(237 days)
The use of MPS (or MPS-T) by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care and when data from a second or third parameter may be deemed useful in optimum patient management.
MPS- Oxiport is a system capable of draining CSF, sensing ICP and receiving two monitoring probes such as oxygen or temperature. MPS stands for Multiple Parameter System. The system consists of bolt, a bolt insert and a ventricular catheter. A slidable insert is common on the catheter at the factory. After the catheter is situated in a ventricle, the insert is moved down the catheter and into the throat of the bolt. The insert has an o-ring that forms a seal with the bolt. It also has two guide tubes. The guide tubes allow the surgeon to place probes such as an oxygen or temperature sensor in the insert has a fixation element that joins the insert to the bolt and three pigtails with Toughy-Borst fittings to fix the monitoring probes and the ventricular catheter to the insert.
The provided document is a 510(k) premarket notification for the MPS-Oxiport device, which is an intracranial pressure (ICP) monitoring device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data to prove performance against specific acceptance criteria.
Therefore, the document does not contain a detailed study proving the device meets acceptance criteria in the way one would expect for a more complex or novel device requiring rigorous clinical validation. Instead, it relies on demonstrating that its characteristics are similar enough to existing, legally marketed devices.
Here's an analysis based on the information provided, highlighting the absence of some requested elements due to the nature of a 510(k) submission for a substantially equivalent device:
1. A table of acceptance criteria and the reported device performance
This document does not present a formal table of "acceptance criteria" and "reported device performance" with quantitative metrics (e.g., accuracy, precision) as would be found in a clinical study report for a new device. Instead, it compares the device's characteristics to predicate devices to demonstrate equivalence.
| Characteristic | Predicate Device (ACT II/III or Licox) | MPS-Oxiport (submitted device) | Comparison for Equivalence (Implicit "Acceptance") |
|---|---|---|---|
| Bolt diameter | 0.250" | 0.250" | Equivalent |
| Bolt material | Polycarbonate | Titanium | Different, but likely deemed equivalent in function |
| Skull Attachment | Ribs | Screw thread | Different, but likely deemed equivalent in function |
| Catheter OD | 3.3 mm (ACT III) | 2.25 mm | Smaller, but noted as similar in system |
| Sensor length | 9 mm (ACT II) | 37 mm | Different length, but bladder volume unchanged, and diameter decreased, length increased - implies functional equivalence maintained |
| Pressure catheter bladder | Butyl (ACT III) | Butyl | Equivalent |
| Depth of bladder in brain | 6-8 cm (ACT III) | 6-8 cm | Equivalent |
| Probe guide diameter | 1.3 mm (Licox 765) | 1.3 mm | Equivalent |
| Probe guide length | Extends from top of cap to distal end of bolt (ACT II) / Extends beyond dura (Licox) | Extends 3 mm beyond the distal end of bolt (Polyimide) | Different in material/extent, but compared to Licox guides which also extend beyond dura. Implicitly deemed equivalent in function for guiding probes to undisturbed tissue. |
| Ventricular Catheter Length | 9" (ACT II) | 9" | Equivalent |
| Ventricular Catheter OD | 10 Fr (ACT III) | 7.5 mm (smaller diameter) | Different, but noted as similar in system |
| Drainage lumen ID | 1.8 mm² (ACT III) | 1.6 mm² | Smaller, but assumed to maintain drain capability |
| Catheter material | Tecoflex (ACT III) | Tecoflex | Equivalent |
| Depth of catheter in brain | 6-8 cm (ACT II/III) | 6-8 cm | Equivalent |
| Compatible probe diameter | 0.7 to 0.9 mm (ACT II) | 0.7 to 0.9 mm | Equivalent |
The "acceptance criteria" here are implicitly that the MPS-Oxiport device's characteristics are sufficiently similar to the predicate devices or that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is the description of the MPS-Oxiport's physical and functional characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not describe a clinical study with a test set of patients/data to evaluate algorithmic performance. It's a medical device submission based on substantial equivalence to existing devices, relying on engineering comparison and functional descriptions rather than clinical data from a "test set."
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. There is no "test set" of data requiring expert-established ground truth in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no "test set" of data requiring adjudication in this submission.
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
- No. This is not an AI-assisted device, nor does the submission describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth data (in a clinical study sense) is presented as the basis for device validation. The "ground truth" for the submission is the established safety and effectiveness of the existing predicate devices.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or associated ground truth.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).