ORTHO-CMS

{0}------------------------------------------------ Ortho-CMS 510(k) Pre-market Notification # JUL 2 7 2004 ## 12. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K041162 Submission in accordance with the requirements of 21 CFR Part 807.87(h) - : Medis medical imaqinq systems bv 1. Submitter : Schuttersveld 9, 2316 XG Leiden, The Netherlands Address : +31 71 522 3244 Telephone : +31 71 521 5617 Fax : J.I. Hollander, Quality Coordinator Contact Person : April 26, 2004 Prepared : Medis Ortho-CMS 2. Device Name : Ortho-CMS Common Name : System Image Processing, Radiological Device Class. Name : 21 CFR 892.2050 (90 LLZ; Class II) Requlation Number : Meridian Technique Ltd: 510(k) K032401 3. Predicate Device(s) eFilm Medical Inc.: 510(k) K020995 #### 4. Description of the device: In orthopaedics, radiographs are used to diagnose and analyse various kinds of orthopaedic disorders, generative joint conditions, and bone fractures, and to evaluate orthopaedic treatments such as osteotomies and total joint arthroplasty. These arthroplasties need to be evaluated in order to assess the quality of the procedure. Measurements on radiographs of endoprostheses include the assessment of radiolucent lines around the prosthesis, bone growth or bone resorption, position of the prosthesis, motion of the prosthesis relative to the surrounding bone, and the determination of wear of the polyethylene components. Since the measurements on radiographs are commonly performed manually, considerable intra-observer and inter-observer variation exists. Automation of the measurements might increase the objectivity and speed of the analysis, and decrease the variation of the results. In radiology, digital roentgen imaging techniques are increasingly being used over plain film radiographs. The digital roentgen images (DICOM CR or DX) are easily accessible from a medical picture archive (PACS) through a network connection. Ortho-CMS supports the radiologist by facilitating the diagnosis of orthopaedic digital images and allows the orthopaedic specialist to perform a pre-surgical planning and a post-surgical evaluation on these images. Further, Ortho-CMS can be deployed as a measurement tool for core-labs that focus on quality assessment of orthopaedic implants or it can be used by bone centres that need to make measurements in donor bone images for joints replacement purposes. #### 5. Intended use: Ortho-CMS is an orthopaedic analysis software tool. It has been developed to optimize preoperative planning through digital prosthesis templating and to enable preoperative and postoperative measurements in digital or digitized X-Ray images. Ortho-CMS software is meant solely for use by trained medical personnel. - · The intended purposes of Ortho-CMS are: - · Displaying of X-Ray images - · Supporting planning of joint replacement operations - · Supporting clinical diagnoses on implant loosening - · Enabling preoperative and postoperative measurements for clinical and research purposes {1}------------------------------------------------ #### 6. Substantial equivalence Information: Ortho-CMS is substantially equivalent to the Predicate Devices of Meridian Technique Ltd. 6132401 "Orthoview™" and of eFilm Medical Inc., K020995 "eFilm"14 Workstation™, using the same technological technique for the same intended use. ### Conclusion respecting safety and effectiveness: It is the opinion of Medis medical imaging systems bv that Ortho-CMS is safe and potential hazards are controlled by a risk management plan for the software development process (See Appendix C), including hazard analysis (See Appendix D), verification and validation tests (See Appendix E). Evaluations by hospitals and literature (See Appendix F) support this statement. The software package Ortho-CMS itself will not have any adverse effects on health. This tool supports the radiologist by facilitating the diagnosis of orthopaedic digital images and allows the orthopaedic specialist to perform a pre-surgical planning and a post-surgical evaluation on orthopaedic images. The analyses results will be interpreted by the operator, who can choose to accept or reject the tools results. It is the opinion of Medis medical imaging systems bv that the level of concern for the stand alone software to view images is 'minor' and that the use of Ortho-CMS software does not change the intended use of X-ray equipment in practice, nor does the use of software result in any new potential hazards. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. J.I. Hollander Quality Coordinator Medis Medical Imaging Systems bv Schuttersveld 9, 2316 XG Leiden P.O. Box 384, 2300 AJ Leiden THE NETHERLANDS Re: K041162 Trade/Device Name: Ortho-CMS Regulatory Number: 21 CFR 892.2050 Regulatory Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: April 26, 2004 Received: May 3, 2004 Dear Mr. Hollander: 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibit.ons against misbranding and adulteration. JUL 27 2004 If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be 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 statutes 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 (21 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and your your of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx. 1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Brydon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure Page 2 {4}------------------------------------------------ Page 4 Page 510(k) Number (if known): #### Device Name 1 2017 11:00:00 10 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 Indications For Use: 。 保安了 Ortho-CMS is an orthopaedic analysis software tool. It has been developed to がなくなっていますが optimize preoperative planning through digital prosthesis templating and to enable preoperative and postoperative measurements in digitized X-Ray images. Ortho-CMS software is meant solely for use by trained medical personnel. - · The intended purposes of Ortho-CMS are: - - · Displaying of X-Ray images - Supporting planning of joint replacement operations - Supporting clinical diagnoses on implant loosening - · Enabling preoperative and postoperative measurements for clinical and research purposes (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Optional Format 3-10-98) Nancy C. Broadlon (Division Sign (Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number