(106 days)
Both the OSV II Lumbar Valve System and the OSV II Low Flow Lumbar Valve System are indicated as implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.
The OSV II® Lumbar Valve System (OSV II Valve) and the OSV II® Low Flow Lumbar Valve System (OSV II Low Flow Valve) are implantable devices for controlled cerebrospinal fluid drainage (CSF) from the lumbar subarachnoid region to the peritoneal cavity. Unlike conventional valves, they are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure. They maintain a drainage rate around 20ml/hr for OSV II Valves and around 10ml/hr for OSV II Low Flow Valves.
The OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are provided with accessories including a 14G tuohy needle, a F5 lumbar catheter, a guidewire, a luer lock connector and a F8-F5 stepdown connector, which are required for using the valves in a lumbar approach. The designs of the accessories are identical to the accessories currently provided with the Integra H-V Lumbar Valve System.
Here's an analysis based on the provided text, outlining the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain explicit acceptance criteria in the form of a table or specific quantitative benchmarks set for the OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System in a clinical study for this 510(k) submission.
Instead, the submission for these devices relies on demonstrating substantial equivalence to previously cleared predicate devices. The performance specifications are stated as being "the same as the predicate valves" because the new devices are designed the same as existing ventricular approach valves but adapted for a lumbo-peritoneal approach.
However, the operating principles define specific flow rate ranges at different differential pressures. These could be considered intrinsic performance specifications verified during manufacturing.
| Performance Characteristic | Acceptance Criteria (Implied / Predicate Performance) | Reported Device Performance (Implied) |
|---|---|---|
| OSV II Lumbar Valve System | ||
| Flow rate at Stage I (Low DP) | ~5 ml/hr (DP 30-80 mm H2O) to 18 ml/hr (DP 40-120 mm H2O) | Meets the same specifications as the predicate OSV II valve |
| Flow rate at Stage II (Flow Regulation) | 18-30 ml/hr (DP 120-300 mm H2O) | Meets the same specifications as the predicate OSV II valve |
| OSV II Low Flow Lumbar Valve System | ||
| Flow rate at Stage I (Low DP) | ~5 ml/hr (DP 30-80 mm H2O) to 8 ml/hr (DP 40-120 mm H2O) | Meets the same specifications as the predicate Integra NPH Low Flow valve |
| Flow rate at Stage II (Flow Regulation) | 8-17 ml/hr (DP 120-300 mm H2O) | Meets the same specifications as the predicate Integra NPH Low Flow valve |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "…supported by the clinical evidence included in this 510(k)…". However, it does not provide details on the sample size used for a specific clinical "test set" in this 510(k) submission. The submission primarily relies on demonstrating substantial equivalence to existing devices.
The text does not specify the country of origin of any data, if clinical data were used, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. The submission focuses on device design, materials, and equivalence to predicates, not on a clinical study that would require expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the given text, as no detailed clinical study with an adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for an implantable medical device (CSF shunt valves), not for an AI or diagnostic imaging device that typically undergoes MRMC studies to evaluate human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the device described. The OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are physical implantable medical devices, not algorithms or AI systems. Therefore, a "standalone algorithm performance" evaluation would not be relevant.
7. The Type of Ground Truth Used
The primary "ground truth" for this 510(k) submission appears to be the established performance and safety profiles of the legally marketed predicate devices. The new devices are being cleared based on their substantial equivalence (same design, materials, principle of operation, and performance specifications) to these existing predicate devices (K971799, K081773, K042192 for the valves, and K944595 for the accessories).
Direct clinical outcomes data for the new devices for this specific 510(k) seem to be a supportive element rather than the primary ground truth for novel performance.
8. The Sample Size for the Training Set
This information is not applicable as the devices are physical medical devices, not algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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).