(462 days)
InterSeed™ implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. InterSeed™ implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.
InterSeed™ is an hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSeed™ is Palladium 103 (Pd-103). InterSeed™ is constructed by placing a platinum radiopaque marker and Pd-103 on the surface of a medical grade titanium inner tube. The device is sealed by sliding an outer tube, also medical grade titanium, over the inner tube and laser welding both ends. The resulting device has a hollow center with an inner diameter of 0.35 mm with all body tissue contacting surfaces made from medical grade titanium.
The provided text describes the InterSeed™ device, a radiotherapeutic source for interstitial implantation, and compares it to a predicate device, the Modified Palladium Seed Model 100, to demonstrate substantial equivalence for regulatory clearance. This is not a study proving device performance against acceptance criteria in the typical sense of a clinical trial or algorithm performance study. Instead, it's a regulatory submission demonstrating equivalence to an already approved device.
However, I can extract the information and frame it as acceptance criteria and reported device performance based on the provided document's structure for the purpose of your request.
Here's the breakdown of the information you requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are the features and performance of the predicate device, and the "reported device performance" is the InterSeed™ device's corresponding features and performance. The goal is to show they are "substantially equivalent."
| Feature/Acceptance Criteria (Predicate Device) | Reported Device Performance (InterSeed™) | Assessment (Acceptance Met) |
|---|---|---|
| Indications: Interstitial implantation for localized, unresectable, low to moderate radiosensitivity tumors (e.g., superficial, intrathoracic, intraabdominal, lung, pancreas, prostate [stage A or B], residual following XRT, recurrent). | Indications: Interstitial implantation of select localized tumors with low to moderate radiosensitivity (e.g., head, lung, neck, pancreas, prostate, unresectable tumors, or residual disease after excision). Used concurrent with or at completion of other treatment modalities (e.g., external beam radiation therapy). | Met (Substantially Equivalent) |
| Physical Size (Outer Tube Length): 4.5 mm | Physical Size (Outer Tube Length): 4.5 mm | Met (Same) |
| Physical Size (Outer Tube Diameter): 0.81 mm | Physical Size (Outer Tube Diameter): 0.81 mm | Met (Same) |
| Radiopaque Marker: Lead | Radiopaque Marker: Platinum | Met (Both have a radiopaque marker) |
| Radioisotope: Palladium 103 | Radioisotope: Palladium 103 | Met (Same) |
| Half-life: 17 days | Half-life: 17 days | Met (Same) |
| Principal Energy Levels: 20.1 keV, 20.2 keV, 22.7 keV, 23.2 keV | Principal Energy Levels: 20.1 keV, 20.2 keV, 22.7 keV, 23.2 keV | Met (Same) |
| Apparent Activity Levels: 0.5 to 5.0 mCi | Apparent Activity Levels: 0.5 to 5.0 mCi | Met (Same) |
| 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.