(90 days)
Source Production & Equipment Co., Inc. (SPEC) Model M23 Source Assembly, with individual activity up to 27 Ci, is indicated for temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy.
SPEC Model M23 is a singly-encapsulated 168 ftterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive 160Ytterbium Oxide pellets. The pellets are sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
This document describes the premarket notification (510(k)) for the SPEC Model M23 169Ytterbium Brachytherapy Source, a device used for high-dose-rate brachytherapy. The submission demonstrates substantial equivalence to a predicate device (Implant Sciences Corp. Model HDR-4140) through nonclinical testing.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SPEC Model M23 Brachytherapy Source are primarily defined by adherence to established industry standards and mechanical performance requirements. The reported device performance is compared against these criteria.
| Feature / Test Category | Acceptance Criteria (Standard / Threshold) | Reported Device Performance (SPEC Model M23) |
|---|---|---|
| Physical Testing (ANSI N43.6 & ISO 2919) | Equal to or exceeding requirements for classification C53211 (brachytherapy sources). | Prototype sources subjected to ANSI N43.6-2007 and ISO 2919-2012, and equaled or exceeded the requirements corresponding to a classification of C53211. This is stated to be equivalent to the physical testing of the predicate device. |
| Tensile Testing (Minimum Failure Load) | Minimum failure load of the source assembly welds greater than 5 times the maximum force applicable by the Varian GammaMed Plus Afterloader (16 N). This implies a minimum failure load > 80 N. | Minimum failure load of 85 N (19 lb), which is more than 5 times the maximum force (16 N, 3.6 lb) applied by the Varian GammaMed Plus Afterloader. This is stated to be equivalent to or better than the predicate device. |
| Tensile Fatigue Testing (Load A) | Withstand a tensile load in excess of 40 N (2.5 times the maximum force of the afterloader). | Prototype sources successfully withstood a tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum force that can be applied by the Varian GammaMed Plus Afterloader. |
| Tensile Fatigue Testing (Load B) | Withstand ten sequential applications of a tensile load in excess of 16 N (the maximum load) of the afterloader. | Prototype sources successfully withstood ten sequential applications of a tensile load in excess of 16 N (3.6 lbs), which is more than the maximum load that can be applied by the Varian GammaMed Plus Afterloader. |
| Tensile Fatigue Testing (Load C) | Withstand a final tensile load in excess of 40 N (2.5 times the maximum force of the afterloader) to failure of each weld. The minimum failure load should be greater than 5 times the maximum afterloader force. | Following the sequential applications, prototype sources withstood a final tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum force. The minimum failure load was 84 N (19 lb), which is more than 5 times the maximum force. |
| Operational Testing (Curved Pathway Performance) | Successfully negotiate various "S" and "U" curves simulating applicator pathways, without damage to the M13 source assembly. | A prototype source assembly successfully negotiated all of these pathways (series of "S" and "U" curves with various radii, simulating GammaMed Plus Afterloader applicators). No damage to the M13 source assembly was observed. |
| Dosimetry (TG43) | Dose Rate Constant (λ) and Anisotropy (φav) deemed acceptable if similar to the predicate device's established values. | For Configuration H: λ = 1.17 cGy h-1 U-1, φav = 0.94. For Configuration P: λ = 1.18 cGy h-1 U-1, φav = 0.94. These values are very close to the predicate device's reported values (λ = 1.18 cGy h-1 U-1, φav = 0.94). |
| Sterility | Not required due to no direct patient contact. | "This source assembly never directly contacts the patient; sterility is not required." |
| Biocompatibility | Not applicable due to no direct patient contact; outer material (stainless steel) is biocompatible. | "This source assembly never directly contacts the patient; biocompatibility assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which is a biocompatible material." |
| Chemical Safety | Not applicable due to no direct patient contact; outer material (stainless steel) will not chemically react with body tissue. | "This source assembly never directly contacts the patient; chemical safety assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which will not chemically react with body tissue." |
| Mechanical Safety Standard | Conformance to ANSI N43.6 Class C64212. | "ANSI N43.6 Class C64212 Applied for Louisiana Registration." (Implies conformance, as it's directly compared to the predicate device meeting this standard). |
| Radiation Safety | Appropriate precautions for handling, personnel monitoring, and use within shielded enclosures. | "[...] appropriate precautions must be taken during handling to minimize radiation exposure to personnel. Personnel monitoring is required. [...] should only be used within a properly shielded enclosure designed to maintain radiation dose rates outside the enclosure within regulatory limits." (These are operational considerations, not direct test results on the device itself, but are part of demonstrating safe use.) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document mentions "Prototype sources" for physical, tensile, and operational testing. It does not specify the exact number of prototype sources used for each test. For example, "Prototype sources were subjected to the tests specified..." and "A prototype source assembly was subjected to a curved pathway performance test...".
- Data Provenance: The data is generated from nonclinical, bench-top testing conducted by the manufacturer, Source Production & Equipment Co., Inc. There is no mention of human clinical data, animal data, or country of origin for such data. This testing appears to be conducted in-house or by a facility contracted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable as the evaluation involves nonclinical, physical, and mechanical performance testing, not diagnostic or interpretive tasks requiring expert ground truth establishment in the traditional sense (e.g., radiologists interpreting images). The "ground truth" here is objective physical measurement against defined standards and engineering principles.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. There is no subjective interpretation or diagnostic outcome that requires an adjudication method. The tests are objective measurements (e.g., tensile strength, adherence to dimensional requirements, successful navigation of pathways).
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
This section is not applicable. The device is a physical brachytherapy source, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical device, not an algorithm or AI system. Its performance is inherent in its design and manufacturing, evaluated through physical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is primarily based on:
- Industry Standards: Compliance with recognized international and national standards such as ANSI N43.6 (American National Standard for Radioactive Materials-Industrial and Medical), ISO 2919 (Radiological protection – Sealed radioactive sources – Classification), and AAPM TG-43 (American Association of Physicists in Medicine Task Group No. 43).
- Engineering Specifications: Specific mechanical thresholds (e.g., tensile strength exceeding a certain multiple of operational force) derived from engineering analysis of the device's operational environment and safety requirements.
- Predicate Device Equivalence: Demonstrating that the new device's characteristics and performance are comparable to a legally marketed predicate device (Implant Sciences Corp. Model HDR-4140).
8. The sample size for the training set
This section is not applicable. This is a nonclinical submission for a physical device. There is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
§ 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.