SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY

K071229 · Senorx, Inc. · JAQ · May 18, 2007 · Radiology

Device Facts

• Record ID: K071229
• Device Name: SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
• Applicant: Senorx, Inc.
• Product Code: JAQ · Radiology
• Decision Date: May 18, 2007
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The SenoRad 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

SenoRad Multi-Lumen Balloon Source Applicator is a brachytherapy device for delivering intracavitary radiation to surgical margins post-lumpectomy. Device consists of a multi-lumen catheter connected to an inflatable spherical balloon (4 or 5 cm diameter, 32 or 55 ml saline volume). Five radiation source wire lumens are provided: one central lumen and four curved lumens symmetrically offset. Device attaches to commercially available High Dose Rate (HDR) remote afterloader equipment. Operated by physicians in clinical settings. Radiation source delivery wire passes through lumens to deliver radiation dose. Benefits include targeted radiation delivery to surgical margins. Safety warning: effectiveness as a replacement for whole breast irradiation has not been established.

Clinical Evidence

Bench testing only. In vitro laboratory studies demonstrated performance under simulated use conditions. Dosimetry characterization confirmed equivalent radiation dose delivery compared to predicate devices. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Multi-lumen catheter with inflatable spherical balloon (32 or 55 ml saline). Five radiation source lumens (one central, four offset). Compatible with HDR remote afterloader systems. Materials meet ISO 10993-1 biocompatibility standards.

Indications for Use

Indicated for patients undergoing lumpectomy for breast cancer requiring intracavitary radiation to surgical margins. Prescription use only.

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

• Adjustable Multi-Catheter Source Applicator (K062241)
• MammoSite Radiation Therapy System (K041929)

Submission Summary (Full Text)

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K671229

:

MAY 1 8 2007

## 5. 510(K) SUMMARY

| Prepared date | April 20, 2007 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) owner | SenoRx, Inc.<br>11 Columbia<br>Aliso Viejo, CA 92656<br>P. 949.362.4800 F. 949.362.3200 |
| Contact person | Eben Gordon |
| Device name | SenoRad Multi-Lumen Balloon Source Applicator for<br>Brachytherapy |
| Common name | Multi-lumen balloon source applicator |
| Classification name | Remote controlled radionuclide source applicator |
| CFR classification | 21 CFR 892.5700<br>90 JAQ |
| Predicate device | Adjustable Multi-Catheter Source Applicator (K062241)<br>MammoSite Radiation Therapy System (K041929) |
| Decision date | 11/9/2006 (K062241)<br>8/26/2004 (K041929) |
| Device description | The SenoRad applicator consists of a multi-lumen catheter<br>connected to an inflatable spherical balloon that can be attached<br>to commercially available High Dose Rate remote afterloader<br>equipment for passage of the radiation source delivery wire.<br>Five radiation source wire lumens are provided; one central<br>lumen located along the long axis of the applicator and four<br>curved lumens symmetrically offset from the central lumen. The<br>balloon is inflated to a 4 or 5 cm spherical shape by a controlled<br>volume injection of physiological saline to approximately 32 or<br>55 ml, respectively. |
| Indications for use | The SenoRad Multi-Lumen Balloon Source Applicator for<br>Brachytherapy is intended to provide brachytherapy when the<br>physician chooses to deliver intracavitary radiation to the<br>surgical margins following lumpectomy for breast cancer. |
| Summary of substantial equivalence | Extensive preclinical testing was conducted to evaluate and<br>characterize the performance of the SenoRad Multi-Lumen<br>Balloon Source Applicator. Preclinical studies conducted<br>included in vitro laboratory studies to demonstrate that the<br>SenoRad applicator performed as intended under simulated use<br>conditions. Biocompatibility testing was performed to |

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SENORx

demonstrate that the materials meet ISO 10993-1 requirements. The dosimetry of the SenoRad applicator was characterized. Based on these findings, it was concluded that the SenoRad applicator could deliver an equivalent radiation dose as the current brachytherapy applicators.

The SenoRad applicator has the following similarities to the previously cleared predicate devices: same indications for use; same intended use; same intended treatment site; same operating principle; same technological characteristics; equivalent dosimetric characteristics; and same sterilization method. The materials of construction vary in a manner that has no impact on device safety.

In summary, the SenoRad Multi-Lumen Balloon Source Applicator as described in this submission is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2007

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

Re: K071229

Trade/Device Name: SenoRad 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: May 2, 2007 Received: May 3, 2007

Dear Mr. Job:

This letter corrects our substantially equivalent letter of May 18, 2007.

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 SenoRad 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): 《071229

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

Indications for Use:

The SenoRad 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 __ X (Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use

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(21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C broador

productive, Abdominal, Radiological Device 510(k) Number

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