MIGUE

K052212 · Direx Systems Corp. · IYE · Mar 10, 2006 · Radiology

Device Facts

• Record ID: K052212
• Device Name: MIGUE
• Applicant: Direx Systems Corp.
• Product Code: IYE · Radiology
• Decision Date: Mar 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

MIGUE is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures.

Device Story

MIGUE is a patient positioning system for linear accelerators used in stereotactic radiosurgery or radiotherapy. It consists of a main unit with two angularly spaced fluoroscopic channels, an electronics cabinet, and a console workstation PC. The device acquires two X-ray images of the patient; each channel displays the acquired image with a superimposed marker indicating the isocenter projection on the fluoroscopic screen. Clinicians use this visual output to align the patient precisely at the linear accelerator's isocenter. The system facilitates accurate target-to-beam set-up, potentially improving the precision of radiation delivery for various body procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises a main unit with two fluoroscopic X-ray channels, an electronics cabinet, and a console workstation PC. Operates via X-ray image acquisition and isocenter projection markers. Software-based image processing for display and control. Connectivity via workstation integration.

Indications for Use

Indicated for patients undergoing stereotactic radiosurgery or radiotherapy procedures for all body sites requiring radiation beam set-up.

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

• 3Dscope (K041213)
• ExacTrac X-Ray 6D (K040585)

Submission Summary (Full Text)

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K0522/2

### SECTION 4 - 510(k) SUMMARY

[Submitted pursuant to 21 CFR 807.92(a)]

Summary Date: October 17, 2005

#### 1. Submitter Information

Submitter:

Direx Systems Corporation 11 Mercer Road Natick Business Park Natick, MA 01760

| Telephone: | [phone] |
|--------------------------------|--------------------------------|
| Fax: | [phone] |
| Contact Person | Larisa Gershtein<br>QA Manager |
| Contact Person e-mail address: | [e-mail] |

#### 2. Device

| Trade / Proprietary Name: | MIGUE |
|------------------------------------|------------------------------|
| Classification Name: | Accelerator, Linear, Medical |
| Classification Name/ Product code: | 90 IYE |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 892.5050 |

## 3. Predicate Devices

3Dscope K041213 ExacTrac X-Ray 6D K040585

## 4. Device Description

MIGUE is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. MIGUE uses x-ray registration as the method of locating the position of the patient. It is indicated for all body procedures.

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The device consists of three units:

- 1. MIGUE Main Unit incorporates two angularly spaced identical Fluoroscopic Channels, mounted on a rigid ring, for acquisition of X-ray images.
- 2. Console Workstation PC with embedded software, used for control, display and image processing.
- 3. Electronics Cabinet.

#### Principle of operation:

- a) Acquire two images, one from each channel.
- b) Each channel displays an acquired image and a marker indicating the IsoCenter projection onto the fluoroscopic screen.

# 5. Indications for Use

MIGUE is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. MIGUE uses x-ray registration as the method of locating the position of the patient. It is indicated for all body procedures.

# 6. Technological Characteristics

The Substantial Equivalence table provides a comparison of MIGUE's technological characteristics to those of the predicate devices. The table is located in Section 8 of this submission.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052212 Trade/Device Name: MIGUE Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 9, 2006 Received: February 10, 2006

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 stred 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, weret 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 provices , 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 affer ting 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 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) I 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.

MAR 1 0 2006

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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 1egally 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 promoter 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" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at inst the netition the 638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. Brigdon

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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# SECTION 3 - INDICATIONS FOR USE STATEMENT

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K052212 Device Name: MIGUE Indications for Use:

> MIGUE is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures.

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

510(k) Number _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over the Counter Use___________________________________________________________________________________________________________________________________________________________________________

David A. Syverson
(Division Sign-Off)

Division of Reproductive, Abdominal, ological Devic