(30 days)
The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
The ventricular catheter is a part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for removal of excess CSF.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Miethke Shunt System. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices. However, the document explicitly states, "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Miethke Shunt System conforms to applicable ASTM and ISO standards."
This crucial statement indicates that
- No specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy) were required or defined for this device in the context of this 510(k) submission. The regulatory pathway here is substantial equivalence, meaning the device is compared to existing legally marketed devices, not assessed against novel performance benchmarks derived from clinical studies.
- No study proving the device meets performance-based acceptance criteria is presented. The "performance data" section only mentions conformity to ASTM and ISO standards, which are related to manufacturing, materials, and mechanical aspects, not clinical efficacy or diagnostic accuracy.
Therefore, many of the requested items cannot be answered from the provided text because they pertain to a type of performance study (e.g., comparative effectiveness, standalone algorithm performance, clinical validation with ground truth) that was not conducted or required for this 510(k) clearance based on substantial equivalence.
Here's an attempt to fill in as much as possible based on the given information, with explanations for what cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Regulatory | Substantial equivalence to predicate devices (J & J Hakim Micro Programmable Valve System (K980778), Heyer-Schulte Novus (K961859), P/S Medtronic Bulton (K911410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating Accessory (K932429), and the Cordis NMT Hakim Standard/Pediatric Valves (K861377)). | The Aesculap Miethke Shunt System is stated to be "essentially identical" to the listed predicate devices. This claim was accepted by the FDA for clearance (K020728). |
| Standards Conformity | Conformity to applicable ASTM and ISO standards. | The new Miethke Shunt System "conforms to applicable ASTM and ISO standards." (Specific standards are not enumerated, but general conformity is asserted). |
| Clinical Performance | (No specific clinical performance standards (e.g., success rates, complication rates relative to a benchmark) were promulgated or required for this 510(k) submission.) | (No clinical performance metrics are reported in this document beyond the claim of substantial equivalence to predicate devices for its intended use.) |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. No specific test set for evaluating device performance against clinical outcomes or diagnostic accuracy was used or reported in this 510(k) summary. The clearance was based on substantial equivalence to existing devices and conformity to design/manufacturing standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. No test set requiring ground truth establishment by experts was part of this submission for performance evaluation.
4. Adjudication method for the test set
- Not applicable / Not provided. No test set requiring adjudication was part of this submission. The regulatory pathway focused on technical and design equivalence.
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 cerebrospinal fluid shunt system, not an AI-assisted diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware medical device (shunt system), not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant and was not assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical ground truth was established for a performance study in this 510(k) submission. The basis for clearance was a comparison of device characteristics and intended use to predicate devices, and conformity to relevant engineering standards.
8. The sample size for the training set
- Not applicable / Not provided. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. Not relevant for this type of device.
§ 882.4100 Ventricular catheter.
(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).