(127 days)
No
The summary describes a physical device (needle with radioactive seed) for breast localization and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for localizing a breast cancer area by introducing a radioactive seed. While it aids in treatment planning and localization, it is not directly performing a therapeutic function itself. The therapy comes from the introduced radioactive seed (Brachytherapy), not the needle.
No.
The device is used for localization (placement of a radioactive seed) within the breast, not for diagnosing a condition.
No
The device description clearly states it is a "single-use sterile device" and contains a "Localization Needle with I-125 Seed," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The "Best Localization Needle with I-125 Seed" is a device used within the body (in vivo) to physically introduce a radioactive seed into breast tissue for localization purposes. It is a surgical/interventional device, not a diagnostic test performed on a sample.
- Intended Use: The intended use is "Breast Localization purpose," which is a procedure performed directly on the patient, not a diagnostic test on a sample.
Therefore, this device falls under the category of a medical device used for a therapeutic or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KXK
Device Description
"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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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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