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510(k) Data Aggregation
(77 days)
The Verrata PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to guide the positioning of a balloon dilatation cather interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
The Verrata PLUS pressure guide wire (hereafter referred to as the "pressure guide wire") is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata PLUS guide wire measures pressure when used with the SmartMap, ComboMap, s5 Series, CORE , and IntraSight series of systems. This pressure guide wire will not operate if connected to any other imaging system. The pressure guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and in straight or pre-shaped tips. The pressure guide wire is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.
The provided document does not contain all the requested information for acceptance criteria and the study that proves the device meets them. This document is a 510(k) summary for the Verrata PLUS Pressure Guide Wire and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a clinical study with specific acceptance criteria and detailed performance statistics.
Here is the information that can be extracted or inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "All device acceptance criteria were met" and that the device "meets its intended use." However, it does not provide a specific table of quantitative acceptance criteria values or the corresponding reported device performance values. It lists types of performance testing completed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| EMC and Electrical Safety | Met (implied) |
| Design Verification | Met (implied) |
| Shelf Life | Met (implied) |
| Drift Performance | Met (implied) |
| System Verification | Met (implied) |
| Sensor Accuracy | SAME as predicate (K161887) |
| Sensor Drift | SAME as predicate (K161887) |
| Sensor Operating Range | SAME as predicate (K161887) |
The comparison table on page 4-5 explicitly states that for "Sensor" attributes, the "Accuracy," "Drift," and "Operating Range" are "SAME" as the predicate device (Verrata PLUS Pressure Guide Wire, K161887). This implies that the acceptance criteria for these sensor-related performance metrics are identical to those established for the predicate device, and the subject device achieved performance equivalent to the predicate.
2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily bench and laboratory-based design verification and system verification, not human clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The document describes performance testing, likely against established engineering and technical standards, rather than expert-established ground truth from clinical data.
4. Adjudication Method for Test Set:
Not applicable. There is no indication of an adjudication method for a test set, as no clinical study or expert review for ground truth establishment is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not mentioned or implied. The device is a pressure guide wire, not an imaging or diagnostic algorithm that would typically involve human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable. The device is a physical medical instrument (pressure guide wire) meant for use in conjunction with other systems and interventional procedures, not a standalone algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the performance testing cited would be based on established engineering specifications, calibration standards, and industry-recognized testing methodologies for medical devices, particularly pressure sensors and guide wires. This is not explicitly stated but is inferred from the types of tests listed (EMC, Electrical Safety, Design Verification, Shelf Life, Drift, System Verification).
8. Sample Size for Training Set:
Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no training set for this device.
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(71 days)
The Verrata® PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
The Verrata® PLUS Pressure Guide Wire (hereafter referred to as the “Verrata PLUS”) is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata® PLUS measures pressure when used with the SmartMap®, ComboMap®, s5 Series™, and CORE™ Series of systems. The Verrata PLUS has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and also in straight or pre-shaped tips. The Verrata PLUS is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.
The provided text describes the Verrata PLUS Pressure Guide Wire and its performance testing to demonstrate substantial equivalence to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection (Cable Routing) | Cable must be routed out the right side of the connector. | Sample wires and connectors were visually inspected to confirm proper routing of the cable out of the connector. Implied: Complied with acceptance criteria. |
| Visual Inspection (Pressure Sensor) | The sensor adhesive is not protruding out of the housing and the sensor is not damaged or misaligned. | Sample wires were visually inspected to confirm that the pressure sensor within the pressure housing is properly aligned, positioned and potted in place. Implied: Complied with acceptance criteria. |
| Wire Outer Diameter | The sensor housing outer diameter must meet product specifications. | The maximum diameter of the sensor housing is measured with a micrometer. Implied: Complied with acceptance criteria. |
| Zero Test and Connection Durability | The wire must successfully zero the first time and after 20 disconnect and re-connect cycles. | Wires with connectors were connected to a Volcano Pressure System and "zeroed". The pressure value on the screen of the System should read "0". Disconnect the wire from the connector and re-connect up to 20 times. After 20 disconnect and re-connects, verified that the wire still "zeros". Implied: Complied with acceptance criteria. |
| Accuracy Test | The pressure measured by the wire must meet product specifications. | The wire is connected to a test fixture and is placed in an air pressure chamber at 37℃. The pressure inside the chamber is varied and the pressure reading from the wire is compared to the pressure to which the chamber is set. Implied: Complied with acceptance criteria. |
| Drift Test | The drift over 10 minutes must meet product specifications. | The wire is connected to a test fixture and placed in saline at 37℃. The pressure reading is recorded for 10 minutes. Implied: Complied with acceptance criteria. |
| Connector to Cable Tensile Test | The tensile strength must meet product specifications. | The connector to cable connection was pull tested to assess its tensile strength. Implied: Complied with acceptance criteria. |
| Biocompatibility (ISO 10993) | Per ISO 10993 and test protocols. | Biocompatibility of the raw materials in the Verrata PLUS wire were assessed per ISO 10993. Implied: Complied with acceptance criteria. |
| Biocompatibility (Direct Hemolysis) | The difference between the hemolytic indices of the test article and negative control must be <2%. | Direct Contact Hemolysis testing was performed. Implied: Complied with acceptance criteria. |
| Biocompatibility (Indirect Hemolysis) | The difference between the hemolytic indices of the test article and negative control must be <2%. | Extract In-direct Contact Hemolysis testing was performed. Implied: Complied with acceptance criteria. |
| Biocompatibility (Latex Elisa test) | Reporting Limit = 0.03ug/ml. | Latex Elisa test for Antigenic Protein was performed. Implied: Complied with acceptance criteria. |
| Biocompatibility (Cytotoxicity) | A score of <2 indicates that the test article is not cytotoxic. | Cytotoxicity testing was performed. Implied: Complied with acceptance criteria. |
| Connector Fluid Ingress | Stable signal time of the Verrata PLUS connector in the presence of saline is equal to or better than the stable signal time of the Verrata connector in the presence of saline. | Sample wires and connectors were connected to a Volcano Pressure System. The connector was placed on top of absorbent drapes. The System was turned on and saline was dripped on the connector while the pressure waveform was monitored on the screen of the System. After 5 minutes, the connector was flipped over. After an additional 5 minutes the recording was stopped. Verrata PLUS was compared to the Verrata. The document states the condition was met. |
| Device Deliverability/Compatibility | Two different heart models in a 37°C water bath were used to assess the ability of the Verrata PLUS to support the delivery and deployment of standard interventional devices. The first model was used to assess device deliverability in simulated Left Circumflex and First Obtuse Marginal vessels. The second model was used to assess the ability of the Verrata PLUS to support the inflation of a standard balloon catheter and the deployment of a stent. Implied: Complied with acceptance criteria. | The document only states the acceptance criteria for this test and implies compliance by stating "Completion of all performance tests concludes that the Verrata PLUS Pressure Guide Wire is substantially equivalent..." It does not provide specific performance results for this test. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of devices/wires) used for each individual bench test. Terms like "Sample wires" (for visual inspection, fluid ingress) are used, suggesting a subset was tested, but no specific number is given.
Data provenance: The testing described is non-clinical bench testing. The data is generated from laboratory experiments and simulations, not from human or animal subjects. Therefore, there is no country of origin of data in the human/clinical sense, nor is it retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests described are bench tests with clearly defined physical and chemical parameters and product specifications. There is no expert review or human interpretation involved in establishing the "ground truth" for these tests, as the ground truth is based on objective measurements and established physical/chemical standards.
4. Adjudication method for the test set
Not applicable. As described above, these are objective bench tests, not clinical studies requiring adjudication of expert opinions.
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
Not applicable. This document describes a medical device (pressure guide wire), not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study or AI-related comparative effectiveness was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
The ground truth for these tests is based on:
- Product Specifications: For wire outer diameter, accuracy, drift, and tensile strength.
- Established Industry Standards: ISO 10993 for biocompatibility, ASTM F756, ASTM D6499.
- Objective Visual Assessment: For cable routing and sensor alignment.
- Functional Performance Requirements: For zeroing, connection durability, and fluid ingress comparison to the predicate.
- Simulated Use Performance: For deliverability/compatibility in heart models.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set.
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