(312 days)
Not Found
No
The description focuses on mechanical and thermal control systems (heat exchanger, pumps, valves, air bladders, vacuum bags) and basic electronic controls (membrane switch, LED screen, remote pendant). There is no mention of AI/ML terms or functionalities like learning, adaptation, or data-driven decision making.
Yes
The device is described as intended to "greatly reduce the likelihood of complications as a result of placement on the operating table surface, such as: pressure ulcers (pressure relief) [and] tissue compromise (positioning)," and to "support and position the patient and to provide warming and cooling during surgery." These functions, especially the prevention of pressure ulcers and tissue compromise and the provision of warming and cooling, are therapeutic in nature as they aim to treat or prevent conditions affecting the patient's health and well-being.
No
The device is an operating table surface designed to reduce complications like pressure ulcers and tissue compromise during surgery by providing support, positioning, warming, and cooling for the patient. It does not perform any diagnostic functions.
No
The device description clearly details physical components such as a control unit, heat exchanger, pressure/vacuum pump, valve network, mattress set, and connecting fittings. While it mentions "resident software in the controller," the device is fundamentally a hardware system with software controlling its functions, not a software-only device.
Based on the provided information, the contOR® Table Surface is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- contOR® Table Surface Function: The contOR® Table Surface is designed to support and position a patient during surgery, provide warming and cooling, and reduce the risk of complications like pressure ulcers and tissue compromise. It interacts directly with the patient's body externally.
- Lack of Specimen Analysis: The description does not mention any collection, preparation, or analysis of human specimens. The device's function is entirely external to the patient's internal biological processes.
Therefore, the contOR® Table Surface falls under the category of a medical device used for patient support, positioning, and temperature management during surgical procedures, not an IVD.
N/A
Intended Use / Indications for Use
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 assist in the reduction of complications of placement on the operating table surface such as:
- Pressure ulcers
- Tissue compromise.
Product codes
DWJ
Device Description
-
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. -
b) Mattress Set
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.
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
Operating Room (OR) staff member in selected combinations which are configured and controller through resident software in the controller.
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)
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
AUG - 7 1998
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Tab 13
Summary
contOR® Table Surface
1
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
2
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.
13: 2 of 4
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3
Hill-Rom® A Hillenbrand Industry
b) Mattress Set
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.
5. INDICATIONS FOR USE:
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)
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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4
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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5
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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.
6
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
7
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
OR
Over-the-Counter Use
ccool
9 15795