(127 days)
The SUREFIRE™ INFUSION CATHETER SYSTEM is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
The Surefire™ Infusion Catheter System is a two-part system comprised of an Infusion Microcatheter and a Guide Sheath.
The Surefire™ Infusion Catheter System is a medical device intended for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system. The provided document is a 510(k) premarket notification summarizing the device's performance testing and substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Surefire™ Infusion Catheter System are based on established international standards and the performance of predicate devices. The study demonstrates the device's performance by showing it meets these acceptance criteria.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance and Acceptance |
|---|---|---|
| Performance Testing | Kink Testing, Tensile Testing, High Pressure Injection Testing, Hub Aspiration Testing, Embolic Agent Infusion Compatibility Testing, Package Integrity Testing, Corrosion Testing, Diagnostic Agent Compatibility Testing, Trackability Testing, Dimensional Inspection, Coating Integrity, Antegrade Flow Testing, Infusion Efficiency | "A battery of tests were performed according to protocols based on the requirements of the following standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device: ISO 10555-1 Sterile, single-use intravascular catheters Part 1 General requirements, ISO 10555-2 Sterile, single-use intravascular catheters Part 2 Angiographic catheters." The document states that the performance characteristics were determined, and the device was proven to be "substantially equivalent to the performance and safety of the Terumo Radifocus Glidecath." Specific numerical performance values are not provided, but the statement confirms the device met the required criteria for these tests. |
| Biocompatibility Testing | Pyrogen Test (USP , ISO 10993-11), Intra-cutaneous Irritation (ISO 10993-10), Hemolysis (ASTM F756, ISO 10993-4), Sensitization (ISO 10993-10), Particulate USP Standards, Cytotoxic Effects (ISO 10993-5), Complement System | All biocompatibility tests were conducted according to the specified international standards and demonstrated compliance. The device passed these tests, indicating it is biocompatible for its intended use. "Blood contacting materials were tested in accordance with the tests recommended in the FDA General program Memorandum. Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part -1 Evaluation and testing'." |
| Sterilization & Packaging | Package Integrity Testing, Ethylene Oxide Sterilization Validation and Routine Control (ISO 11135-1) | Package integrity was confirmed. Sterilization processes were validated and controlled per ISO 11135-1. |
| Safety and Risk Management | Risk/Hazard Analysis (EN ISO 14971), Acute System Toxicity | A risk/hazard analysis was conducted according to EN ISO 14971. The device's safety was demonstrated, and it was found substantially equivalent to predicate devices. Acute System Toxicity testing was performed. |
| Manufacturing Controls | Visual, Functional, Dimensional, and Sterility Tests | Manufacturing controls include visual, functional, dimensional and sterility tests. These tests are implicitly part of the acceptance criteria to ensure consistent product quality. |
The primary study type is an equivalence study, specifically demonstrating substantial equivalence to predicate devices (Terumo Radifocus GLIDECATH for the Guide sheath and EmboCath Plus Infusion Microcatheter by BioSphere Medical for the Microcatheter). This is a common approach for 510(k) submissions where a new device is compared to legally marketed devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each specific performance or biocompatibility test. However, it indicates that a "battery of tests were performed" using "protocols based on the requirements of the following standards." This implies that the sample sizes would have been determined by the requirements of the cited standards (e.g., ISO 10555-1, ISO 10555-2, ISO 10993 series, ASTM F756, USP).
The data provenance is the manufacturer's internal testing and is considered prospective as it was conducted specifically for this regulatory submission to demonstrate device performance. The country of origin of the data is implicitly the United States, where Surefire Medical, Inc. is located. The document also mentions "animal study data is submitted in this 510(k) and is on file at Surefire Medical," indicating some pre-clinical animal testing was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission does not involve a "test set" in the traditional sense of a clinical diagnostic study requiring expert ground truth establishment for patient data (e.g., image interpretation). Instead, the "ground truth" for this device's performance is established by the specified acceptance criteria defined by international standards and validated engineering principles.
Therefore, there were no "experts" in the sense of clinical specialists providing interpretations. The "experts" involved would be engineers, quality assurance specialists, and regulatory professionals who designed the tests, interpreted the results against the standards, and compiled the submission. Their qualifications are inherent in their roles within a medical device company and their adherence to recognized standards.
4. Adjudication Method for the Test Set
Not applicable. As explained above, this submission does not involve a test set requiring adjudication of, for example, diagnostic interpretations or clinical outcomes by multiple experts. The "adjudication" is primarily against pre-defined engineering and biocompatibility specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. The Surefire™ Infusion Catheter System is an intravascular catheter, not a diagnostic imaging AI system. The comparison for this device is primarily against established performance benchmarks and predicate devices through physical and chemical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance assessment (in the context of an algorithm's performance without human interaction) was not done. This device is a physical, manually operated catheter system. Its performance evaluation focuses on its mechanical, material, and biological properties, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Engineering Specifications and Performance Standards: The device's performance (e.g., kink resistance, tensile strength, flow rates, dimensions) is compared against pre-defined, acceptable ranges and thresholds derived from international standards (e.g., ISO 10555-1, ISO 10555-2).
- Biocompatibility Standards: The device's biological safety is assessed against the requirements of ISO 10993 series and USP standards.
- Predicate Device Performance: For substantial equivalence, the device's performance characteristics are compared to those of legally marketed predicate devices to ensure it performs as safely and effectively.
- Risk/Hazard Analysis: Per EN ISO 14971, safety criteria are established based on potential risks, and the device is evaluated against these.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).