(365 days)
The SCIMED Informer™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire is not intended for use in the cerebral vasculature. The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment. The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts.
The SCIMED® Informer™ Pressure Wire System consists of the following components:
- · a guide wire,
- · a disposable transducer with attached cable, and
- · a permanent cable.
The guide wire is a steerable coronary guide wire available in a nominal diameter of 0.014 inches, overall lengths of 185 and 300 centimeters, radiopaque tip lengths of 3 and 5 centimeters, straight and J-tip configurations and one tip flexibility that falls between the ChoICE Floppy and Intermediate models, similar to the ChoICE Extra Support. The guide wire is designed to monitor intravascular pressures and to facilitate the placement of balloon dilatation catheters.
The disposable transducer with attached cable converts hemodynamic pressure signals from the guide wire into electrical signals. This transducer interfaces with standard physiologic monitors to display the electrical signals in phasic waveforms via the permanent cable.
The provided text describes a submission for a medical device called the SCIMED® Informer™ Pressure Wire System, seeking 510(k) clearance from the FDA. This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than establishing de novo acceptance criteria and proving they are met through a specific study with statistical performance metrics.
Therefore, the requested information (acceptance criteria, specific study, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) related to proving a device meets acceptance criteria is largely not applicable in the context of this 510(k) summary.
However, I can extract information related to the testing performed to demonstrate substantial equivalence, which serves a similar purpose in this regulatory pathway.
Here's a breakdown of the available information and what is not available based on the provided text:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria/Performance Metrics: Not explicitly stated as pass/fail criteria with numerical thresholds. The submission focuses on demonstrating "substantial equivalence" to predicate devices through various tests.
- Reported Device Performance: The "Non-Clinical Test Summary" section briefly mentions the types of tests conducted.
| Test Category | Description of Test / Performance Assessment |
|---|---|
| In-Vitro Tests | |
| Informer™ Guide Wire | Standard guide wire tests were used to evaluate. (No specific performance metrics provided in this summary) |
| Disposable Transducer | Experienced standard ANSI/AAMI BP-22 testing. (No specific performance metrics provided in this summary) |
| Cable Testing | Included Cable Connection Cycling, Disposable Transducer Cable Connector Tensile, Transducer Housing/Cable Tensile, Strain Relief and Permanent Cable Connector Tensile. (No specific performance metrics provided in this summary) |
| Complete Informer™ System | System Response and Shelf Life testing was conducted. (No specific performance metrics provided in this summary) |
| In-Vivo Tests | |
| Comparative Testing | Performed to compare pressure reading capabilities and guide wire performance characteristics to currently marketed devices. (No specific performance metrics provided, but implies comparison to predicates) |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text for any of the in-vitro or in-vivo tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The in-vivo testing suggests real-world data, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. The safety and effectiveness summary for a 510(k) primarily relies on engineering performance tests and comparison to predicates, not expert-adjudicated ground truth in a clinical sense for a test set. The in-vivo tests would likely have involved medical professionals, but their role in establishing "ground truth" (e.g., for diagnostic accuracy) is not elaborated upon as this is not a diagnostic device.
4. Adjudication method for the test set:
- Not applicable / Not provided. This concept is usually relevant for studies involving human interpretation or subjective assessments, which are not detailed here for this device.
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 device is not an AI-powered diagnostic tool, and the concept of "human readers improve with AI vs without AI assistance" does not apply. The device's function is to directly measure pressure and facilitate catheter placement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (guide wire, transducer, cable system) that operates in conjunction with physiological monitors and human clinical procedures. It doesn't have a "standalone algorithm" in the sense of AI or image analysis. Its "performance" is its ability to accurately measure pressure and perform its mechanical functions. The in-vivo and in-vitro tests mentioned describe its standalone operational performance.
7. The type of ground truth used:
- For the in-vitro tests, the "ground truth" would be established by the physical standards and measurement techniques defined for each test (e.g., a calibrated pressure source for transducer accuracy, specified forces for tensile tests).
- For in-vivo tests, the comparison of "pressure reading capabilities" and "guide wire performance characteristics" implies a comparison against existing, accepted methods or devices within a clinical setting. The specific "ground truth" for accuracy (e.g., what pressure reading is considered correct) would be determined by the reference standard used in the comparison (e.g., simultaneous measurement with a gold-standard pressure measurement system).
8. The sample size for the training set:
- Not applicable / Not provided. This device is not an AI/machine learning device that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established:
- Not applicable. As above, this device does not utilize a training set.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.