(219 days)
The Target 2 V1.1 is a radiation oncology treatment planning system which uses CT and non-CT data to produce External Beam and Irregular Field plans, and non-CT data to provide Interstitial/Intracavitary Dosimetry plans.
The Target 2 V1.1 is an independent radiation oncology treatment planning system which uses CT and non-CT data to produce External Beam and Irregular Field plans, and non-CT data to provide Interstitial/Intracavitary Dosimetry plans. The system is interactive, using an optical mouse and defined display screen areas on the monitor, in conjunction with operating menus, to produce accurate planning routines. The treatment plan is contructed and displayed on the patient image. Plans can be stored on the system disk, output as hard copy and archived.
The provided document is a 510(k) premarket notification for a Radiation Treatment Planning (RTP) system, specifically the "Target 2 Version 1.1". It primarily focuses on demonstrating substantial equivalence to a predicate device (Target 2 Version 1.0) rather than presenting a detailed study with acceptance criteria, sample sizes, and expert adjudication for a novel AI-powered device.
Therefore, the document does not contain the information required to answer your request about acceptance criteria, a study proving the device meets them, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI device.
The document makes a high-level statement: "Test results indicate that Target 2 V1.1 performs its intended use and meets specifications in a safe and effective manner." However, it does not provide any specifics about these "test results" or "specifications" beyond stating its intended use is for planning radiation oncology treatments.
In summary, the information requested is not present in the provided text. This is a regulatory submission for a software update to a radiation treatment planning system, not a clinical validation study for an AI algorithm.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jul 23 1997
Larry A. Kroger, Ph.D. Acting Manager Quality, Safety and Regulatory Programs GE Medical Systems P.O. Box 414. W-709 Milwaukee, WI 53201
Re: K965010 Target 2 Version 1.1 Radiation Treatment Planning (RTP) System Dated: May 9, 1997 Received: May 12, 1997 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Dr. Kroger:
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 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 OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. 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 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/odrh/dsmamain.html".
Sincerely yours.
W.Liau Yu
Lillian Yiu, Ph.D.
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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Image /page/1/Picture/1 description: The image shows the text "GE Medical Systems". The text is in a bold, sans-serif font. The text is black and the background is white.
Gaperal Fiertur Comcan PO Box 414 Milwaukee : VI 5320
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87 (h).
Identification Of Submitter
JUL 2 3 1997
| Submitter: | |
|---|---|
| ------------ | -- |
Telephone:
Date Of Preparation:
Fax:
Larry A. Kroger, Ph.D GE Medical Systems 3000 N. Grandview Blvd., W-709 Waukesha, WI 53188 (414) 544-3894 (414) 544-3863 December 12, 1996
Identification Of The Product
| Device Proprietary Name: | Target 2 Version 1.1 |
|---|---|
| Common Name: | Radiation Oncology Treatment Planning System |
| Classification Name: | Radiation Therapy Simulation System,21 CFR 892.5840 |
| Establishment Reg. Number: | 2126677 |
| Import Agent For: | GE Medical Systems - Europe283 Rue de la Miniere78530 Buc, France |
Marketed Devices
Predicate Device:
System Target 2 Version 1.0 Manufacturer GE Medical Systems 510(k) # K896353
Device Description
The Target 2 V1.1 is an independent radiation oncology treatment planning system which uses CT and non-CT data to produce External Beam and Irregular Field plans, and non-CT data to provide Interstitial/Intracavitary Dosimetry plans.
The system is interactive, using an optical mouse and defined display screen areas on the monitor, in conjunction with operating menus, to produce accurate planning routines.
Image /page/1/Picture/19 description: The image shows a logo with the text "100 Years of Raciology" and the years "1895 - 1995" below it. Above the text is a stylized graphic, possibly representing a medical instrument or symbol. The text and graphic are in black against a white background. The overall design suggests a celebration or commemoration of a centennial anniversary related to the field of radiology.
Image /page/1/Picture/20 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The circular shape has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.
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The treatment plan is contructed and displayed on the patient image. Plans can be stored on the system disk, output as hard copy and archived.
Summary Of Safety And Effectiveness Target 2 V1.1 Page 2
Indications For Use
The Target 2 V1.1 is a radiation oncology treatment planning system which uses CT and non-CT data to produce External Beam and Irregular Field plans, and non-CT data to provide Interstitial/Intracavitary Dosimetry plans.
Comparison With Predicate Device
The Target 2 V1.1 is a modification to the Target 2 Version 1.0 predicate device. They are independent oncology treatment planning systems that use CT and non-CT images to produce external beam dose distributions. A comparison of the features indicates that the Target 2 V1.1 has the same intended use as Target 2 Version 1.0. No new safety or effectiveness concerns are raised by the design of Target 2 V1.1. It shares common hardware with the predicate device.
Summary Of Studies
Test results indicate that Target 2 V1.1 performs its intended use and meets specifications in a safe and effective manner.
Conclusions
In the opinion of GE Medical Systems, the Target 2 V1.1 is substantially equivalent to the Target 2 Version 1.0 (510(k) # K896353). The Target 2 V1.1 is a modification of the predicate device and has the same intended use. No new safety or effectiveness concerns are raised by the design of the Target 2 V1.1.
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510(k) Number (if known):
Device Name: Target 2 Version 1.1 Radiotherapy Treatment Planning System
Indications For Use:
The Target 2 V1.1 is a radiation oncology treatment planning system which uses CT and non-CT data to produce External Beam-and Irregular Field ........ plans, and non-CT data to provide Interstitial/Intracavitary Dosimetry plans.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alvin C. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, ENI; and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
OR
§ 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.