(70 days)
No
The summary describes an image correlation system for spatial registration, which is a standard image processing technique. There is no mention of AI, ML, or related concepts, and the description of the device and its intended use aligns with traditional image processing methods.
No
The device is intended for diagnosis and planning treatments, but not for direct therapeutic intervention. It enhances imaging information for physicians to use in their diagnostic and planning processes.
Yes
The "Intended Use / Indications for Use" states that the resulting image sets "can then be used for diagnosis and planning treatments." While it does not directly perform the diagnosis, it provides essential information for a physician to make a diagnosis, thus functioning as a diagnostic aid.
Yes
The device is described as "Image Correlation Software" and "image processing system," with no mention of accompanying hardware components. The predicate device is also an "Image Correlation System," implying a software-centric function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for "enhancing the imaging information presented to a physician" and for "diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy." This involves processing medical images obtained from the patient's body, not analyzing samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: It's described as an "image correlation system" and "image processing system." These descriptions align with medical imaging software, not devices used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device operates on medical images, which are a different type of data.
N/A
Intended Use / Indications for Use
The ImMerge Image Correlation Software Version 2.0 is intended to provide precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, and radiotherapy.
Product codes
90 LLZ
Device Description
This submission describes updates made to the ImMerge™ System to provide an automatic first attempt at image correlation. The ImMerge Image Correlation Software Version 2.0 is intended to provide precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, and radiotherapy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
Date Prepared: May 6, 1999
-
I. Submitter Information:
Contact: Angelique Destruel Clinical and Regulatory Affairs Associate Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709 -
Trade name: ImMerge™ Image Correlation System Version 2.0; II. Common or usual name: image correlation system; Classification name: image processing system
-
III. The above device is substanitally equivalent to the ImMerge V1.0 Image Correlation System (K970623). Evidence of the substantial equivalence was provided.
-
This submission describes updates made to the ImMerge™ System to provide an IV. automatic first attempt at image correlation. The ImMerge Image Correlation Software Version 2.0 is intended to provide precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, and radiotherapy.
-
V. The device like its predicates is intended for use in cranial surgery, radiosurgery and radiotherapy procedures
-
VI. The technological charecteristics are the same as or similar to those found with the predicate device
1 1 5
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design, with three parallel lines forming a shape reminiscent of a bird or abstract human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 1999
Roger White Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, Colorado 80020
Re:
K991468 ImMerge Image Correlation System V2.0 Dated: April 26, 1999 Received: April 27, 1999 Regulatory Class: II 21 CFR 892.2050/procode: 90 LLZ
Dear Mr. White:
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 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 redassified 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 practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation 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/dsma/dsmamain.html".
Sincerely yours,
BART D. Golding, M.D.
CAPT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): _
ImMerge™ Image Correlation System Version 2.0 Device Name: . . .
Indications For Use:
The ImMerge Image Correlation Software Version 2.0 is intended to provide precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
David A. Syverson
Reproductive, Abdominal, 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)