(273 days)
The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation.
The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive.
The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor. the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring.
Sentec's Digital Monitoring System is intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PC2), oxygen saturation (SpO2) and pulse rate (PR) in adult and pediatric patients as well as for PCO2 and PO2 monitoring in neonatal patients.
The tCOM+ (REF 103164) is a portable, lightweight, stand-alone monitor with a convenient carrying handle and with an integrated calibration and storage facility for the V-Sign™ Sensor 2 or OxiVenT™ Sensor, respectively. It provides continuous and noninvasive PCO2, SpO2 and PR monitoring if used with a V-Sign™ Sensor 2 or PCO2, PO2, SpO2 and PR monitoring if used with a OxiVenT™ Sensor.
Acceptance Criteria and Study for Sentec Digital Monitoring System (SDMS) tCOM+
The Sentec Digital Monitoring System (SDMS) tCOM+ is a transcutaneous blood gas monitoring system intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PO2), oxygen saturation (SpO2), and pulse rate (PR). The tCOM+ is an updated version of the previously cleared Sentec Digital Monitor (SDM), with technological upgrades such as a touchscreen user interface and wireless communication capabilities.
The submission focuses on demonstrating substantial equivalence to its predicate device, the SDM, and updated disposables. The core performance of the device, particularly its measurement modalities, is considered unchanged from the predicate. Therefore, the acceptance criteria and supporting studies primarily revolve around verifying the safety and effectiveness of the new monitor features and updated accessories, and demonstrating that the clinical performance remains consistent with the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Electrical Safety | Compliance with AAMI ANSI ES 60601-1: 2005 + A1: 2012 + A2: 2021 (General requirements for basic safety and essential performance). | Device was tested to applicable standards and all specified requirements were met. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: 2014 + A1:2020 (Electromagnetic disturbances - Requirements and tests) and IEC TR 60601-4-2 (Guidance and interpretation --Electromagnetic immunity). | Device was tested to applicable standards and all specified requirements were met. |
| Home Healthcare Environment Use | Compliance with IEC 60601-1-11:2015 + A1:2020 (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment). | Device was tested to applicable standards and all specified requirements were met. |
| Particular Requirements (TC Partial Pressure Monitoring) | Compliance with IEC 60601-2-23:2011 (Particular requirements for the basic safety and essential performance of TC partial pressure monitoring). | Device was tested to applicable standards and all specified requirements were met. |
| Particular Requirements (Pulse Oximeter) | Compliance with ISO 80601-2-61:2017 (Particular requirements for basic safety and essential performance of pulse oximeter equipment). | Device was tested to applicable standards and all specified requirements were met. |
| Wireless Coexistence | Compliance with AAMI TIR69:2017 (Risk management of radio-frequency wireless coexistence) and ANSI C63.27-2017 (Evaluation of Wireless Coexistence). | Device was tested to applicable standards and all specified requirements were met. |
| Usability | Compliance with IEC 60601-1-6:2020 (Usability) and successful Human Factors Evaluation testing according to FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" (February 2016). | A Human Factor Evaluation testing was performed following the FDA Guidance and the results demonstrate that the device meets specified requirements. |
| Alarm Systems | Compliance with IEC 60601-1-8:2020 (General requirements, tests and guidance for alarm systems). | Device was tested to applicable standards and all specified requirements were met. |
| Bench Performance | All specified requirements for mechanical strength, ingress of liquids, and electronic performance. | Bench tests were conducted, and all specified requirements were met. |
| Biocompatibility | Compliance with ISO 10993-1:2018 for all patient contact materials (e.g., Contact Gel, Multi-Site Attachment Ring, Non-Adhesive Wrap). | Biocompatibility testing was conducted for all patient contact materials in compliance with ISO 10993-1:2018, and all materials met Biocompatibility requirements. |
| Risk Management | All hazards mitigated as far as possible, and residual risks determined to be acceptable. | Detailed risk, hazard, and failure analyses were performed, all hazards were mitigated, and residual risks were determined to be acceptable. |
| Software Development | Development in accordance with FDA guidelines for MODERATE level of concern devices; software verified to requirements and validated to meet specified intended use(s). | The software was developed in accordance with FDA guidelines for MODERATE level of concern devices, verified to requirements, and validated to meet the specified intended use(s). |
| Clinical Performance | No degradation in clinical functionality or performance compared to the predicate device (SDM) for tcPCO2, tcPO2, SpO2, and PR monitoring. This includes the performance of the updated disposables. | No new clinical performance data were generated as the tCOM+ uses the same sensors without software changes impacting algorithm or clinical performance. The updated disposables (Calibration Gas, MARe-MI, Non-Adhesive Wrap, Contact Gel, Membrane Changer) do not affect the clinical functionality or performance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not specify sample sizes for test sets in the context of clinical performance data. The submission explicitly states:
- "No clinical performance data were generated on the tCOM+, because compared to its predicate device, the Sentec Digital Monitor (SDM), it uses the same sensors without software changes impacting algorithm or clinical performance."
- "The introduction of the updated disposables...do not affect the clinical functionality or performance of Sentec's Digital Monitoring System. No further clinical data was required to support safety and performance."
Therefore, there isn't a "test set" of patient data for clinical performance in the context of the tCOM+ submission. The testing done involved non-clinical performance (bench testing, biocompatibility, risk management, software validation, human factors) and compliance with various recognized standards.
For the Human Factors Evaluation testing, while a sample size for participants is typically part of such studies, the document does not disclose this information or the data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Given that "no clinical performance data were generated" for the tCOM+ as the clinical functionality and performance are considered unchanged from the predicate, no experts were used to establish ground truth for a new clinical test set for this submission. The ground truth for the predicate device's performance would have been established during its initial clearance, but that information is not part of this 510(k) summary.
4. Adjudication Method for the Test Set
Since no new clinical test set was generated for the tCOM+, there was no adjudication method employed for clinical data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states that no clinical performance data were generated for the tCOM+, as the device's core measurement technology and algorithms are identical to its predicate. Therefore, there is no effect size reported for human readers with or without AI assistance, as AI assistance is not described as a new feature requiring such a study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The submission does not specifically describe a standalone (algorithm only) performance study in the context of new clinical data. The device is a monitoring system that interacts with a human user (professional medical personnel or trained lay operators). The core measurement algorithms for PCO2, PO2, SpO2, and PR are stated to be "unchanged" and "identical" to the predicate. The software development and testing focused on verification to requirements and validation to meet specified intended uses, implying the algorithm's performance inherited from the predicate was considered sufficient.
7. The Type of Ground Truth Used
For the non-clinical aspects:
- Mechanical, Electrical, EMC, Safety Standards: Compliance with industry-recognized standards (e.g., IEC 60601 series, ISO 80601-2-61). The "ground truth" here is adherence to the technical specifications and test methodologies defined by these standards.
- Biocompatibility: Compliance with ISO 10993-1:2018. The "ground truth" is established by laboratory testing results against the criteria within this standard.
- Risk Management: Identification and mitigation of hazards, with acceptable residual risks. The "ground truth" is the thoroughness of the risk analysis and the documented resolution of identified risks.
- Software Development: Verification to requirements and validation to intended use. The "ground truth" is the functional correctness and reliability of the software against its specifications.
- Human Factors: Conformance to usability engineering principles as per FDA guidance. The "ground truth" is successful completion of human factors testing.
For clinical performance, the ground truth is assumed to be equivalent to the predicate device's established clinical ground truth, as the core measurement technology, sensors, and algorithms remain unchanged. The original predicate device's clearance would have relied on appropriate clinical data (e.g., comparison to arterial blood gas measurements for PCO2/PO2, or co-oximetry for SpO2), but this is not detailed in the current submission.
8. The Sample Size for the Training Set
The submission does not mention a training set in the context of new algorithm development or machine learning. Since the software changes primarily relate to the user interface and connectivity, and the measurement algorithms are "identical to the configuration listed under K151329" (the predicate), there was no new training required for clinical algorithms.
9. How the Ground Truth for the Training Set Was Established
As no new training set for algorithms was used in this submission, this question is not applicable.
§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
(a)
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.(b)
Classification. Class II (special controls). The special control for this device 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.