Modified Palladium Seed Model 100
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K874787 FDA 510(k)
- FDA Product Code
- IWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5730 FDA 510(k)
- Regulation Number
- 892.5730 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Modified Palladium Seed Model 100 is a sealed radioactive isotope source designed for brachytherapy, a form of internal radiation therapy. It delivers localized radiation to treat malignant tumors, particularly in radiology applications such as prostate cancer. Constructed with palladium, gold, titanium, and platinum, this device is intended for permanent implantation within tissue to provide targeted radiation exposure over time.
This device is supplied as a single-use, sterile implant intended for use in controlled clinical settings. It is classified as a Class II medical device under FDA regulation 892.5730 and was cleared via a 510(k) submission (K874787) in 1987. Handling and implantation must comply with radiation safety protocols, and its use is restricted to qualified healthcare professionals in radiology. Storage and disposal follow radioactive material regulations to ensure safety and compliance.
Frequently asked questions
What is the Modified Palladium Seed Model 100 used for in clinical practice?
The Modified Palladium Seed Model 100 is designed for permanent implantation during brachytherapy, a form of internal radiation therapy. It delivers localized radiation to treat malignant tumors, most commonly used in radiology settings for conditions like prostate cancer. The seed emits radiation directly into the tissue over time, providing targeted treatment while minimizing exposure to surrounding healthy areas.
Is the Modified Palladium Seed Model 100 intended for single-use or can it be reused?
The Modified Palladium Seed Model 100 is explicitly labeled as a single-use, sterile implant. Due to its radioactive nature and permanent implantation design, reuse is not permitted or safe. Each seed is intended for one-time use in a controlled clinical setting, adhering to radiation safety protocols.
What materials are used in the construction of the Modified Palladium Seed Model 100, and why does this matter?
The seed is constructed from palladium (the radioactive isotope), gold, titanium, and platinum. These materials are chosen for their durability, biocompatibility, and ability to safely contain the radioactive palladium while ensuring minimal irritation or reaction in the implanted tissue. The combination of metals also helps maintain structural integrity during implantation and over the treatment period.
How should the Modified Palladium Seed Model 100 be stored, and what precautions must be taken?
Storage of the Modified Palladium Seed Model 100 must comply with radioactive material regulations to ensure safety. Since it is a sealed radioactive source, it should be kept in a designated radiation storage area with proper shielding, access controls, and inventory tracking. Handling and storage must follow protocols outlined by radiation safety guidelines to prevent exposure and ensure compliance with regulatory requirements.
Who is authorized to handle and implant the Modified Palladium Seed Model 100, and what regulatory pathway was followed for its approval?
The Modified Palladium Seed Model 100 is restricted for use by qualified healthcare professionals in radiology, as its implantation requires specialized training and adherence to radiation safety protocols. The device was cleared via an FDA 510(k) submission (K874787) in 1987 under the Radiology advisory committee (RA), with a classification as a Class II medical device (regulation number 892.5730). The clearance was based on a determination of substantial equivalence to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MODIFIED PALLADIUM SEED MODEL 100 - Innolitics, Theragenics Modified Palladium Seed 100 - allmed.wiki, MODIFIED PALLADIUM SEED MODEL 100 510(k) K874787 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K874787 | Class II | Active |
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Manufacturer
- Manufacturer
- Theragenics Corp.
Sources (1)
- FDA 510(k) K874787 24 fields · synced Sep 19, 2026