(144 days)
Model 110-4BT: Use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the parenchyma. Model 110-4HMT: Use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the ventricles and cerebrospinal fluid drainage. Intended to be used with an external drainage system as indicated by individual manufacturers.
The Intracranial Pressure-Temperature Monitoring System consists of a catheter and monitor. The catheter is a sterile transducer-tipped pressure monitoring catheter with thermistor and accessory items to be used as a diagnostic tool for rapidly determining and continuously monitoring intracranial pressure and temperature. The Camino catheter has a miniature transducer and thermistor at the distal tip. The pressure transducer is identical to the Camino predicate device. The design eliminates the need for a "fluid-filled system" to carry pressure waves to an external transducer is 4F, fiber optic with a pressure measurement range of -10 to 250 mmHg and a temperature measurement range of 30°C -40°C. The Multi-Parameter Monitor (MPM) is a compact, portable device for use with Camino The MPM measures Intracranial Pressure (ICP). Pressure-Temperature catheters. Intracranial Temperature (ICT) and calculates Cerebral Perfusion Pressure (CPP). The MPM provides a continuous display of the pressure waveform, as well as mean ICP. CPP. temperature or systolic and diastolic values. A continuous record of mean pressure and temperature values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 8 or 24 hour period. An analog output accessory provides a continuous ICP waveform for hard copy documentation or data acquisition. Although the MPM is intended to be a stand alone system, it also conveniently connects to any hospital bedside monitoring system. A builtin rechargeable battery permits monitoring during patient transport. The monitor is equipped with an high ICP alarm. The dimensions are 274 mm x 216 mm x 89 mm and weighs 4.3 Kg.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Camino device:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Temperature Measurement Accuracy | ± 0.4°C (vs. predicate device) |
Note: The document does not explicitly state "acceptance criteria" as a set of quantified thresholds. The performance data provided is primarily for demonstrating substantial equivalence based on a comparison to a predicate device, rather than meeting predefined, independent performance targets. The implicit acceptance criterion for temperature is that the new device's temperature readings should be very close to those of the predicate device. For pressure, the device uses the same transducer as a predicate, implying inherited performance without new testing.
Study Details
2. Sample Size and Data Provenance
- Test Set Sample Size: 10 animals
- Data Provenance: Not explicitly stated, but "animal studies" suggest it's likely a controlled laboratory or research setting. Given the context of a 1996 submission, it's almost certainly prospective as part of the regulatory submission process.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Note: The study described is a comparison of two devices' readings, not an assessment by human experts against a "ground truth" established by experts in the typical clinical sense (e.g., radiologists interpreting images). The "ground truth" for the temperature measurement was essentially the reading from the predicate device placed alongside the test device.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The study involved a direct comparison of physical measurements from two devices, not an interpretive task requiring expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This device is a medical monitoring instrument, not an AI or diagnostic imaging tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance
- Standalone Performance Done: Yes, in essence. The device inherently operates in a standalone manner, providing direct measurements. The study evaluated the device's intrinsic measurement capabilities (temperature) by comparing it to another device. The "algorithm" here is the physical measurement principle and sensor, not an AI algorithm.
7. Type of Ground Truth Used
- Ground Truth Type: "Predicate device comparison." For temperature, the readings from the established predicate device were used as the reference against which the subject device's readings were compared. For pressure, the device uses the identical transducer as a predicate, inferring equivalence.
8. Sample Size for Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML model that requires a training set. It's a physical monitoring device.
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).