(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.
§ 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).