(268 days)
The SmartFlow™ Flex Ventricular Catheter is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."
The Catheter has a stepped distal tip with a 30 cm removable rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. The stylet is removed after insertion to the desired point. Soft tubing protects the lumen in the center portion and at the distal end where it terminates. The fluid containing central lumen is manufactured from PEEK tubing.
The Catheter will be marketed in the following sizes:
Ventricular Catheter .008 x 7.5mm tip
Ventricular Catheter .008 x 15mm tip
Ventricular Cathcter .021 x 7.5mm tip
Ventricular Catheter .021 x 15mm tip
Each unit will provide for an approximate 23 inch tubing extension.
The provided document is a 510(k) summary for a medical device (MRII MR Compatible Ventricular Catheter) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against specific acceptance criteria for a new AI/software device.
Therefore, the information required to populate most sections of the table and answer the subsequent questions is not present in the provided text, as this document describes a traditional medical device submission, not an AI/software device.
However, I can extract information related to the device's technical specifications and the Performance Testing – Bench section, which acts as the "study" proving the device meets certain operational criteria.
Here's a breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Flow Rate Testing (constant pressure) | Flow rates at 0.7 psi for the device to be greater than the predicate. (Predicate: .008" ID 0.6 mL/hr, .021" ID 34 mL/hr) | .008" ID Device 4.0 mL/hr |
| .021" ID Device 56 mL/hr | ||
| High Pressure Flow Testing | Equivalent to or better than the predicate. | Equivalent to or better than the predicate. |
| Aspiration | Better than (higher aspiration rates achievable) the predicate. | Better than the predicate. |
| Leak/Burst Testing | Withstand 70 psi internal pressure without any leaks (same as predicate). | All samples withstood 70 psi internal pressure without any leaks. Equivalent to the predicate. |
| Distal Tip Compressive Strength | No damage to the tip (same as predicate's specification). | All samples met the requirement without damage to the tip. Equivalent to the predicate. |
| Distal Tip Lateral Load | Meet minimum force limit (same as predicate's specification). | All samples met the specification. Substantially equivalent to the predicate. |
| Ceramic Stylet Lateral Load | Device to meet specification (same as predicate's specification). (Note: Predicate has fixed, integrated rigid tube, not removable internal stylet). | Device met the specification. |
| Catheter Axial Tensile Load | Device to meet specification (same as predicate). | All devices met the specification. Equivalent to the predicate. |
| Catheter Insertion into Bone Anchor | Insert without difficulty. | The device was inserted into the Bone Anchor without difficulty. |
| Catheter Retention in Bone Anchor | Retained to the specified limit. | All samples were retained to the specification. |
| Stylet Removal from Bone Anchor | Meet specification of maximum pull force for Stylet removal. | The device met the specification of maximum pull force for Stylet removal. |
| Catheter Tissue Insertion | No tissue in or on the device, no plugging or damage (equivalent to predicate). | There was no tissue in or on the device after insertion and removal. Equivalent to the predicate device. |
| Backflow | No observed backflow (equivalent to predicate). | There was no observed backflow. Equivalent to predicate device. |
| Tip Deflection at Max Pressure | No movement of the tip at 70 psi internal pressure (equivalent to predicate). | There was no movement of the tip at applied internal pressure of 70 psi. Equivalent to the predicate device. |
| Tip Deflection at Max Aspiration | No movement of the tip at 2.0 psi vacuum (equivalent to predicate). | There was no movement of the tip at applied vacuum of 2.0 psi. Equivalent to the predicate device. |
| Bend Radius Withstand | No kinking or damage to the tubing at the specified bend radius (equivalent to predicate). | There was no kinking or damage to the tubing at the specified bend radius. Equivalent to the predicate device. |
| Syringe Dropping Test | No damage sustained by the device after the syringe was dropped with the device connected (equivalent to predicate). | There was no damage sustained by the device after the syringe was dropped with the device connected. Equivalent to the predicate device. |
| Tip Deflection after Stylet Removal | No tip movement upon Stylet removal. | There was no tip movement upon Stylet removal. Device met specification. |
| Bone Anchor Insertion Force | Insert fully with a downward force below the requirement. | All Bone Anchors were all inserted fully with a downward force below the requirement. |
| Bone Anchor Insertion Torque | Insert fully with a torque below the requirement. | All Bone Anchors were all inserted fully with a torque below the requirement. |
| Bone Anchor Side Load Force | Withstand minimum load with no damage or yielding. | All Bone Anchors all withstood the minimum load with no damage or yielding. |
| Bone Anchor Side Impact Force | Withstand minimum energy without damage or yielding. | All Bone Anchors withstood the minimum energy without damage or yielding. |
| Bone Anchor Retention Force | Remain in place under the applied tensile load. | All Bone Anchors remained in place under the applied tensile load. |
| Bone Anchor-Driver Detachment Force | Below the maximum limit for detachment force. | All pairs of Bone Anchors and Drivers were below the maximum limit for detachment force. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test, but phrases like "All samples" and "All Bone Anchors" suggest that specific, likely small, batches of devices/components were tested. The exact number of units per test is not provided.
- Data Provenance: The studies are described as "Bench testing" performed by "MRII, Inc." This indicates the data is from in-vitro (lab/bench) testing of the physical device, not patient data. No country of origin for data is specified beyond the company's location (Irvine, CA, USA). It's prospective in the sense that the tests were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a traditional device submission focused on physical and material properties, not an AI/software device requiring expert ground truth for classification or detection tasks. The "ground truth" for these tests is based on objective physical measurements and adherence to engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, often for AI performance evaluation. The tests described here are objective bench tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software device. The device's "performance" is its physical function, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests is derived from:
- Pre-defined engineering specifications and limits (e.g., specific flow rates, pressure limits, force thresholds).
- Comparative performance against the legally marketed predicate device.
- Objective physical measurements (e.g., fluid volume, pressure, force, visual inspection for damage/leaks).
- Compliance with recognized standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11137-2 for sterility).
8. The sample size for the training set
Not applicable. This is not an AI/software device and does not involve training data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device.
§ 882.4100 Ventricular catheter.
(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).