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The Revolution® 45 MHz Rotational IVUS Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidate for transluminal coronary interventional procedures.

The Revolution catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The Revolution® 45 MHz Rotational IVUS Imaging Catheter is substantially equivalent to the Revolution® 45 MHz Rotational Imaging Catheter cleared under K050995 on 06/20/2005. Modifications include implementation of a double seal on the pouch packaging.

The Revolution® 45 MHz Rotational Imaging Catheter uses the same fundamental scientific technologies and has the same intended use as that of the predicate device, Revolution® 45 MHz Rotational Imaging Catheter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Revolution™ 45 MHz Rotational IVUS Imaging Catheter:

Summary of Device and Context:

The Revolution™ 45 MHz Rotational IVUS Imaging Catheter is an intravascular ultrasound device for examining coronary arteries, indicated for patients undergoing transluminal coronary interventional procedures. This 510(k) submission (K080891) is for a modification to an already cleared device (K050995), specifically involving a double seal on the pouch packaging.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the submission focuses on demonstrating substantial equivalence for a packaging modification, not on establishing new performance claims for the imaging capabilities of the device itself. Therefore, the "acceptance criteria" and "reported device performance" are primarily related to the packaging change and its impact on the device's functional integrity.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific sample size for a "test set" in the context of device performance, as the submission primarily concerns a packaging change. It broadly mentions "Applicable testing was performed in accordance with Design Controls," which would include verification and validation activities for the packaging.

• Test Set Sample Size: Not explicitly stated as this submission primarily addresses a packaging change, not a clinical performance study. The "testing" referred to would be V&V for the packaging.
• Data Provenance: Not applicable in the context of a clinical study. The relevant data would be internal engineering and quality testing data related to the packaging.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided and is not relevant to this specific 510(k) submission. The submission is for a packaging change, not a new imaging algorithm or clinical diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided and is not relevant to this specific 510(k) submission as it does not involve expert interpretation or subjective assessment of clinical images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or at least not mentioned in this submission. This type of study is typically performed for AI or diagnostic imaging devices where human interpretation is involved and needs to be compared with or augmented by AI. This submission is for a packaging modification.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done or mentioned. The device is purely an imaging catheter, not an algorithm. Its "performance" refers to its ability to acquire images, which is not evaluated as a standalone algorithm in this context.

7. The Type of Ground Truth Used

The concept of "ground truth" (e.g., pathology, outcomes data) as typically understood in AI or diagnostic imaging performance studies is not applicable to this submission. The "ground truth" here would relate to the successful performance of the packaging (e.g., sterility maintenance, seal integrity) as determined by validated engineering and quality control tests, which are not detailed in this summary.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission. This device is a physical medical device (an IVUS catheter), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

As indicated above, the concept of a "training set" and its "ground truth" is not applicable to this submission.

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