(89 days)
The Image Fusion and Review System is intended to register images geometrically in 3D and display sets of different types of medical images, such as, MCD, SPECT, PET, CT, and MRI, as composite images. It allows the operator to rotate, translate, and align images anatomically, and match the geometric position of the images relative to each other.
The Image Fusion and Review System is an image registration software that is applicable to planar or volumetric images acquired using MCD, SPECT, PET, CT, and MRI modalities. Different image modalities provide complementary information. For example, anatomical imaging modalities like CT and MRI show anatomical features with little regard to function, while functional imaging modalities, such as, MCD, SPECT, etc., show the physiology, blood flow or metabolism. As a result, functional information is difficult to derive from anatomical modalities and anatomical information is hard to identify in functional modalities. Thus, image registration provides a tool to combine information from different modalities to produce a new and more comprehensive image.
The provided text describes the ADAC Laboratories Image Fusion and Review System, a device for registering and displaying medical images from various modalities.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to combine information from different modalities. | Demonstrated that "information from different modalities could be combined to produce a new and more comprehensive image." |
| Quality of combined images similar to the predicate device. | "The quality of the images produced was similar to the quality of images produced by the predicate device." |
| Ability to register images geometrically in 3D. | Intended to "register images geometrically in 3D." (Implied successful demonstration by 510k clearance) |
| Ability to display composite images from multiple modalities. | Intended to "display sets of different types of medical images...as composite images." (Implied successful demonstration by 510k clearance) |
| Ability for operator to rotate, translate, and align images. | "It allows the operator to rotate, translate, and align images anatomically, and match the geometric position of the images relative to each other." (Implied successful demonstration by 510k clearance) |
| Display functions (checkerboard, dithered, splash) similar to predicate. | Utilizes "the same display algorithms, types of display and operating principle" as the predicate's display portion. |
| Operator interface consistent with Pegasys interface. | "The display systems differ only in the operator interface, which has been modified for Image Fusion and Review to be consistent with the Pegasys interface." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). It simply states "A study was conducted."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. It focuses on the technical capability of image fusion and qualitative similarity to a predicate device.
6. Standalone Performance:
The study described is focused on the device's ability to combine and display images, which inherently describes its standalone functionality (algorithm only). The comparison to the predicate device also refers to the display systems and their operating principles, implying standalone performance evaluation for the fusion and display capabilities.
7. Type of Ground Truth Used:
The document implies a qualitative assessment of the "quality of the images produced" in comparison to a predicate device. This suggests that the ground truth was likely based on expert assessment or comparison to established clinical standards/predicate device performance, rather than pathology or outcomes data. However, the exact nature of this "quality" assessment is not detailed.
8. Sample Size for the Training Set:
The document does not provide information on a training set or its sample size. This device appears to be an image processing and display tool, not a machine learning model that typically requires a distinct training phase.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth might have been established.
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Image Fusion and Review ADAC Laboratories 510(k) Premarket Notification
Appendix VIII, 510(k) Summary of Safety and Effectiveness Data Page 1 of 2
K973233
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
I. General Information
| A. | Submitted By: | ADAC Laboratories540 Alder DriveMilpitas, CA 95035Tel: (408) 321-9100Fax: (408) 321-9686 |
|---|---|---|
| Contact Person: | Dennis Henkelman at address above | |
| B. | Device Trade Name: | Image Fusion and Review System |
| Common Name: | Gamma Camera Systems | |
| Classification Name: | System, Emission Computed Tomography | |
| C. | Predicate Device: | ADAC Pinnacle³ Apex |
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Device Description: D.
The Image Fusion and Review System is an image registration software that is applicable to planar or volumetric images acquired using MCD, SPECT, PET, CT, and MRI modalities. Different image modalities provide complementary information. For example, anatomical imaging modalities like CT and MRI show anatomical features with little regard to function, while functional imaging modalities, such as, MCD, SPECT, etc., show the physiology, blood flow or metabolism. As a result, functional information is difficult to derive from anatomical modalities and anatomical information is hard to identify in functional modalities. Thus, image registration provides a tool to combine information from different modalities to produce a new and more comprehensive image. -
Indications for Use: E.
The Image Fusion and Review System is intended to register images geometrically in 3D and display sets of different types of medical images, such as, MCD, SPECT, PET, CT, and MRI, as composite images. It allows the operator to rotate, translate, and align images anatomically, and match the geometric position of the images relative to each other.
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Technological Comparison: F.
The display portion of Pinnacle3 Apex has the same indications for use as the Image Fusion and Review in that both display diagnostic images using such functions as checkerboard, dithered, splash, etc. They utilize the same display algorithms, types of display and operating principle. The display systems differ only in the operator interface, which has been modified for Image Fusion and Review to be consistent with the Pegasys interface.
II. Testing
A study was conducted to demonstrate that information from different modalities could be combined to produce a new and more comprehensive image. The quality of the images produced was similar to the quality of images produced by the predicate device.
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Image /page/2/Picture/0 description: The image shows a partial view of a seal or emblem. The emblem features a stylized depiction of an eagle or bird with outstretched wings, rendered in a simple, bold line style. The words "DEPARTMENT OF HEALTH & HUM" are visible, arranged in a circular fashion around the bird symbol, suggesting the emblem belongs to a health-related department or organization.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 1997
Dennis W. Henkelman Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, CA 95035
Re: K973233
Image Fusion and Review System Dated: August 26, 1997 Received: August 28, 1997 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Henkelman:
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 Device Amendments, or to 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 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 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 requirement, 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 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 marketd 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 yitro 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 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,
Sincerely yours,
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
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Image Fusion and Review Device Name:
ADAC Laboratories Sponsor Name:
Indications for Use
The Image Fusion and Review System is intended to register images geometrically in 3D and display sets of different types of medical images such as, MCD, SPECT, PET, CT, and MRI, as composite images. It allows the operator to rotate, translate, and align images anatomically, and match the geometric position of the images relative to each other.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use છ Over-The-Counter Use ರ
Elbert A. Segura
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.