(48 days)
Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source, with individual activity up to 12 Ci, is indicated for temporary interstital, intraluminal, intraoperative or surface application to treat selected localized turnors. 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.
Source Production & Equipment Co., Inc. Model M13 192 ridium Brachytherapy Source is a sinqly-encapsulated 1921ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1921ridium pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
The provided document is a 510(k) premarket notification for a medical device: the Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source. This device is a radionuclide brachytherapy source used for targeted cancer treatment.
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to recognized standards and performance metrics compared to a legally marketed predicate device (Source Production & Equipment Co., Inc. Model M15).
| Test/Characteristic | Acceptance Criteria (Standard / Predicate Equivalence) | Reported Device Performance (Model M13) |
|---|---|---|
| Physical Testing | - ANSI N43.6 Class C53211 | - Equaled or exceeded Class C53211 requirements after testing. |
| - ISO 2919 | - Equaled or exceeded requirements of ISO 2919 after testing. | |
| - Equivalent to predicate device (SPEC Model M15) | - Equivalent to the physical testing of the predicate device. | |
| Tensile Testing | - Minimum failure load > 5 times maximum force of afterloader (16 N) | - Minimum failure load of 85 N (19 lb), which is > 5 times 16 N. |
| - Tensile fatigue: withstands loads > 2.5 times max afterloader force (40 N) | - Withstood tensile load > 40 N after multiple cycles. | |
| - Tensile fatigue: withstands loads > max afterloader force (16 N) | - Withstood ten sequential applications of tensile load > 16 N. | |
| - Final weld failure load > 5 times max afterloader force (16 N) | - Minimum failure load of 84 N (19 lb) for welds, which is > 5 times 16 N. | |
| - Equivalent to or better than predicate device (SPEC Model M15) | - Equivalent to or better than the tensile testing of the predicate device. | |
| Operational Testing (Curved Pathway) | - Successfully negotiates "S" and "U" curves simulating applicators. | - Source capsule and cable successfully negotiated all pathways. |
| - No damage to source assembly. | - No damage to the M13 source assembly. | |
| - Equivalent to physical testing of predicate device. | - Equivalent to the physical testing of the predicate device. | |
| Operational Testing (Endurance) | - Performs a minimum number of exposure/retract cycles without failure. | - Performed > 35,000 exposure/retract cycles. |
| - No failure of source cable, capsule, or connection. | - No failure of source cable, capsule, or connection. | |
| - Equivalent to physical testing of predicate device. | - Equivalent to the physical testing of the predicate device. | |
| Dosimetry | - Calculated by Monte Carlo simulation. | - Calculated by Monte Carlo simulation. |
| - In accordance with AAPM and ESTRO recommendations. | - In accordance with AAPM and ESTRO recommendations. | |
| - Equivalent to predicate device (SPEC Model M15) | - Equivalent to the dosimetry of the predicate device. | |
| Materials (Radionuclide, Encapsulation, Cable) | - 192Iridium; Stainless Steel; Stainless Steel | - 192Iridium; Stainless Steel; Stainless Steel |
| Sterility | - Not required (device never directly contacts patient). | - Not required. |
| Biocompatibility | - Not applicable (device never directly contacts patient); external stainless steel is biocompatible. | - Not applicable; external stainless steel is a biocompatible material. |
| Chemical Safety | - Not applicable (device never directly contacts patient); external stainless steel is inert. | - Not applicable; external stainless steel will not chemically react with body tissue. |
| Energy Delivered | - 192Iridium decay with characteristic photons/electrons, betas/electrons absorbed by stainless steel. | - Identical description to predicate: 192Iridium decay, betas/electrons absorbed. Principal photon emissions (67, 201, 311, 467, 603 keV). |
| Compatibility with Environment & Other Devices | - Strict control of radioactive material; use per licensing authority; shielded storage; reporting loss; normal room temp storage; authorized disposal. | - Identical description to predicate for all points. |
| Where Used | - Within properly shielded enclosure to maintain regulatory limits. | - Identical description to predicate. |
| Standards Met | - Mechanical: ANSI N43.6; Dosimetry: AAPM TG-43 | - ANSI N43.6; AAPM TG-43 |
| Electrical/Thermal Safety | - Not Applicable | - Not Applicable |
| Radiation Safety | - Appropriate precautions, personnel monitoring, shielded enclosure, emergency operations. | - Identical description to predicate for all points. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document refers to "Prototype sources" and "A prototype source assembly" for the nonclinical tests. This implies a small sample size, likely one or a few units, manufactured specifically for these rigorous engineering tests. The exact number is not explicitly stated.
- Data Provenance: The tests are described as nonclinical tests conducted on prototype devices. The document does not specify the country of origin of the data, but given the company is US-based (Saint Rose, LA), it's highly probable the testing was conducted in the US or by a US-affiliated lab. These are prospective tests performed specifically to evaluate the new device model.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This category is not applicable in the context of this 510(k) submission.
- This device is a physical medical device (a brachytherapy source), not an AI/software device that requires human expert interpretation for "ground truth" establishment in a test set.
- The "ground truth" for this device's performance is established through physical measurements and engineering tests against industry standards (ANSI, ISO) and comparison to an established predicate device. For example, tensile strength is measured objectively with equipment, not adjudicated by an expert.
- Dosimetry involves Monte Carlo simulations, which are computational models, and adherence to physics guidelines (AAPM, ESTRO).
4. Adjudication Method for the Test Set
This is not applicable. As explained above, the tests are objective engineering and physics evaluations, not subjective clinical assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms which assess how AI impacts the performance of human readers. This device is a therapeutic source, and its evaluation focuses on its physical and dosimetric properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The entire submission details the standalone performance of the device itself and its components (source, cable, encapsulation) without human intervention in determining its core functional characteristics. The "performance" refers to its physical integrity (tensile strength, endurance, pathway negotiation) and its radiation dose distribution (dosimetry), which are intrinsic properties of the device, independent of a human operator's direct "performance interpretation" during testing. While a human initiates tests, the results themselves are objective measurements of the device's capabilities.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established through:
- Objective Engineering Standards: Adherence to established standards like ANSI N43.6 and ISO 2919 for physical integrity.
- Physics Principles: Use of Monte Carlo simulation and adherence to guidelines from organizations like AAPM and ESTRO for dosimetry.
- Predicate Device Equivalence: Direct comparison of technological characteristics and performance test results to a legally marketed predicate device (SPEC Model M15) to demonstrate substantial equivalence. This is the primary method of evaluation for 510(k) submissions.
8. The Sample Size for the Training Set
This is not applicable. This is a physical brachytherapy source, not an AI algorithm that requires a "training set" of data. The device itself is manufactured, and its performance characteristics are tested against established criteria.
9. How the Ground Truth for the Training Set was Established
This is not applicable. As mentioned, there is no training set for this 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.