(198 days)
Siemens Transcutaneous tpO2/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous oxygen in the neonatal population when the patient is not under gas anesthesia.
Siemens Transcutaneous tp02/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous carbon dioxide partial pressure in any patient population.
The device is indicated for use in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required.
The Transcutaneous Gas Module (tpO/CO2 pod) is an addition to Siemens SC9000 patient monitoring series which provides transcutaneous measurement of partial pressures of the 02 and CO2 in the peripheral tissue of a patient.
The Siemens SC9000/SC9015 Transcutaneous Gas Module (tpO2/CO2) is indicated for continuous, noninvasive trend monitoring of transcutaneous oxygen in the neonatal population (when not under gas anesthesia) and transcutaneous carbon dioxide partial pressure in any patient population.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) Notification, primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for performance in a tabular format. The document states: "Currently there are no FDA standards for this device." However, it does mention that "The transcutaneous gas module (tpO2/CO2) was deemed to be safe and effective." This suggests that the device's performance was evaluated against the general safety and effectiveness requirements expected for devices of its type, likely by demonstrating similar performance characteristics to the predicate devices.
Acceptance Criteria (Inferred from Substantial Equivalence and Predicate Device Characteristics):
The acceptance criteria are not explicitly defined with numerical thresholds but are implicitly based on the performance of the predicate devices. The study likely aimed to show that the Siemens Transcutaneous tpO2/CO2 Gas Module performs similarly to the predicate devices across key operational parameters.
| Parameter | Acceptance Criteria (Inferred from Predicate Device) | Reported Device Performance |
|---|---|---|
| tpO2 Monitoring | - Measuring Range: 0 to 800 mmHg (from Radiometer predicate) - Correction Factor: No (from Radiometer predicate) - Temperature Setting: 37 to 45°C (from Radiometer predicate) - Heating Power: 0 to 600 mW ± 10 mW (from Radiometer predicate) - Calibration: Single point (from Radiometer predicate) - Alarm: Alarms >.2°C from selected electrode temperature (from Radiometer predicate) | The Siemens SC9000/SC9015 Transcutaneous Gas Module is stated to have the "Same" performance characteristics as the Radiometer predicate device for tpO2 monitoring, implying it meets or operates within these established ranges and functionalities. |
| tpCO2 Monitoring | - Measuring Range: 0 to 200 mmHg (from Siemens SIRECUST 404/404N predicate) - Correction Factor: Yes (from Siemens SIRECUST 404/404N predicate) - Temperature Setting: 37 to 45°C (from Siemens SIRECUST 404/404N predicate) - Heating Power: 0 to 600 mW ± 10 mW (from Siemens SIRECUST 404/404N predicate) - Calibration: Single point (from Siemens SIRECUST 404/404N predicate) - Alarm: Alarms >.2°C from selected electrode temperature (from Siemens SIRECUST 404/404N predicate) | The Siemens SC9000/SC9015 Transcutaneous Gas Module is stated to have the "Same" performance characteristics as the Siemens SIRECUST 404/404N predicate device for tpCO2 monitoring, implying it meets or operates within these established ranges and functionalities. |
| Intended Use | Continuous, noninvasive trend monitoring of transcutaneous oxygen (neonatal, not under gas anesthesia) and transcutaneous carbon dioxide (any patient population). | The device's intended use is stated as "Same" as the predicate device (Siemens SIRECUST 404/404N for tpCO2 and Radiometer for tpO2 portions), indicating it aligns with the established uses of the predicate devices. |
| Intended Population | Neonatal (for tpO2), Adult, Neonatal (for tpCO2). | The device's intended population for tpO2 is "Neonatal" (same as predicate). For tpCO2, while the predicate was "Adult, Neonatal," the new device specifies "Neonatal," but the overarching indication for tpCO2 is "any patient population." This indicates a compliance with, and potentially broader applicability for, tpCO2 than one of the predicates. |
| Safety and Effectiveness | Overall deemed safe and effective for its intended use. (General regulatory expectation) | "The transcutaneous gas module (tpO2/CO2) was deemed to be safe and effective." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for any testing. It mentions "Assessment of non-clinical performance data for equivalence" and "Assessment of clinical performance data for equivalence," but it does not provide details on the number of subjects or cases included in these assessments.
The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned in the provided text.
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 document. The summary focuses on comparing the device to predicates based on performance specifications rather than a new clinical study involving expert ground truth determination.
4. Adjudication Method for the Test Set
This information is not provided in the given document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission is a 510(k) notification, which typically focuses on demonstrating substantial equivalence through technical and functional comparisons, not necessarily on comparative effectiveness studies with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a "Transcutaneous Gas Module" which directly measures physiological parameters. It is not an imaging AI algorithm, and therefore the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI in imaging is not applicable in this context. The module itself performs the measurements.
7. The Type of Ground Truth Used
The document implies that the ground truth for establishing equivalence and "deeming safe and effective" would be based on the established performance and safety profiles of the predicate devices. The phrase "Assessment of clinical performance data for equivalence" suggests that data was collected to show agreement with current clinical standards or established measurement methods, but the specific "type of ground truth" (e.g., expert consensus, pathology, directly measured outcomes from a reference standard) is not explicitly stated. Given the nature of a transcutaneous gas module, the ground truth would typically come from a more invasive, established method (e.g., arterial blood gas analysis for oxygen and carbon dioxide partial pressures) if a new clinical study was performed. However, the document does not elaborate on this.
8. The Sample Size for the Training Set
The concept of a "training set" is primarily relevant for machine learning or AI algorithms. Since this device is a physical medical monitor, there is no mention or applicability of a training set in the context of AI. The device's calibration and performance would be based on engineering design and validation, not on a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set applicable to this device, this question is not relevant.
§ 868.2500 Cutaneous oxygen (PcO2) monitor.
(a)
Identification. A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.