(219 days)
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Vanguard reprocessed Livewire diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 5 - 7 French in diameter and 95 to 115 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The hand piece is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation and pacing equipment. The catheters are available with various steerable distal curves for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array. The catheters are also available in a variety of electrode configurations that are selected by the clinician based on preference and/or indication.
The shaft polymer is manufactured with additives (barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream.
Vanguard collects previously used diagnostic EP catheters from healthcare facilities, and cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to a healthcare facility for an additional clinical use.
The provided text describes the 510(k) summary for Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters. However, it does not contain details about acceptance criteria, specific device performance metrics (beyond "perform as intended"), or a study design with ground truth, sample sizes, or expert adjudication as typically seen in AI/ML device submissions.
The summary focuses on establishing substantial equivalence to a predicate device through:
- Identical technological characteristics: The reprocessed catheters are stated to be "essentially identical" to the Original Equipment Manufacturer (OEM) devices, with "no changes made to the device materials or specifications."
- Performance and biocompatibility testing: This is a general statement.
Given this, I will describe what is available in the text.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical performance and safety equivalent to predicate device | Reprocessed devices perform "as intended" |
| Biocompatibility equivalent to predicate device | Biocompatibility testing demonstrates safety and efficacy |
| Sterilization effectively renders the device sterile | Sterilization validations performed |
| Cleaning effectively prepares the device for reprocessing | Cleaning validations performed |
| Packaging maintains sterility and device integrity | Packaging validations performed |
| Device materials and specifications remain unchanged from OEM | "No changes are made to the device materials or specifications" |
| Radiopacity maintained for fluoroscopic guidance | "Manufactured with additives (barium sulfate) that enhance the catheter's radiopacity" |
Study Details (as inferred from the provided text):
The submission does not detail a study in the context of an AI/ML device submission, but rather a validation of a reprocessed medical device.
- Sample size used for the test set and the data provenance: The document mentions "performance and biocompatibility testing" and "cleaning, sterilization, and packaging validations" but does not specify sample sizes for these tests. The provenance of the data is not mentioned, but it would typically be from laboratory testing and validation rather than clinical or retrospective patient data in this context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. Ground truth as typically understood for AI/ML models is not directly established in this context. The "truth" would be determined by whether the reprocessed device meets established engineering and clinical performance specifications.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 is a reprocessed medical device, not an AI/ML diagnostic or assistive device.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this medical device's performance would be against engineering specifications, biocompatibility standards, and the performance characteristics of the original predicate device as verified through laboratory testing.
- The sample size for the training set: Not applicable. This is a reprocessed medical device, not an AI/ML model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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).