(166 days)
125I Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
The 125I Brachytherapy Seeds consist of 125I absorbed onto the surface of a spherical polymeric substrate sealed in a welded titanium casing. A typical Brachytherapy Seed is shown below. For higher activity levels the number of beads with absorbed 1431 may be increased from 2 to 4.
Typically, the 1351 Brachytherapy Seeds are placed within or in close to the turnor to be treated utilizing guidance. The devices are delivered using an 18 gauge or greater diameter hypodermic needle.
The provided text describes the Prostec 125I Brachytherapy Seed and its substantial equivalence to a predicate device, rather than a study with detailed acceptance criteria and performance metrics in the typical sense of a clinical trial or algorithm validation. This submission is for a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device.
However, I can extract the "acceptance criteria" as implied by the comparison to the predicate device and the reported "device performance" as stated in the document.
Here's an interpretation based on the provided text, recognizing that this is a technical equivalence comparison, not a performance study in the context of diagnostic algorithms or clinical outcomes:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Prostec 125I Brachytherapy Seeds) |
|---|---|
| Intended Use: For permanent interstitial implantation in selected localized tumors, as a source of nuclear radiation for therapy. | Matches predicate intended use. |
| Material-Capsule: Titanium | Titanium |
| Material-Radioisotope: 125I | 125I |
| Material-Substrate: Dowex® | Dowex® |
| Physical Dimensions - Length: 4.5 mm | 4.5 mm |
| Physical Dimensions - Outside Diameter: 0.8 mm | 0.8 mm |
| Key Radiological Characteristics - Half-life: 59.4 days | 59.4 days |
| Key Radiological Characteristics - Principal Energy Levels (keV): 27.4, 31.4, and 35.5 | 27.4, 31.4, and 35.5 |
| Key Radiological Characteristics - Point-source approximation anisotropy constant (φan): 0.95 (predicate) | 0.96 (Prostec) - considered equivalent |
| Key Radiological Characteristics - Dose rate Constant (cGy/hr/U, 1999 NIST): 1.04 (predicate) | 1.05 (Prostec) - considered equivalent |
| Key Radiological Characteristics - Residual Activity: |
§ 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.