The KODAK DirectView CR Mammography Feature together with KODAK DirectView CR Mammography Cassette comprise a device which, when used in conjunction with a KODAK DirectView CR System and a mammographic x-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.

Device Description

The Carestream CR Mammography Cassette with SNP-M1 Screen is a structured needle phosphor detector used in conjunction with the Kodak DirectView CR Mammography Feature on Kodak DirectView CR Systems for generating digital mammographic images. The Carestream CR Mammography Cassette SNP-M1 Screen is used in the same manner as a traditional screen-film cassette when performing radiographic patient exposures and will be used in the DirectView CR Systems: CR850, readers problem on on and Elite CR readers using the Kodak DirectView CR Mammography Feature.

AI/ML Overview

The provided text describes a Special 510(k) submission for the Kodak DirectView CR Mammography System by Carestream Health, Inc. The submission is for a modification to an existing device, specifically a new storage phosphor screen (SNP-M1) for mammography. The document focuses on showing substantial equivalence to the predicate device (Kodak DirectView CR Mammography System: P080018/S001).

However, the provided text does not contain specific acceptance criteria or an explicit study proving performance against such criteria. The document states:

"Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Non-clinical physical laboratory testing was conducted to assess performance. Clinical image evaluation was also conducted. Predefined acceptance criteria was met and demonstrated that the device is substantially equivalent to and as safe and as effective as the predicate device."

This statement confirms that performance testing and clinical image evaluation were done, and predefined acceptance criteria were met, but it does not provide the details of those criteria or the study results.

Therefore, I cannot populate the requested information. The document focuses on demonstrating substantial equivalence through technological characteristics comparison and a general statement that acceptance criteria were met, rather than detailing the specific performance metrics and study design/results.

Summary

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Special 510(k): Carestream Health, Inc.

K120246

"510(k) Summary"

AUG 2 8 2012

510(k) Owner Name	Carestream Health, Inc.
510(k) Owner Address	150 Verona StreetRochester, New York 14608
510(k) Owner Phone	585 627-6491
510(k) Owner Fax	585 323-7643
Contact Name & Info	Katherine HonsingerRegulatory Affairs Managerkatherine.honsinger@carestreamhealth.com
Date Summary Prepared	September 29, 2011
Device Trade Name	Kodak DirectView CR Mammography System
Device Common Name	CR Digital Mammography System
Classification Name	Full Field Digital, System, Xray, Mammographic
Regulation Name	Full-Field Digital Mammography System
Device Class	Class II
Device Code	MUE
Regulation Number	21 CFR 892.1715, Full-Field Digital MammographySystem
Predicate Device	Kodak DirectView CR Mammography System(P080018/S001)

Device Description

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Intended Use

Indications for Use and Intended Use of the modified device remain unchanged from the predicate device.

The Kodak DirectView CR Mammography Feature together with the CR Mammography Cassette comprise a device which, when used in conjunction with a Kodak DirectView CR System and a mammographic X-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammooraphic systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.

Comparison of Technological Characteristics

The SNP-M1 storage phosphor screen consists of a structured needle phosphor layer. The predicate device EHR-M3 storage phosphor screen consists of a powdered-base phosphor laver. The SNP-M1 needle-shaped phosphor crystals, which are oriented at 90 degrees to the screen surface, reduce the spread of light within the screen, and produce a more uniform screen structure compared to the EHR-M3 powder-based phosphors. The SNP-M1 structured needle phosphor screen with reader optimization kit is designed to provide improved image quality, increased sharpness, and reduced noise, delivered at a lower dose compared to the EHR-M3 powdered-based phosphor screen. Either screen type is adhered to a rigid aluminum cassette plate assembly which is inserted within the cassette housing. There are minor modifications to the cassette housing to protect the SNP-M1 screen/plate assembly from scratching or damage.

As with the EHR-M3 screen, the SNP-M1 screen is used in the same manner as a traditional screen-film cassette when performing radiographic patient exposures and will be used in all DirectView CR Systems: CR850, CR975, Classic CR and Elite CR readers that utilize the Kodak DirectView CR Mammography Feature. The CR readers are modified to optimize image quality of images captured with the SNP-M1 Screen.

There is no difference in image acquisition. Use and functional operation of the CR Mammography Cassette with SNP-M1 Screen in the CR850, CR975, Classic CR and Elite CR Readers is the same as that for the predicate device CR Mammography Cassettes with EHR-M3 Screen.

There are no significant changes in the image processing software used with the CR Mammography Cassette with SNP-M1 Screen. The Kodak DirectView CR Mammography Feature utilizing Kodak ECLIPSE Image Processing Software v5.4 is the same as that used with the CR Mammography Cassette with EHR-M3 Screen. A modified looks database enhances the image quality by adjusting noise, contrast, brightness, sharpness and detail of the images captured with the SNP-M1 Screen.

Discussion of Testing

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Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Non-clinical physical laboratory testing was conducted to assess performance. Clinical image evaluation was also conducted. Predefined acceptance criteria was met and demonstrated that the device is substantially equivalent to and as safe and as effective as the predicate device.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

AUG 28 2012

Ms. Katherine Honsinger Regulatory Affairs Manager Carestream Health, Inc. 150 Verona Street ROCHESTER NY 14608

Re: K120246

Trade/Device Name: KODAK DirectView CR Mammography System Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: August 23, 2012 Received: August 24, 2012

Dear Ms. Honsinger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because of the device is substantially equivalent (for the indications ferenced above and have vire) to legally marketed predicate devices marketed in interstate for use stated in the encreating to 10gail) to the Medical Device Amendments, or to conniered print to May 20, 1978, are occordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The T ou may, distore, mailer of the Act include requirements for annual registration, listing of general controls provisions of mactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such II your device is classified (see above) into enas ffecting your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Sour of Fouring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination cates of the ot that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a determination ana younder Federal agencies. You must of any Federal statutes and regulations annimities out not limited to: registration and listing (21 Comply with an the Act 3 requirements, artical device reporting (reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set forum in the quality systems (<< ) your Section 510(k) prematket will allow you to begin marketing your device of your device to a legally marketed notification. The FDA finalig of substantial equivalise 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 Parts 801 and If you desire specific advice for your device of our interestig Eyestland (1) 796-1961)
809), please contact the Office of In Vitro Diagnostic Device Evanuation and Safety at 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5450. Also, prease note the regulation vialest, "Legarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

under the MDR regulation (21 CFR Pat 603), promo go go
http://www.fda.gov/MedicalDevices/Safety/Reportal good of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Y ou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Kodak DirectView CR Mammography System

Special 510(k); Carestream Health, Inc.

Indications for Use

510(k) Number (if known):

Device Name:

KODAK DirectView CR Mammography System

Indications for Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-C
(21 CFR §

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

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

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices

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Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.