BEST LOCALIZATION NEEDLE WITH I-125 SEED

K122704 · Best Medical Intl. · KXK · Jan 9, 2013 · Radiology

Device Facts

• Record ID: K122704
• Device Name: BEST LOCALIZATION NEEDLE WITH I-125 SEED
• Applicant: Best Medical Intl.
• Product Code: KXK · Radiology
• Decision Date: Jan 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2

Intended Use

Best® Localization Needle with I-125 Seed, is a device intended to be used with or without absorbable strands to facilitated to introduction of a radionuclide (Iodine-125) seed to non patpable breast lesions for excision.

Device Story

Device consists of 18-gauge needle (5-20 cm length) containing low-activity Iodine-125 seed, either loose or within absorbable strands. Used by physicians in clinical settings to mark non-palpable breast lesions. Needle facilitates precise placement of radioactive seed into target tissue; seed remains in situ to guide surgeon during subsequent excision procedure. Device is single-use and provided sterile. Benefits include improved localization accuracy for non-palpable lesions, aiding surgical planning and tissue removal.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

18-gauge stainless steel needle, 5-20 cm length. Contains Iodine-125 radionuclide seed (K912170). Provided sterile in pouch. Manual operation.

Indications for Use

Indicated for breast localization of non-palpable breast lesions to facilitate excision. For use under the direct supervision of a qualified physician. Prescription use only.

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.

Predicate Devices

• BrachySciences Radioactive Seed Localization Needle with AnchorSeed (K111979)

Reference Devices

• Best I-125 (K912170)

Submission Summary (Full Text)

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## Best medical international

"510(k) Summary"

Date Prepared:

Manufacturer:

December 18, 2012

Best Medical International, Inc. 7643 Fullerton Road, Springfield, VA 22153 Phone: [phone] Fax: [phone].

Contact Person :

Dharmendra Thakur Manager, Quality and Regulatory Affairs Phone: [phone] Ext-162 Fax: [phone].

Source, Brachytherapy, Radionuclide

"Best® Localization Needle with I-125 Seed"

Trade Name:

Common Name:

Classification name:

Predicate device:

Description:

Intended Use:

Summary of Substantial Equivalence:

Radionuclide Brachytherapy Source (21 CFR 892.5730) BrachySciences Radioactive Seed Localization Needle with AnchorSeed (K111979)

"Best" Localization Needle with I-125 Seed" contains low activity Iodine seed (Best I-125- K912170). The lodine-125 seed is loaded as loose or as stranded inside the needle. Most commonly, 18 giuge 5cm to 20 cm needles are used as a breast localization needle to facilitate the introduction of radionuclide seed into the breast cancer area. The devices are packaged in a pouch with label and provided sterile.

Best® Localization Needle with I-125 Seed, is a device intended to be used with or without absorbable strands to facilitated to introduction of a radionuclide (Iodine-125) seed to non patpable breast lesions for excision.

The technological characteristic and intended use of Best® Localization Needle with I-125 Seed is similar to the predicate device (BrachySciences Radioactive Seed Localization Needle with AnchorSeed). In summary, "Best" Localization Needle with 1-125 Seed" as described in this submission is substantially equivalent to the predicate device.

7643 Fullerton Road, Springfield, VA 22153 USA phone [phone] 336 4970 fax [phone] www.bestmedical.com

Image /page/0/Picture/20 description: The image shows the word "Best" in a stylized, italicized font. The word is white against a black background, creating a high contrast. A small registered trademark symbol is visible in the upper right corner of the image, next to the letter "t".

JAN 0 9 2013

healthcare

AFRICA ASIA EUROPE LATIN AMERICA Middle East NORTH AMERICA

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

C/O Mr. Dharmendra Thakur Manager, Ouality and Regulatory Affairs Best Medical International 7643 Fullerton Road SPRINGFIELD VA 22153

January 9, 2013

Re: K122704

Trade/Device Name: Best Localization Needle with I-125 seed Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: November 9, 2012 Received: November 13, 2012

Dear Mr. Thakur:

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. Please note: CDRH does not evaluate information related to contract liability warranties. · We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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## Page 2-Mr. Thakur

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K122704

Device Name: Best Localization Needle with I-125 Seed

Indications for Use:

The device is indicated as "single-use sterile device". Best Localization Needle with I-125 Seed is indicated in the use for Breast Localization purpose under the direct supervision of a qualified physician.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K122704 510(k)

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