(139 days)
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No
The summary describes a physical device for irradiating blood products using an x-ray tube and a rotating carousel. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on radiation dose measurements, not algorithmic performance.
No
This device irradiates blood products ex vivo to reduce the risk of Graft Versus Host Disease before transfusion, not directly treating a patient.
No
The device is an irradiator used for treating blood products to reduce the risk of Graft Versus Host Disease, not for diagnosing medical conditions.
No
The device description clearly states it consists of a shielded enclosure, x-ray tube, power supply, controller, and a carousel, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the irradiation of blood or blood products to reduce the risk of Graft Versus Host Disease. This is a therapeutic or preventative treatment applied to the blood before transfusion, not a diagnostic test performed on the blood to determine a medical condition.
- Device Description: The device is an X-ray irradiator designed to expose blood products to radiation. This is a physical process applied to the sample, not a method for analyzing the sample's properties or components to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing blood components, detecting biomarkers, or providing information for diagnosis. The focus is solely on the physical process of irradiation.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The RS 3400 Rad Source X-ray Blood Irradiator is 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.
Product codes (comma separated list FDA assigned to the subject device)
MOT
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data Used in Determining Substantial Equivalency: The submitted device is indicated for the irradiation of blood and therefore the tests performed include measuring the radiation field resulting within the rotating containers when a blood product (using water as a sample) is contained within the rotating containers. The measured dose and field result in producing the necessary radiation to support the Indications for Use substantially equivalent to the predicate device.
Clinical Performance Data Used in Determining Substantial Equivalency: None.
Conclusions Drawn from the Non-Clinical Tests: Based on the Non-Clinical tests performed, it is concluded that the Submitted Device is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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N/A
0
FEB 1 7 2009
RAD SOURCE TECHNOLOGIES, INC.
6825 Shiloh Road East, Ste. B-2 Alpharetta, GA 30005 (770) 887-8669 email: info@radsource.com
510(k) Summary
Owner:
Rad Source Technologies, Inc. 6825 Shiloh Road East, Ste. B-2 Alpharetta, GA 30005 (770) 887-8669
Contact:
Randy Kirk, President
Device:
Trade name - RS 3400 Rad Source X-ray Blood Irradiator Common name - Blood Irradiator Classification name - N/A
Predicate Device:
RS 3000 Shielded Cabinet X-ray Radiation Source. 510(k) number K974210,
Description of Device:
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.
Intended Us of the Device:
The RS 3400 Rad Source X-ray Blood Irradiator is 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
1
establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated. This document is attached in Section 21 - Other.
Summary of Technological Characteristics of Device Submitted and Predicate Device:
The RS 3400 Rad Source X-ray Blood Irradiator is substantially equivalent to the RS 3000 Shielded Cabinet X-ray Radiation Source (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. The primary technological characteristic of both machines is the controlled production of X-ray radiation.
| Characteristic | Submitted Device
RS 3400 | Predicate Device
RS 3000 |
|--------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Source | 150kVdc x-rays, .45 mm Cu filter,
hvl app. H₂O cooled | 160kVdc x-rays, .38 mm Cu
filter, hvl app. 4 cm H2O |
| Dose Rate | >5 Gy/minute | 3 Gy/minute |
| Max/Min dose ratio: |