(109 days)
Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
The Telescope guide extension catheter is a single-lumen rapid exchange catheter. The guide extension catheter is designed to act as an extension to a traditional guide catheter and to facilitate the delivery of interventional devices into the vasculature. The guide extension catheter is intended to be used within the coronary and/or peripheral vasculature to provide support.
The Telescope™ Guide Extension Catheter is offered in sizes compatible with 6F and 7F guide catheters as indicated by the product model numbers below.
The provided text describes the 510(k) premarket notification for the Medtronic Telescope™ Guide Extension Catheter. It outlines the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical testing performed to establish this equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantitative "acceptance criteria" in the format of a table with numerical thresholds. Instead, it describes various "Design Verification/In-Vitro Bench Testing" and "Biocompatibility Testing" categories that were performed to demonstrate substantial equivalence to the predicate device. The implied acceptance criterion for each test is that the device's performance is acceptable and does not raise new questions of safety and effectiveness, making it comparable to the predicate.
Here's an interpreted table based on the testing categories mentioned:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Design Verification/In-Vitro Bench Testing: | |
| Simulated Use | No new safety or effectiveness issues raised. |
| Deliverability | No new safety or effectiveness issues raised. |
| Tip compression | No new safety or effectiveness issues raised. |
| Pushwire Integrity | No new safety or effectiveness issues raised. |
| Torque | No new safety or effectiveness issues raised. |
| Lumen Patency | No new safety or effectiveness issues raised. |
| Maximum outer diameter | No new safety or effectiveness issues raised. |
| Catheter effective length | No new safety or effectiveness issues raised. |
| Kink resistance | No new safety or effectiveness issues raised. |
| Tensile Strength | No new safety or effectiveness issues raised. |
| Coating Integrity | No new safety or effectiveness issues raised. |
| Coating Particulate | No new safety or effectiveness issues raised. |
| Biocompatibility Testing (in compliance with ISO 10993-1): | |
| Cytotoxicity | No new safety or effectiveness issues raised. |
| Acute Systemic Toxicity | No new safety or effectiveness issues raised. |
| Material Mediated Pyrogenicity | No new safety or effectiveness issues raised. |
| ASTM Hemolysis | No new safety or effectiveness issues raised. |
| Complement Activation | No new safety or effectiveness issues raised. |
| Partial thromboplastin time | No new safety or effectiveness issues raised. |
| In-vivo Thromboresistance | No new safety or effectiveness issues raised. |
| Irritation / Intracutaneous Reactivity | No new safety or effectiveness issues raised. |
| Sensitization | No new safety or effectiveness issues raised. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the exact sample sizes used for each individual test within the "Design Verification/In-Vitro Bench Testing" and "Biocompatibility Testing." It broadly states that "non-clinical data" was generated.
The data provenance is from Medtronic Ireland, the manufacturer, through in-vitro bench testing and biocompatibility testing. This is typically considered prospective for the purposes of generating data to support the 510(k) submission, as the tests were specifically conducted for the purpose of demonstrating substantial equivalence of the new device. The country of origin for the data generation would be Ireland, where Medtronic Ireland is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The document describes bench testing and biocompatibility testing, which typically involve laboratory personnel and engineers, rather than clinical experts establishing ground truth in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. The testing described is objective, technical testing (e.g., tensile strength, lumen patency) and biocompatibility testing against defined standards. It does not involve human interpretation or adjudication of results in the way a clinical study would.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical investigation has been performed for this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This concept is not applicable to this device. The Telescope™ Guide Extension Catheter is a physical medical device, not a software algorithm or AI model. Therefore, "standalone algorithm performance" is not a relevant metric.
7. The Type of Ground Truth Used:
For the "Design Verification/In-Vitro Bench Testing," the ground truth is established by engineering specifications, industry standards, and internal Medtronic test protocols that ensure the device meets its functional and performance requirements. For "Biocompatibility Testing," the ground truth is established by international standards, specifically ISO 10993-1: 2009/ Cor 1: 2010, which outlines the requirements for biological evaluation of medical devices.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. As this is a physical medical device submission and no AI/machine learning component is mentioned, there is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for an AI/machine learning algorithm.
§ 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).