(215 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and material properties of drainage catheters, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The devices described are drainage catheters intended for external drainage of bodily fluids (e.g., abscess, urine, bile). While they alleviate symptoms, they do not directly treat the underlying disease or condition.
No
Explanation: The devices described are drainage catheters designed for therapeutic purposes (draining fluids like abscesses or urine), not for diagnosing conditions.
No
The device description clearly details physical components such as catheters, needles, dilators, and wire guides, which are hardware. There is no mention of software as the primary or sole component.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses clearly state that these devices are for drainage of bodily fluids (abscess contents, urine, bile) from within the body. This is a therapeutic or interventional procedure, not a diagnostic one.
- Device Description: The descriptions detail catheters designed for insertion into the body to remove fluids. They are physical tools for drainage.
- Lack of Diagnostic Function: There is no mention of these devices being used to analyze samples in vitro (outside the body) to diagnose a disease or condition. IVDs are typically reagents, instruments, or systems used to examine specimens like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical characteristics and functionality of the catheters (tensile strength, flow rate, kink resistance, radiopacity, lubricity, biocompatibility, MRI compatibility). These are relevant to a drainage device, not an IVD.
In summary, these devices are designed for the physical removal of fluids from the body, which is a medical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FGE, LJE, GBO
Device Description
The Gordon Large-Bore Curved Drainage Catheter is a drainage catheter that aspirates abscess cavity contents. The catheters are manufactured from radiopaque polyetherurethane 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 Catheter 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-DrainTM 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abscess cavity, renal pelvis, abdominal cavity, chest, abdomen, pelvis, urinary system, biliary tree.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance and biocompatibility testing was conducted in accordance with applicable standards to confirm the reliable performance of device characteristics. The following tests have been conducted on the drainage catheters, subject of this submission, to ensure reliable design and performance under the specified design requirements:
- Catheter/Set Compatibility Testing performed demonstrated the drainage catheters and sets met the compatibility requirements.
- Simulated Bile Soak Test articles studied in tensile, gravity flow rate, and kink testing had undergone simulated bile soak prior to the tests.
- Tensile Testing – Testing performed on the components per applicable ISO and USP standards demonstrated that the devices met the acceptance criteria.
- Gravity Flow Rate Testing Testing performed prior to kink and after kink testing per applicable standards demonstrated that the devices met the acceptance criteria.
- Kink Testing Testing characterized the kink radius of the drainage catheters.
- Radiopacity Testing Testing performed per applicable standards demonstrated that the radiopacity of the drainage catheters met the acceptance criteria.
- Lubricity Testing – Testing performed demonstrated that the lubricity of the drainage catheters met the acceptance criteria.
- MRI Compatibility - Testing established the conditions for safety of the drainage catheters in the MR environment according to applicable standards.
- Biocompatibility Testing - Per ISO 10993-1 and FDA guidance, testing for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Genotoxicity, and 4- and 13-Weeks Implantation demonstrated that the devices are biocompatible.
For these tests, all pre-determined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
May 1, 2018
Cook Incorporated Erum B. Nasir Regulatory Affairs Team Lead 750 Daniels Way Bloomington, IN 47402
Re: K173035
Trade/Device Name: Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter and the Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set. Multipurpose Drainage Catheters and Sets Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE, LJE, GBO Dated: March 26, 2018 Received: March 27, 2018
Dear Erum B. Nasir:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are evenly spaced, and the overall impression is clean and legible. The "-S" is slightly smaller than the rest of the name.
Benjamin R. Fisher, Ph.D. For Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Gordon Large-Bore Curved Drainage Catheter Nephrostomy Pigtail Drainage Catheter and the Percutaneous Nephrostomy Set Pigtail Drainage Catheter Needle Set
Indications for Use (Describe)
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).
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
Device Name Multipurpose Drainage Catheters and Sets
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Cook Incorporated - Traditional 510(k) Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, and Multipurpose Drainage Catheters and Sets 25 April 2018
510(k) Summary
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, and Multipurpose Drainage Catheters and Sets As required by 21 CFR, §807.92(c) Date Prepared: April 25, 2018
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact: | Erum B. Nasir |
| Email: | regsubmissions@cookmedical.com |
| Contact Phone Number: | (812) 335-3575 x102607 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| Trade Name: | Gordon Large-Bore Curved Drainage Catheter,
Nephrostomy Pigtail Drainage Catheter and Percutaneous
Nephrostomy Set, Pigtail Drainage Catheter Needle Set,
and Multipurpose Drainage Catheters and Sets |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Biliary, Nephrostomy, Multipurpose Percutaneous
Drainage Catheters |
| Classification Name: | • 21 CFR §876.5010, Biliary catheter and accessories,
Class II, Product Code FGE
• 21 CFR§878.4200, Introduction/drainage catheter and
accessories, Class I, Product Code GBO
• Pre-Amendment, Catheter, Nephrostomy, Unclassified,
Product Code LJE |
5
Gordon Large-Bore Curved Drainage Catheter. Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, and Multipurpose Drainage Catheters and Sets 25 April 2018
| Product Code: | FGE, LJE, GBO |
|---|---|
| Classification Panel: | Gastroenterology/Urology |
| Predicate Devices: |
Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, and Exodus Believe Biliary Drainage Catheter cleared on September 24, 2015 (K152069).
Device Description:
The Gordon Large-Bore Curved Drainage Catheter is a drainage catheter that aspirates abscess cavity contents. The catheters are manufactured from radiopaque polyetherurethane 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
6
Gordon Large-Bore Curved Drainage Catheter. Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, and Multipurpose Drainage Catheters and Sets 25 April 2018
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.
Indications for Use:
- . The Gordon Large-Bore Curved Drainage Catheter is intended for abscess drainage.
- . The Nephrostomy Pigtail Drainage Catheter and the 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.
7
Gordon Large-Bore Curved Drainage Catheter. Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, and Multipurpose Drainage Catheters and Sets 25 April 2018
Comparison to Predicates:
The proposed devices are considered to be substantially equivalent to the predicate devices, the Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, and Exodus Believe Biliary Drainage Catheter (cleared under K152069), in that they have the same intended use, which is to provide percutaneous drainage of fluid. Additionally, the subject devices have similar technological characteristics, methods of placement, and principles of operation to the predicate devices. The differences between the subject device and the predicate device include indications for use, dimensions, materials, presence of hydrophilic coating, radiopaque marker and depth marker, locking mechanisms, distal tip configurations, set components, catheter indwell time, and sterilization.
The substantial equivalence comparison between the subject devices and the predicate devices is provided in Table 1.
8
Cook Incorporated - Traditional 510(k) Gordon Large-Bore Curved Drainage Catheter and Perutaneous Nephrostomy Set, Pigail Drainage Catheter Needle Set, and Multipurpose Drainage Catheter and Set 25 April 2018
| Table 1 Substantial Equivalence Comparison Table | |||||||
|---|---|---|---|---|---|---|---|
| Device | Predicate Device | ||||||
| Exodus Array Multipurpose Drainage | |||||||
| Catheter, | |||||||
| Exodus Nuance Nephrostomy Drainage | |||||||
| Catheter, | |||||||
| Exodus Believe Biliary Drainage | |||||||
| Catheter - K152069 | Gordon Large-Bore | ||||||
| Curved Drainage | |||||||
| Catheter | Nephrostomy Pigtail | ||||||
| Drainage Catheter/ | |||||||
| Percutaneous | |||||||
| Nephrostomy Set | Pigtail Drainage | ||||||
| Catheter Needle Set | Multipurpose Drainage | ||||||
| Catheters and Sets | |||||||
| Regulation | |||||||
| Number | 876.5010 | 878.4200 | 878.4200; Pre- | ||||
| Amendment | 878.4200; Pre- | ||||||
| Amendment | 876.5010; 878.4200; Pre- | ||||||
| Amendment | |||||||
| Regulation | |||||||
| Description | Biliary catheter and accessories | Introduction/drainage | |||||
| catheter and | |||||||
| accessories (GBO) | Introduction/drainage | ||||||
| catheter and | |||||||
| accessories (GBO); | |||||||
| Catheter, | |||||||
| Nephrostomy (LJE) | Introduction/drainage | ||||||
| catheter and | |||||||
| accessories (GBO); | |||||||
| Catheter, | |||||||
| Nephrostomy (LJE) | Biliary catheter and | ||||||
| accessories (FGE); | |||||||
| Introduction/drainage catheter | |||||||
| and accessories (GBO); | |||||||
| Catheter, Nephrostomy (LJE) | |||||||
| Product Code | FGE, LJE, GBO | GBO | GBO; LJE | GBO; LJE | FGE; GBO; LJE | ||
| Classification | Class II | Class I | Class I; Unclassified | Class I; Unclassified | Class II; Class I; Unclassified | ||
| Indication For | |||||||
| Use | • Exodus Array Multipurpose Drainage | ||||||
| Catheters are intended for percutaneous | |||||||
| drainage of fluid or air in the chest, | |||||||
| abdomen and pelvis, e.g., abscesses, cysts, | |||||||
| pneumothoraces, and other general purpose | |||||||
| drainage applications. | |||||||
| • Exodus Nuance Nephrostomy Drainage | |||||||
| Catheters are intended for percutaneous | |||||||
| drainage of fluid collections in the urinary | |||||||
| system. | |||||||
| • Exodus Believe Biliary Drainage Catheters | |||||||
| are intended for percutaneous drainage of | |||||||
| the biliary tree. | The Gordon Large- | ||||||
| Bore Curved Drainage | |||||||
| Catheter is intended | |||||||
| for abscess drainage. | The Nephrostomy | ||||||
| Pigtail Drainage | |||||||
| Catheter is intended | |||||||
| for external urine | |||||||
| drainage from the | |||||||
| renal pelvis. / | |||||||
| The Percutaneous | |||||||
| Nephrostomy Set is | |||||||
| 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). | Multipurpose Drainage | ||||||
| Catheters 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. | |||||||
| Representative | |||||||
| pictures | Image: Exodus Array Multipurpose Drainage Catheter | Image: Gordon Large-Bore Curved Drainage Catheter | Image: Nephrostomy Pigtail Drainage Catheter | Image: Pigtail Drainage Catheter Needle Set | Image: Multipurpose Drainage Catheters and Sets | ||
| Device | Predicate Device | ||||||
| Exodus Array Multipurpose Drainage | |||||||
| Catheter, | |||||||
| Exodus Nuance Nephrostomy Drainage | |||||||
| Catheter, | |||||||
| Exodus Believe Biliary Drainage | |||||||
| Catheter - K152069 | Subject Devices | ||||||
| Gordon Large-Bore | |||||||
| Curved Drainage | |||||||
| Catheter | Nephrostomy Pigtail | ||||||
| Drainage Catheter/ | |||||||
| Percutaneous | |||||||
| Nephrostomy Set | Pigtail Drainage | ||||||
| Catheter Needle Set | Multipurpose Drainage | ||||||
| Catheters and Sets | |||||||
| Catheter | Catheter | ||||||
| Size (Fr) | 6, 8, 10, 12, 14 | 16, 18, 20, 22 | 8.3 | 5, 6, 7, 8.3 | 5, 6, 6.3, 7, 8.5, 10.2, 12, 14, | ||
| 16, 18, 20 | |||||||
| Catheter | |||||||
| Length (cm) | 15, 25, 35 | 40 | 30 | 15, 25 | 15, 25, 30, 35, 40, 45, 50, 60 | ||
| End Hole | |||||||
| Size (inch) | 0.038 | 0.038 | 0.038 | 0.035, 0.038, 0.045 | 0.018, 0.035, 0.038 | ||
| Catheter | |||||||
| Material | Blended: | ||||||
| Carbothane 55D (70%) | |||||||
| Carbothane 95A (30%) | Polyether-urethane | Polyurethane | Polyurethane | Polyether-urethane | |||
| Hydrophilic | |||||||
| Coating | Yes | Yes | No | No | Hydrophilic coating on select | ||
| Multipurpose Catheters | |||||||
| Radiopaque | |||||||
| Marker | Polymer Marker band on select | ||||||
| Multipurpose Catheters and all | |||||||
| Biliary Drainage Catheters | None | None | None | Radiopaque band on select | |||
| Multipurpose Catheters | |||||||
| Shaft Depth | |||||||
| Markers | Yes | None | None | None | No | ||
| Locking | |||||||
| Mechanism | SureTwist Hub | None | None | None | Mac-Loc, Cope, or none | ||
| Distal Tip | |||||||
| Config. | Locking Pigtail | J-shaped | Pigtail | Pigtail | Pigtail, loop, J-shaped, or | ||
| straight | |||||||
| Sideports | Yes | Yes | Yes | Yes | Yes¹ | ||
| Components | Plastic Stiffening Cannula, | ||||||
| Metal Stiffening Cannula, | |||||||
| Trocar | Flexible Stiffening | ||||||
| Cannula, | |||||||
| Rigid Stiffening | |||||||
| Cannula, | |||||||
| Trocar Stylet | Peel-Away | ||||||
| Straightener; or | |||||||
| Dilator, Wire Guide, | |||||||
| Trocar/Chiba Needle, | |||||||
| Connecting Tube with | |||||||
| a Stopcock, Fixation | |||||||
| Device (Set only) | Peel-Away | ||||||
| Straightener, Rigid | |||||||
| Stiffening Cannula, | |||||||
| Trocar Stylet, Loading | |||||||
| Obturator | Flexible and/or Rigid | ||||||
| Stiffening Cannula, Fixation | |||||||
| Device; or Wire Guide, | |||||||
| Dilator, Neff percutaneous | |||||||
| introducer set, Connecting | |||||||
| Tube with a Stopcock (Set | |||||||
| only) | |||||||
| Predicate Device | |||||||
| Exodus Array Multipurpose Drainage | |||||||
| Catheter. | |||||||
| Exodus Nuance Nephrostomy Drainage | |||||||
| Catheter, | |||||||
| Exodus Believe Biliary Drainage | |||||||
| Catheter - K152069 | Subject Devices | ||||||
| Device | Gordon Large-Bore | ||||||
| Curved Drainage | |||||||
| Catheter | Nephrostomy Pigtail | ||||||
| Drainage Catheter/ | |||||||
| Percutaneous | |||||||
| Nephrostomy Set | Pigtail Drainage | ||||||
| Catheter Needle Set | Multipurpose Drainage | ||||||
| Catheters and Sets | |||||||
| Indwell Time | 3 months2 | 3 months | |||||
| Packaging | Tyvek/Mylar (PET/LDPE) Pouch | Inner/Outer Tyvek Peel Pouch | |||||
| Sterilization | |||||||
| method | Ethylene oxide | Identical | |||||
| Sterility level | 10-6 | 10-6 |
Table 1 Substantial Equivalence Comparison Table
9
Cook Incorporated - Traditional 510(k) Gordon Large-Bore Curved Drainage Catheter and Perutaneous Nephrostomy Set, Pigail Drainage Catheter Needle Set, and Multipurpose Drainage Catheter and Set 25 April 2018
Table 1 Substantial Equivalence Comparison Table (continued)
10
Cook Incorporated - Traditional 510(k) Gordon Large-Bored Drainage Catheter, Nephrostomy Pigail Drainage Catheter and Perutaneous Nephrostomy Set, Pigatil Drainage Catheter Needle Set, and Multipurpose Drainage Catheter and Set 25 April 2018
I One of the 8.5 Fr Straight Drainage Catheres is designed with no sideports does not compromise the drainage of the liquid because all of the subject drainage catheters are open-ended. The Soft-Shaft Malecot Drainage Catheters are designed with Malecot sideports.
² The interest the Exodus Array Multipurpose Drains to its IFU; the indusly to its IFU; the indus Nance Nephrostomy Drainge Cather and Exodus Believe Biliary Drainage Catheter is unknown.
11
Gordon Large-Bore Curved Drainage Catheter. Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, and Multipurpose Drainage Catheter and Set 25 April 2018
Technological Characteristics:
Performance and biocompatibility testing was conducted in accordance with applicable standards to confirm the reliable performance of device characteristics. The following tests have been conducted on the drainage catheters, subject of this submission, to ensure reliable design and performance under the specified design requirements:
- Catheter/Set Compatibility Testing performed demonstrated the drainage . catheters and sets met the compatibility requirements.
- Simulated Bile Soak Test articles studied in tensile, gravity flow rate, and kink . testing had undergone simulated bile soak prior to the tests.
- . Tensile Testing – Testing performed on the components per applicable ISO and USP standards demonstrated that the devices met the acceptance criteria.
- Gravity Flow Rate Testing Testing performed prior to kink and after kink . testing per applicable standards demonstrated that the devices met the acceptance criteria.
- Kink Testing Testing characterized the kink radius of the drainage catheters. .
- Radiopacity Testing Testing performed per applicable standards demonstrated . that the radiopacity of the drainage catheters met the acceptance criteria.
- . Lubricity Testing – Testing performed demonstrated that the lubricity of the drainage catheters met the acceptance criteria.
- . MRI Compatibility - Testing established the conditions for safety of the drainage catheters in the MR environment according to applicable standards.
- . Biocompatibility Testing - Per ISO 10993-1 and FDA guidance, testing for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Genotoxicity, and 4- and 13-Weeks Implantation demonstrated that the devices are biocompatible.
For these tests, all pre-determined acceptance criteria were met.
Conclusion
The results of the testing provide reasonable assurance that the subject devices have been designed so that they conform to the requirements of their intended use. The available evidence demonstrates that the subject devices are substantially equivalent to the predicate device, the Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, and Exodus Believe Biliary Drainage Catheter, cleared on September 24, 2015 (K152069). The minor differences in the subject devices also do
12
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, and Multipurpose Drainage Catheter and Set 25 April 2018
not raise new questions of safety or effectiveness and therefore support a determination of substantial equivalence to the predicate device.