(193 days)
The FluidiTube® 2.7F Infusion Micro Catheter is intended to facilitate infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels and all coronary vessels. It is also intended for drug infusion in intra-arterial therapy and embolic materials for hemostasis. The FluidiTube® 2.7F Infusion Micro Catheter is not to be used in cerebral blood vessels.
The FluidiTube® 2.7F Infusion Micro Catheter is a tapered 2.7F/2.9F single lumen catheter with a luer lock hub designed to facilitate the access of distal vasculature over a guidewire. The FluidiTube® has a semi-rigid proximal shaft that becomes progressively more flexible towards the distal end. The shaft is reinforced with braided stainless steel wire for kink resistance. The inner lumen is lined with a lubricious material to facilitate the movement of a guidewire. The outer surface of the catheter has a hydrophilic coating that becomes lubricious when wet with saline or blood. The FluidiTube® catheter is introduced to the target location through a guiding catheter 0.038" (0.97 mm) or larger and is compatible with 0.021" (0.53 mm) guidewires or smaller. Device configurations consist of one profile size (2.7F) with two different usable lengths (110cm, 130cm). The final device is packaged in a Tyvek pouch and sterilized by ethylene oxide (EO). The device is for single use only.
The document provided is a 510(k) premarket notification for the Callisyn FluidiTube® 2.7F Infusion Micro Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than full clinical trials for novel devices. Therefore, the "acceptance criteria" and "device performance" are typically framed in terms of equivalence to the predicate and meeting established engineering and biocompatibility standards, rather than specific performance metrics like sensitivity/specificity for diagnostic devices.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a medical device (infusion micro catheter), "acceptance criteria" and "device performance" are defined by the comprehensive non-clinical testing and a comparative animal study demonstrating equivalence to the predicate device. The performance is assessed against established engineering standards and functional requirements relevant to the device's intended use.
| Acceptance Criterion (Category) | Specific Test/Evaluation | Acceptance Standard/Methodology | Reported Device Performance (FluidiTube® 2.7F) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | ISO 10993-5:2009 | Compliant |
| Irritation | ISO 10993-10:2010 | Compliant | |
| Sensitization | ISO 10993-10:2010 | Compliant | |
| Acute Systemic Injection | ISO 10993-11:2006 | Compliant | |
| Materials Mediated Rabbit Pyrogen | USP | Compliant | |
| Thrombosis (in vivo) | ISO 10993-4:2002 | Compliant | |
| Hemolysis | ASTM F756-08 | Compliant | |
| Complement Activation - C3a and SC5b-9 Assay | ISO 10993-4:2002 | Compliant | |
| In vitro Mouse Lymphoma with Extended Treatment | ISO 10993-3:2003 | Compliant | |
| In vivo Mouse Micronucleus Assay | ISO 10993-3:2003 | Compliant | |
| ISO Bacterial Mutagenicity Test - Ames Assay | ISO 10993-3:2002 | Compliant | |
| Extractables | ISO 10993-18:2005 | Compliant | |
| Physical & Mechanical Properties | Kink Resistance | Not specified (standard engineering test) | Met specifications |
| Tensile (Catheter) | Not specified (standard engineering test) | Met specifications | |
| Tensile (Hub-catheter) | Not specified (standard engineering test) | Met specifications | |
| Reliability (Marker Band Durability) | Not specified (standard engineering test) | Met specifications | |
| Coating Lubricity | Not specified (standard engineering test) | Met specifications | |
| Corrosion Resistance | Not specified (standard engineering test) | Met specifications | |
| Torqueability Testing | Not specified (standard engineering test) | Met specifications | |
| Guidewire Compatibility | 0.021" (0.53mm) or smaller | Met specifications (compatible with 0.021" in RCA, 0.014" in hepatic artery, 0.018" in iliac artery during animal study) | |
| Static Pressure (Burst) | Not specified (standard engineering test) | Met specifications | |
| Trackability | Not specified (standard engineering test) | Met specifications (successfully tracked microcatheters in animal study) | |
| Flow Rate | Not specified (standard engineering test) | Met specifications | |
| Size, OD and ID | Defined dimensions: distal OD 2.7F (0.90mm), proximal OD 2.9F (0.97mm), ID 0.025in (0.65mm) | Met specifications | |
| Hydrophilic Coating Coverage | Not specified (standard engineering test) | Met specifications | |
| Particulate Testing | Not specified (standard engineering test) | Met specifications | |
| Liquid and Air Leakage Testing | Not specified (standard engineering test) | Met specifications | |
| Guide Catheter Compatibility | 0.038" (0.97mm) or bigger | Met specifications | |
| Sterilization & Packaging | Shelf-life Testing | Not specified (standard stability test) | Compliant |
| Packaging Validation | ISO 11607-1:2006 | Compliant | |
| Simulated Transport Testing | ISTA 2A:2011 | Compliant | |
| Functional Equivalence (Animal Model) | Ability to flush packaging hoop and remove without damage | Qualitative assessment by operators | Acceptable |
| Ability to track through vessels and visualize fluoroscopically | Qualitative assessment by operators | Acceptable | |
| Compatibility with specified guidewires | Qualitative assessment by operators | Acceptable (0.014 in RCA, 0.021 in hepatic artery, 0.018 in iliac artery) | |
| Ability to visualize device under fluoroscopy | Qualitative assessment by operators | Acceptable | |
| Compatibility with infusion of contrast media, therapeutic drugs, and embolic materials | Qualitative assessment by operators | Acceptable | |
| Integrity (no kinking or damage to tip) | Qualitative assessment by operators | Acceptable (no kinking/damage, no | |
| No vascular dissection/thrombus observed | Microscopic/visual inspection post-procedure | No vascular dissection, no thrombus observed |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the simulated use environment (animal study), the document states the study was conducted in "a healthy male Yorkshire swine." This indicates a sample size of one animal.
- Data Provenance: The animal study was prospective, conducted in a simulated use environment using an animal model (Yorkshire swine). The country of origin of the data is not explicitly stated, but it's part of a submission to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Two operators (presumably veterinarians or interventional specialists/researchers experienced in animal models for medical device testing) participated in the animal study.
- Qualifications of Experts: Their specific qualifications (e.g., years of experience, specific board certifications) are not detailed in the document. They are referred to as "Operators."
4. Adjudication Method for the Test Set
The document states: "Both Operators rated all test and control microcatheters as acceptable for:" followed by a list of performance criteria. This implies that:
- There was no explicit adjudication method described beyond the consensus or agreement of the two operators on the "acceptable" rating for all performance features.
- It appears to be a 100% agreement or shared determination approach, as both operators individually rated them as acceptable, and the conclusion mentions "both Operators determined that all study protocol specified acute performance requirements...were successfully met."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is more common for diagnostic imaging devices where reader performance is a key metric. For an infusion microcatheter, the focus is on device function, safety, and equivalence to established products.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical instrument, an infusion microcatheter, not an algorithm or AI system. Therefore, a standalone performance study in the context of an algorithm is not relevant.
7. Type of Ground Truth Used (for the animal study / simulated use)
For the animal study, the "ground truth" was established by the direct observation and qualitative assessment by the two experienced operators during and after the procedure in the swine model. This included visual inspection for tracking success, fluoroscopic visualization, compatibility with other devices, functional performance (infusion), and post-procedure integrity assessment of the catheter and animal vasculature. This falls under expert observation/assessment in a simulated environment.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning. The non-clinical testing (biocompatibility, physical/mechanical) establishes the device's inherent properties and performance against specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no "training set" in the machine learning sense for this medical device. The "ground truth" for the non-clinical testing is based on established engineering standards, ISO standards, and other recognized methodologies (e.g., ASTM, USP).
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).