(74 days)
The PrimeWire PRESTIGE® Plus Pressure Guide Wire Device 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 PrimeWire PRESTIGE® Plus pressure guide wire is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The PrimeWire PRESTIGE® Plus guide wire measures pressure when used with the SmartMap®, s5™ Family, and ComboMap® systems. The PrimeWire PRESTIGE® Plus guide wire 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 PrimeWire PRESTIGE® Plus guide wire is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.
The document K111395 describes the Volcano PrimeWire PRESTIGE® Plus Pressure Guide Wire, a steerable guide wire with a pressure transducer, which is substantially equivalent to the predicate device, PrimeWire PRESTIGE® Pressure Guide Wire (K100930).
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "Design Input Description" as the acceptance criteria and the "Required Testing, Leveraged, or Justification" as the reported device performance.
| Acceptance Criteria (Design Input Description) | Reported Device Performance (Required Testing, Leveraged, or Justification) |
|---|---|
| Working Length - product shall come in 185cm and 300 cm lengths | Testing |
| Flexible Distal Length - length of flexible section shall be ~ 30 cm in length | Testing |
| Distal Radiopaque Length - length of distal tip shall be 3.0 cm | Testing |
| Maximum outer diameter of .0145" | Justification – 100% verified in manufacturing |
| The distal 1.0 cm of the wire shall be equivalent stiffness to the predicate device tip. | Testing |
| Better torqueability than predicate device in distal or tortuous anatomy. | Testing |
| Maintain lubricity within the body throughout procedure (approx. 60 minutes). | Testing |
| Particulate generation in simulated use shall meet USP 788: Maximum of 3000 particles $\ge$ 10 microns; maximum of 300 particles $\ge$ 25 microns. | Testing |
| Sensor Housing to Core Tensile shall be $\ge$ 1.0 pounds. | Testing |
| Tip Tensile $\ge$ 1.0 pounds. | Testing |
| Turns to Failure $\ge$ 10 turns | Testing |
| Wire connector must withstand 10 insertions in connector. | Testing |
| Sensor shall have same accuracy as predicate device | Leveraged from previously cleared predicate device |
| Sensor drift shall not exceed 5 mmHG in 10 minutes | Leveraged from previously cleared predicate device and 100% verified in manufacturing |
| Subjecting PLUS to clinically relevant tortuosity shall not cause erratic output | (No explicit testing method mentioned; implied by "No change from predicate device" for this input) |
| 3 year shelf life | Testing |
| Biocompatibility | Testing |
| Packaging | Leveraged from previously cleared predicate device |
| Sterilization | Leveraged from previously cleared predicate device |
Biocompatibility Acceptance Criteria and Performance:
| Test Description | Results |
|---|---|
| Cytotoxicity Study using the Colony Assay Extraction Method | Pass |
| ISO Intracutaneous Study (Irritation Test), Extract 0.9% NaCl | Pass |
| ISO Intracutaneous Study (Irritation Test), Extract Sesame Oil | Pass |
| ISO Systemic Toxicity Study, Sesame Oil | Pass |
| ISO Systemic Toxicity Study, 0.9% NaCl | Pass |
| ISO Maximum Sensitization Study, Extract Sesame Oil | Pass |
| ISO Maximum Sensitization Study, Extract 0.9% NaCl | Pass |
| Pyrogen Study, Material Mediated, 0.9% NaCl | Pass |
| ASTM Partial Thromboplastin Time - Plasma Extract | Pass |
| ASTM Hemolysis CMF PBS Extract | Pass |
| C3a Complement Activation (Hemocompatibility), Normal Human Serum Extract | Pass |
| SC5b-9 Complement Activation (Hemocompatibility), Human Serum Extract | Pass |
| In Vivo Thromboresistance Study, Peripheral Vessel / Jugular Vein | Pass |
| Preliminary Extraction, Japanese MHLW | Pass |
| Exaggerated Extraction Method 1 or 2, Japanese MHLW | Pass |
| Maximum Sensitization Study, Method 1 or 2, MHLW | Pass |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes for each of the performance tests (e.g., how many wires were tested for tensile strength or torqueability). It generally refers to "Testing" being performed.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a medical device modification, the testing is typically conducted by the manufacturer (Volcano Corporation, US-based) in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are physical and chemical characteristic evaluations of the device, rather than diagnostic interpretations requiring human expert consensus.
4. Adjudication method for the test set:
Not applicable. The tests are objective physical and chemical measurements rather than subjective interpretations requiring adjudication.
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 a medical instrument (pressure guide wire), not an AI-assisted diagnostic tool or software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth for most performance criteria is defined by established engineering and material science standards, ISO standards (e.g., ISO 10993-1 for biocompatibility), USP standards (e.g., USP 788 for particulate generation), and the performance characteristics of the legally marketed predicate device (K100930). For example, "Sensor shall have same accuracy as predicate device" means the predicate device's accuracy serves as the ground truth.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a "training set" or AI.
§ 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.