(28 days)
Not Found
No
The document describes a standard X-ray irradiation system for blood products and explicitly states it is identical to the predicate device except for labeling. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No
The device is used for irradiating blood and blood products, not directly for treating a patient or a disease. Its function is to prepare blood products for transfusion by reducing the risk of Graft Versus Host Disease, which is a preventive measure applied to the product, not a therapeutic action on a patient.
No
Explanation: The device is described as an "X-ray System" for the "irradiation of blood and blood products." It is used to reduce the risk of Graft Versus Host Disease, which is a treatment or preventative measure, not a diagnostic one. No mention of image processing or analysis for diagnosis is present.
No
The device description explicitly lists hardware components such as a sample holder, x-ray tubes, power supplies, shielding, control electronics, and cooling assemblies. This indicates it is a hardware device, not software-only.
Based on the provided information, the Raycell™ Shielded Cabinet X-ray System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the irradiation of blood and blood products packaged in transfusion bags to reduce the risk of Graft versus Host Disease. This is a treatment or processing step applied to a biological product before it is administered to a patient.
- Device Description: The description details an X-ray system designed for irradiation, not for analyzing or testing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health or condition
IVD devices are typically used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Raycell™ system's purpose is to modify a biological product (blood) for therapeutic use, not to diagnose a condition.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
90 MOT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
SEP 2 6 2003
Image /page/0/Picture/1 description: The image shows the logo for MDS Nordion. The logo consists of the text "MDS Nordion" in a bold, sans-serif font, with a curved line above the "MDS" portion. Below the main text, in a smaller, italicized font, is the tagline "Science Advancing Health."
447 March Road Ottawa, ON K2K 1X8 Tel: + 1 613 592 2790 Fax: +1 613 592 6937 www.mds.nordion.com
Canada
532684 page 1 of 2
Section 2.0
510(k) Summarv Prepared Auqust 25, 2003
2.1 Submitter: MDS Nordion Tel: Fax: 447 March Road Ottawa, Ontario K2K 1X8 CANADA
613-592-3400 x2372 613-592-2006
Contact Person: E. S. Martell, Vice President Quality & Regulatory Affairs 447 March Road Ottawa, Ontario K2K 1X8 CANADA
- 2.2 Device Manufacturer: MDS Nordion 447 March Road Ottawa, Ontario K2K 1X8 CANADA
- 2.3 Device Name: Raycell™
- 2.4 Classification Name: Blood irradiators have not been classified
- Common or Usual Name: Cabinet X-Ray System 2.5
- 2.6 Legally Marketed Predicate Device:
RS 3000 Shielded Cabinet X-Ray Blood Irradiator (K974210), see Appendix 1 for RS 3000 510(k) Notification.
2.7 Description of Device:
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.
1
K032684
Page 2 of 2
2.8 Intended Use of Device:
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).
2.9 Summary of Technological Characteristics:
The Raycell is substantially equivalent to the RS 3000 (K974210). Both are indicated for the irradiation of blood and blood products to reduce the risk of transfusion-associated graft-versus-host disease in recipients at risk of this complication. MDS Nordion has not made any modifications to the RS 3000, with the exception of labeling changes to reflect the new name of the device "Raycell" and MDS Nordion as the manufacturer. The significant technological characteristics of the two devices are as follows:
| Technological
| Characteristics | RS 3000 | Raycell |
|---|---|---|
| Source | 160 kVdc x-rays | Same |
| Beam filtration | 0.38 mm copper | Same |
| Single beam HVL, | ||
| water | Approximately 4 mm | Same |
| Dose rate | 3 Gy min¯¹ | Same |
| Max/min dose ratio |