CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY

K081079 · Senorx, Inc. · JAQ · May 2, 2008 · Radiology

Device Facts

• Record ID: K081079
• Device Name: CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
• Applicant: Senorx, Inc.
• Product Code: JAQ · Radiology
• Decision Date: May 2, 2008
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Contura Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

Device Story

Contura Multi-Lumen Balloon (MLB) Source Applicator is a brachytherapy device used in clinical settings by physicians. It consists of a multi-lumen catheter attached to an inflatable spherical balloon (4.5-6 cm diameter). The balloon is inflated with a saline/contrast solution to fill the lumpectomy cavity. The device connects to commercially available High Dose Rate (HDR) remote afterloader equipment. It features five radiation source wire lumens: one central lumen and four symmetrically offset lumens. This configuration allows for radiation dose modulation. The device is inserted into the surgical cavity post-lumpectomy to deliver targeted intracavitary radiation to the surgical margins. By providing multiple lumens, it enables the physician to adjust the radiation dose distribution, potentially improving coverage of the target tissue while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and dosimetry analysis demonstrating equivalent performance to predicate devices under simulated use conditions.

Technological Characteristics

Multi-lumen catheter with inflatable spherical balloon (4.5-6 cm). Five radiation source lumens (one central, four offset). Material: Medical grade catheter/balloon components. Energy source: External High Dose Rate (HDR) remote afterloader. Connectivity: Mechanical interface to HDR afterloader. Sterilization: Not specified.

Indications for Use

Indicated for patients undergoing lumpectomy for breast cancer who require intracavitary radiation therapy to surgical margins.

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

• SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy (K071229)
• MammoSite Radiation Therapy System (K030558)

Submission Summary (Full Text)

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K081029

MAY - 2 2008

## 5. 510(K) SUMMARY

| Date prepared | April 2, 2008 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | SenoRx, Inc.<br>11 Columbia<br>Aliso Viejo, CA 92656<br>T. 949.362.4800; F. 949.362.0300 |
| Contact person | Eben Gordon<br>Vice President, RA/QA<br>SenoRx, Inc.<br>T. 949.362.4800; F. 949.362.0300 |
| Device name | Contura MLB Source Applicator for Brachytherapy |
| Common name | Multi-Lumen balloon source applicator |
| Classification name | Remote controlled radionuclide source applicator |
| Classification regulation | 21 CFR 892.5700;<br>90 JAQ |
| Predicate devices | SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy<br>(K071229) |
| | MammoSite Radiation Therapy System (K030558) |
| Description | The Contura MLB Applicator consists of a multi-lumen catheter connected to<br>an inflatable spherical balloon that can be attached to commercially available<br>High Dose Rate remote afterloader equipment for passage of the radiation<br>source delivery wire. Five radiation source wire lumens are provided; one<br>central lumen located along the long axis of the applicator and four lumens<br>symmetrically offset from the central lumen. The balloon is inflated to a 4.5 - 6<br>cm spherical shape by a controlled volume injection of a saline/contrast<br>solution. |
| Indications for use | The Contura Multi-Lumen Balloon Source Applicator for Brachytherapy is<br>intended to provide brachytherapy when the physician chooses to deliver<br>intracavitary radiation to the surgical margins following lumpectomy for breast<br>cancer. |
| Summary of substantial<br>equivalence | Preclinical studies demonstrated that the Contura MLB Applicator performed as<br>intended under simulated use conditions. The dosimetry of the Contura MLB<br>Applicator and the predicate devices demonstrated that the Contura MLB<br>Applicator could deliver an equivalent radiation dose. In summary, the Contura<br>MLB Applicator as described in this submission is substantially equivalent to<br>the predicate devices. |

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY - 2 2008

SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1393 25th Street NW BUFFALO MN 55313

Re: K081079

Trade/Device Name: Contura Multi-Lumen Balloon Source Applicator for Brachytherapy Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: April 15, 2008 Received: April 16, 2008

Dear Mr. Job:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of the Contura Multi-Lumen Balloon Source Applicator for Brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

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The Warning must be presented within a black box, and the font should be bold and the same size as any surrounding text. The Warning should be the first item in your list of warnings.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4. INDICATIONS FOR USE

510(k) Number (if known): KU81079

Device Name: _______ Contura Multi-Lumen Balloon Source Applicator for Brachytherapy _

Indications for Use:

The Contura Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

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510(k) Number K081079