FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The ISAAC™ Neurovascular Navigation Catheter is indicated for use in facilitating advancement of catheters through the neuro and peripheral vasculature and introduction of diagnostic agents. The ISAAC™ Neurovascular Navigation Catheter is not intended for use in the coronary vasculature.

Device Description

The ISAAC™ Neurovascular Navigation Catheter) is a braid-reinforced variable stiffness catheter with a pre-shaped distal segment. The distal end of the catheter is coated with a hydrophilic coating around the curve of the pre-shaped section of the Simmons (SIM) configuration. It is a single lumen catheter with a radiopaque distal coiled section and a Luer hub on the proximal end. The ISAAC Catheter is sterile, non-pyrogenic and intended for single use only.

AI/ML Overview

The FDA 510(k) summary for the MicroVention, Inc. ISAAC Neurovascular Navigation Catheter (K222115) indicates that a range of performance testing was conducted to demonstrate the device's substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria / Performance Claim	Reported Device Performance
Physical Attributes	Measurement of usable length, proximal/distal outer diameters, distal length, and inner diameters.	Pass
Tip Flexibility	Device shall have less force to bend at the distal tip than the comparator reference device.	Pass
Simulated Use	Performance rated during simulated-use testing in benchtop vessel model.	Pass
Radio Detectability	Catheter must be visible under X-ray fluoroscopy.	Pass
Kink Resistance	Kink resistance measured by subjecting the device to bending in simulated tortuous anatomy.	Pass
Static Burst	Fluid injected into the lumen at increasing pressure until catheter burst while distal tip occluded.	Pass
Liquid Leakage	Pressure maintained for 30 seconds with occluded distal tip; device inspected for leakage per ISO 10555-1.	Pass
Leakage and Damage Under High Static Pressure Conditions	Dyed fluid injected until rated burst pressure reached and held for 10 seconds while distal tip occluded.	Pass
Air Leakage	Vacuum applied; observed for air bubbles per ISO 80369-7 and ISO 10555-1.	Pass
Dynamic Burst	Catheter injected with fluid at a set pressure and inspected for damage.	Pass
Force at Break (Hub/Distal)	Hub/distal sections secured into tensile test machine; pulled until catheter broke, pull force recorded.	Pass
Particulate Testing	Catheter underwent simulated-use testing in a benchtop model and evaluated for particulates.	Pass
Surface Contamination	Device must be free from visible surface defects.	Pass
Corrosion Resistance	Catheter tested per ISO 10555-1 and ISO 11070.	Pass
Coating Durability and Lubricity	Device secured to tensile machine, hydrated, force to slide through clamp recorded (20 cycles for lubricity, 100 cycles for durability).	Pass
Catheter Flexural Fatigue	Tensile strength and pressure characteristics measured per ISO 10555-1.	Pass
Hub and Luer Connector	Luer connector tested to dimensional and performance requirements per ISO 80369-7.	Pass
Stiffness	Catheter stiffness profile compared to the reference device.	Pass
Torque Strength	Evaluated by measuring number of catheter rotations until failure after tracking through a tortuous anatomical model.	Pass
Biocompatibility (Cytotoxicity)	Non-cytotoxic	Non-cytotoxic
Biocompatibility (Irritation Reactivity)	Non-irritant	Non-irritant
Biocompatibility (Maximization - Sensitization)	Non-sensitizing	Non-sensitizing
Biocompatibility (Systemic Toxicity)	Non-acute systemically toxic	Non-acute systemically toxic
Biocompatibility (Pyrogenicity)	Non-pyrogenic	Non-pyrogenic
Biocompatibility (Hemocompatibility In-Vitro Blood Loop Assay)	Thrombogenic risk potential similar to the predicate	Similar to predicate
Biocompatibility (Hemocompatibility Hemolysis Assay)	Non-hemolytic	Non-hemolytic
Biocompatibility (Hemocompatibility Complement Activation Assay)	Non-activator of complement system	Non-activator of complement system
Biocompatibility (Hemocompatibility Partial Thromboplastin Time (PTT) Assay)	No effect on the PTT	No effect on PTT
Biocompatibility (Hemocompatibility Heparinized Blood Platelet and Leukocyte Count Assay)	Pass	Pass
Animal Study (Tracking Performance, Support, Safety)	Perform comparably to the control article (Chaperon Guiding Catheter) in terms of tracking, support, and safety.	Performed comparably
Animal Study (Device-associated Complications)	No significant device-associated complications (dissection, perforation, embolic debris, thrombus, hemorrhage, ischemia, necrosis, fibrin deposition, IEL rupture, EEL rupture, mineralization, neointimal maturation, medial/adventitial injury/fibrosis).	No significant complications

2. Sample Size Used for the Test Set and Data Provenance:

Benchtop and Biocompatibility Testing: The specific sample sizes for each individual benchtop and biocompatibility test are not explicitly detailed in this summary. However, these tests are generally conducted on a statistically significant number of device units or material samples to ensure representativeness and reproducibility.
Animal Study: The animal study was conducted using a "porcine model." The exact number of animals involved is not specified, but it's referred to as an "acute animal testing" in a "porcine model."
Data Provenance:
- Benchtop Testing: Likely laboratory-generated data from MicroVention, Inc., performed under controlled conditions.
- Biocompatibility Testing: Performed on material extracts or the device itself, likely by specialized laboratories following ISO standards.
- Animal Study: Conducted in accordance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58), indicating a prospective study specifically designed to assess the device. The provenance is internal to the controlled study environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Benchtop and Biocompatibility Testing: The summary does not specify the use of "experts" to establish a ground truth in the traditional sense (e.g., for image interpretation). Instead, these tests rely on objective, measurable criteria defined by established international standards (e.g., ISO, ASTM). The "ground truth" would be the direct measurement or observation of the device's physical, mechanical, and biological properties against predefined limits or comparison with a predicate.
Animal Study: The evaluation of the animal study results regarding complications and performance comparability would involve veterinarians and potentially pathologists who are experts in animal physiology and disease interpretation. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set Without Explanation:

Benchtop and Biocompatibility Testing: An "adjudication method" in the sense of resolving discrepancies between multiple expert interpretations is generally not applicable to the objective measurements performed in these tests. Results are typically pass/fail based on predetermined specifications or direct comparison to controls/predicates.
Animal Study: While not explicitly stated, observations in animal studies, especially pathological findings, often involve review by multiple experts (e.g., veterinary pathologists). If discrepancies occur, an adjudication process involving consensus or a tie-breaking expert would likely be in place, though this is not detailed in the provided text.

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. The ISAAC Neurovascular Navigation Catheter is a physical medical device (catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not Applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Benchtop Testing: Objective physical and mechanical measurements, adherence to industry standards, and comparison to predicate device characteristics.
Biocompatibility Testing: Results obtained from standardized biological assays (e.g., cell cultures, animal models for irritation/sensitization) providing objective data on biological reactions, evaluated against established acceptance criteria (e.g., "non-cytotoxic," "non-irritant").
Animal Study: Direct observation of device performance (tracking, support) and histological/pathological assessment for complications (e.g., dissection, thrombus, tissue injury) in a living porcine model, compared against the control article.

8. The Sample Size for the Training Set:

Not Applicable. This is a physical medical device, and the concept of a "training set" for an AI algorithm is not relevant here. The device design and manufacturing process would involve extensive engineering development and iterative testing (developmental testing) which is distinct from an AI training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no "training set" in the context of an AI algorithm for this device, a method for establishing its ground truth is not relevant. The device development relies on engineering principles, material science, and performance testing against established standards and predicate device characteristics.

Summary

Regulation Number and Section

§ 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).