TRACKPORT

K072529 · Direx Systems Corp. · IYE · Oct 26, 2007 · Radiology

Device Facts

• Record ID: K072529
• Device Name: TRACKPORT
• Applicant: Direx Systems Corp.
• Product Code: IYE · Radiology
• Decision Date: Oct 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

TrackPort is an online EPID intended to aid in target-to-beam relative positioning for administration of radiotherapy. It is indicated for all body procedures and operable in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system

Device Story

TrackPort is an online Electronic Portal Imaging Device (EPID) used in radiotherapy. It functions as an imaging tool to assist clinicians in verifying target-to-beam relative positioning during radiation treatment delivery. The device operates in conjunction with the TrackLeaf Micro Multi Leaf Collimating (MMLC) system. By providing real-time or near-real-time imaging, it allows healthcare providers to confirm that the radiation beam is accurately aligned with the intended target area within the patient's body. This alignment verification helps ensure the precision of radiotherapy administration, potentially improving treatment accuracy and patient outcomes. It is intended for use in clinical settings where radiotherapy is performed.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic Portal Imaging Device (EPID). Operates as an accessory to radiotherapy systems, specifically the TrackLeaf MMLC. Digital imaging technology for target-to-beam positioning.

Indications for Use

Indicated for patients undergoing radiotherapy procedures requiring target-to-beam positioning. Applicable to all body procedures. Used in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system.

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.

Reference Devices

• TrackLeaf Micro Multi Leaf Collimating (MMLC) system

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Larisa Gershtein QA Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021

Re: K072529

Trade/Device Name: TrackPort Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 29 2007 Received: September 7, 2007

#### Dear Ms. Gershtein:

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.

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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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Direx Systems Corp. The word "Direx" is in large, bold, black letters with a line underneath. Below the line, the words "Systems Corp." are written in smaller, black letters.

## SECTION 4: INDICATIONS FOR USE STATEMENT

# Indications for Use Statement

K072529 510(k) Number (if known): _

Device Name: TrackPort

Indications for Use:

TrackPort is an online EPID intended to aid in target-to-beam relative positioning for administration of radiotherapy. It is indicated for all body procedures and operable in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use (Per 21 CFR § 801.109)

OR

Over the Counter Use

Tony M Whing

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

437 Turnpike Street . Canton, MA 02021 Phone: [phone] ♦ Fax: [phone] e - [e-mail]