(165 days)
The MultiCross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
The MultiCross Support Catheter is a sterile, single-use, triple lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange. The MultiCross Support Catheter consists of an inner shaft, outer sheath, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and retractable distal Nitinol scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site. Subsequent to conventional guidewire placement, therapeutic devices such as atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The MultiCross Support Catheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support.
The provided 510(k) summary for the MultiCross Support Catheter (K121763) describes a medical device, not an AI/ML-driven software or diagnostic tool. Therefore, many of the requested categories in the prompt, which are typically relevant for AI/ML device evaluations (e.g., sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance, etc.), are not applicable or not explicitly detailed in this type of submission.
This submission focuses on demonstrating "substantial equivalence" to predicate devices through engineering bench testing and an animal study, which are standard for physical medical devices of this type.
Here’s an attempt to address the prompt based only on the provided document, acknowledging that most AI/ML-specific criteria will not be found:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench Testing | Device meets established specifications for consistent performance for its intended use and is substantially equivalent to predicate devices. | All testing performed in accordance with recognized standards. Results demonstrate the device meets established specifications for consistent performance for its intended use and is substantially equivalent. |
| Catheter Inspection (Visual/Physical Dimensions) | Not explicitly stated, but implies meeting design specifications. | Performed (results not detailed but deemed acceptable for equivalence). |
| Particulate Testing | Not explicitly stated, but implies meeting acceptable limits. | Performed (results not detailed but deemed acceptable for equivalence). |
| Radial Outward Force | Not explicitly stated, but implies meeting functional requirements. | Performed (results not detailed but deemed acceptable for equivalence). |
| Contrast Flush Injection | Not explicitly stated, but implies meeting functional requirements. | Performed (results not detailed but deemed acceptable for equivalence). |
| Simulated Use | Device performs as intended during simulated clinical scenarios. | Performed (results not detailed but deemed acceptable for equivalence). |
| Torque Strength | Not explicitly stated, but implies meeting mechanical strength requirements. | Performed (results not detailed but deemed acceptable for equivalence). |
| Flexibility and Kink Resistance | Not explicitly stated, but implies meeting mechanical and functional requirements. | Performed (results not detailed but deemed acceptable for equivalence). |
| Leak: Liquid & Air | Not explicitly stated, but implies no unacceptable leaks. | Performed (results not detailed but deemed acceptable for equivalence). |
| Tensile Strength | Not explicitly stated, but implies meeting mechanical strength requirements. | Performed (results not detailed but deemed acceptable for equivalence). |
| Corrosion Resistance Test | Not explicitly stated, but implies no unacceptable corrosion. | Performed (results not detailed but deemed acceptable for equivalence). |
| Coating Integrity | Not explicitly stated, but implies coating remains intact and functional. | Performed (results not detailed but deemed acceptable for equivalence). |
| Biocompatibility | Meets ISO 10993 or equivalent standards for patient contact. | Performed (results not detailed but deemed acceptable for equivalence). |
| Sterilization Validation | Device can be effectively sterilized without compromising integrity. | Performed (results not detailed but deemed acceptable for equivalence). |
| Packaging and Shelf-life | Packaging maintains sterility and device integrity over specified shelf-life. | Performed (results not detailed but deemed acceptable for equivalence). |
| In vivo Animal Validation Study | Safety acceptance criteria for the study are met, and performance/handling are acceptable. | Based on pathology and histopathology results, the safety acceptance criteria were met. No untoward observations were found by the clinician regarding performance and handling. |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for bench tests (which would typically involve multiple units tested). For the animal study, the sample size is not numerically provided, but it is referred to as "a GLP animal study."
- Data Provenance: The studies were conducted by Roxwood Medical, Inc. (applicant). The location of the animal study (country of origin) is not specified. The studies are prospective in the sense that they were designed and executed to test the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document refers to a "clinician" who made performance and handling observations in the animal study.
- The qualifications of this clinician are not specified (e.g., radiologist with X years of experience).
- For pathology and histopathology results in the animal study, it's implied that experts (e.g., pathologists) evaluated the tissues, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Not applicable as this is a physical device submission. Ground truth regarding safety (e.g., pathology) is established by standard medical/scientific evaluation, not multi-reader adjudication in the context of diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the diagnostic performance of software or imaging systems with human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
- For the animal study:
- Pathology and Histopathology results: Used to establish safety ground truth.
- Clinician observations: Used to establish performance and handling ground truth.
- For bench testing: The "ground truth" is adherence to engineering specifications and recognized standards for physical performance parameters.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, and there is no "training set" in the AI/ML sense. Design and development would involve iterative testing, but not a formally defined "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).