(20 days)
The Brachytherapy Source Device, with apparent activities between 0.19mCi and 1.01mCi, is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intra-abdominal, and intra-thoracic tumors. Tumors of the head, neck, lung, pancreas and prostate (early stages) are commonly treated.
The Brachytherapy Source Device, with total apparent activities greater than 1.01mCi, is indicated for interstitial treatment of tumors which have the following characteristics; unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation applications as temporary implants.
The Brachytherapy Source Device is indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with seeds.
The Brachytherapy Source Device, Model 9011, is a welded titanium capsule containing Iodine-125 adsorbed onto a silver rod.
Here's an analysis of the provided text regarding the Brachytherapy Source Device, Model 9011.
It's important to note that this document is a 510(k) summary for a medical device, specifically a brachytherapy source. Brachytherapy sources are physical objects that emit radiation for cancer treatment, not a diagnostic AI/ML algorithm. Therefore, many of the requested categories related to AI/ML software performance (like effect size of AI assistance, MRMC studies, ground truth establishment for training, etc.) are not applicable to this type of device. The acceptance criteria and "studies" are focused on the physical characteristics and safety of the radiation source itself, not its diagnostic accuracy or AI performance.
Acceptance Criteria and Device Performance (Brachytherapy Source Device, Model 9011)
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate OncoSeed, Model 6711) | Reported Device Performance (Brachytherapy Source Device, Model 9011) |
|---|---|---|
| Seeds | ||
| Regulatory Status | K914281 (Cleared) | Subject Application |
| Capsule Material | Titanium, type A-40 | Titanium, type A-40 |
| Capsule Length | 4.20 - 4.90mm (0.165 - 0.193in) | 4.20 - 4.90mm (0.165 - 0.193in) |
| Capsule Wall Thickness | 0.051 - 0.0635mm (0.002 - 0.0025in) | 0.051 - 0.0635mm (0.002 - 0.0025in) |
| Capsule Diameter | 0.77 - 0.96mm (0.031 - 0.38in) | 0.48 - 0.67mm (0.019 - 0.026in) (Modified) |
| Carrier Substrate | 99.9% silver | 99.9% silver |
| Carrier Length | 2.74 - 2.85mm (0.108 - 0.112in) | 2.74 - 2.85mm (0.108 - 0.112in) |
| Carrier Diameter | 0.48 - 0.53mm (0.019 - 0.021in) | 0.27 - 0.33mm (0.011 - 0.013in) (Modified) |
| Isotope | Iodine I-125 | Iodine I-125 |
| Sterilization | Not sterile (User sterilized) | Not sterile (User Sterilized) |
| Other Performance | ||
| Sealed Source Integrity | Met ISO 2919 requirements | Tested according to ISO 2919 for sealed sources |
| Activity Measurement | - | Obtained from NIST Report (Air-Kerma rate measurements) |
| Design Validation | - | Prototype sources manufactured and assessed against predetermined criteria for Design Verification and Design Validation |
Note on Acceptance Criteria: For a 510(k) submission, "acceptance criteria" are largely based on demonstrating substantial equivalence to a predicate device. This means the new device should be as safe and effective as the predicate, often by meeting the same or equivalent engineering specifications and performance standards. In this case, the predicate's characteristics serve as the de facto acceptance criteria that the new device aims to match or justify deviations from. The substantial equivalence is based on the argument that the modified characteristics (smaller diameter) do not raise new questions of safety or effectiveness, especially since other critical parameters (like capsule material, isotope, length ranges) remained the same.
2. Sample Size for Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI/ML algorithm or a study involving patient data. This is a physical medical device. The "testing" involved:
- Physical Prototypes: "Prototype sources have been manufactured and assessed against predetermined criteria for Design Verification and Design Validation." The exact number of prototypes is not specified.
- Sealed Source Testing: The device was tested according to ISO 2919, which is a standard for sealed radioactive sources. This likely involves a series of physical tests (e.g., temperature cycling, external pressure, impact, vibration, puncture) on a sample of devices to ensure their integrity. The sample size for these specific tests is not explicitly stated in the 510(k) summary, but ISO standards typically define sample requirements.
- Activity Measurements: "Activity measurements have been obtained from NIST Report (Report of Air-Kerma rate measurements)." This refers to calibration and measurement standards from the U.S. National Institute of Standards and Technology.
Data Provenance: Not applicable in the context of patient data as this is a physical device safety and performance evaluation. The provenance of the testing (e.g., "NIST Report") is mentioned, indicating U.S. national standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is a physical device, not a diagnostic imaging or AI algorithm that relies on expert interpretation of data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of patient cases requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is relevant to diagnostic imaging devices or AI algorithms where human readers interpret medical images. It is not applicable to a radioactive implantable seed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical brachytherapy source, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on engineering specifications, international standards (ISO 2919), and national metrology standards (NIST).
- Device Specifications: The stated dimensions, materials, and isotope are the design "ground truth."
- Performance Standards: Compliance with ISO 2919 for sealed source integrity ensures the physical safety and containment of the radioactive material.
- Radioactivity Calibration: NIST reports provide the "ground truth" for the accurate measurement of the device's radioactive output (Air-Kerma rate), which is critical for safe and effective dosimetry in patient treatment.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this physical medical device.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets acceptance criteria consists of non-clinical testing focused on the physical and radiological properties of the brachytherapy source.
- ISO 2919 Testing: The device underwent testing "according to ISO 2919 for sealed sources." This standard specifies the classification of sealed radioactive sources based on their safety requirements and defines a series of environmental and mechanical tests (e.g., temperature, external pressure, impact, vibration, puncture) designed to demonstrate that the source will maintain its integrity and containment of radioactive material under normal and accident conditions. Meeting this standard indicates the physical robustness and safety of the sealed source.
- NIST Report for Activity Measurements: "Activity measurements have been obtained from NIST Report (Report of Air-Kerma rate measurements)." This confirms that the radioactive output of the device (Iodine-125) has been accurately measured and calibrated to national standards as verified by the National Institute of Standards and Technology. Accurate activity measurement is fundamental for physicians to calculate appropriate treatment dosages for patients.
- Design Verification and Design Validation: "Prototype sources have been manufactured and assessed against predetermined criteria for Design Verification and Design Validation." This process ensures that the manufactured device meets its design specifications (verification) and fulfills its intended use requirements (validation). This typically involves comparing actual prototype performance against the established design requirements and user needs.
These non-clinical tests demonstrate that the Brachytherapy Source Device, Model 9011, is physically safe, robust, and accurately characterized in terms of its radioactive output, thereby establishing its substantial equivalence to the predicate device despite minor dimensional changes.
§ 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.