(71 days)
IsoRay, Inc. Lawrence CSERION seeds are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. The seeds may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.
The IsoRay, Inc. Lawrence CSERION Model CS-1 is a small, cylindrical sealed source which contains the low energy gamma (X-ray) emitting radionuclide, cesium-131, adsorbed onto an internal inorganic substrate. The nominal external seed dimensions (4.5 mm length and 0.8 mm diameter) and patient-contacting material (titanium) are identical to predicate device(s).
The provided text is a 510(k) Summary for the IsoRay, Inc. Lawrence CSERION Model CS-1, a brachytherapy source. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove that the device meets those criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training and test sets is not available in this document.
The document states that the device is "substantially equivalent" to predicate devices based on a comparison of parameters. The "Comparison Chart" on page 0 outlines these parameters. This comparison is the "study" demonstrating the device meets the criteria for substantial equivalence, implying that if the new device's parameters are similar enough to an already approved device, it is considered safe and effective.
Here's a breakdown of what is provided, framed in terms of the closest available information to your request:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide "acceptance criteria" in the traditional sense of a performance study with specific thresholds. Instead, it presents a "Comparison Chart" to demonstrate substantial equivalence to predicate devices. The "acceptance criterion" here is essentially that the new device's parameters are comparable to those of already cleared devices.
| Parameters for Evaluating Substantial Equivalence | IsoRay, Inc. Lawrence CSERION (Reported Performance) | Predicate Device(s) (Reference) |
|---|---|---|
| Indications for Use | Malignant Disease | Same |
| Radionuclide | Cs-131 | Same for K924261, I-125 for K914281, Pd-103 for K010283 |
| Half-Life (days) | 9.69 | Same for K924261, 59.4 for K914281, 17.0 for K010283 |
| Principle Energies (keV) | 29.5, 29.8, 33.6 | Same for K924261, 27.4, 31.4, 35.5 for K914281, 20-22 for K010283 |
| Patient-Contacting Capsule: | Welded Titanium | Same |
| Nominal External Length (mm) | 4.5 | Same |
| Nominal External Diameter (mm) | 0.8 | Same |
| Radiographic Marker | Gold Wire | Various (Predicate: Silver Rod, Lead Piece) |
| Apparent Activity Range (mCi) | 0.20 to 50.0 | 0.1 to 100 (Predicate: 5.0 to 40, 0.1 to 10) |
| External Contamination (uCi) |
§ 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.