(182 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a drainage catheter, with no mention of AI or ML.
Yes
The device is used for "drainage of bile within the biliary system," which is a therapeutic intervention aimed at alleviating a medical condition.
No
The device is described as a "drainage catheter" used for "drainage of bile within the biliary system," which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a physical catheter made of polyurethane with various hardware components like tubing, drainage holes, a suture hole, stiffening cannulas, a pigtail straightener, a dead end cap, a suture locking mechanism, and a radiopaque marker band. It also mentions physical performance testing. There is no mention of software as a component of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "drainage of bile within the biliary system." This is a therapeutic or interventional procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a catheter designed for insertion into the biliary system for drainage. This aligns with a medical device used for treatment or intervention, not for analyzing samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the ReSolve® Biliary Drainage Catheter is a medical device used for drainage, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ReSolve® Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The ReSolve® Biliary Locking Drainage Catheter consists of single lumen tubing with 17 to 18 drainage holes (depending on the French size of the catheter) and a single dedicated suture hole. One of the drainage holes doubles as a suture hole. The tubing is made from a polyurethane material. A hydrophilic coating reduces entry site/catheter friction during placement. The catheter is offered in two drainage hole configurations. The RBC (long) configuration has a lesion gap (distance between the proximal pigtail and the distal shaft drainage hole) of 5 cm. The RBDC (standard) has a lesion gap of 2 cm. The components of the catheter allow initial placement using an over-the-wire technique. These include a metal stiffening cannula, flexible stiffening cannula, pigtail straightener and repositioning tool. The hubs of the flexible and metal stiffening cannula are color coded for catheter French size identification. The pigtail straightener is provided to assist in feeding the guide wire through the catheter. A dead end cap is included to prevent fluid from exiting the catheter after placement. Once the catheter position is established in the area to be drained, the pigtail is formed by retracting a suture which is looped from the hub to catheter tip then back to the hub. The hub incorporates a suture locking mechanism to retain the distal pigtail shape. It may be unlocked using the repositioning tool to allow repositioning or replacement of the catheter. A single radiopaque marker band is located proximal to the most proximal drainage hole to assist in accurate placement of the drainage holes in the biliary duct. In addition, the shaft of the catheter is printed with markings for the clinician to determine how deep the catheter is in the patient. The catheter is available in the same sizes 8.5F, 10F, 12F, and 14F with the same useable length, 40 cm, as the predicate device. The ReSolve® Biliary Locking Drainage Catheter is a single use device that is supplied sterile and non-pyrogenic. The device is marketed with the following components, depending on the product configuration: StayFIX® or Revolution™ catheter securement device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system
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)
Safety & Performance Tests cont. Performance Testing-Bench
Cyclic Fatigue Testing
Material Improvement
Chemical Testing
Optical Density/Radio-detectability
Curve Shape
Visual
Product Dimensions – Useable Length
Product Dimensions – Marker Band to Pigtail Distance
Product Dimensions – Distal Shaft Hole to Pigtail Distance
Marker Band/Proximal Hole Location
Punched Holes Orientation and Number of Holes
Hydrophilic Coating Coverage/Adherence and Length
Guide Wire Passage Test
Flow Testing
Pigtail Pull Test
Tip Penetration Test
Cannula and Stiffener Insertion Test
Tip Geometry
Drainage Hole Tensile Test
Catheter Collapse
Tubing Kink Testing
Hub Leak/Liquid Ingress Test
Hub Tensile Test
Marker Band Transition
Ink Adherence
14F Metal and Plastic Stiffening Cannula Hub Tensile Test and Visual Inspection
Pigtail Straightener Test
Biocompatibility
Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity
Pyrogenicity
Genotoxicity
Implantation
Chemical Characterization
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces overlapping to create a sense of depth and connection. The logo is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2014
Merit Medical Systems, Inc. Glenn Norton Vice President, Regulatory Affairs 1600 West Merit Parkway South Jordan, UT 84095
Re: K141408
Trade/Device Name: ReSolve® Biliary Locking Drainage Catheter Regulation Number: 21 CFR 876.5010 Regulation Name: Gastroenterology and Urology Regulatory Class: Class II Product Code: FGE Dated: October 27, 2014 Received: May 28, 2014
Dear Clea Feight:
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
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
2
Indications for Use
510(k) Number (if known)
Device Name ReSolve Biliary Locking Drainage Catheter
Indications for Use (Describe)
The ReSolve Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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:
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5.0 510(k) Summary
| General Provisions | Submitter Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit Parkway | |
| South Jordan, UT 84095 | ||
| Telephone Number: | (801) 826-4019 | |
| Fax Number: | (801) 316-4853 | |
| Contact Person: | Clea Feight | |
| Date of Preparation: | May 27, 2014 | |
| Registration Number: | 1721504 | |
| Subject Device | Trade Name: | ReSolve® Biliary Locking Drainage |
| Catheter | ||
| Common/Usual Name: | Biliary Drainage Catheter | |
| Classification Name: | Catheter, Biliary, Diagnostic | |
| Predicate Device | Trade Name: | ReSolve® Biliary Locking Drainage |
| Catheter | ||
| Classification Name: | Catheter, Biliary, Diagnostic | |
| Premarket Notification: | K121832 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Classification | Class II | |
| 21 CFR § 876.5010 | ||
| FDA Product Code: FGE | ||
| Review Panel: Gastroenterology and Urology | ||
| Intended Use | The ReSolve® Biliary Drainage Catheter with locking pigtail and | |
| hydrophilic coating is used for drainage of bile within the biliary | ||
| system. |
4
The ReSolve® Biliary Locking Drainage Catheter consists of single lumen tubing with 17 to 18 drainage holes (depending on the French size of the catheter) and a single dedicated suture hole. One of the drainage holes doubles as a suture hole. The tubing is made from a polyurethane material. A hydrophilic coating reduces entry site/catheter friction during placement. The catheter is offered in two drainage hole configurations. The RBC (long) configuration has a lesion gap (distance between the proximal pigtail and the distal shaft drainage hole) of 5 cm. The RBDC (standard) has a lesion gap of 2 cm. The components of the catheter allow initial placement using an over-the-wire technique. These include a metal stiffening cannula, flexible stiffening cannula, pigtail straightener and repositioning tool. The hubs of the flexible and metal stiffening cannula are color coded for catheter French size identification. The pigtail straightener is provided to assist in feeding the guide wire through the catheter. A dead end cap is included to prevent fluid from exiting the catheter after placement. Once the catheter position is established in the area to be drained, the Device Description pigtail is formed by retracting a suture which is looped from the hub to catheter tip then back to the hub. The hub incorporates a suture locking mechanism to retain the distal pigtail shape. It may be unlocked using the repositioning tool to allow repositioning or replacement of the catheter. A single radiopaque marker band is located proximal to the most proximal drainage hole to assist in accurate placement of the drainage holes in the biliary duct. In addition, the shaft of the catheter is printed with markings for the clinician to determine how deep the catheter is in the patient. The catheter is available in the same sizes 8.5F, 10F, 12F, and 14F with the same useable length, 40 cm, as the predicate device. The ReSolve® Biliary Locking Drainage Catheter is a single use device that is supplied sterile and non-pyrogenic. The device is marketed with the following components, depending on the product configuration: StayFIX® or Revolution™ catheter securement device.
5
| | The technological characteristics of the subject ReSolve® Biliary
Locking Drainage Catheter are substantially equivalent to those
of the predicate device. The subject device has the same basic
design as the predicate device in that it consists of single lumen
tubing with drainage holes, hub, and suture locking mechanism
and is provided with a metal stiffening cannula, flexible stiffening
cannula, pigtail straightener, repositioning tool and dead end
cap. The ReSolve® Biliary Locking Drainage Catheter is similar
in clinical use and function to the predicate ReSolve® Biliary
Locking Drainage Catheter. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
Predicate Device | The main difference is in the catheter shaft material and that the
subject device is coated with a different hydrophilic coating on
the outer surface of the catheter tubing. In addition, printed
depth markings have been added to the catheter shaft and the
location of the drainage holes has been modified to standardize
the gap between the pigtail and the shaft holes (RBC versus
RBDC) across all French sizes with adjustment of the marker
band location to account for this change. The geometry of the
tip has been modified slightly to have a longer taper. |
| | Minor changes have also been made to the colorant formulation
(color additives) used in molding three of the accessory
components of the device due to discontinuation notices from
suppliers. |
6
- United States Pharmacopeia Section , USP 36 . Pyrogen Testing, 2013-12-01
- o United States Pharmacopeia Section , USP 36 Physiochemical Tests for Plastics
7
| Safety &
Performance Tests
cont.
Performance Testing-Bench Cyclic Fatigue Testing Material Improvement Chemical Testing Optical Density/Radio-detectability Curve Shape Visual Product Dimensions – Useable Length Product Dimensions – Marker Band to Pigtail Distance Product Dimensions – Distal Shaft Hole to Pigtail Distance Marker Band/Proximal Hole Location Punched Holes Orientation and Number of Holes Hydrophilic Coating Coverage/Adherence and Length Guide Wire Passage Test Flow Testing Pigtail Pull Test Tip Penetration Test Cannula and Stiffener Insertion Test Tip Geometry Drainage Hole Tensile Test Catheter Collapse Tubing Kink Testing Hub Leak/Liquid Ingress Test Hub Tensile Test Marker Band Transition Ink Adherence 14F Metal and Plastic Stiffening Cannula Hub Tensile Test and Visual Inspection Pigtail Straightener Test
Biocompatibility Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Genotoxicity Implantation Chemical Characterization | Summary of
Substantial
Equivalence
Based on the indications for use, design, safety and
performance testing, the subject ReSolve® Biliary Locking
Drainage Catheter meets the requirements that are considered
essential for its intended use and is substantially equivalent to
the predicate device, the ReSolve® Biliary Locking Drainage
Catheter, K131832. |
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|