Search Results
Found 1 results
510(k) Data Aggregation
(238 days)
The RAUMEDIC® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concem.
Use of the parenchymal intracranial pressure monitoring kit with bolt is indicated for children who are at least one year old.
The RAUMEDIC® -PTO-Monitoring-System determines the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors, in temperature using thermistors, and in partial oxygen pressure ptiO2 using a luminescence optical sensor fibre.
The PTO-Monitoring-System consists of intracranial catheters, a cranial bolt kit, the user interface unit (EASY logO), cables to connect the catheters to the EASY logO and cables for the EASY logO to send the measurements to specific patient monitoring units.
Three intracranial catheters are provided: NEUROVENT®-PTO, NEUROVENT® TO and NEUROVENT® PTO 2L. The NEUROVENT®-PTO measures three physiological parameters - ICP, temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO). The NEUROVENT -PTO 2L also measures these three parameters, but has to be placed with a multi lumen Bolt (BOLT KIT PTO 2L) or via tunneling process. The NEUROVENT® TO measures two physiological parameters – temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO).
The NEUROVENT®-PTO or the NEUROVENT®-TO is implanted in the parenchyma using a BOLT KIT PTO. The NEUROVENT®-PTO 2L is implanted in the parenchyma using a BOLT KIT PTO 2L or using a RAUMEDIC® spliceable tunnelling sleeve CH8 (already cleared for market under 510(k) K112017).
For connecting the catheters to the EASY logO two cables – cable PTO and cable LWL - are needed. The cable PTO transfers the electrical signal for ICP and temperature. The cable LWL transfers the optical signal for oxygen pressure.
The EASY logO is the user interface that displays the measurements and alerts the user to the status of the intracranial catheters. The EASY logO displays: oxygen partial pressure pO2, intracranial pressure ICP, pulse amplitude ICPA and temperature T. ICP is a pulsatile signal that consists of the ICP average value and a pulsatile ICPA component, which is superimposed over the ICP average value.
DATALOGGER cables allows the EASY logO to send the measurements to specific patient monitoring units.
The provided text describes the RAUMEDIC® -PTO-Monitoring-System and its performance testing to demonstrate substantial equivalence to previously cleared devices. It does not contain information about a study proving the device meets explicit acceptance criteria in the format requested. However, it does provide performance specifications and comparison to predicate devices, which serve as a de facto set of acceptance criteria for regulatory clearance.
Here’s a summary of the available information, fitted to the request structure where possible.
Device Name: RAUMEDIC® -PTO-Monitoring-System
Intended Use: Measures intracranial pressure (ICP), temperature, and oxygen (ptiO2) as an adjunct monitor of trends, indicating perfusion status of cerebral tissue local to sensor placement. Not for use as the sole basis for diagnosis or therapy. For use in children at least one year old.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance specifications of the predicate devices and relevant standards (ANSI/AAMI NS 28:1988/(R) 2006 for ICP, ASTM E1112-00 (2006) for Temperature, and comparison to K980380 for ptiO2). The tables provided (Table 5, Table 6, and Table 7) list the performance testing and results, demonstrating that the device meets these established comparables.
| Feature / Parameter | Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (RAUMEDIC® -PTO-Monitoring-System) |
|---|---|---|
| ICP Performance (Based on ANSI/AAMI NS 28:1988/(R) 2006) | ||
| Frequency response | > 100 Hz | 167 Hz (Meets Standard) |
| Slew rates | > 7,500 torr/s | 10,000 torr/s (Meets Standard) |
| Time constants | < 5 ms | 3 ms (Meets Standard) |
| Pressure range | Min 0 to +100 mmHg | -50 to +250 mmHg (Meets Standard) |
| Accuracy (Catheter alone) | < maximum deviation point 3.2.2_NS 28 (-50 to +250 mmHg) | < maximum deviation point 3.2.2_NS 28 (Meets Standard) |
| Accuracy (with NPS-3 display) | < maximum deviation point 3.2.2_NS 28 (-40 to +100 mmHg) | < maximum deviation point 3.2.2_NS 28 (Meets Standard) |
| Stability (20 ± 1°C, 39 ± 1°C) | dPx < 1.52 torr | ≤ 1.44 torr (Meets Standard) |
| Zero-Point Stability (24h) | < 1 torr | ≤ 0.7 torr (Meets Standard) |
| Zero-Point Stability (168h) | < 1.5 torr | ≤ 1.2 torr (Meets Standard) |
| Accuracy at 10 torr | < 1.5 torr | ≤ 0.9 torr (Meets Standard) |
| Accuracy at 20 torr | < 1.5 torr | ≤ 1.2 torr (Meets Standard) |
| Accuracy at 50 torr | < 1.5 torr | ≤ 1.1 torr (Meets Standard) |
| Accuracy at 100 torr | < 1.5 torr | ≤ 1.2 torr (Meets Standard) |
| Risk current | < 10 µA at 120 V AC | < 0.98 µA at 120 V AC (Meets Standard) |
| Maximum temperature | No temperature increase > 40 °C (104 °F) | max. 39.5 °C (Meets Standard) |
| Temperature Performance (Based on ASTM E1112-00 (2006)) | ||
| Cleaning | No visible of technical changes | No visible of technical changes (Meets Standard) |
| Toxicity | Toxicity Test | Toxicity Test (Meets Standard) |
| Accuracy | No difference between the in vivo and in vitro accuracy | No difference between the in vivo and in vitro accuracy (Meets Standard) |
| Operating Environment (Temp/RH) | < Max. Error Temp. Rang. Table 1 ASTM E1112 (for 40°C/15%RH, 40°C/80%RH, 16°C/40%RH, 16°C/95%RH) | < Max. Error Temp.Rang. (Meets Standard for all conditions) |
| Storage (after 1 month) | Test point o.k. after storage at -20 °C, 50 °C/15% RH, 35 °C/95% RH | o.k. (Meets Standard) |
| Oxygen Performance (Compared to DIAMETRIC MEDICAL LTD. NEUROTREND MULTIPARAMETER SENSOR K980380) | ||
| Drift over 5.5 days (2.5% O2) | < 1.5 mmHg | ≤ 1.2 mmHg (within predicate's < 11.9 mmHg) (Yes) |
| Drift over 5.5 days (10% O2) | < 1.5 mmHg | ≤ 1.2 mmHg (within predicate's < 46.2 mmHg) (Yes) |
| Absolute accuracy (0-120 mmHg) | 0+/- 2.5 mmHg | ≤ 0.2 mmHg (within predicate's 0+/- 3.0 mmHg) (Yes) |
| Absolute accuracy (>120 mmHg) | 150.00+/-15 mmHg (for predicate: 135.0-165.0 mmHg for values from 120-200 mmHg) | 146.9 mmHg; 152.3 mmHg (within predicate's range) (Yes) |
| Response time T90 | < 200 s for change 150+/-15 mmHg to 0.0 mmHg | ≤ 51 s (within predicate's ≤ 55 s) (Yes) |
| ptiO2 sensitive surface | > 13 mm² (predicate: ≥ 5 mm²) | ≥ 15.1 mm² (> 5mm² is o.k. in brain) (Yes) |
| Length ptiO2 sensitive area | > 4mm | > 4.9 mm (within predicate's > 4 mm) (Yes) |
| Outer catheter diameter | < 1.35 mm (predicate: ≤ 0.5 mm) | ≤ 0.99 mm (Yes, noted as "Yes" despite a larger diameter, likely due to similar performance or acceptable clinical difference, or comparison to K120252 predicate which has larger diameters). For Oxygen, the comparison is specifically to K980380. The rationale for "Yes" is not explicitly detailed but stated. |
2. Sample Size Used for the Test Set and Data Provenance
The document discusses bench testing rather than clinical studies with human subjects. Therefore, details like "test set," "sample size," "country of origin," and "retrospective or prospective" are not applicable in the context of human data. The testing described is primarily physical and analytical.
- ICP Performance: The tests were performed on the RAUMEDIC® ICP-Monitoring-System (K103206) and the results were transferred, implying testing of components or integrated systems in a lab setting. The specific number of units tested is not stated.
- Temperature Performance: Performed on the RAUMEDIC® PTO-Monitoring-System, likely in a lab setting. The specific number of units tested is not stated.
- Oxygen Performance: Performed internally on the RAUMEDIC® PTO-Monitoring-System, likely in a lab setting. The specific number of units tested is not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as the "test set" refers to bench testing against engineering specifications and predicate device performance, not human-annotated data. Ground truth here is defined by physical measurements and established standards.
4. Adjudication Method for the Test Set
Not applicable, as there were no human experts involved in adjudicating the results of the bench testing. The results were compared directly to numerical specifications or predicate device performance.
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 is a medical device for direct physiological measurement, not an AI-based diagnostic or imaging interpretation system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance testing described (ICP, Temperature, Oxygen) is inherently "standalone" in the sense that it evaluates the device's physical and measurement capabilities independent of a human interpreter. The device provides raw data (measurements) which are then interpreted by clinicians.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing is based on:
- Established international performance standards (ANSI/AAMI NS 28, ASTM E1112).
- Comparative performance data from legally marketed predicate devices (K120252, K980380, K002765).
- Direct physical measurements using calibrated equipment in a controlled laboratory environment.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device that requires a training set.
Ask a specific question about this device
Page 1 of 1