(60 days)
The ViperCath XC Peripheral Exchange Catheter is intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.
The ViperCath XC Exchange Catheter (ViperCath XC) is intended to be used to facilitate vascular access and guidewire exchanges during peripheral vascular intervention procedures. It is provided in a 200 cm length, to facilitate the radial access approach, with either a straight or angled tip. There are no accessories for this device. The catheter shaft has radiopaque marker bands at distances of 1 cm and 5 cm from the distal tip. Two additional printed markers are located 120 cm and 150 cm from the distal tip and are provided to aid with placement.
The provided document is a 510(k) premarket notification for a medical device called the ViperCath XC Peripheral Exchange Catheter. It outlines the device's intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy) because the device being reviewed is a physical medical instrument (catheter), not an AI/software device. Instead, the "acceptance criteria" for this type of device are met through demonstrating functional equivalence and safety to a legally marketed predicate device via a series of performance and safety tests.
The table below summarizes the comparison to the predicate device and the types of testing performed on the ViperCath XC, which effectively serve as the criteria for its acceptance by the FDA for substantial equivalence.
| Acceptance Criteria (Implied by Equivalence to Predicate and Performance Testing) | Reported Device Performance / Evidence |
|---|---|
| Functional and Physical Characteristics: |
- Effective Length(s): 200 cm compatible with specified use. | 200 cm (Specific to the subject device for radial access).
- Recommended Guide Catheter Compatibility: 5 Fr | 5 Fr
- Shaft Design: Braid-reinforced for support and pushability. | Braid-reinforced
- Tip Shape: Straight, Angled for navigation. | Straight, Angled
- Maximum Injection Pressure: Ability to withstand pressure during fluid delivery. | 600 psi
- Guidewire Compatibility: 0.035" | 0.035"
- Hydrophilic Coating: Presence/absence as per design. | No (Differentiator from predicate, but not identified as a safety/effectiveness concern).
- Sterility: Sterilized for single use. | Yes
- Single Use: Disposable after one use. | Yes
Biocompatibility (Safety): | - Non-toxic to biological systems. | Passed Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Thrombogenicity, Pyrogenicity tests.
Bench Testing (Performance & Safety): | - Dimensional Verification: Conformance to specified dimensions (luer, shaft, tip). | Performed
- Bond Strengths: Structural integrity of device components. | Performed
- Tracking: Ability to navigate through vasculature. | Performed
- Guidewire Exchange: Facilitates smooth guidewire exchange. | Performed
- Radiopacity: Visibility under fluoroscopy. | Performed
- Wrap/Kink Resistance: Resists kinking or wrapping. | Performed
- Torque Transfer: Efficient transfer of torque from hub to tip. | Performed
- Torque to Failure: Ability to withstand twisting forces. | Performed
- Fluid Flow: Adequate flow rate for injectates. | Performed
- Burst Pressure: Withstands internal pressure without rupture. | Performed
- Leakage: Prevents leakage of fluids. | Performed
Overall Safety and Effectiveness: | - No new questions of safety or effectiveness identified compared to the predicate device. | Conclusion: "The ViperCath XC Exchange Catheter data supports that no new questions of safety or effectiveness were identified compared to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in terms of patients or a test set, as this is a 510(k) submission for a physical medical device based primarily on bench testing and biocompatibility studies, not a clinical study involving a patient test set for performance metrics like sensitivity or specificity.
- Test Set: Not applicable in the context of a clinical test set. The "test set" here refers to the actual ViperCath XC devices that underwent the various bench and biocompatibility tests. The exact number of devices tested for each parameter is not provided in this summary.
- Data Provenance: The testing was conducted by Cardiovascular Systems, Inc. in accordance with applicable standards and guidance (e.g., FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 2010)). This testing is typically performed in a laboratory setting, not derived from patient data from a specific country or as retrospective/prospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. For this type of device submission, "ground truth" is established through engineering specifications, material science, and established laboratory testing protocols and standards, rather than expert consensus on diagnostic interpretations. The "experts" involved would be engineers, material scientists, and toxicologists who design and conduct these tests and interpret the results against predefined safety and performance criteria. Their qualifications are inherent in their roles in a medical device company and adherence to regulatory standards.
4. Adjudication Method for the Test Set
- Not applicable. As there is no clinical test set requiring expert interpretation, there is no need for an adjudication method like 2+1 or 3+1. Performance is based on direct measurement and observation during physical and chemical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?
- Not applicable. This device is a physical catheter, not an AI or software device. Therefore, no MRMC study involving human readers or AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical catheter, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the ViperCath XC Peripheral Exchange Catheter is established by:
- Engineering Specifications: The design and manufacturing specifications of the device itself (e.g., dimensions, material properties, bond strengths).
- Industry Standards and Regulatory Guidance: Adherence to recognized national and international standards for medical devices (e.g., ISO standards for biocompatibility, FDA guidance documents for catheters).
- Direct Measurement and Observation: Results from bench tests are directly measured (e.g., burst pressure, fluid flow) or observed to meet established pass/fail criteria (e.g., no leakage, successful guidewire exchange).
- Chemical and Biological Analysis: Results from biocompatibility tests are analyzed against established criteria for toxicity, sensitization, etc.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The engineering design and manufacturing processes are refined through iterative development, but this is distinct from training an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 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).