(388 days)
The Arrow Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various cardiovascular devices into the left side of the heart through the interatrial septum.
The Arrow Transseptal Super Arrow-Flex Percutaneous Sheath Introducer Set consists of a long radiopaque wire-reinforced sheath and dilator with curved distal tips for positioning against the atrial septum.. The introducer sheath contains an integral hemostasis valve and side port with a three-way stopcock. The dilator accommodates a curved transseptal needle (18ga. needle for adults and 19ga. needle for pediatrics) and has a long gradual tapered tip that steps up to the OD for ease of insertion.
The provided text describes a 510(k) submission for a medical device (Arrow Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven device evaluation. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and biocompatibility testing.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an attempt to answer the questions based only on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility of sheath/dilator with the Brockenbrough needle assembly | Comparable performance to the Bard predicate device |
| Kink radius | Comparable performance to the Bard predicate device |
| Tensile strength of sheath blank material | Comparable performance to the Bard predicate device |
| "In use" simulation test advancing and retracting the Brockenbrough needle in the sheath introducer | Comparable performance to the Bard predicate device |
| Tensile test results all bonds and joints | Comparable performance to the Bard predicate device |
| Flexibility and maneuverability test | Comparable performance to the Bard predicate device |
| Biocompatibility | Additional biocompatibility testing was provided (details not specified) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the tests. The text mentions "test results" but no specific number of units tested.
- Data Provenance: Not specified. The tests are described as "nonclinical test results," implying laboratory or bench testing rather than clinical data from human subjects or specific geographical locations.
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)
Not applicable. The tests described are non-clinical, evaluating physical properties and performance against a predicate device, not relying on expert interpretation of medical data for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints, not for the non-clinical engineering tests described.
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
No. This document does not describe an AI/ML device or a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not describe an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests appears to be established by engineering specifications and comparative performance relative to a predicate device. For example, "comparability of sheath/dilator with the Brockenbrough needle assembly" implies the predicate device's performance as the benchmark.
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML device, and thus no training set.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI/ML device, and thus no training set.
§ 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).