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

Device Description

The Inflatable Positioning Cushion is designed to be used on a standard nuclear imaging table with cradle dimensions of 80" long by 14" wide, such as the SPECT Table manufactured by Medical Imaging Electronics. The Inflatable Positioning Cushion is comprised of a Head Section and Abdominal Section, containing foam cushions and inflatable cushions, and a Lower Body Section of foam cushions. The cushions are secured to the nuclear imaging table with Velcro straps and inflatable straps that wrap underneath the table. The blower for the inflatable cushions is in a separate enclosure that can hang at the end of the nuclear imaging table or sit on the floor.

AI/ML Overview

This is a 510(k) summary for a medical device and therefore does not contain the detailed study information typically found in a standalone clinical study report. The document focuses on demonstrating substantial equivalence to previously marketed devices rather than proving performance against specific acceptance criteria through a dedicated study.

However, based on the provided text, we can infer some information and identify what is missing.

Inferred Acceptance Criteria and Reported Device Performance:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to predicate devices. The device's performance is described in terms of its intended use and features, positioning it as functionally equivalent to the predicates.

Acceptance Criteria (Implied)	Reported Device Performance
1. Intended Use: To be used on nuclear imaging tables for Scintimammography procedures, allowing for comfortable, anatomically correct, prone positioning of the patient during Scintimammography.	Met: The Inflatable Positioning Cushion device is "intended to be used on nuclear imaging tables for Scintimammography procedures." It "allows for comfortable, anatomically correct, prone positioning of the patient during Scintimammography." This directly matches the intended use.
2. Functional Equivalence to Predicate Devices: Similar design, materials, and operational principles as predicate devices.	Met: The submission claims substantial equivalence to "General Purpose T-Foam Pads," "Scintimammography Prone Breast Cushion," "Scintimammography Table Overlay," and "Scinti Mammography Positioning Pads." The device description details its components (foam and inflatable cushions, Velcro straps, blower) and use on a standard nuclear imaging table, which is consistent with the general features of the predicate devices (e.g., T-Foam pads for comfort and pressure distribution; Scintimammography cushions for breast separation, prone positioning, and material properties). The text doesn't provide a direct, explicit comparison table, but the FDA's clearance implies they found sufficient similarities based on the submitted information. The "Comparative Information" section points to "attached Promotional Material" (which is included in the input), indirectly serving as evidence of similar-by-design and similar-by-function.
*Implied Safety & Efficacy:* Non-attenuating, comfortable, radiolucent, easy to clean (based on predicate device descriptions).	Implied: While not explicitly stated for the submitted device, the predicate devices detail features like being "Radiolucent and artifact free" (T-Foam), "free of attenuating materials," "made of top-quality, medical-grade materials," and having an "impermeable surface that is easy to clean" (Scintimammography Prone Breast Cushion). Given the substantial equivalence claim, it is implied that the submitted device shares these performance characteristics. The primary purpose of the device (positioning for imaging) suggests that artifacts or attenuation would be critical adverse effects to avoid.

Missing Information (Commonly found in detailed study reports):

The provided text does not contain the following detailed study information typically associated with a robust performance evaluation against specific acceptance criteria for AI/diagnostic devices:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing. There is no specific test set or data mentioned for the subject device. The clearance is based on substantial equivalence to existing devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Missing. This type of evaluation is not relevant for a physical positioning device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing. Not relevant for this type of device.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Missing. This is a physical support device, not an AI or diagnostic imaging device that involves human readers interpreting results.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing. Not applicable; this is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Missing. The "ground truth" for this device would be its ability to physically position a patient comfortably and correctly for scintimammography, and to do so without interfering with image acquisition (e.g., radiolucency). This is evaluated through engineering specifications, material properties, and comparison to predicates, rather than clinical ground truth for a diagnostic outcome.
The sample size for the training set:
- Missing. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Missing. Not applicable.

Crucial Point: This 510(k) submission is for an "Inflatable Positioning Cushion," a relatively low-risk physical accessory. The FDA's 510(k) process for such devices relies heavily on demonstrating substantial equivalence to predicate devices already on the market, rather than requiring extensive clinical trials with specific performance endpoints like those for new diagnostic or therapeutic technologies. The "study" mentioned for the predicate device (Scintimammography Prone Breast Cushion) was a clinical study on the technique of scintimammography itself and the efficacy of that predicate cushion in the detection of breast cancer, not a study specifically on the acceptance criteria of the new inflatable cushion alone. Therefore, the information you're looking for regarding concrete performance metrics and detailed study designs is not typically part of such a 510(k) substantial equivalence submission for this type of device.

Summary

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510 (k) Summary

NOV 1 0 1997

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

Device Description: IV.

V. Indications

VI. Comparative Information

See attached Promotional Material.

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AliMed Diagnostic Imaging Products

Image /page/1/Picture/1 description: The image shows the text "20 new replacement table pads!" in white text on a black background. The text is arranged in two lines, with "20 new replacement" on the first line and "table pads!" on the second line. The font is bold and sans-serif, and the text is centered in the image.

· Substantially reduces lower back pain during long procedures!
Helps reduce patient movement—you work faster!
Radiolucent and artifact free

20am represents a unique breakthrough in pressure distribution! Immobilized patients often experience lower back discomfort and painful pressure during long procedures, such as cardiac cath, angiographies and hypertensive IVPs. The lumbar region is not supported well by ordinary table pads. Patients react by moving to relieve the pain and pressure-blurring images and complicating procedures. T-Foam precisely molds to each patient's contours to provide a total contact resting surface-eliminating lower back discomfort and painful pressure. Patient comfort soars. Procedures are completed quickly and efficiently.

Image /page/1/Picture/6 description: The image shows an advertisement for T-Foam. The text in the advertisement says "T-Foam fits every need in Imaging". The background of the advertisement is dark and blurry, but it appears to be a medical image.

Image /page/1/Picture/7 description: The image shows a comparison of pressure distribution with and without a T-Foam Pad. The top half of the image shows dangerous high-pressure peaks, while the bottom half shows safe, distributed pressure with the T-Foam Pad. The text indicates that the T-Foam Pad helps to reduce peak pressure safely.

T-Foam pads are radiolucent. They are 11/2"thick and are covered wi. blue nylon cover with water resistant seams.

Image /page/1/Figure/9 description: This image shows a variety of general-purpose T-foam pads with different dimensions and prices. The pads are labeled with codes such as #E9-213, #E9-211, #E9-210, #E91-370, #E9-677, #E9-546, #E9-545, #E920177, #E920176, #E920161, #E920162, #E920159, and #E920158. The prices range from $299.95 to $644.0, and the dimensions vary, including lengths like 77", 87", 75", 95", 101", 118", 79", 82", 94", and 98".

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Image /page/2/Figure/0 description: This image shows a collection of medical equipment parts with their corresponding names, ID numbers, dimensions, and prices. The parts include models from Phillips, Picker, Siemens, and Toshiba, such as the Nuclear Medicine Spect, EP 94, 1200X CT, and Somatom Plus. Prices range from $183.00 for a Toshiba TCT 500S to $642.60 for an XRE-ADC, with dimensions varying for each part.

lf you don't see your pad above, we'll make one to your specifications!

stom Table Pad Order Form

Custom Table Pad Order Form

Fill in the information below and provide either a dimensional sketch on the graph form at right or a full-scale tracing of the original pad. Include location and description of any Velcro
®
fasteners or zippers desired.

MAIL TO:	OR FAX TO: (617) 329-8392
Custom Table Pad DepartmentAliMed, inc.297 High StreetDedham, MA 02026	Each square=2"

Name		Title
Facility		Customer #
Bill to Address:

Blue Nylon (Radiolucent)
T-Foam Polyfoam
Length		Width	Height
Water Resistant Seams	Yes No

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NUCLEAR ASSOCIATES

New!

SCINTIMAMMOGRAPHY PRONE BREAST CUSHION

Now you can effortlessly and affordably perform scintimammography by using Nuclear Associates' Scintimammography Prone Breast Cushion and the FREE "Guide to Scintimammography."

The Scintimammography Prone Breast Cushion is an Innovative Product That:

Provides optimal separation of the breast from the chest wall, making it easy to get THE BEST RESULTS!
· Allows lateral breast compression for larger imaging surfaces.
· Is free of attenuating materials, unlike expensive, bulky imaging tables.
· Allows you to image a full range of breast sizes-from an A cup to a double D.
· Is made of top-quality, medical-grade materials.
· Features an impermeable surface that is easy to clean.
· Can be used with any camera system; it's universal.
· Comes with an invaluable, FREE "GUIDE TO SCINTIMAMMOGRAPHY"!

Was clinically proven in a study conducted by Departments of Nuclear Medicine, Surgery and Radiology, Hotel-Dieu de Montreal, University of Montreal, Canada, to evaluate the sensitivity and the specificity of 99mTc-sestamibi scintimammography in the detection of breast cancer and axillary lymph node involvement. (See next page for FREE reprint information.)

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DO VOICE BOAD . PO BOY 349 CARLE PLACE, NY 11514-0349 US (516) 741-6360 · FAX (516) 741 ail: NclrAssoc@aol.cor

Image /page/3/Picture/17 description: The image shows a logo for Visa. The logo is a rectangle with the word "VISA" in white letters on a blue background. There are two horizontal lines, one above and one below the word "VISA", that are black. The logo is surrounded by a white border.

8:00 AM to 5:00 PM Monday thru Friday,
FAX (24 hours) (516) 741-5414,
E-Mail: NclrAssoc@aol.com or write.

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SCINTIMAMMOGRAPHY TABLE OVERLAY

· Simplifies patient positioning for Scintimammography imaging
· Converts standard SPECT imaging tables to Scintimammography tables
· Also available for standard flat bed planar imaging tables
· Locking guide rails facilitate fast setup and removal of table overlay

The Scintimammography Table Overlay is designed to improve the guality of providing by providing a stable, more comfortable platform for your patient during a scintimammography procedure. Prone imaging allows the breast to be positioned from the chess wall, which can greatly increase the target-to-background ration. Your scanning table can now be fitted with the Scintimammography Table Overlay to provide the necessary indentations for prone imaging.

The Scintimating graphy Table Overlay is fabricated light a ½" thick polymer plastic material. The normal overall dimensions are 81" x 24" but will vary according to the size of your inaging table. Each table overlay is built to the specifications of your existing intelle using locking guide rails. The svstem includes a 5/8" foam core heavy-duty vinyl pad Please specify the model of your camera and table with your order.

JRT-STO/S Scintimammography Table Overlay for Spect Tables 5 1,330 Scintimammography Table Overlay for Planar Tables JRT-STO/P S 1.430

JRT Associates

124 Saw Mill River Road Elmsford, NY 10523 800-221-0111 FAX 914-592-3167

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Scinti Mammography Positioning Pads

Image /page/5/Picture/1 description: The image shows a collection of various 3D shapes and objects. There are several rectangular prisms of different sizes, along with a few curved shapes that resemble ribbons or decorative elements. Additionally, there is a long, rectangular object that appears to be broken or segmented into two parts, and a more complex, irregular shape that could be a decorative molding or architectural detail.

Scinti Mammographv Positioning Pads.

Part #PBI-3 849900

· Universal Imaging System Application · Comfortable, Anatomically Correct Positioning · · Durable Seamless Foam Construction ·

ie specialized design of the positioning pads allow comfortable, anatomically correct, prone patient positioning on virtually any imaging system. The unique design of the pads makes right, left, or bilateral breast image acquisition easy.

Compatible with flat or concave imaging tables, the PBI-3 pad set comes with all the accessories needed to facilitate Scinti Mammography on your imaging system.

KIT INCLUDES: 1 Upper Body Pad 2 Breast Compression Pads 1 Lower Body Pad 1 Ankle/Foot Rest Pad 1 Roll of Patient Safety Strap 4 Velcro Brand Mounting Strips
Call today for complete details or a catalog of our entire product line.

Image /page/5/Picture/9 description: The image is a black and white logo with a star and the letters "PTI". The star is a five-pointed star and is located at the top of the logo. The letters "PTI" are located below the star. The background of the logo is black, and the star and letters are white. The logo is surrounded by a black border.

Technology. Inc.

P.O. Box 824, Greenville, PA 16125

Your complete source for Nuclear Medicine Supplies and Accessories.

Toll Free:	800-682-2226
Phone:	412-932-2121
Fax:	412-932-3176
Email:	pti@nauticom.net

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Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 10 1997

William H. Quirk Director. Regulatory Affairs KCI New Technologies Inc. 3440 East Houston San Antonio, TX 78219

K973915 Inflatable Positioning Cushions Dated: October 9, 1997 Received: October 14, 1997 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH

Dear Mr. Quirk:

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 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 II (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 Regulation (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 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 Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device 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 question 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

William Yu

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

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Page

510(k) Number (if known):

Device Name: Inflatable Positioning Cushions__________________________________________________________________________________________________________________________________

Indications for Use:

The Inflatable Positioning Cushion device 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Timith le. Sygm

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973915

Prescription Use / (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(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.