(86 days)
The IsoRay Medical, Inc. Cesium-131 Implant Devices are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.), and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. These devices may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.
The Cesium-131 Implant Devices have the same indications for use as the original device, the IsoRay Medical, Inc. Cs-131 Brachytherapy Seed, Model CS-1.
The IsoRay Medical, Inc. Cesium-131 Strand, Model PL-1, contains absorbable seeding spacers and Cs-131 Brachytherapy Seeds enclosed in a bio-absorbable brachytherapy sleeve and sterilized using ethylene oxide. The seeds and spacers are arranged according to a treatment plan provided by a physician or medical physicist.
For the IsoRay Medical, Inc. Cesium-131 Strand Preload, Model PL-2, each Cesium-131 Strand, Model PL-1, is placed in a brachytherapy needle which is pre-plugged with bone wax to hold the strand in position. The arrangement of the seeds and spacers and the strands in the needles is dictated by the treatment plan. The strands are sterilized after loading into needles using ethylene oxide.
The IsoRay Medical, Inc. Cesium-131 Preload, Model PL-3, contains absorbable seeding spacers and Cs-131 Brachytherapy Seeds within a brachytherapy needle which is pre-plugged with bone wax to keep the seeds and spacers in position. The arrangement of the seeds and spacers in each needle is dictated by the treatment plan. The preloaded needles are then sterilized using ethylene oxide.
The IsoRay Medical, Inc. Cesium-131 S-Cartridge, Model PL-4 contains Cs-131 Brachytherapy Seeds, loaded into Mick® cartridges and sterilized by either steam or ethylene oxide.
Note: The above-listed devices may be assembled using components with equivalent composition and function that are FDA-cleared for the same intended use or otherwise determined to be exempt or pre-amendment devices.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cesium-131 Implant Devices:
The provided document is a 510(k) Summary of Safety and Effectiveness, not a detailed study report. A 510(k) submission demonstrates substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical or performance study in the way one might expect for a novel device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or not specified in this type of regulatory document.
However, I can extract the relevant information regarding the approach to demonstrating equivalence, which serves as the "study" in this context.
Acceptance Criteria and Study for Cesium-131 Implant Devices (K062384)
1. Table of Acceptance Criteria and Reported Device Performance
In a 510(k) submission, the "acceptance criteria" are generally that the new device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use, and the technological characteristics are either the same or, if different, do not raise new questions of safety and effectiveness. The "performance" is demonstrated by showing these equivalencies.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (vs. Predicate Devices) |
|---|---|
| Intended Use: Same as predicate device. | The IsoRay Medical, Inc. Cesium-131 Implant Devices have the same indications for use as the original predicate device, the IsoRay Medical, Inc. Cs-131 Brachytherapy Seed, Model CS-1. They are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. |
| Technological Characteristics: | |
| a) All are sterile. | Met. Device descriptions state sterilization using ethylene oxide or steam. |
| b) All materials contacting the patient are biocompatible. | Met. Explicitly stated: "All of the materials that contact the patient are biocompatible". |
| c) All brachytherapy sources contain a radiopaque marker for imaging (CT, fluoroscopy, X-ray) and dose calculation. | Met. "All the devices... have a radiopaque marker is used to determine the exact location of the implanted sources and assist in the calculation of the therapeutic radiation dose pattern." |
| d) All are low energy x-ray emitting brachytherapy sources. | Met. Explicitly stated. The primary isotope, Cesium-131, is compared to Palladium-103 and Iodine-125, all providing therapeutic doses of radiation. |
| e) All brachytherapy sources have short half-lives. | Met. Explicitly stated. |
| Similar Science and Technology: Developed and manufactured with similar principles. | The devices are "developed and manufactured with the same science and technology as the IsoRay Medical, Inc. Cs-131 Brachytherapy Seed." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. This is a substantial equivalence submission, not a study involving a "test set" in the context of clinical or performance data. The "test" is the comparison against predicate devices based on their established characteristics.
- Data Provenance: Not applicable. The comparison is based on the characteristics of the devices themselves and existing predicate device information.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. No external experts were used to establish "ground truth" for a test set in this 510(k) for device characteristics. The "ground truth" is essentially the regulatory classification and demonstrated safety/effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. No test set or expert adjudication was involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
- No. This device is a brachytherapy implant, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a medical device (brachytherapy implant), not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this 510(k) substantial equivalence determination is the established safety and effectiveness profile of the legally marketed predicate devices, as determined by prior FDA clearances. The new devices are deemed safe and effective because they are demonstrated to be equivalent to these already-cleared devices.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not a machine learning model.
§ 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.