(215 days)
The Gordon Large-Bore Curved Drainage Catheter is intended for abscess drainage.
The Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set are intended for external urine drainage from the renal pelvis.
The Pigtail Drainage Catheter Needle Set is intended for percutaneous external drainage in multiple applications (e.g., nephrostomy, abscess drainage and other abdominal cavity drainage procedures).
The Multipurpose Drainage Catheters and Sets are intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique.
The Gordon Large-Bore Curved Drainage Catheter is a drainage catheter that aspirates abscess cavity contents. The catheters are manufactured from radiopaque polyether-urethane material with hydrophilic coating on the surface of the catheter and are designed with six sideports at the distal curve. The catheters are available in diameters ranging from 16 to 22 French and in a length of 40 cm. The device includes flexible and rigid catheter introduction stiffening cannulas that aid in the placement of the catheter.
The Nephrostomy Pigtail Drainage Catheter is a drainage catheter used to drain urine from the kidney. The catheter is manufactured from radiopaque polyurethane tubing with a distal pigtail tip. The catheter is manufactured with six drainage sideports spaced within the pigtail curve. The catheter is available in a diameter of 8.3 French and in a length of 30 cm. The catheter is supplied with a Peel-Away straightener. The Percutaneous Nephrostomy Set is composed of the 8.3 Fr Nephrostomy Pigtail Drainage Catheter and several set components, including dilators, a wire guide, a Trocar needle, a Chiba needle, a connecting tube with a stopcock, and a fixation device.
The Pigtail Drainage Catheter Needle Set includes a drainage catheter used in multiple drainage applications, including nephrostomy, abscess drainage, and other abdominal cavity drainage procedures. The catheters are manufactured from radiopaque polyurethane tubing with a pigtail distal curve configuration. Four, six, or eight sideports are spaced evenly within the pigtail curve. The catheters are available in diameters of 5.0, 6.0, 7.0 and 8.3 French and in lengths of 15 or 25 cm. The Pigtail Drainage Catheter Needle Set is supplied with a Peel-Away straightener and a rigid stiffening cannula composed of a stainless steel needle, trocar stylet, and loading obturator.
The Multipurpose Drainage Catheters are used in a variety of drainage applications, e.g., nephrostomy, biliary, and abscess. There are 13 types of multipurpose drainage catheters and/or sets that fall into three different groups depending on the type of loop-locking mechanism, i.e., catheters without a locking mechanism, catheters with a Mac-Loc locking mechanism, and catheters with a Cook-Cope locking mechanism. Six product lines (Amplatz Universal Drainage Catheter and Set, Straight or Straight-Drain™ Drainage Catheter, Multipurpose Drainage Catheter, Universal Curved Drainage Catheters, Ring Biliary Duct Drainage Catheter, and Soft-Shaft Malecot Drainage Catheters) are designed without a locking mechanism. Four product lines (Multipurpose Drainage Catheter and Set, Dawson-Mueller Drainage Catheter and Set, Multipurpose Small Pigtail Drainage Catheter, and Biliary Drainage Catheters) are designed with a Mac-Loc® Locking Mechanism. Three product lines (Multipurpose Drainage Catheter, Biliary Drainage Catheter, and Cope Proximal Biliary Loop Catheter) are designed with a Cook-Cope or Luer lock Cook-Cope locking mechanism. The catheters are available in diameters ranging from 5.0 to 20.0 French and in lengths ranging from 15 to 60 cm. All catheters are manufactured from radiopaque polyether-urethane material. Most of the catheters are designed with distal curve configurations. The catheters may have a hydrophilic coating applied to their surface. The catheter size, number of sideports, distal tip configuration, and loop-locking mechanism are specific to the product type and drainage set specification. Many of these devices are supplied with a flexible and/or rigid stiffening cannula, as well as a catheter fixation device. The Multipurpose Drainage Set is composed of the Multipurpose Drainage Catheter and several set components, including a wire guide, dilator(s), a Neff percutaneous introducer set, and a connecting tube with a stopcock.
The provided text describes a 510(k) premarket notification for various drainage catheters. This document focuses on the substantial equivalence of new devices to existing predicate devices, rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria for a novel device. Therefore, much of the requested information, particularly regarding a "study that proves the device meets the acceptance criteria" in the context of clinical performance, is not available.
The document outlines acceptance criteria in terms of various performance and biocompatibility tests conducted on the catheters to ensure reliable design and performance under specified design requirements. For all these tests, it is stated that "all pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria for each test and the detailed reported device performance against these criteria are not provided.
Here's a breakdown of the available and unavailable information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria and Reported Device Performance (as inferred from the document)
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Catheter/Set Compatibility Testing | Met compatibility requirements. | "The drainage catheters and sets met the compatibility requirements." |
| Simulated Bile Soak Test | Maintenance of tensile strength, gravity flow rate, and kink resistance after bile soak. | "Test articles studied in tensile, gravity flow rate, and kink testing had undergone simulated bile soak prior to the tests." (Implied: met criteria for these properties after soak) |
| Tensile Testing | Met applicable ISO and USP standards for tensile properties. | "The devices met the acceptance criteria." |
| Gravity Flow Rate Testing | Met applicable standards for flow rate, both prior to and after kink testing. | "The devices met the acceptance criteria." |
| Kink Testing | Characterized kink radius within acceptable limits. | "Tested characterized the kink radius of the drainage catheters." (Implied: demonstrated acceptable kink resistance) |
| Radiopacity Testing | Met applicable standards for radiopacity. | "The radiopacity of the drainage catheters met the acceptance criteria." |
| Lubricity Testing | Met acceptance criteria for lubricity. | "The lubricity of the drainage catheters met the acceptance criteria." |
| MRI Compatibility | Established conditions for safety in the MR environment according to applicable standards. | "Established the conditions for safety of the drainage catheters in the MR environment according to applicable standards." |
| Biocompatibility Testing | Met ISO 10993-1 and FDA guidance requirements for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Genotoxicity, and 4- and 13-Weeks Implantation. | "Demonstrated that the devices are biocompatible." |
Note: The document explicitly states for physical and biocompatibility testing: "For these tests, all pre-determined acceptance criteria were met." However, the specific quantitative values for these criteria (e.g., "tensile strength of X N" or "flow rate of Y mL/hr") are not detailed in this submission. This is typical for a 510(k) where the focus is on demonstrating equivalence to predicates through adherence to recognized standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the performance or biocompatibility tests.
- Data Provenance: The tests were "conducted in accordance with applicable standards," which suggests they were performed internally by Cook Incorporated or by a contracted laboratory. The country of origin of the data is implicitly the USA (Cook Incorporated is based in Bloomington, IN, USA). The studies appear to be prospective in nature, in that they were conducted for the purpose of demonstrating equivalence for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: This type of information is generally relevant for studies involving diagnostic accuracy or clinical judgment (e.g., reading medical images). The testing described here is primarily laboratory and bench testing of physical and biological properties. Experts were likely involved in developing the product and interpreting the results, but not in establishing a "ground truth" for a test set in the way you've described.
4. Adjudication Method for the Test Set
- Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for diagnostic endpoints, to resolve disagreements among multiple expert readers. This document does not describe such a study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: A MRMC comparative effectiveness study was not done. The document does not describe any studies involving human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No: This document describes medical devices (catheters), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- Not Applicable (Clinical/Diagnostic Context): As mentioned above, the "ground truth" in the context of clinical diagnostic accuracy is not relevant here. For the performance and biocompatibility tests, the "ground truth" is established by the specifications of applicable ISO and USP standards. For instance, if a tensile test is performed, the "ground truth" is whether the material's tensile strength meets the specified minimum value as per the standard.
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: There is no "training set" as this is not an AI/ML device.
In summary, this 510(k) notification demonstrates substantial equivalence by comparing the technological characteristics of the new devices to predicate devices and by conducting various performance and biocompatibility bench tests in accordance with recognized standards, all of which "met the acceptance criteria." It does not involve complex clinical trials, expert adjudication, or AI performance studies that would require the specific details you've requested for those types of evaluations.
§ 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.