(149 days)
The drainage catheter is intended to provide percutaneous drainage of abscess fluid and biliary collections.
The drainage catheter is intended to provide external and internal percutaneous drainage of the biliary system.
Expel™ drainage catheters are nonvascular intervention catheters that consist of a single lumen tube with drainage holes in the distal region and a proximal hub. The catheters are inserted using percutaneous access to provide internal and/or external drainage of fluid collections in body cavities. They can be long-term indwelling devices not to exceed 90 days in the body.
Expel™ APD™, APDL, and APD Large Capacity families differentiate the available French sizes, distal shape geometries, and hub types. These families contain the widest range of products with catheter outer diameters ranging from 6 to 26 French, and working lengths ranging from 15 to 45 cm. The distal ends of the catheters contain drainage holes, an adjacent radiopaque marker band, and a tapered tip. The catheter shafts have graduation markings with numeric values and a hydrophilic coating distally. Expel™ APDL family has a distal locking pigtail and a proximal Twist-Loc™ hub. Expel™ APD™ and APD Large Capacity families have a distal J-tip geometry and a proximal non-locking hub.
Expel™ Biliary drainage catheters are available in outer diameters of 8 to 14 French and lengths ranging from 20 to 40 cm. The distal end of the catheter contains drainage holes within a locking pigtail, an adjacent radiopaque marker band, and a tapered tip. The catheter shaft has additional drainage holes, graduation markings and numeric values, and a hydrophilic coating distally. The distal locking pigtail is activated by the proximal Twist-Loc™ hub.
The Expel™ drainage catheters come with a variety of accessories that aid in percutaneous access, device placement, device securement, and drainage fluid management. Accessories include:
- Cannulas
- Trocars
- Connecting Tubes
- Plugs / Caps
- Pigtail Straightener
- Facial Dilators
- Guidewires
- Dressing
- Catheter Cuff
- Introducers / Needles
- Cable Ties
This document is a 510(k) summary for the Expel™ APD Drainage Catheter System. It describes the device, its intended use, and its equivalence to predicate devices, supported by performance data from bench testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The Expel™ drainage catheter families, including packaging, met the predetermined acceptance criteria." However, specific numerical acceptance criteria values are not provided in the text. The table below lists the performance characteristics tested, but the actual pass/fail criteria and the quantitative reported performance are not detailed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Catheter OD | Met acceptance criteria |
| Catheter Shaft Tensile Strength | Met acceptance criteria |
| RO Marker Band Tensile Strength | Met acceptance criteria |
| Hub to Shaft Tensile Strength | Met acceptance criteria |
| Tip Tensile Strength | Met acceptance criteria |
| Distal Tip Robustness | Met acceptance criteria |
| Pigtail Retention (Curl Strength) / Removal Force | Met acceptance criteria |
| Resistance to Deformation | Met acceptance criteria |
| Kink Resistance | Met acceptance criteria |
| Flow Recovery Post Kinking | Met acceptance criteria |
| Resistance to Liquid Leakage | Met acceptance criteria |
| Alcohol Compatibility | Met acceptance criteria |
| MRI Compatibility | Met acceptance criteria |
| Urine and Bile Compatibility | Met acceptance criteria |
| Accessory to Catheter Connection Force | Met acceptance criteria |
| Cannula to Catheter Compatibility | Met acceptance criteria |
| Guidewire to Catheter/ Accessory Compatibility | Met acceptance criteria |
| Large Capacity Catheter to Large Capacity Connecting Tube Compatibility | Met acceptance criteria |
| Flexible Stiffening Cannula/Dilator Hub to Shaft Tensile Strength | Met acceptance criteria |
| Large Capacity Stiffening Dilator ID to Metal Stiffening Cannula OD Compatibility | Met acceptance criteria |
| Large Capacity Connecting Tube Hub to Shaft Tensile Strength | Met acceptance criteria |
| Sterile Barrier Integrity | Met acceptance criteria |
| Pouch Seal Strength | Met acceptance criteria |
| Thermoformed Tray Visual | Met acceptance criteria |
| Packaging Card Visual | Met acceptance criteria |
| Shelf Life | Met acceptance criteria |
| Sterilization | Met acceptance criteria |
| Biocompatibility | Met acceptance criteria |
| Coefficient of Friction | Met acceptance criteria |
| Radiopacity | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the bench tests. It also does not provide any information regarding the country of origin of the data or whether it was retrospective or prospective, as this was likely a series of internal engineering bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The study involved bench testing of physical device properties, not clinical data requiring expert review for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving reader interpretations of data, not for bench testing of physical device characteristics.
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
No such study was conducted. This document describes the 510(k) clearance for a physical medical device (drainage catheter system), not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is not an algorithm or software. It is a physical medical device.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" was established by engineering specifications and industry standards for device performance. Each test would have a defined acceptable range or passing condition that the device needed to meet. For example, a "Catheter Shaft Tensile Strength" test would have a minimum force required before breakage, which would be the ground truth for that specific test.
8. The Sample Size for the Training Set
This is not applicable. As this document describes the 510(k) for a physical medical device and its bench testing, there is no concept of a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of device submission.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.