(298 days)
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic devices into the vasculature, excluding coronary and neuro vasculature.
The Shuttle® -SL Flexor® Tuohy-Borst Side-Arm Introducer Set is composed of an introducer sheath and a dilator. These devices will be manufactured in 4.0, 5.0. 6.0, 7.0. and 8.0 French and in lengths of 80. 90 and 110 centimeters.
The Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Sets are manufactured with a polycarbonate Tuohy-Borst proximal fitting on a Teflon lined, coil-reinforced nylon introducer sheath (Flexor material). The dilator (composed of nylon or polyethylene depending on French size) is characterized by a distal taper allowing for a smooth transition with the appropriately sized wire guide. A hydrophilic coating is applied to the distal portion of both the sheath and dilator components
The Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Set is designed specifically to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. Using the Seldinger technique, the physician gains percutaneous access to the vascular system and then employs the Shuttle-SL introducer sheath as a conduit for inserting diagnostic and/or interventional devices into the patient.
The provided document describes the Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Set and its substantial equivalence to predicate devices, but lacks comprehensive details about acceptance criteria and a specific study proving device performance against those criteria in a format applicable to evaluating AI/ML-based medical devices.
Instead, the document focuses on general performance testing for a physical medical device. I will extract the information that is present and indicate where information relevant to AI/ML device evaluation is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance and Acceptance Status |
|---|---|
| Biocompatibility Testing | |
| - Cytotoxicity | Met predetermined acceptance criteria |
| - Sensitization | Met predetermined acceptance criteria |
| - Intracutaneous Reactivity | Met predetermined acceptance criteria |
| - Systemic Toxicity | Met predetermined acceptance criteria |
| - Pyrogenicity | Met predetermined acceptance criteria |
| - Hemocompatibility | Met predetermined acceptance criteria |
| - Complement Activation | Met predetermined acceptance criteria |
| - Partial Thromboplastin Time | Met predetermined acceptance criteria |
| Dilator and Introducer Sheath Tensile Testing | Peak load values in accordance with BS EN ISO 11070:1999. Met predetermined acceptance criteria. |
| Dilator and Introducer Sheath Liquid Leakage | No leakage when tested in accordance with BS EN ISO 11070:1999, Annex D and E. Met predetermined acceptance criteria. |
| Dilator and Introducer Sheath Mechanical Abrasion | Hydrophilic coating met requirements for durability. Met predetermined acceptance criteria. |
| Dilator and Introducer Sheath Lubricity | Peak force over 10 cm stroke less than 100g during 10 cycles while hydrated and subjected to 300g normal force. Met predetermined acceptance criteria. |
| Thromboresistance Testing | 0% to 25% estimated patency impact due to thrombus. Met predetermined acceptance criteria. |
| Acute Performance Testing | Performance parameters acceptable for clinical use. Met predetermined acceptance criteria. |
| Coating Integrity and Device Compatibility (simulated use) | Coating appearance absent of defects before and after simulated use. |
| Dimensional Verification Testing | Dilator accepts appropriately sized wire guide, dilator passes through sheath, inner diameter within specified French size, sheath length within specified tolerance. |
| Torque Strength Testing | Withstood one full rotation without failure. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify sample sizes for any of the tests, nor does it refer to a "test set" in the context of an algorithm or AI model. The tests described are laboratory and simulated use tests on the physical device. Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The tests performed are for a physical medical device (introducer set), not an AI/ML algorithm. Ground truth, in this context, would involve objective measurements and established standards (e.g., ISO standards, material properties), not expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable. The tests are for a physical medical device, not an AI/ML algorithm requiring an adjudication method for interpreting results. The acceptance criteria were met based on direct measurements and observations during laboratory and simulated use.
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 not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Established Standards: AAMI/ANSI/ISO 10993-1:2009 for biocompatibility; BS EN ISO 11070:1999 for tensile and liquid leakage testing.
- Objective Measurements: Tensile strength, liquid leakage, mechanical abrasion, lubricity, thromboresistance, dimensional verification, torque strength, and visual inspection for coating integrity.
- Simulated Clinical Use: Testing under conditions mimicking clinical use (e.g., acute performance, coating integrity under simulated use).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this product as it does not involve algorithms learning from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).