(93 days)
The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Ocelot System consists of the Ocelot Catheter, the Lightbox Console and the Umbilical. The Ocelot Catheter is an over-the-wire device that is compatible with a 6F sheath and 0.014" guidewire. The Ocelot Catheter has a working length of 110cm and incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.
The Ocelot System, as described in the provided 510(k) Premarket Notification (K122380), is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions in the peripheral vasculature. The device's performance was evaluated through a multi-center, prospective, non-randomized study called CONNECT II.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Safety Endpoint: Composite endpoint including site-reported major adverse events (MAEs) and angiographic data (clinically significant perforations, embolizations, and Grade C or greater dissections). | Met. Two clinically significant perforations (2%) occurred during the procedure, with no reported sequelae prior to discharge. No MAEs (0.0%) or unanticipated adverse events. |
| Primary Effectiveness Endpoint: Successful CTO crossing by the Ocelot System and subsequent guidewire positioning through the distal true lumen (confirmed by angiography). | Met. Achieved in 97% of subjects. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 122 subjects.
- Data Provenance: The study (CONNECT II) was a multi-center study conducted in the United States and European Union. The data was collected prospectively.
3. Number of Experts and Qualifications for Ground Truth
The document states that "Primary safety and effectiveness endpoints were based on independent angiographic reviewers." However, the specific number of experts and their qualifications (e.g., years of experience, subspecialty) are not explicitly mentioned in the provided text.
4. Adjudication Method for the Test Set
The document notes that endpoints were assessed by "independent angiographic reviewers." This implies that the reviewers independently assessed the angiographic data to establish the ground truth for the safety and effectiveness endpoints. However, the specific adjudication method (e.g., 2+1, 3+1, none, or if there was a consensus or tie-breaking process) is not detailed. It simply states "independent angiographic reviewers," which could suggest individual independent assessments rather than a strict consensus or multiple-reader adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in the provided text. The study evaluated the performance of the Ocelot System as a tool, not the improvement of human readers with AI assistance. The Ocelot System uses OCT-assisted orientation as an adjunct to fluoroscopy, implying it assists the clinician, but the study design was not an MRMC to quantify the improvement of human readers.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not conducted for the Ocelot System. The system is described as an "OCT-assisted orientation as an adjunct to fluoroscopy," indicating it's designed to be used by a human operator to facilitate guidewire placement. The effectiveness endpoint explicitly states "successful CTO crossing by the Ocelot System and subsequent guidewire positioning," implying human interaction.
7. Type of Ground Truth Used
The ground truth used was primarily expert judgment/consensus based on angiographic data, along with site-reported safety data.
- Effectiveness: Confirmed by angiography, assessed by independent angiographic reviewers.
- Safety: Site-reported safety data (MAEs) and angiographic data (clinically significant perforations, embolizations, and Grade C or greater dissections) assessed by independent angiographic reviewers.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. The CONNECT II study is described as evaluating the device's performance, not as a study to train an algorithm or AI component. While the Ocelot System incorporates "OCT-assisted orientation," the text does not suggest an AI model that requires a distinct training set in the context of this 510(k) submission.
9. How Ground Truth for the Training Set Was Established
As no specific training set is mentioned in the context of an AI-driven system requiring ground truth for training, this information is not applicable and not provided in the given text. The "OCT-assisted orientation" is technology integrated into the device, not an AI algorithm that would typically undergo a separate training phase with a dedicated ground truth dataset.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).