(57 days)
The LiquID Guide Catheter Extension is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
The LiquID device is a guide catheter extension that is substantially equivalent to currently marketed devices with the distinction of having a larger intraluminal diameter. The device is available in two models: Liquid 061 and LiquID 071 which are designed to fit within 6F and 7F conventional guide catheters, respectively. The device has a 150 cm working length and a 0.018" diameter proximal stainless-steel shaft connected to a 15cm single lumen distal shaft (exchange length).
The LiquID device distal shaft includes an internal PTFE liner, a MP35N coil internally clad with a tantalum core for support and radiopacity, and an exterior nylon-based encapsulation layer. The rounded and atraumatic distal tip includes PTFE and Pebax that is monolithically attached (no joints) to the distal shaft. The distal shaft exterior is wiped with silicone fluid for lubricity.
The transition between the single lumen distal shaft and proximal shaft includes a stainless collar that is welded to the proximal shaft, positioned over the PTFE liner, and encapsulated in polymer. This construction provides a smooth transition and structural integrity.
The LiquID device has proximal positioning marks (laser created oxide marks) that are approximately 95cm and 105cm from the distal tip and has a colored proximal handle that follows the coronary guide catheter size color code. The proximal shaft is not coated.
The LiguID device is packaged in a HDPE hoop within a Tyvek poly sealed pouch. The pouch is contained in an SBS shelf box. Twenty-five (25) shelf boxes are contained within a shipping container. The shipping containers are used for transporting the devices between the manufacturer, the ethylene oxide (EO) sterilization contractor, and the distribution locations.
The document provided is a 510(k) premarket notification for a medical device (guide catheter extension). It does not describe a study involving an AI algorithm or software. Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, pertaining to AI-related aspects like sample size, ground truth, expert adjudication, or MRMC studies, cannot be extracted from this document.
The document focuses on the physical and functional performance of the medical device itself, establishing its substantial equivalence to predicate devices. It lists verification tests, biocompatibility tests, and sterilization validation:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Test Name | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Physical/Functional | Shaft Marker Location and Visibility | (Not explicitly stated, but implied to be within design specifications and visible) | Met specified acceptance criteria |
| Inside Diameter | (Not explicitly stated, but implied to be within design specifications) | Met specified acceptance criteria | |
| Outside Diameter | (Not explicitly stated, but implied to be within design specifications) | Met specified acceptance criteria | |
| Working Length | (Not explicitly stated, but device specs mention 150 cm) | Met specified acceptance criteria | |
| Exchange Length | (Not explicitly stated, but device specs mention 15 cm) | Met specified acceptance criteria | |
| Distal Tip Length | (Not explicitly stated, but implied to be within design specifications) | Met specified acceptance criteria | |
| Device Preparation | (Not explicitly stated, but implied to be functional and as intended) | Met specified acceptance criteria | |
| Functionality with a Hemostasis Valve | (Not explicitly stated, but implied to be compatible and functional) | Met specified acceptance criteria | |
| Trackability | (Not explicitly stated, but implied to meet performance for guiding in vasculature) | Met specified acceptance criteria | |
| Contrast Injection | (Not explicitly stated, but implied to function effectively for contrast delivery) | Met specified acceptance criteria | |
| Compatibility with Interventional Devices | (Not explicitly stated, but implied to allow placement of interventional devices) | Met specified acceptance criteria | |
| Radiopacity | (Not explicitly stated, but implied to be visible under fluoroscopy) | Met specified acceptance criteria | |
| Kink Resistance | (Not explicitly stated, but implied to resist kinking during use) | Met specified acceptance criteria | |
| Distal and Proximal Flexibility | (Not explicitly stated, but implied to meet flexibility requirements for navigation) | Met specified acceptance criteria | |
| Surface Inspection | (Not explicitly stated, but implied to be free of defects) | Met specified acceptance criteria | |
| Tensile and Torsional Strength | (Not explicitly stated, but implied to withstand forces during use) | Met specified acceptance criteria | |
| Push Rod to Attachment Bend | (Not explicitly stated, but implied to demonstrate structural integrity) | Met specified acceptance criteria | |
| Burst Pressure | (Not explicitly stated, but implied to withstand internal pressure) | Met specified acceptance criteria | |
| Corrosion Resistance | (Not explicitly stated, but implied to resist corrosion in physiological environment) | Met specified acceptance criteria | |
| Coating Durability | (Not explicitly stated, but implied to maintain integrity during use) | Met specified acceptance criteria | |
| Particulate Evaluation | (Not explicitly stated, but implied to have acceptable particulate levels) | Met specified acceptance criteria | |
| Biocompatibility | Cytotoxicity | In accordance with ISO 10993-1 | Passed |
| Sensitization | In accordance with ISO 10993-1 | Passed | |
| Irritation | In accordance with ISO 10993-1 | Passed | |
| Systemic Toxicity | In accordance with ISO 10993-1 | Passed | |
| Pyrogenicity | In accordance with ISO 10993-1 | Passed | |
| ASTM Hemolysis | In accordance with ISO 10993-1 | Passed | |
| Complement Activation | In accordance with ISO 10993-1 | Passed | |
| Thrombogenicity | In accordance with ISO 10993-1 | Passed | |
| Sterilization | Sterility Assurance Level (SAL) | SAL of 10-6 (implied standard, based on common medical device requirements) | Validated to meet a SAL of 10-6 in accordance with ISO 11135 (document states 10e-9, which is a stricter SAL, confirming compliance). |
2. Sample size(s) 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 document. The listed tests are likely laboratory bench tests and material characterization, not studies involving human or animal data sets in the context of AI.
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):
Not applicable. This document does not describe studies involving human interpretation or ground truth establishment by experts for data sets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device submission.
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 device is a physical medical instrument, not an AI software/algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device's performance would be engineering specifications, material properties, and established biological safety standards, not medical diagnostic ground truth.
8. The sample size for the training set:
Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established:
Not applicable. There is no AI algorithm being trained.
§ 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).