(57 days)
No
The summary describes a pre-processing registration software with QA tools, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The description focuses on standard image fusion techniques and quality assurance.
No
The device is described as a "pre-processing registration tool" and "fusion software" for medical images, intended for use with treatment planning systems. It does not directly provide therapy or treatment.
No
The device is described as pre-processing registration (fusion) software for use with other treatment planning systems, indicating it prepares data for treatment rather than diagnosing.
Yes
The device description explicitly states it is "pre-processing registration (fusion) software" and mentions it can be used on a "HP UNIX or Linux workstation," indicating it is a software application running on general-purpose computing hardware, not a dedicated hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems." This clearly indicates a purpose related to surgical planning and treatment, not the diagnosis of disease based on in vitro examination of specimens.
- Device Description: The description focuses on image processing (fusion of CT, MR, and PET scans) for use with other applications. This aligns with a medical imaging software tool, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological specimens
- Providing information for diagnosis, monitoring, or screening of diseases based on in vitro tests.
The device's function is to prepare medical images for use in other systems, which is a common function of medical imaging software used in surgical planning.
N/A
Intended Use / Indications for Use
A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.
Product codes
MUJ
Device Description
The above system is a pre-processing registration (fusion) software for CT, MR and PET scans. The software provides QA tools for the user to evaluate the fusion results. The results are used with other Integra Radionics applications. The software can be used on a HP UNIX or Linux workstation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR and PET scans
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)
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Section 6: 510(k) Summary
Integra Radionics ImageFusion 3 510(k) Summary DEC 2 1 2006
This 510(k) Summary information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.
1.0 The submitter of this premarket notification is:
Kevin J. O'Connell Regulatory Affairs Manager Integra Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 Tel.: (781) 565-1227 Fax: (781) 238-0645
This summary was prepared on October 24, 2006.
- 2.0 The name of the device is the Integra Radionics ImageFusion 3. The common name is System, Image Correlation and its classification name is Medical charged-particle radiation therapy system.
- 3.0 The above device is substantial equivalent to the Radionics ImageFusion 2, 510(k), K990071
- 4.0 The above system is a pre-processing registration (fusion) software for CT, MR and PET scans. The software provides QA tools for the user to evaluate the fusion results. The results are used with other Integra Radionics applications. The software can be used on a HP UNIX or Linux workstation.
- 5.0 The device like its predicates is intended for registering (fusing) stereotactic and nonstereotactic scans. The indications for use are: A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems
- 6.0 The technological characteristics are the same or similar to those found with the predicate devices.
1
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Kevin J. O'Connell Regulatory Affairs Manager Integra Radionics, Inc. 22 Terry Avenue BURLINGTON MA 01803-2516
Re: K063230
Trade/Device Name: Integra Radionics ImageFusion 3 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 21, 2006 Received: November 22, 2006
DEC 2 1 2006
Dear Mr. O'Connell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. Three stars are located below the word "Centennial". The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.
Protecting and Promoting Public Health
2
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K063230
Device Name: Integra Radionics ImageFusion 3
Indications For use: A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.
PRESCRIPTION USE X (Part 21 CFR 801 Subpart D) ANDIOR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Seym
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5 : O(k) Number ______________________________________________________________________________________________________________________________________________________________