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The catheter is used for cerebrospinal fluid (CSF) shunting.

The ventricular catheter is part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for shunting of excessive CSF.

The ventricular catheter will be offered in lengths of 18 cm or 25 cm with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. The ventricular catheter contains five stripe depth markers at 3, 5, 7, 10 and 13 cm from the catheter tip. The ventricular catheter is manufactured using barium sulfate filled silicone elastomer.

The purpose of this submission is to seek clearance for modifications to the ventricular catheter which is part of the Miethke Shunt System (K020728). This submission proposes the following modification:

• adding stripe depth markers at 4, 6, 8, 9, 11 and 12 cm and point markers at 1 cm intervals on both sides of the tubing starting at 3.5 cm to 12.5 cm from the catheter tip.

The ventricular catheter is designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System, Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System, proSA Progammable Shunt System, Miethke Shunt System miniNAV valve, Miethke Shunt System Gravity Assisted Valve (GAV), and the Miethke Shunt System (DSV, ShuntAssistant, paedi-GAV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K120559/K110206/K103003/K062009/K031303/ K030698/K011030).

The provided text is a 510(k) summary for the Miethke Ventricular Catheter, which addresses a modification to an existing device rather than a new AI-powered diagnostic tool. Therefore, much of the requested information regarding AI study design, such as MRMC comparative effectiveness, standalone performance, training set details, and expert ground truth establishment, is not applicable to this document.

However, I can extract information related to the acceptance criteria and the study performed for this specific device, as it pertains to the physical catheter modification.

Here's the relevant information:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document mentions "All samples" in relation to meeting acceptance criteria, implying a test set was used, but the exact number is not provided.
• Data Provenance: Not explicitly stated, but it is implied to be from non-clinical laboratory performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This device is a physical medical device (catheter) and the testing performed relates to its physical properties (radiopacity) rather than diagnostic accuracy requiring expert interpretation for ground truth.

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

• Not Applicable. As mentioned above, this testing does not involve human interpretation or adjudication in the context of diagnostic accuracy.

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 physical medical device, not an AI-powered diagnostic tool.

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 AI-powered diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the radiopacity testing, the "ground truth" would be established by the physical measurements and standards defined in the ASTM F 640-12 standard test methods. This is an objective measurement rather than a subjective interpretation requiring expert consensus or pathology.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI algorithm.

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

• Not Applicable. There is no training set for this type of device.

Study Details:

• Study performed: Non-clinical laboratory performance testing.
• Standard used: ASTM F 640-12 standard test methods for determining radiopacity for Medical Use.
• Purpose: To demonstrate that the modification (additional depth markers) to the ventricular catheter maintains its intended performance, particularly regarding radiopacity, and is substantially equivalent to the predicate device.

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The probes kits are intended for extravascular monitoring of microcirculation blood flow in buried tissues, specifically, in monitoring cerebral blood flow in patients at risk of cerebral ischemia.

The Ventraflo Catheter/Probe is a standard ventricular catheter with a laser Doppler blood perfusion probe embedded into the side wall of the Catheter. So when the catheter is placed within a brain ventrical the clinician will be able to use the catheter as a CSF drain . measure intracranial ventricular pressure. If connected to an external transducer and measure parenchymal blood flow simultaneously.

This 510(k) submission for the Vasamedics Ventraflo Blood Flow Monitoring Probe Kits is primarily focused on demonstrating substantial equivalence to predicate devices for its design, materials, and sterilization methods. It does not include a study that details acceptance criteria and device performance in the way typically expected for a software or AI-driven diagnostic device.

Therefore, many of the requested sections (1-9) cannot be filled with relevant information from the provided text, as the document does not describe a clinical performance study with acceptance criteria for device accuracy or effectiveness in measuring blood flow.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

Summary of Device and 510(k) Approach:

The Ventraflo Ventricular Catheter/Probe kit is a combination device. It integrates a laser Doppler blood perfusion probe into a standard ventricular catheter.

• Purpose: To allow simultaneous CSF drainage, intracranial ventricular pressure measurement, and parenchymal blood flow measurement (using the embedded probe).
• Predicate Device Strategy: The submission argues for substantial equivalence by breaking down the device into its components:
  • Laser Doppler Probe: Equivalent to Vasamedics' SUPR-434 Blunt Needle Probe (previously cleared in K951832).
  • Ventricular Catheter & Accessories: Equivalent to PS Medical "Becker Ventricular Catheter" and "PS Medical Ventriculostomy Kit" (products already in commercial distribution).
• Key Focus: Biocompatibility validation and sterilization validation are explicitly mentioned as crucial aspects of this submission, ensuring the new combined device is safe for human use.

Detailed Breakdown of Requested Information (Based on the Provided Text):

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

   • Not provided. The document does not describe any specific performance metrics (e.g., accuracy, sensitivity, specificity for blood flow measurement) or their corresponding acceptance criteria. The equivalence argument is based on the components having been cleared previously.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not provided. There is no performance study described that would involve a test set of data.

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. No test set or ground truth establishment relevant to device performance (e.g., blood flow measurement accuracy) is described.

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

   • Not applicable. No test set or related adjudication method is described.

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 device is a measurement tool, not an AI-assisted diagnostic. No MRMC study is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This is a physical medical device (catheter with an embedded probe) used to measure blood flow, not a standalone algorithm. Its performance relies on the physics of laser Doppler measurements, not computational algorithms in the AI sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable. As no performance study with ground truth for blood flow measurement is detailed, this information is not present. The "ground truth" for this 510(k) is primarily that the individual components (probe, catheter, accessories) have established safety and performance records or are substantially equivalent to marketed devices.

8. The sample size for the training set

   • Not applicable. No training set is mentioned as this is not a machine learning/AI device.

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

   • Not applicable. No training set or ground truth establishment for a training set is mentioned.

Key Information from the Document that IS Provided:

• Intended Use: Extravascular monitoring of microcirculation blood flow in buried tissues, specifically, cerebral blood flow in patients at risk of cerebral ischemia.
• Biocompatibility: Materials are biocompatible. The probe part is equivalent to the Vasamedics SUPR-434 (Trimflo) probes (K951832). The ventricular catheter is silicone. All accessories are standard neurosurgery items.
• Sterilization: ETO sterilization, validated per AAMI guidelines using an overkill method to a sterility assurance level (SAL) of at least 1 x 10^-4. Residual levels target FDA 1978 guidelines.
• Predicate Devices:
  • Laser Doppler Probe: Vasamedics' SUPR-434 Single use Blunt Needle Probe (K951832).
  • Kit accessories and ventricular catheter: PS Medical "Becker Ventricular Catheter" and "PS Medical Ventriculostomy Kit".

In conclusion, this 510(k) submission relies on the substantial equivalence of its components to previously cleared devices, particularly for safety and efficacy in terms of material compatibility and sterilization. It does not present a new clinical performance study for the integrated device with specific acceptance criteria for blood flow measurement.

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The Ventricular Catheter Set is used to obtain access to a ventricular cavity of the brain to drain fluid externally for the purpose of relieving elevated intracranial pressure or fluid volume.

The Ventricular Catheter Set is used to obtain access to a ventricular cavity of the brain to drain fluid externally for the purpose of relieving elevated intracranial pressure or fluid volume. The device is supplied sterile and is intended for one-time use. The materials comprising the device have an established history of use in medical product manufacturing.

This document (K962097) is a 510(k) summary for a Ventricular Catheter Set. It describes the device, its intended use, and its substantial equivalence to predicate devices.

However, a crucial piece of information is missing: the entire section outlining the acceptance criteria and the study proving the device meets those criteria. The provided text only includes the administrative and descriptive parts of the 510(k) summary.

Therefore, I cannot provide the requested information in the format specified because the core information about testing, acceptance criteria, and study details is not present in the provided snippet.

To answer your request, I would need a section of the 510(k) summary that details:

• Performance testing conducted (e.g., mechanical testing, biocompatibility, sterility, flow rates).
• Specific acceptance criteria for each test.
• Results from those tests.
• Protocols for how those results were obtained.

Without that, I can only state what the document does provide, which is not what you asked for regarding acceptance criteria and study details.

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