(178 days)
The TorFlex™ Transseptal Guiding Sheath is used for the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture.
The TorFlex™ Transseptal Guiding Sheath kit consists of three components: a sheath, a dilator, and a J-tipped guidewire. The TorFlex™ Transseptal Guiding Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.
This document describes the premarket notification (510(k)) for the TorFlex™ Transseptal Guiding Sheath, a medical device. It does not pertain to an AI/ML powered device, therefore many of the requested categories (such as sample size, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance) are not applicable.
Here's the relevant information extracted and structured to the extent possible for a non-AI device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Safe for intended use | Passed all tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity (Acute), Hemocompatibility, Pyrogenecity) |
| Mechanical Testing | Able to withstand physical stresses without failure | Passed all tests (Torque transmission + Strength of union -Torque test, Flow rate measurement, Three point bend test, Freedom from liquid/air leaking through hemostasis valves + valve integrity, Freedom from liquid/air leakage, Strength of union-Pull test, Valve insertion force, Tip transition, Snap fit) |
| General Physical | Acceptable surface quality and corrosion resistance | Passed evaluation for Surface Defects, Corrosion Resistance |
| Bench Testing | Compatible with 8F devices | Demonstrated compatibility with 8F devices |
| Sterilization | Sterilized according to relevant standards; compliant ETO residue | Validated as per ANSI/AAMI/ISO 11135-1 and FDA Guideline on Validation of LAL Test; ETO residue levels compliant with ISO 10993-7 |
| Packaging | Validated for integrity | Validated in accordance with ANSI/AAMI/ISO 11607 |
2. Sample Size Used for the Test Set and Data Provenance
This is a device for physical intervention, not an AI/ML algorithm that processes data. Therefore, the concept of a "test set" with data provenance (country of origin, retrospective/prospective) is not applicable. The device undergoes laboratory and bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for device performance is established through defined engineering and biological testing standards, not expert consensus on data interpretation.
4. Adjudication Method for the Test Set
Not applicable. Testing involves objective measurements against established engineering and biological standards.
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-powered device, and no human reader studies are described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established through:
- Compliance with recognized industry standards (e.g., ISO, AAMI) for biocompatibility, sterilization, and packaging.
- Engineering specifications and test methodologies for mechanical performance, flow rates, and physical characteristics.
- Safety thresholds for material residues (e.g., Ethylene Oxide).
8. The Sample Size for the Training Set
Not applicable. This is a physical device, and the concept of a "training set" is irrelevant.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of 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).