(219 days)
Not Found
No
The summary describes a standard interactive treatment planning system and explicitly states that AI, DNN, or ML were not found in the document.
No.
The device is a treatment planning system, not a device that directly administers therapy.
No
The device is a treatment planning system, not a diagnostic device. It uses imaging data to produce treatment plans for radiation oncology, which is a therapeutic rather than diagnostic function.
No
The device description explicitly mentions hardware components like an optical mouse, defined display screen areas on the monitor, and system disk, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "radiation oncology treatment planning system." This type of system is used to plan and deliver radiation therapy to a patient, which is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description reinforces its function as a treatment planning system, using patient image data to construct and display treatment plans.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status based on 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 purpose is to plan a medical treatment based on imaging data.
N/A
Intended Use / 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.
Product codes
90 IYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and non-CT data
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
Test results indicate that Target 2 V1.1 performs its intended use and meets specifications in a safe and effective manner.
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
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
1
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 - Europe |
| 283 Rue de la Miniere | |
| 78530 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.
2
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.
3
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