The intended use of the product is to remove the cold from the bucky by placing this sheet between the patient's breast and the imaging receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.

Indications for Use: To be applied to the mammography receptor plate, one per patient

Device Description

Bella is to be used on the bucky or the imaging receptor plate of mammography imaging equipment where the breast is placed for mammograms. The purpose of the product is to remove the cold from the bucky by placing this sheet between the patient's breast and the imaging receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.

Bella is designed to include a non-woven fabric type material that will feel like fabric on the skin. The material is non-compressable and the sizes are to include all leading mammography equipment for small and large buckies. Bella includes printed graphics to aid in the mental comforting of the patient. There is adhesive backing to Bella which allows easy application and removal from the bucky. The material and adhesive do not affect imaging.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bella device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for Bella revolve around its intended use and comparison to the predicate device (MammoPad). Both devices aim to increase patient comfort during mammography without compromising image quality.

Acceptance Criteria Category	Specific Criteria	Bella Reported Performance
Patient Comfort	Removes cold from the bucky/imaging receptor plate and makes the patient feel more comfortable and less cold.	"The product proved to fulfill its design intentions of removing the cold from the mammography receptor plate with its fabric type material, making the patient more at ease with its floral pattern..." (Implied via patient feedback and design intention, though no quantitative comfort scores are presented).
Image Quality	Does not interfere with image quality. Images produced with the device should be comparable to images produced without the device (or without the predicate device). "Radiolucent" and "does not interfere with imaging."	Non-clinical (prototype testing): "This test proved there were no differences in the image with Bella as compared to without." Clinical (patient testing): "...again no differences between the image with Bella as compared to the image without." "The product... did not interfere with imaging quality." "Substantial equivalence based on assessment of clinical performance-Both products are considered radiolucent and do not interfere with imaging."
Physical Properties	- Remains where placed (adherence to bucky). - Non-compressible. - Compatible with mammography equipment. - Disposable. - Biocompatible.	- "Remain where placed" (listed in table). - "The material is non-compressable" (from description). - "The product is applied directly to the bucky." (description) - "Disposable" (listed in table). - "Fabric and FDA approved varnish on ink" (listed in table).
Safety	No adverse effects (radiation, chemical, mechanical, electrical, thermal safety, biocompatibility, etc.).	- "Does not image" (radiation safety, listed in table). - No specific safety tests mentioned beyond biocompatibility (fabric and FDA approved varnish on ink). Implied safety through "does not interfere with imaging" and comparison to predicate.

Study Information

This 510(k) summary describes a series of non-clinical and clinical tests for Bella, primarily focused on proving substantial equivalence to the MammoPad predicate device by demonstrating no interference with image quality.

Information Category	Detail
1. Sample size (Test Set)	Non-clinical: Not explicitly stated, described as "a prototype to be tested on the mammography equipment receptor plate under the phantom." Clinical: 200 tests (implying 200 patients/cases, each having one breast imaged with Bella and one without).
2. Data Provenance (Test Set)	Country of origin: Not explicitly stated, but "6 locations" are mentioned for the clinical tests. No geographical specifics are provided. Retrospective/Prospective: Prospective (tests were conducted for the purpose of this submission).
3. Number of Experts (Ground Truth)	Not explicitly stated. The text mentions "no differences in the image" and "did not interfere with imaging quality," implying expert assessment of image quality, but the number and qualifications are not provided. For the predicate device, Dr. Laszlo Tabar is mentioned as performing "intense clinical trials" and concluding no adverse effects.
4. Adjudication Method (Test Set)	Not explicitly stated. The nature of the assessment ("no differences in the image") suggests a direct comparison, likely by radiologists, but no formal adjudication process like `2+1` or `3+1` is described.
5. MRMC Comparative Effectiveness Study	No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. The study focused on demonstrating non-inferiority in image quality (i.e., no interference) rather than an improvement in human reader performance with AI assistance (as this is not an AI device).
6. Standalone Performance Study	Yes, the study essentially describes standalone performance regarding image quality. It evaluated whether the device itself, when placed on the bucky, interfered with the resulting mammogram image. The conclusion was that it did not.
7. Type of Ground Truth Used	Expert assessment of image quality. The determination of "no differences in the image" implies a qualitative assessment by qualified personnel (likely radiologists or radiographers) of the mammograms taken with and without Bella. It is not pathology, outcomes data, or a formalized consensus panel.
8. Sample Size (Training Set)	Not applicable. Bella is a physical accessory, not a machine learning algorithm, so there is no "training set" in the conventional sense.
9. How Ground Truth for Training Set Established	Not applicable. As above, there is no training set for this type of device.

Summary

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K073262

510K Summary

MAR 2 6 2008

Beekley Corporation 150 Dolphin Road Bristol, CT 06011 Martine M Boutté Phone 1-800-233-5539 Fax 1-800-735-1234 mboutte@beckley.com

Device Name - Bella

Predicate Device - MammoPad

Description of Device

The product is applied directly to the bucky. The sheet itself will have a peel off backing to expose the adhesive back. The corners of the shortest ends are taken in both hands and as the mammographer moves towards the bucky. Bella is allowed to adher to the front of the bucky using this adherence as a guide to place Bella wrinkle free to the top of the bucky. After the patient's mammogram the mammographer peels Bella off the bucky and disposes of it. This is a one time use only product and the bucky does not have to be cleaned in between Bellas or in essence between patients.

Intended Use

Page 1

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	Bella	MammoPad K062141
Intended use	A self adhering fabric sheet to beapplied to the mammographyequipment receptor plate toprovide a more comfortablemammogram	A self adhering foam pad to beapplied to the mammographyequipment receptor plate toprovide a more comfortablemammogram
Indications for use	To be applied to themammography receptor plate,one per patient	To be applied to themammography receptor plate, oneper patient
Target population	Women over the age of 35having mammograms	Women over the age of 35 havingmammograms
Anatomical sites	Breast	Breast
Where used	Hospitals, radiology centers	Hospitals, radiology centers
Energy used and/or delivered	n/a	n/a
Human factors	Mammographers apply Bella tothe mammography equipmentand place women's breasts onthe product	Mammographers applyMammoPad to the mammographyequipment and place women'sbreasts on the product
Design	Rectangular in shape, whitefabric, adhesive backing, pinkflowers printed on white fabric	Rectangular in shape, high densityfoam with adhesive backing
Performance	Provides a more comfortablemammogram	Provides a more comfortablemammogram
Standards met	Remain where placed	Remain where placed
Materials	fabric, adhesive backing, ink	High density foam, adhesivebacking
Biocompatibility	Fabric and FDA approvedvarnish on ink	Visco elastic foam
Compatibility with theenvironment	Disposable	disposable
Sterility	n/a	n/a
Electrical safety	n/a	n/a
Mechanical safety	n/a	n/a
Chemical safety	n/a	n/a
Thermal safety	n/a	n/a
Radiation safety	Does not image	Does not image

Comparison of device (Bella) to predicate device (MammoPad)

Substantial equivalence based on an assessment of non-clinical performance data both products are intended to provide comfort

Substantial equivalence based on assessment of clinical performance-Both products are considered radiolucent and do not interfere with imaging

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Conclusions drawn from nonclinical and clinical tests that demonstrate the device is as safe, as effective and performs as well as or better than the predicate device

Bella

The first step in testing Bella was to develop a prototype to be tested on the mammography equipment receptor plate under the phantom, to be compared to an image with the phantom and no Bella. This test proved there were no differences in the image with Bella as compared to without.

The next step in testing was to find locations where Bella could be tested as part of a mammogram where you again compare an image with Bella and one without. The test conducted included imaging, with the patient's consent, one breast with Bella and one without. 200 tests were completed in 6 locations with again no differences between the image with Bella as compared to the image without.

The product proved to fulfill it's design intentions of removing the cold from the mammography receptor plate with it's fabric type material, making the patient more at ease with it's floral pattern and did not interfere with imaging quality.

MammoPad

Biol.ucent Inc., took the MammoPad to Laszlo Tabar, M.D., at Falun Central in Sweden to perform intense clinical trials. Almost 1,000 Swedish women had mammograms either with or without the MammoPad, and Tabar - could not see any adverse effects between mammograms done either way, even when examining the images with a magnifying glass. In the study, a majority of the women reported that the MammoPad cut the pain of mammography in half.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird 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 Blvd. Rockville MD 20850

MAR 2 6 2008

Ms. Martine M. Boutté New Product Development Specialist Beekley Corporation 150 Dolphin Road BRISTOL CT 06011

Re: K073262

Trade/Device Name: Bella Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: February 21, 2008 Received: February 21, 2008

Dear Ms. Boutté:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo. Below the letters, the word "Centennial" is written in cursive. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.

oling Public Hoalth

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892:xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K073262

Device Name: Bella

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hozai Toth

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

Page of of a

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.