(43 days)
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).
BEST Model Nos. 81-01-11, 81-01-14, and 81-01-14 sources. These sources are pure Ir-192 sources.
Acceptance Criteria and Study for BEST Model Nos. 81-01-11, 81-01-14, and 81-01-17 Ir-192 Sources
This document describes the acceptance criteria and the study performed to demonstrate the safety and effectiveness of the BEST Model Nos. 81-01-11, 81-01-14, and 81-01-17 Ir-192 sources.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are based on substantial equivalence to the BEST Model No. 81-01 source, which is documented in the AAPM's TG-43 report, and compliance with FDA recognized standards for Photon-emitting Brachytherapy Sources.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to the BEST Model No. 81-01 source, as described in AAPM's TG-43 document, regarding dosimetry. This implies the new sources exhibit comparable gamma ray spectrum and dosimetric characteristics. | 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 showed 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 the 81-01-17 source. Therefore, for brachytherapy applications, the dosimetry of all three new sources (81-01-11, 81-01-14, and 81-01-17) are considered to be the same and substantially equivalent to that of TG-43 (and by extension, to the predicate 81-01 source). |
| Compliance with FDA recognized standards for Photon-emitting Brachytherapy Sources, specifically ANSI N43.6-1977 Classification of Sealed Radioactive Sources and ISO 2919 Sealed radioactive sources - General requirements and classification. | BEST provided testing data to the NRC (as part of an amendment to NRC to register these sources under NRC Registration Certificate NR-187-S-101-S) that demonstrated these new sources meet the FDA recognized standards ANSI N43.6-1977 and ISO 2919. This commitment was made by BEST. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the traditional sense of a clinical or image-based AI study. Instead, the "testing data" refers to physical measurements and characterizations of the sources themselves.
- Sample Size: The study involved measurements on at least one representative model: the BEST Model No. 81-01-17 intermediate downsize source. The text implies that the other two models (81-01-11 and 81-01-14) were considered to have the "same pure Ir-192 gamma ray spectrum" as the 81-01-17, suggesting that detailed individual measurements might have been carried out for 81-01-17 which then was extrapolated. The specific number of physical sources tested or measurements taken is not detailed beyond "measurements" for 81-01-17.
- Data Provenance:
- Air kerma measurements: Conducted at NIST (National Institute of Standards and Technology), an institution located in the USA.
- TG-43 parameter measurements: Conducted at the University of Kentucky, an institution located in the USA.
- Compliance testing for FDA recognized standards: Data provided to the NRC (Nuclear Regulatory Commission) for source registration. The location where these tests were performed is not explicitly stated, but given the context of NRC registration in the USA, it's highly probable the testing was conducted in the USA or at facilities complying with US regulatory standards.
- Retrospective or Prospective: This type of testing is inherently prospective as it involves the physical characterization of newly manufactured devices under controlled conditions.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The concept of "experts" for establishing ground truth in this context differs from an AI study involving human interpretation of clinical data. Here, "ground truth" is established by:
- Scientific consensus/standards: The AAPM's TG-43 document provides the established dosimetry parameters for Ir-192 sources, representing a consensus among medical physicists.
- National metrology institutes: NIST performs highly calibrated physical measurements, establishing a reference "ground truth" for physical quantities like air kerma.
- Academic institutions: The University of Kentucky performed TG-43 parameter measurements, implying expertise in medical physics and dosimetry.
The document does not specify the number or specific qualifications of individual experts at NIST or the University of Kentucky explicitly, but their departmental and institutional affiliations imply:
- Qualifications: Experts would be highly qualified medical physicists with expertise in brachytherapy dosimetry, radiation measurement, and knowledge of the TG-43 formalism and relevant ANSI/ISO standards. Their experience would be implicit in their roles at these institutions.
4. Adjudication Method for the Test Set
Not applicable in this context. The "test set" consists of physical measurements and characterizations against established standards (TG-43, ANSI, ISO), not subjective interpretations requiring adjudication. Agreement is based on meeting numerical parameters and qualitative characteristics (e.g., pure Ir-192 spectrum).
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a pre-market notification for a medical device (brachytherapy source), not an AI algorithm intended for interpretation or diagnostic assistance. Therefore, no MRMC study involving human readers or AI assistance was performed.
6. Standalone (Algorithm Only) Performance Study
Not applicable. There is no AI algorithm involved in the function or evaluation of these brachytherapy sources. The devices are physical radioactive sources.
7. Type of Ground Truth Used
The ground truth used is a combination of:
- Established scientific consensus and guidelines: The AAPM TG-43 document defines the expected dosimetric properties of Ir-192 sources.
- Metrological standards: NIST provides a gold standard for physical measurements (e.g., air kerma).
- Recognized industry standards: ANSI N43.6-1977 and ISO 2919 define safety and classification requirements for sealed radioactive sources.
8. Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained for this device. The "training set" concept is not relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
{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
§ 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.