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510(k) Data Aggregation
(161 days)
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
Integra® Jarit® Heparin Cannulas, Injectors, and Needles are used in conjunction with various syringe sizes (not supplied by Integra®) for flushing, irrigation and solution injection into a vessel or cavity during vascular, bypass or other cardiovascular surgical procedures.
Integra® Jarit® Heparin Cannulas, Injectors, and Needles are manual, stainless steel catheter cannulas provided in various sizes, shapes, and lengths for use during cardiovascular surgical procedures such as coronary artery bypass surgery. The cannulas are intended to be connected to a syringe filled with heparinized saline to confirm there is no leakage as well as ensure patency of harvested and/or grafted veins. The syringes are not being supplied with the cannulas nor are the syringes offered by Integra; therefore they are not part of this submission. These reusable devices are packaged non-sterile and are steam sterilizable.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Integra® Jarit® Heparin Cannulas, Injectors, and Needles:
Context: The provided text is a 510(k) Summary for a medical device seeking substantial equivalence to predicate devices, not an AI/ML medical device. Therefore, many of the typical acceptance criteria and study components associated with AI devices (like ground truth, expert consensus, MRMC studies, training/test sets, etc.) are not applicable here. This document focuses on demonstrating physical and material properties, and reusability.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Standard/Test) | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Manual Cleaning Validation (Protein Analyses) per AAMI TIR30:2003 | Pass |
| Mechanical Cleaning Validation (Protein Analyses) per AAMI TIR30:2003 | Pass | |
| Sterilization Validation | Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure Time of 4 minutes and Drying Time of 30 minutes | Pass |
| Material/Durability Testing | Repeated Autoclave Testing, Boiling Water Testing, Copper Sulfate Corrosion Testing and Thermal Testing per ISO 13402:1995 and ASTM F 1089-02 | Pass |
| Mechanical Strength | Laser Weld Joint Mechanical Strength Testing | Pass |
| Brazed Joint Mechanical Strength Testing | Pass | |
| Biocompatibility | Use of recognized biocompatible materials (304 and 303 Stainless Steel) per ASTM F899-11 and ISO 7153-1, with a long history of safe and effective use. | Not performed (deemed unnecessary based on material properties and history) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The tests conducted are typically on a sample of the devices designed to be representative of production, but the specific number is not disclosed in this summary.
- Data Provenance: The tests are controlled bench tests performed on the physical devices manufactured by Integra York PA, Inc. The data is prospective for the purpose of this submission; it's generated specifically to demonstrate compliance for the 510(k). Country of origin for data generation is not specified beyond "Integra York PA, Inc." (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not directly applicable to this type of device submission. The "ground truth" for these tests is established by recognized industry standards (e.g., AAMI, ASTM, ISO) and the scientific principles behind them (e.g., measuring protein residue, assessing material integrity, verifying sterilization efficacy). These standards themselves are developed by committees of experts, but specific individual experts are not cited for establishing the ground truth for this particular test of this device.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human interpretation or consensus. The tests performed yield objective, measurable results (e.g., "Pass" or "Fail" based on whether predefined thresholds from the standards are met).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a manual surgical instrument, not an AI/ML-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., Algorithm-Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical, manual surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used is defined by adherence to established national and international performance standards and test methods (e.g., ANSI/AAMI ST79, ASTM TIR 30, ISO 13402, ASTM F1089-02, ISO 7153-1). These standards specify acceptable levels for cleanliness, sterilization, corrosion resistance, and mechanical strength. In the case of biocompatibility, the ground truth is based on the recognized biocompatibility profiles of the specified stainless steel materials as per relevant material standards (ASTM F899-11 and ISO 7153-1) and their long history of safe use in medical devices.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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