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510(k) Data Aggregation
(185 days)
PERIMED, INC.
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.
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(195 days)
PERIMED, INC.
The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.
The PeriFlux System 5000 Modular Laser Doppler Flowmeter System 5000 consists of a PF 5001 Main Unit, which can accommodate up to four Function Units. The first available Function Unit is the PF 5010 LDPM (Laser Doppler Perfusion Monitor) Unit. A PF 5990 Blank Panel takes the place of a Function Unit if less than four Units are required. Probes are attached to collect the information, which is analysed, using the PeriSoft analysis program.
Here's an analysis of the provided text regarding the PeriFlux System 5000 Modular Laser Doppler Flowmeter, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary letter from the FDA. It does not contain detailed information about specific acceptance criteria, study designs, or performance metrics. It primarily establishes substantial equivalence to a predicate device. Therefore, many of the requested details cannot be extracted directly from this document.
1. Table of Acceptance Criteria and Reported Device Performance
As the provided document is a 510(k) summary for substantial equivalence, it does not specify explicit acceptance criteria or report detailed device performance metrics in the way a clinical study report would. The primary "acceptance criterion" met here is the FDA's determination of substantial equivalence to the predicate device, the PeriFlux System 4000. This implies that the performance characteristics are considered comparable.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Substantial Equivalence to Predicate Device (PeriFlux System 4000) | Technological Characteristics: "The technology is the same but the design has been modified to simplify use... and allow customers to more easily choose the number of channels they need." |
| Functionality: "The PeriFlux System 5000 presents only Perfusion and TB (CMBC and Velocity are measured by the instrument to calculate Perfusion)." (Predicate presented CMBC and Velocity directly) | |
| Probe Compatibility: "The probes... are identical in every way with those used for the PeriFlux System 4000 laser Doppler Flowmeter - they are interchangeable between the two systems." | |
| Safety | Implicitly deemed safe through substantial equivalence to a legally marketed device and compliance with general controls. |
| Effectiveness | Implicitly deemed effective for its stated intended use through substantial equivalence to a legally marketed device. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document focuses on technological comparison rather than a formal clinical or performance testing study with a defined test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. As there's no mention of a formal clinical test set or ground truth establishment, this detail is absent.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of an MRMC comparative effectiveness study is present in this 510(k) summary. Given the nature of the device (a Laser Doppler Flowmeter measuring microvascular perfusion, not an imaging diagnostic device that typically involves human interpretation), such a study would be highly unlikely and generally not relevant for this type of device.
6. Standalone (Algorithm Only) Performance Study
This is not applicable and not mentioned. The PeriFlux System 5000 is a measurement device, not an algorithm that operates independently without human interaction or a physical sensor. Its "performance" would relate to the accuracy and precision of its measurements, not to algorithm-only operation in the context of interpretation.
7. Type of Ground Truth Used
Given that this is a 510(k) submission primarily focused on demonstrating substantial equivalence based on technological characteristics and intended use, there is no explicit mention of a 'ground truth' in the context of a performance study. For a measurement device like a flowmeter, "ground truth" would typically refer to a validated reference method for measuring microvascular perfusion against which the device's measurements are compared for accuracy and precision. This document does not detail such a comparison study.
8. Sample Size for the Training Set
This information is not provided. Laser Doppler Flowmeters are typically based on established physical principles for blood flow measurement, not on machine learning algorithms that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as the device does not appear to be an AI/ML-based system requiring a training set with established ground truth.
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