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510(k) Data Aggregation
(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.
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(77 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 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 that includes pre-programmed diagnostic computer with a touchscreen display and graphical user interface (GUI).
The provided text extensively details the non-clinical and clinical studies conducted for the EpiAccess System, but it does not explicitly state specific quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating that the device meets design requirements, functions as intended, and is safe and effective through various tests compliant with recognized standards.
Despite the lack of explicit acceptance criteria values, the document implies that the device successfully met all implicit criteria of the conducted tests to achieve its 510(k) clearance.
Here's an analysis of the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit quantitative acceptance criteria are not provided in the document. However, the reported device performance is broadly stated as:
| Test/Category | Implicit Acceptance Criteria (implied) | Reported Device Performance | Study Type |
|---|---|---|---|
| Non-Clinical Testing | Compliance with relevant ISO and AAMI standards for dimensional, performance, electrical safety, EMC, pressure transducer, biocompatibility, sterilization, shelf life, packaging, and software. | The EpiAccess System functioned as intended and results observed were as expected. Confirmed device is safe, meets design inputs, and raises no new safety or efficacy concerns. | Bench, Animal |
| Biocompatibility Testing | Passed required tests for patient-contacting materials. | L929 Neutral Red Uptake Cytotoxicity Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Rabbit Pyrogen Test, Hemolysis Rabbit Blood Complement Activation Assay, Unactivated Partial Thromboplastin Time Assay all passed. | Bench |
| Sterilization & LAL Pyrogen Validation | Compliance with relevant ANSI/AAMI/ISO standards and FDA Guidance. | Compliance demonstrated. | Bench |
| Shelf Life & Packaging Validation | Compliance with relevant ASTM standards. | Compliance demonstrated. | Bench |
| Software Validation | Compliance with BS EN ISO 62304 and FDA Guidance. | Compliance demonstrated. | Bench |
| Comparative Animal Studies | Compliance with 21 CFR § 54 and FDA Guidance for cardiovascular devices. | Successfully demonstrated comparative usability, ensuring the device performs similarly or better than predicate devices. | Animal |
| Usability and Human Factors Testing | Compliance with SI/AAMI HE 75, IEC 62366, and FDA Guidance. | Demonstrated usability and addressed human factors. | Human Factors Study |
| Clinical Performance (Technical Success) | Ability to safely access the pericardial space and deliver a guidewire. | 100% technical success. | Clinical |
| Clinical Performance (Adverse Events) | Absence of serious adverse events or adverse events related to the device. | No serious adverse events and no adverse events related to the EpiAccess System. | Clinical |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical/Bench Testing: The document does not specify sample sizes for individual bench tests (dimensional, electrical, biocompatibility, etc.).
- Animal Studies: The sample size for comparative usability testing in animals is not specified. Data provenance is not specified (e.g., country of origin, specific animal models).
- Clinical Study (Test Set): "[T]o date there has been 100% technical success, no serious adverse events, and no adverse events related to the EpiAccess System." This implies an ongoing study. The exact number of patients enrolled to date for the purpose of this 510(k) submission is not explicitly stated.
- Data Provenance: European study (EASe Study - ClinicalTrials.gov Identifier: NCT02209064). This is a prospective, post-market clinical follow-up study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Non-Clinical/Bench/Animal Data: Not applicable in the context of expert ground truth.
- Clinical Data: The document does not specify the number or qualifications of experts (e.g., clinicians, electrophysiologists) involved in assessing technical success or adverse events in the EASe clinical study. However, clinical trials inherently involve medical professionals.
4. Adjudication Method for the Test Set
- Clinical Data: The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the clinical study results. Adverse events and technical success are typically reviewed by clinical investigators and potentially a data safety monitoring board, but the specific process isn't detailed here.
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, an MRMC comparative effectiveness study was not done. The EpiAccess System is a medical device (introducer needle with pressure transducer), not an AI-assisted diagnostic imaging tool with "readers." The "AI" component is a "pre-programmed diagnostic computer" which processes internal pressure transducer data and external A-line data, not images for human interpretation. The clinical study assessed the device's technical success, ease of use, and clinical benefit of its pressure frequency information display, and adverse events, not its impact on human reader performance with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in essence, standalone performance of the pressure transducer and its processing unit was assessed as part of the non-clinical testing. The "pre-programmed diagnostic computer" and the integrated pressure transducer were tested to standards like AAMI/ANSI BP22 and IEC 60601-2-34 which evaluate the accuracy and reliability of pressure measurement independent of human interpretation. While a human uses the device and interprets the displayed pressure information, the foundational performance of the measurement system itself is evaluated as a standalone component. The device "displays the pressurement information, which physicians may be able to use to determine needle tip location," but it "does not alert the user to tip location or provide clinical decision guidance," implying the algorithm's direct output is raw pressure data, not a diagnostic interpretation requiring human-in-the-loop validation for its accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical/Bench Testing: Ground truth was established by adherence to recognized international and national standards (e.g., ISO, ASTM, AAMI, IEC) which define expected performance characteristics and measurement accuracy. For biocompatibility, it was based on standard biological test outcomes.
- Clinical Study: Ground truth for technical success (safe access and guidewire delivery) was based on clinical observation and procedural outcomes during the epicardial electrophysiology procedures. Adverse events were identified through clinical monitoring and reporting.
8. The Sample Size for the Training Set
- Not Applicable. The EpiAccess System is a hardware device with an integrated pre-programmed diagnostic computer, not a machine learning model that undergoes a "training phase" with a labeled dataset in the conventional sense. The "pre-programmed" nature suggests fixed algorithms for pressure data processing, validated against engineering and physiological standards.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, there is no "training set" in the context of machine learning for this device. The device's "programming" and performance are validated against established engineering principles and medical standards during its design and verification phases.
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