(21 days)
The BEBIG I-125 sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.
The BEBIG brachytherapy I-125 sources are indicated for the treatment of selected localized turnors. These sources are commonly used to treat superficial, intra-abdominal and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.
The BEBIG I-125 sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The radiopaque marker is composed of gold alloy.
I-125 has a half live of 59.46 days and decays by electron capture with emission of characteristic photons and electrons. The titanium wall of the I-125 source absorbs the electrons.
The BEBIG I-125 sources are available in a range of activity levels. They are provided nonsterile and must be sterilized before use.
This document is a 510(k) summary for a medical device (BEBIG brachytherapy I-125 source), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document explicitly states:
"In Summary, the BEBIG brachytherapy I-125 sources are substantially equivalent to a legally marketed device. Quality System Controls assure the device is substantially equivalent to the predicate device with respect to its performance, safety, and effectiveness."
This means the submission relies on the established safety and effectiveness of the predicate device (UroMed Brachytherapy Iodine-103 Source, K982226) and adherence to quality system regulations, rather than a new performance study to defined acceptance criteria.
To directly answer your request based only on the provided text, the following would be reported:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device and adherence to regulatory standards.
- Reported Device Performance:
- "Technically identical" to the UroMed Brachytherapy Iodine-103 Source.
- Intended Use: Treatment of cancer with radioactive sources in close proximity to or within the tumor.
- Indications for Use: Treatment of selected localized tumors (superficial, intra-abdominal, intrathoracic, head, neck, lung, pancreas, prostate), alone or in combination with external beam radiation.
- Physical Characteristics:
- Cylindrical sealed source.
- Contains iodine-125 radioactivity.
- 4.5 mm long, 0.8 mm in diameter.
- Outer capsule: titanium, sealed by laser weld.
- Iodine-125 deposited as silver iodide (AgI) within a porous ceramic tube.
- Radiopaque marker: gold alloy in the center of the ceramic tube.
- Half-life of I-125: 59.46 days.
- Decays by electron capture with emission of characteristic photons and electrons (titanium wall absorbs electrons).
- Available in a range of activity levels.
- Provided non-sterile, must be sterilized before use.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable/Not provided. This document does not describe a performance study involving a test set of data. It describes a medical device and its intended use, asserting substantial equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable/Not provided. No ground truth establishment is described as there is no specific performance study outlined.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. No MRMC study or any comparative effectiveness study is mentioned. This document focuses on the device's technical specifications and substantial equivalence, not its clinical efficacy improvement with human-AI interaction.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- No. This device is a physical brachytherapy source, not an algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.
7. The Type of Ground Truth Used:
- Not applicable/Not provided. No performance study requiring a distinct "ground truth" (like pathology or outcomes data for diagnostic accuracy) is described. The "ground truth" for this submission is implicitly the established safety and efficacy of the predicate device and adherence to manufacturing standards.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. This document does not describe a machine learning algorithm or any training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided. As there is no training set mentioned, no ground truth establishment for it is described.
§ 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.