(28 days)
The Raycell™ Shielded Cabinet X-ray System is intended for the irradiation of blood and blood products packaged in transfusion bags when irradiation to reduce the risk of Graft versus Host Disease is indicated, and is used 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 for Biologics Evaluation and Research, FDA to all registered blood establishments).
The Raycell Shielded Cabinet X-ray System consists of a sample holder (canister) between the two (2) x-ray tubes, dual power supplies, radiation shielding, control electronics, cooling assemblies and operator controls. The radiation source of the Raycell™ Shielded Cabinet X-ray System includes of two vertically opposed xray tubes contained in a shielded enclosure. It is identical to the predicate device with the exception of labeling changes to reflect the new product name and identify MDS Nordion as the manufacturer.
The provided document describes a 510(k) submission for the Raycell™ Shielded Cabinet X-ray System. This submission is for a medical device that irradiates blood and blood products. It is a declaration of substantial equivalence to an existing predicate device, the RS 3000 Shielded Cabinet X-Ray Blood Irradiator (K974210).
The document does not contain information about studies to prove device performance against acceptance criteria in the context of AI/ML or diagnostic performance. Instead, the "acceptance criteria" here refers to the device's technological characteristics remaining the same as the predicate device, which is the basis for claiming substantial equivalence.
Therefore, many of the requested fields are not applicable to this type of regulatory submission.
Here's an attempt to fill out the information based on the provided text, with clarifications where the requested information is not available or relevant:
Acceptance Criteria and Study Details for Raycell™ Shielded Cabinet X-ray System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Technological Characteristics) | Reported Device Performance (Raycell™) |
|---|---|
| Source: 160 kVdc x-rays | Same (160 kVdc x-rays) |
| Beam filtration: 0.38 mm copper | Same (0.38 mm copper) |
| Single beam HVL, water: Approximately 4 mm | Same (Approximately 4 mm) |
| Dose rate: 3 Gy min⁻¹ | Same (3 Gy min⁻¹) |
| Max/min dose ratio: |
N/A