(207 days)
The Trellis-8 Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The Trellis-8 Peripheral Infusion System enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. The device also has a central lumen that is compatible with a 0.035" guidewire. The Dispersion Wire provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit (ODU) that oscillates the Dispersion Wire within the isolated region to further disperse the infused fluid. Once the procedure is complete, the contents in the treatment area can be aspirated via the guide wire lumen and the infusion/aspiration (IA) window if desired.
This document pertains to the Trellis-8 Peripheral Infusion System, a medical device intended for controlled and selective infusion of physician-specified fluids into the peripheral vasculature. The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. As such, some of the requested information cannot be directly extracted or is not applicable to this type of submission.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in the format of a table. Instead, it describes various performance tests performed to demonstrate substantial equivalence to an existing predicate device (Trellis-8 Peripheral Infusion System K050147). The "reported device performance" is the successful completion of these tests, indicating that the modified device "continues to meet the product specifications" and "causes no more vessel trauma than the predicate."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Integrity | The device met requirements for tensile strength, kink resistance, catheter trackability, and compliance with sheath and guidewire. |
| Balloon Integrity | The device met requirements for balloon seal, burst pressure, and tensile strength. |
| ODU and Dispersion Wire Integrity | The ODU and Dispersion Wire met requirements for speed, torque, and hemostatic valve seal. |
| Vessel Trauma | The modified device caused no more vessel trauma than the predicate device in animal testing. |
| Biocompatibility | The device passed biocompatibility testing per ISO 10993, demonstrating it is biocompatible for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each bench test. For animal testing, the sample size is not explicitly stated but it is implied that a sufficient number of animals were used to assess vessel trauma. The data provenance is primarily from bench testing and animal testing conducted by the manufacturer, Covidien. The country of origin for this testing is not specified, but the manufacturer is based in Mansfield, MA, USA. This appears to be retrospective testing performed on the modified device to compare it to the predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as this submission is for substantial equivalence based on bench and animal testing, not a clinical study involving expert assessment of patient-specific outcomes or images. Ground truth in this context refers to the performance specifications and the comparative assessment against the predicate device.
4. Adjudication Method for the Test Set
This is not applicable as there are no human adjudicators for the specified bench and animal tests. The assessment is based on objective measurements and comparisons to predefined specifications or the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic devices that involve human interpretation of images or data, which is not the primary function of the Trellis-8 Peripheral Infusion System as described.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not performed. This phrase is typically used for AI/ML algorithms. The Trellis-8 Peripheral Infusion System is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for the performance data in this submission is established through:
- Engineering specifications and test methodologies: For mechanical, balloon, and ODU/Dispersion Wire integrity.
- Comparative animal studies: For assessing vessel trauma against the predicate device.
- International standards (ISO 10993): For biocompatibility testing.
8. Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).