(154 days)
The Reprocessed 3D Diagnostic Ultrasound eco Catheters are indicated for intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible Carto® 3 EP Navigation Systems (version 2.3 and higher) the reprocessed 3D Diagnostic Ultrasound eco Catheters provide location information.
Sterilmed Reprocessed 3D Diagnostic Ultrasound eco Catheters are specially designed catheters that provide two-dimensional imaging using an ultrasound transducer and three-dimensional location sensor. They are IntraCardiac Echo (ICE) Catheters with acoustic array and magnetic location sensor equivalent to the currently cleared SoundStar eco 8F G Ultrasound Catheter, and SoundStar eco 8F Ultrasound Catheters 510(k) K140318. The magnetic location sensor (providing location information to the CARTO® 3 EP Navigation System) and an ultrasound transducer (acquiring real time ultrasound images) are embedded in the catheter tip. The Reprocessed 3D Diagnostic Ultrasound Catheters, when connected to the corresponding Ultrasound Systems, will provide real-time integration of the ultrasound images with CARTO® 3 electromagnetic acquired maps.
The document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of reprocessed 3D Diagnostic Ultrasound eco Catheters to new (OEM) devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test) | Reported Device Performance | Result |
|---|---|---|
| Mechanical Reliability | ||
| Joint Bond Strength (SM5653/5840) | Tensile strength of device joints confirmed reprocessing has no effect. | Pass |
| Torsional Strength (SM5652/5842) | Torsional strength of flexible tip and shaft sections confirmed reprocessing has no effect. | Pass |
| Flexation Fatigue (SM5604/5827) | Flexation through maximum range of deflection (100 times) confirmed reprocessing has no effect. | Pass |
| Deflection Fatigue (SM5605/5823) | Deflection in simulated use model (multiple times) confirmed reprocessing has no effect. | Pass |
| Tip Buckling (SM4091/5923) | Force required to cause tip buckling ensured reprocessing had no effect. | Pass |
| Sensor/System Functionality | ||
| CCS Check (SM5523/5822) | Calibration check confirmed reprocessing has no effect on device's ability to maintain sensor location. | Pass |
| Auto ID (SM5800/5830) | Reprocessed devices continue to be identified as Soundstar eco 8F catheters. | Pass |
| EEPROM Reset Verification (SM5802/5841) | EEPROM can be effectively reset and continue to function as intended. | Pass |
| AMCS Acoustic Verification (SM5522/5828) | Acoustic Manual Calibration System functions for reprocessed devices. | Pass |
| Safety | ||
| Thrombogenicity Testing (SM6020/6828) | Reprocessed devices do not cause any new risk of thrombus formation. | Pass |
| Biocompatibility Testing (ISO 10993-1) | Data demonstrates no risk presented by reprocessed catheters. | Pass |
| EM Compatibility (IEC 60601-1:2005 A1:2012) | Compliance to defibrillation protection (peak differential signal ) | Performed to validate sterilization procedures. |
| Ethylene Oxide Residual Testing (ISO 10993-7) | Performed. | Pass |
| Packaging Validation (ASTM D4169, F88, F2096) | Performed. | Pass |
| Shelf Life Validation (ASTM 1980-99) | Performed. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size for each individual test within the "Verification Testing" or "Summary of Non-Clinical Tests Conducted" sections. It refers to "representative samples of reprocessed devices" for functional characteristics testing. Other tests like "100% in-process inspected" indicate testing of every reprocessed device during manufacturing.
Data Provenance: The data is generated internally by Sterilmed, Inc. as part of their reprocessing validation. It is retrospective in the sense that it evaluates the performance of reprocessed devices after the reprocessing procedure has been applied. The country of origin of the data is the USA (Maple Grove, MN).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the described tests are primarily physical, electrical, chemical, and functional performance benchmarks against defined standards and specifications, rather than a clinical study requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" here is the established performance parameters of the original (OEM) device and relevant industry standards.
4. Adjudication Method for the Test Set:
This is not applicable as the tests performed are objective, quantitative measurements against predefined pass/fail criteria, not subjective assessments requiring 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:
This is not applicable. The document describes the validation of reprocessed medical devices (catheters), not an AI algorithm or a study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable. The document describes the validation of reprocessed medical devices (catheters), not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on:
- Performance specifications of the original (OEM) devices: The reprocessed devices are compared to the performance characteristics of the Biosense Webster SoundStar eco 8F and eco 8F G Ultrasound Catheters (K140318).
- Industry Standards: Compliance with various ISO, ASTM, USP, and IEC standards (e.g., ISO 11135, USP , ISO 10993-1, ISO 10993-7, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-99, IEC 60601-1:2005 A1:2012, IEC 61161:2013).
- Internal Specifications: Criteria established by Sterilmed, Inc. for functional performance, cleaning, and sterilization.
8. The Sample Size for the Training Set:
This is not applicable. The document describes the validation of reprocessed medical devices, not a machine learning model that would require a training set. The "process validation testing" for cleaning and sterilization procedures are internal validation processes, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no training set mentioned in the context of machine learning. The "ground truth" for the processes mentioned (cleaning, sterilization) is established through rigorous scientific testing and adherence to recognized industry standards to ensure the reprocessed devices meet safety and efficacy requirements.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).