(101 days)
The Source Production & Equipment Co., Inc. (SPEC) Model M15 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal, intraoperative or surface application to treat selected tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Nucletron microSelectron Classic High Dose Rate Remote Afterloader. The Model M15 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 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 M15 is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 192Iridium pellet. The pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
The provided text describes a 510(k) premarket notification for a medical device, the SPEC Model M15 192Iridium High Dose Rate Brachytherapy Source. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness. Therefore, the study described is primarily comparative, showing that the new device meets established safety and performance standards equivalent to the predicate.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Predicate Device (Alpha-Omega Services, Inc. Model CSN0010-192) Performance | SPEC Model M15 Performance | Acceptance Criteria / Equivalence Standard |
|---|---|---|---|
| Design | Solid 192Iridium pellet (0.6 mm dia x 3.5 mm long) singly encapsulated in stainless steel (1.1 mm dia x 4.5 mm long) and welded to a 7x7 stranded stainless steel cable (1.1 mm dia x 2000 mm long). | Solid 192Iridium pellet (0.6 mm dia x 3.5 mm long) singly encapsulated in stainless steel (1.1 mm dia x 4.8 mm long) and welded to a 7x7 stranded stainless steel cable (1.1 mm dia x 2000 mm long). | Essentially identical design. Minor length difference in encapsulation (4.5 mm vs 4.8 mm) is considered equivalent. |
| Materials | Radionuclide: 192Iridium, Encapsulation: Stainless Steel, Cable: Stainless Steel | Radionuclide: 192Iridium, Encapsulation: Stainless Steel, Cable: Stainless Steel | Identical materials. |
| Performance Dosimetry (TG43) | Dose Rate Const (λ): 1.13 cGy h⁻¹ U⁻¹, Anisotropy (Φav): 0.95 | Dose Rate Const (λ): 1.11 cGy h⁻¹ U⁻¹, Anisotropy (Φav): 0.97 | Equivalent dosimetry characteristics based on Monte Carlo simulation in accordance with AAPM and ESTRO recommendations. The slight numerical difference is within expected ranges for equivalence. |
| Sterility | "This source assembly never directly contacts the patient; sterility is not required." | "This source assembly never directly contacts the patient; sterility is not required." | Not required (same as predicate). |
| Biocompatibility | "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." | "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." | Not applicable, due to external contact only through biocompatible stainless steel (same as predicate). |
| Mechanical Safety | ANSI N43.6 Class C53211 | ANSI N43.6 Class C53211, Applied for Louisiana Registration | Meets ANSI N43.6 Class C53211 (same as predicate). Physical testing confirmed this. |
| Chemical Safety | "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." | "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." | Not applicable due to external contact only through stainless steel (same as predicate). |
| Energy Delivered | 192Iridium (half-life: 73.81 days) decays by beta emission and electron capture with characteristic photons (67 keV x-rays, 201, 311, 467, 603 keV gammas). Betas and electrons absorbed by stainless steel capsule. | 192Iridium (half-life: 73.81 days) decays by beta emission and electron capture with characteristic photons (67 keV x-rays, 201, 311, 467, 603 keV gammas). Betas and electrons absorbed by stainless steel capsule. | Identical radioactive properties and shielding (same as predicate). |
| Mechanical Performance (Tensile Strength) | Sufficient for intended application. | Minimum failure load > 10x max force of Nucletron microSelectron "Classic" afterloader. Cyclic test: after sequential loads > 10x max force, failure load > 10x max force. | Equivalent to or better than the predicate device. Demonstrated robust tensile strength exceeding operational requirements. |
| Operational Performance | Successfully negotiates pathways. | Successfully negotiated all "S" and "U" curves in Nucletron microSelectron "Classic" Afterloader without damage. | Equivalent to the physical testing of the predicate device; demonstrated compatibility with intended afterloader. |
| Standards Met | Mechanical: ANSI N43.6, Dosimetry: AAPM TG-43 | Mechanical: ANSI N43.6, Dosimetry: AAPM TG-43 | Device meets ANSI N43.6 for mechanical aspects and AAPM TG-43 for dosimetry, aligning with predicate device and regulatory guidance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document refers to "Prototype sources" being subjected to tests. It does not specify an exact number of prototype sources used for each test (physical, tensile, operational). For the tensile cyclic test, it mentions "each prototype" was subjected to sequential loads, implying multiple prototypes were used, but an exact 'n' is not given.
- Data Provenance: The tests were conducted by the manufacturer, Source Production & Equipment Co., Inc. (SPEC). The data is prospective as it involves new testing on the SPEC Model M15 prototypes specifically for establishing its performance. The country of origin for the data generation would be the United States, given SPEC's location in St. Rose, LA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission is a 510(k) for a physical medical device, not an AI/software device that requires human expert review for "ground truth" to evaluate diagnostic performance. Therefore, the concept of "experts" establishing ground truth in the context of diagnostic interpretations (e.g., radiologists reviewing images) is not applicable here.
The "ground truth" for this device's performance is based on established engineering and physics standards:
- ANSI N43.6 (American National Standard)
- ISO 2919 (International Organization for Standardization)
- AAPM TG-43 (American Association of Physicists in Medicine Task Group 43) and ESTRO (European Society for Therapeutic Radiation Oncology) recommendations for dosimetry.
The experts involved would be the engineers and physicists who performed and analyzed these standardized tests and calculations, ensuring adherence to the specified methodologies. Their qualifications would be expertise in mechanical engineering, radiation physics, and relevant national/international standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this device does not involve subjective human interpretation or diagnostic decision-making that would require an adjudication method like 2+1 or 3+1. The tests yield objective measurements or pass/fail outcomes against predefined performance standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or decision-support AI where human readers interact with the device. The SPEC Model M15 is a physical brachytherapy source, and its performance is assessed through physical, mechanical, and dosimetric testing against established standards and comparison to a predicate device's specifications.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a physical radionuclide brachytherapy source, not an algorithm or AI system. Its performance is inherent to its physical properties and how it functions as part of a treatment system (e.g., with a remote afterloader). The nonclinical tests (physical, tensile, operational, dosimetry) serve as the "standalone" performance evaluation of the device itself.
7. Type of Ground Truth Used
The ground truth for evaluating the SPEC Model M15 is based on:
- Established international and national standards (ANSI N43.6, ISO 2919, AAPM TG-43, ESTRO recommendations).
- Physical performance characteristics of the predicate device (as defined in its 510(k) clearance and specifications).
- Empirical measurements from laboratory testing (e.g., tensile strength, operational movement, Monte Carlo simulations for dosimetry).
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance is based on its physical design, manufacturing, and inherent properties of the radioactive material, all of which are validated through nonclinical testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.