(175 days)
The Spinal Manometer NRFit/ Spinal Manometer LUER is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.
The Spinal Lumbar Puncture Manometer with either NRFit Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7. The manometer is considered a Class II medical device as defined in 21 CFR §880.2500, product code FMJ. The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to repackagers/ medical device manufacturers. Materials: PVC, Polycarbonate, HDPE. No patient contact.
Here's a breakdown of the acceptance criteria and the study information for the Spinal Manometer NRFit and Spinal Manometer LUER, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to recognized standards and internal protocols, with the reported performance being "Pass" for all tests.
| Acceptance Criteria / Test Detail | Standard / Protocol | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11135 | Pass |
| Residuals | ISO 10993-7 | Pass |
| Biocompatibility | ISO 10993-1 | Pass (based on no patient contact & sterilization/residuals validation) |
| Liquid Leakage (Luer) | ISO 80369-7, 6.1 | Pass |
| Air Leakage (Luer) | ISO 80369-7, 6.2 | Pass |
| Stress Cracking (Luer) | ISO 80369-7, 6.3 | Pass |
| Axial Load (Luer) | ISO 80369-7, 6.4 | Pass |
| Unscrewing torque (Luer) | ISO 80369-7, 6.5 | Pass |
| Overriding (Luer) | ISO 80369-7, 6.6 | Pass |
| Liquid Leakage (NRFit) | ISO 80369-6, 6.1 | Pass |
| Air Leakage (NRFit) | ISO 80369-6, 6.2 | Pass |
| Stress Cracking (NRFit) | ISO 80369-6, 6.3 | Pass |
| Axial Load (NRFit) | ISO 80369-6, 6.4 | Pass |
| Unscrewing torque (NRFit) | ISO 80369-6, 6.5 | Pass |
| Overriding (NRFit) | ISO 80369-6, 6.6 | Pass |
| Accuracy of Markings | Internal protocol | Pass |
| Durability of Markings | Internal Protocol | Pass |
| Stability of Glue Connection | Internal Protocol | Pass |
| Compatibility LUER | Internal Protocol | Pass |
| Compatibility NRFit | Internal Protocol | Pass |
| Batch Inspection report | Internal Protocol | Pass |
| Sterility Assurance Level (SAL) | 10^-6 | Met |
| Ethylene Oxide (EtO) Residuals | 25 ppm | Met |
| Ethylene Chlorhydrine (ECH) Residuals | 25 ppm | Met |
| Pyroburden/Endotoxin | 0.06 EU/ml and 2.15 EU/device | Met |
| Shelf Life Performance | 5 years | No decrease in performance after real-time and accelerated aging |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of devices or test samples used for each individual performance test (e.g., liquid leakage, axial load). It mentions:
- Sterility tests: "performed using worst case devices already cleared for market and being packed in identical packaging (material and dimensions)."
- Shelf-life performance: "tested with real time aged devices (1 year) and devices subject to accelerated aging (1 year, 3 years, 5 years)."
The provenance of the data is internal testing conducted by PAJUNK® GmbH Medizintechnologie, located in Geisingen, Germany, and its contract sterilizer, Sterigenics Germany GmbH, located in Wiesbaden, Germany. All testing appears to be retrospective in the sense that it's performed on manufactured devices to demonstrate compliance, rather than a prospective clinical trial.
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 document. The tests described are primarily engineering and laboratory-based performance tests against established international standards (ISO) and internal protocols. There is no mention of human expert evaluation to establish a "ground truth" in the clinical sense, as the device is for mechanical measurement and connectivity rather than diagnostic interpretation.
4. Adjudication Method for the Test Set
This is not applicable as the tests are objective, quantifiable physical and chemical performance metrics against defined standards, not subjective assessments requiring expert adjudication. The result for each test is a simple "Pass" or "Fail."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation of clinical data (e.g., AI in radiology). The Spinal Manometer is a physical device for measuring pressure, not an AI or diagnostic imaging tool.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI is not relevant. The device operates independently of human interpretation of its internal function; humans use it to observe a reading. All performance tests evaluated the device in its intended operational context without human interpretation being part of its core "performance" beyond reading the scale.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests relies on:
- International Standards: Adherence to ISO standards (e.g., ISO 11135, ISO 10993-7, ISO 80369-6, ISO 80369-7) defines acceptable physical and chemical properties.
- Internal Protocols: For aspects not covered by specific ISO standards (e.g., Accuracy/Durability of Markings, Glue Connection Stability), internal, presumably validated, protocols establish the acceptance criteria.
- Measurement against predefined limits: For sterilization residuals and endotoxin, specific quantitative limits (e.g., 25 ppm, 0.06 EU/ml) serve as the ground truth.
8. The Sample Size for the Training Set
There is no training set as this device is not an AI/machine learning product. The term "training set" doesn't apply.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this question is not applicable.
§ 880.2500 Spinal fluid manometer.
(a)
Identification. A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading the height of the fluid.(b)
Classification. Class II (performance standards).