(260 days)
The reprocessed ViewFlex™ Xtra ICE catheter is in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
The Reprocessed ViewFlex™ Xtra ICE catheter is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use.
The Reprocessed ViewFlex™ Xtra ICE catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction.
The provided text describes the regulatory clearance for a reprocessed medical device, specifically the Reprocessed ViewFlex™ Xtra ICE Catheter (K190478). This document primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical performance and safety tests. It does not pertain to an AI/ML-driven device or a study involving human readers or efficacy in diagnosing conditions. Therefore, many of the requested categories in the prompt are not applicable.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document details various tests performed to ensure the reprocessed device is substantially equivalent to the original predicate device. The "acceptance criteria" are implied to be that the reprocessed device performs "as originally intended" and meets the same functional and safety characteristics as the new, original (OEM) device.
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Cleaning Validation | Demonstrated appropriate functional characteristics and validated cleaning procedures. |
| Sterilization Assurance | Sterilization Verification | Validated sterilization procedures. |
| Biocompatibility | Ethylene Oxide Residual Testing (ISO 10993-7) | Confirmed acceptable residual levels. |
| Cytotoxicity | Met biocompatibility requirements per ISO 10993-1. | |
| Sensitization | Met biocompatibility requirements per ISO 10993-1. | |
| Irritation/Intracutaneous Reactivity | Met biocompatibility requirements per ISO 10993-1. | |
| Acute Systemic Toxicity | Met biocompatibility requirements per ISO 10993-1. | |
| Pyrogenicity | Met biocompatibility requirements per ISO 10993-1. | |
| Hemocompatibility | Met biocompatibility requirements per ISO 10993-1. | |
| Thrombogenicity | Met biocompatibility requirements per ISO 10993-1. | |
| Packaging & Shelf-life | Packaging Validation (ASTM D4169, ASTM F88, ASTM F2096) | Validated packaging procedures. |
| Shelf-life Validation (ASTM 1980-07) | Validated shelf-life. | |
| Functional Performance | Electrical Leakage | Performed as originally intended. |
| (Bench Testing) | Torsional Strength | Performed as originally intended. |
| Flexation Fatigue | Performed as originally intended. | |
| Fluid Integrity | Performed as originally intended. | |
| Joint Bond Strength | Performed as originally intended. | |
| Deflection Fatigue | Performed as originally intended. | |
| Stiffness | Performed as originally intended. | |
| Tip Buckling | Performed as originally intended. | |
| Transducer Sensitivity | Performed as originally intended. | |
| Ultrasound console compatibility | Compatible with listed consoles (ViewMate™ II, ViewMate™ Z, ViewMate™, Philips CX50a). | |
| Acoustic Output | Performed as originally intended. | |
| Thermistor Functionality | Performed as originally intended. | |
| Manufacturing Process | Visual and validated functional testing of all products | Included in the manufacturing process to ensure product quality. |
| Device Tracking | Reprocessed device is marked and tracked | Ensures the device is rejected from further reprocessing after one cycle, indicating control over reprocessing limits. |
| Overall Conclusion | Substantial Equivalence to Predicate Device (K133853) | Performance testing demonstrated substantial equivalence to the predicate device and did not raise different questions in safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each particular test (e.g., number of catheters tested for electrical leakage). It refers to "representative samples of reprocessed devices" for functional testing. The data provenance is implied to be from internal lab testing conducted by Sterilmed, Inc. No information on country of origin or retrospective/prospective nature of the testing is provided beyond it being part of the 510(k) submission process for a reprocessed device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The study described is a non-clinical, bench-top engineering and biocompatibility study comparing a reprocessed device to a new device, not a diagnostic study requiring expert interpretation of medical images or data. Therefore, there is no "ground truth" established by medical experts for a test set in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies to resolve discrepancies in expert interpretation. This document describes physical, chemical, and functional engineering tests.
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 device is an intracardiac ultrasound catheter for visualization, not an AI-driven diagnostic tool that assists human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the performance and safety specifications of the original (OEM) predicate device (ViewFlex™ Xtra ICE Catheter, K133853). The reprocessed device is tested to ensure it meets these established technical specifications and performance characteristics, demonstrating "substantial equivalence" rather than diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
This is not applicable. There is no AI/ML algorithm that requires a training set. The study involves reprocessed physical devices.
9. How the ground truth for the training set was established
This is not applicable. There is no AI/ML algorithm or training set.
§ 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).