(23 days)
Proxcelan™ (Gesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands, containing cesium-131 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity applications for tumors with known radiosensitivity. These devices may be used as a rimary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment modalites, after excision of primory tumore after excision of primary tumors.
The Proxcelan (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands are single use, prescription devices, will consisting of IsoRay Model CS-1 Brachytherapy Seeds that are preloaded into into a body series of the Implant Devices are designed to be preloaded into into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. The PL-5 – Cs-131 Preloaded Braided Braided Strands consist of a series of Proxcelan (Cesium-131) Brachytherapy Seeds held in place within a bioabsorbable braided sleeve (or strand). The seeds are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on a treatment plan prepared by the physician or medical physicist for an individual patient. If required by the treatment plan, the braided strands containing the brachytherapy seeds may be woven into a bioabsorbable mesh supplied as a kit component for implant. A (non-patient contact) needle may also be provided either attached or unattached to the braided strand to attach it to the mesh.
This document is a 510(k) Summary and an FDA clearance letter for a medical device called Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands. The purpose of this submission is to demonstrate substantial equivalence to a previously cleared device, not to present a new clinical study proving effectiveness. Therefore, many of the requested categories related to clinical study design and performance metrics cannot be answered from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) for the device in a clinical setting, nor does it report on such performance for this submission. The device is a brachytherapy source, and its effectiveness is related to its physical characteristics and how it's used in treatment, not a diagnostic or AI-driven performance metric.
However, the document does mention "release specifications" for finished products to ensure safety and effectiveness. These are internal manufacturing and quality control criteria, not clinical performance metrics.
| Acceptance Criteria (Internal) | Reported Device Performance (Internal) |
|---|---|
| Meet all required release specifications (e.g., leak testing for external contamination, apparent activity, labeling). | All finished products are tested and must meet all required release specifications before distribution. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission is for demonstrating substantial equivalence based on material and structural changes to an existing device, not a clinical effectiveness study requiring a test set of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As above, this is not a clinical effectiveness study.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a brachytherapy seed, not an AI-driven image analysis tool or a diagnostic aid requiring human reader interpretation studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable.
7. The Type of Ground Truth Used
Not applicable for clinical performance. For manufacturing release, the "ground truth" would be established by validated test methods demonstrating that the device meets its design specifications (e.g., activity levels, leak integrity).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device and Approval:
- Device Name: Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands
- Manufacturer: IsoRay Medical, Inc.
- Intended Use: Single-use prescription devices for interstitial, surface, and intracavity brachytherapy for malignant disease (e.g., head and neck, brain, breast, lung, prostate, eye). Can be used as primary treatment or with other modalities.
- Nature of Submission: 510(k) clearance for a modification to a previously cleared device (K062384). The modification is the addition of a preloaded flexible braided strand instead of a rigid hollow tubular strand.
- Basis for Equivalence: Substantial equivalence to the IsoRay Proxcelan™ (Cesium-131) Implant Devices (K062384). The technical characteristics are essentially the same (Cesium-131 brachytherapy seeds), with the change being the flexible braided sleeve. All materials are biocompatible and used in similar marketed devices.
- Safety and Effectiveness (as stated in the document): Ensured through internal testing of all finished products to meet required release specifications (e.g., leak testing, apparent activity, labeling) as defined by written and approved procedures conforming to product design specifications. This refers to manufacturing quality control, not clinical study results.
- FDA Decision: Substantially equivalent.
§ 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.