(548 days)
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Not Found
No
The document describes software for pre-operative planning using measurements and an implant database, but does not mention AI or ML.
No
The device is a medical stand-alone software used for preoperative planning, measurements, and post-operative comparisons, not for providing direct therapy or treatment.
No
The device is described as a "medical stand-alone software" for "preoperative measurements" and "planning of orthopedic surgeries," which uses "diagnostic images" but does not itself perform diagnosis. Its purpose is to aid in surgical planning rather than to diagnose medical conditions.
Yes
The device description explicitly states "The mediCAD classic V4.0 is a medical stand-alone software". The intended use also refers to it as "a medical stand-alone software". There is no mention of accompanying hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of mediCAD classic V4.0 clearly states its purpose is to analyze and measure existing diagnostic images (x-rays and CT scans) of the patient's anatomy. It does not involve the analysis of blood, tissue, or other bodily fluids or substances.
- The intended use is for pre-operative planning and analysis of medical images. This falls under the category of medical image analysis and surgical planning software, not in vitro diagnostics.
The device's function is to aid surgeons in planning procedures based on imaging data, which is distinct from the diagnostic testing of biological samples that defines an IVD.
N/A
Intended Use / Indications for Use
The mediCAD classic V4.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). 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 4.0 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 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
- · Rheumatology
- · Pediatric Orthopedics
MediCAD is designed for pre-operative planning for the following applications:
- · Hip Manual Planning
- Hip Automatic Planning
- · Hip Biometry
- · Hip Intertrochanteric osteotomy
- · Hip Coxometry
- · 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 surgical intervention
- · Osteotomy determines optimum osteotomy locations
- Osteotomy by Dror Paley
- · Osteotomy (DualSide)
- · Spine
- Foot Hallux Valgus
- · Foot Ankle Joint
- · Upper Extremities
- · Biological Age Determination by Hand
- Trauma
- · Hip 3D
- · Spine 3D
Product codes
LLZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays (2D) and CT (3D)
Anatomical Site
Hip, Knee, Spine, Foot (Hallux Valgus, Ankle Joint), Upper Extremities, Hand
Indicated Patient Age Range
pediatrics (for Coxometry tracking)
Intended User / Care Setting
professional orthopedics, surgeons, health professional
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)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 7, 2018
mediCAD Hectec GmbH % Mr. Claas-Fabian Luers Ouality Assurance Representative Opalstrasse 54 Altdorf, Bavarian 84032 GERMANY
Re: K170702
Trade/Device Name: mediCAD 4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 17, 2018 Received: August 21, 2018
Dear Mr. Luers:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does 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 (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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jeff Rodgers
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170702
Device Name mediCAD 4.0
Indications for Use (Describe)
The mediCAD classic V4.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). 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 4.0 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 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
- · Rheumatology
- · Pediatric Orthopedics
MediCAD is designed for pre-operative planning for the following applications:
- · Hip Manual Planning
- Hip Automatic Planning
- · Hip Biometry
- · Hip Intertrochanteric osteotomy
- · Hip Coxometry
- · 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 surgical intervention
- · Osteotomy determines optimum osteotomy locations
- Osteotomy by Dror Paley
- · Osteotomy (DualSide)
- · Spine
- Foot Hallux Valgus
- · Foot Ankle Joint
- · Upper Extremities
- · Biological Age Determination by Hand
- Trauma
- · Hip 3D
- · Spine 3D
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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