Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital.

Productivity-Enhancing Second Console Workstations – Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians.

Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modality softcopy images. This includes the use of prosthetic template overlays

Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.)

Device Description

The Cedara Orthopedic tool set is a new option available in the Cedara I-SoftView product which is a line extension of Cedara's medical image processing workstation product, "Medical Imaging Family of Workstations". The Cedara Orthopedic tool set is a software accessory that will be typically used for orthopedic applications and consists of features that allow the qualified medical professional to make measurements that are commonly required when doing orthopedic surgical planning. In addition to circle, line and angle measurements, the physician can also display electronic implant templates that can aid in implant size and positioning determination prior to surgery.

AI/ML Overview

The provided text is a 510(k) summary for the Cedara I-SoftView™ with Orthopedic Module, submitted to the FDA in 2002. This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing a specific clinical study with acceptance criteria and performance metrics of the device itself.

Therefore, the requested information regarding acceptance criteria, study performance, sample sizes, expert qualifications, ground truth establishment, and MRMC studies is not available within this document.

The document describes the device, its intended use, and compares it to predicate devices to argue for substantial equivalence based on technological characteristics and intended use, not based on a rigorous performance study against specific acceptance criteria.

In summary, the provided text does not contain the information needed to answer the request.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for CEDARA. The logo consists of the word "CEDARA" in a bold, sans-serif font. Above the word is a circular graphic made up of horizontal lines that are thicker in the middle and thinner at the top and bottom, giving the impression of a globe or sphere.

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B. Administrative Information

1.	510(k) Summary	OCT 22 2002
Submitter:	Cedara Software Corporation
Address:	6509 Airport RoadMississauga, OntarioCanada L4V 1S7
Contact:	Carol Nakagawa.
Telephone:	(905) 672-2100.
Date:	August 29, 2002.
Trade Names:	Cedara I-SoftView™; Cedara Orthopedic Tool Set; Cedara I-SoftView with Orthopedic Module
Common Name:	Medical Image processing software.
Classification Name:	Picture archiving and communications system.
Predicate Devices:	Sectra IDS5 image Display System 510(k) No. K002936; AgfaADC Compact Plus 510(k) No. K013138; ISG Medical ImagingFamily of Workstations, 510(k) No. K941933.
Device Description:	The Cedara Orthopedic tool set is a new option available in theCedara I-SoftView product which is a line extension of Cedara'smedical image processing workstation product, "Medical ImagingFamily of Workstations". The Cedara Orthopedic tool set is asoftware accessory that will be typically used for orthopedicapplications and consists of features that allow the qualifiedmedical professional to make measurements that are commonlyrequired when doing orthopedic surgical planning. In addition tocircle, line and angle measurements, the physician can also displayelectronic implant templates that can aid in implant size andpositioning determination prior to surgery.

Indications for Use:

"Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the

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Image /page/1/Picture/0 description: The image shows the word "CEDARA" in a bold, sans-serif font. Above the word is a circular design composed of many horizontal lines. The lines are not perfectly straight, giving the circle a slightly textured appearance.

medical environment from multiple locations within and outside the hospital."

"Productivity-Enhancing Second Console Workstations – Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians. "

"Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modality softcopy images. This includes the use of prosthetic template overlays"

"Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.)"

Comparison to The intended use and technological characteristics of Cedara I-Predicate: SoftView™ software are substantially equivalent, in the opinion of Cedara Software Corporation to those of the predicate devices and do not pose any new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a wavy line forming the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Nakagawa Manager of Regulatory Affairs Cedara Software Corporation 6509 AirPort Road Mississauga, Ontario CANADA, L4V 1S7

Re: K022881

Trade/Device Name: Cedara I-Soft View™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: August 29, 2002 Received: August 30, 2002

Dear Ms. Nakagawa:

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 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 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.

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This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Snogdon

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 Form

Page	1 of 1
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510(k) Number (if known):

KD22881

Device Name:

Cedara I-SoftView™

Indications For Use :

"Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K022881

510(k) Number

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(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).