PROSTATE TISSUE MARKER

{0}------------------------------------------------ SENORx ## K081170 page 1 ## 7. MAY 2 8 2008 and the control control control control controlled in the controlled | 7. 510(K) SUMMARY | | MAY 28 2008 | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Date prepared | April 23, 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 | Prostate Tissue Marker | | | Common name | Tissue marker | | | Classification name | Implantable Clip | | | Classification regulation | 878.4300 NEU | | | Predicate device | Gel Mark UltraCor Biopsy Site Marker, K080698, Clearance date: 3/31/2008; NEU<br>Fiducial Markers, K071614, Clearance date: 9/11/2007; IYE | | | Description | The Prostate Tissue Marker consists of a pure gold marker placed inside a 17 Ga<br>disposable beveled needle applicator. Also contained in the needle are 2 resorbable<br>polylactic acid/polyglycolic acid (PLA/PGA) pellets and a polyethylene glycol (PEG)<br>plug in the needle bevel. The gold marker is intended for long-term radiographic<br>marking of the tissue site. The pellets are visible via ultrasound for approximately 4<br>weeks and are essentially resorbed in approximately 12 weeks. | | | Indications for use | The Prostate Tissue Marker is indicated for use to radiographically mark prostate tissue. | | | Summary of substantial<br>equivalence | The Prostate Tissue Marker is identical to the Gel Mark UltraCor Biopsy Site Marker<br>(SenoRx, K080698) except for the intended use being prostate tissue rather than another<br>soft tissue, breast. The Fiducial Marker (CIVCO, K071614) is also used to mark soft<br>body tissues, including the prostate for the treatment of tumors. The CIVCO Fiducial<br>Marker itself is also pure gold with approximately the same mass as the proposed<br>device. The principle of operation, method of use, technological characteristics, and<br>basic design are the same for the SenoRx device and similar to the CIVCO device. The<br>indication for use, intended use, and treatment site for the Prostate Tissue Marker is a<br>subset of that for the CIVCO device and represents a different soft tissue target for the<br>SenoRx device. | | and the comments of the comments of the comments of the comments of {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Public Health Service MAY 2 8 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SenoRx, Inc. % Mr. Eben Gordon VP, RA/QA 11 Columbia Aliso Viejo, California 92656 Re: K081170 Trade/Device Name: Prostate Tissue Marker Regulation Number: 21 CFR 878.4300 Device Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: April 23, 2008 Received: April 29, 2008 Dear Mr. Hawkins: 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 (PMA), 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. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ ## Page 2 - Mr. Eben Gordon 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 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 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark M. Milliman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## 6. INDICATIONS FOR USE 510(k) Number (if known): KOG | | 70 Device Name: _________________________________________________________________________________________________________________________________________________________________ Prostate Tissue Marker Indications for Use: The Prostate Tissue Marker is indicated for use to radiographically mark prostate tissue. Prescription Use _ X (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) Neil Rp Oyl for rxn Page ⊥ of ⊥ (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K081170 11