Free Complaint - District Court of California - California

Case 5:08-cv-00133-RMW

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Su"RXRi
5. 510(K) SUMMARY
April 20, 2007 SenoRx, Inc. 11 Columbia Aliso Viejo, CA 92656 P. 949.362.4800 F. 949.362.3200 Eben Gordon SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy Multi-lumen balloon source applicator Remote controlled radionuclide source applicator 21 CFR 892.5700 90 JAQ Adjustable Multi-Catheter Source Applicator (K062241) MammoSite Radiation Therapy System (K041929) 11/9/2006 (K062241) 8/26/2004 (K041929) The SenoRad applicator consists of a multi-lumen catheter connected to an inflatable spherical balloon that can be attached to commercially available High Dose Rate remote afterloader equipment for passage of the radiation source delivery wire. Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four curved lumens symmetrically offset from the central lumen. The balloon is inflated to a 4 or 5 cm spherical shape by a controlled volume injection of physiological saline to approximately 32 or 55 ml, respectively. 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.

Prepared date 510(k) owner

Contact person Device name Common name Classification name CFR classification Predicate device Decision date Device description

Indications for use

Summary of substantial equivalence Extensive preclinical testing was conducted to evaluate and characterize the performance of the SenoRad Multi-Lumen Balloon Source Applicator. Preclinical studies conducted included in vitro laboratory studies to demonstrate that the SenoRad applicator performed as intended under simulated use conditions. Biocompatibility testing was performed to 12

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SEN6DRX
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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Case 5:08-cv-00133-RMW Document 1-7 Filed 01/08/2008 DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration
9200 Corporate Blvd.

Rockville MD 20850

SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25 th Street NW BUFFALO MN 55313

MAY I 8 2007

Re: K071229 Trade/Device Name: SecoRad Multi-Lumen Ballon Source Applicator for Brachytherapy Regulation Number: 21 CFR §892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: May 2, 2007 Received: May 3, 2007

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) 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.

FZ'X
11% **

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Page 2 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 53 1-542 of the Act); 21 CFR I1000-1 050. This letter will allow you to begin marketing your device as described in your Section 5 10(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 80 1), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: 21 CUR 876.xxx 21 CUR 884.xxx 2! CFR 894.xxx Other (Gastroenterology/Renal/Urology, (Obstetrics/Gynecology) (Radiology) 240-276-0115 240-276-0115 240-276-0120 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 the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address litrp:H//ww\w.fda.eov/cdrhl/industrv/support/indexitml. Sincerely yours,

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

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SenoRx Inc. SenoRad Multi-Lumen Balloon Source Applicator 510(k) Submission

4.

INDICATIONS FOR USE

510(k)Number(ifknown):

1C07jt :-

Device Name:

__

SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy

__

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

AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

..........................................................................

(Division Sign-Off '.' Division of Reprod uctive, Abdominal, and Radiological Devices 510(k) Number ¾b1IO.Qq
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