(127 days)
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.
"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.
The provided document is a 510(k) summary for the "Best® Localization Needle with I-125 Seed." The primary purpose of this document is to establish substantial equivalence to a predicate device, not to detail the results of a primary clinical study proving performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in this document.
The document states that the new device is "substantially equivalent" to the predicate device, "BrachySciences Radioactive Seed Localization Needle with AnchorSeed (K111979)." This equivalence is based on similar technological characteristics and intended use.
Here's a breakdown of the requested information, indicating what is not available:
1. A table of acceptance criteria and the reported device performance
- Not available. The document does not specify performance acceptance criteria or report specific performance metrics for the device. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific performance acceptance criteria from a new clinical study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available. No new clinical study data or test set information is provided in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not available. No test set or ground truth establishment details are provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not available. No adjudication method is mentioned as no specific test set data is discussed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a medical needle with an I-125 seed, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical instrument, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available. No ground truth information is mentioned because no primary clinical data for performance assessment is presented.
8. The sample size for the training set
- Not applicable. This device is a physical medical product, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not a machine learning algorithm.
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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: (703) 451-2378 Fax: (703) 451-4736.
Contact Person :
Dharmendra Thakur Manager, Quality and Regulatory Affairs Phone: (703) 451-2378 Ext-162 Fax: (703) 451-4736.
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 703 451 237.8 800 336 4970 fax 703 451 5228 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 (800) 638 2041 or (301) 796-7100 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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§ 892.5730 Radionuclide brachytherapy source.
(a)
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.(b)
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.