(32 days)
To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft versus host disease.
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 moved the beaker to the irradiation position. 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 the unload position and the audible alarm sounds.
This 510(k) summary describes a modification to an existing medical device, the Gammacell 1000 Elite and Gammacell 3000 Elan blood irradiators. The submission focuses on demonstrating substantial equivalence to the previously marketed versions (Gammacell 1000E and 3000E, K963497) due to a specific design change.
Acceptance Criteria and Device Performance Study:
The primary acceptance criteria for this 510(k) submission are related to demonstrating that the modified devices maintain the same safety and effectiveness as their predicate devices, despite the internal design change. Since the change is specifically to replace an obsolete PCB and its associated firmware with a new board and operating system, the performance evaluation centers on ensuring that the core functionality, safety systems, and intended use remain unaffected.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | Electrical safety compliance with IEC 60601-1 and IEC 60601-1-2 (General requirements for safety and Electromagnetic Compatibility). | "The Gammacell 1000 Elite and 3000 Elan are designed to comply with IEC 60601-1, Medical Electrical Equipment. Part 1; General requirements for safety, and IEC 60601-1-2, Medical Electrical Equipment, Part 1; General requirements for safety; Electromagnetic Compatibility Requirements for Tests." |
| Overall safety equivalent or better than the predicate device. | "The safety of the Gammacell is equivalent or better than the predicate device." | |
| Effectiveness/Functionality | Maintenance of core functional requirements: irradiation process (species, timing, counting functions), ancillary equipment security, safety functions operation sensing system, and operator interface. | "The performance of the device was tested against a set of functional specifications in an environment that simulated, as much as possible, the actual operating environment. The functional requirements included species, timing and counting functions, ancillary equipment security and safety function's operation sensing system, operator interface, etc." |
| Control system design meets the same intended use requirements as the current model. | "The control system is designed to meet the same intended use and is based on the same requirements as the current model." | |
| No changes to interlock circuits, switches, motors, mechanical structure, shielding, outside appearance, irradiation source, or radioactivity of the Caesium-137 source(s). | "There are no changes to any interlock circuits, switches or motors." | |
| "There are no changes to the mechanical structure or shielding of the Gammacell and the outside appearance remains the same." | ||
| "The irradiation source and radioactivity of the caesium-137 source(s) remains unchanged." | ||
| Substantial Equivalence | Demonstrates substantial equivalence to the previously cleared predicate devices (K963497). | "The Gammacell 1000 Elite and Gammacell 3000 Elan are substantially equivalent to the previous versions of the Gammacell 1000E and 3000E (K963497)." |
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not specify a numerical "sample size" in the context of typical clinical trials. Instead, the testing appears to be functional and engineering-based on the modified device itself. The "functional specifications" against which the device was tested constitute the "test set" in this engineering context.
- Data Provenance: The study is described as having been performed "in an environment that simulated, as much as possible, the actual operating environment." This suggests in-house testing and validation by MDS Nordion, rather than a multi-center clinical study with patient data. The country of origin of the data would be Canada, where MDS Nordion is located. The nature of the study is prospective, as it involves testing the newly modified device.
3. Number of Experts and Qualifications for Ground Truth:
- The document does not mention the use of external experts or a ground truth established by medical professionals in the typical sense for analyzing diagnostic images or clinical outcomes. The "ground truth" here is the established, known performance and safety requirements of the predicate device and relevant international standards (IEC 60601-1). The validation team at MDS Nordion and the independent test house (mentioned implicitly by "Independent body concluded that the device is as safe and effective as the predicate device") would have served as the "experts" in verifying compliance against these predefined engineering and safety standards. Their qualifications would be in electrical engineering, regulatory affairs, and quality assurance.
4. Adjudication Method:
- No adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as this was not a study involving human interpretation of data where consensus among multiple reviewers would be required. The "adjudication" was against predefined engineering specifications and international standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for an irradiator, a therapeutic device, and the changes are internal component replacements, not changes to the output that would require human interpretation.
6. Standalone (Algorithm Only) Performance Study:
- A standalone performance study was conducted in the sense that the modified device was tested by itself against its functional specifications and safety standards. The new embedded firmware and operating system represent the "algorithm" in this context, and its performance was directly evaluated. The text states: "The performance of the device was tested against a set of functional specifications in an environment that simulated... the actual operating environment." This describes a standalone, functional validation of the device's internal operations.
7. Type of Ground Truth Used:
- The ground truth used was a combination of:
- Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices (Gammacell 1000E and 3000E, K963497). The modified device must perform equivalently.
- Functional Specifications: Engineering specifications detailing the required operation of the irradiator, including timing, counting, safety interlocks, and operator interface.
- International Safety Standards: Compliance with electrical safety standards (IEC 60601-1 and IEC 60601-1-2).
8. Sample Size for the Training Set:
- The concept of a "training set" is not applicable here as this is not a machine learning or AI development project that requires data for model training. The "training" for this device's new software would have been part of its development and debugging process, not a distinct "training set" in the context of clinical or image data.
9. How the Ground Truth for the Training Set Was Established:
- As a "training set" in the AI/ML sense is not relevant, this question does not apply. The functional behavior of the device's control system (which includes the new firmware and QNX operating system) was effectively the "product" of its development. The "ground truth" for its correct operation was established by the engineering design requirements and functional specifications, which would have been based on the predicate device's proven functionality and regulatory standards.
N/A