The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide highresolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.

Device Description

The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide highresolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.

The subject device and predicate devices use the same technical design base. The printers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK DRYVIEW imaging media is removed from a daylight cartridge and transported to the laser imaging station. Image data and media merge at the laser station and the film is scanned. The exposed media is transported through the integrated processor and exits the printer.

Software is used to control the image management and machine functions. AIQC (Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.

AI/ML Overview

The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide high-resolution hard copy images from digital imaging source output signals for medical diagnosis and referral to physicians and their patients.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety and Effectiveness	Compliance with voluntary standards	Assured via meeting voluntary standards: DICOM, SMPTE, UL 60950, IEC 60601-1-1, IEC 60825-1, ISO 12207, ISO 14971.
Equivalence to Predicate Device	Same safety standards as predicate	Designed to equivalent safety standards as KODAK DRYVIEW 8900 with Mammography Accessory.
Consistency of Image Quality	Assure consistency between input signals and output density	Incorporates a test pattern generator and Automatic Image Quality Control (AIQC) system.
High Resolution Printing	High resolution printing capability	Described as a "high resolution printer."
Quality Assurance Testing	Tools for MQSA quality assurance testing	Incorporates test patterns to assist in MQSA quality assurance testing.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly describe a formal "test set" in the context of clinical or performance data. The evaluation of the device relied on compliance with standards and a comparison to a predicate device. Therefore, no information is available regarding:

Sample size for a test set.
Country of origin of data.
Retrospective or prospective nature of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the document does not describe a study involving a "test set" that required expert establishment of ground truth for a diagnostic outcome. The device is a printer, and its performance evaluation focused on technical specifications and output quality.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or reported in the provided document. The focus was on the device's technical performance and equivalence to a predicate, not on how its use might impact human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is a standalone device in the sense that its primary function is to print images based on digital inputs. However, the document does not describe a "standalone study" in the common understanding of an algorithm's diagnostic performance without human interaction. Instead, it describes technical performance and image quality as objectively measured and compared to standards and a predicate device.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the technical specifications and image quality standards that the device is designed to meet, as well as the performance characteristics of the predicate device. It's about how accurately the printer reproduces digital images, not about diagnostic accuracy of the images themselves. The document states that "Medical personnel review images displayed by the subject device and its predicate. This offers ample opportunity for competent human intervention in case of a malfunction or other failure." This implies the ultimate "ground truth" for diagnostic purposes remains with the human medical expert reviewing the printed image.

8. Sample Size for the Training Set

This information is not applicable. The device is a hardware printer with software control, not an AI/ML algorithm that undergoes "training" with a dataset in the typical sense. Its design and automated functions (like AIQC) are built-in, not learned from a training set of images.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8. The "ground truth" for its internal calibration and quality control (AIQC) would be factory-set parameters and established film characteristics.

Summary

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K090469
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510(k) Summary

May 20, 2009

MAY 22 2009

CARESTREAM Health, Inc. 150 Verona Street Rochester NY 14608

Contact: Gayle Carroll 1 Imation Wav Oakdale, MN 55128 Phone: 651-393-1501 FAX: 651-393-1160

Device

Trade name:	CARESTREAM DRYVIEW 5850 Laser Imager
Common name:	Laser Printer
Classification name:	Medical Image Hardcopy Device (21 CFR 892.2040)

Predicate device

Kodak DRYVIEW 8900 Laser Imager with Mammography Accessory (K033821)

Description and Intended Use of Device

The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide highresolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.

Technological Characteristics

Performance Data

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K090469
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Safety and effectiveness are assured via meeting voluntary standards, including: DICOM, SMPTE, UL 60950, IEC 60601-1-1, IEC 60825-1, ISO 12207 and ISO 14971.

Conclusion

The subject device, like the predicate, has no patient contact. The device does not control, monitor or otherwise affect any devices directly connected to or affecting the patient. Medical personnel review images displayed by the subject device and its predicate. This offers ample opportunity for competent human intervention in case of a malfunction or other failure.

The subject CARESTREAM DRYVIEW 5850 Laser Imager and predicate device KODAK DRYVIEW 8900 with Mammography Accessory have both been designed to the equivalent safety standards. As with the predicate device, a test pattern generator and automatic image quality control (AIQC) system are incorporated to assure consistency between input signals and output density. Both are high resolution printers with incorporated test patterns to assist in MQSA quality assurance testing.

Carestream Health therefore concludes that the CARESTREAM DRYVIEW 5850 Laser Imager is as safe and 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAY 22 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Gayle Carroll Regulatory Affairs Manager Carestream Health, Inc. 1 Imation Way, 304-4B-28 OAKDALE MN 55128-3414

Re: K090469

Trade/Device Name: Carestream DRYVIEW 5850 Laser Imager · Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: February 20, 2009 Received: February 23, 2009

Dear Ms. Carroll:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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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.

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting 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): __

K090469

Device Name: Carestream DRYVIEW 5850 Laser Imager

Indications for Use:

Prescription Use V (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulu Palmer

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

Regulation Number and Section

§ 892.2040 Medical image hardcopy device.

(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.