MEDICAD CLASSIC

K140434 · Hectec GmbH · LLZ · Jun 5, 2014 · Radiology

Device Facts

• Record ID: K140434
• Device Name: MEDICAD CLASSIC
• Applicant: Hectec GmbH
• Product Code: LLZ · Radiology
• Decision Date: Jun 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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 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 . 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

Device Story

Standalone software for orthopedic preoperative planning; inputs diagnostic images (digitized x-rays) from PACS or conventional media; overlays orthopedic implant geometries from integrated database onto images; enables manual and automatic measurements (biometry, coxometry, wear, FAI, osteotomy planning); outputs digital plans as DICOM files to PACS. Used by orthopedic surgeons, traumatologists, and rheumatologists in clinical settings. Supports workflow for comparing pre- and post-operative radiographs to assess surgical outcomes; integrates with physical exam data to assist in treatment/therapy prescription. Benefits include improved prosthesis selection, accurate implant placement, and minimized intraoperative complications through detailed presurgical planning.

Clinical Evidence

No clinical trials performed. Verification testing conducted by manufacturer to ensure requirement specifications met. Validation testing performed by health professionals in clinical environments to confirm performance, measurement, and usability requirements.

Technological Characteristics

Standalone software; runs on Microsoft Windows; DICOM V3.0 compliant; utilizes integrated orthopedic implant geometry database; scaling technology for image dimensioning. Conforms to ISO/IEC 90003:2004, ISO 14971:2007/2012, and ISO 13485:2003/2010.

Indications for Use

Indicated for orthopedic, surgical, traumatology, rheumatology, and pediatric orthopedic patients requiring preoperative planning, measurement, and implant selection based on diagnostic x-ray images.

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

• AGFA IMPAX Orthopedic Tool (K071972)
• TraumaCad (K073714)

Submission Summary (Full Text)

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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<br>and communications system)<br>21 CFR 888.4800 (orthopedic devices.template<br>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: [phone] FAX: [phone] Email: [e-mail]

## 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

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- 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

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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<br>classic<br>3.0 | TraumaCad<br>2.0 | AGFA<br>IOT |
|--------------------------------------------|---------------------------|------------------|-------------|
| Hip - Manual<br>Planning | ☑ | ☑ | ☑ |
| Hip - Automatic<br>Planning | ☑ | ☑ | ☑ |
| Hip - Biometry | ☑ | | ☑ |
| Hip - Coxometry<br>/ Pediatrics | ☑ | ☑ | ☑ |
| Hip - Wear<br>Measurement | ☑ | ☑ | |
| Hip - FAI | ☑ | | |
| Knee | ☑ | ☑ | ☑ |
| Osteotomy | ☑ | ☑ | ☑ |
| Osteotomy by<br>Dror Paley | ☑ | | ☑ |
| Osteotomy<br>(DualSide) | ☑ | ☑ | |
| Intertrochanteric<br>Osteotomy | ☑ | | |
| Spine | ☑ | ☑ | ☑ |
| Foot | ☑ | ☑ | ☑ |
| Upper<br>Extremities | ☑ | ☑ | ☑ |
| Biological Age<br>Determination by<br>Hand | ☑ | | |
| TAYLOR<br>SPATIAL<br>FRAME (TSF) | | ☑ | |
| Trauma | ☑ | ☑ | ☑ |

Table 1: Predicate Device Comparison

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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.

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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