(62 days)
For use in Screening Mammographic Imaging as a Specialty Paddle for Full Breast Compression as an alternative to conventional breast compression paddles.
The Advantage paddle is a breast compression paddle comprising of a rectangular tray-like structure of an FDA approved biocompatible material (Eastman Kodak PETG Copolyester #6763). The paddle has a flat section and a tilted section made possible by two-section construction. The first section of the paddle is foamed rigidly and is positioned near the patient's chest and extends about one inch away from the chest. In operation, this provides a vertically oriented force to the breast that tends to keep the breast tissue from being forced into the chest wall and provides a clearer film of the breast tissue adjacent the chest. The scond section is formed and structured to flex for the purpose of tilting the paddle downward to compress the nipple end of the breast in a steady position as the X-ray is taken. The "Advantage" paddle is mcant for use with an 18 x 24cm bucky. That is a standard size used in the industry
The provided document is a 510(k) summary for a breast compression paddle, not an AI/ML device. Therefore, it does not contain information related to acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML device.
The document discusses the substantial equivalence of the "Advantage Breast Compression Paddle" to a predicate device ("S.O.F.T. Paddle") based on design, materials, indications for use, and a comparison of construction and images. There is no performance data in the context of diagnostic accuracy, sensitivity, specificity, etc., that would be applicable to an AI/ML algorithm.
Therefore, I cannot provide the requested information for an AI/ML device based on this document.
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Ko33202
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EXHIBIT 2
Livingston Products, Inc. 260 Holbrook Drive Wheeling, IL 60090 Phone 847-808-0900 Fax 847-808-0904 Contact: Troy Livingston, President September 18, 2003 510(k) Summary
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- Identification of the Device: Proprietary-Trade Name: Advantage Breast Compression paddle Classification Name: IZH Common/Usual Name: Breast Compression Paddle
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- Equivalent legally marketed device: This product is similar in design and identical in. function to the S.O.F.T. Paddle, American Mammographics, Inc, K023229
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- Indications for Use (intended use) For use in Screening Mammographic Imaging as a Specialty Paddle for Full Breast Compression as an alternative to conventional breast compression paddles..
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- Description of the Device: The Advantage paddle is a breast compression paddle comprising of a rectangular tray-like structure of an FDA approved biocompatible material (Eastman Kodak PETG Copolyester #6763). The paddle has a flat section and a tilted section made possible by two-section construction. The first section of the paddle is foamed rigidly and is positioned near the patient's chest and extends about one inch away from the chest. In operation, this provides a vertically oriented force to the breast that tends to keep the breast tissue from being forced into the chest wall and provides a clearer film of the breast tissue adjacent the chest. The scond section is formed and structured to flex for the purpose of tilting the paddle downward to compress the nipple end of the breast in a steady position as the X-ray is taken. The "Advantage" paddle is mcant for use with an 18 x 24cm bucky. That is a standard size used in the industry
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K033202
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- Safety and Effectiveness, comparison to predicate device: Comparison of construction isatory and Excell renest, o, and examination of images taken during use of the device reveals the Advantage Paddle is as safe and effective ad the predicate device.
| Comparison Areas | S.O.F.T. Paddle, AmericanMammographics, Inc, K023229 | Livingston ProductsAdvantage Paddle |
|---|---|---|
| Indications for use | For use in ScreeningMammographic Imaging as aSpecialty Paddle for Full BreastCompression as an alternative toconventional breast compressionpaddles | SAME |
| Materials | LEXAN, a GE productPolycarbonate plastic and steel | KODAK PETG Copolyesterand steel, essentially theSAME. |
| Where used | Mammography procedures | SAME |
| Reason for use overconventional paddles | Improved patient comfort andbetter images | SAME |
- Conclusion: In all important respects, the Advantage Breast Compression Paddle is substantially cquivalent to the S.O.F.T. Paddle, American Mammographics, Inc, K023229
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Livingston Products, Inc. c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Rc: K033202
Trade/Device Name: Advantage Breast Compression Paddle Regulation Number: 21 CFR §892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: September 30, 2003 Reccived: October 2, 2003
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the 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 I va may, ateres 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 (PMA), it may be subject to 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.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act that i Federal statutes and regulations administered by other Federal agencies. You must or any I 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin markeding of your antial equivalence of your device to a legally premarket notification. The PDA inding of substantial of 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 If you desire specific advice for your device on our line of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| (301) 594-4692 | |
| Other |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, pease one of the interest of the occ Othce of Compliance at (301) 574-1057. This promote of the Bigging of Sept by reference to premarket nonitation (21 Or Fer are over 1) ) (1 Crims) be Division of Small
information on your responsibilities under the Act may be obtained from the 1800 information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-drivers (d Manufacturers, International and Collisonier Fibastanter Fibanavismaldsmamain.html.
Sincerely yours,
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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j) Indications for Use
033202 510(k) Number__
Device Name: Advantage Breast Compression Paddle.
Indications for Use: For use in Screening Mammographic Imaging as a Spccialty Paddle finalcations for Got 1 or are alternative to conventional breast compression paddles.
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR 深 Prescription Use (Per 21 CFR 801.109)
Over the Counter Use_
Danille Symmin
§ 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.