(119 days)
The Implant Sciences 125 Jodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The 125 lodine Seeds may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.
The Implant Sciences 125 Iodine Brachytherapy Seeds consist of a laser welded titanium capsule containing an aluminum clad copper rod that serves as both a substrate for the radioactive iodine source and as a radiopaque x-ray marker. The marker identifies the source location and orientation. The seeds are provided non-sterile and must be sterilized prior to use.
The provided document describes the safety and effectiveness of the Implant Sciences "I-plant" 125Iodine Brachytherapy Seeds (Model 3000) by demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance against those criteria through a new clinical study. The device is for brachytherapy treatment of localized tumors.
Here's an analysis based on the information provided, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices and Standards) | Reported Device Performance (Implant Sciences "I-plant" 125Iodine Brachytherapy Seeds) |
|---|---|---|
| Physical Dimensions | Same length and diameter as predicate devices | Consistent with predicate devices |
| Material Composition | Use of titanium capsule material common to predicate devices | Same titanium capsule material as predicate devices |
| Activity Levels | Range of apparent activity levels similar to predicate devices (0.1 to 5.0 mCi) | Similar to predicate devices |
| Safety Testing (ANSI/HPS N43.6 - 1997) | Performance requirements for temperature resistance | Consistent with test results for predicate devices |
| Performance requirements for external pressure resistance | Consistent with test results for predicate devices | |
| Performance requirements for impact resistance | Consistent with test results for predicate devices | |
| Performance requirements for vibration integrity | Consistent with test results for predicate devices | |
| Performance requirements for puncture resistance | Consistent with test results for predicate devices | |
| Radiation Profile | Profiles consistent with data generated from other Iodine-125 brachytherapy seeds with similar physical geometries | Consistent with data from other Iodine-125 brachytherapy seeds with similar physical geometries |
| Capsule Leak Testing | Adherence to ANSI standards | Carried out in accordance with ANSI standards, supporting equivalence |
| Sterilization Method | Provided non-sterile, requiring sterilization (autoclave or ethylene oxide) at the hospital | Provided non-sterile, requiring sterilization (autoclave or ethylene oxide) at the hospital |
| Absence of New Chemical/Biological Entities | Manufacturing and cleaning processes introduce no new chemical or biological entities to the device surface | Manufacturing and cleaning processes introduce no new chemical or biological entities to the device surface |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The submission relies on in vitro studies and comparison to predicate devices, not a clinical test set from human subjects to evaluate clinical efficacy or performance.
- Data Provenance: The studies mentioned are described as "in vitro studies" and involve tests against ANSI standards. They are not clinical studies from a specific country or collected retrospectively/prospectively from patients. The comparison is primarily against existing predicate device specifications and recognized industry standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. This submission does not describe a clinical study where expert ground truth was established for a test set. The "ground truth" here is compliance with established engineering and safety standards (ANSI N43.6-1997) and equivalence in characteristics to legally marketed predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a radioactive implant (brachytherapy seed), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on:
- Compliance with ANSI Standard N43.6-1997: For safety and performance parameters like temperature, pressure, impact, vibration, and puncture resistance, and capsule leak testing.
- Established characteristics of legally marketed predicate devices: For physical dimensions, material composition, activity range, and radiation profiles.
- Accepted manufacturing and sterilization practices: For ensuring the device does not introduce new chemical or biological entities and requires appropriate sterilization.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve a training set as it's not an AI/machine learning model. The "studies" mentioned are laboratory/engineering tests and comparisons.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, for the same reason as above.
In summary: The submission for the Implant Sciences "I-plant" 125Iodine Brachytherapy Seeds (Model 3000) is a 510(k) Pre-market Notification demonstrating substantial equivalence to existing legally marketed predicate devices. It relies on in vitro studies proving compliance with recognized safety and performance standards (ANSI N43.6-1997) and matching the characteristics of predicate devices, rather than a clinical trial with human subjects. Therefore, many of the requested elements pertaining to clinical studies, AI performance, expert review, and ground truth establishment from patient data are not relevant to this type of regulatory submission.
§ 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.