(19 days)
The Surefire Spark Infusion 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 Spark Infusion System is a 0.021" lumen microcatheter with a seff-expanding tip at the distal end. The Surefire Spark serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles 500um or less in size and glass microspheres 110um or less in size. The Surefire Spark has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, self-expanding tip is sized for use in vessels of 1.5-3.5mm.
There are two radiopaque markers located at the distal end of the Surefire Spark to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels.
The Surefire Spark Infusion System is provided sterile (EtO) for single patient use.
The Surefire Infusion Systems will be available in the following sizes:
Inner Diameter: 0.021 inch, Length: 120 cm, Tip / Vessel Size: 1.5 - 3.5 mm
Inner Diameter: 0.021 inch, Length: 150 cm, Tip / Vessel Size: 1.5 - 3.5 mm
The Surefire Spark Infusion System is a medical device and the provided text describes its 510(k) premarket notification to the FDA. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical study with quantifiable acceptance criteria for diagnostic performance metrics like sensitivity or specificity.
Therefore, many of the requested categories for a study proving device acceptance (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of device and regulatory submission as described in the provided text. The device is an intravascular catheter designed for delivering agents, not for diagnosis or image interpretation.
Instead, the acceptance criteria and performance evaluation for this device revolve around engineering and physical performance tests, and a comparative animal study against a predicate device.
Here's the information that can be extracted and inferred from the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Surefire Spark Infusion System are implicitly defined by meeting the same performance specifications as its predicate device and demonstrating comparable performance in various physical and functional tests. The study demonstrates that the device met these criteria.
| Acceptance Criteria Category | Reported Device Performance and Study Findings |
|---|---|
| Physical/Mechanical Tests | The Surefire Spark Infusion System met the same performance specifications for: |
- Visual and Dimensional (Implicitly met comparable dimensions)
- Tensile (Pull) Strengths
- Kink Radius
- Torque Resistance
- Burst Pressure
- Coating Frictional Force
- Base Catheter Insertion/Retraction Force
- Corrosion Resistance
- Hub Solvent Compatibility
- Coating Durability and Uniformity
- Particulates
- Pouch Integrity
- Pouch Seal Strength
Overall: The test results demonstrate that the Surefire Spark Infusion System meets the same performance specifications and acceptance criteria as the predicate device. |
| Functional Compatibility | The Surefire Spark Infusion System met the same performance specifications for: - Diagnostic Agent Compatibility
- Embolic Agent Compatibility
- Hub Aspiration
- Antegrade Flow
- Infusion Efficiency
Overall: The test results demonstrate that the Surefire Spark Infusion System meets the same performance specifications and acceptance criteria as the predicate device. |
| Biocompatibility | No direct new biocompatibility testing was performed on the subject device. Testing was leveraged from previously cleared predicate devices (Surefire High Flow Microcatheter K121677, Surefire Guiding Catheter K162359, and Surefire Precision Infusion System K171355), implying that the materials are deemed biocompatible based on prior assessments. |
| Thrombogenicity | Testing for thrombogenicity was performed on the Surefire Spark Infusion System Catheter as a part of an Animal Study. (Specific results are not detailed, but the overall conclusion of the animal study indicates acceptability). |
| Sterilization Residuals | EtO Residuals testing was leveraged from previous testing of the predicate device. |
| Acute Performance (Animal Study) | "An animal study was performed to assess the comparative acute performance of the Surefire Spark Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The Surefire Spark Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device." |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each bench test. For the animal study, the sample size is not specified beyond "An animal study was performed."
- Data Provenance: The bench tests and animal study were performed by the manufacturer to support the 510(k) submission. No country of origin is specified for the data, but the manufacturer is based in Westminster, CO, USA. The study would be considered prospective for the purpose of demonstrating equivalence for this specific device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Bench Tests: Not applicable in the sense of expert review for ground truth on performance specifications. These are objective engineering measurements against defined criteria.
- Animal Study: The acute performance was "defined by physicians in a simulated clinical environment." The number and qualifications of these "physicians" are not specified. Their role was to assess performance, not establish ground truth in a diagnostic sense.
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Adjudication method for the test set:
- Not applicable as the tests involve objective measurements (bench tests) or physician assessment (animal study) rather than diagnostic interpretation requiring adjudication.
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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. This device is an intravascular catheter for substance delivery, not an AI-powered diagnostic tool, so such a study is not relevant to its regulatory approval in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench tests, the "ground truth" is defined by established engineering and material performance specifications which the device must meet or perform comparably to the predicate.
- For the animal study, the "ground truth" for acute performance was based on "user needs" defined by physicians in a simulated clinical environment and comparison to the predicate device's performance.
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The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable as there is no training set mentioned or implied.
§ 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).