(66 days)
Not Found
No
The description focuses on basic control system functions like timing, counting, and error display, with no mention of AI or ML terms or capabilities.
No.
The device irradiates blood components to inactivate leukocytes and lymphocytes outside of the body, which is a pre-treatment of the blood, not a therapeutic treatment of a patient.
No
Explanation: The device is described as an irradiator for blood components, designed to inactivate leukocytes and lymphocytes, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states that the device is a "modified Gammacell E- series Blood Irradiator models" which are physical devices that irradiate blood. While the submission focuses on a software update (version 1.0 control system), the device itself is a hardware system with integrated software, not a standalone software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "effectively irradiate blood components to inactivate leukocytes and lymphocytes." This is a physical process applied to a biological sample (blood components) outside of the body, but it's not for the purpose of diagnosing a disease or condition.
- Device Description: The description details the mechanical and software functions of an irradiator. It describes how it physically handles and irradiates blood products.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples to detect or measure substances, identify markers, or provide information for diagnosis.
- Performance Studies: The performance studies focus on functional specifications, safety, and effectiveness in terms of irradiation, not on diagnostic accuracy or analytical performance related to a biological assay.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device performs a physical treatment on blood components.
N/A
Intended Use / Indications for Use
The intended use of the modified Gammacell with version 1.0 control system remains unchanged. Both the improved and the predicate device effectively irradiate blood components to inactivate leukocytes and lymphocytes.
Product codes
Not Found
Device Description
The modified Gammacell E- series Blood Irradiator models, the 1000 Elite and the 3000 Elan use the new software version 1.0 control system. With the exception of the modified control system, the 1000 Elite and 3000 Elan are identical to previously cleared models.
The basic operation of an irradiator involves placing of the blood product into the beaker, loading the beaker into the Gammacell, closing the safety door and pressing the "start" button. Upon start of the cycle, the unit moves the beaker to irradiate position and rotates the blood product continuously at a uniform speed to provide a consistent dose of irradiation. Concurrently, the timer begins to count down (irradiation time is pre-programmed by the site supervisor) from the set time and when the time reaches zero, the sample returns to unload position and the audible alarm sounds. If the cycle is completed as pre-programmed the message "cycle completed OK." is displayed. Any problems in the irradiation cycle will be displayed specifically and clearly.
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
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Description of the test set, sample size, data source, and annotation protocol
The performance of the device was tested against a set of functional specifications in an environment which simulated, as much as possible, the actual operating environment. The functional requirements included security and safety functions, operational features, timing and counting functions, ancillary equipment such as independent Backup Timer and Beaker Rotation Sensing System, operator interface etc.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation testing results provide documented evidence that the equipment design tested, adequately meets the functional requirements and the device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows a logo with a stylized key on the left and the text "A Tradition of Excellence" and "1946-1996" on the right. The key is abstract and appears to be made of thick, black lines. The text is in a serif font and is arranged in two lines, with the phrase "A Tradition of Excellence" above the years "1946-1996". The overall design is simple and classic, suggesting a sense of history and quality.
Image /page/0/Picture/1 description: The image shows the logo for Nordion International Inc. The logo features a stylized infinity symbol with a maple leaf incorporated into the left side. Below the logo is the text "K963497" in a handwritten style.
NOV - 8 1996
510K SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Submitter's Name: | Nordion International Inc. |
|---|---|
| Submitter's Address: | 447 March Road |
| Kanata, Ontario | |
| CANADA K2K 1X8 | |
| Submitter's Telephone No.: | (613) 592-2790 |
| Contact Person: | Mr. Grant Malkoske |
| Vice-President | |
| Quality, Regulatory Affairs and Operations | |
| Services | |
| Date Summary Prepared: | August 27, 1996 |
| 2. Common or Usual Name: | Blood irradiator. |
| Proprietary Name: | Gammacell 3000 ELAN, Version 1.0 |
| Gammacell 1000 ELITE, Version 1.0 | |
| 3. Legally Marketed Device: | Gammacell 3000 Elan, Version 2.09 |
| Gammacell 1000 Elite, Version 2.09 | |
| File Number of Last 510(k): | K952291 |
447 March Road, Kanata. Ontario. Canada K2K 1X8 Tel.: (613) 592-2790 Fax: (613) 592-6937
1
4. Product description:
The modified Gammacell E- series Blood Irradiator models, the 1000 Elite and the 3000 Elan use the new software version 1.0 control system. With the exception of the modified control system, the 1000 Elite and 3000 Elan are identical to previously cleared models.
The basic operation of an irradiator involves placing of the blood product into the beaker, loading the beaker into the Gammacell, closing the safety door and pressing the "start" button. Upon start of the cycle, the unit moves the beaker to irradiate position and rotates the blood product continuously at a uniform speed to provide a consistent dose of irradiation. Concurrently, the timer begins to count down (irradiation time is pre-programmed by the site supervisor) from the set time and when the time reaches zero, the sample returns to unload position and the audible alarm sounds. If the cycle is completed as pre-programmed the message "cycle completed OK." is displayed. Any problems in the irradiation cycle will be displayed specifically and clearly.
ട. Intended Use:
The intended use of the modified Gammacell with version 1.0 control system remains unchanged. Both the improved and the predicate device effectively irradiate blood components to inactivate leukocytes and lymphocytes.
6. Technological Comparison:
The basic function of the Gammacell 1000 Elite and Gammacell 3000 Elan with the modified control system has not been changed from the predicate Gammacell 1000E and 3000E. However, some technological changes are being made to the control system primarily to make the unit more user friendly. Precisely, the operator display panel has been simplified, and the information and error messages displayed on the panel have been written so that they can be readily understood by the operator. The access to the machine is effectively controlled through enhanced security and access controls. In addition, the modified unit is proven to withstand any electromagnetic interference that may affect the function of the control system.
Safety and Efficacy: 7.
Safety:
The safety of the Gammacell is equivalent or better than the predicate device. The irradiation source and the radioactivity of the caesium-137 source(s) remains unchanged.
In terms of electrical safety, all units are designed to comply with applicable standards of the Canadian Standards Association and are certified as such by the CSA. In addition, the modified units are tested and demonstrated for compliance with Electromagnetic Compatibility (EMC).
Efficacy:
2
The performance of the device was tested against a set of functional specifications in an environment which simulated, as much as possible, the actual operating environment. The functional requirements included security and safety functions, operational features, timing and counting functions, ancillary equipment such as independent Backup Timer and Beaker Rotation Sensing System, operator interface etc. Validation testing results provide documented evidence that the equipment design tested, adequately meets the functional requirements and the device is as safe and effective as the predicate device.
8. Conclusion:
Although some new features have been added to the new control system, mainly for the purpose of operator conveniences, these new features in no way compromise the intended use, safety or effectiveness of the device. The modified device models, with Version 1.0, are substantially equivalent to the 510(k) cleared models with Version 2.09