(83 days)
The major indication for use of the External CSF Drainage Management Systems is the management of hydrocephalic shunt infections. If an internal shunt is not indicated, treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring may also require external drainage to control increased intracranial pressure.
External CSF Drainage Management Systems
This 510(k) submission (K972994) for the Heyer-Schulte NeuroCare External CSF Drainage Management Systems does not contain a study demonstrating the device meets specific acceptance criteria in the format typically seen for AI/ML devices. Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that instead of conducting new performance studies, the manufacturer argues that their device is safe and effective because it is similar to devices already legally marketed.
Therefore, many of the requested categories for a study proving acceptance criteria are not directly applicable or reported in this document.
Here's a breakdown based on the provided text, heavily emphasizing the substantial equivalence argument:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Efficacy (for intended use) | Demonstrated through substantial equivalence to predicate devices: |
| - Heyer-Schulte Hermetic External CSF Drainage System (K864676A, approved 1982) | |
| - P-S Medical Becker External Drainage and Monitoring System | |
| - Codman External Drainage System II | |
| - Heyer-Schulte/Camino Ventricular Drainage System (K932769) | |
| Functionality | Substantially equivalent to predicate devices. |
| Design | Substantially equivalent to predicate devices. |
| Placement | Substantially equivalent to predicate devices. |
| Use | Substantially equivalent to predicate devices. |
| Clinical History | Years of clinical history with external drainage systems manufactured from the same materials as the predicate device (K864676A). |
| Proper Placement for Intracranial Pressure Control | Critical, controlled by height of the system; changes only by qualified personnel on physician orders. |
| Drug Compatibility | Not tested; not intended for drug administration. |
Explanation for Absence of Direct Performance Metrics:
The document explicitly states: "The determination of safety and efficacy for the Heyer-Schulte NeuroCare External CSF Drainage Management Systems is based on years of clinical history with external drainage systems manufactured from the same materials beginning with the Heyer-Schulte Hermetic External CSF Drainage System (K864676A)..." and "Heyer-Schulte NeuroCare determines substantial equivalence and safety and efficacy of the Hever-Schulte NeuroCare External CSF Drainage Management Systems based on predicate and currently marketed devices as noted in the summary above."
This indicates that a direct, new performance study with specific quantifiable acceptance criteria for this particular device was not conducted or submitted as part of this 510(k). Instead, the argument is that because the device is functionally, materially, and operationally similar to already approved devices, it can be presumed to meet similar safety and efficacy standards.
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 (N/A) / Not reported. This information is not present because a dedicated "test set" and a study to evaluate performance against specific acceptance criteria were not part of this 510(k) submission. The reliance is on the equivalence to existing devices' performance and clinical history.
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)
- N/A / Not reported. The concept of "ground truth" as it pertains to a new performance study's test set is not relevant here due to the substantial equivalence pathway chosen.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A / Not reported. This relates to performance studies that are not described in the submission.
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. This is a medical device for CSF drainage, not an AI/ML diagnostic tool involving human readers. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Historical clinical outcomes of predicate devices. The "ground truth," in an indirect sense, is derived from the established safety and efficacy profiles and long-term clinical use of the predicate devices. The submission leverages this existing "truth" rather than establishing a new one for this specific device.
8. The sample size for the training set
- N/A / Not reported. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- N/A / Not reported. As above, not an AI/ML algorithm.
§ 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).