(105 days)
Not Found
No
The document describes software for pre-operative planning using existing images and a database of implants. It mentions image processing but does not contain any terms or descriptions indicative of AI or ML technology being used for analysis, prediction, or automated decision-making beyond standard software functions.
No
The device is a pre-operative planning software for orthopedic surgeries and provides comprehensive data for treatment and therapy, but it does not directly administer therapy or provide therapeutic treatment.
No
The device is described as a "medical stand-alone software" for "preoperative measurements" and "planning of orthopedic surgeries" using diagnostic images. Its primary function is to aid surgeons in planning rather than to perform a diagnosis itself.
Yes
The device is explicitly described as a "medical stand-alone software" and its function is entirely based on processing and manipulating digital images and data, without any mention of accompanying hardware components required for its primary function.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The mediCAD classic V3.0 is a software used for preoperative planning based on medical images (x-rays). It helps surgeons measure and plan orthopedic surgeries by overlaying implant geometries onto these images.
- Input: The input is diagnostic images (x-rays), not biological samples from the patient.
- Output: The output is a digital surgical plan, not a diagnostic result derived from analyzing biological material.
The software is a medical device used in the planning and assessment of surgical procedures, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The mediCAD classic V3.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays. The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to their planning of orthopedic surgeries. mediCAD classic 3.0 can hand over the digital plannings as DICOMs to PACS-systems. Federal law restricts this device to sale by or on the order of a health professional.
mediCAD will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The system is designed for the following medical specialties:
- Orthopedics
- Surgery and Traumatology .
- . Rheumatology
- Pediatric Orthopedics
MediCAD is designed for pre-operative planning for the following applications:
- Hip Manual Planning
- Hip Automatic Planning .
- Hip Biometry
- Hip Coxometry
- Hip Wear Measurement
- Hip FAI
- Knee Prosthetic Planning
- Biometry Planning -takes into account patient motion and metrics
- Coxomery tracking of known measurement values in pediatrics to determine surgical intervention
- Osteotomy determines optimum osteotomy locations
- Osteotomy by Dror Paley
- Osteotomy (DualSide)
- Spine
- Foot
- Upper Extremities
- Biological Age Determination by Hand
- Trauma
Product codes
LLZ
Device Description
Concentrating within the specialty of joint replacement, mediCAD 3.0 will provide an orthopedic surgeon with the ability to produce pre-surgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, mediCAD provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper presurgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.
The device has been designed and manufactured to conform to the following standards: Digital Imaging and Communications in Medicine (DICOM) V3.0, ISO/IEC 90003:2004 Software engineering - Guidelines for the application of ISO 9001:2000 to Computer software. ISO 14971:2007 Application of Risk Management of Medical Devices and ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays
Anatomical Site
Hip, Knee, Spine, Foot, Upper Extremities, Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health professional / Not Found
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)
Verification testing have been executed by Hectec-employees to ensure that the requirement specifications have been fulfilled. Validation testing through professional medics in clinical environment confirm that the device meets performance, measurement and usability requirements. No clinical trials were performed in the development of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K1408434
page 1 of 4
TRADITIONAL 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
JUN 0 5 2014
Submitted by: Hectec GmbH Ottostr. 16 84030 Landshut GERMANY
A. Date Prepared
May 20, 2014
B. Device Name and Classification
| Trade Name: | mediCAD classic V3.0 |
|---|---|
| Common Name | Software for Clinical Use |
| Classification Name: | Software for Clinical Use |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.2050 (radiology.picture archiving |
| and communications system) | |
| 21 CFR 888.4800 (orthopedic devices.template | |
| for clinical use) | |
| Device Class: | Class II |
| Device Code: | LLZ (system, image processing, radiological) |
Contact: Thomas Wengenmayer, quality management representative and requlatory affairs representative HECTEC GmbH Phone: +49 871 142370-0 FAX: +49 871 142370-9 Email: thomas.wengenmaver@hectec.eu
C. Device Intended Use
The mediCAD classic V3.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays. The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD classic 3.0 can hand over the digital plannings as DICOMs to PACS-systems. Federal law restricts this device to sale by or on the order of a health professional.
mediCAD will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Intearating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The system is designed for the following medical specialties:
- Orthopedics .
- . Surgery and Traumatology
1
- Rheumatology t
- . Pediatric Orthopedics
MediCAD is designed for pre-operative planning for the following applications:
- Hip Manual Planning .
- Hip Automatic Planning t
- Hip Biometry .
- . Hip - Coxometrv
- . Hip - Wear Measurement
- . Hip - FAI
- Knee Prosthetic Planning .
- Biometry Planning takes into account patient motion and metrics .
- Coxometry tracking of known measurement values in pediatrics to . determine surqical intervention
- . Osteotomy - determines optimum osteotomy locations
- . Osteotomy bv Dror Palev
- Osteotomy (DualSide)
- Spine
- Foot
- Upper Extremities
- Biological Age Determination by Hand
- Trauma
D. Device Description
Concentrating within the specialty of joint replacement, mediCAD 3.0 will provide an orthopedic surgeon with the ability to produce pre-surgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, mediCAD provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper presurgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.
The device has been designed and manufactured to conform to the following standards: Digital Imaging and Communications in Medicine (DICOM) V3.0, ISO/IEC 90003:2004 Software engineering - Guidelines for the application of ISO 9001:2000 to Computer software. ISO 14971:2007 Application of Risk Management of Medical Devices and ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
E. Substantial Equivalence Summary
The mediCAD 3.0 is substantially equivalent to AGFA's IMPAX Orthopedic Tool (FDA Clearence # K071972. Clearence Date 07/30/2007) for equal modules as the same software coding is used. Since the clearance date of AGFA's IMPAX
2
Orthopedic Tool, the modules Osteotomy dual side and hip FAI (femoroacetabular-impingement) have been added.
For claiming substantial equivalence, TraumCad (K073714) has been used for further discussion and argumentation. Modules that are not components of the predicates have been subject to thorough testing. Performance has been proven through underlying medical literature and validation through health professionals.
| | mediCAD
classic
3.0 | TraumaCad
2.0 | AGFA
IOT |
|--------------------------------------------|---------------------------|------------------|-------------|
| Hip - Manual
Planning | ☑ | ☑ | ☑ |
| Hip - Automatic
Planning | ☑ | ☑ | ☑ |
| Hip - Biometry | ☑ | | ☑ |
| Hip - Coxometry
/ Pediatrics | ☑ | ☑ | ☑ |
| Hip - Wear
Measurement | ☑ | ☑ | |
| Hip - FAI | ☑ | | |
| Knee | ☑ | ☑ | ☑ |
| Osteotomy | ☑ | ☑ | ☑ |
| Osteotomy by
Dror Paley | ☑ | | ☑ |
| Osteotomy
(DualSide) | ☑ | ☑ | |
| Intertrochanteric
Osteotomy | ☑ | | |
| Spine | ☑ | ☑ | ☑ |
| Foot | ☑ | ☑ | ☑ |
| Upper
Extremities | ☑ | ☑ | ☑ |
| Biological Age
Determination by
Hand | ☑ | | |
| TAYLOR
SPATIAL
FRAME (TSF) | | ☑ | |
| Trauma | ☑ | ☑ | ☑ |
Table 1: Predicate Device Comparison
3
K140434
Page 4 of 4
F. Comparison of Technological Differences:
MediCAD and its predicate devices are stand-alone software that can connect to PACS. Microsoft Windows is intended as operating system. Only scaling technologies differ. Nevertheless MediCAD's scaling method is as precise as the scaling methods of its predicate devices. Predicate devices also use an implant library in order to overlay them with digitized x-rays.
G. Testing
Verification testing have been executed by Hectec-employees to ensure that the requirement specifications have been fulfilled. Validation testing through professional medics in clinical environment confirm that the device meets performance, measurement and usability requirements. No clinical trials were performed in the development of the device.
The device has been designed and manufactured to conform to the following standards:
-
ISO 14971:2012 Application of Risk Management to Medical Devices
-
ISO 13485:2010 Medical Devices - Quality Management Systems -Requirements for Regulatory purposes
H. Conclusion
This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2014
Hectec GmbH % Mr. Thomas Wengenmayer Quality Assurance Representative Ottostr, 16 Landshut, Bavaria 84030 GERMANY
Re: K140434 Trade/Device Name: mediCAD Classic 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 1.LZ Dated: May 19, 2014 Received: May 28, 2014
Dear Mr. Wengenmayer:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a move 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 for use stated in the enorosals) to regard cate of the Medical Device Amendments, or 10 conninered prof to thay 20, 7779) 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 Tou may, merciole, market the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (sec 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 It may be subject to additions. 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 that I DA has made a deter regulations administered by other Federal agencies. You must of any I catal statives and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the clectronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2-Mr. Wengenmayer
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Àpproved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140434
Device Name
mediCAD classic 3.0
Indications for Use (Describe)
The mediCAD classic V3.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays. The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to their planning of orthopedic surgeries. mediCAD classic 3.0 can hand over the digital plannings as DICOMs to PACS-systems. Federal law restricts this device to sale by or on the order of a health professional.
mediCAD will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.
The system is designed for the following medical specialties:
- Orthopedics
- Surgery and Traumatology .
- . Rheumatology
- Pediatric Orthopedics
MediCAD is designed for pre-operative planning for the following applications:
- Hip Manual Planning
- Hip Automatic Planning .
- Hip Biometry
- Hip Coxometry
- Hip Wear Measurement
- Hip FAI
- Knee Prosthetic Planning
- Biometry Planning -takes into account patient motion and metrics
- Coxomery tracking of known measurement values in pediatrics to determine surgical intervention
- Osteotomy determines optimum osteotomy locations
- Osteotomy by Dror Paley
- Osteotomy (DualSide)
- Spine
- Foot
- Upper Extremities
- Biological Age Determination by Hand
- Trauma
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm