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510(k) Data Aggregation
(245 days)
HEARTRAIL III GUIDING CATHETER
The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.
The Heartrail™ III Guiding Catheter (5Fr.) is a three-layer construction comprised of a stainless steel mesh sandwiched between a layer of polytetrafluoroethylene and a layer of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tin is a flexible, supple polyester elastomer containing tungsten. This tip is permanently welded to the catheter shaft. Depending on the product code, the tip is either straight or curved into a specific shape.
The Heartrail™ III Guiding Catheter (5Fr.) is operated manually or by a manual process. During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing a guide wire and introducer within a vessel. Then the Heartrail™ III Guiding Catheter would be advanced over the guide wire. Next, the guide wire and Guiding Catheter would be advanced to the target vessel. The Heartrail™ III Guiding Catheter can then be used for injection of radiopaque media or for support and exchange of guide wires, catheters, and/or therapeutic agents.
This document is a 510(k) summary for the Terumo Heartrail™ III Guiding Catheter (5Fr.). It describes a device that is substantially equivalent to a previously cleared device (K092372). This is a medical device submission, not a study evaluating an AI device or a novel medical device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable.
Here's an analysis based on the provided text, focusing on what is applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for the Heartrail™ III Guiding Catheter (5Fr.) is a Special 510(k) based on substantial equivalence to a predicate device due to minor modifications (primarily a reduction in catheter outer diameter from 6Fr. to 5Fr. and additional tip shapes/lengths). Therefore, the "acceptance criteria" are not reported as strict performance metrics with thresholds in the typical sense of a novel device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through various nonclinical performance tests and biocompatibility assessments, ensuring the modified device performs as safely and effectively.
| Acceptance Criteria Category (Implied by Substantial Equivalence and Testing) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Nonclinical Performance (Bench Testing) | The performance of the Heartrail™ III Guiding Catheter (5Fr.) is substantially equivalent to the predicate device, as shown through bench testing on non-aged and aged devices for parameters such as: Surface, Tip configuration, Product dimensions, Force at break, Freedom from leakage, Radio detectability, Catheter burst/Leakage pressure, Flexibility/Catheter stiffness, Tip durability, Flow rate, Tip strength, Catheter inner surface friction, Torque control, Simulated use testing, Torque Strength, Flexibility and Kink Test, Catheter Bond Strength. |
| Biocompatibility (Blood Contacting Materials) | All blood contacting materials were tested per ISO 10993-1 and successfully passed: |
- Cytotoxicity: Non-cytotoxic
- Sensitization: No evidence of causing delayed dermal contact sensitization
- Acute Intracutaneous Reactivity: No evidence of significant irritation or toxicity
- Acute Systemic Toxicity: No mortality or evidence of systemic toxicity
- Hemolysis: Non-hemolytic
- Pyrogenicity: Non-pyrogenic
- InVivo Thromboresistance: Thromboresistant
- Complement Activation: Not a complement system activator |
| Biocompatibility (Aged Device) | Limited screening tests demonstrated that aging (14 weeks at 60°C) does not affect biocompatibility: - Physicochemical Profile: Meets requirements
- Cytotoxicity: Non-cytotoxic
- Hemolysis: Non-hemolytic |
| Sterilization | Validated in accordance with ANSI/AAMI/ISO 11135-1, achieving a Sterility Assurance Level (SAL) of 10-6. |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a clinical study with a "test set" in the context of an AI/algorithm evaluation. The "test set" here refers to the physical devices (non-aged and aged) that underwent bench testing and biocompatibility assessments. The exact number of units/samples for each specific test is not provided in this summary but would be detailed in the full test reports. The data provenance is from bench testing conducted by the manufacturer, Terumo Corporation, for a medical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a medical device submission, not a study involving human interpretation of data for ground truth establishment. Performance is evaluated against engineering specifications and established biological safety standards.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as this is not a study requiring expert consensus for interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This submission pertains to a physical medical device, not a diagnostic algorithm requiring human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This document is about a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by engineering specifications, recognized national and international standards for medical device performance (e.g., burst pressure, flow rate, bond strength), and biocompatibility standards (e.g., ISO 10993 series, ASTM F756). The device demonstrating substantial equivalence to a legally marketed predicate confirms its safety and effectiveness relative to those established benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through engineering and materials science principles, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
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(37 days)
HEARTRAIL III GUIDING CATHETER
The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.
The Heartrail III Guiding Catheter is a three-layer construction comprised of a stainless steel mesh sandwiched between a layer of polytetrafluoroethylene and a layer of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyester elastomer containing tungsten. This tip is permanently welded to the catheter shaft. Depending on the product code, the tip is either straight or curved into a specific shape.
The provided text is for a 510(k) premarket notification for a medical device called the "Heartrail™ III Guiding Catheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional study with acceptance criteria and performance metrics in the way a new, novel device might.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, training set sample size, detailed ground truth establishment) are not applicable in this context because the manufacturer is not conducting a de novo clinical trial or an AI/software performance study.
Here's how to interpret the provided information in the context of your request:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
For a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the new device is "substantially equivalent" to predicate devices across several key attributes. The "reported device performance" is then framed in relation to these predicates, primarily through bench testing.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (as stated in submission) |
|---|---|
| Intended Use Equivalence: The device's intended clinical application must be the same as the predicate. | The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures to deliver radiopaque media, guide wires, catheters, and therapeutic agents. This is stated to be substantially equivalent to the predicate devices. |
| Technological Characteristics Equivalence: Design, materials, and principle of operation should be similar, and any differences should not raise new questions of safety or effectiveness. | The Heartrail™ III Guiding Catheter utilizes a three-layer construction (stainless steel mesh, PTFE, polyester elastomer with tungsten), a "soft-tip", and similar materials to the predicate devices (Radifocus® Optitorque™ Angiographic Catheter K082736 and Boston Scientific Mach 1 Catheter K981788). Differences in materials are explicitly stated not to raise new issues of safety and effectiveness. The principle of operation is manual, similar to predicates. |
| Performance Equivalence: The device must perform as safely and effectively as the predicate, typically demonstrated through non-clinical testing. | Bench Testing: "The performance of the Heartrail III Guiding Catheter is substantially equivalent to the performance of the predicate devices. The equivalence was shown through bench testing." Specific quantitative results for individual performance parameters (e.g., maximum injection pressure, catheter length, available sizes) are listed: |
- Available Sizes: 6 Fr.
- Catheter Length: 100 cm
- Maximum Injection Pressure: 700 psi.
These specifications implicitly meet the performance of equivalent predicate devices.
Biocompatibility: Materials are biocompatible, tested according to ISO-10993, for limited contact (
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