(206 days)
Not Found
No
The summary describes image coregistration functionality for radiation therapy planning, which is a standard image processing technique. There is no mention of AI, ML, or any related concepts like training or test sets for model development. The performance testing is compared to predicate devices using similar specifications, not metrics typically associated with AI/ML performance evaluation.
No
The device is described as a "Coregistration function" intended for use as part of an RT (Radiation Therapy) planning system to correlate multiple image sets. Its purpose is to assist in planning, not to deliver therapy directly.
No
This device is described as a "Coregistration function" intended for use as part of an RT (radiation therapy) planning system. Its purpose is to correlate multiple image sets for treatment planning, not to diagnose a condition or disease.
Yes
The device is described as a "Coregistration function" intended for use as "part of an RT planning system." The description focuses solely on the software's capability to correlate and coregister image sets. There is no mention of any accompanying hardware or physical components that are part of this specific device submission. While it integrates with an RT planning system (which would include hardware), the device itself, as described, appears to be the software 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 it's for use as part of an RT planning system (such as CORVUS). This is a system used for planning radiation therapy treatments, which is a clinical procedure performed on a patient, not a diagnostic test performed on a sample outside the body.
- Device Description: The description reiterates its use within an RT planning system for correlating image sets for treatment planning.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on these samples, or providing diagnostic information derived from such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function of coregistering medical images for radiation therapy planning falls outside of this definition.
N/A
Intended Use / Indications for Use
The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system.
The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT.
Product codes
90 IYE
Device Description
The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system.
The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Testing shows that the device meets similar performance specifications as those for the predicate devices. No new issues of safety or effectiveness are introduced by using this device.
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
972451
JAN.22, 1998
ry of Safety and Effectivenes I) of the Federal Food, Drug and Cosmetic Compliance w
June 27, 1997
General Provisions 1.
Common/Usual Name Image Correlation System Proprietary Name Coregistration function Applicant Name and Address NOMOS Corporation 2591 Wexford Bavne Road
Name of Predicate Devices 2.
ImageFusion - Radionics Software Applications (RSA), Inc. (K960071)'
Sewickley, PA 15143
3. Classification
]
CORVUS™ (Cleared as PEACOCK® Plan (K940663) is classified as class II devices according to 21 CFR 882.5050 (90 IYE). These devices are reviewed by the Radiological Devices Panel of the Reproductive, Abdominal, Ear, Nose, and Throat and Radiological Division of the Office of Device Evaluation.
The predicate Radionics ImageFusion Software is unclassified by FDA but was grouped in LLZ with no CFR designation by the Radiological Devices Division.
4. Performance Standards
Performance standards for treatment planning systems have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, " ... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).
1
re Intended Use and Device Description
The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system.
The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT.
6. Biocompatibility
Not applicable.
7. Summary of Substantial Equivalence
This device is similar in design, intended use and performance characteristics to the predicate devices. Testing shows that the device meets similar performance specifications as those for the predicate devices. No new issues of safety or effectiveness are introduced by using this device.
2
Public Health Service
Image /page/2/Picture/1 description: The image shows a logo with a circular shape on the lower left and a stylized bird-like figure on the upper right. The text "DEPARTMENT OF HEALTH &" is arranged in a curved manner around the top and right side of the circle. The logo appears to be a vintage or older design, possibly representing a health organization or government department.
DEPARTMENT OF HEATTH & HUMAN SERVICE:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 1998
Marvin L. Sussman, Ph.D. Vice President Product Assurance NOMOS Corporation 2591 Wexford Bayne Road Suite 400 Sewickley, PA 15143
Re: K972451
Coregistration Function Dated: October 27, 1997 Received: October 28, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Dr. Sussman:
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 stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 fequirement, 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 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 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 question 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.
W.Liau Yu
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
3
510(k) Number (if known)
Device Name: Coregistration
Indications for Use:
能
The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system.
The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue ............ density information from the CT.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR Over-The Counter Use (Optional Format 1-2-96)
Ekinl A. Seysson
Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devjo 510(k) Number
Image /page/3/Picture/12 description: The image is completely white and contains no discernible content. It is a blank canvas with no objects, shapes, or colors present. The image appears to be a solid white background. There are no visible details or features in the image.