(49 days)
Not Found
No
The document mentions "automatically" performing analysis, but does not use terms like AI, ML, deep learning, or neural networks, which are typically associated with AI/ML technologies in regulatory submissions. The description focuses on image post-processing and analysis based on established techniques (Roentgen Stereophotogrammetric Analysis).
No
The device is a software package for image analysis in clinical trials, not for directly treating or diagnosing a disease or condition.
No
The device is described as an analytical software package used in image post-processing for the evaluation of new implant designs, coatings, and cementation techniques in clinical trials. It helps derive conclusions from these trials when interpreted by trained physicians, but it does not directly diagnose medical conditions in patients. Instead, it seems to be a research or development tool for assessing implant performance.
Yes
The device is explicitly described as a "software package" that runs on a standard PC operating system and performs image analysis. There is no mention of any accompanying hardware components or hardware-specific functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the analysis of digital roentgen images (medical images) for the evaluation of orthopedic implants in clinical trials. This is image analysis and post-processing, not the analysis of biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Device Description: The device is a software package that performs image analysis.
- Input: The input is medical imaging data (digital roentgen images). IVDs typically analyze biological samples.
- Anatomical Site: While not explicitly stated, the context of orthopedic implants implies analysis related to the human body, not in vitro analysis of samples.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device analyzes medical images, which are not biological specimens in the context of IVD regulation.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
In orthopaedics clinical practice, loosening of prostheses is assessed indirectly by measuring radiolucent lines around the prosthesis and position differences of the prosthesis relative to the bone in successive radiographs. Radiolucent lines indicate the existence of a fibrous layer. However, they are occluded by the metal of the implant and the amount of radiolucency can be underestimated. Migration of the implant reflects 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-dimensional motion. This technique was denoted Roentgen Stereophotogrammetric Analysis (RSA). The reported accuracy of RSA ranges between 0.05 and 0.1 mm for translations and 0.15° and 1.15° for rotations (95% confidence interval). Because of the high accuracy of RSA, small patient cohorts may be sufficient to study economic outcomes due to changes in implant design, surgical techniques, and new bone cements.
RSA is the most accurate radiographic technique for the assessment of three-dimensional motion of orthopaedic implants. RSA-CMS is a software package that "automatically" performs RSA on digital images. This software runs on a PC with the Windows 2000 or XP operating system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
roentgen images (DICOM CR or DX) or digitised images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopaedic 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.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 2 0 2004
K042383 12. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- 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 |
| 2316 XG Leiden, The Netherlands | |
| Telephone | : +31 71 522 3244 |
| Fax | : +31 71 521 5617 |
| 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:
- 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.
1
6. Substantial equivalence Information:
:
- 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.
2
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.
3
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
4
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