The KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory is intended to provide high-resolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW DVM film for use with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology) and FFDM (Full Field Digital mammography). The images are to be used for medical diagnosis medical and referring physicians and their patients.

Device Description

The KODAK DRYVIEW 8900 Laser Imager Mammography Accessory's intended use is as a hard copy device for output from imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the 8900 and transformed optically to expose KODAK DRYVIEW imaging media. The system is intended for use with a variety of digital modalities, including, but not limited to CR, DR, CT, MR, Ultrasound, Nuclear Medicine, FFDM etc. for diagnostic use by medical radiologists and communications to referring 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 provided text describes a 510(k) summary for the KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory. This document outlines the device's intended use and technological characteristics, and importantly, references performance data related to its safety and effectiveness. However, it does not detail specific acceptance criteria or a study demonstrating the device meets those criteria in the way typically expected for an AI/ML medical device.

The "Performance Data" section states that "Safety and effectiveness are assured via meeting voluntary standards, including: DICOM, SMPTE, UL 60950, IEC 60601-1-1-1, IEC 60825-1, ISO 12207, and ISO 14971." This indicates that compliance with these established standards serves as the basis for demonstrating safety and effectiveness, rather than a novel clinical or algorithmic performance study with specific acceptance metrics.

This device is a hard copy device (laser printer) for medical images, not an AI/ML diagnostic or prognostic algorithm. Therefore, the questions related to AI performance metrics, ground truth, expert adjudication, training/test sets, and human-in-the-loop assessments are not applicable to this type of device submission.

Here's a breakdown based on the information provided, recognizing the nature of the device:

Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific quantitative acceptance criteria or device performance metrics in the format usually associated with diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it relies on compliance with broader industry and safety standards to assure performance.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with DICOM standard for medical imaging communication	Assured via meeting DICOM voluntary standard.
Compliance with SMPTE standard for display performance	Assured via meeting SMPTE voluntary standard.
Compliance with safety standards (UL, IEC, ISO)	Assured via meeting UL 60950, IEC 60601-1-1-1, IEC 60825-1, ISO 12207, and ISO 14971 voluntary standards.
Consistency between input signals and output density	Assured by the incorporation of a test pattern generator and an Automatic Image Quality Control (AIQC) system. "AIQC (Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality." Both the subject and predicate devices are high-resolution printers with incorporated test patterns to assist in MQSA (Mammography Quality Standards Act) quality assurance testing.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This is not a study assessing diagnostic performance on a dataset of patient images.
- Data Provenance: Not applicable.
Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable, as this is a device for outputting images, not an algorithm that generates diagnostic insights requiring ground truth.
Adjudication Method:
- Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is for evaluating diagnostic performance of an AI system, which is not the function of this device. The document mentions that "Medical personnel review images displayed by the subject device and its predicates," indicating human interpretation of the printed output.
Standalone Performance Study (Algorithm Only):
- Not applicable. This device is a printer, not a standalone algorithm. Its "software" controls image management and machine functions, and its AIQC system monitors output quality, but it does not perform diagnostic algorithms.
Type of Ground Truth Used:
- Not applicable. The performance assurance is based on adherence to engineering and safety standards, and the physical quality control of the printing process (AIQC, test patterns), rather than diagnostic accuracy against a clinical ground truth.
Sample Size for the Training Set:
- Not applicable. The device's functionality does not involve a "training set" in the context of machine learning.
How Ground Truth for the Training Set Was Established:
- Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" or rather, the evidence proving the device meets its acceptance criteria, is based on a demonstration of compliance with established industry and safety standards, and the inherent design features for quality control.

Reliance on Voluntary Standards: The primary method for assuring safety and effectiveness is by meeting voluntary standards such as DICOM, SMPTE, UL 60950, IEC 60601-1-1-1, IEC 60825-1, ISO 12207, and ISO 14971. These standards provide specifications for various aspects, including image communication, display performance, electrical safety, laser safety, software lifecycle processes, and risk management.
Technological Equivalence to Predicate Device: The submission emphasizes that the subject device (KODAK DRYVIEW 8900) uses the "same technical design base" as the predicate device (KODAK DRYVIEW 8610), which was already cleared. This "substantial equivalence" is a core tenet of the 510(k) pathway.
Intrinsic Quality Control Mechanisms: The device incorporates a "test pattern generator" and an "Automatic Image Quality Control (AIQC) system." The AIQC system "matches printing power with film characteristics to provide consistently high image quality." Both the subject and predicate devices include test patterns to help with MQSA quality assurance testing, which is crucial for mammography equipment. These features are designed to ensure the printer consistently reproduces high-quality images.

In essence, the "study" is an engineering and quality assurance process demonstrating that the device's design and built-in controls enable it to operate reliably and safely, adhering to recognized industry benchmarks for hardcopy medical imaging. It is not a clinical trial or an AI performance validation study.

Summary

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FEB 2 0 2004

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K033821
Page 1 of 2

510(k) Summary

November 26, 2003

Contact: Stephen Slavens Eastman Kodak Company 1 Imation Way, 304-3B-61 343 State Street Oakdale, MN 55128 Rochester NY 14650 Phone: 651-393-1395 FAX: 651-393-1440

Device:
Trade name:	KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory
Common name:	Laser Printer
Classification name:	Medical Image Hardcopy Device 21 CFR 892.2040
Predicate device:	Kodak DRYVIEW 8610 Laser Imager/ for Mammography (K002146)

Description And Intended Use of Device:

Technological Characteristics:

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K033821
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Performance Data:

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

Conclusion:

The subject device, like the predicate, has no patient contact. The devices also do 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 predicates. This offers ample opportunity for competent human intervention in case of a malfunction or other failure.

The subject KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory and predicate device KODAK DRYVIEW 8610 Laser Imager for mammography have both been designed to the equivalent safety standards. As with this 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.

Eastman Kodak therefore concludes that the KODAK DRYVIEW 8900 Laser Imager Mammography Accessory is as safe and effective as the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen Slavens Regulatory Affairs Director Eastman Kodak Health Imaging Group 1 Image Way 304-3B-61

Re: K033821

FEB 2 0 2004

Trade/Device Name: KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: December 4, 2003 Received: December 9, 2003

Dear Mr. Slavens:

OAKDALE MN 55127

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 (PMA), 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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.

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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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one 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
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogden

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

Enclosure

Page 2

to proceed to the market.

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Section B2

Statement of Indications for Use:

510(K) Number (if known)

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	/	OR	Over the Counter
Use

Nancy C Brogdon (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number	K033821
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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.