(120 days)
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.
The Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheters are intended for temporary intracardiac sensing, recording, stimulation, and temporary pacing during the evaluation or cardiac arrhythmias. The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.
The provided FDA 510(k) clearance letter (K250772) pertains to a reprocessed medical device, specifically the Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter. This document largely focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and functional performance testing.
Crucially, the provided text does not contain information about acceptance criteria or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device, as assumed by the structured request. The clearance is for a physical medical device (a reprocessed catheter), not a software or AI/ML algorithm. Therefore, many of the requested categories (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information contained within this document.
The "Non-clinical Testing Summary" section describes the types of tests performed to demonstrate safety and effectiveness for a reprocessed physical device. These tests assess the physical and electrical properties of the catheter after reprocessing.
I will attempt to answer the applicable sections based on the information provided, and explicitly state when information is not available or not applicable due to the nature of the device.
Description of Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria for K250772
As noted above, this 510(k) clearance is for a reprocessed physical medical device (a catheter), not an AI/ML-powered device. Therefore, the "acceptance criteria" and "study" described herein are related to the physical, functional, and safety performance of the reprocessed catheter compared to the original, new device, rather than a statistical evaluation of an AI algorithm's diagnostic performance.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary (pages 6-8) describes the non-clinical testing performed to establish substantial equivalence. While explicit numerical acceptance criteria values are not provided in this public summary, the types of tests indicate the areas where the reprocessed device must perform equivalently to the predicate. The "reported device performance" is implied by the statement "found to be substantially equivalent to the predicate device based on the following tests."
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Functional Performance (overall) | Found to be substantially equivalent to the predicate device. |
| Visual Inspection | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Dimensional Measurement | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Electrical Safety | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Mechanical Characteristics | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Continuity | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Isolation | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Resistance | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Corrosion Resistance | Met acceptance criteria (implied by "found to be substantially equivalent"). |
| Cleaning Validation | Validated (implies meeting pre-defined criteria for residual contaminants). |
| Biocompatibility | Met acceptance criteria (implies no adverse biological reactions). |
| Packaging and Shelf Life Validation | Validated (implies maintaining sterility and integrity over time). |
| Sterilization Validation | Validated (implies achieving required Sterility Assurance Level). |
| Product Stability | Met acceptance criteria (implies maintaining performance over time). |
| Reprocessing Cycle Limit | Does not exceed validated reprocessing cycles (stated as 1). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of reprocessed catheters (the "test set") used for each functional and safety test. For medical devices, particularly reprocessed ones, sample sizes are typically determined by statistical rationale to demonstrate equivalence or meet performance specifications, but these details are not in the summary.
- Data Provenance: This relates to the testing of the reprocessed device itself. The data would be prospective, as it involves testing reprocessed devices manufactured by Medline ReNewal. The country of origin for the data would be where Medline ReNewal conducts its testing, likely the USA given the FDA clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A. This concept applies to diagnostic or AI/ML devices where a "ground truth" is established by human experts (e.g., radiologists interpreting images). For a reprocessed physical device, "ground truth" is established by objective engineering and safety standards (e.g., measuring dimensions against specifications, testing electrical resistance against a standard). The "experts" would be qualified engineers and technicians performing the tests.
4. Adjudication Method for the Test Set
- N/A. Adjudication (e.g., 2+1, 3+1 consensus) is used in studies with human readers interpreting data, often to resolve discrepancies in diagnoses or interpretations. This is not applicable to the direct physical and functional testing of a medical device like a catheter.
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
- N/A. This type of study is relevant for AI/ML-assisted diagnostic tools, not for a reprocessed physical device like this catheter. The clearance is based on the catheter's physical and functional equivalence to new catheters, not on improving human diagnostic accuracy.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This refers to the performance of an AI/ML algorithm on its own. It is not applicable to a physical medical device.
7. The Type of Ground Truth Used
- For the physical and functional aspects of the reprocessed catheter, the "ground truth" is established by:
- Engineering Specifications: The design and performance specifications of the original (predicate) new device. The reprocessed device must meet these same specifications.
- Regulatory Standards: Relevant FDA and international standards for medical device safety and performance (e.g., electrical safety, biocompatibility, sterilization).
- Objective Measurements: Direct measurements (e.g., dimensions, electrical properties, mechanical strength) and analytical tests (e.g., for residual contaminants).
8. The Sample Size for the Training Set
- N/A. "Training set" refers to data used to train an AI/ML algorithm. This is not applicable to a physical reprocessed medical device. The "training" for this device is the validation of the reprocessing procedure itself.
9. How the Ground Truth for the Training Set Was Established
- N/A. Since there is no "training set" in the AI/ML sense, this question is not applicable. For a reprocessed device, the "ground truth" is inherent in the established manufacturing and safety standards that the reprocessing procedure must meet. The reprocessor (Medline ReNewal) developed and validated a controlled process (cleaning, inspection, testing, packaging, sterilization) to ensure that the reprocessed catheter performs equivalently to a new device.
§ 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).