(76 days)
The SterilMed Reprocessed Imaging Catheter is intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. This device is intended for use in the right-heart only.
The SterilMed Reprocessed Imaging Catheter is intended to be used with a compatible ultrasound imaging system. It is steerable, has a useable length of 90 cm and a diameter of 10 French. The distal end of the catheter contains an ultrasonic phased array imaging transducer. The transducer offers imaging modes at frequencies between 4.0 and 10.0 MHz.
The SterilMed Reprocessed IVUS Imaging Catheter (K043453) is a reprocessed medical device, and its acceptance criteria primarily hinge on demonstrating "substantial equivalence" to a predicate device. This is achieved through functional and safety testing to ensure the reprocessed device performs identically to the original.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Characteristics | The reprocessed catheter must demonstrate appropriate functional characteristics, identical to the predicate device, including steerability, usable length, diameter, and ultrasonic imaging parameters (frequency range). | "Representative samples of reprocessed imaging catheters underwent design testing to demonstrate appropriate functional characteristics." The conclusion states the device "is identical to the predicate device in terms of its design, materials, indications for use, and construction." Specific quantitative results for each functional parameter are not provided in this summary but are implied to have met the predicate's specifications. |
| Cleaning and Sterilization | The cleaning and sterilization procedures must be validated to ensure the device is safe for patient use and meets established sterility assurance levels (SALs). | "Process validation testing was done to validate the cleaning and sterilization procedures..." Specific validation results (e.g., bioburden reduction, SAL) are not provided but are implied to have met regulatory standards. |
| Device Packaging | The packaging must maintain sterility and protect the device during transport and storage. | "...as well as the device's packaging." Specific packaging validation results (e.g., seal integrity, shelf-life) are not provided but are implied to have met regulatory standards. |
| Manufacturing Process | The manufacturing process must include visual and functional testing of all products to ensure consistency and quality. | "...the manufacturing process includes visual and functional testing of all products produced." This indicates internal quality control measures are in place. |
| Special 510(k) Report | Any additional testing required for the Special 510(k) pathway (due to reprocessing) must be successfully performed and submitted. | "Finally, testing to support the required Special 510(k) Report was successfully performed and provided to the Agency." The specific tests are not detailed but would typically involve material integrity, biocompatibility, and electrical safety after reprocessing. |
| Substantial Equivalence | The reprocessed device must be substantially equivalent to the predicate device "in terms of its design, materials, indications for use, and construction." This is the overarching criterion for 510(k) clearance for reprocessed devices. | The conclusion explicitly states: "The imaging catheters reprocessed by SterilMed are substantially equivalent to the AcuNav™ Diagnostic Ultrasound Catheter Manufactured by Acuson Corp. (K992631). This conclusion is based upon the fact that this device is identical to the predicate device in terms of its design, materials, indications for use, and construction." |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not specify the exact sample size used for the test set. It mentions "Representative samples of reprocessed imaging catheters." This typically means a statistically significant number of devices were tested, but the precise count is not disclosed.
The data provenance is retrospective in the sense that the reprocessed device is being compared to an already marketed predicate device. The performance data generated for the reprocessed device itself would be prospective for that specific batch of reprocessed devices. The country of origin of the data is implicitly the United States, as the submission is to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. For reprocessed devices, ground truth isn't typically established by expert consensus on specific cases but rather by comparison to the known performance specifications of the original predicate device and adherence to reprocessing standards. The "experts" involved would likely be engineers, microbiologists, and regulatory specialists involved in the design, testing, and approval process.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of reprocessing, "adjudication" in the sense of clinician agreement on imaging findings is not typically relevant. Instead, the testing involves objective measurements against predefined specifications.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a reprocessed hardware component (an imaging catheter), not an AI-powered diagnostic algorithm. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study was not done. This device is a hardware component and does not operate as a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this reprocessed device is the performance specifications and safety profile of the original, new predicate device (AcuNav™ Diagnostic Ultrasound Catheter Manufactured by Acuson Corp., K992631). The reprocessed device must meet or exceed these established parameters. This is achieved through:
- Engineering measurements (e.g., dimensional checks, electrical tests, imaging performance).
- Microbiological testing (e.g., sterility, endotoxin levels).
- Biocompatibility testing (if materials are altered or new residues are introduced).
8. The Sample Size for the Training Set
This information is not applicable as this is a reprocessed hardware device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reason stated above.
§ 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).