(112 days)
The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.
The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The catheters have a high-torque shaft with a braided bi-directional deflectable tip section containing an array of ten platinum electrodes that includes a 2 mm tip dome, which can be used for stimulation and recording. The catheters are 7 french with a usable length of 115 cm. The rocker lever located on the hand piece is used to deflect the tip section. A friction control knob is located on the opposite side of the rocker lever and can be rotated clockwise to lock both the tip curve and rocker lever in place. The high-torque shaft allows the plane of the curved tip to rotate, enabling accurate positioning of the catheter tip.
The provided text describes the 510(k) summary for Sterilmed, Inc.'s Reprocessed Electrophysiology Diagnostic Catheters. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria for a new AI or diagnostic device.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document, as it outlines the regulatory pathway for a reprocessed medical device.
However, I can extract information related to the functional and safety testing performed, which serves a similar purpose of demonstrating the device's acceptable performance.
Acceptance Criteria and Study for Reprocessed Electrophysiology Diagnostic Catheters (K121158)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in a tabular format as would be typical for a new diagnostic device. Instead, the "acceptance criteria" are implied by demonstrating that the reprocessed device performs "as originally intended" and is "substantially equivalent" to the predicate device.
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional & Safety | Reprocessed catheters must demonstrate appropriate functional characteristics. | "Representative samples of reprocessed EP diagnostic catheters were tested to demonstrate appropriate functional characteristics." |
| Cleaning Validation | Demonstrated efficacy of cleaning procedures. | "Process validation testing was performed to validate the cleaning... procedures." Specific non-clinical tests included "cleaning validation." |
| Sterilization | Demonstrated efficacy of sterilization procedures (ISO 11135, USP ). | "Process validation testing was performed to validate the ... sterilization procedures." Specific non-clinical tests included "sterilization (ISO 11135, USP )." |
| Biocompatibility | Demonstrated biocompatibility (ISO 10993-1). | Specific non-clinical tests included "biocompatibility testing (ISO 10993-1)." |
| Ethylene Oxide Residue | Demonstrated acceptable ethylene oxide residuals (ISO 10993-7). | Specific non-clinical tests included "ethylene oxide residual testing (ISO 10993-7)." |
| Packaging Validation | Demonstrated integrity and protection (ASTM D 4169, ASTM F 2096). | Specific non-clinical tests included "packaging validation (ASTM D 4169, ASTM F 2096)." |
| Shelf Life Validation | Demonstrated maintenance of product integrity over time (ASTM F 1980). | Specific non-clinical tests included "shelf life validation (ASTM F 1980)." |
| Functional Performance (Bench Testing) | Demonstrated performance as originally intended through simulated use, visual inspection, fatigue testing, and function testing. | "validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. Performance testing shows the reprocessed EP diagnostic catheters to perform as originally intended." |
| Manufacturing Process | Includes visual and validated functional testing of 100% of reprocessed products. | "the manufacturing process includes visual and validated functional testing of 100% of products reprocessed." |
| Substantial Equivalence | Device is as safe and effective as the predicate device (Biosense Webster Coronary Sinus Catheters with EZ Steer Technology (K101345)). | "Sterilmed concludes that the reprocessed EP diagnostic catheters are safe, effective, and substantially equivalent to the predicate devices, Biosense Webster Coronary Sinus Catheters with EZ Steer Technology (K101345), as described in this premarket notification submission." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Representative samples of reprocessed EP diagnostic catheters were tested." It also mentions "100% of products reprocessed" undergo visual and validated functional testing as part of the manufacturing process. However, specific numbers for the "representative samples" used in the validation studies (cleaning, sterilization, biocompatibility, etc.) are not provided.
- Data Provenance: The studies were conducted by Sterilmed, Inc. and are related to their reprocessing procedures. This would be considered prospective testing and validation of their reprocessed devices. The country of origin of the data is implicitly the United States, where Sterilmed, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. Ground truth established by experts is typically relevant for diagnostic devices that analyze medical images or data requiring clinical interpretation. This submission is for a reprocessed electrophysiology diagnostic catheter, where the "truth" is its functional performance, safety, and sterility, verified through engineering and laboratory testing rather than expert clinical consensus.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. The safety and performance of a reprocessed medical device are determined by standardized physical, chemical, and biological testing methods.
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
This is not applicable. This submission is for a reprocessed medical device, not an AI or imaging diagnostic device. No human-in-the-loop diagnostic performance studies are mentioned or relevant for this type of product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Reference to predicate device specifications and intended performance.
- Validated engineering and laboratory testing (e.g., functional bench testing, cleaning validation, sterilization validation, biocompatibility studies, packaging integrity tests, shelf-life tests) against recognized industry standards (ISO, ASTM, USP).
- Visual inspection and functional testing of 100% of reprocessed products.
8. The Sample Size for the Training Set
This is not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this 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).