(29 days)
The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.
The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.
The Surefire Guiding Catheter is a single-lumen 5F catheter with a soft distal tip and a Luer-Lock hub and strain relief. The Surefire Guiding Catheter has a three-layer construction, consisting of a Teflon inner liner, metal mid-layer, and a polymer outer shaft jacket. The polymer is filled with a radiopacifier agent, to provide visibility of the catheter under fluoroscopy.
The Surefire Guiding Catheter is available in 65 cm and 80 cm lengths with a variety of pre-shaped tip designs (including but not limited to Axis and Sim1) to accommodate access and positioning in a range of peripheral vascular anatomies.
The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.
The Surefire Guiding Catheter is provided sterile (EtO) for single patient use.
The provided text describes a 510(k) summary for the Surefire Guiding Catheter, which is seeking substantial equivalence to a predicate device. This submission focuses on engineering and biocompatibility testing for a modified device, rather than a study on an AI/ML algorithm's performance meeting acceptance criteria. Therefore, most of the information requested in your prompt (1-9) about AI device performance and ground truth establishment is not available in the given document.
The document does describe acceptance criteria and performance data for the catheter device itself. I will provide the available information based on the document, noting where the requested AI-specific information is not present.
Acceptance Criteria and Device Performance (for the physical device, not AI):
The document states that the design verification/validation tests performed on the modified Surefire Guiding Catheter demonstrated that it "meets the same performance specifications and acceptance criteria as the predicate device." This implies a direct comparison to the previously cleared predicate device's established performance. The specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly listed in a table, but rather implied by statements of "meeting" or "comparable" performance.
Detailed Breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Biocompatibility | No significant biological reaction affecting the patient due to contact with materials. | All biocompatibility testing results (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility) did not indicate any significant biological reaction. |
| Performance Testing | Meet same performance specifications as predicate device. | Modified device meets the same performance specifications and acceptance criteria as the predicate device for: Visual Inspection/Distal Kink, Dimensional Inspection, Proximal Kink, Pull Strength, Trackability/Device Compatibility, Torque, High Pressure Injection (Burst), Corrosion, Particulate. |
| Animal Testing | Acceptable performance as defined by a physician in a clinical environment; comparable to predicate device. | Modified device was found to have acceptable performance and comparable performance to the predicate device. |
2. Sample size used for the test set and the data provenance:
- For Biocompatibility: The document refers to "testing" and "studies" but does not explicitly state sample sizes for each test type (e.g., number of cells for cytotoxicity, number of animals for sensitization/irritation). The "previously completed biocompatibility testing" was leveraged from the predicate device (K140034).
- For Performance Testing (Bench Tests): No specific sample sizes for each bench test are provided. It states these tests were performed and results demonstrate the device meets criteria.
- For Animal Testing: A "GLP animal study was performed," but the number of animals used is not specified.
- Data Provenance: The biocompatibility testing was conducted by NAMSA (Northwood, OH) and Toxicon (Bedford MA). The animal study was also a GLP study; the location is not specified, but it's implied to be a controlled environment for generating data for regulatory submission. All data would be prospective for the purpose of this submission, though some biocompatibility data was leveraged from previous testing of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This information is relevant for AI/ML device studies where experts define the "correct" diagnostic or classification outcome. For this physical catheter device, "ground truth" relates to objective physical and biological properties measured via standardized tests and potentially assessed by "a physician" in the animal study. The qualifications of the "physician" are not detailed.
4. Adjudication method for the test set:
- Not Applicable. Again, this is typically for AI/ML studies involving human interpretation disagreements. For this device, standard testing protocols are followed, and performance is measured against established specifications or comparison to a predicate device.
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:
- Not Applicable. This is an AI/ML specific question. No MRMC study was conducted as this is a physical medical device (guiding catheter).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is an AI/ML specific question. No algorithm is involved in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and observation of biological reactions (e.g., no significant cytotoxicity, no sensitization, no irritation, no systemic toxicity, acceptable hemocompatibility). This is essentially data derived from standard biological assays.
- For Performance Testing (Bench Tests): Ground truth is based on engineering specifications and direct physical measurements (e.g., visual inspection, dimensional checks, force measurements for pull strength, burst pressure).
- For Animal Study: Ground truth involves "acceptable performance" as defined by a physician's assessment in a clinical environment during the study, and comparison to the predicate device. This is a form of expert assessment of device function in vivo.
8. The sample size for the training set:
- Not Applicable. There is no training set for a physical catheter device. This is an AI/ML specific question.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for a physical catheter device. This is an AI/ML specific question.
In summary, the provided document describes a regulatory submission for a physical medical device (Surefire Guiding Catheter) and focuses on demonstrating substantial equivalence to a predicate device through engineering (bench) tests, biocompatibility testing, and an animal study. It does not involve an AI/ML algorithm, and therefore the details requested about AI performance, ground truth, and study design for AI are not present.
§ 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).