(43 days)
No
The summary describes a radioactive source for brachytherapy and does not mention any AI or ML components.
Yes
The 'Intended Use / Indications for Use' explicitly states that the sources are "intended for the delivery of therapeutic doses of gamma radiation for the purpose of brachytherapy treatments". This statement clearly indicates a therapeutic purpose.
No
The device is described as being for "the delivery of therapeutic doses of gamma radiation for the purpose of brachytherapy treatments," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states that the device is a "pure Ir-192 source," which is a physical radioactive material used for brachytherapy, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "delivery of therapeutic doses of gamma radiation for the purpose of brachytherapy treatments." This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "pure Ir-192 source," which is a radioactive source used for radiation therapy.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is used to treat disease with radiation.
N/A
Intended Use / Indications for Use
The BEST Model No. 81-01 Series Sources are intended for the delivery of therapeutic doses of gamma radiation for the purpose of brachytherapy treatments (e.g., interstitial, intracavitary, intralumen, or topical radiation therapy).
Product codes
90 KXK
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The safety and effectiveness of the BEST Model Nos. 81-01-11, 81-01-14, and 81-01-14 sources will be demonstrated if these sources are substantially equivalent to the BEST Model No. 81-01 source (FDA 510(K) Approval No. K910710), which is addressed in the AAPM's TG 43 document. Air kerma measurements at NIST and TG-43 parameter measurements at the University of Kentucky for the BEST Model No. 81-01-17 intermediate downsize source has shown that it is a pure Ir-192 source, whose dosimetry is in substantial agreement with that of TG-43. The BEST Model Nos. 81-01-11 and 81-01-14 sources have the same pure Ir-192 gamma ray spectrum as that of the BEST Model No. 81-01-17 source. Therefore, for brachytherapy applications, the dosimetry of the three sources (i.e., the BEST Model Nos. 81-01-11, 81-01-14, and 81-01-17) should all be the same, and substantially equivalent to that of the TG-43. Further, BEST has committed that these sources will meet FDA recognized standards.
BEST has filed an amendment to NRC to register these sources under NRC Registration Certificate NR-187-S-101-S. Under the new NRC guidelines, BEST provided testing data to the NRC to demonstrate the safety of these sources. Part of the testing data provided to the NRC demonstrated that these new sources meets FDA recognized standards for Photon-emitting Brachytherapy Sources (i.e., ANSI N43.6-1977 Classification of Sealed Radioactive Sources, and ISO 2919 Sealed radioactive sources -General requirements and classification).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for Best Medical International, Inc. along with the text "Pioneer in Brachytherapy" and "ISO Certified". The date "NOV 18 2004" is printed at the top of the image. The logo features the word "BEST" inside a diamond shape, superimposed on a globe.
Attachment to Appendix 1
Summary of Safety and Effectiveness Information
The safety and effectiveness of the BEST Model Nos. 81-01-11, 81-01-14, and 81-01-14 sources will be demonstrated if these sources are substantially equivalent to the BEST Model No. 81-01 source (FDA 510(K) Approval No. K910710), which is addressed in the AAPM's TG 43 document. Air kerma measurements at NIST and TG-43 parameter measurements at the University of Kentucky for the BEST Model No. 81-01-17 intermediate downsize source has shown that it is a pure Ir-192 source, whose dosimetry is in substantial agreement with that of TG-43. The BEST Model Nos. 81-01-11 and 81-01-14 sources have the same pure Ir-192 gamma ray spectrum as that of the BEST Model No. 81-01-17 source. Therefore, for brachytherapy applications, the dosimetry of the three sources (i.e., the BEST Model Nos. 81-01-11, 81-01-14, and 81-01-17) should all be the same, and substantially equivalent to that of the TG-43. Further, BEST has committed that these sources will meet FDA recognized standards.
BEST has filed an amendment to NRC to register these sources under NRC Registration Certificate NR-187-S-101-S. Under the new NRC guidelines, BEST provided testing data to the NRC to demonstrate the safety of these sources. Part of the testing data provided to the NRC demonstrated that these new sources meets FDA recognized standards for Photon-emitting Brachytherapy Sources (i.e., ANSI N43.6-1977 Classification of Sealed Radioactive Sources, and ISO 2919 Sealed radioactive sources -General requirements and classification).
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2004
Mr. Sankara I. Ramaswamy Manager, Regulatory Affairs Best Medical International, Inc. 7643 Fullerton Road SPRINGFIELD VA 22153
- Re: K042786 Trade/Device Name: Best Model No. 81-01 Series Ir-192 Sources Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II
Product Code: 90 KXK Dated: September 23, 2004 Received: October 6, 2004
Dear Mr. Ramaswamy:
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 (Premarket Approval), 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 (QS) 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
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for Best Medical International, Inc. The logo includes the text "BEST MEDICAL INTERNATIONAL, INC." in a bold, sans-serif font. To the left of the text is a globe with the word "BEST" in a white box in the center. The text "Pioneer in Brachytherapy" is curved around the top of the globe, and the text "ISO Certified" is curved around the bottom.
Appendix 2
Indications for Use Form
510 (k) Number: Reference K910710 Ko42786
Device Name: BEST Model No. 81-01 Series Sources
Indications For Use:
The BEST Model No. 81-01 Series Sources are intended for the delivery of therapeutic doses of gamma radiation for the purpose of brachytherapy treatments (e.g., interstitial, intracavitary, intralumen, or topical radiation therapy).
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use \ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Darcy C. Brogdon
(Division Sign-Off)(
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042786