(56 days)
The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
The IntellaMap Orion High Resolution Mapping Catheter is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve on an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the RHYTHMIA HDx™ Mapping System.
The provided text describes a medical device, the IntellaMap Orion™ High Resolution Mapping Catheter, and its clearance process with the FDA. It does not contain information about the acceptance criteria or a study that specifically proves the device meets those criteria, as typically found in a clinical trial report or a performance study for AI/software devices. The document focuses on establishing substantial equivalence to a predicate device through design verification and biocompatibility testing.
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1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics for mapping performance. The goal is to be "as safe, as effective, and performs as well as the predicate device." | Design Verification Bench Testing: |
- Electrical Testing: Pass
- Reliability Testing: Pass
- Catheter Joint Strength: Pass
- Tip Buckle: Pass
- Visual Inspections and Dimensions: Pass
- Simulated Use: Pass
Biocompatibility Testing: - Cytotoxicity: Pass
- Hemolysis Direct Contact and Extract Methods: Pass
- Sensitization Maximization: Pass
- Intracutaneous Irritation: Pass
- Acute Systemic Toxicity: Pass
- Materials Mediated Rabbit Pyrogen: Pass
- Partial Thromboplastin Time: Pass
- In Vitro Hemocompatibility: Pass
- Complement Activation: Pass
- USP Physicochemical Test: Pass
- Latex Assay: Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of electrical, reliability, mechanical, simulated use, and biocompatibility bench testing as described. There are no "test sets" of patient data in the sense of a clinical or image-based AI study.
- Data Provenance: The data comes from internal Boston Scientific Corporation design verification and biocompatibility testing. The country of origin for this data is not specified but is implicitly internal to the manufacturer's testing processes. This is retrospective in the sense of being an assessment of the manufactured device's characteristics rather than a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in this context, refers to established engineering standards, material science properties, biological responses, and simulated use protocols rather than expert clinical consensus on patient data.
4. Adjudication method for the test set:
- Not applicable. The "Pass" results indicate that the device met pre-defined internal specifications and regulatory requirements for each test, which serves as the "adjudication."
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 comparative effectiveness study was done. This device is a mapping catheter, a hardware device, not an AI software intended to assist human readers with diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the performance claims comes from established engineering specifications, material science testing standards (e.g., ISO 10993-1 for biocompatibility), and simulated use protocols.
8. The sample size for the training set:
- Not applicable. There is no AI component requiring a "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no AI component requiring a "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).