(127 days)
Not Found
No
The device is a physical sheet designed for patient comfort during mammography and does not involve any computational processing of images or data.
No.
The primary purpose of the device is to provide patient comfort by addressing the cold sensation from the mammography receptor plate, not to treat or diagnose a disease.
No
Explanation: The device's intended use is to provide patient comfort by reducing the cold sensation from the bucky without interfering with image quality. It does not perform any diagnostic function such as detecting, diagnosing, or predicting diseases.
No
The device description clearly states it is a physical sheet made of non-woven fabric material with adhesive backing, not 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 described device, "Bella," is a physical sheet placed on a mammography receptor plate. Its purpose is to improve patient comfort by reducing the cold sensation and providing a more pleasant feel and appearance.
- Lack of Biological Sample Analysis: The device does not interact with or analyze any biological samples from the patient. It is a physical barrier and comfort aid.
- Focus on Comfort and Image Non-Interference: The intended use and device description clearly state the primary functions are patient comfort and ensuring no interference with the mammography image quality. There is no mention of analyzing patient samples or providing diagnostic information based on biological markers.
Therefore, Bella falls outside the scope of an In Vitro Diagnostic device. It is a medical device used in conjunction with a diagnostic imaging procedure (mammography), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
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.
Product codes
IZH
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Women over the age of 35 having mammograms
Intended User / Care Setting
Hospitals, radiology centers
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MammoPad K062141
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
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
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.
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
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.
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1
| Bella | MammoPad K062141 | |
|---|---|---|
| Intended use | A self adhering fabric sheet to be | |
| applied to the mammography | ||
| equipment receptor plate to | ||
| provide a more comfortable | ||
| mammogram | A self adhering foam pad to be | |
| applied to the mammography | ||
| equipment receptor plate to | ||
| provide a more comfortable | ||
| mammogram | ||
| Indications for use | To be applied to the | |
| mammography receptor plate, | ||
| one per patient | To be applied to the | |
| mammography receptor plate, one | ||
| per patient | ||
| Target population | Women over the age of 35 | |
| having mammograms | Women over the age of 35 having | |
| mammograms | ||
| 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 to | |
| the mammography equipment | ||
| and place women's breasts on | ||
| the product | Mammographers apply | |
| MammoPad to the mammography | ||
| equipment and place women's | ||
| breasts on the product | ||
| Design | Rectangular in shape, white | |
| fabric, adhesive backing, pink | ||
| flowers printed on white fabric | Rectangular in shape, high density | |
| foam with adhesive backing | ||
| Performance | Provides a more comfortable | |
| mammogram | Provides a more comfortable | |
| mammogram | ||
| Standards met | Remain where placed | Remain where placed |
| Materials | fabric, adhesive backing, ink | High density foam, adhesive |
| backing | ||
| Biocompatibility | Fabric and FDA approved | |
| varnish on ink | Visco elastic foam | |
| Compatibility with the | ||
| environment | 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
2
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.
3
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
4
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
5
Indications for Use
510(k) Number (if known): K073262
Device Name: Bella
Indications for Use:
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.
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.
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