(109 days)
The Zoom 6F Insert Catheters are indicated for use in delivering radiopaque media to selected sites in the peripheral vascular system in conjunction with routine diagnostic procedures.
The Imperative Care Zoom™ 6F Insert Catheters are single lumen, braid reinforced, variable stiffness catheters. The catheters feature a standard luer hub on the proximal end, a radiopaque distal shaft and tip, and a tapered distal tip provided pre-shaped with various curve configurations. The curve configurations are designed to selectively engage arteries from the access sites such as the femoral, radial, and brachial arteries. The Zoom 6F Insert Catheter outer diameter is 0.082" (2.08 mm), the inner diameter is 0.041" (1.04 mm), and the tapered distal tip outer diameter is 0.061" (1.55 mm). The catheters are offered in working lengths of 137 cm, 139 cm, 140 cm, and 143 cm and come in three different tip configurations: VRT, SIM and VTK. The Zoom 6F Insert Catheters are compatible with standard luer lock devices (e.g., syringes), ≤ 0.038" diameter guidewires, ≥ 180 cm length guidewires, ≥ 6F introducer sheaths and ≥ 0.088" inner diameter guide catheters.
The provided text describes the submission for a medical device called the "Zoom 6F Insert Catheter." This is a regulatory submission to the FDA, demonstrating "substantial equivalence" to a legally marketed predicate device, the "Impress Angiographic Catheter."
Crucially, this document does not describe an AI/ML device. It describes a physical medical device (a catheter) and its performance through bench and laboratory (in-vitro) testing against physical specifications, not algorithm performance. Therefore, many of the requested items related to AI/ML device testing (e.g., sample size for AI test sets, expert consensus for ground truth, MRMC studies, training set details) are not applicable to this document.
However, I can extract the acceptance criteria and performance data for the physical device as presented.
Description of Acceptance Criteria and Study (for this physical device)
The submission details the design verification and validation testing performed on the Zoom 6F Insert Catheter to demonstrate its substantial equivalence to a predicate device. The "study" here refers to a series of in-vitro bench and laboratory tests, not a clinical trial or an AI/ML model validation.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table (Table 2) summarizing the performance specifications (acceptance criteria) and the results ("Pass") for the Zoom 6F Insert Catheter.
| Test Attribute | Specification | Results ("Performance") |
|---|---|---|
| Visual | The external surface of the effective length of the device shall be defect free when removed from packaging. | Pass |
| Effective Length | Effective lengths of the catheters are within the specified tolerances. | Pass |
| Guidewire compatibility | The catheters shall be compatible with guidewire specified in labeling. | Pass |
| Dimensional (Proximal OD, Midsection OD, Maximum OD) | All defined catheter dimensions shall be within specified tolerances. | Pass |
| Shape/Curve Retention | The device shall be offered with the SIM, VERT, and VTK tip shapes. | Pass |
| Distal Tip | The distal tip shall be a smooth taper and contain a radiused edge. | Pass |
| Radiopacity | At least the shaped portion of the device shall be visible under fluoroscopy during use. | Pass |
| Flexibility and Kink Resistance (2 specifications) | The device must be capable of being inserted into the access site, selecting the target vessel a minimum and being retracted without damage to the device. | |
| The device shall be able to bend to a minimum specified radius at all locations without kinking. | Pass | |
| Tensile Strength | Each junction of the device must meet the specified minimum tensile requirement. | Pass |
| Torque Strength | The device shall withstand 720 degree rotation without separation of any portion of the device. | Pass |
| Freedom from Leakage (2 specifications) | The device shall not leak liquid when a pressure of 300 kPa minimum is applied and maintained for 30 seconds. | |
| Air shall not leak into the hub assembly or device shaft during aspiration when vacuum is applied using a 10 mL syringe for 10 seconds. | Pass | |
| Proximal Stiffness (Pushability) | The proximal shaft of the catheters shall have sufficient stiffness that the user can easily push the catheter to the target anatomy. | Pass |
| Dynamic Flow | The device shall remain free of leak and rupture, when used with a power injector set to a determined maximum pressure setting and maximum commanded flow rate. | Pass |
| Burst Strength | The device shall exceed the peak pressure present in the catheter at maximum flow conditions as determined per ISO 10555-1. | Pass |
| Flowrate, Positive | The device shall provide a flow rate which complies with ISO 10555-1. | Pass |
| Luer Compatibility | Device shall contain a female hub luer which complies with ISO 80369-7. | Pass |
| Corrosion | The metallic components of the device intended for fluid path contact shall be free of corrosion throughout the use of the device. | Pass |
| Particulate | The amount of particulate matter that comes off the shaft during simulated use testing shall be characterized and compared to competitive products. (Note: "Compared to competitive products" implies a standard, but the specific numerical acceptance criterion is not explicitly stated as "X |
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).