(395 days)
Leaderflex mini and Leaderflex nano are indicated for:
•Peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure, or
· Arterial catheterization
Leaderflex Mini and Leaderflex Nano are a radiopaque biostable polyurethane catheters suitable for peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure. Leaderflex Mini and Leaderflex Nano catheters are inserted via Seldinger technique, same as the predicate device. The Leaderflex mini and Leaderflex nano catheters are intended to be used by clinicians such as nurses at in- and out-patient locations. The primary requirement for environment of use is to ensure the environment is appropriate for supporting aseptic technique. These catheters are typically inserted into a peripheral vein on the forearm or leg, with the catheter tip located below the axilla of the arm or below the groin of the leg; however, the catheter is not limited to these anatomical placement locations. This is the same environment of use and anatomical location as the predicate device.
The subject Leaderflex Mini and Leaderflex Nano devices are accompanied by compatible accessories necessary to perform the Seldinger technique; these include: an introducer needle, guidewire, and guidewire insertion aid. The predicate Leaderflex device (K141026) is currently available in 22G configurations with usable lengths of 4cm, 6cm, 8cm and 20cm. The subject device will extend the device configurations to include 24G (Leaderflex Mini) and 26G catheters (Leaderflex Nano) with usable lengths of 2cm, 3cm, and 4cm and will add introducer needle and guidewires.
The subject device also introduces a new guidewire insertion aid for all gauge sizes. The overall device description of the subject and predicate Leaderflex models is the same.
Here's a breakdown of the acceptance criteria and study information for the Leaderflex Mini and Leaderflex Nano devices, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Leaderflex K141026) rather than defining explicit "acceptance criteria" as pass/fail thresholds for clinical performance metrics (like sensitivity, specificity, accuracy). Instead, the acceptance criteria are implicitly met by demonstrating that the new devices (Leaderflex Mini and Nano) are as safe and effective as the predicate device, despite minor design changes. This is primarily shown through adherence to recognized standards and bench testing.
The "reported device performance" is described through the comparison of technological characteristics and compliance with various international standards for medical devices.
| Feature | Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (Leaderflex Mini & Nano) |
|---|---|---|
| Indications for Use | Must be substantially equivalent or a subset of the predicate device's indications, without raising new safety/effectiveness questions. | Indicated for: |
| • Peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure | ||
| • Arterial catheterization (This is a subset of the predicate, removing central venous catheterization). | ||
| User Group | Same as predicate. | Clinicians qualified to place intravascular catheters such as nurses or doctors. |
| Use Environment | Same as predicate. | Clinical setting appropriate for aseptic technique. |
| Anatomical Placement | Same as predicate. | Peripheral veins in any patient population with consideration given to the adequacy of vascular anatomy. |
| Single Use | Same as predicate. | Yes. |
| Material Biocompatibility | Must meet established biocompatibility standards. | Complies with ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process". |
| Sterilization | Must meet established sterilization standards. | Supplied Sterile, EtO Sterilization (ISO 11135:2014, ISO 10993-7:2008), AAMI TIR 28, AAMI ST 72. |
| Shelf-life | Same as predicate. | 5 years. |
| Functional Performance (Catheter) | Must meet general requirements for intravascular catheters, demonstrating that dimensional differences do not affect clinical safety or effectiveness. | Compliance with ISO 10555-1:2013 "Intravascular catheters-Sterile and single-use catheters-Part 1: General requirements". Performance testing was done per this standard to demonstrate that minor dimensional differences in the catheter, guidewire, and introducer needles do not affect safety or effectiveness. |
| Flow Rate | Must be appropriate for the intended use and consistent with smaller gauge sizes. | Range: 3 to 17 ml/min (Predicate: 4.4 to 17 ml/min). The difference is attributed to smaller gauge and is considered acceptable. |
| Luer Taper | Must comply with standards for conical fittings. | Complies with ISO 594-1 & 2 "Conical Fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1 and Part 2". |
| Risk Management | Must follow accepted risk management principles. | Complies with ISO 14971:2019 "Medical Devices – Application of risk management to medical devices". |
| Packaging | Must comply with standards for packaging of sterile medical devices. | Complies with ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier System of Medical Devices" and ISO 11607-1:2019 "Packaging for terminally sterilized medical device-Part 1: Requirements for materials, sterile barrier systems and packaging systems". |
2. Sample Size Used for the Test Set and the Data Provenance
This submission is for a medical device (intravascular catheter) which primarily relies on non-clinical (bench) testing and comparison to a predicate device for demonstrating substantial equivalence. It does not involve a "test set" in the context of an AI/algorithm-driven device with a dataset of patient cases.
- Sample Size for Test Set: Not applicable in the context of a dataset of patient cases. Performance testing was conducted on samples of the physical devices.
- Data Provenance: The data provenance for non-clinical testing refers to the standards (e.g., ISO, AAMI, ASTM) that govern the methodologies. The document does not specify a country of origin for the test data, as it's typically bench testing performed by the manufacturer or accredited labs. The testing is prospective in the sense that the tests were performed on the new device designs to demonstrate compliance, but not in the clinical trial sense.
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 physical medical device, not an AI/software device requiring expert-labeled ground truth for a test set of images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There's no "ground truth" to adjudicate in the typical sense of a diagnostic software. Device compliance is determined by meeting the specified requirements of the various ISO and ASTM standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an intravascular catheter; it is not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by the requirements of recognized international and national standards (e.g., ISO 10555-1 for intravascular catheters, ISO 10993-1 for biocompatibility). Device performance is measured against these established engineering and biological criteria through bench testing.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no training set as would be used for machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).