RADIOACTIVE SEED LOCALIZATION NEEDLE

K111979 · Biocompatibles, Inc. · KXK · Oct 18, 2011 · Radiology

Device Facts

• Record ID: K111979
• Device Name: RADIOACTIVE SEED LOCALIZATION NEEDLE
• Applicant: Biocompatibles, Inc.
• Product Code: KXK · Radiology
• Decision Date: Oct 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2

Intended Use

The BrachySciences Radioactive Seed Localization Needle with AnchorSeed is intended for the localization of suspicious tissues (non-palpable lesions) for excision.

Device Story

Device consists of a localization needle and AnchorSeed; used for marking non-palpable suspicious tissue lesions prior to surgical excision. Physician inserts needle to place radioactive seed at lesion site; seed acts as a marker for surgical guidance. Device facilitates precise identification of target tissue during surgery; aids in removal of non-palpable lesions. Used in clinical settings by physicians.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radioactive seed localization needle with AnchorSeed. Class II device under 21 CFR 892.5730 (Radionuclide brachytherapy source).

Indications for Use

Indicated for the localization of non-palpable suspicious tissue lesions to facilitate surgical excision.

Regulatory Classification

Identification

A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

Special Controls

*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HL" is arranged in a semi-circular fashion around the left side of the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Image /page/0/Picture/4 description: The image shows a date, "OCT 18 2011". The month is October, the day is the 18th, and the year is 2011. The text is in a bold, sans-serif font.

Mr. Wayne Richardson Director of Quality, Regulatory Affairs-Radiation Safety Officer Biocompatibles, Inc. 115 Hurley Road, Bldg 3 OXFORD CT 06478

Re: K111979

Trade/Device Name: BrachySciences Radioactive Seed Localization Needle with AnchorSeed Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: September 26, 2011 Received: October 3, 2011

Dear Mr. Richardson:

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, Or to 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 24, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish frither 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 Parts 801 and 809); medical device reporting (reporting of

{1}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## EXHIBIT 1

5 10(k) Number (if known):

K111979

Device Name: BrachySciences Radioactive Seed Localization Needle with AnchorSeed.

Indications For Use:

The BrachySciences Radioactive Seed Localization Needle with AnchorSeed is intended for the The BrachySciences Radioactive Seed Localization Needle with Antionscours in the use of radioaclive seeds
localization of suspicious tissues (non-palpable lesions ) for exci

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use_

(Optional Format 1-2-96)

16

Mary S Potter

OR

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Sefety

510K K///979

Wayne Rich 10/5/11