(239 days)
The Caterpillar and Caterpillar Micro Arterial Embolization Devices are indicated for arterial embolization in the peripheral vasculature. The Caterpillar Micro Arterial Embolization Devices are contraindicated for use in vessels subject to cyclic bending, such as highly locomotive joints or muscle beds.
The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices are self-expanding arterial occlusion plugs. The devices consist of the following components and are intended to be a permanent implant: cobalt-chrome stem, nickel-titanium fibers, platinum-iridium radiopaque marker bands, and a polyurethane and polyethylene occlusion membrane.
The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device Systems are packaged as a single unit with the implant, loader, dispenser hoop, detachable delivery wire, and torque tool. The Caterpillar™M Micro delivery wire is coated with a hydrophilic coating. While the Caterpillar™ delivery wire has a PTFE hydrophobic coating. The system is provided sterile and non-pyrogenic and is intended for single use only.
The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device is designed for a specific arterial diameter range. The artery diameter range and required delivery catheter (ID)) for deployment are provided in the table below.
| Product Name | Product
Reference | Target Artery
Diameter (mm) | Delivery Catheter
Compatibility: Inner
Diameter (in/mm) | Marker to
Marker
Length
(mm)1 | Maximum
Deployed
Length
(mm)2 | Delivery
Wire
Length
(cm) |
|-----------------------|----------------------|--------------------------------|---------------------------------------------------------------|----------------------------------------|----------------------------------------|------------------------------------|
| Caterpillar™
Micro | 027 | 1.5 - 4 | 0.027 / 0.686 | 7 | 16 | 170 |
| Caterpillar™ | 038 | 3 - 6 | 0.038 / 0.965 | 17 | 26 | 155 |
| Caterpillar™ | 056 | 5 - 7 | 0.056/ 1.422 | 18 | 37 | 155 |
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices). This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy through a clinical trial with specific performance metrics against a defined acceptance criterion. The "acceptance criteria" referred to in the document are primarily related to general design verification and safety testing, not specific clinical performance endpoints in the way you might find for an AI algorithm.
Therefore, the answers below will reflect the nature of this type of regulatory submission. There is no information provided in this document regarding AI algorithms, human-in-the-loop performance, or AI-specific ground truth methodologies.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a table of specific numerical acceptance criteria with corresponding performance values for clinical efficacy. Instead, it lists types of tests performed and states that the device "met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs." The animal study concluded that "the study device performance was equivalent or superior to control devices across each of the evaluated endpoints."
Here's an interpretation based on the provided information, focusing on categories of testing:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical & Mechanical Properties: | "Met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs" for: |
| - Dimensions (Implant Length, Catheter Compatibility, Delivery Wire Length and OD) | - Measured values were within specified tolerances. |
| - Radial Force | - Device exhibited sufficient radial force for its intended function. |
| - Luer Connection Testing | - Connections met established integrity standards. |
| - Radiopacity | - Device was adequately visible under fluoroscopy. |
| - Fatigue Resistance (Pulsatile and Pinching) | - Device maintained integrity and function under simulated physiological stresses. |
| Simulated Use & Delivery System Performance: | "Met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs" for: |
| - Visual Inspection | - All components were free from defects. |
| - Delivery, Load, Track, and Deployment Forces | - Forces required were within clinically acceptable ranges. |
| - Accuracy of Deployment | - Device deployed accurately to the target site. |
| - Detachment Time and Mechanism Reliability | - Detachment occurred reliably and within target timeframes. |
| - Tensile and Torsional Strength | - System demonstrated sufficient strength during use. |
| - Recapture and Resheathing for Removal | - Device could be recaptured and resheathed if necessary. |
| - Delivery System Removal (withdrawal) | - System could be safely withdrawn after deployment. |
| Material Safety & Biocompatibility: | "Met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs" for: |
| - Corrosion Resistance | - Materials demonstrated adequate corrosion resistance. |
| - Nickel Leaching | - Nickel leaching was below toxicological thresholds. |
| - Particulate | - Particulate generation was within acceptable limits. |
| - MRI Compatibility and Safety | - Device was demonstrated to be safe and compatible with MRI. |
| - Packaging Testing | - Packaging maintained sterility and protected the device. |
| - Biocompatibility (ISO 10993) | - Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, genotoxicity, hemolysis, and complement activation tests passed. |
- Chronic ovine study also addressed subchronic toxicity, implantation, chronic toxicity, and in vivo thrombogenicity.
- Chemical characterization testing and toxicological assessment evaluated genotoxicity, chronic toxicity, and carcinogenicity. |
| In Vivo Performance (Animal Study): | A chronic ovine study found that "the study device performance was equivalent or superior to control devices across each of the evaluated endpoints," which included: - Migration resistance
- Ease of delivery
- Occlusion efficiency
- Recanalization
- Deliverability
- Hemostasis after procedure
- Thrombogenicity
- Device safety
- Freedom from complications |
Regarding aspects typically related to AI performance, the document does not contain information on the following:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No "test set" in the context of an AI algorithm. Performance data was generated through various bench tests and one pre-clinical animal study.
- Animal Study Sample Size: Not explicitly stated, but implies multiple animals to evaluate chronic effects and comparisons.
- Data Provenance: Non-clinical (bench) and pre-clinical (animal) studies. No human data (clinical data) is mentioned as a "test set" for performance evaluation in this 510(k) summary.
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 for this type of device submission. "Ground truth" in the context of an AI algorithm is not relevant here. For the animal study, evaluations would typically be done by veterinary specialists, pathologists, and dedicated study personnel according to a protocol.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device submission. This is relevant for AI image review. For the animal study, endpoints would be assessed according to pre-defined criteria, likely by the study investigators and possibly independently reviewed by a pathologist for tissue samples.
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
- No MRMC study was done, as this is not an AI device. This section is entirely irrelevant to the provided document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for an AI device. For the non-clinical and pre-clinical animal studies, "ground truth" would be established by:
- Bench Testing: Engineering measurements, adherence to specifications, validated test methods.
- Animal Study: Direct observation by study personnel, pathology findings following necropsy, physiological measurements, imaging results, and histological analysis.
8. The sample size for the training set
- Not applicable, as this is not an AI device. No training set exists.
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI device. No training set exists.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).