(182 days)
The ReSolve® Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.
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.
The provided document is a 510(k) premarket notification for a medical device (ReSolve® Biliary Locking Drainage Catheter) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria related to AI or algorithmic performance. The studies mentioned are primarily bench tests and biocompatibility tests for the physical device.
Therefore, most of the requested information regarding AI/algorithmic performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, cannot be extracted from this document.
However, I can provide what is available regarding the safety and performance tests performed on the physical device.
1. Table of acceptance criteria and the reported device performance:
The document lists various Safety & Performance Tests, implying that for each of these tests, specific acceptance criteria would have been met to deem the device safe and effective and substantially equivalent to the predicate. However, the specific quantitative acceptance criteria or the detailed reported performance results are not provided in this summary. The document only lists the types of tests conducted.
| Test Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Performance Testing - Bench | Cyclic Fatigue Testing | Not detailed in document (Implied to meet pre-defined criteria for substantial equivalence) |
| Material Improvement | Not detailed in document | |
| Chemical Testing | Not detailed in document | |
| Optical Density/Radio-detectability | Not detailed in document | |
| Curve Shape | Not detailed in document | |
| Visual Product Dimensions – Useable Length | Not detailed in document | |
| Product Dimensions – Marker Band to Pigtail Distance | Not detailed in document | |
| Product Dimensions – Distal Shaft Hole to Pigtail Distance | Not detailed in document | |
| Marker Band/Proximal Hole Location Punched Holes Orientation and Number of Holes Hydrophilic Coating Coverage/Adherence and Length Guidance 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 | Not detailed in document (Implied to meet pre-defined criteria for substantial equivalence). Specific changes noted are: "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." | |
| Biocompatibility | Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Genotoxicity Implantation Chemical Characterization | Not detailed in document (Implied to meet ISO 10993 requirements and pass tests as per USP sections <151> and <661>). |
The document concludes that "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." This statement indicates that all safety and performance tests were successfully completed and the device performed as expected against established criteria (though not explicitly detailed).
Regarding the other points, the document is a 510(k) submission for a physical medical device and does not pertain to AI/algorithmic performance. Therefore, the following information is not available:
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device, not an AI algorithm. The performance tests mentioned are bench tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would refer to defined physical or chemical properties, not expert-derived labels.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI for human reader assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical device, "ground truth" refers to specifications, standards, and established metrics for physical and chemical properties and performance (e.g., tensile strength, leak rates, biocompatibility test results).
- The sample size for the training set: Not applicable (no AI training set).
- How the ground truth for the training set was established: Not applicable (no AI training set).
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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
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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
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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)
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5.0 510(k) Summary
| General Provisions | Submitter Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit ParkwaySouth 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 DrainageCatheter |
| Common/Usual Name: | Biliary Drainage Catheter | |
| Classification Name: | Catheter, Biliary, Diagnostic | |
| Predicate Device | Trade Name: | ReSolve® Biliary Locking DrainageCatheter |
| Classification Name: | Catheter, Biliary, Diagnostic | |
| Premarket Notification: | K121832 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Classification | Class II21 CFR § 876.5010FDA Product Code: FGEReview Panel: Gastroenterology and Urology | |
| Intended Use | The ReSolve® Biliary Drainage Catheter with locking pigtail andhydrophilic coating is used for drainage of bile within the biliarysystem. |
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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.
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| The technological characteristics of the subject ReSolve® BiliaryLocking Drainage Catheter are substantially equivalent to thoseof the predicate device. The subject device has the same basicdesign as the predicate device in that it consists of single lumentubing with drainage holes, hub, and suture locking mechanismand is provided with a metal stiffening cannula, flexible stiffeningcannula, pigtail straightener, repositioning tool and dead endcap. The ReSolve® Biliary Locking Drainage Catheter is similarin clinical use and function to the predicate ReSolve® BiliaryLocking Drainage Catheter. | |
|---|---|
| Comparison toPredicate Device | The main difference is in the catheter shaft material and that thesubject device is coated with a different hydrophilic coating onthe outer surface of the catheter tubing. In addition, printeddepth markings have been added to the catheter shaft and thelocation of the drainage holes has been modified to standardizethe gap between the pigtail and the shaft holes (RBC versusRBDC) across all French sizes with adjustment of the markerband location to account for this change. The geometry of thetip 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 accessorycomponents of the device due to discontinuation notices fromsuppliers. |
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- United States Pharmacopeia Section <151>, USP 36 . Pyrogen Testing, 2013-12-01
- o United States Pharmacopeia Section <661>, USP 36 Physiochemical Tests for Plastics
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| Safety &Performance Testscont.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 TestBiocompatibility Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Genotoxicity Implantation Chemical Characterization | Summary ofSubstantialEquivalenceBased on the indications for use, design, safety andperformance testing, the subject ReSolve® Biliary LockingDrainage Catheter meets the requirements that are consideredessential for its intended use and is substantially equivalent tothe predicate device, the ReSolve® Biliary Locking DrainageCatheter, K131832. |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.