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

The OffRoad Re-Entry Catheter System is intended to facilitate the placement and positioning of guidewires within the peripheral vasculature beyond stenotic lesions, including sub and chronic total occlusions.

Device Description

The OffRoad Re-Entry Catheter System consists of two components; the OffRoad Positioning Balloon Catheter and the OffRoad Micro-Catheter Lancet. Together they assist in accessing the true lumen after bypassing a chronic total occlusion lesion in the peripheral vasculature.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted for the OffRoad™ Re-Entry Catheter System.

1. Table of Acceptance Criteria and Reported Device Performance

Endpoint Type	Acceptance Criteria	Reported Device Performance	Device Meets Criteria?
Safety	Composite rate of major adverse events (MAEs) related to the OffRoad System through 30 days post index procedure less than 15%.	3.3% (3/90) with a one-sided 95% upper confidence bound of 6.5%.	Yes
Effectiveness	Device technical success (placement of a guidewire in the true lumen distal to a CTO as confirmed by the angiography core lab) greater than 76%.	Site-reported: 84.8% (78/92) with a one-sided 95% lower confidence bound of 79%. Core Lab Confirmed: 92.1% (70/76) with a one-sided 95% lower confidence bound of 87%.	Yes

Note: The clinical study also included secondary endpoints (death, perforation requiring intervention, clinically significant peripheral embolism, major amputation), but acceptance criteria were only explicitly stated for the composite MAE rate and device technical success.

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

Human Clinical Study (Re-ROUTE, NCT01500031):

Sample Size: 92 subjects.
Data Provenance: Prospective, multi-center clinical study conducted at 12 investigational sites. The document does not specify the country of origin of the data, but it is implied to be within the US given the context of a 510(k) submission to the FDA.

Pre-Clinical Animal Study:

Sample Size: N=7 OffRoad™ Re-entry Catheter devices and N=5 Cordis OUTBACK® LTD™ Re-Entry Catheter devices (used in 6 common swine).
Data Provenance: Pre-clinical animal study.

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

Human Clinical Study (Re-ROUTE): The primary effectiveness endpoint (device technical success) was confirmed by an angiography core lab. The number and specific qualifications of experts within this core lab are not detailed in the provided text.
Pre-Clinical Animal Study: The study noted that two instances of arterial wall perforations were "not considered a safety concern by the Study Pathologist and Study Director." This indicates at least two experts (a Study Pathologist and a Study Director) were involved in establishing the ground truth for the animal study's safety assessment, but their specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

Human Clinical Study (Re-ROUTE): The document mentions "CEC data" (Clinical Event Committee), which suggests that a Clinical Event Committee was responsible for adjudicating adverse events and potentially other study endpoints, ensuring uniformity and reliability of outcome assessment. The specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated. The primary effectiveness endpoint was confirmed by an angiography core lab.
Pre-Clinical Animal Study: The assessment of safety concerns was done by the "Study Pathologist and Study Director." No specific formal adjudication method (like 2+1) is described beyond their joint assessment.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.
This device (OffRoad™ Re-Entry Catheter System) is a physical medical device (catheter system) and not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

No, a standalone (algorithm only) performance study was not done.
As explained above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Human Clinical Study (Re-ROUTE):
- Safety: Composite Major Adverse Events (MAEs) were defined by specific clinical outcomes (death, perforation requiring intervention, clinically significant peripheral embolism, major amputation). These are objective clinical endpoints, likely confirmed by the Clinical Event Committee based on patient records and diagnostic evidence.
- Effectiveness: Device technical success was defined as "placement of a guidewire in the true lumen distal to a CTO as confirmed by the angiography core lab." Angiography provides visual evidence of guidewire placement, serving as the ground truth.
Pre-Clinical Animal Study: Ground truth was established through histological characterization and direct observation of vessel wall effects after using the devices, assessed by a Study Pathologist and Study Director.

8. The Sample Size for the Training Set

The provided text does not mention a training set. This is consistent with the device being a physical catheter system, for which the concepts of "training set" and "test set" in the context of machine learning or AI models are not directly applicable. The studies described are performance and safety evaluations for human use and pre-clinical testing, not algorithm development.

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

As a training set is not applicable and not mentioned, the method for establishing its ground truth is also not mentioned.

Summary

Regulation Number and Section

§ 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).