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510(k) Data Aggregation
(106 days)
The Creganna-Tactx Steerable Sheath Set is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The Creganna-Tactx Steerable Sheath is a stainless steel braided steerable sheath which is compatible with EP Catheters ≤ 8.7Fr and has an approximate working length of 720mm. It is designed to provide flexible catheter positioning in the cardiac anatomy. The handle is equipped with a bi-directional rotating knob to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. There are two different models: The Symmetric Steerable Sheath has a tip that can be deflected into two distal curve geometries of equal symmetry, with reduced stroke in one direction; and the Asymmetric Steerable Sheath - one distal curve equal to the symmetric curve geometry above and a longer 'reach' curve geometry on the opposite curve to facilitate broader steering angles.
The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side-port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The steerable sheath features distal perfusion holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
The Creganna-Tactx Steerable Sheath is packaged as a set with the following accessories that are compatible with the dimensions of the steerable sheath: a polymer curved dilator (approximately 8.7 Fr), a 0.032" PTFE coated stainless steel J-tipped quidewire, and a guidewire J-straightener (introducer). The Set components are packaged together, provided sterile, and is intended for single use only.
The Creganna-Tactx Steerable Sheath Set assembly is comprised of materials that are commonly used in medical device applications.
This document describes the Creganna-Tactx™ Steerable Sheath Set and its clearance via a 510(k) submission. The clearance is based on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria for performance metrics. Therefore, the device "meets acceptance criteria" by demonstrating this substantial equivalence through a series of in vitro and in vivo tests.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) summary focused on substantial equivalence, explicit quantitative "acceptance criteria" and "reported device performance" in the traditional sense (e.g., sensitivity, specificity for an AI algorithm) are not provided in the document. Instead, the "acceptance criteria" are implied by the need to demonstrate performance comparable to the predicate device and adherence to relevant standards. The "reported device performance" is a statement that the device meets these requirements.
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in the document) |
|---|---|
| Reliable design and performance (according to standards/use) | "The test results demonstrate that the Creganna-Tactx Steerable Sheath Set meets the requirements in the applicable standards and specifications." |
| Substantial equivalence to predicate device | "The test results demonstrate... and is substantially equivalent to legally marketed predicate device." |
| Meets user requirements and intended use (in vivo) | "Results of this testing demonstrate that the device meets user requirements and meets the intended use of the device." |
| Biocompatibility standards (ISO10993-1) | "Testing per ISO10993-1 included the following tests: Cytotoxicity, Sensitization, Intracutaneous, Systemic Toxicity, Pyrogen, Hemolysis, C3a Complement Activation, SC5b-9 Complement Activation, In Vivo Thromboresistance." |
| Sterilization validation (ISO11135-1) | "Testing was performed in compliance with... ISO11135-1 for Ethylene Oxide Sterilization Validation." |
| Packaging validation (ISO11607-1) | "Testing was performed in compliance with ISO11607-1 for Packaging of Sterile devices." |
| Functional Performance (e.g., flexibility, tracking, torque, etc.) | Detailed list of functional tests performed (e.g., "Shaft and Tip Flexibility," "Tracking Test," "Torque Testing," "Articulation Tests," etc.) - results indicated meeting requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for in vitro testing: Not explicitly stated. The document lists types of tests (e.g., Shaft and Tip Flexibility, Tracking Test), but doesn't provide the number of devices or iterations tested for each.
- Sample size for in vivo (animal) study: Not explicitly stated, but mentioned as "A GLP Animal study was performed in swine." The number of swine used is not given.
- Data provenance: Not explicitly stated in terms of country of origin. The in vitro and in vivo studies were conducted by the submitter, Creganna-Tactx Medical, located in Galway, Ireland. These were prospective studies designed to evaluate device performance.
- Retrospective or prospective: Both in vitro and in vivo studies were prospective tests designed to evaluate the device's performance against pre-defined criteria and standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the provided document. The "ground truth" concept is more relevant to studies involving human interpretation (e.g., imaging diagnostics). For this device, performance is evaluated through physical and biological testing against established standards and comparison to a predicate device. The "experts" would be the engineers, scientists, and technicians performing and evaluating the tests, but their specific number and qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations, typically in clinical studies or studies involving ground truth established by human readers. The tests performed for this device (functional, biocompatibility, sterilization, animal study) involve objective measurements and observations, not subjective interpretation requiring an adjudication process.
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
This is not applicable. The device is a medical instrument (steerable sheath), not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or assessment of AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm. Standalone performance as described for AI algorithms is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for evaluating this device's performance is established by:
- Applicable Standards: International and national standards (e.g., ISO 11070, ISO 10555-1, ISO 10993-1, ISO 11607-1, ISO 11135-1) define acceptable performance limits and test methodologies.
- Predicate Device Performance: The performance observed in the legally marketed predicate device (Agilis NxT™ Steerable Introducer) serves as a benchmark for substantial equivalence.
- User Requirements: The device's ability to meet intended use and user requirements as demonstrated in the GLP animal study.
- Objective Measurements: Functional tests involve quantifiable physical properties (e.g., torque values, deflection angles, leak rates).
- Biological Endpoints: Biocompatibility tests rely on established biological response criteria (e.g., no cytotoxicity, no sensitization, etc.).
8. The sample size for the training set
This is not applicable. This device is not an AI algorithm that requires a training set. The tests performed are for evaluating the physical device itself.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of medical device.
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