REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR) by KCI NEW TECHNOLOGIES, INC.

The Inflatable Positioning Cushion with Remote Hand Control is intended to be used on nuclear imaging tables for Scintimammography procedures. The Inflatable Positioning Cushion (a.k.a. ImageAir) allows for comfortable, anatomically correct, prone positioning of the patient during Scintimammography.

Device Description

The ImageAir Remote Hand Control is a remote control transmitter, utilizing 4 AA batteries. It is utilized in conjunction with an integrated Infrared receiver, located in the Main Control Panel of the Blower Assembly, to inflate and deflate the air cushions. The Remote Control transmitter incorporates a membrane keypad which provides control over the following functions:

Torso Strap On/Off .
Head Strap On/Off .
Height Adjust Up/Down .
Roll Adjust Left/Right .
Roll Adjust Level .
Lower All (Patient Exit) .
The Blower Assembly incorporates a microprocessor control as an additional safety feature to ensure the valves which regulate air pressure to the various inflatable cushions are operated in the proper sequence. For example, it would be inadvisable to raise or lower the patient when the table locking straps are disengaged. The microprocessor inside the blower box monitors strap status and will not allow the valves which direct air into the height adjustment cushions to be operated until the straps are verified as being locked.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a medical device: "Inflatable Positioning Cushions with Remote Hand Control" (also known as ImageAir). This document outlines the device's description, indications for use, and a statement of substantial equivalence to predicate devices. It does not contain any information regarding clinical studies, acceptance criteria, or performance data comparing the device to a ground truth.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because the document does not contain this type of data.

To clarify, the 510(k) process is primarily a pre-market notification to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. It does not typically require the submission of clinical trial data or performance studies in the same way a Premarket Approval (PMA) would. The provided document focuses on descriptions, intended use, and a comparison to existing, similar devices to establish this substantial equivalence.

Summary

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K980235
APR -9 1998

510 (k) Summary

I.	Name of Device:	Inflatable Positioning Cushions with Remote Hand Control
II.	Classification Name:	Patient supports, accessories to Mammographic x-ray system.
III.	Substantial Equivalence:	General Purpose T-Foam PadsScintimammography Prone Breast CushionScintimammography Table OverlayScinti Mammography Positioning Pads

IV. Device Description:

Torso Strap On/Off .
Head Strap On/Off .
Height Adjust Up/Down .
Roll Adjust Left/Right .
Roll Adjust Level .
Lower All (Patient Exit) .

The Blower Assembly incorporates a microprocessor control as an additional safety feature to ensure the valves which regulate air pressure to the various inflatable cushions are operated in the proper sequence. For example, it would be inadvisable to raise or lower the patient when the table locking straps are disengaged. The microprocessor inside the blower box monitors strap status and will not allow the valves which direct air into the height adjustment cushions to be operated until the straps are verified as being locked.

Corporate: 8023 Vantage Drive San Antonio, Texas 78230-4726 (210) 524-9000

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510(k) Summary Page 2

V. Indications

The Inflatable Positioning Cushion with Remote Hand Control is intended to be used on nuclear imaging tables for Scintimammography procedures. The Inflatable Positioning Cushion allows for comfortable, anatomically correct, prone positioning of the patient during Scintimammography.

Inflatable Cushion Assessory with Remote Hand Control 510(k) Summary

Prepared by: J. Harbour Kinetic Concepts, Inc. P.O. Box 659508 San Antonio, TX 78265 Date Prepared: January 20, 1998

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 1998

Judith A. Harbour Regulatory Affairs KCI New Technologies, Inc. P.O. Box 659508 Antonio, Texas 78265-9508 Re:

K980235 Remote Hand Control to the Inflatable Positioning Cushion (a.k.a. ImageAir) Dated: January 20, 1998 Received: January 22, 1998 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH

Dear Ms. Harbour:

We have reviewed your Section 510%) 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 of the Act. The general controls provisions 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 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 requirements, as set forth in the Quality System Regulation (OS) 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 action. In addition, FDA may publish further announcements 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 regulations.

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) 594-4613. 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/dsmaldsmam.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: Inflatable Positioning Cushions (a.k.a. ImageAir) with Remote Hand Control

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)Division of Reproductive, Abdominal, ENT,and Radiological Devices
510(k) Number	K980235

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1710 Mammographic x-ray system.

(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.