(53 days)
The GlideCross™ Support Catheter is intended to be used for guide wire support during access of the vasculature allowing for exchange of guide wires and provides for the delivery of saline and/or diagnostic contrast agents. The GlideCross™ Support Catheter is indicated for use in the peripheral vasculature.
The GlideCross Support Catheters are single lumen intravascular catheters designed for use in the peripheral vasculature. The catheters provide support to guide wires during access of the vasculature and allow for exchange of guide wires while maintaining vessel access. The GlideCross Support Catheters are available in 9 models compatible with various guide wire sizes and have a lubricous hydrophilic coating on the distal shaft and a female Luer on the proximal end. The catheters have 3 encapsulated radiopaque marker bands evenly spaced along the distal shaft, with the distal band 3 mm from the tip, to aid in positioning of the catheter tip and in estimating distances.
The provided document describes a medical device, the GlideCross Support Catheter, and its clearance through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove efficacy against specific acceptance criteria in a human study. Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, expert ground truth, sample sizes for training/test sets, etc.) is not applicable in this context.
Instead, acceptance criteria and performance are demonstrated through engineering testing, material comparisons, and biocompatibility assessments to show that the new device is as safe and effective as its predicate.
Here's an analysis of the provided information, framed to address the spirit of your request where applicable, even if direct answers for AI/ML device studies are not available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GlideCross Support Catheter are largely derived from ensuring its specifications and performance are similar to its predicate device (Spectranetics QUICK CROSS CATHETERS, K033678) and that it meets established industry standards for medical devices of its type. The "reported device performance" refers to the results of various engineering and biocompatibility tests.
| Acceptance Criteria Category | Specific Criteria / Test | Performance Outcome (Reported Device Performance) |
|---|---|---|
| Device Specifications | Effective lengths | 65, 90, 135, 150 cm (Similar to predicate) |
| Number of radiopaque markers | 3 (Similar to predicate) | |
| Distance from distal tip to first radiopaque marker | 3 mm (Similar to predicate) | |
| Radiopaque marker spacing (0.014 & 0.018 wire) | 15 mm (Similar to predicate) | |
| Radiopaque marker spacing (0.035 wire) | 50 mm (Similar to predicate) | |
| Guidewire Compatibility | 0.014, 0.018, 0.035 inch (Similar to predicate) | |
| Maximum Injection Pressure | 300 psi (Similar to predicate) | |
| Minimum Introducer Sheath Compatible With | 5 Fr (Predicate: 4Fr-5Fr depending on model number; GlideCross meets 5Fr) | |
| Tip design/shape | Straight (Similar to predicate) | |
| Hydrophilic Coating | Distal 40-60 cm (Predicate: Distal 40 cm; GlideCross covers this range) | |
| Functional Performance | Trackability | Substantially equivalent to predicate devices |
| Wire Support | Substantially equivalent to predicate devices | |
| Pushability/Crossability | Substantially equivalent to predicate devices | |
| Lubricity | Substantially equivalent to predicate devices | |
| Simulated use | All test results met pre-approved specifications | |
| Length | All test results met pre-approved specifications | |
| Penetration | All test results met pre-approved specifications | |
| Visual inspections - Catheter Tip | All test results met pre-approved specifications | |
| Visual inspections - Marker bands | All test results met pre-approved specifications | |
| Visual appearance / foreign matter | All test results met pre-approved specifications | |
| Outer diameter: Catheter tip | All test results met pre-approved specifications | |
| Outer diameter: Proximal shaft | All test results met pre-approved specifications | |
| Flow rate | All test results met pre-approved specifications | |
| Catheter burst | All test results met pre-approved specifications | |
| Inner diameter: Hub | All test results met pre-approved specifications | |
| Inner diameter: Catheter tip | All test results met pre-approved specifications | |
| Luer taper | All test results met pre-approved specifications | |
| Luer assembly | All test results met pre-approved specifications | |
| Luer resistance to overriding | All test results met pre-approved specifications | |
| Force at break | All test results met pre-approved specifications | |
| Kink resistance | All test results met pre-approved specifications | |
| Catheter leakage | All test results met pre-approved specifications | |
| Marker spacing | All test results met pre-approved specifications | |
| Coating length | All test results met pre-approved specifications | |
| Coating Integrity and Particulate Release Verification | All test results met pre-approved specifications | |
| Torque Testing | All test results met pre-approved specifications | |
| Biocompatibility | Physicochemical profile | Meets Requirements (USP ) |
| Cytotoxicity | Not considered to have cytotoxic potential (ISO 10993-5) | |
| Hemolysis | Non-hemolytic (ASTM F756) | |
| In vitro Hemocompatibility Assay | Pass (ISO 10993-4) | |
| Thrombogenicity Study in Dogs | Thrombosis was not considered significant (ISO 10993-4) | |
| Complement Activation | Meets Requirements (ISO 10993-4) | |
| Unactivated Partial Thromboplastin time | Meets Requirements (ISO 10993-4) | |
| Prothrombin Time | No adverse effect on the prothrombin time of human plasma (ISO 10993-4) | |
| Sensitization | Meets requirements (ISO 10993-10) | |
| Intracutaneous Reactivity | Meets requirements (ISO 10993-10) | |
| Acute Systemic Toxicity | Negative (ISO 10993-11) | |
| Pyrogenicity | Meets Requirements (ISO 10993-11) | |
| Genotoxicity | Not considered to be mutagenic (ISO 10993-3) | |
| Sterilization | Sterility Assurance Level (SAL) | 10⁻⁶ (Validated per ISO 11135) |
| Residual Ethylene Oxide (EO) | Not exceeding 4 mg per device (Meets ISO 10993-7 for limited exposure) | |
| Residual Ethylene Chlorohydrin (ECH) | Not exceeding 9 mg per device (Meets ISO 10993-7 for limited exposure) | |
| Non-pyrogenic certification | Certified non-pyrogenic; LAL test performed each lot (per USP ) and validated per FDA guideline. |
2. Sample Size Used for the Test Set and Data Provenance
For a traditional medical device (not AI/ML), the "test set" primarily refers to the number of individual devices or components subjected to each specific physical, mechanical, or biological test. The document does not specify exact sample sizes for each test (e.g., how many catheters were tested for trackability or burst pressure). However, it implies that sufficient samples were tested to demonstrate conformity to specifications and substantial equivalence to the predicate.
The data provenance is from Terumo Medical Corporation's in-house testing facilities, likely following established laboratory procedures and standards (e.g., ISO, ASTM, USP) for medical device evaluation. This is a prospective generation of data specifically for this 510(k) submission, comparing the new device's performance against its own pre-approved specifications and in comparison to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not directly applicable to a traditional medical device 510(k) submission concerning physical and mechanical properties. "Ground truth" in this context is established by:
- Engineering specifications and standards: These are the objective benchmarks (e.g., maximum pressure, specific lengths, material properties) that the device must meet.
- Predicate device's performance: The Spectranetics QUICK CROSS CATHETERS (K033678) serves as the established benchmark for "safe and effective" performance through its prior clearance.
- Regulatory standards: ISO, ASTM, and USP standards for biocompatibility and sterilization are the "ground truth" for these aspects.
The expertise lies in the engineers, scientists, and quality assurance personnel who design the tests, conduct them, and interpret the results against these established standards. Their qualifications would typically involve degrees in engineering, materials science, biology, and chemistry, with experience in medical device testing and regulatory affairs. Their 'number' is not specified globally but would involve teams for each testing area.
4. Adjudication Method for the Test Set
Again, this is not applicable in the context of a physical medical device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of data (e.g., imaging reads) to resolve disagreements. For engineering tests, the "adjudication" is inherent in:
- Objective measurements: A tensile strength test yields a numerical result. Either it meets the specification or it doesn't.
- Pre-defined pass/fail criteria: Each test has clear parameters for what constitutes a successful outcome.
- Comparison to predicate: Direct comparison of measurements or observations with the predicate device's characteristics.
- Standard compliance: Meeting the requirements of relevant ISO or ASTM standards.
Any discrepancies or failures would lead to investigation, redesign, or retesting, rather than an "adjudication" in the clinical sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. MRMC studies are clinical effectiveness studies typically used for diagnostic devices (like imaging software) to assess how human reader performance changes with or without AI assistance across multiple cases and readers. The GlideCross Support Catheter is an interventional/support device, and its safety and effectiveness are demonstrated through engineering tests, biocompatibility, and comparison to a predicate device, not through human reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an AI algorithm. Its performance is entirely dependent on the physical properties of the catheter and its interaction with physiological systems and clinicians.
7. The Type of Ground Truth Used
The ground truth used for this device can be categorized as:
- Engineering Specifications/Standards: Detailed quantitative and qualitative requirements for the device's physical and mechanical properties (e.g., dimensions, strength, flexibility, flow rates, coating integrity).
- Predicate Device Performance Profile: The known and accepted performance characteristics of the legally marketed predicate device (Spectranetics QUICK CROSS CATHETERS, K033678). The "substantial equivalence" claim relies on the new device performing similarly.
- International and National Standards: Compliance with recognized standards for biocompatibility (ISO 10993 series, ASTM F756), sterilization (ISO 11135, ISO 10993-7), and endotoxin testing (USP , FDA guidelines). These standards themselves represent established "ground truths" for safety.
8. The Sample Size for the Training Set
No "training set" in the context of machine learning was used. This device is a physical product, not an AI/ML model. Therefore, the concept of a training set is not applicable. The design and manufacturing processes are refined through engineering development and quality control, not iterative training on data.
9. How the Ground Truth for the Training Set Was Established
Since there was no "training set" for an AI/ML model, this question is not applicable. For physical device development, the "ground truth" (i.e., desired performance and specifications) for the design phase is established through:
- Clinical needs assessment: Understanding the requirements for guide wire support and delivery in peripheral vasculature.
- Benchmarking against existing products: Analyzing the predicate device (Spectranetics QUICK CROSS CATHETERS) and other similar devices to inform design goals.
- Material science: Selecting materials with known properties suitable for the intended use.
- Engineering principles: Applying principles of mechanical engineering and fluid dynamics to design the catheter.
- Regulatory requirements: Ensuring the design inherently meets relevant safety and performance standards.
§ 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).