TARGET 2 VERSION 1.1

K965010 · GE Medical Systems · IYE · Jul 23, 1997 · Radiology

Device Facts

• Record ID: K965010
• Device Name: TARGET 2 VERSION 1.1
• Applicant: GE Medical Systems
• Product Code: IYE · Radiology
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Target 2 V1.1 is an independent radiation oncology treatment planning system; utilizes CT and non-CT image data as input; produces External Beam, Irregular Field, and Interstitial/Intracavitary Dosimetry plans. System is interactive; uses optical mouse and screen-based menus for planning routines. Plans are constructed/displayed on patient images; stored on system disk; output as hard copy; archived. Used in clinical oncology settings by medical professionals to calculate radiation dose distributions; assists in treatment planning to optimize radiation delivery to patients.

Clinical Evidence

Bench testing only. Test results indicate the device performs its intended use and meets specifications in a safe and effective manner.

Technological Characteristics

Independent radiation oncology treatment planning system; utilizes CT and non-CT data; interactive interface with optical mouse and monitor menus; supports external beam, irregular field, and interstitial/intracavitary dosimetry planning; hardware shared with predicate device.

Indications for Use

Indicated for radiation oncology treatment planning using CT and non-CT data to generate External Beam, Irregular Field, and Interstitial/Intracavitary Dosimetry plans.

Regulatory Classification

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.

Predicate Devices

• Target 2 Version 1.0 (K896353)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

JUL 23 1997

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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 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 the Electronic Product 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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K965010

GE Medical Systems

General Electric Company
PO Box 414, Milwaukee, WI 53201

# 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 23 1997

Submitter:
Larry A. Kroger, Ph.D
GE Medical Systems
3000 N. Grandview Blvd., W-709
Waukesha, WI 53188

Telephone:
[phone]

Fax:
[phone]

Date Of Preparation:
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 | Manufacturer | 510(k) # |
| --- | --- | --- |
| Target 2 Version 1.0 | GE Medical Systems | 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.

100 Years of Radiology

1395 - 1995

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The treatment plan is constructed 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): K9650/0

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K9650/0

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use