(133 days)
The Compass™ Vascular Access is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of invasive blood pressure.
The Compass™ Lumbar Puncture is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of intracranial pressure.
The Compass is a disposable, point-of-use pressure measurement and monitoring device that incorporates a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass is provided as two different models, each corresponding to a specific indication for use:
- (1) The Compass Vascular Access (VA) is for invasive blood pressure measurement and monitoring during the insertion of vascular access devices.
- (2) The Compass Lumbar Puncture (LP) is for intracranial pressure measurement and monitoring via lumbar puncture or intraventricular catheter.
Both models are designed to attach distally to an inserted needle or catheter, measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD.
The Compass VA and Compass LP devices are identical except for two differences: 1) the measurement units in which the pressure is displayed on the LCD (mm Hg for blood pressure measurements with the Compass VA and cm H2O for intracranial pressure measurements with the Compass LP), and 2) the Compass VA blood pressure monitoring device has a proximal port through which commercially available guidewires can be inserted during pressure measurement.
The provided 510(k) summary for the Mirador Compass™ device (K101518) describes the device, its indications for use, and the testing performed. However, it does not provide a specific table of acceptance criteria with corresponding reported device performance values in a side-by-side format as typically found in comprehensive performance studies for AI/CAD devices.
Instead, the documentation outlines various tests conducted and generally states that the device "meet defined design requirements" and can "perform in a manner equivalent to devices currently on the market."
Let's break down the information based on your requested points:
Acceptance Criteria and Reported Device Performance
The document describes several categories of testing, implying that the acceptance criteria are met if the device performs "per Mirador Biomedical's in-house test methods, protocols, and requirements or in accordance with applicable recognized standards by accredited outside laboratories," and that the results "demonstrate that the technological and performance characteristics... meet defined design requirements and that they can perform in a manner equivalent to devices currently on the market."
Due to the nature of the provided document, a specific table of acceptance criteria and reported device performance with numerical values cannot be fully constructed as the exact numerical acceptance limits and reported performance values are not explicitly stated for all tests. However, we can infer the categories of performance that were assessed.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (as stated in document) |
|---|---|
| Biocompatibility | Met ISO 10993-1 standards (cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, sensitization, pyrogenicity). |
| Functional Testing (General) | Met applicable functional testing per ANSI/AAMI BP22:1994(R)2006, ISO 594-1, and ISO 594-2. |
| Luer Fittings | Met defined design requirements. |
| Mechanical Strength and Durability | Met defined design requirements. |
| Power Switch | Met defined design requirements. |
| Dimensional and Weight Verification | Met defined design requirements. |
| Battery Life | Met defined design requirements. |
| Pressure Overrange Capability | Met defined design requirements. |
| Pressure Accuracy | Met defined design requirements. (In vivo study showed accurate measurement equivalent to predicate) |
| Drift, Temperature Error Band, Temperature Error Band of Sensitivity | Met defined design requirements. |
| Light Sensitivity | Met defined design requirements. |
| Frequency Response | Met defined design requirements. |
| Guidewire Testing (Compass VA) | Met defined design requirements. |
| Spillage | Met defined design requirements. |
| Safety | Met defined design requirements. |
| Simulated Use Testing (Vascular Access & Lumbar Puncture) | Met defined design requirements. |
| In vivo Performance | Compass VA and LP devices accurately measure and monitor labeled physiologic pressures (invasive blood pressure/intracranial pressure) in a manner equivalent to the predicate device. |
Detailed Information on Studies and Ground Truth:
This device (Mirador Compass™) is a disposable pressure transducer with an integrated digital display and pre-programmed diagnostic computer. It is not an AI/CAD (Computer-Aided Detection/Diagnosis) system in the modern sense. Therefore, many of the typical questions for AI/CAD devices, such as those related to observer performance studies (MRMC), ground truth established by experts, adjudication methods, and training/test sets for AI models, are not applicable to this type of medical device.
1. Sample sized used for the test set and the data provenance:
- In vitro (Bench) Testing: The document lists several in vitro tests (Luer Fittings, Mechanical Strength, Power Switch, etc.). The sample sizes for each of these component-level or functional tests are not specified in the summary.
- In vivo Animal Study: The "in vivo animal study" used a swine model. The specific number of animals or the number of measurements taken is not provided.
- Data Provenance: The in vitro tests were conducted by "Mirador Biomedical's in-house test methods, protocols, and requirements or in accordance with applicable recognized standards by accredited outside laboratories." The animal study was conducted in a swine model. The country of origin for the animal study is not specified, but the manufacturer is US-based (Seattle, Washington).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device. The device's performance is measured against physical standards, calibrated equipment, and physiological measurements in an animal model, not against human expert interpretations of images or data that require adjudication for ground truth.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As this is not an AI/CAD device based on expert interpretation, no adjudication method was used.
4. 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:
- No MRMC study was done. This device is a measurement tool, not an AI assistance tool for human interpretation.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a "standalone" measurement device in that it directly measures and displays pressure. However, it's not an "algorithm-only" standalone performance test in the context of AI/CAD where the algorithm's output is being evaluated for accuracy without human input. Its performance was assessed through direct physical and physiological measurements.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- In vitro Tests: Ground truth would be established by reference standards, calibrated measurement equipment, and specified engineering tolerances as defined by design requirements and industry standards (e.g., ANSI/AAMI BP22, ISO 594-1/2).
- In vivo Animal Study: Ground truth for pressure measurements would be established by direct physiological measurements from the swine model, likely using a highly accurate reference pressure transducer or established invasive pressure monitoring techniques, against which the Compass device's readings are compared. The summary explicitly states that a "predicate Shenzhen DPT pressure sensor was used for relative comparison."
7. The sample size for the training set:
- Not applicable. This device is not an AI/Machine Learning diagnostic system that undergoes a "training" phase with a dataset.
8. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.
In summary, the K101518 submission for the Mirador Compass™ device demonstrates substantial equivalence through extensive bench testing and an in vivo animal study against established standards and a predicate device. The information provided aligns with typical submissions for Class II measurement devices, rather than AI-driven diagnostic tools.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).