(94 days)
Not Found
No
The device description focuses on mechanical components and their functions for drainage. There is no mention of AI/ML terms, image processing for analysis, or performance metrics typically associated with AI/ML algorithms.
Yes.
The device is used for temporary endoscopic drainage of the biliary duct, which is a therapeutic intervention aimed at alleviating a medical condition.
No
The device is described as a drainage catheter for temporary endoscopic drainage of the biliary duct, not for diagnosing conditions. Its primary function is to facilitate the removal of bile.
No
The device description clearly outlines multiple physical components including a drainage catheter, nasal transfer tube, drainage connecting tube, and pigtail straightener. It also mentions radiopaque material for fluoroscopic positioning and various physical tests performed.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary endoscopic drainage of the biliary duct through the nasal passage by use of an indwelling catheter." This describes a procedure performed on the patient's body to drain a bodily fluid.
- Device Description: The device components (catheter, tubes, connectors) are designed for insertion into the body and facilitating drainage.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide diagnostic information. IVDs are typically used to test blood, urine, tissue samples, etc., in a laboratory setting.
- Input Imaging Modality: The use of fluoroscopy is for guiding the placement of the device within the body, not for analyzing a sample.
- Performance Studies: The performance studies described (simulated use, dimensional verification, flow rate, tensile, leakage, radiopacity, etc.) are related to the physical and functional performance of the device for its intended use within the body, not for diagnostic accuracy based on sample analysis.
In summary, this device is a medical device used for a therapeutic procedure (drainage) performed directly on the patient, not for diagnosing a condition by testing samples outside the body.
N/A
Intended Use / Indications for Use
This device is used for temporary endoscopic drainage of the biliary duct through the nasal passage by use of an indwelling catheter.
Product codes
FGE
Device Description
The subject device consists of a drainage catheter, nasal transfer tube, drainage connecting tube and pigtail straightener (provided with drainage catheters which have a pigtail configuration at the distal end). The drainage catheter has anti-migration features, side ports and a touhy-borst connector. The anti-migration features (which include pigtails, duodenal loops and a curved tip) help prevent migration enabling the drainage catheter to remain in the desired position. The side ports, also located at the distal end of the drainage catheter assist in the drainage of bile. The touhy-borst connector allows connection of the drainage catheter to the drainage connection tube; it also allows the drainage catheter to be flushed. The drainage connection tube allows the drainage catheter to be connected to a drainage collection bag. In the middle of the drainage connecting tube is a three way stopcock; this allows a flow through the drainage connecting tube during the procedure. The nasal transfer tube enables the drainage catheter to be threaded through the oral cavity and out through the nostril. The drainage catheter contains radiopaque material which allows the user to ensure the drainage catheter is accurately positioned using fluoroscopically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopically
Anatomical Site
biliary duct, nasal passage
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use
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)
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA's Use of International Standard ISO 10993-1,"Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" June 16, 2016 and International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (ISO10993-1:2009).
Testing performed included simulated use, dimensional verification. resistance to collapse, flow rate, tensile, leakage, radiopacity, testing (tensile and marker band attachment/ corrosion) post exposure to simulated gastric environment (in simulated bile), MRI and shelf life testing.
Testing was performed as per Cook Ireland's design control system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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July 6, 2018
Cook Ireland Ltd. Jacinta Kilmartin Regulatory Affairs Manager O'Halloran Road, National Technology Park Limerick Ireland
Re: K180868
Trade/Device Name: Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set Regulation Number: 21 CFR& 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: June 21, 2018 Received: June 25, 2018
Dear Jacinta Kilmartin:
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 comprehensive regulatory information about medical devices and radiation-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 FDA logo on the left. To the right of the logo is the text "Jeffrey W. C" followed by the date "2018.07.06" and the time "-04'00'". The text is black and the background is white.
Jeffrey W. Cooper -S 2018.07.06 17:28:21
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180868
Device Name
Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
Indications for Use (Describe)
This device is used for temporary endoscopic drainage of the biliary duct through the nasal passage by use of an indwelling catheter.
| Type of Use (Select one or both, as applicable) |
|---|
| For activities identified in 33 CFR 160.3, Subpart C |
| Other - For activities not identified in 33 CFR 160.3, Subpart C |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K180868: Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
Section 5: 510(k) Summary
I. SUBMITTER
Cook Ireland Ltd. O' Halloran Road National Technology Park Limerick Ireland
Phone: +353 61 334440 Fax: +353 61 239293
Contact Person: Jacinta Kilmartin, Regulatory Affairs Manager
Phone: +353 61 334440 Fax: +353 61 239293
Date Prepared: Jul 06, 2018
II. DEVICE
- Trade Name of Device: Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
The model numbers are
ENBD-X, ENBD-X-LIGUORY, ENBD-X-LIGUORY-RT, ENBD-X-NAG, ENBD-X-LEUNG-Y.
The X in the model number denotes the catheter Fr size and the Y denotes the number of drainage ports on the catheter.
Common or Usual Name: Drainage Catheter
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Classification Name: Biliary Catheter and Accessories (21 CFR 876.5010) Regulatory Class: II Product Code: FGE
III. PREDICATE DEVICE
Predicate: Cook Endoscopic Nasal Biliary Drainage Set cleared under 510(k) K896323 cleared on April 09, 1990
DEVICE DESCRIPTION IV.
The subject device consists of a drainage catheter, nasal transfer tube, drainage connecting tube and pigtail straightener (provided with drainage catheters which have a pigtail configuration at the distal end). The drainage catheter has anti-migration features, side ports and a touhy-borst connector. The anti-migration features (which include pigtails, duodenal loops and a curved tip) help prevent migration enabling the drainage catheter to remain in the desired position. The side ports, also located at the distal end of the drainage catheter assist in the drainage of bile. The touhy-borst connector allows connection of the drainage catheter to the drainage connection tube; it also allows the drainage catheter to be flushed. The drainage connection tube allows the drainage catheter to be connected to a drainage collection bag. In the middle of the drainage connecting tube is a three way stopcock; this allows a flow through the drainage connecting tube during the procedure. The nasal transfer tube enables the drainage catheter to be threaded through the oral cavity and out through the nostril. The drainage catheter contains radiopaque material which allows the user to ensure the drainage catheter is accurately positioned using fluoroscopically.
V. INDICATIONS FOR USE
This device is used for temporary endoscopic drainage of the biliary duct through the nasal passage by use of an indwelling catheter.
The indications for use statement for the subject device is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. The subject and predicate device have the same intended use, drainage of the biliary duct through the nasal passage.
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K180868: Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH A PREDICATE DEVICE
The subject device is substantially equivalent to the currently marketed predicate, the Cook Endoscopic Nasal Biliary Drainage Set cleared under the following 510(k): K896323 cleared on April 09, 1990
In brief, the subject device has the same intended use and technological characteristics as the predicate Cook Endoscopic Nasal Biliary Drainage Set with respect to the following:
- Both devices have the same intended use for duct drainage. .
- . Both devices are used in the biliary duct.
- . Both devices are used for external drainage via the nasal cavity.
- . Both devices contain the following components; Drainage Catheter (with touhy-borst connector), Nasal Transfer Tube and Drainage Connecting Tube.
- . The subject device is offered in a number of lengths; one length (250cm) matches that of the predicate.
- The following drainage catheter diameters are in common between the subject and ● predicate devices: 5, 6, 7, and 10 Fr.
- . Certain models of the subject device share a common drainage catheter material with the predicate device. Radiopaque Polyethylene.
- . Both drainage catheters have side ports to assist drainage.
- Both drainage catheters share types of anti- migration features.
- Both Nasal Transfer Tubes are composed of Polyvinylchloride and are 50cms in length.
- Both Drainage Connecting Tubes are composed of Polyvinyl chloride
- Both devices are visible under fluoroscopy (radiopaque). ●
- Both devices are placed endoscopically over a wire guide.
- Both sets are compatible with 0.035'' wire guides. ●
- Both devices are for professional use.
- . Both devices are intended for single use only.
- Both devices are supplied sterile and are sterilised using ethylene oxide. .
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The following technological differences exist between the subject device and the Cook Endoscopic Nasal Biliary Drainage Set, predicate device:
- i) Components supplied
- ii) Dimensions
- iii) Features-Marker Bands, Number of Side Ports and Curved Tip Feature
- iv) Drainage Catheter Materials
VII. PERFORMANCE DATA
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA's Use of International Standard ISO 10993-1,"Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" June 16, 2016 and International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (ISO10993-1:2009).
Testing performed included simulated use, dimensional verification. resistance to collapse, flow rate, tensile, leakage, radiopacity, testing (tensile and marker band attachment/ corrosion) post exposure to simulated gastric environment (in simulated bile), MRI and shelf life testing.
Testing was performed as per Cook Ireland's design control system.
VIII. CONCLUSIONS
The non-clinical data supports the safety of the subject device and demonstrates that the subject device is safe and effective and should perform as intended in the specified use conditions. This non-clinical data supports the substantial equivalence of the subject device to the predicate device.