ART SHIELDED BREAST APPLICATOR

K062135 · Advanced Radiation Therapy, LLC · JAQ · Nov 7, 2006 · Radiology

Device Facts

• Record ID: K062135
• Device Name: ART SHIELDED BREAST APPLICATOR
• Applicant: Advanced Radiation Therapy, LLC
• Product Code: JAQ · Radiology
• Decision Date: Nov 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ART Shielded Breast Brachytherapy Applicator is intended for use with Nucletron or Varian remote afterloading systems for non-invasive brachytherapy in areas of intact skin.

Device Story

The ART Shielded Breast Applicator is a passive accessory for HDR brachytherapy. It is positioned either against the breast or external to a mammography-style immobilization paddle. The device aligns with the target tissue to facilitate radiation delivery while providing external shielding to reduce dose to surrounding healthy tissue. It is available in five sizes (4, 5, 6, 7, and 8 cm ID). The device is used in a clinical setting by radiation oncology professionals to treat breast tissue while maintaining skin integrity.

Clinical Evidence

Bench testing only.

Technological Characteristics

Passive shielded applicator for HDR brachytherapy. Available in 5 sizes (4-8 cm ID). Designed for use with Nucletron or Varian remote afterloading systems. Non-invasive, external application.

Indications for Use

Indicated for non-invasive brachytherapy of the breast in areas of intact skin, using Nucletron or Varian remote afterloading HDR equipment.

Regulatory Classification

Identification

A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Predicate Devices

• ART Breast Brachytherapy Applicator (K060299)
• Mick Nuclear - HDR-IORT Shielded Applicator (K052351)
• Varian Medical Systems - Shielded Applicator Set (K033371)

Submission Summary (Full Text)

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Advanced Radiation Therapy

K062135

July 25, 2006

# ART Shielded Breast Applicator Premarket Notification 510k Summary of Safety and Effectiveness

ART Shielded Breast Applicator

#### 1. Sponsor Name

NOV - 7 2006

Advanced Radiation Therapy, LLC 9 Linnell Circle, Billerica, MA 01821 Telephone: [phone] Fax [phone] Contact Individual: Raymond J. Bricault Jr., Chief Operating Officer

#### 2. Device Name

ART Shielded Breast Applicator

#### 3. Identification of Predicate or Legally Marketed Device

Advanced Radiation Therapy - ART Breast Brachytherapy Applicator -K060299 Mick Nuclear - HDR-IORT Shielded Applicator - K052351 Varian Medical Systems - Shielded Applicator Set - K033371

#### ﻬﺎ Device Description

The Advanced Radiation Therapy (ART) Shielded Breast Applicator is used for non-invasive HDR treatment of the breast. The applicator is designed to be positioned either external to a mammography style paddle which immobilizes the breast or directly against the breast with intact skin. Once the target has been immobilized and imaged the applicator is placed such that it is aligned with the target. The exterior shielding of the applicator will reduce dose to the surrounding tissue. The applicator is available in 5 sizes - 4, 5, 6, 7 and 8 cm ID.

#### 5. Intended Use

The ART Shielded Breast Brachytherapy Applicator is intended for use with Nucletron or Varian remote afterloading systems for non-invasive brachytherapy in areas of intact skin.

#### 6. Comparison of Technological Characteristics

The predicate devices and the ART Shielded Applicator are used to provide radiation to tissue via a remote afterloader device; all are intended as accessories to remote afterloaders.

#### 7 Performance Testing

The Advanced Radiation Therapy Shielded Breast Applicator is a passive device. Performance testing was not required.

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### Advanced Radiation Therapy July 25, 2006 ART Shielded Breast Applicator Premarket Notification

## Statement of Equivalency

The ART Shielded Breast Applicator is substantially equivalent to the predicates, which provide the same or similar functions. The intended use, statement of indications, and technological and performance characteristics of the ART Shielded Breast Applicator support the concept of substantial equivalence.

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Ravmond J. Bricault Jr. Chief Operating Officer Advanced Radiation Therapy, LLC 9 Linnell Circle BILLERICA MA 01821-3902

NOV - 7 2006

Re: K062135

Trade/Device Name: ART Shielded Breast Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: October 6, 2006 Received: October 10, 2006

Dear Mr. Bricault:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "PA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. There are four stars at the bottom of the logo.

Protecting and Promoting Public Health

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reast be advised that I Driv issually in that your device complies with other requirements of the Act that I DA has made a regulations administered by other Federal agencies. You must of any I cacal surates und regarants, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY at 807), adomig (21 OF N P 21 CFR Part 820); and if applicable, the electronic forum in all quality systems (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) This letter will anow you'ls cognitudios of substantial equivalence of your device to a legally premarket notication: "The PDF intems
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 If you desire specific advise to your of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 (21GT K Fall 607.97): "100 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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### July 25, 2006 Advanced Radiation Therapy ART Shielded Breast Applicator Premarket Notification Indications for Use

510(k) Number (if known):

K062135

Device Name: ART Shielded Breast Applicator

Indications for Use:

The ART Shielded Breast Applicator is intended for use with Nucletron or Varian remote afterloading HDR equipment for non-invasive brachytherapy of the breast in areas of intact skin.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leagrom

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices

510(k) Number K062135