissue compromise (positioning)

The contOR® Table Surface is intended to be used to support and position the patient and to provide warming and cooling during surgery. The surface will greatly reduce the likelihood of complications as a result of placement on the operating table surface such as:

Pressure ulcers
Tissue compromise

Device Description

The control unit is a self-contained unit requiring only input of the local power system. The control unit contains the heat exchanger used to heat/cool the medium. In addition, the controi unit contains a pressure/vacuum pump and valve network for Inflating the positioning air bladders and deflating the beaded vacuum bags. The control unit also contains all the controls required to manipulate and monitor the previously mentioned subsystems as well as any other subsystems that might be required for the patient and/or table surface pad while being used in the O. R. Suite. The control unit, which utilizes membrane switch technology and LED screen display the functions of the contOR® Table Surface. Additionally there is a remote pendant that is wired to the control unit that performs the same functions as the main control unit's screen.

The mattress set of the contOR® Table Surface Unit is designed to be used on different operating room tables in lieu of the standard mattress set. The mattress is 21 Inches wide, 72 to 84 inches long and 4 inches high. All aspects of the OR table surface pad are as modular in design as possible to facilitate serviceability and repair. The OR surface pad consists of 3 sections: a head section, a main body section, and a footleg section. The OR surface pad is a multi-ply system contained in an outer cover. The outer cover material has bi-directional stretch and is a nylon web substrate with urethane laminated on both sides. This outer cover will be cleanable throughout the life of the product using standard Hospital disinfectants that are alcohol or phosphate detergent based. The multi-ply system contained in the outer cover consists of several different layers.

The contOR® Table Surface pads are interconnected using Colder fittings for air, vacuum and water supply. Each section is secured to the OR table by longitudinal Velcro strips placed down the center of the under surface each section.

AI/ML Overview

This appears to be a 510(k) summary for the Hill-Rom contOR® Table Surface, a medical device intended for use on operating room tables. However, the provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on:

Device identification: Names, submitter, contact information.
Predicate devices: Devices used for comparison to establish substantial equivalence.
Device description: Details about the control unit and mattress set.
Indications for use: Preventing pressure ulcers and tissue compromise, and providing warming/cooling.
Comparison to predicates: Highlighting differences in design, but stating they don't significantly affect safety and efficacy.
FDA clearance letter: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your request, I would need a different document that details the performance study and its results against specific acceptance criteria.

Summary

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AUG - 7 1998

K973705

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Tab 13

Summary

contOR® Table Surface

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Hill-Romo

Tab 13

510(k) Summary contOR® Table Surface

Date Prepared: 9-26-97

1. SUBMITTER NAMES:

Hill-Rome Submitter: 4349 Corporate Road Charleston SC 29405

Contact:

Edwin Bills Manager Quality Services & Regulatory Affairs 4349 Corporate Road Charleston SC 29405 (803)740-8380 (803)740-8059 FAX:

2. DEVICE NAMES:

Common or Usual or Specialty Mattresses for use on Operating Room Classification Name: Tables and Patient Stretchers contOR® Table Surface Proprietary Name: ・・・・・・・・・・

3. PREDICATE DEVICES:

Surface

Action Gel Pad manufactured by Action Products, Inc. Hagerstown, MD AMSCO Operating Room Table Pad, AMSCO International, Erie, Pa. Olympic VAC-Pac manufactured by Olympic Medical, Seattle, WA Hyper- Hypothermia Pad/Blanket and Controls

Blanketrol II manufactured by Cincinnati Sub-Zero, Cincinnati, OH TROPI-Cool Hyper/Hypothermia manufactured by Seabrook Medical, Cincinnati, OH

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Hill-Rom® A Hillenbrand Industry

4. SUBJECT DEVICE:

a) Control Unit
The control unit is a self-contained unit requiring only input of the local power system. The control unit contains the heat exchanger used to heat/cool the medium. In addition, the controi unit contains a pressure/vacuum pump and valve network for Inflating the positioning air bladders and deflating the beaded vacuum bags. The control unit also contains all the controls required to manipulate and monitor the previously mentioned subsystems as well as any other subsystems that might be required for the patient and/or table surface pad while being used in the O. R. Suite. The control unit, which utilizes membrane switch technology and LED screen display the functions of the contOR® Table Surface. Additionally there is a remote pendant that is wired to the control unit that performs the same functions as the main control unit's screen.

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ノベアなかない。シン

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Hill-Rom® A Hillenbrand Industry

b) Mattress Set

5. INDICATIONS FOR USE:

pressure ulcers (pressure relief)
tissue compromise (positioning)

6. COMPARISON TO PREDICATES:

Differences in design between the subject device and the predicates (none of which have significant effect on safety and efficacy) are as follows:

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Hill-Rom® A Hillenbrand Industry

Mattress Set

a) The contOR® Table Surface Incorporates numerous layers, each of which is similar to a predicate. The predicate devices exist as single units.
b) The range of the thermal pad is from 39 degrees F to 104 degrees F in the contOR® Table Surface and from 39 degrees F to 107 degrees F for the stand alone thermal. Unit.

(See Tab 8: Comparison Chart for further comparisons.)

7. SUMMARY:

The functions of the contOR® Table Surface Unit and the predicate devices are designed for:

a) the prevention and treatment of pressure ulcers through pressure reduction/relief;
b) any use where benefits may be derived from warming/cooling the patient;
c) the position assistance/protection of the patient to reduce the risk of tissue compromise.

The c ontOR Table Surface® Unit is able to accomplish these functions through the operation of the specially coordinated steps performed by an OR staff member in selected combinations which are configured and controller through resident software in the controller.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 1998

Mr. Edwin L. Bills Official Correspondent Hill-Rom, Inc. 4349 Corporate Road Charleston, South Carolina 29405-7445

Re: K973705 contOR® Table Surface Requlatory Class: II DWJ Product Code: Dated: April 8, 1998 Received: May 20, 1998

Dear Mr. Bills:

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 reqistration, 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 Regulations, 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 Requlation (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 requlation may result in requlatory 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Edwin L. Bills

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) 594-4659. 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 regarderen Chereroa) Missiananiy by Dother 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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

contOR® Table Surface

Indications for Use:

The contOR® Table Surface is intended to be used to support and position the The contone Table Canaming and cooling during surgery. The surface will patient and to provice waming and ossim of placement on the operating table surface such as:

Pressure ulcers 1
Tissue compromise .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) X

Over-the-Counter Use

ccool

9 15795

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).