Search Results

The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.

The RX ACCUNET™ Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System, the RX ACCUNET Recovery Catheter, Shapeable Tip Design and the RX ACCUNET™ 2 Recovery Catheter, Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET™ Embolic Protection System is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside one of the provided Recovery Catheters. Recovery Catheter selection will be based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy.

The provided text is a 510(k) premarket notification for the RX ACCUNET™ Embolic Protection System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study results with precise acceptance criteria and detailed performance data like a PMA (Premarket Approval) would.

Therefore, many of the requested elements for a detailed study description are not present in this document. The document explicitly states that "No changes were made to any of the individual components of the RX ACCUNET™ Embolic Protection System" and that the submission is for a "3 in 1 packaging configuration." The "Performance Data" section only mentions "packaging integrity studies."

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., specific sensitivity, specificity, accuracy thresholds). The overarching acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device.
• Reported Device Performance: The only performance data mentioned is related to "packaging integrity studies." No clinical performance metrics (like efficacy in embolic capture, complication rates, or patient outcomes) are provided for the device itself.

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

• Test Set Sample Size: Not applicable/not provided for clinical performance testing, as no new clinical study data on device performance is presented. The submission focuses on packaging changes and substantial equivalence.
• Data Provenance: Not applicable for clinical performance. The packaging studies would likely be internal Guidant testing.

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

• Not applicable, as no new clinical test set requiring expert ground truth establishment for device performance is described.

4. Adjudication Method for the Test Set

• Not applicable, as no new clinical test set requiring adjudication is described.

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

• No, a TRMC study was not done, as this is solely a 510(k) submission for a packaging change, demonstrating substantial equivalence, not a new clinical study for effectiveness.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a medical device (embolic protection system), not an AI algorithm.

7. Type of Ground Truth Used

• Not applicable for clinical performance. For the packaging studies, the "ground truth" would be the verified integrity and sterility of the packaged device after testing.

8. Sample Size for the Training Set

• Not applicable, as no new clinical performance data or AI model training data is described.

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

• Not applicable.

Summary derived from the document:

The 510(k) K052166 for the RX ACCUNET™ Embolic Protection System "3 in 1 packaging configuration" is a submission demonstrating substantial equivalence to previously cleared predicate devices (RX ACCUNET™ Embolic Protection Systems K042218 and RX ACCUNET™ 2 Recovery Catheter K042908).

The document explicitly states:

• "No changes were made to any of the individual components of the RX ACCUNET™ Embolic Protection System."
• The "Technological Characteristics" are considered "substantially equivalent" in materials, biocompatibility, performance properties, sterilization, and packaging to the currently marketed predicate devices.

The only performance data mentioned are packaging integrity studies, which "demonstrated the safety and effectiveness of the proposed RX ACCUNET™ Embolic Protection System '3 in 1 packaging configuration.'" No details about these packaging studies (sample size, specific tests, acceptance criteria for packaging) are provided in this summary.

This 510(k) does not present a new clinical study to prove the device meets specific performance criteria beyond the existing predicate devices. The "study" referenced in the document is effectively the demonstration of substantial equivalence through comparison of technological characteristics and confirmation of packaging integrity for the new configuration.

Ask a specific question about this device