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510(k) Data Aggregation
(196 days)
InterSource125 implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. InterSource125 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.
InterSource125 is a hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSource125 is Iodine-125 (I-125). InterSource125 is constructed by placing a platinum / iridium radiopaque marker and I-125 on the surface of a medical grade titanium inner tube. The device is sealed by sliding an outer tube, also medical grade titanium, over the inner tube and laser welding both ends. The resulting device has a hollow center with an inner diameter of 0.37 mm with all body tissue contacting surfaces made from medical grade titanium.
The InterSource125 device, an Iodine-125 seed for brachytherapy, demonstrated substantial equivalence to its predicate device, the Amersham/Medi+Physics Model 6711 Therapeutic Seed Source, rather than a direct performance study against acceptance criteria from a standalone test. The assessment of substantial equivalence was based on a comparison of key characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission, direct "acceptance criteria" as would be seen in a performance study with defined thresholds for metrics like sensitivity or specificity are not present. Instead, the "acceptance criteria" are implied by the similarity to the predicate device's characteristics. The "reported device performance" is the InterSource125's characteristics and its computed radiation distribution compared to the predicate's known characteristics and measured radiation distribution.
| Feature Description | Acceptance Criteria (Predicate Device) | Reported Device Performance (InterSource125) | Basis of Equivalence |
|---|---|---|---|
| Indications for Use | For interstitial treatment of tumors with specific characteristics (unresectable, localized, slow growth rate, low to moderate radiosensitivity). | Interstitial implantation of select localized tumors with low to moderate radiosensitivity. Used as primary treatment or for residual disease after excision. Used concurrently or after other modalities like external beam radiation therapy. | Indication statements were compared and found to be substantially equivalent in intent. |
| Physical Size | Length: 4.5 mm, Outside Diameter: 0.8 mm (Outer Tube) | Length: 4.5 mm, Outside Diameter: 0.8 mm (Outer Tube) | Identical dimensions. |
| Radiopaque Marker | Silver | Platinum / Iridium | Both devices incorporate a radiopaque marker. The material difference was assessed as not affecting equivalence. |
| Biocompatibility | Titanium (Outer Tube), Silver (Isotope Carrier) | Medical grade titanium (Outer Tube, Inner Tube, Isotope Carrier) | Both use known biocompatible materials. Titanium is specified for all body-tissue contacting surfaces in InterSource125. |
| Radioisotope | Iodine-125 | Iodine-125 | Identical radioisotope. |
| Half-life | 59.4 days | 59.4 days | Identical. |
| Principal Energy Levels | 27.2 keV, 27.5 keV, 31.0 keV, 35.5 keV | 27.2 keV, 27.5 keV, 31.0 keV, 35.5 keV | Identical. |
| Distribution of Isotope | Deposited onto the surface of the isotope carrier | Deposited onto the surface of the isotope carrier | Identical method. |
| Apparent Activity Levels | 0.18 to 5.99 mCi | 0.1 to 5.0 mCi | Comparable range, with InterSource125's range falling largely within or closely to the predicate's. |
| Residual Activity | < 1.3 µCi at 2 years | < 1.1 µCi at 2 years | InterSource125's residual activity is slightly lower, indicating comparable or better performance. |
| Radiation Dose | Measured values from published data | Computed values (Figure 5) | Figure 5 demonstrates a similar distribution of radiation dose between the InterSource125 (computed) and the predicate device (measured). |
2. Sample Size Used for the Test Set and the Data Provenance
This submission is a comparison to a predicate device for substantial equivalence, not a standalone clinical performance study with a distinct "test set" of patients or cases. The "test set" in this context refers to the characteristics and properties of the InterSource125 device itself, which were compared against the known characteristics of the predicate device.
- Sample Size: Not applicable in the traditional sense of patient data. The "sample" is the InterSource125 device's design, materials, and its computed radiation characteristics.
- Data Provenance: The data for the InterSource125 is based on its design specifications, material compositions, and computational modeling (for radiation dose). The predicate device's data is based on its known characteristics as a legally marketed device and previously published measured values for radiation dose. The submission originated from the USA (IBt, Inc.) and Belgium (IBt SA) in 1998/1999.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for device characteristics (like physical dimensions, materials, and radioisotope properties) is established through technical specifications, manufacturing processes, and validated measurement methods, not typically by expert consensus in this context. For the radiation dose comparison, the "ground truth" for the predicate device was based on previously published measured values, implying a scientific consensus or accepted measurement methodology, rather than specific expert adjudication for this submission.
4. Adjudication Method for the Test Set
Not applicable. This was a comparative analysis based on objective device specifications and published data for the predicate, not a subjective assessment requiring adjudication.
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
Not applicable. This is a submission for a brachytherapy seed, a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable to a physical medical device like a brachytherapy seed. Performance is inherent to the device's physical and radioactive properties. The "device performance" relies on the accurate emission of radiation and reliable physical integrity, not an algorithm. The computation of radiation dose can be considered a "standalone" assessment of a device characteristic.
7. The Type of Ground Truth Used
The "ground truth" for the InterSource125 device and its comparison to the predicate device relied on:
- Device Specifications: Engineering drawings, material lists, and manufacturing process descriptions for both devices.
- Published Data/Measurements: For the predicate device's radiation dose distribution.
- Radioisotope Properties: Established physics data for Iodine-125 (e.g., half-life, principal energy levels).
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set."
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