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The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

The Innova series digital fluoroscopy systems labeling is modified to allow the use of this device in an Operating Room environment that is suitable for this device. The device is suitable for Interventional XRAY procedures (catheter, needle, Minimally Invasive Surgery ) and can be used either in an Interventional Room (i.e. Cath Lab) or in an Operating Room Environment. The device is not suitable to do surgical procedures (ie. open surgery).

1. Table of Acceptance Criteria and Reported Device Performance:

   The submission does not provide a table of acceptance criteria or quantitative performance metrics for the device itself. Instead, it focuses on the device's substantial equivalence to predicate devices based on a labeling change.

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

   • Sample Size: Not applicable. The submission explicitly states, "There is no clinical testing for this modification since the intended use, indications for use and other product specifications do not change."
   • Data Provenance: Not applicable. No new clinical or performance data was generated for this specific modification.

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

   Not applicable. No new test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set:

   Not applicable. No new test set was adjudicated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   No. The submission explicitly states, "The subject of this Premarket submission, Innova in Operating room environment, did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study:

   No. This submission is for a medical device (digital fluoroscopy system) whose labeling was modified, not a standalone algorithm. The device's performance is considered substantially equivalent to its predicate devices, which were previously cleared.

7. Type of Ground Truth Used:

   Not applicable. No new ground truth was established for this submission. The ground truth for the predicate devices' initial clearance would have been established, but this information is not part of this specific submission.

8. Sample Size for the Training Set:

   Not applicable. This submission is for a labeling modification to an existing device, not for the development of a new algorithm or system requiring a training set.

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

   Not applicable. No training set was used.

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