(89 days)
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No
The summary describes image registration software and mentions image processing, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The description focuses on geometric alignment and combining information from different modalities.
No
The device is an image fusion and review system that produces composite images from different medical imaging modalities. It does not directly treat or diagnose a condition.
No
The device is described as an "Image Fusion and Review System" that combines and displays existing medical images. Its function is to register, rotate, translate, and align images, not to interpret or provide new diagnostic information directly from patient data. While it creates "more comprehensive images," this is for review and fusion, suggesting it is a tool for diagnostic interpretation rather than a diagnostic device itself.
Yes
The device is described as "image registration software" and its function is to process and display medical images. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is an "Image Fusion and Review System." Its purpose is to register and display medical images acquired from various imaging modalities (MCD, SPECT, PET, CT, MRI). It processes and combines existing images, but it does not analyze biological samples from the patient.
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological samples. Its input is medical images, not patient specimens.
Therefore, the function and intended use of this device clearly fall outside the scope of an In Vitro Diagnostic. It is a medical image processing and display system.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
MCD, SPECT, PET, CT, and MRI
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
ADAC Pinnacle3 Apex
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.
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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).
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§ 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.
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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 Laboratories
540 Alder Drive
Milpitas, CA 95035
Tel: (408) 321-9100
Fax: (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.
1
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.
2
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