Search Results

The use of a Hummingbird HUMV-500 or HUMV-500MR 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, when data from one or more parameters may be deemed useful in providing optimum patient management and, in the case of the Hummingbird-500MR, when an MRI may be indicated.

The MPS catheter has three lumens, a drainage lumen, a thermocouple lumen and an air column lumen. An MPS catheter has a thin-wall tube termed the cage attached to its distal end. The cage holds the pressure-sensing bladder and provides the inlet holes through which CSF enters the catheter. The Continuous Pressure model eliminates the affect of clogged intet holes on the ICP reading by inserting a partition into the cage that separates cage into two compartments, an upper compartment for the sensing bladder and a lower compartment for CSF inflow. A transfer tube passing through the bladder compartment conveys CSF from the inflow compartment to the drainage lumen of the catheter. The manifold of the approved device has two probe ports. The diameter of one of the ports has been increased to allow the passage of either a flow or dialysis probe. The distal body of the manifold has been extended 1 cm to both accommodate the diameter change and improve the distal end profile for insertion into the brain. The thermocouple of the MRI Conditional catheters has been placed in a removable probe. The probe is removed prior to an MRI and replaced after. The temperature probe is placed in a polyimide tube that has been inserted into a dedicated lumen in the catheter.

This document pertains to a 510(k) premarket notification for a medical device, specifically the InnerSpace Hummingbird HUMV-500 and HUMV-500MR, which are intracranial pressure monitoring devices. It is a submission to the FDA for market clearance and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML performance evaluation.

The document describes modifications to existing predicate devices and ensures the safety and effectiveness of the new models through comparison to predicate devices and testing related to MRI compatibility and physical properties. It does not involve a study with acceptance criteria in the context of diagnostic or classification performance metrics (e.g., sensitivity, specificity, AUC) that would be applicable to AI/ML devices.

Therefore, many of the requested fields cannot be populated as they are related to performance studies of AI/ML algorithms, which are not present in this regulatory submission.

Here is an attempt to address the request based only on the provided text, while acknowledging the limitations for AI/ML related questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for a diagnostic device. Instead, the submission focuses on substantial equivalence to predicate devices. The "performance" reported relates to physical characteristics and compatibility.

• MPS 8.1 Fr: 3.46 x $10^{-3}$ Sq. in. (Camino Large 2: 1.96 x $10^{-3}$ Sq. in.)
• MPS 9.0 Fr: 4.91 x $10^{-3}$ Sq. in. (Camino Large 1: 2.37 x $10^{-3}$ Sq. in.)
  (MPS catheters have a larger drainage lumen due to polyurethane construction allowing thinner walls, compared to predicate silicone catheters.)

Manifold Port Diameters:

• Modified Device Port 1: .056" (Same as Approved device Port 1)
• Modified Device Port 2: .063" (Larger than Approved device Port 2: .056")
  (Port 2 enlarged to accommodate larger flow/dialysis probes.) |
  | Material Strength | Catheter body made of polyurethane, which is "stronger than silicone." |
  | Continuous Pressure | New "Continuous Pressure" model has a modified cage design with a partition to isolate the sensing bladder from pressure changes due to clogged inlet holes, eliminating the need to stop CSF drainage for true ICP reading. |
  | MRI Compatibility | Hummingbird HUMV-500MR:
• Thermocouple placed in a removable probe to be removed prior to MRI.
• Bolted component (HUMV-500MR) found to be "MR Conditional" as defined by ASTM F2503 using 1.5T and 3.0T MR systems.
  (Catheter and manifold are plastic and MRI safe without the probe.) |
  | Indications for Use | Substantially equivalent to predicate devices, used for direct measurement of intracranial pressure, CSF drainage, and relevant parameter monitoring, with additional indication for MRI compatibility for the -MR model. |

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 describes physical device characteristics and MRI compatibility testing, not performance on a "test set" of diagnostic data. The MRI testing for the bolt (ASTM F2503) would have involved specific test methods and conditions but not a "sample size" in the context of data points for AI/ML evaluation.

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 not an AI/ML device requiring expert ground truth for a diagnostic test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device evaluation.

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-assisted diagnostic device.

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. Ground truth, in the context of AI/ML, refers to definitively correct labels for data. For this device, "ground truth" would be the physical properties measured against engineering specifications or established standards (e.g., ASTM F2503 for MRI compatibility).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that undergoes a "training set."

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device