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The MoniTorr ICP™ External CSF Drainage and Monitoring Systems allow for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.

The Integra Pole Mount Assemblies are utilized with the MoniTorr ICP™ External Drainage and Monitoring Systems to provide support and alignment on an I.V. Pole.

The Integra Pole Mount Assembly has been modified to include a line level and a laser level. The MoniTorr ICP™ External CSF Drainage and Monitoring Systems can be used with a pole mount assembly. The Integra Pole Mount Assemblies are designed provide support and alignment to the MoniTorr ICP™ External CSF Drainage and Monitoring Systems on an I.V. Pole. The Integra Pole Mount Assemblies are designed to be reusable. The reusable Integra Pole Mount Assembly is comprised of a graduated rail with a grooved profile to support the sliding bracket which facilitates setting the pressure level while using the disposable external drainage system. The Pole Mount Assembly is aligned with the patient's anatomical reference point by using a pointer, line level or laser.

The MoniTorr ICP™ External CSF Drainage and Monitoring Systems are designed to externally drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space to a drainage bag in selected patients. The systems connect to a ventricular or lumbar catheter via a luer connection to a patient line and ultimately to a drainage bag. In most of the systems, the patient line is connected to a graduated burette that is then connected to the drainage bag. CSF can be collected and measured in the burette and subsequently emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag. In systems with this burette, an antimicrobial vent is included in the burette cap. This antimicrobial vent allows air to enter the burette to facilitate drainage from the burette to the drainage bag while protecting the system from microbial contamination. These systems are designed for single use only.

This 510(k) pertains to a device modification for the Integra MoniTorr ICP™ External CSF Drainage and Monitoring Systems. The modification involves adding a line level and a laser level to the Integra Pole Mount Assembly, an accessory used with the drainage system. This submission claims substantial equivalence to previously cleared versions of the device (K920156 and K022554) and does not contain detailed information about specific acceptance criteria and performance studies in the provided text.

Based on the provided text, the device is a Class II medical device (Central Nervous System Shunt and Components JXG). For Class II devices modified through a Special 510(k), the focus is often on demonstrating that the modifications do not alter the fundamental safety and effectiveness of the device and that the new features (like the laser level) comply with relevant standards.

Here's an analysis based on the available information:

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

The provided document does not explicitly state quantitative acceptance criteria or detailed performance data for the MoniTorr ICP™ External CSF Drainage and Monitoring Systems or its modified pole mount assembly. The submission focuses on demonstrating compliance of the modified component (the laser level) with existing safety standards.

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

The document does not mention a test set with a specific sample size or data provenance for evaluating the performance of the MoniTorr ICP™ External CSF Drainage and Monitoring Systems or its modified pole mount assembly. This is an accessory modification submission, and testing likely focused on the modified component's compliance with safety standards rather than a clinical performance study.

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):

The document does not mention experts or ground truth establishment for a test set. This type of evaluation is not typical for a device modification focused on an accessory like a pole mount with a laser level, where the primary concern is the safe operation and compliance of the new feature.

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

The document does not mention any adjudication method for a test set, as no specific clinical test set 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:

This device is not an AI-powered diagnostic or interpretive system. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.

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

This device is a physical medical device for CSF drainage and monitoring, not an algorithm. Therefore, standalone algorithm performance is not applicable and was not done.

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

The concept of "ground truth" as typically applied to diagnostic or interpretive algorithms is not relevant for this physical device modification. The "truth" here would relate to the laser level accurately indicating alignment, and the device continuing to safely and effectively drain and monitor CSF as intended by the predicate devices.

8. The sample size for the training set:

As this is a physical device modification, not an AI or machine learning algorithm, there is no training set in the traditional sense.

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

Not applicable, as there is no training set for this type of device modification.

Summary of what the document does provide regarding safety and compliance:

The submission focuses on the safety and compliance of the added laser level on the Integra Pole Mount Assembly.

• The laser level is categorized as a Class II Laser and is stated to comply with 21 CFR 1040.10 and 1040.11, with deviations pursuant to Laser Notice No. 50 dated July 26, 2001.
• It is also stated to be "fully compliant with the following standards":
  • BS EN 60601-1-2 (1993)
  • EN 60601-1-2 (2003)
  • EN 61000-4-2 (1995)
  • EN 61000-4-3 (1996) above 1 GHz
  • EN 61000-4-8 (1993) in accordance with EN 60601-1-2 (2001)

These standards are related to medical electrical equipment, electromagnetic compatibility, and laser product safety. The "study" proving the device meets criteria in this context would be the testing and documentation demonstrating adherence to these specific regulatory and international standards for the laser component, along with a substantial equivalence argument for the overall device's continued safety and effectiveness with the modification. The 510(k) clearance itself (K062599) confirms that the FDA reviewed these claims and found the device substantially equivalent.

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