(42 days)
The Advocate PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Advocate PTA Catheter consists of two lumens, a compatible guidewire lumen (0.014", 0.018" or 0.035") extending from guide wire port in the manifold to the catheter distal tip, and an inflation lumen extending from the proximal inflation port in the manifold to the balloon interior. There are various size balloons in the product matrix, ranging from 2.0-12.0mm in diameter and 15-300mm in length. The catheter has two radiopaque marker bands that facilitate visibility and location during the placement and inflation of the balloon. The catheter is inserted through a 4Fr, 5Fr, 6Fr or 7Fr haemostatic or non haemostatic introducer, depending on the model selected.
This document describes the Advocate PTA Catheter and its 510(k) premarket notification (K192907). It addresses a change in manufacturing location and an expansion of the Indications for Use. The relevant information provided focuses on the safety and performance testing related to these changes.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with corresponding device performance metrics for the expanded indications for use. Instead, it states that "extra Validation testing was done on the device to qualify the expanded indications for use" and lists the types of tests successfully completed. This implies that the tests performed met internal acceptance criteria for demonstrating safety and performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device successfully navigates anatomical pathways (AVF) | Deliverability (AVF Trackability) - Successfully completed |
| Device demonstrates sufficient force transmission for advancement | Deliverability (Pushability) - Successfully completed |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample size used for the test set (i.e., the number of catheters or tests performed for Deliverability AVF Trackability and Pushability).
The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective testing conducted by Merit Medical Systems, Inc. to qualify the expanded indications for use and the manufacturing location change.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable as the document describes physical performance testing of a medical device, not a diagnostic or AI-based study requiring expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes physical performance testing of a medical device, not a study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The document describes the testing of a medical device (PTA Catheter), not an AI algorithm. Therefore, no MRMC study or comparison of human readers with/without AI assistance was performed.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The document describes the testing of a medical device (PTA Catheter), not an AI algorithm.
7. Type of Ground Truth Used
This information is not applicable in the context of expert consensus, pathology, or outcomes data. For the physical performance tests, the "ground truth" would be the engineering specifications and expected performance characteristics of the device, assessed through laboratory testing.
8. Sample Size for the Training Set
This information is not applicable as the document describes the testing of a medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the document describes the testing of a medical device, not an AI algorithm that requires a training set and ground truth establishment.
Summary of Key Information from the Document:
- Device: Advocate PTA Catheter
- Purpose of Submission (K192907): Change in Indications for Use and manufacturing location.
- Expanded Indications for Use: Balloon dilation of iliac, femoral, popliteal, infra-popliteal, renal arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Testing Performed to Qualify Expanded Indications: Deliverability (AVF Trackability) and Deliverability (Pushability).
- Outcome of Testing: Successfully completed.
- Manufacturing Change: Moved from a subcontractor (Arravasc) to Merit Medical in Galway, using the same qualified processes.
- The document implies that the successful completion of the listed safety and performance tests demonstrates that the device meets the necessary acceptance criteria for the expanded indications. However, it does not provide detailed quantitative acceptance criteria or specific numerical results.
§ 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).