(25 days)
The ReSolve® Biliary Locking 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 two suture holes and 17 to 18 drainage holes in the distal curve region. It is made from a biocompatible thermoplastic. A hydrophilic coating reduces entry site/catheter friction during placement. The components of the catheter allow initial placement using an over-the-wire technique. These include a metal stiffening cannula, flexible stiffening cannula, straightener, and repositioning tool. The pigtail straightener is provided to assist in feeding the guide wire through the catheter. 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 the catheter tip and 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.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: ReSolve® Biliary Locking Drainage Catheter
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a "Special Premarket Notification 510(k)" for the ReSolve® Biliary Locking Drainage Catheter. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical efficacy data. As such, the "acceptance criteria" are primarily related to safety and performance testing to ensure the device performs as intended and is safe for its stated use, and that these characteristics are substantially equivalent to the predicate device.
The document lists various tests performed, indicating that the device "met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." However, it does not explicitly quantify the specific acceptance thresholds for each test. For example, it lists "Hub Leak" as a test but doesn't state "leakage must be less than X mL/hr."
Below is a table summarizing the tests performed and the general reported performance.
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Design Verification | Conditioning | Met pre-determined acceptance criteria |
| Dimensional | Met pre-determined acceptance criteria | |
| Drainage Hole Orientation | Met pre-determined acceptance criteria | |
| Marker Band/Hole Location | Met pre-determined acceptance criteria | |
| Tip Penetration | Met pre-determined acceptance criteria | |
| Hub Leak | Met pre-determined acceptance criteria | |
| Vacuum Test | Met pre-determined acceptance criteria | |
| Tubing Kink Test | Met pre-determined acceptance criteria | |
| Safety & Performance | Marker Band Adhesion | Met pre-determined acceptance criteria |
| Hub Tensile Testing | Met pre-determined acceptance criteria | |
| Tubing Tensile Testing | Met pre-determined acceptance criteria | |
| Material Durability Testing | Met pre-determined acceptance criteria | |
| Bile Exposure Testing | Met pre-determined acceptance criteria | |
| Stiffening Cannula Friction Test | Met pre-determined acceptance criteria | |
| Biocompatibility | Cytotoxicity | Met pre-determined acceptance criteria (per ISO 10993) |
| Irritation | Met pre-determined acceptance criteria (per ISO 10993) | |
| Acute Systemic Toxicity | Met pre-determined acceptance criteria (per ISO 10993) | |
| Pyrogenicity | Met pre-determined acceptance criteria (per USP 34 <151>) | |
| Chemical Characterization | Met pre-determined acceptance criteria (per ISO 10993) | |
| Ethylene Oxide Sterilization (Validation) | Met requirements of ISO 11135-1:2007 | |
| Ethylene Oxide Residuals | Met requirements of ISO 10993-7:2008 | |
| Sterile Barrier Systems | Accelerated Aging | Met requirements of ASTM F 1980-07:2007 |
| Shipping/Packaging | Performance Testing of Shipping Containers and Systems | Met requirements of ASTM D4169-09:2009 |
| Conditioning for Testing | Met requirements of ISO 2233:2000 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the performance and safety tests listed. The data provenance is implied to be from internal testing conducted by Merit Medical Systems, Inc. There is no information regarding the country of origin of the data or whether the tests were retrospective or prospective, though device performance testing is typically prospective (i.e., conducted specifically for the submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this submission. The "ground truth" concept, especially involving expert consensus or adjudication, is typically relevant for studies validating diagnostic algorithms (e.g., AI in radiology) where a human expert's judgment or a definitive diagnostic method is used as the reference standard. This document describes a 510(k) submission for a physical medical device (a catheter) based on performance testing and substantial equivalence, not a diagnostic algorithm. Therefore, no experts were used to establish "ground truth" in this context.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in studies involving subjective assessments or disagreements among experts, which is not the case for the physical and biocompatibility tests described for this catheter.
5. 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
This section is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices or AI algorithms that assist human readers. The ReSolve® Biliary Locking Drainage Catheter is a physical therapeutic device, not an imaging device or an AI assistant. Therefore, no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This section is not applicable. This refers to the standalone performance of an AI algorithm, which is not relevant for a physical medical device like a catheter.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by objective engineering specifications, material standards, and biological safety standards. For example:
- Engineering Specifications: Dimensional tolerances, tensile strength requirements, leak rates, kink resistance, marker band adhesion force.
- Material Standards: Biocompatibility (cytotoxicity, irritation, systemic toxicity, pyrogenicity, chemical characterization) as defined by ISO 10993 series and USP 34.
- Sterilization and Packaging Standards: Requirements for ethylene oxide sterilization (ISO 11135-1), residuals (ISO 10993-7), accelerated aging of sterile barriers (ASTM F 1980-07), and shipping performance (ASTM D4169-09).
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of a physical medical device like this catheter. Training sets are used for machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
{0}------------------------------------------------
ReSolve® Biliary Locking Drainage Catheter
Section 5, 510(k) Summary Special Premarket Notification 510(k)
·
:
.
·
·
PAGE 1 OF 4
: ﯔ ﺭەﻳﻖ ﺋﺎﺭﯨﺪﯨﻦ ﺑﻮﻟﯘﭖ ﺗﺎﺭﯨﺨﻰ ﺑﯩﺮ ﻗﺎﺭﯨﺪﯨﻐﺎ
| Section 5 | JUL 17 | ||
|---|---|---|---|
| 510(k) Summary | |||
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-4932(801) 316-4860Casey Hughes06/18/20121721504 | |
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | ReSolve® Biliary Locking Drainage CatheterBiliary Drainage CatheterCatheter, Biliary, Diagnostic | |
| PredicateDevice | Trade Name:Common/Usual Name:Classification Name:Premarket Notification:Manufacturer: | ReSolve® Biliary Drainage CatheterBiliary Drainage CatheterCatheter, Biliary, DiagnosticK063733Merit Medical Systems, Inc. | |
| Classification | Class II21 CFR § 876.5010Gastroenterology/Urology | ||
| Intended Use | The ReSolve® Biliary Locking Drainage Catheter with locking pigtailand hydrophilic coating is used for drainage of bile within the biliarysystem. |
్ట్రీ మా
{1}------------------------------------------------
ReSolve® Biliary Locking Drainage Catheter Section 5, 510(k) Summary Special Premarket Notification 510(k)
Device Description The ReSolve® Biliary Locking Drainage Catheter consists of single lumen tubing with two suture holes and 17 to 18 drainage holes in the distal curve region. It is made from a biocompatible thermoplastic. A hydrophilic coating reduces entry site/catheter friction during placement. The components of the catheter allow initial placement using an over-the-wire technique. These include a metal stiffening cannula, flexible stiffening cannula, straightener, and repositioning tool. The pigtail straightener is provided to assist in feeding the guide wire through the catheter. 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 the catheter tip and 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.
Technological Characteristics
The technological characteristics of the subject ReSolve Biliary Locking Drainage Catheter are substantially equivalent to those of the predicate device, the ReSolve Biliary Drainage Catheter, 510(k) K063733.
{2}------------------------------------------------
K121832
PAGE 3 OF 4
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the ReSolve Biliary Locking Drainage Catheter was conducted based on a risk analysis and based on the requirements of the following international standards:
- ISO 11135-1:2007, Sterilization of health care products -. Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 10993-1:2009, Biological Evaluation of Medical Devices ● Part-1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile
- ISO 10993-5:2009. Biological evaluation of medical devices -. Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008, Biological Evaluation of Medical Devices -. Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-10:2010. Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
Safety & Performance Tests
- ISO 10993-11:2006, Biological evaluation of medical devices -. Part 11: Tests for systemic toxicity
- ISO 10993-17:2002, Biological Evaluation of Medical Devices -. Part 17: Methods for the Establishment of Allowable Limits for Leachable Substances
- ISO 10993-18:2005, Biological Evaluation of Medical Devices -� Part 18: Chemical Characterization of Materials
- USP 34 <151>:2011, United States Pharmacopeia 34, National ● Formulary 29, 2011. <151> Pyrogen Test.
- EN 1617:1997, Sterile Drainage Catheters and Accessory . Devices for Single Use
- ASTM D4169-09:2009, Standard Practice for Performance . Testing of Shipping Containers and Systems
- ASTM F 1980-07:2007, Standard Guide for Accelerated Aging ● of Sterile Barrier Systems for Medical Devices
- ISO 2233:2000, Packaging Complete, Filled Transport . Packages and Unit Loads - Conditioning for Testing
The following is a list of all significant testing that was successfully completed:
{3}------------------------------------------------
ReSolve® Biliary Locking Drainage Catheter Section 5, 510(k) Summary Special Premarket Notification 510(k)
Design Verification Conditioning Dimensional Drainage Hole Orientation Marker Band/Hole Location Tip Penetration Hub Leak Vacuum Test Tubing Kink Test Safety & Marker Band Adhesion Performance Hub Tensile Testing Tests cont. Tubing Tensile Testing Material Durability Testing Bile Exposure Testing Stiffening Cannula Friction Test Biocompatibility Tests Cytotoxicity Irritation Acute Systemic Toxicity Pvrogenicitv Chemical Characterization Safety & The results of the testing demonstrated that the subject ReSolve Performance Biliary Locking Drainage Catheter met the pre-determined acceptance criteria applicable to the safety and efficacy of the Tests cont. device. Based on the indications for use, design, and safety and performance testing, the subject ReSolve Biliary Locking Drainage Summary of Catheter meets the requirements that are considered essential for Substantial its intended use and is substantially equivalent to the predicate Equivalence device, the ReSolve Biliary Drainage Catheter, manufactured by
Merit Medical Systems. Inc.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ms. Casey Hughes Manager, Regulatory Affairs Merit Medical Systems, Inc. 1600 West Merit Parkway SOUTH JORDAN UT 84095
JUL 1 7 2012
K121832 Re:
Trade/Device Name: Resolve® Biliary Locking Drainage Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: June 18, 2012 Received: June 22, 2012
Dear Ms. Hughes:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
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.
{5}------------------------------------------------
Page 2 - Ms.Casey Hughes
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Hubert Demerino
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
{6}------------------------------------------------
ReSolve® Biliary Locking Drainage Catheter Section 4, Indications for Use Special Premarket Notification 510(k)
Section 4
Indications for Use
510(k) Number (if known):
Device Name: ReSolve® Biliary Locking Drainage Catheter
Indications for Use:
The ReSolve® Biliary Locking Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulut Leen
Division Sign-Off) Division of Reproductive, Gastro-Renal, and Jrological Devices 121832 510(k) Number
§ 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.