(144 days)
The MR Compatible Aspiration System is used for controlled aspiration of blood, cystic components of tumors, abscess, colloid cysts, and cerebrospinal fluid using a manual syringe during surgery of the Ventricle System or Cerebrum.
The MCA Kit is an accessory to the cleared ClearPoint System (K171257). The MCA Kit consists of a MCA device guide, guide sheath, stylet, depth stops, cannula (with attached tube) and adapter. The MCA Kit is designed to aid a physician in the removal of specific tissue or fluid types from the brain during image guided surgery. It is MR safe, as all materials are non-metallic. The MCA Kit is comprised of single use only, sterile-packaged disposable components that are packaged together.
The provided document describes the MRI Interventions, Inc.'s MR Compatible Aspiration Kit (MCA Kit) and the studies performed to demonstrate its substantial equivalence to a predicate device, the Penumbra Apollo System (K152699).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy Testing | Mean error below 2.0mm and mean angular error below 2.0° for a stereotaxic device intended for general neurological use. | Mean error below 1.0mm, with the highest standard deviation being 0.75mm (X direction) and highest 99% upper confidence limit of 1.48mm (X direction). Mean angular error below 1°, with a standard deviation of 0.34° and 99% upper confidence limit of 0.72°. |
| MCA-Kit Device Guide – SmartFrame XG Compatibility | Not explicitly stated but implied: Compatibility between the device guide and SmartFrame XG, including secure insertion and retention, stability under loading, and maintained accuracy. | All acceptance criteria were met to demonstrate that the MCA Kit components are compatible with the cleared ClearPoint System SmartFrame XG. |
| Flow and Leak Testing | Device must be able to aspirate at least 10cc of various simulated materials without leaking or collapsing and at an acceptable flow rate. | The tests demonstrated that the MCA Kit functions as intended and is substantially equivalent to the legally marketed predicate. |
| Aspiration Test | Device must remain operable for a limited period of time at 29.0 inHg without collapsing, leaking, or failing. Minimal change in inner diameter (I.D.). | All Cannulas tested were able to withstand collapsing, leaking, or failing at a minimum aspiration pressure of 29.0 inHg. Measured change in Rigid section I.D.: 0.0% (12 Fr.), 0.8% (16 Fr.). Measured change in flexible Tubing I.D.: 1.3% (12 Fr.), 2.9% (16 Fr.). |
Note: The document sometimes indirectly states the "acceptance criteria" by describing what the results demonstrated/met. For the "Flow and Leak Testing" and "MCA-Kit Device–SmartFrame XG Compatibility," the specific numerical acceptance criteria were not explicitly detailed in the provided text, but the document states they were met.
2. Sample Size Used for the Test Set and Data Provenance
- Accuracy Testing: The specific numerical sample size (number of placements) for the accuracy test is not explicitly stated. It mentions that "Placements were performed using the 12 Fr x 30 cm and 16 Fr x 30 cm MCA Kits," representing the smallest and largest outer diameter sizes. However, the total number of repetitions or distinct placements is not given.
- MCA-Kit Device Guide – SmartFrame XG Compatibility: Not specified.
- Flow and Leak Testing: Not specified.
- Aspiration Test: "Twelve Fr. and 16 Fr. Cannulas that have undergone worst-case conditioning were used for this test." The exact number of cannulas tested is not specified beyond indicating both sizes were used.
Data Provenance: This was a bench testing study, not involving human subjects. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical clinical sense. The data was generated through controlled laboratory experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a mechanical instrument (aspiration kit). The ground truth for its performance (e.g., accuracy, flow, leak, aspiration capacity) was established via engineering measurements and predefined physical/mechanical standards, not by expert medical interpretations.
4. Adjudication Method for the Test Set
Not applicable. As this was bench testing based on physical measurements and predefined criteria, there was no need for expert adjudication of results.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is an aspiration kit, not an imaging or diagnostic device that relies on human reader interpretation. The effectiveness studies focused on the physical performance of the device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, the studies described are standalone performance tests of the device itself (e.g., accuracy, flow, aspiration), without human interaction as part of the measured performance metric, although human operators would have performed the tests. The device does not involve an algorithm.
7. Type of Ground Truth Used
The ground truth used was based on:
- Predefined engineering specifications and limits (e.g., 2mm and 2° accuracy limits for stereotaxic devices).
- Quantitative physical measurements (e.g., mean error in mm, angular error in degrees, aspiration pressure in inHg, change in inner diameter in percentage).
- Qualitative observations of physical integrity (e.g., "without leaking or collapsing," "remains undamaged").
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or artificial intelligence, so there is no training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).