(207 days)
The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature.
The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel pushrod is covered on the distal end by a semi-circular polymer ("half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The trapping balloon is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon.
The provided text describes a 510(k) premarket notification for the TrapLiner Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific clinical performance acceptance criteria through the kind of study described in the prompt.
Therefore, many of the requested elements (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets) are not applicable or not available in this type of regulatory submission. The submission centers on verification testing against engineering specifications and biocompatibility standards to demonstrate that the new device performs similarly and safely to already approved devices.
Here's the information that can be extracted or inferred from the provided text, alongside explanations for the N/A sections:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, specific numerical acceptance criteria (e.g., "Kink Resistance shall be > X Newtons") and precise reported performance values (e.g., "Kink Resistance was Y Newtons") are not detailed in this summary. The document lists the types of tests performed:
| Test Name | Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Kink Resistance | Met specified criteria | Passed |
| Distal Shaft Flexibility | Met specified criteria | Passed |
| Distal Tip Compression Force | Met specified criteria | Passed |
| Collar Crush Force | Met specified criteria | Passed |
| Interventional Device Passage Track Force | Met specified criteria | Passed |
| Guidewire Holding Force | Met specified criteria | Passed |
| Fluoroscopy Visualization | Met specified criteria | Passed |
| Guide Catheter Backup Support | Met specified criteria | Passed |
| TrapLiner Balloon Deflation, Device Passage | Met specified criteria | Passed |
| TrapLiner Balloon Fatigue | Met specified criteria | Passed |
| TrapLiner Balloon Burst | Met specified criteria | Passed |
| Balloon-to-Shaft Tensile Strength | Met specified criteria | Passed |
| Pushwire-to-Shaft Tensile Strength | Met specified criteria | Passed |
| Distal Tensile Strength | Met specified criteria | Passed |
| Friction Force | Met specified criteria | Passed |
| Hydrophilic Coating Particulate in a Simulated Anatomy | Met specified criteria | Passed |
| Shaft O.D. | Met specified criteria | Passed |
| Shaft Length | Met specified criteria | Passed |
| Effective I.D. | Met specified criteria | Passed |
| Hub Luer Compatibility | Met specified criteria | Passed |
| In Vivo Efficacy | Met specified criteria | Passed |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Pyrogenicity, Hemocompatibility) | Per ISO 10993-1 standards; met specified criteria for each test | Passed all tests |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided summary. These are typically engineering or lab tests, not clinical studies with patients. Sample sizes would refer to the number of device units tested for each specific verification test.
- Data Provenance: Not explicitly stated as "country of origin" for data. The tests are laboratory-based and include an "In Vivo Efficacy" test, which implies animal or cadaveric testing, but the specifics are not provided. The overall submission originates from Vascular Solutions, Inc. in Minneapolis, MN, USA.
- Retrospective or Prospective: Not applicable in the context of device verification testing for a 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for these engineering and biocompatibility tests is based on established scientific principles, industry standards (e.g., ISO 10993-1), and pre-defined acceptance criteria, not expert clinical consensus on patient data.
4. Adjudication method for the test set
- Not applicable. This refers to clinical data review, not engineering test results. Compliance with pre-defined pass/fail criteria is the "adjudication" method.
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 is a physical medical device (catheter), not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI-assisted performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As above, this is a physical medical device, not an algorithm.
7. The type of ground truth used
- For the engineering and mechanical tests, the "ground truth" is defined by pre-specified engineering specifications and performance standards.
- For biocompatibility tests, the "ground truth" is established by adherence to international standards like ISO 10993-1.
- The "In Vivo Efficacy" test's ground truth would have been established by its specific protocol, likely measuring device function in a simulated biological environment, but the details are not provided.
8. The sample size for the training set
- Not applicable. This is a physical medical device, and the concept of "training set" is relevant to machine learning algorithms, not to the verification and validation of a catheter.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).