(50 days)
The EpiAccess System with introducer needle and integrated needle tip pressure transducer is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in electrophysiology procedures in adult patients.
The modified EpiAccess System consists of the following components and accessories: a sterile, single-use (disposable) Tuohy Type Needle with an integrated, distal, needle tip pressure transducer (sensor), and a reusable integrated Control Unit (Gen2). The EpiAccess Needle component remains the same as with the predicate device.
The reusable Control Unit (Gen2) has been modified for a reduction in overall size, which eliminates the need for a custom cart. The modified Control Unit component also allows for connection to an existing display monitor in the Cath Lab rather than having a dedicated touch screen LCD display monitor as with the predicate device.
Both Control Unit components are for use with the cleared EpiAccess Needle component and have an input for a commercial A-Line component and video output to a display monitor. Both the modified and the predicate device use embedded, validated software with the same algorithm to provide the same pressure/frequency information to the user via the same graphical user interface screen for the same intended use.
The EpiAccess System displays the pressure measurement information, which physicians may be able to use to determine needle tip location based on known anatomical pressure differences. This additional information regarding needle tip location is an added convenience feature over standard Tuohy introducer needles for epicardial access. The system does not alert the user to tip location or provide clinical decision guidance. The EpiAccess Needle is placed under visualization with fluoroscopic imaging standard for electrophysiology procedures.
Both control unit components are reusable and not patient contacting. Both control units have been tested and passed for electrical safety and EMC, reliability, and transit testing.
This document describes a 510(k) premarket notification for the EpiAccess System (with A0005 EpiAccess Control Unit (Gen2)). The submission is for a modification to a previously cleared device, focusing on changes to the control unit. Therefore, the performance data presented is primarily to demonstrate that the modified device remains equivalent to the predicate device and does not introduce new safety or efficacy concerns.
Here's an analysis of the provided information against your requested criteria:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the typical format of quantitative metrics (e.g., sensitivity, specificity, accuracy) that would be expected for an AI/algorithm-based device.
Instead, the submission focuses on demonstrating that the modified device (EpiAccess System with Control Unit (Gen2)) meets design requirements and performs equivalently to its predicate device (K142245). The performance data cited are primarily for general device safety, electrical safety, EMC, packaging validation, software validation, and usability.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| General Device Performance | Function as intended; meets defined design requirements; performs in a manner equivalent to the predicate device; safe; meets design inputs; raises no new safety or efficacy concerns. | "In all instances, the modified EpiAccess System functioned as intended and results observed were as expected. These test results confirm that EpiAccess System is safe, meets the design inputs, and raises no new safety or efficacy concerns." |
| Risk Management | Compliance with BS EN ISO 14971:2012 (Medical Devices – Application of Risk Management to Medical Devices). | Performed "risk analysis" as part of design control activities. |
| Electrical Safety & EMC | Compliance with IEC 60601-1 Edition 3.1, ANSI/AAMI/IEC 60601-1-2 Edition 4.0, and IEC 60601-1-6 Edition 3.1. | "Both control units have been tested and passed for electrical safety and EMC." Specific compliance to the listed standards is implied by their inclusion under nonclinical testing. |
| Packaging Validation | Compliance with ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems). | Performed packaging validation. |
| Software Validation | Compliance with BS EN ISO 62304:2015, FDA Guidance (Jan 11, 2002), FDA Guidance (May 11, 2005), and FDA Guidance (Sep 9, 1999). Software algorithm for pressure/frequency information must be the same and validated. | "embedded, validated software with the same algorithm to provide the same pressure/frequency information to the user." Software validation was performed. |
| Usability & Human Factors | Compliance with IEC 62366:2015 (Medical Devices - Application of Usability Engineering to Medical Devices). | Performed usability and human factors testing. |
| Substantial Equivalence | Same intended use, indications for use, and similar technological characteristics as the predicate device (K142245). Differences do not adversely affect safety and effectiveness or raise different questions of safety and efficacy. No new questions of safety or effectiveness due to minor differences in dimensions and design of the Control Unit (Gen2). | "The EpiAccess System has the same intended use and indications for use, and similar technological characteristics as the predicate device." "performance testing demonstrated that these differences do not adversely affect the safety and effectiveness... or different question of safety and efficacy." "The minor differences... do not raise any new questions of safety or effectiveness." |
Important Note: This device is a catheter introducer system that relies on pressure measurements, and the key "algorithm" mentioned is "the same algorithm to provide the same pressure/frequency information to the user." This is not an AI/ML algorithm in the modern sense that classifies, predicts, or makes diagnostic recommendations. It is a measurement and display system.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in the context of an algorithm evaluation with a specific number of cases or images. The testing described is primarily engineering verification and validation testing for hardware, software, and system functionality. This type of testing typically involves a sufficient number of units to demonstrate statistical confidence per design and quality system requirements, but not a large "test set" of patient data as would be used for AI/ML performance.
Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned, as this is bench testing on the device itself.
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 type of testing described. Ground truth as typically understood for AI/ML validation (e.g., expert labels on images, pathology results) would not be established for the electrical safety, EMC, software functionality, or general performance tests of a medical device's control unit. The "ground truth" here is the expected behavior and measurement accuracy of the device itself, verified by engineers against specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of expert adjudication for defining ground truth in the context of the described device testing.
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 MRMC study was conducted or is mentioned. The device provides "additional information regarding needle tip location" as an "added convenience feature" and "does not alert the user to tip location or provide clinical decision guidance." Therefore, a comparative effectiveness study showing improvement with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's software algorithm provides pressure/frequency information to the user. It is not an AI that performs a standalone diagnostic function. The functioning of the software algorithm was validated as part of the overall software validation, ensuring it provides "the same pressure/frequency information." However, this is distinct from "standalone performance" of an AI algorithm in isolation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of AI/ML ground truth. For the described engineering tests, "ground truth" would be the pre-defined engineering specifications, expected electrical characteristics, mechanical performance, and software outputs.
8. The sample size for the training set
Not applicable. The device's software uses a previously validated, fixed algorithm. There is no mention of machine learning or an AI model that would require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model.
§ 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).