(29 days)
K032401, KO31590
Not Found
No
The description focuses on basic image overlay, measurement tools, and digital templating, with no mention of AI/ML terms or functionalities typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, prediction, or analysis based on learned patterns). The performance study compares digital templating to traditional methods, not AI-driven analysis.
Yes.
The device assists healthcare professionals in preoperative planning of orthopedic surgery, which is a medical purpose aimed at guiding patient treatment.
No
The device assists in preoperative planning of orthopedic surgery by overlaying templates and performing measurements, which is a planning tool, not a diagnostic one. It does not identify or confirm the presence of a disease or condition.
Yes
The device description explicitly states that TraumaCAD is a "software application" and can be used as "standalone software" on a workstation or PC. It does not mention any accompanying hardware components that are part of the medical device itself. While it interacts with other systems for image acquisition and storage, and relies on prosthetic templates from manufacturers, the core device being submitted for 510(k) is the software for preoperative planning.
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.
- TraumaCAD's Function: TraumaCAD is a software program used for preoperative planning of orthopedic surgery. It works with radiological images (like X-rays) and prosthesis templates. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states assisting healthcare professionals in preoperative planning of orthopedic surgery, not diagnosing or monitoring a condition through in vitro testing.
- Device Description: The description reinforces its use with medical images and prosthesis templates for surgical planning.
- Image Processing System: The mention of "Image Processing System" (892.2050) further indicates its function is related to manipulating and analyzing medical images, not biological samples.
Therefore, TraumaCAD falls under the category of medical imaging software used for surgical planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TraumaCAD program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
TraumaCAD is a software application to be used by licensed physicians for preoperative planning of orthopedic surgical procedures. The application can be used in a workstation or in a PC as standalone software.
The system allows the physician to import medical images, and to overlay them with templates of medical prosthesis and to perform measurements to facilitate surgical planning. The surgical plan is available on the hospital network, and can be sent to the Operating Room prior to surgery.
The TarumaCAD does not have any image acquisition or image storage functionality, this is the responsibility of the systems alongside which TraumaCAD. In addition the system does not specify the requirements for the prosthetic template - this is the responsibility of the prosthetic manufacturer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiological images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physicians / workstation or PC, hospital network, Operating Room
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)
A study entitled "The Accuracy of Digital (filmless) Templating in Total Hip Replacement" was performed comparing pre-operative planning methods for total hip procedures. 20 cases planned using standard acetate overlays and radiographs were compared with 20 cases using TraumaCAD to perform digital preoperative planning.
It was found that using standard templating, sixty percent of implanted stems were the same size as templated, 30 percent were within one size, and 10 percent were within 2 sizes. With digital templating 65 percent were the same size, 23 percent were within 1 size and 11 percent were within two sizes. For acetabular components using acetate overlays, 40 percent of implanted cups were the same size as templated, 30 percent were within 2 mm, and 30 percent within 4 mm. Digitally, 47 percent were the identical size, 47 percent were within 2 mm, and 6 percent within 4mm. All postoperative films show good fit of the components and there were no intraoperative or postoperative fractures.
Thus the non-clinical testing of the pre-operative planning using TraumaCAD produces results comparable to planning using acetate overlays with the additional advantages of digital planning including ease of use, improved case documentation, access to a wider arrange of tools, and greater accessibility.
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.
K032401, KO31590
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
NOV 1 0 2004
510(k) Summary of Safety and Effectiveness
The Following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).
807.92(a)(1) - Submitter Details:
| Submitter name | OrthoCrat Ltd |
|---|---|
| Address: | Bar Kochva 34/3 |
| Tel Aviv | |
| Israel | |
| Phone: | |
| Fax: | +972 3 7255731 |
| E-mail: | zeev@orthocrat.com |
| Contact Person: | Adi Ickowicz |
| MedicSense Ltd | |
| P.O.B 367 | |
| Ramat Hasharon | |
| Israel | |
| Phone: +972 3 9233666 | |
| Fax: + 972 3 923 1274 | |
| E mail: adi@medicsense.com | |
| Date: | August 18, 2004 |
1
807.92(a)(2) - Device Details:
| Trade Name | TraumaCAD Release 1.00 |
|---|---|
| Common Name | Picture Archiving and Communication |
| (PACS) System | |
| Classification | 892.2050 Image Processing System |
| Class | II |
| Product Code | LLZ |
807.92(a){3) - Predicate Devices:
| Medical Device
Name | Applicant Name | 510(k)
Number | Classification |
|------------------------------|------------------------|------------------|-------------------------------|
| Orthoview | Meridian Technique Ltd | K032401 | Class II, Product
code LLZ |
| Sectra Orthopedic
Package | Sectra Imtec AB | KO31590 | Class II, Product
code LLZ |
Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.
2
SEP 28 2004
807.92(a)(4) - Device Description:
Device Functions:
TraumaCAD is a software application to be used by licensed physicians for preoperative planning of orthopedic surgical procedures. The application can be used in a workstation or in a PC as standalone software.
The system allows the physician to import medical images, and to overlay them with templates of medical prosthesis and to perform measurements to facilitate surgical planning. The surgical plan is available on the hospital network, and can be sent to the Operating Room prior to surgery.
The TarumaCAD does not have any image acquisition or image storage functionality, this is the responsibility of the systems alongside which TraumaCAD. In addition the system does not specify the requirements for the prosthetic template - this is the responsibility of the prosthetic manufacturer.
807.92(a)(5) — Device Intended Use:
The TraumaCAD program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.
Non-Clinical Testing
A study entitled "The Accuracy of Digital (filmless) Templating in Total Hip Replacement" was performed comparing pre-operative planning methods for total hip procedures. 20 cases planned using standard acetate overlays and radiographs were compared with 20 cases using TraumaCAD to perform digital preoperative planning.
9
3
It was found that using standard templating, sixty percent of implanted stems were the same size as templated, 30 percent were within one size, and 10 percent were within 2 sizes. With digital templating 65 percent were the same size, 23 percent were within 1 size and 11 percent were within two sizes. For acetabular components using acetate overlays, 40 percent of implanted cups were the same size as templated, 30 percent were within 2 mm, and 30 percent within 4 mm. Digitally, 47 percent were the identical size, 47 percent were within 2 mm, and 6 percent within 4mm. All postoperative films show good fit of the components and there were no intraoperative or postoperative fractures.
Thus the non-clinical testing of the pre-operative planning using TraumaCAD produces results comparable to planning using acetate overlays with the additional advantages of digital planning including ease of use, improved case documentation, access to a wider arrange of tools, and greater accessibility.
4
| Parameter | OrthoView | Sectra Orthopedic
Package | TraumaCAD |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------|
| Computer | PC Compatible | Part of workstation
and PC compatible | PC Compatible |
| Operating System | Windows | Same | Same |
| Image input | Can receive digital
images from
various sources | Same | Same |
| Number of
images that can
be simultaneously
viewed on the
screen | Four | One | One |
| Runs on server | Yes | Yes | Yes |
| Trauma module | No | No | Yes |
| Osteotomy
module | No | No | Yes |
| Digital Prosthetic
templates | Template overlay
capability
Interactive
template
positioning
Automatic Scaling
Template support
from
manufacturers
Permits template
rotation | Same | Same |
| Pre-operative
planning | Allowed | Same | Same |
| Patient contact | None | Same | Same |
| Control of life-
saving devices | None | Same | Same |
| Human
intervention for
interpretation and
manipulation of
images | Required | Same | Same |
| Ability to add
additional
modules when
available | Yes | Yes | Yes |
807.92(a)(6) – Substantial Equivalence Comparison Table:
5
Technological Characteristics
TraumaCAD will run on Windows 2000 or Windows XP.
Performance Data
The subject device is developed according to IS0 9001 :2000.
Conclusion
Similar to the predicate devices the TraumaCAD does not control life-sustaining equipment or contact the patient and does not alter the source data and original image. In addition all three require intervention of trained medical for process and interpretation of the images.
Based on the information supplied in this 510(k), we conclude that this device is safe, effective, and substantially equivalent to the predicate devices.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes extending from its body, representing health, human services, and well-being. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2004
Orthocrat, Ltd. 1% Mr. Robert Mosenkis President Citech Medical Device Testing and Consulting 5200 Butler Pike Plymouth Meeting PA 19462-1298 Re: K042816 Trade/Device Name: TraumaCAD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and
communications system
Regulatory Class: II Product Code: 90 LLZ Dated: October 28, 2004 Received: October 29, 2004
· Dear Mr. Mosenkis:
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 do not require approvial or wisions 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 (Premarket n Jour av 100 ho 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 complies with other requirements of the Act or any Federal statues 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 / 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.
7
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 a legal This letter will allow you to begin marketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA finding of substantial of 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 If you desire specific advice for your device on our laboring regulation (
contact the 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 prematic notification" (21 CFR Also, please note the regulation entitled, "Whisonation on your responsibilities under the Act from the 180 807.97). You may obtain other general manon on Juner Assistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumers of Manufacturers, Division of Small Manufacturers, International and Consulter Particle.
638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmadsmamain.html
Sincerely yours,
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
8
2. STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
TraumaCAD Device Name:
Indication For Use:
The TraumaCAD program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _