(185 days)
When installed in the Periflux System 5000, the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) is intended to monitor the levels of oxygen and/or carbon dioxide from tissue transcutaneously. The unit provides continuous, non-invasive monitoring of cutaneous oxygen and carbon dioxide.
The Periflux System 5000 with the pO₂/pCO₂ module is intended to be used in hospitals and facility offices. It is intended to monitor transcutaneous pCO₂ in adults and pO₂ in infants not under gas anesthesia. The system is not intended for use by patients without the supervision of a physician.
The Transcutaneous PO₂ and PCO₂ Monitor (PF5040) is a modular unit which can be installed in the Periflux System 5000 transcutaneous monitoring system. Patient monitoring is accomplished by the application of an electrode to specific sites on the patient after calibration of the unit.
The Periflux System 5000 is a multi-channel, multi-function system capable of hosting several function units including: the Modular Laser Doppler system for blood perfusion and the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) for monitoring oxygen and/or carbon dioxide levels. The Periflux system 5000 can accommodate up to four different function units enabling different types of simultaneous measurements.
The provided document is a 510(k) Summary of Safety and Effectiveness Data for the Perimed Transcutaneous PO₂ and PCO₂ Monitor (PF5040). It details the device's general information, a brief description, its intended use, and a comparison to a predicate device. Importantly, it mentions testing was performed to demonstrate the safety and performance characteristics and that the device met test requirements and performed in accordance with applicable standards. However, it does not explicitly detail the acceptance criteria or the specifics of the study that proves the device meets those criteria.
Therefore, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text. The document refers generally to "test requirements" and "applicable standards." | "The testing demonstrated that the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) met test requirements and performed in accordance with applicable standards." (Specific performance metrics are not provided.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not specified in the provided text. The document refers to "testing" but does not describe the methodology for establishing ground truth or the involvement of experts in that process.
4. Adjudication Method for the Test Set:
- Not specified in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size Improvements:
- Not mentioned or implied in the provided text. The document focuses on demonstrating the device's performance against "test requirements" and "applicable standards," not comparative effectiveness with human readers or AI assistance.
6. If a Standalone Performance Study was done:
- The text states, "Testing was performed to demonstrate the safety and performance characteristics of the Transcutaneous PO₂ and PCO₂ Monitor (PF5040)." This implies a standalone performance evaluation of the device itself. However, it does not explicitly use the term "standalone study" in the context of an algorithm's performance only without human in the loop. Given the nature of a medical monitoring device, the "device" performance is inherently standalone in its measurement function.
7. Type of Ground Truth Used:
- Not specified in the provided text. The nature of transcutaneous monitoring suggests comparison with a reference standard for blood gas measurements, but this is not explicitly stated.
8. Sample Size for the Training Set:
- Not applicable/mentioned. This device is a monitor, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable/mentioned, as it is not an AI/machine learning algorithm.
Summary of what is present:
The document states that the device was tested to demonstrate its safety and performance and that it met test requirements and applicable standards. It establishes substantial equivalence to a predicate device, the Novametrix TCO₂M Transcutaneous O₂/CO₂ Monitor, based on similar indications for use, measurement principles, and output ranges. However, specific quantitative acceptance criteria or detailed study results are not included in this summary. The FDA's letter indicates clearance for marketing based on this summary.
§ 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.