RSA-CMS

K042383 · Medis Medical Imaging Systems BV · LLZ · Oct 20, 2004 · Radiology

Device Facts

• Record ID: K042383
• Device Name: RSA-CMS
• Applicant: Medis Medical Imaging Systems BV
• Product Code: LLZ · Radiology
• Decision Date: Oct 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

RSA-CMS has been developed for the objective and reproducible analysis on digital roentgen images (DICOM CR or DX) or digitised images in a PACS environment. Orthopedic specialist and core labs use the RSA-CMS standalone analytical software package in image post-processing for the evaluation of new implant designs, coatings and new cementation techniques in clinical trials. When interpreted by trained physicians these parameters may be useful to derive conclusions from these clinical trials. RSA-CMS is developed in close cooperation with the Division of Image Processing (LKEB) and the Department of Orthopedics of the Leiden University Medical Center. It has been validated and complies with international safety and quality standards.

Device Story

RSA-CMS is a standalone software package for PC (Windows 2000/XP) used by orthopedic specialists and core labs to assess prosthetic loosening and migration. It processes digital roentgen images (DICOM CR/DX) within a PACS environment. The software performs stereophotogrammetric analysis (RSA) to measure 3D motion of prosthetic and bony landmarks over time. The system provides quantitative outputs regarding implant position and migration. Physicians interpret these outputs to evaluate the performance of new implant designs, coatings, and cementation techniques in clinical trials. The device aids clinical decision-making by providing objective data on implant stability, potentially benefiting patients by facilitating the development of improved orthopedic implants and surgical techniques.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by hazard analysis, verification, and validation testing, as well as evaluations by hospitals and literature.

Technological Characteristics

Standalone software for PC (Windows 2000/XP). Operates on digital roentgen images (DICOM CR/DX). Implements stereophotogrammetric analysis (RSA) for 3D motion assessment. Software level of concern is 'minor'.

Indications for Use

Indicated for orthopedic specialists and core labs to perform objective, reproducible analysis of digital roentgen images (DICOM CR/DX) for evaluating new implant designs, coatings, and cementation techniques in clinical trials.

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

• Ortho-CMS of Medis (K041162)

Submission Summary (Full Text)

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### OCT 2 0 2004

# K042383 12. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

12. 510(K) SUMMART OF SA ETT AND LTF AND Live Storements of 21 CFR Part 807.87(h)

| 1. Submitter | : Medis medical imaging systems b.v. |
|--------------------|------------------------------------------------------|
| Address | : Schuttersveld 9<br>2316 XG Leiden, The Netherlands |
| Telephone | : [phone] |
| Fax | : [phone] |
| Contact Person | : J.I. Hollander, Quality Coordinator |
| Prepared | : August 25, 2004 |
| 2. Device Name | : Roentgen Stereophotogrammetric Analysis - CMS |
| Common Name | : RSA-CMS |
| Device Class. Name | : System Image Processing, Radiological. |
| Regulation Number | : 21 CFR 892.2050 (90 LLZ; Class II) |

: Ortho-CMS of Medis K041162 3. Predicate Device(s)

#### 4. Description of the device:

4. Description of the device.
In orthopaedics dinical practice, loosening of prostheses is assessed indirectly by in orthopaedics clinical practice, foosening or prosiness and position differences of the measuring radioucent lines around the prosticular and ographs. Radiographs. Radiolucent lines prosthesis relative to the pone measured in successive naturements are not very indicate the existence of a misfous layer. Thewer, are occluded by the metal of the implant and the amount of radiolucency can be underestimated. Migration of the implant and the amount of facilities in the relative positions of prosthetic . landmarks and bony landmarks over time.

In 1974, Selvik developed a very accurate technique for the assessment of three-In 1974, Selvin developed a very asserato technique was denoted for and Stereophotogrammetric Analysis (RSA). The reported accuracy of RSA ranges Stereophotogrammethe Andrysis (translations and 0.15° and 1.15° for rotations (95%between 0.05 and 0.0 min for transitions and of RSA, small patient conomic conomic conim in implom tocian comfidence interval). Decause of the migh accuration due to changes in implant design, be sumclent to stouy and surgical techniques, and new bone cements.

RSA is the most accurate radiographic technique for the assessment of three-RSA-IS-the most accarace radiographic RSA-CMS is a software package dimensional inicomotion of orthopacity in digital images. This software that "automatically" portomis" a PC with the Windows 2000 or XP operating system.

#### 5. Intended use:

RSA-CMS has been developed for the objective and reproducible analysis on digital RSA-OMS has been ucveloped %X) or digitised images in a PACS environment.

Orthopaedic specialist and core labs use the RSA-CMS standalone analytical software Orthopaedic specialist and core labs use the Roll one new implant designs, coalings and new cernentation techniques in clinical trials.

When interpreted by trained physicians these parameters may be useful to derive conclusions from these clinical trials.

conclusions in in these cimical thans.
RSA-CMS is developed in close cooperation with the Division of Image Processing KSA-GMS is beveloped in diese boopedics of the Leiden University Medical Center. It (LRLD) and the Department plies with international safety and quality standards.

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K042383

### 6. Substantial equivalence Information:

:

6. Substantial equivalence information.
RSA-CMS is substantially equivalent to the Predicate Device of Medis medical use RSA-CMS is substantially equivalent to the Predicate of the same intended use.

## Conclusion respecting safety and effectiveness:

Conclusion respecting safety and enectives.
It is the opinion of Medis medical imaging systems by that RSA-CMS is software It is the opinion or Medis medical imaging 'systems on on for the software potential hazards are controlled by a nonysis, verification and validation tests.
development process, including hazard analysis, verification and validation nackage development process, including thazard and literature the software package Evaluations by nospitals and merature support this onealth. This tool calculates the RSA-CMS itself will not have any adverse the bone. The operator interprets the relative Thotion of prosulesis the scept or reject the results.
results of the analysis and chooses to accept or that the lost

results of the analysis and Chooses to accord in that the level of concern for the level of concern for the software It is the opinion of Medisan maging systems that that the use of RSA-CMS software
stand alone software to view images is 'minor' and that it assetting not does the use of stand alone software to view inlages is "millo" that the see of the use of software result in any new potential hazards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature. The logo is black and white and appears to be a scanned or printed image.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 0 2004

Mr. J. I. Hollander Quality Coordinator ·Medis Medical Imaging Systems bv Schutterveld 9 2316 XG Leiden P.O. Box 384 2300 AJ Leiden . THE NETHERLANDS

Re: K042383

Trade/Device Name: RSA-CMS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems

Regulatory Class: II Product Code: 90 LLZ Dated: August 25, 2004 Received: September 1, 2004

Dear Mr. Hollander:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leveleved your becalled by o(t); probantially equivalent (for the indications for use stated in above and nave decemined the as needicate devices marketed in interstate commerce prior to the enclosure) to regally marketed products do received. Or to devices that have been May 26, 1970, the Chacinent dato of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, markethe do not require approval or a prematics approvisions of the Act. The general controls provisions of the Act device, subject to the general controls provices, 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 If your device is classified (see ao ro) and controls. Existing major regulations affecting your Apploval), it thay oc subject to securations, Title 21, Parts 800 to 898. In addition, FDA device can be round in nouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that PDF 3 issualled on 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 Federal statues and regulations administer to registration and listing (21 CFR Part 807); labeling, Act s requirements, including. but hot minted to reguirements as set forth in the quality systems (QS) (21 CFK Part 801); good manatating product radiation control product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his leter will anow you to begin manceing your antial equivalence of your device to a legally premarket nothleation. The I DA mining of basisman - ------------------------------------------------------------------------------------------------------------------------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 cerror 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 premarket notification" (21 CFR Also, please note the regulation on your responsibilities under the Act from the 807.97). You may ootain other general missistance at its toll-free number (800) DWISION of Silan Manufacturers, Internet address http://www.fda.gov/cdrh/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

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510(k) Number (if known): K042383

Device Name: RSA - CMS

Indications For Use:

RSA-CMS has been developed for the objective and reproducible analysis on digital
e of the subser ENDEM CD on DX) es digitiese images in a PACS environment. RSA-CMS has been developed Tur une sitised images in a PACS environment.
roentgen images (DICOM CR or DX) or digitised images in a PACS environment.

roentgen images (DICOM Cit of DX) or big in a friends in a r resolution analytical software
Orthopedic specialist and core labs use the RSA-CMS standalone and Orthopedic specialist and core labs use the RSA-CMS standership and your and
package in image post-processing for the evaluation of new implant designs, coatings and package in image techniques in clinical trials.

new cementation techniques in clinical trials.
When interpreted by trained physicians these parameters may be useful to derive conclusions from these clinical trials.

condusions from these cinical trais.
RSA-CMS is developed in close cooperation with the Division of Image Processing (LKEB)
RSA-CMS is developed of Olders of the Loiden Unive RSA-CMS is developed in close cooperation win the Unitego Premier of Conter. It has been
and the Department of Orthopedics of the Leiden University and cuslines and and the Department of Ofthopedies of the Ecolour of Collect of Childers and ards.
validated and complies with international safety and quality standards.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Nancy C. Hogdon

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 51(0(k) Number _

Prescription Use