(113 days)
The YOGA Microcatheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.
The YOGA Microcatheter is a variable stiffness, end to end braided single lumen catheter designed to access small, tortuous vasculature. The microcatheter has an outer hydrophilic coating that provides lubricity during navigation of vessels. The lubricious PTFE lined inner lumen is designed to facilitate movement of guide wires and other devices. A radiopaque marker band is provided at the catheter tip to aid fluoroscopic visualization. A luer fitting located on the proximal end of the catheter hub is used to attach accessories. A steam shaping mandrel is provided in the package.
The provided document describes the substantial equivalence determination for the YOGA Microcatheter (K162563) based on its comparison to a predicate device, the ENVOY DA Guiding Catheter (K140080), and other reference devices. The focus of the provided text is on demonstrating the device's functional integrity and biological compatibility through various performance tests, rather than clinical efficacy as would be seen with an AI/ML device.
Here's an analysis of the "acceptance criteria and the study that proves the device meets the acceptance criteria" based on the provided text, structured to address your specific points:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the YOGA Microcatheter are implicitly defined by the "PASS" results for each of the performance tests listed. The device is deemed to meet these criteria if its performance matches or is equivalent to established standards or those of the predicate device.
| Test Title | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Visual Inspection | Samples meet established acceptance criteria (e.g., no defects) | PASS |
| Catheter ID | Catheter ID verified to pass requirements | PASS |
| Catheter OD | Catheter OD measured within established specifications | PASS |
| Catheter Working Length | Catheter working length measured within established specifications | PASS |
| Distal Tip Length | Distal Tip Length measured within established specifications | PASS |
| Catheter Tensile Strength | Withstands specified tensile forces | PASS |
| Hub Luer Taper | Complies with ISO 594-1 and ISO 594-2 | PASS |
| Air Leak testing | No air leakage observed | PASS |
| Flow Rate (static) | Complies with ISO 10555-1 specified flow rates | PASS |
| System Liquid Leakage | No liquid leakage under specified pressure | PASS |
| Flow Rate (dynamic) | Meets dynamic flow rate specifications at 100/300 psi | PASS |
| Burst Pressure (static) | Withstands specified burst pressure | PASS |
| Lumen flush | Meets particulate count requirements per USP | PASS |
| Coating Integrity | Meets particulate count requirements per USP after simulated use | PASS |
| Delamination of PTFE Liner | No delamination of PTFE liner observed | PASS |
| Aseptic Removal | Facilitates aseptic removal per procedure | PASS |
| Steam Shaping | Successful shaping per Instructions for Use | PASS |
| Linear Stiffness Test | Meets linear stiffness specifications | PASS |
| Lateral Stiffness Test | Meets lateral stiffness specifications | PASS |
| Track Testing | Force required to track through anatomical model within limits | PASS |
| Radiopacity (Animal Model) | Distal end of catheter visible under fluoroscopy | PASS |
| Biocompatibility (various tests) | Complies with ISO 10993 series and FDA Bluebook Memorandum G95-1 | PASS |
| Sterilization Assurance Level (SAL) | Achieves SAL of 10^-6 | PASS |
| Shelf-Life (3 years) | Demonstrated shelf-life equivalent to predicate devices | PASS |
Study Details
The provided document describes physical and biological performance testing for a medical device (microcatheter), not an AI/ML device. Therefore, many of your specific questions regarding AI/ML studies (like ground truth, experts, MRMC, standalone performance) are not applicable to this submission. However, I will answer the relevant points based on the provided text.
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Sample size used for the test set and the data provenance:
- Sample Size: The document states that "All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures." However, specific sample sizes for each test are not provided in this document.
- Data Provenance: The tests are "bench" (in vitro) and "animal" (in vivo) tests conducted by the manufacturer, Codman & Shurtleff, Inc. The document does not specify the country of origin for the animal studies, but the manufacturer is based in Raynham, Massachusetts, USA. The studies are prospective as they were conducted to support the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes performance testing for a physical medical device, not an AI/ML algorithm requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests is based on established engineering and biological standards (e.g., ISO, ASTM, USP).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are typically relevant for human review of AI/ML outputs or clinical endpoints with subjective interpretation. For the physical and biological tests described, the determination of "PASS" or "FAIL" would be based on objective measurements against pre-defined acceptance criteria, not an adjudication process involving multiple human reviewers.
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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 is not applicable. This document describes the clearance of a physical medical device and does not involve AI or human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a microcatheter, a physical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is based on established engineering standards, international standards (ISO, ASTM, USP), and validated internal design control procedures. For example, tensile strength is measured against engineering specifications, biocompatibility against ISO 10993 standards, and flow rates against ISO 10555-1. For radiopacity, the ground truth is the visual confirmation by a qualified individual (presumably a radiologist or veterinarian during the animal study) that the catheter is visible under fluoroscopy.
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The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established:
- This is not applicable. There is no "training set" for this physical device.
§ 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).