(373 days)
Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Extension Set is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
The Zynergy Zolution Electrophysiology Catheter is intended as a primary diagnostic tool for intracardiac electrogram recording and pacing, for the determination of conduction times from one location to another, to identify aberrant conduction pathways and to assess arryhthmia vulnerability of the cardiac chambers. Initial sizes to be marketed are 5Fr and 6Fr which include lengths of 1-5mm, electrode spacing of 1mm -1cm and varying in the number of electrodes per catheter of 2 - 20. Various curve styles are available in order to meet anatomical constraints and/or physician preference. The Zynergy Zolution, Zyp-Lok Accessory Cable is a reusable, medical grade cable in lengths of 18", 36" and 72" and 4, 10 & 20 conductor configurations.
This document is a 510(k) summary for the Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Accessory Cable, submitted by Zynergy CardioVascular, Inc. It describes the device's intended use, design, and performance testing, but it does not present a formal study with acceptance criteria and results proving device performance in the manner typically expected for AI/ML medical devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through comparative features and successful completion of standard performance and biocompatibility testing. The "acceptance criteria" discussed are related to these physical and biological tests, not statistical performance metrics derived from a clinical study for diagnostic accuracy.
Here's an analysis based on the provided text, acknowledging the limitations for your specific request regarding traditional AI/ML device study parameters:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of quantitative acceptance criteria with reported performance metrics for diagnostic accuracy or any similar, statistically analyzed outcome. Instead, it describes successful completion of various engineering and biological tests relevant to the device's function and safety. The acceptance criteria are implied to be "successful completion" or "compliance."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength | Successfully completed |
| Engagement (of components) | Successfully completed |
| Electrical Impedance | Successfully completed |
| Torque Transmission | Successfully completed |
| Cytotoxic Injection (Biocompatibility) | Successfully completed per ISO10993 and FDA guidelines |
| Intracutaneous Injection (Biocompatibility) | Successfully completed per ISO10993 and FDA guidelines |
| Hemolysis (Biocompatibility) | Successfully completed per ISO10993 and FDA guidelines |
| Complement Activation (Biocompatibility) | Successfully completed per ISO10993 and FDA guidelines |
| Unactivated Partial Thromboplastin Time Assay | Successfully completed per ISO10993 and FDA guidelines |
| Lee White Clotting Time (Biocompatibility) | Successfully completed per ISO10993 and FDA guidelines |
| Pyrogenicity (Biocompatibility) | Successfully completed per ISO10993 and FDA guidelines |
| Intravenous Toxicity (Biocompatibility) | Successfully completed per ISO10993 and FDA guidelines |
| Sensitization (Biocompatibility) | Successfully completed per ISO10993 and FDA guidelines |
| Sterility Assurance Level | 10⁻⁶ (ETO sterilized, monitored for compliance with ISO/FDA guidelines) |
| Ethylene Oxide Residuals | Monitored for compliance with ISO/FDA guidelines |
| Bacterial Endotoxin Levels | Monitored for compliance with ISO/FDA guidelines |
| Design, Composition, and Function Similarity | Similar to Elecath Defector Series (K933450) and Arrow Intracardiac Electrode Catheter Products (K953651) |
Regarding the "study that proves the device meets the acceptance criteria":
The document states: "Performance testing including tensile, engagement, electrical impedence and torque transmission was successfully completed." and "Biocompatibility testing, including cytotoxic injection, intracutaneous injection, hemolysis, complement activation, unactivated partial thromboplastin time assay, Lee White Clotting Time, pyrogenicity, intravenous toxicity, sensilisation has been successfully completed per ISO10993 and FDA guidelines."
This indicates that internal in-vitro and bench testing, along with standard biocompatibility assessments, were performed. These are not structured clinical studies with human subjects or complex diagnostic performance evaluations. The "proof" is the successful execution and passing of these standard tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not mentioned in the provided text. The tests described are bench tests and biocompatibility assays, not clinical studies involving patient data or test sets in the typical sense for AI/ML devices.
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 information is not applicable or mentioned. Ground truth establishment by experts is relevant for diagnostic devices that interpret patient data. This device is a catheter for electrophysiological studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or mentioned. Adjudication methods are used in studies involving reader interpretation of clinical data.
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
There is no indication that an MRMC comparative effectiveness study was done. This type of study is specifically for evaluating the impact of AI assistance on human reader performance, which doesn't apply to this non-AI catheter device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
There is no indication of a standalone algorithm performance study. This is a physical medical device (catheter) and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance and biocompatibility testing, the "ground truth" would be the established physical and chemical standards (e.g., specific tensile strength values, absence of cytotoxic effects, sterility assurance level). These are determined by engineering specifications and biological safety standards, not expert consensus on diagnostic images or pathology.
8. The sample size for the training set
This information is not applicable or mentioned. There is no "training set" in the context of this device.
9. How the ground truth for the training set was established
This information is not applicable or mentioned. There is no "training set" for this device.
In summary: The provided document is a 510(k) summary for a legacy medical device (electrophysiology catheter). It describes standard engineering and biocompatibility testing to demonstrate safety and effectiveness and substantial equivalence to existing devices. It does not present clinical study data or performance metrics in a way that aligns with the typical requirements for evaluating AI/ML medical devices. Many of your requested categories (like MRMC studies, ground truth for AI, training/test sets) are not relevant to this type of device submission.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).