(29 days)
The Hermetic Plus™ External CSF Drainage System is indicated for draining and monitoring of cerebrospinal fluid (CSF) from the lateral ventricles of the brain or lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), monitor intracranial pressure, to monitor cerebrospinal fluid, and provide temporary CSF drainage for patients with infected hydrocephalic shunts.
The Hermetic Plus™ External Drainage 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. 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. 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. The antimicrobial vent used on the Hermetic Plus™ systems will allow better drainage of the CSF to the drainage bag and will resist occlusion after contact with CSF without the need for clamping the burette vent tube. The Safety Locking Knob of the Hermetic Plus™ system will now contain a titanium screw component and the cord lock of the suspension cord has been changed to an all plastic component.
The provided 510(k) summary for the Hermetic Plus™ External CSF Drainage System (K030289) focuses on demonstrating substantial equivalence to a predicate device through modifications that do not affect the intended use or fundamental scientific technology, and do not raise new safety or effectiveness issues.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Maintain functional and intended use equivalence to predicate (K972994). | "The Hermetic Plus™ External CSF Drainage System is substantially equivalent in function and intended use to the unmodified External CSF Drainage and Management Systems which has been cleared to market under Premarket Notification 510(k) K972994." |
| MR Safety: Device should be safe for use in an MR environment. | "The Hermetic Plus™ External CSF Drainage Systems have been demonstrated to be MR safe* when used in the Magnetic Resonance (MR) environment." (Definition of MR safe provided). |
| Antimicrobial Vent Occlusion Resistance: The antimicrobial vent should resist occlusion after fluid exposure. | "Testing has shown that the antimicrobial vent is resistant to occlusion after 30 minutes of exposure to fluids with high protein levels." |
| Strength of Bonded Components: Components must maintain integrity. | "The systems have been tested for strength of bonded components..." |
| Leakage: The system must not leak. | "...leakage..." |
| Drainage: The system must effectively drain CSF. | "...drainage..." |
| Package Integrity: The packaging must maintain sterility and integrity. | "...and package integrity." |
| Reduction of Needlestick Injuries: Needleless sampling sites should reduce risk. | "Additionally, the needleless sampling sites were designed to reduce needlestick injuries and subsequent exposure to infected fluids." |
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 provide information on the sample size used for any test set or the data provenance. The described tests (MR safety, vent occlusion, strength, leakage, drainage, package integrity) appear to be bench testing or in-vitro tests, rather than clinical studies with human subjects.
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)
This information is not applicable or not provided. The "tests" described appear to be engineering or laboratory-based, not clinical evaluations requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided. Adjudication methods are typically used in clinical studies with human expert readers, which is not described here.
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 MRMC comparative effectiveness study was done, as this device is not an AI-powered diagnostic tool. It is a CSF drainage system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done, as this device is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the tests described:
- MR Safety: Ground truth would be established by specific MR environment test protocols and measurements.
- Antimicrobial Vent Occlusion Resistance, Strength of Bonded Components, Leakage, Drainage, and Package Integrity: Ground truth would be established by engineering specifications, validated test methods, and quantitative measurements.
8. The sample size for the training set
This information is not applicable. This is a physical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
Overall Study Description:
The provided document describes a technical performance and safety study (or series of studies) focused on demonstrating that specific modifications to an existing CSF drainage system do not compromise its safety, effectiveness, or functional equivalence to a previously cleared predicate device. These studies are primarily bench tests or in-vitro tests, rather than clinical trials. The modifications involved a change in an antimicrobial vent material, a titanium screw component in a safety locking knob, and an all-plastic cord lock. The studies aimed to confirm that these changes did not introduce new risks or negatively affect established performance characteristics like drainage efficiency, structural integrity, and MR safety. The primary "study" is the demonstration of substantial equivalence to an existing cleared device (K972994) based on these technical performance assessments.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).