The CDP 5000 is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).

The CDP 5000 receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources).

Users of CDP 5000 can perform the following tasks:

Query and retrieve images from the CDP 5000 Archive, using u any third party workstation capable of performing DICOM query/retrieve functions.
Use DIAGNET network viewer to search, retrieve and . manipulate patient images.
Create DICOM compliant portable media (i.e. CD-R) I containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application.

Tasks that users of DIAGNET may perform include, but are not limited to: navigation; adjustment of window width and level; image stacking; measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR (Multi-Planar Reformatting).

Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians, technologist, and others.

Device Description

Users of CDP 5000 can perform the following tasks:

. Query and retrieve images from the CDP 5000 Archive, using any third party workstation capable of performing DICOM query/retrieve functions.
L Use DIAGNET network viewer to search, retrieve and manipulate patient images.
. Create DICOM compliant portable media (i.e. CD-R) containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application.

Tasks that users of DIAGNET may perform include, but are not limited to: navigation; adjustment of window width and level; image stacking: measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR (Multi-Planar Reformatting).

Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist, and others.

The CDP 5000 Ensemble is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The DIAGNET Viewer software, which is copied to every CD produced, runs automatically when the CD is placed in any Windows-based PC; it allows the examinee to view, manipulate, perform measurements on, and post-process the received images. The images can then be saved, copied, and/or sent to a file, emailed, or included in a report in process.

AI/ML Overview

The provided document for CDP Ltd.'s CDP 5000 is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies with acceptance criteria in the way one would see for a novel AI/CAD device.

Based on the provided text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Functional Equivalence	Device functions as intended for receiving, managing, archiving, distributing, and recording medical images onto portable digital media.	"In all instances, the CDP 5000 functioned as intended and the results observed were as expected."
DICOM Compliance	Ability to create DICOM compliant portable media and query/retrieve images using DICOM functions.	"Create DICOM compliant portable media" and "Query and retrieve images... using any third party workstation capable of performing DICOM query/retrieve functions."
Image Viewing & Manipulation	DIAGNET viewer allows for navigation, adjustment of window width and level; image stacking; measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR.	"Allows the examinee to view, manipulate, perform measurements on, and post-process the received images." Specific features listed in the 'Indication for Use' are implicitly met.
Substantial Equivalence	Device is substantially equivalent to eFilm Medical Inc.'s eFilm Workstation with Modules (K020995) and raises no new safety or effectiveness issues.	"The CDP 5000 is substantially equivalent to the currently marketed eFilm Medical Inc.'s eFilm Workstation with Modules... The CDP 5000 and its predicate device are both picture archiving communications systems. Thus, the CDP 5000 raises no new issues of safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a sample size for a test set, nor does it provide information about data provenance. The "Performance Data" section simply states that "Performance tests were performed by CDP Ltd. on the CDP 5000." This suggests internal testing, but no details on the data used are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts or the establishment of ground truth in the context of performance testing. This type of detail is typically associated with evaluating diagnostic accuracy, which is not the primary focus of this device's 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The CDP 5000 is a PACS (Picture Archiving Communications System) and not an AI or CAD device designed to assist in diagnostic interpretation, so such a study would not be relevant to its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The CDP 5000 is a software application for image management, not a diagnostic algorithm. Therefore, a "standalone algorithm only" performance study, as typically understood for AI/CAD, was not performed or reported. Its performance is demonstrated through its ability to perform its defined functions (receiving, managing, archiving, etc.).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not specify any type of "ground truth" as it would be understood for an AI/CAD diagnostic device. The performance tests appear to be functional in nature, verifying that the system performs its intended operations correctly (e.g., images are received, archived, and displayed as expected).

8. The sample size for the training set

The document does not mention a training set. This device is an image management system and does not appear to utilize machine learning for diagnostic purposes.

9. How the ground truth for the training set was established

Not applicable, as no training set or machine learning component is described.

Summary

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KC72960
Page 1 of 3

510(k) SUMMARY

CDP Ltd.'s CDP 5000

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

CDP Ltd. 23 Efal Street Kiriat Arie Petach Tikva, ISRAEL P.O. Box 3325 Zip Code 49130 Ph. +972-3-9191940 Fx. +972-3-9241023

NOV 0 8 2007

Contact Person: Doron David

Date Prepared: June 5, 2007

Name of Device and Name/Address of Sponsor

CDP 5000, Media & Distribution Center, DiagNET

23 Efal Street Kiriat Arie Petach Tikva, ISRAEL P.O. Box 3325 Zip Code 49130 Ph. +972-3-9191940 Fx. +972-3-9241023

Common or Usual Name

Picture Archiving Communications System (PACS)

Classification Name

Image Processing system Product Code LLZ -- 21 CFR 892.2050

Predicate Device

eFilm Medical Inc. eFilm Workstation with Modules, K020995, for image viewing and manipulation.

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KC7296C
Page 2 of 3

Users of CDP 5000 can perform the following tasks:

. Query and retrieve images from the CDP 5000 Archive, using any third party workstation capable of performing DICOM query/retrieve functions.
L Use DIAGNET network viewer to search, retrieve and manipulate patient images.
. Create DICOM compliant portable media (i.e. CD-R) containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application.

Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist, and others.

Technological Characteristics and Substantial Equivalence

SUMMARY OF TECHNICAL DEVICE DESCRIPTION AND SPECIFICATIONS

The CDP 5000 is substantially equivalent to the currently marketed eFilm Medical Inc.'s eFilm Workstation with Modules, which was referenced above. The CDP 5000 and its predicate device are both picture archiving communications systems. Thus, the CDP 5000 raises no new issues of safety or effectiveness.

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K072960
Page 3 of 3

Performance Data

Performance tests were performed by CDP Ltd. on the CDP 5000. In all instances, the CDP 5000 functioned as intended and the results observed were as expected.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus in the seal is depicted with three intertwined strands and a stylized bird-like figure at the top.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 8 2007

CPD, Ltd. % Mr. Harry van Vugt Official Correspondent KEMA Quality B.V. 4377 County Line Road CHALFONT PA 18914

Re: K072960

Trade/Device Name: CPD 5000/MEDIA & Distribution Center and Diagnet Client Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 15, 2007 Received: October 19, 2007

Dear Mr. van Vugt:

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.

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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

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Indication for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: CDP 5000/MEDIA & DISTRIBUTION CENTER and

DIAGNET CLIENT

Indication for Use:

Users of CDP 5000 can perform the following tasks:

Query and retrieve images from the CDP 5000 Archive, using u any third party workstation capable of performing DICOM query/retrieve functions.
Use DIAGNET network viewer to search, retrieve and . manipulate patient images.
Create DICOM compliant portable media (i.e. CD-R) I containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application.

Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians, technologist, and others.

20729

Prescription Use X	Over-the-Counter Use
(Part 21 CFR 801 Subpart D)	(21 CFR 801 Subpart C)

(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices 11072660510(k) Number _

Regulation Number and Section

N/A