(26 days)
The OmniWire 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 facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
The OmniWire pressure guide wire is a steerable guide wire with a pressure sensor mounted 3 cm proximal to the tip. The pressure guide wire measures pressure when used with the IntraSight and CORE Series of systems and is intended to be used in adult patients eligible for endovascular procedures. The pressure guide wire has a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straight or pre-shaped tips. It is coated with hydrophilic coating (39 cm length) on the distal portion to reduce surface friction and enhance lubricity. It is also coated with a hydrophobic coating (146 cm length) on the proximal portion to reduce surface friction. The pressure guide wire is packaged attached to the connector with an OmniWire-specific torque device to facilitate navigation through the vasculature.
This document is a 510(k) summary for the OmniWire Pressure Guide Wire (K202543). It indicates that the device is substantially equivalent to a previously marketed predicate device (OmniWire Pressure Guide Wire, K192886).
Based on the provided information, the device is a pressure guide wire, and the 510(k) is for demonstrating its substantial equivalence. The document explicitly states that no new clinical testing was completed, nor relied upon, in support of this Special 510(k) submission. Therefore, the information regarding acceptance criteria and studies demonstrating that the device meets these criteria is very limited to what is typically found in a clinical study report.
However, the document does contain information about non-clinical testing (bench testing) that was conducted. This bench testing serves as the "study" proving the device meets certain acceptance criteria related to its design, electrical safety, electromagnetic compatibility, and aging.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance (as inferred from Non-Clinical Testing)
| Acceptance Criteria Category | Reported Device Performance (from "Summary of Non-Clinical Testing") |
|---|---|
| System Design Verification | Performed, indicated that the subject device performed as intended. |
| Electrical Safety | Evaluated, indicated that the subject device performed as intended. |
| Electromagnetic Compatibility | Evaluated, indicated that the subject device performed as intended. |
| Aging Studies | Evaluated, indicated that the subject device performed as intended. |
| Physical Properties | "identical design, materials, physical properties, and performance specifications" to the predicate. Example: Wire Diameter: 0.0145", Wire Length: 185 cm, Sterility Assurance Level (SAL): 10^-6 |
Note: The document states that the subject device and the predicate device have identical design, materials, physical properties, and performance specifications. This implies that the acceptance criteria for these physical and performance specifications are met if they are identical to the already cleared predicate device. Specific numerical acceptance criteria for these physical properties are not listed as distinct "acceptance criteria" but are stated as identical to the predicate's known specifications.
Other Requested Information:
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for specific non-clinical tests. The document mentions "Bench testing was completed as part of design verification."
- Data Provenance: Not specified, but generally, bench testing data for medical devices originates from the manufacturer's testing facilities (Volcano Corporation in this case). The document is a 510(k) submission, not a detailed test report. The general context suggests lab-based, pre-market non-clinical testing. It is retrospective in the sense that results are reported after testing is completed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. For non-clinical bench testing, "ground truth" is typically established by engineering specifications, calibration standards, and established testing methodologies (e.g., ASTM, ISO standards) rather than expert consensus on a test set. This type of analysis (expert review to establish ground truth) is more common in clinical studies, especially those involving image interpretation or diagnostic accuracy by human readers.
4. Adjudication method for the test set:
- Not applicable. See explanation for #3. Adjudication methods like 2+1 or 3+1 are primarily used in multi-reader studies to resolve discrepancies in expert interpretation, which is not the nature of the non-clinical bench testing described.
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. The document explicitly states: "No new clinical testing was completed, nor relied upon, in support of this Special 510(k) submission." This device is a physical medical device (pressure guide wire), not an AI-powered diagnostic tool, so an MRMC study comparing human performance with and without AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device for measuring pressure, not a standalone algorithm.
7. The type of ground truth used:
- For the non-clinical testing: The ground truth is engineering specifications, calibrated instruments, and established industry test standards (e.g., for electrical safety, EMC, material properties). The device's performance was compared against these predefined physical and functional requirements.
8. The sample size for the training set:
- Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The "training" for such a device involves its design and manufacturing processes to meet specifications.
9. How the ground truth for the training set was established:
- Not applicable. See explanation for #8.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).