(213 days)
The MedAmicus Percutaneous Introducer is intended to be used in the exact same manner as the previous introducers manufactured by MedAmicus and cleared by FDA under K893658 and K951313. The intended use of these introducers is to create a percutaneous pathway for the introduction of catheters, ports, and pacing leads into the venous vasculature.
The MedAmicus Percutaneous Introducer is indicated for use to access The wennineds of the circulatory system to create an access port to che volled interventional procedures with catheters or implant long or conduct interventional devices
The MedAmicus Percutaneous Introducer package consists of a thin-wall needle, a disposable syringe, and a flexible guidewire. Percutaneous introducers are small diameter tubular shaped devices with an integrated proximal handle. These MedAmicus introducers all have a feature for removal common to introducers. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The design of the MedAmicus Percutaneous Introducer incorporates a nylon braiding material in the wall of the sheath which improves kink resistance and a marker band near the distal tip to assist in introducer tip location during the pacing lead, catheter, or infusion port introduction process under fluoroscopy.
Here's an analysis of the provided text regarding the MedAmicus Percutaneous Introducer:
It's important to note that this document is a 510(k) summary for a Percutaneous Venous Introducer, a medical device, and not an AI/ML medical device. Therefore, many of the typical questions for AI/ML device studies (like sample size for training/test sets, ground truth establishment, expert adjudication, MRMC studies, efficacy metrics like sensitivity/specificity/AUC) are not applicable to this type of device and its regulatory review process.
The regulatory approval here is based on substantial equivalence to predicate devices, meaning it's similar enough in safety and effectiveness to a device already legally marketed. The "study" referenced is primarily bench testing to demonstrate that the new features don't negatively impact performance and that the device meets its own specifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Specification | Reported Device Performance |
|---|---|
| Workmanship (Visual Examination) | All samples met required specifications. |
| Kink Resistance (via radius models) | Improved kink resistance (due to nylon braiding). All samples met required specifications. |
| Marker Band Removal Integrity | All samples met required specifications. |
| Marker Band Security Evaluations | All samples met required specifications. |
| Sterility Assurance Level (SAL) | Greater than one in one million devices being non-sterile. (Achieved through ETO sterilization cycle validated with AAMI method and spore strips showing complete kill at one-half cycle). |
| Biocompatibility (for new materials) | Fully evaluated and successfully passed evaluations. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states "Sample devices were subjected to physical bench testing" and "All samples met the required specifications," and "Validation tests were performed with spore strips...placed in sample product." However, the exact number of samples tested for each criterion is not specified in this summary.
- Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The testing was physical bench testing performed by the manufacturer, MedAmicus, Inc., likely at their facilities in Minneapolis, Minnesota, USA. It's a prospective testing program for the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical medical device, not an AI/ML diagnostic. "Ground truth" in this context refers to engineering specifications and standard performance benchmarks (e.g., kink resistance, sterility), which are established through scientific principles and regulatory standards, not by expert interpretation of clinical images or data.
4. Adjudication Method for the Test Set
- Not Applicable. There is no "adjudication" in the sense of reconciling discrepant expert opinions for diagnostic interpretations. The testing involves objective measurements against predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is for evaluating the diagnostic performance of software, often involving human readers. It is not relevant for a physical medical device like a Percutaneous Venous Introducer.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is a physical medical device. There is no algorithm or AI component to evaluate independently.
7. Type of Ground Truth Used
- The "ground truth" for the performance evaluation is based on engineering specifications, regulatory standards, and objective measurements during bench testing. For example, sterility is confirmed by microbiological testing against a defined sterility assurance level (SAL). Kink resistance is evaluated against a physical standard (radius models). Biocompatibility is evaluated against established biological safety standards.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
Summary of the Device and its "Study" for 510(k) Clearance:
The MedAmicus Percutaneous Introducer received 510(k) clearance based on its substantial equivalence to previously cleared MedAmicus introducers (K893658 and K951313). The key changes in the new device were:
- Addition of nylon braiding material in the sheath wall for improved kink resistance.
- Attachment of a Platinum/Iridium marker band near the distal tip for fluoroscopic location.
The "study" demonstrating this involves:
- Bench testing: Visual examination for workmanship, kink resistance testing via radius models, and marker band removal integrity and security evaluations.
- Material evaluation: Biocompatibility testing for the new nylon and Platinum/Iridium materials.
- Sterilization validation: Conforming to AAMI methods to achieve a sterility assurance level (SAL) of >10^-6.
The manufacturer asserted that these additional materials and technologies are "standard in other medical devices used in a variety of arterial procedures" and that their application in this device is substantially equivalent to existing, approved technologies. The intended use, materials (apart from the specified additions), sterilization, packaging, labeling, method of operation, and manufacturing methods were all deemed substantially equivalent to predicate devices.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).