CEDARA I-SOFTVIEW

K022881 · Cedara Software Corp. · LLZ · Oct 22, 2002 · Radiology

Device Facts

• Record ID: K022881
• Device Name: CEDARA I-SOFTVIEW
• Applicant: Cedara Software Corp.
• Product Code: LLZ · Radiology
• Decision Date: Oct 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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. 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 Story

Cedara I-SoftView is a medical image processing software workstation. It accepts multi-modality medical images as input. The software provides tools for 2D and 3D image review, manipulation, and analysis. The Orthopedic Tool Set module allows clinicians to perform measurements (circle, line, angle) and display electronic implant templates to assist in surgical planning, specifically for implant size and positioning. Used by radiologists and surgeons in hospitals or remote locations for diagnostic review and therapy planning. Output is displayed on the workstation screen to aid clinical decision-making regarding surgical procedures and patient treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based medical image processing workstation. Features include 2D/3D image manipulation, measurement tools (circle, line, angle), and electronic prosthetic template overlays. Operates as a multi-modality softcopy display system. Connectivity supports hospital-wide and remote (teleradiology) access.

Indications for Use

Indicated for radiologists and surgeons requiring 2D/3D image review, manipulation, analysis, and therapy planning for multi-modality medical images. Supports diagnostic review, surgical planning, and remote access via teleradiology/teleconferencing.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Sectra IDS5 image Display System (K002936)
• Agfa ADC Compact Plus (K013138)
• ISG Medical Imaging Family of Workstations (K941933)

Submission Summary (Full Text)

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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 Road<br>Mississauga, Ontario<br>Canada L4V 1S7 | |
| Contact: | Carol Nakagawa. | |
| Telephone: | [phone]. | |
| Date: | August 29, 2002. | |
| Trade Names: | Cedara I-SoftView™; Cedara Orthopedic Tool Set; Cedara I-<br>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; Agfa<br>ADC Compact Plus 510(k) No. K013138; ISG Medical Imaging<br>Family of Workstations, 510(k) No. K941933. | |
| Device Description: | The Cedara Orthopedic tool set is a new option available in the<br>Cedara I-SoftView product which is a line extension of Cedara's<br>medical image processing workstation product, "Medical Imaging<br>Family of Workstations". The Cedara Orthopedic tool set is a<br>software accessory that will be typically used for orthopedic<br>applications and consists of features that allow the qualified<br>medical professional to make measurements that are commonly<br>required when doing orthopedic surgical planning. In addition to<br>circle, line and angle measurements, the physician can also display<br>electronic implant templates that can aid in implant size and<br>positioning 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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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 |
|------|--------|
|------|--------|

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."

"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.)"

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span></span> | 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