FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.

Device Description

The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound Catheter is a 9F (3mm) diameter and 9 MHz frequency IntraCardiac Echocardiography Catheter which is 110cm in lenath. The Ultra IntraCardiac Echo Catheter is constructed with an inner core and proximal connector. The catheter has a distal imaging window and an inserted rotatable imaging core with a distal ultrasound transducer. The 9F (3mm)/9MHz Ultra IntraCardiac Echo Catheter can be used with the ClearView Ultra™ DSP system only after implementation of version 4.22 software or higher, or the Galaxy™ system. Ultra IntraCardiac Echo Catheters rely on the rotational fidelity of the internal transducer and driveshaft assembly to accurately coincide with the position sensing electronics located in the Motordrive Unit (MDU). This arrangement is necessary in order to reduce the overall diameter of the catheter and to ensure that image information is displayed correctly on the screen.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria or specific performance metrics from benchmark tests with target values. Instead, it states a general conclusion about performance.

Category	Acceptance Criteria (Implicit)	Reported Device Performance
Overall Performance	The reprocessed device performs as originally intended, demonstrating safety and effectiveness comparable to the predicate device.	"Performance testing demonstrates that Reprocessed Ultra ICE™ IntraCardiac Echo Catheter perform as originally intended."
"Stryker Sustainability Solutions concludes that the modified devices (Reprocessed Ultra ICE™ IntraCardiac Echo Catheter) are safe, effective, and substantially equivalent to the predicate devices as described herein."
Biocompatibility	The reprocessed device must be biocompatible.	"Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultra ICE™ IntraCerdiac Echo Catheter. This included the following tests: - Biocompatibility" (Implies successful completion without specific data provided).
Reprocessing	The reprocessing method must be validated.	"Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultra ICE™ IntraCerdiac Echo Catheter. This included the following tests: - Validation of reprocessing" (Implies successful completion without specific data provided). Stryker's reprocessing includes "removal of adbrent visible soil and decontamination."
Sterilization	The sterilization method must be validated.	"Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultra ICE™ IntraCerdiac Echo Catheter. This included the following tests: - Sterilization Validation" (Implies successful completion without specific data provided).
Functional Tests	The device's components must function appropriately.	"Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultra ICE™ IntraCerdiac Echo Catheter. This included the following tests: - B Function test(s)" (Implies successful completion without specific data provided). "Each individual device is tested for appropriate function of its components prior to packaging and labeling operations."
Packaging	The packaging must be validated.	"Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultra ICE™ IntraCerdiac Echo Catheter. This included the following tests: - Packaging Validation" (Implies successful completion without specific data provided).
Technological Equivalence	The design, materials, intended use, mechanism of action, claims, indications, clinical applications, patient population, performance specifications, and method of operation must be identical to the predicate device.	"The design, materials, and intended use of Reprocessed Ultra IntraCardiac Echo Catheter are identical to the predicate devices. The mechanism of action of the reprocessed device is identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation."

Study Information:

Based on the provided document, the study conducted is primarily a reprocessing validation and device performance study to demonstrate substantial equivalence to a predicate device. It is not a clinical study involving human patients to assess diagnostic accuracy or improvement with or without AI.

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 the sample size for the test set used in the "Bench and laboratory testing." It mentions "Performance data" and lists categories of tests.
- Data Provenance: Not specified. Given it's "bench and laboratory testing," it refers to in-vitro testing rather than patient data.
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):
- Not applicable. This was bench and laboratory testing of a reprocessed medical device, not a diagnostic accuracy study requiring expert ground truth or interpretation of images/data by medical professionals. The "ground truth" would be the expected functional performance and safety parameters of the device itself.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as this was not a study involving human interpretation or clinical adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This device is an intracardiac echo catheter, and the study relates to its reprocessing and functional performance, not AI assistance for human readers of medical images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This document describes a physical medical device, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study was the established specifications and performance characteristics of the original, new predicate device. The reprocessed device's performance was compared against these known, acceptable standards for safety and function. This includes:
  - Meeting biocompatibility standards.
  - Demonstrating effective reprocessing (e.g., cleanliness, decontamination).
  - Achieving terminal sterility.
  - Passing functional tests for its mechanical and electrical components (e.g., rotational fidelity, emission/reception of ultrasound energy).
  - Maintaining packaging integrity.
The sample size for the training set:
- Not applicable. This is a study on a reprocessed physical medical device, not an AI or machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there was no training set.

Summary

Regulation Number and Section

§ 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).