(53 days)
Not Found
No
The description focuses on standard image manipulation, measurement, and template overlay features, with no mention of AI, ML, or automated decision-making based on learned patterns.
No
Explanation: The device is described as a software accessory for image review, manipulation, analysis, and therapy planning, specifically for orthopedic surgical planning. Its functions include making measurements and displaying implant templates, all of which aid in planning and review but do not directly treat a patient's condition. While it supports therapy planning, it is not therapy itself.
Yes
The "Diagnostic Review Workstations" section explicitly states that the workstations are "designed to assist radiologists and surgeons in conducting primary diagnostic review."
Yes
The device is described as a "software accessory" and a "line extension of Cedara's medical image processing workstation product," which is also implied to be primarily software-based ("Medical Imaging Family of Workstations"). The description focuses on software features like measurements and template overlays, with no mention of specific hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a software accessory for a medical image processing workstation. Its primary function is to review, manipulate, analyze, and plan based on medical images (like X-rays, CT scans, etc.). It uses these images for diagnostic review and surgical planning, including measurements and implant templating.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from a patient. Its input is image data, not biological specimens.
Therefore, the device falls under the category of medical imaging software and workstations, not In Vitro Diagnostics.
N/A
Intended Use / 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.)"
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multi-modality softcopy images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professional, radiologists and surgeons, physicians. within and outside the hospital.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
102 2881
B. Administrative Information
| 1. | 510(k) Summary | OCT 22 2002 |
|---|---|---|
| Submitter: | Cedara Software Corporation | |
| Address: | 6509 Airport Road | |
| Mississauga, Ontario | ||
| Canada 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; Agfa | |
| ADC Compact Plus 510(k) No. K013138; ISG Medical Imaging | ||
| Family of Workstations, 510(k) No. K941933. | ||
| 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. |
Indications for Use:
"Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the
1
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.
2
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.
3
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
4
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 | 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