(240 days)
The reprocessed steerable introducer devices are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The reprocessed steerable introducer consists of a steerable sheath and plastic dilator, which is indicated for introducing various cardiovascular catheters including the left side of the heart through the interatrial septum. The device is always delivered over a guidewire. The steerable introducer device enters through the right femoral vein and is guided into the right atrium of the heart. A knob on the introducer handle dictates the amount and direction of curl at the distal tip of the sheath. The shaft of the introducer is filled with radiopaque material so the device can be seen using fluoroscopy. A guidewire pokes through the septum into the left atrium and a tapered dilator enlarges the hole. The dilator is then removed allowing the introduction of a catheter.
The device is an 8.5F asymmetrical bi-directional steerable introducer with a varying amount of curl (small, medium or large) at the distal tip and a useable length of 61 or 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect the large curl 90 degrees in the counterclockwise direction and 180 degrees in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.
The provided document is a 510(k) premarket notification letter from the FDA to Sterilmed, Inc. for a Reprocessed Steerable Introducer. This document is not a study report that includes details about acceptance criteria and device performance in the context of an AI/ML medical device.
The content focuses on demonstrating substantial equivalence of the reprocessed device to legally marketed predicate devices, rather than on the performance of a novel AI/ML algorithm. Therefore, many of the requested details about acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this document.
However, I can extract the information that is relevant to the device's functional and safety performance, as established for its substantial equivalence claim, even though it doesn't involve AI.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance testing intended to show that the reprocessed device performs similarly to the new predicate device. While specific numerical acceptance criteria values are not explicitly listed in the submission summary, the intent is that the reprocessed device meets the functional and safety standards expected of the original, new device.
| Performance Test Category | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical/Functional | Devices operate as intended, meeting design specifications of the original device. | "Functional testing has shown the reprocessing does not affect the performance of the devices." The reprocessed devices are "identical in form, fit, functionality and intended use as the predicate devices." |
| Cap Retention | Similar to predicate device | |
| Shaft Deflection and Flexation | Similar to predicate device | |
| Joint Strength | Similar to predicate device | |
| Leak | Similar to predicate device | |
| Shaft Torque | Similar to predicate device | |
| Stiffness | Similar to predicate device | |
| Distribution | Similar to predicate device | |
| Torque Response | Similar to predicate device | |
| Dimensional Verification | Dimensions match original device specifications. | Similar to predicate device |
| Systems Use | Device functions correctly in its intended system. | Similar to predicate device |
| Biocompatibility | Meets ISO 10993-1 standards for short-duration blood contact (-6. | Achieved by ethylene oxide sterilization. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample size for each performance test. It mentions that "the device was tested" and "functional testing has shown."
- Data Provenance: The testing was conducted by Sterilmed, Inc. as part of their premarket notification submission to the FDA. The nature of this document suggests the data is prospective for the reprocessed device, generated specifically for this submission to demonstrate substantial equivalence. The country of origin of the data is implied to be the USA (Plymouth, MN, where Sterilmed is located).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as this submission relates to a reprocessed medical device and its physical/functional characteristics, not an AI/ML algorithm requiring expert ground truth for classification or prediction. The "ground truth" here is the performance of the new, predicate device and established engineering/biocompatibility standards.
4. Adjudication method for the test set:
- Not applicable. There is no expert adjudication process described, as the evaluation is based on objective measurements against engineering specifications and regulatory standards for device performance.
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 document is about a physical medical device (steerable introducer), not an AI/ML system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is about a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the reprocessed device is its ability to meet the established performance specifications and safety profiles of the original, new predicate devices (St. Jude Agilis™ NxT Steerable Introducers, K061363 and K081645), as well as relevant international standards (e.g., ISO 10993-1 for biocompatibility) and regulatory requirements. This is an engineering and materials science-based ground truth, not an expert consensus or pathology-based one.
8. The sample size for the training set:
- Not applicable. This document is about a reprocessed physical device, not an AI/ML system that utilizes a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.
§ 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).