Search Results

PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessel.

PressureWire® is a .014" guidewire with an integrated pressure and temperature sensor. together with a detachable cable or transmitter/receiver for connection to a diagnostic computer or a cathlab hemodynamic recording system.

The provided 510(k) summary for the PressureWire® Aeris and PressureWire® Receiver describes its technical characteristics and claims substantial equivalence to predicate devices. However, the document does not describe the acceptance criteria and a study proving the device meets those criteria, as typically understood for sophisticated diagnostic or AI-powered devices.

Instead, this submission focuses on functional/safety testing to demonstrate that the new device (which incorporates wireless technology) is as safe and performs as well as previous wired versions. It does not present a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy or effect size.

Here's an analysis based on the information provided, highlighting the absence of what was requested:

1. A table of acceptance criteria and the reported device performance

Explanation: The 510(k) summary does not define explicit, quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a particular diagnostic task). The "performance testing" mentioned is likely related to the device's functional integrity as a pressure guidewire, rather than its diagnostic efficacy in a clinical setting against a gold standard. The primary focus of this 510(k) is the change from a wired to a wireless signal transfer mechanism.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable. The document does not describe a clinical performance study involving a test set of patient data.
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication method: Not applicable.

5. 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

• MRMC study: No, this device is a medical instrument (pressure guidewire) for measuring physiological parameters, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
• Effect size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone performance: Not applicable. The device itself is the "standalone" instrument. It measures physiological parameters for clinicians to interpret. There is no "algorithm only" performance to evaluate in the context of interpretation, as this is not an AI-driven image analysis or diagnostic software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of ground truth: Not explicitly stated or applicable as no clinical performance study against a diagnostic ground truth is described. The "performance requirements" would likely be engineering specifications for pressure and temperature measurement accuracy and reliability, validated against calibrated standards or in-vitro models rather than clinical ground truth for diagnostic interpretation.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Ground truth for training set: Not applicable.

Summary of Device and 510(k) Filing:

The K080813 submission for the PressureWire® Aeris focuses on the technical modifications of an existing device (PressureWire®) by introducing a wireless signal transfer mechanism. The key argument for substantial equivalence is that the new wireless version performs its intended function (directing a catheter and measuring physiological parameters) and meets safety standards just like its predicate wired versions. The 510(k) summary explicitly states: "The guidewire part of subject device is identical to the predicate device (K062769)." The "Functional/Safety Testing" mentioned refers to electrical, EMC, radio, sterilization, and general performance testing to ensure the new wireless components do not introduce new safety concerns or functional degradation compared to the wired predicate. This is a common approach for 510(k) submissions where the changes are primarily technological rather than a new diagnostic claim or a new type of device.

Ask a specific question about this device

The PressureWire Sensor is intended for use in coronary and peripheral blood vessels to measure blood pressure during percutaneous procedures and to facilitate the placement of interventional devices.

The PressureWire™ Sensor consists of a pressure sensor mounted steerable guidewire to perform real-time invasive pressure measurement in the vasculature and a detachable cable for connection to RADI Medical Systems PressureWire™ Interface only. The guidewire has an outer diameter of .014" and is 175 cm in length. The pressure sensor is mounted just proximal of the 3 cm shapeable radiopaque tip.

PressureWire™ Sensor is connected to the PressureWire™ Interface via the Interface Cable which has an identification memory chip containing the individual calibration parameters for the sensor.

The readings from the PressureWire™ Sensor and the one measured through a guiding catheter can be used as input for calculation of various indices which require one or two input values e.g. gradient or Fractional Flow Reserve (FFR) etc.

The information provided focuses on the substantial equivalence of the "PressureWire™ Sensor" to a predicate device and does not contain detailed acceptance criteria, a specific study with performance metrics against those criteria, or the other requested study design details.

Here's a breakdown based on the provided text, highlighting the absence of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified. The study was a "bench test," which typically implies laboratory testing rather than human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The study was a bench test evaluating physical impact on a pressure signal, not an assessment requiring expert ground truth on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for a bench test of physical properties.

5. 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 medical guidewire with a pressure sensor, not an AI-powered diagnostic imaging tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, a standalone bench test was done. The device's performance (impact on pressure signal) was evaluated independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the bench test, the "ground truth" would be the direct measurement of pressure signals, comparing signals with and without the device's presence to determine the impact. This is not an expert consensus, pathology, or outcomes data, but a direct physical measurement.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. As above, this device is not an AI algorithm requiring a training set.

Summary of Device Performance Justification:

The 510(k) submission for the PressureWire™ Sensor relies heavily on the substantial equivalence to its predicate device (PressureWire™ Sensor (K972793)). The document explicitly states:

• "Due to the extreme similarity in design and materials between subject and predicate devices further product performance testing has not been considered necessary."
• "The technical characteristics of PressureWire™ Sensor is almost identical with the predicate device."
• "The device is almost identical with predicate device and found to be suitable for its intended use."

The only performance data mentioned is a bench test to demonstrate that the presence of the new PressureWire™ Sensor within a guiding catheter does not "clinically significantly impact the pressure signal recorded by the catheter." This test was likely performed to address any potential concerns with the specific embodiment of the new device relative to the predicate, even given the overall similarity. However, no specific quantitative acceptance criteria for this impact are provided, nor are detailed results beyond the qualitative statement of "no clinically significant impact."

Ask a specific question about this device