(29 days)
The SJMTM Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used in the ● evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with ● MediGuide™ Technology to enable real-time tip positioning and navigation.
The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy. ●
The Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
St Jude Medical (SJM) Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.
St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The MediGuide Enabled Livewire Steerable Electrophysiology Catheter is designed to allow electrophysiological mapping at various endocardial and intravascular sites including the inferior vena cava, superior vena cava, pulmonary veins and coronary sinus.
The use of the MediGuide Enabled Livewire diagnostic mapping catheter in conjunction with the MediGuide gMPS system allows real-time tip positioning and navigation during routine diagnostic evaluation.
When connected to the ECG, the MediGuide Enabled Livewire Catheter will transmit routine electrical signals while the passive sensor at the tip of the catheter is tracked by gMPS and is superimposed on any 2D X-ray image in real time (“Live”) fluoroscopy mode (the actual 3D position of the catheter tip is projected on the real time 2D image).
The SJM Livewire™ Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by a remote means located at the proximal end of the catheter.
The Response™ Electrophysiology Catheter with Lumen is a sterile, single use, electrophysiological diagnostic catheter with a fixed distal curve and multiple electrodes. The electrodes detect cardiac electrical signals that are transmitted to an electrocardiogram recorder for diagnosis or deliver the electrical signal from an external pacemaker to the heart for electrical pacing purposes. The catheter body is a continuous tube with a central lumen for fluid infusion through a 3-way valve.
The Response™ Electrophysiology Catheter is a sterile, single use, electrophysiological diagnostic catheter. The catheter has fixed distal curve available in various styles, no lumen, and varying electrode numbers and spacing. The electrodes detect cardiac electrical signals that are transmitted to an electrocardiogram recorder for diagnosis or deliver the electrical signal from an external pacemaker to the heart for electrical pacing purposes.
The SJM™ Epicardial Catheter System consists of the following SJM components:
• 17 Gauge Tuohy Needle, 11.4 cm
• Response™ Electrophysiology Catheter, 6F
• Agilis™ NxT Steerable Introducer, 40 cm (includes steerable sheath, dilator, and guidewire)
The Response™ Electrophysiology Catheter, 6F, is designed to provide pacing and recording capabilities during electrophysiology studies involving the epicardial surface of the heart. The distal tip of the catheter contains four platinum electrodes. It is curved to facilitate greater reach when advanced out of the steerable introducer.
The Supreme™ Electrophysiology Catheter is a sterile, single use, electrophysiological diagnostic catheter. The catheter has fixed distal curve available in various styles, no lumen, and varying electrode numbers and spacing. The electrodes detect cardiac electrical signals that are transmitted to an electrocardiogram recorder for diagnosis or deliver the electrical signal from an external pacemaker to the heart for electrical pacing purposes.
The provided text describes a 510(k) premarket notification for several electrophysiology catheters. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with acceptance criteria and performance metrics for AI-powered devices.
Therefore, the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study with effect size
- Standalone performance for an algorithm
- Type of ground truth used
- Sample size for training set
- How ground truth for the training set was established
cannot be extracted from this document because it is not relevant to a 510(k) submission for non-AI medical devices and this document does not describe any AI component.
The document details a comparison with predicate devices and focuses on non-clinical testing to demonstrate that a manufacturing process change (a new outer insulation manufacturing process resulting in a different surface morphology) does not adversely affect device safety and effectiveness.
Here's what can be extracted regarding the study that proves the device meets (safety and effectiveness) criteria, as presented in this 510(k) summary:
Study and Acceptance Criteria:
The "study" in this context refers to non-clinical testing performed to demonstrate that the modified devices are substantially equivalent to their predicates. The acceptance criteria are implicit in meeting the standards for biocompatibility and product performance.
1. Table of Acceptance Criteria and Reported Device Performance (as relevant to this submission):
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Complies with ISO 10993 (to ensure the modified material does not cause adverse biological reactions). | "The catheters with the modified surface morphology of the proximal shaft demonstrated acceptable biocompatibility profile." |
| Product Performance/Safety & Effectiveness: Complies with ISO 10555 (specific to sterile, single-use intravascular catheters) and overall product specifications (to ensure functional integrity and performance are maintained despite the surface morphology change). | "DV testing was performed according to ISO 10555. The catheters with the modified surface morphology of the proximal shaft met product performance specifications." and "does not adversely affect the device safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a number of devices, but it refers to the "catheters with the modified surface morphology of the proximal shaft" that underwent Biocompatibility and Design Verification (DV) testing. This typically involves a sufficient number of samples to statistically demonstrate compliance with the standards, but the exact count is not in this summary.
- Data Provenance: This is non-clinical lab test data, conducted internally or by contract labs following ISO standards. It is retrospective in the sense that the testing was completed prior to the submission. The country of origin of the data is not specified, but it would be where the manufacturing and testing facilities are located for St. Jude Medical (Minnetonka, MN, USA, as per the submitter information).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This is not a study requiring expert clinical assessment for ground truth. The "ground truth" here is compliance with established engineering and biological safety standards (ISO 10993 and ISO 10555).
4. Adjudication Method for the Test Set:
- Not applicable. This is not a comparative clinical study requiring expert adjudication. Acceptance is based on meeting predefined technical and biological endpoints in laboratory testing.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is not an AI or imaging device, and no MRMC study was conducted or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This device is a physical electrophysiology catheter, not an algorithm, and does not operate in a "standalone" algorithmic capacity.
7. The Type of Ground Truth Used:
- For Biocompatibility: Compliance with ISO 10993 biological endpoints (e.g., cytotoxicity, irritation, sensitization).
- For Product Performance: Compliance with ISO 10555 mechanical and functional requirements, and internal product specifications (e.g., physical dimensions, electrical conductivity, steering mechanism integrity, fluid flow in the lumen for the Response with Lumen catheter).
8. The Sample Size for the Training Set:
- Not applicable. This is not a machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable (as there is no training set).
§ 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).