(183 days)
The MR Compatible Ventricular Cannula is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. The device is intended for "single patient use only."
The Cannula has a stepped distal tip with a 30 cm rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. Soft this in areets the lumen in the center portion and at the distal end where it terminates at a female luer fitting. The fluid containing central lumen is manufactured from non-reactive silica. The cannula will be marketed in the following sizes: 16 ga Ventricular Cannula, .008" ID x 4ft; 16 ga Ventricular Cannula. .008" ID x 10ft; 14 ga Ventricular Cannula, .021" ID x 4ft; 14 ga Ventricular Cannula, .021" ID x 10ft.
The provided text describes the SurgiVision MR Compatible Ventricular Cannula and its substantial equivalence to a predicate device (Adson Cannula), but it does not contain information about the acceptance criteria or a study designed to prove the device meets those criteria in the context of typical AI/ML device evaluations. This document describes a traditional medical device submission (a cannula), not a diagnostic AI/ML device.
Therefore, many of the requested details about acceptance criteria, specific performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance are not present because they are not applicable to this type of device submission.
However, I can extract the information relevant to the device's technical validation and comparison to the predicate device.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for performance metrics like those seen in AI/ML diagnostic devices (e.g., sensitivity, specificity). Instead, it describes performance and material characteristics that are either equivalent to the predicate or designed for specific needs (like MR compatibility). The "reported device performance" is essentially that it functions as intended and is safe and effective.
| Characteristic Category | Acceptance Criteria (Implied) | Reported Device Performance | Discussion/Evidence (from the document) |
|---|---|---|---|
| Intended Use | Equivalent to predicate (injection/aspiration of fluids in ventricles). | Injection of Cytarabine or removal of CSF from ventricles. | Equivalent to predicate, validated using Cytarabine and primate CSF. |
| MR Compatibility | Safe in 1.5T MRI environment. | Safe in 1.5T MRI environment. Device is MR Compatible/MR Safe. | Designed for MR environment; not restricted to non-MRI environment. Predicate is not indicated for MR environments. |
| Material/Rigidity | Sufficiently rigid to pass through brain tissue. | Sufficiently rigid to pass through brain tissue. | Uses ceramic (VC) vs stainless steel (predicate); both rigid. |
| Fluid Movement | Contains a channel for fluid removal/placement. | Contains a channel for fluid removal/placement. | Equivalent to predicate. |
| Flow Rate | Capability to move fluids (differs due to diameter) | Flow rate of 0.3 ml/hr (0.008" I.D.) to 25.0 ml/hr (0.021" I.D.) at 0.7 PSI. | Both devices moving fluids; different flow rates result from different diameters. VC provides flow vs. pressure tables (additional information). |
| Biocompatibility | Meet ISO 10993 for tissue contact. | Tissue contact tested per ISO 10993: Biological Evaluation of Medical Devices with acceptable results. | Equivalent to predicate (presumed). |
| Sterility | Sterilized. | Yes, per ANSI/AAMI/ISO 11137-2. | Supplied sterile. Predicate is provided non-sterile and sterilized on-site, but both achieve sterility. |
| Mechanical Safety | Safe for intended use. | Performance Testing Bench, including design verification testing, comparison testing with the predicate Adson Cannula, pressure withstand testing and injection/aspiration testing, lateral tip deflection testing, transit testing in conformance to D4169 and accelerated aging testing. acceptable results. | Equivalent to predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is bench testing, not a clinical study on human subjects where patient data provenance would be relevant.
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 medical device, not an AI/ML diagnostic algorithm requiring expert-established ground truth from images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.
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 a medical device, not an AI/ML diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, "ground truth" is established through engineering and materials testing, demonstrating that the device physically performs as intended and meets safety standards. For example:
- Biocompatibility: In vitro and in vivo (animal) studies to confirm material safety, assessed against ISO 10993 standards.
- Performance (flow rates, rigidity): Bench testing using simulated conditions and fluids (e.g., Cytarabine, primate CSF).
- MR Compatibility: Physical testing of the device in an MRI environment to confirm safety (e.g., no excessive heating, no significant image artifact).
8. The sample size for the training set
Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.
Summary of the Study/Testing that Proves the Device Meets Acceptance Criteria:
The document describes several types of testing performed to demonstrate the device's safety, effectiveness, and substantial equivalence to the predicate device:
- Sterilization and Shelf Life Testing: Validation using the VDmax25 procedure of ISO 11137-2 to ensure the device remains sterile and functional over its shelf life.
- Biocompatibility Testing: Conducted per ISO 10993 (Biological Evaluation of Medical Devices), including cytotoxicity, material mediated pyrogen, ISO maximization study, intracutaneous toxicity, and systemic toxicity. All tests yielded acceptable results.
- Performance Testing Bench:
- Design verification testing.
- Comparison testing with the predicate Adson Cannula.
- Pressure withstand testing.
- Injection/aspiration testing.
- Lateral tip deflection testing.
- Transit testing in conformance to D4169.
- Accelerated aging testing.
- Cytarabine Injection and Primate CSF Aspiration Testing: Completed with acceptable results, validating the device's intended use with specific fluids.
- MR Compatibility Testing: The device is stated to be "Safe in a 1.5T MRI environment" and "MRI Safe. All brain contacting components tested safe in a 1.5T environment."
The conclusion from these tests was that the "MR Compatible Ventricular Cannula functions as intended and is substantially equivalent to legally marketed predicate device." The differences in design (e.g., single-patient use, MR compatibility, different materials, longer rigid section, no stylet, integral extension) are noted to "meet the needs of the MR work environment and do not represent changes that effect the safety or effectiveness of the device."
§ 882.4060 Ventricular cannula.
(a)
Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.