DYNATRAC, COD. 50-1A

K034051 · 3D Line USA, Inc. · IYE · Apr 5, 2004 · Radiology

Device Facts

• Record ID: K034051
• Device Name: DYNATRAC, COD. 50-1A
• Applicant: 3D Line USA, Inc.
• Product Code: IYE · Radiology
• Decision Date: Apr 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

It is intended for localization of patient position in the conduct of radiation therapy with a linear accelerator and registration of patient position between the planning and conduct of treatment.

Device Story

DynaTrac System is an optical patient tracking system used in radiotherapy clinics. It tracks patient position in real-time before and during treatment sessions. By providing rapid spatial registration between the patient's current position and the treatment plan, the system enables the treatment unit to respond to unexpected patient movements. The system is operated by clinical staff to ensure accurate patient positioning, thereby facilitating precise radiation delivery and potentially reducing treatment preparation time.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Optical tracking system for patient positioning. Designed for integration with linear accelerators for 3D radiotherapy. Operates as an accessory to radiation therapy systems (21 CFR 892.5050).

Indications for Use

Indicated for localization and tracking of patient position before and during 3D radiotherapy treatment sessions using linear accelerators.

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

• ExacTrac (K983660)

Submission Summary (Full Text)

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APR = 5 2004

K03405

APPENDIX 7: 510 (K) SUMMARY

## 510(k) Summary As required by 807.92 For DynaTrac System Cod. 50-1A Prepared on December 17, 2003

Submitted by: 3D Line Medical Systems Reston Executive Center 12100 Sunset Hills Road Reston, VA 20190

Tel. [phone]

Itax: 703-467-8421

Contact Person: Nader Salehi, Vice President

Device Trade Name: DynaTrac System

Common Name: optical patient tracking system for radiation therapy

Classification: Medical charged-particle radiation therapy system device Class II, Sec. 21 CFR 892.5050

Predicate Device: ExacTrac (K983660)

Manufactured by: BrainLab USA, Inc., Bldg. 4A, Mailstop E233, 3100 Hansen Way, Palo Alto, CA 94304

Description of the Device: DynaTrac System Cod. 50-1A is a state-of-the-art optical tracking system that tracks patient position before and during a radiotherapy treatment session. It can track the patient in real time allowing the treatment system to respond to uncxpected movements. It shortens the time required to prepare a patient for a treatment session because of the speed with which spatial registration with a treatment plan can be confirmed.

Intended Use for the Device: It is intended for localization of patient position in the conduct of radiation therapy with a linear accelcrator and registration of patient position between the planning and conduct of treatment.

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Substantial Equivalence to Predicate Device: DynaTrac has the same intended use and Davoluntial Dquiraliso to ExacTrac. There are no technical differences that raise issues of safety and effectiveness.

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Image /page/2/Picture/12 description: The image shows a circular seal or logo. The seal contains a stylized graphic of three abstract human figures in profile, stacked vertically. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged around the left side of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 5 2004

Mr. Nader Salehi Vice President 3D Line USA, Inc. Reston Executive Center 12100 Sunset Hills Road, Suite 150 RESTON VA 20190

Re: K034051

Trade/Device Name: DynaTrac System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: December 22, 2003 Received: January 9, 2004

Dear Mr. Salehi:

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 (PMA), 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.

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.

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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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Boyden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Applicant: _3D Line USA, Inc. ________________________________________________________________________________________________________________________________________________

K034051_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ DynaTrac System_

Indication For Use:

Patient Tracking System is an optical system for tracking patient position Patient Tracking System is an optical system to linear accelerators used for before and during facilomeraly. It is an accessory of 3 dimensional radiotherapy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductiv and Radiological Devices 510(k) Number

*Prescription Use*