(77 days)
Not Found
Not Found
No
The device description mentions a microprocessor for safety interlocks, but there is no indication of AI or ML being used for image analysis, decision making, or adaptive control beyond basic safety sequencing.
No.
The device is described as an inflatable positioning cushion for patient comfort and positioning during nuclear imaging procedures, not for treating any specific condition or disease.
No
Explanation: The device is described as an "Inflatable Positioning Cushion" used for patient positioning during nuclear imaging procedures, specifically Scintimammography. Its function is to facilitate comfortable and anatomically correct prone positioning, and it controls air cushion inflation/deflation to adjust patient position. There is no mention of the device analyzing biological samples, acquiring medical images, or producing diagnostic information. Its purpose is solely to assist in patient positioning for an existing imaging modality.
No
The device description explicitly details hardware components such as an inflatable cushion, a remote hand control utilizing batteries, an infrared receiver, a blower assembly, and a microprocessor control. While there is software involved (microprocessor control), the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Inflatable Positioning Cushion with Remote Hand Control is a physical device used to position a patient comfortably and correctly during a nuclear imaging procedure (Scintimammography). It manipulates the patient's physical position, not biological samples.
- Intended Use: The intended use is for patient positioning during a medical imaging procedure, not for analyzing biological samples.
The device is a medical device used in conjunction with a diagnostic imaging system, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
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.
Product codes
90 IZH
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.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
General Purpose T-Foam Pads, Scintimammography Prone Breast Cushion, Scintimammography Table Overlay, Scinti Mammography Positioning Pads
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for KCI. The logo consists of a series of curved lines on the left, followed by the letters "KCI" in a bold, sans-serif font. There is a registered trademark symbol to the right of the "I". A horizontal line is underneath the logo.
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 Pads |
| Scintimammography Prone Breast Cushion | ||
| Scintimammography Table Overlay | ||
| Scinti Mammography Positioning Pads |
IV. 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.
Corporate: 8023 Vantage Drive San Antonio, Texas 78230-4726 (210) 524-9000
1
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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
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
3
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: Inflatable Positioning Cushions (a.k.a. ImageAir) with Remote Hand Control
Indications for Use:
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.
(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) |