(139 days)
Intended for the irradiation of blood or blood products packaged in transfusion bags in accordance with "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director Office of Blood Research and Review, Center of Biologics Evaluation and Research, FDA to all registered blood establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.
The RS 3400 Rad Source X-ray Blood Irradiator consists of a shielded enclosure containing one x-ray tube capable of emitting radiation in a 360 degree output around its cylindrical design, a power supply and controller. A carousel capable of holding 5 cylindrical containers rotates those cylinders around the cylindrical x-ray tube radiation source causing the blood products contained therein to be irradiated.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
The document describes a 510(k) premarket notification for the RS 3400 Rad Source X-ray Blood Irradiator, seeking substantial equivalence to a predicate device, the RS 3000 Shielded Cabinet X-ray Radiation Source (K974210). Since this is a submission for an X-ray irradiation device, not an AI/ML medical device, many of the standard questions regarding AI/ML acceptance criteria, reader studies, and ground truth establishment for diagnostic performance are not applicable.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to its predicate for safety and effectiveness in irradiating blood products. This is primarily evaluated through measurable technical characteristics and the ability to achieve the required radiation dose.
| Characteristic | Acceptance Criteria (from Predicate Device) | Reported Device Performance (Submitted Device) |
|---|---|---|
| Source | 160kVdc x-rays, .38 mm Cu filter, hvl app. 4 cm H2O | 150kVdc x-rays, .45 mm Cu filter, hvl app. H₂O cooled |
| Dose Rate | 3 Gy/minute | >5 Gy/minute |
| Max/Min dose ratio: |
N/A