(110 days)
The PV 2000 Synchro®2 Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
The PV 2000 is a member of the Synchro® Guidewire family of products having a 0.014" outside diameter, being a sterile, single use/disposable product, with a shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral and neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer/shaping mandrel (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 35cm length. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal portion of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.
The provided text describes safety and performance tests for the PV 2000 Synchro®2 Guidewire to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria or a study proving that a device meets its acceptance criteria. Therefore, most of the requested information cannot be extracted directly from the given content.
However, based on the information provided, here's what can be addressed:
1. A table of acceptance criteria and the reported device performance:
The document states that "Performance testing of materials comprising the PV 2000 Synchro®2 Guidewire was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers." It then lists the types of tests performed and their outcomes. While specific numerical acceptance criteria are not explicitly stated, the reported performance is that each test yielded "acceptable safety & performance outcomes" or "acceptable results."
| Test Category | Acceptance Criteria (Not explicitly stated in numerical terms) | Reported Device Performance |
|---|---|---|
| Performance Testing (ISO 11070:1998) | Assumed to be compliance with ISO standard and safety/performance benchmarks | "acceptable safety & performance outcomes" |
| Dimensional inspection | Assumed to meet design specifications | "acceptable safety & performance outcomes" |
| Fatigue assessment | Assumed to meet durability requirements | "acceptable safety & performance outcomes" |
| Tip flexibility | Assumed to meet functional requirements | "acceptable safety & performance outcomes" |
| Tip shaping | Assumed to meet functional requirements | "acceptable safety & performance outcomes" |
| Tensile strength | Assumed to meet mechanical strength requirements | "acceptable safety & performance outcomes" |
| Guidewire compatibility testing | Assumed to be compatible with other devices | "acceptable safety & performance outcomes" |
| Performance under simulated conditions | Assumed to meet functional requirements in simulated clinical use | "acceptable safety & performance outcomes" |
| Torsional strength | Assumed to meet mechanical strength requirements | "yielded acceptable results" |
| Torqueability | Assumed to meet functional requirements for steerability | "yielded acceptable results" |
| EO sterilization adoption tests | Assumed to meet sterilization effectiveness requirements | "yielded acceptable results" |
| Biocompatibility Testing (ISO 10993-1) | Assumed to be compliance with ISO standard for biological safety | "confirmed biocompatibility of the subject device" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given text. The document mentions "Performance testing of materials" and "tests," but does not specify sample sizes for these tests. The country of origin of data or whether it was retrospective or prospective is also not mentioned.
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):
This information is not provided in the given text, as the tests described are primarily engineering and material performance tests, not clinical studies requiring expert ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given text.
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:
This information is not provided in the given text. The device is a guidewire, a physical medical instrument, not an AI-assisted diagnostic or interventional system that would typically undergo MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a physical guidewire, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the performance and biocompatibility tests, the "ground truth" or reference for acceptance would be:
- Engineering specifications and regulatory standards: For dimensional inspection, fatigue, tensile strength, torsional strength, torqueability, tip flexibility, tip shaping, guidewire compatibility, and performance under simulated conditions.
- ISO 10993-1 and ISO 11070:1998 standards: For biocompatibility and design/material performance.
- Sterilization validation protocols: For EO sterilization adoption tests.
There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the tests described.
8. The sample size for the training set:
This information is not applicable as the device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is not an AI algorithm that requires 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.