(331 days)
No
The device description and performance studies focus on the physical characteristics and mechanical function of a drainage catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used to drain bile within the biliary system, which addresses a physiological condition and provides therapeutic benefit to the patient.
No
The device description clearly states its purpose is for "drainage of bile within the biliary system," which is a treatment function, not a diagnostic one.
No
The device description clearly details a physical catheter made of biocompatible thermoplastic with various hardware components like a metal stiffener, flexible plastic stiffener, straightener, repositioning tool, and a suture locking mechanism. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Resolve® Biliary Drainage Catheter is a device that is inserted into the body (in vivo) to drain bile from the biliary system. It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Testing: The description focuses on the physical characteristics and function of the catheter for drainage, not on analyzing biological samples for diagnostic purposes.
Therefore, based on the provided information, the Resolve® Biliary Drainage Catheter is a medical device used for treatment (drainage), not for in vitro diagnostic testing.
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
FGE
Device Description
The Resolve® Biliary 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 thermo-plastic. 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 stiffener, flexible plastic stiffener, 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 hib, 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 cather. A single reditorsale marker band is located proximal to the most proximal drainage hole to assist in accurate placement of the drainage holes in the biliary duct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary system; biliary duct
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)
Bench testing was conducted on the Resolve® Biliary Drainage Catheter in order to establish substantial equivalence. Performance testing was conducted according to international standards as well as Merit's in-house protocols. Where performance could affect the safety or effectiveness of the Resolve® Biliary Drainage Catheter, comparison tests with the predicate device was conducted. Performance data demonstrates that the Resolve® Biliary Drainage Catheter is substantially equivalent to the predicate device.
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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Merit Medical Systems, Inc. ReSolve® Biliary Drainage Catheter PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary
Submitter
Establishment Registration Number
Contact Person(s) Primary Contact Person Title
Phone Fax e-mail
Alternate Contact Person Title
Phone Fax e-mail
Date Prepared
Name of Medical Device
Classification Name: Common/Usual Name: Trade/Proprietary Name:
Device Classification
Panel: Device Class: Product Code: Regulation Number:
Predicate Device Identification
Device Brand Name
- Classification Name Device Class Classification Panel Number Product Code Clearance Status Manufacturer Registration Number ·
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, Utah 84095-2416 USA
1721504
Amy McKinney Amy Mercimey
Merit Medical Systems, Inc. amckinne@merit.com
William D. Jordan Senior Regulatory Affairs Specialist Merit Medical Systems, Inc. (801) 208-4196 (801) 253-6960 bjordan@merit.com
December 15, 2006
Catheter, Biliary, Diagnostic (21 CFR 876.5010) Biliary Drainage Catheter ReSolve® Biliary Drainage Catheter
Gastroenterology - Urology Devices Class II FGE 21 CFR 876.5010
UreSil Hydrophilic-coated Chole-Cath® Biliary Drainage Catheter Catheter, Biliary, Diagnostic (21 CFR 876.5010) Class II 876 FGE K981344 Uresil L.P. 1450395
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Merit Medical Systems, Inc. ReSolve® Biliary Drainage Catheter PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary
Device Description
The Resolve® Biliary 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 thermo-plastic. 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 stiffener, flexible plastic stiffener, 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 hib, 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 cather. A single reditorsale marker band is located proximal to the most proximal drainage hole to assist in accurate placement of the drainage holes in the biliary duct.
Intended Use
The Resolve® Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.
2
Merit Medical Systems, Inc. ReSolve® Biliary Drainage Catheter PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary
Summary of Characteristics in Relation to the Predicate Device
Does the new device have the same indication statement as the predicate device?
Yes.
Although there are minor differences, the intended use is the same.
Does the new device have the same technological characteristics, e.g., design, materials, etc. as the predicate device?
Yes.
The Resolve® Biliary Drainage Catheter employs a similar method of operation and design as compared to the predicate device. Both the new and predicate devices consist of a hub, shaft with pigtail tip, drainage holes on the distal end and a pigtail locking mechanism. Both the new and predicate devices are comprised of similar materials and are the same sizes.
Are the descriptive characteristics precise enough to ensure equivalence to the predicate device?
No.
Bench testing was conducted on the Resolve® Biliary Drainage Catheter in order to establish substantial equivalence.
Are performance data available to assess effects of the new device as compared to the predicate device?
Yes.
Performance testing was conducted according to international standards as well as Merit's in-house protocols. Where performance could affect the safety or effectiveness of the Resolve® Biliary Drainage Catheter, comparison tests with the predicate device was conducted.
Does performance data demonstrate equivalence?
Yes.
Performance data demonstrates that the Resolve® Biliary Drainage Catheter is substantially equivalent to the predicate device.
Conclusion: "Substantial Equivalence" Determination
Based on CDRH's substantial equivalence decision tree, the Resolve® Biliary Drainage Catheter is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle symbol is composed of three curved lines that suggest the shape of an eagle's head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2007
Ms. Amy E. McKinney Regulatory Affairs Consultant Merit Medical Systems, Inc. 1111 South Velasco ANGLETON TX 77515
Re: K063733
Trade/Device Name: ReSolve Biliary Drainage Catheter Regulation Number; 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: October 31, 2007 Received: November 1, 2007
Dear Ms. McKinney:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Merit Medical Systems, Inc. ReSolve® Biliary Drainage Catheter PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL
INDICATION(S) FOR USE STATEMENT *
510(k) Number (if known):
Device Name:
ReSolve® Biliary Drainage Catheter
Indications for Use:
The Resolve® Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.
Prescription Use X (Part 21 CFR 901 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart O)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helmut Rempel
(Division Sign-Off) (Division Sign-Olf)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number