(74 days)
Not Found
No
The summary describes image processing software and hardware for creating 3D models from medical imaging data, but there is no mention of AI or ML algorithms being used in the process. The performance study focuses on the accuracy of the generated models, not on the performance of any AI/ML component.
No
The device is used to create three-dimensional models from imaging data as a diagnostic tool, for pre-operative planning, and for communication. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to create three dimensional models from 3D surface representation data or 2D contour data as a diagnostic tool".
No
The device description explicitly lists "FDM Hardware" and "Modeling Materials" as main parts of the system, indicating it is not software-only.
Based on the provided information, the Stratasys FDM MedModeler is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Stratasys FDM MedModeler is described as an image processing accessory that creates 3D anatomical models from imaging data (CT and MRI). It is used for diagnostic tools, pre-operative planning, and communication.
- Lack of Biological Sample Analysis: The device does not analyze biological samples from the patient. Its input is imaging data, not biological material.
Therefore, while it is a medical device used in a diagnostic context, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Stratasys FDM MedModeler is indicated as an image processing accessory, used to create three dimensional models from 3D surface representation data or 2D contour data as a diagnostic tool, as a pre-operative planning tool, and to enhance communication with patients, other professionals or students.
Product codes
Not Found
Device Description
The Stratasys FDM MedModeler produces anatomical models for use in a variety of medical applications using CT and MRI imaging data. The four main parts of the FDM system, as displayed in Figure 1 (previous page) are 1) the QuickSlice Software, 2) FDM Hardware, 3) Modeling Materials and a 4) Computer Workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
HazardRisk Analysis demonstrates that the safety of the Stratasys FDM MedModeler is acceptable and that identified potential risks are within acceptable limits for likelibood of occurrence and severity of hazards. The model generation report demonstrates that the FDM MedMedeler performed as intended and within system requirements for CAD, CT and MRI image modeling, and produced satisfactory models. Software development information, software validation and hardware validation information are also provided according to FDA guidance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
971290
June 20, 1997
510(k) Summary
SUBMITTER:
Submitted on behalf of:
Company Name: Address:
STRATASYS, Inc. 14950 Martin Drive Minneapolis, MN 55344-2020
by:
Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082
CONTACT PERSON: Elaine Duncan
DATE SUMMARY PREPARED: April 3, 1997
Stratasys FDM® MedModeler System TRADE NAME: Radiology Accessory COMMON NAME:
SUBSTANTIALLY EQUIVALENT TO: The Stratasys FDM MedModeler System is substantially equivalent to the SurgiCAD image processing accepted under premarket notification K924630.
DESCRIPTION of the DEVICE: The Stratasys FDM MedModeler produces anatomical models for use in a variety of medical applications using CT and MRI imaging data. The four main parts of the FDM system, as displayed in Figure 1 (previous page) are 1) the QuickSlice Software, 2) FDM Hardware, 3) Modeling Materials and a 4) Computer Workstation.
INDICATIONS FOR USE: The Stratasys FDM MedModeler is indicated as an image processing accessory, used to create three dimensional models from 3D sufface representation data or 2D contour data as a diagnostic tool, as a pre-operative planning tool, and to enhance communication with patients, other professionals or students.
CLINICAL INFORMATION and SAFETY and EFFECTIVENESS: HazardRisk Analysis demonstrates that the safety of the Stratasys FDM MedModeler is acceptable and that identified potential risks are within acceptable limits for likelibood of occurrence and severity of hazards. The model generation report demonstrates that the FDM MedModeler performed as intended and within system requirements for CAD, CT and MRI image modeling, and produced satisfactory models. Software development information, software validation and hardware validation information are also provided according to FDA guidance requirements.
1
ang majallu som vide
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 1997
Stratasys, Inc. c/o Elaine Duncan, RAC, M.S.M.E. President Paladin MedicalsM, Inc. P.O. Box 560 Stillwater, MN 55082-0560
Re: K971290
Stratasys FDM® MedModeler System Radiology Accessory Dated: April 3, 1997 Received: April 7. 1997 Unclassified/Procode: 90 LLZ
Dear Ms. Duncan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please not: this response to your premarket notification does not affect any obligation you might have under sections 531 tirough 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro disgnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Ollain'
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Image /page/1/Picture/16 description: The image shows the word "Enclosure" written in a serif font. To the left of the word is a black circle with vertical lines on the left side. The circle appears to be partially obscured or incomplete on the left side, giving it a unique visual characteristic. The text and the shape are the primary elements in the image.
2
510(k) Number (if known)
Device Name: Stratasys FDM® MedModeler System
Indications for Use: -- --------------------
The Stratasys FDM MedModeler is indicated as an image processing accessory, used to create three dimensional models from 3D surface representation data or 2D contour data as a diagnostic tool, as a pre-operative planning tool, and to enhance communication with patients, other professionals or students.
(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over -The-Counter Use _
(Copiona: Format 1-2-96)
Ylmid h. Segmen
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971290
Image /page/2/Picture/13 description: The image shows a black and white graphic of a letter. The letter appears to be a lowercase 'b' or 'd'. The letter is bolded and slightly distorted, with the left side appearing darker than the right. The letter is vertically oriented.