IMMERGE IMAGE CORRELATION

K991468 · Surgical Navigation Technologies, Inc. · LLZ · Jul 6, 1999 · Radiology

Device Facts

• Record ID: K991468
• Device Name: IMMERGE IMAGE CORRELATION
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

ImMerge Image Correlation System V2.0 is an image processing software system. It takes two distinct image sets as input and performs spatial registration to align them. The system provides an automatic first attempt at image correlation to enhance imaging information presented to physicians. Used in clinical settings for diagnosis and planning of cranial surgery, stereotactic radiosurgery, and radiotherapy. The output consists of registered image sets, which assist clinicians in surgical navigation and treatment planning. The device is intended for prescription use by physicians.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Image processing software system. Version 2.0 introduces automated image registration functionality. Operates as an image correlation system (21 CFR 892.2050).

Indications for Use

Indicated for use in cranial surgery, radiosurgery, and radiotherapy procedures requiring precise spatial registration of two image sets for diagnosis and treatment planning.

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

• ImMerge V1.0 Image Correlation System (K970623)

Submission Summary (Full Text)

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## 510(k) Summary

K991468

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 [phone]

- 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

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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.

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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)