Who is the manufacturer of CONCIERGE GUIDING CATHETER?

Merit Medical Systems, Inc. filed the 510(k) submission for CONCIERGE GUIDING CATHETER (K121051).

What is the FDA product code for CONCIERGE GUIDING CATHETER?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CONCIERGE GUIDING CATHETER?

510(k) clearance (submission type: Special).

What are the predicate devices for CONCIERGE GUIDING CATHETER?

Concierge® Guiding Catheter (K043387).

Who can help prepare an FDA 510(k) submission like CONCIERGE GUIDING CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CONCIERGE GUIDING CATHETER

K121051 · Merit Medical Systems, Inc. · DQY · Jun 13, 2012 · Cardiovascular

Device Facts

Record ID	K121051
Device Name	CONCIERGE GUIDING CATHETER
Applicant	Merit Medical Systems, Inc.
Product Code	DQY · Cardiovascular
Decision Date	Jun 13, 2012
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

The Concierge Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

Device Story

6 French Concierge Guiding Catheter is a single-lumen catheter used for intravascular delivery of diagnostic or interventional devices into coronary or peripheral vasculature. Device features nylon body reinforced with stainless steel wire braid, PTFE lubricious inner lumen, and soft radiopaque tip. Available in 6F size, 100cm length, and various shapes. Used in clinical settings by physicians to facilitate access for other interventional tools. Device provides a conduit for procedures; output is the successful placement of interventional/diagnostic devices. Benefits include improved access to vascular sites.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included design verification (dimensions, air/liquid leak, tip support, tensile, kink, stiffness, ink adherence) and biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility) per ISO 10993 and ISO 10555 standards.

Technological Characteristics

Single-lumen catheter; nylon body with stainless steel wire braid reinforcement; PTFE lubricious inner lumen; soft radiopaque tip. 6F size, 100cm length. Sterilized via ethylene oxide. Complies with ISO 10555-1/2, ISO 10993 series, and ASTM F756-08.

Indications for Use

Indicated for intravascular introduction of interventional or diagnostic devices into coronary or peripheral vascular systems.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

Concierge® Guiding Catheter (K043387)

Related Devices

K132409 — CONCIERGE GUIDING CATHETER · Merit Medical Systems, Inc. · Aug 29, 2013
K043387 — VASCON POLARIS GUIDING CATHETER · Vascon, LLC · Feb 16, 2005
K033633 — VASCON POLARIS GUIDING CATHETER · Vascon, LLC · Feb 18, 2004
K153703 — Guiding Catheter · Texasmedical Technologies, Inc. · May 12, 2016
K052004 — VASCON NEUROPATH GUIDING CATHETER · Vascon, LLC · Jan 19, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ | Section 5 510(k) Summary | | | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Provisions | Submitter Name: Address: | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 | | | Telephone Number: | (801) 208-4196 | | | Fax Number: | (801) 253-6932 | | | Contact Person: | Michaela Rivkowich | | | Date of Preparation: | April 5, 2012 | | | Registration Number: | 1721504 | | Subject Device | Trade Name: | 6 French Concierge® Guiding Catheter | | | Common/Usual Name: | Guiding Catheter | | | Classification Name: | Percutaneous Catheter | | Predicate Device | Trade Name: | Concierge® Guiding Catheter | | | Common/Usual Name: | Guiding Catheter | | | Classification Name: | Percutaneous Catheter | | | Premarket Notification: | K043387 | | | Manufacturer: | Merit Medical Systems, Inc. | | Classification | Class II 21 CFR § 870.1250 Cardiovascular | | | Intended Use | The Concierge Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. | | | Device Description | The 6 French Concierge Guiding Catheter is a single lumen catheter that incorporates a nylon body reinforced with stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip. It is available in 6F size and 100cm length and in a variety of shapes. | | | Technological Characteristics | The technological characteristics of the subject 6 French Concierge Guiding Catheter are substantially equivalent to those of the predicate device, the Concierge Guiding Catheter, 510(k) K043387. | | | Safety & Performance Tests | No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject 6 French Concierge Guiding Catheter was conducted based on the risk analysis and based on the requirements of the following FDA guidance document and international standards: ISO 10555-1:1995, Sterile, single-use intravascular catheters - Part 1: General requirements ISO 10555-2:1996, Sterile, single-use intravascular catheters - Part 2: Angiographic catheters ANSI/AAMI/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 ASTM F756-08, Standard Practice for Assessment of Hemolytic Properties of Materials ISO 10993-3 :2003, Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ISO 10993-4:2002, Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-11:2006, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity ISO 2233:2000, Packaging - complete, filled transport packages and unit loads - conditioning and testing ASTM D4169-08, Standard practice for performance testing of shipping containers and systems The following is a list of all significant testing that was successfully completed: | | | Safety & Performance Tests cont. | Design Verification Dimensions Air Leak Liquid Leak Catheter Tip Support and Attachment Tensile Shaft Kink Shaft Stiffness Ink Adherence Biocompatibility Tests Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Genotoxicity Hemocompatibility Physicochemical Tests | | | | Safety & Performance Tests cont. | The results of the testing demonstrated that the subject 6 French Concierge Guiding Catheter met the pre-determined acceptance criteria applicable to the safety and efficacy of the device. | | Summary of Substantial Equivalence | Based on the indications for use, design, and safety and performance testing, the subject 6 French Concierge Guiding Catheter meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Concierge Guiding Catheter, manufactured by Merit Medical Systems, Inc. | | {1}------------------------------------------------ . {2}------------------------------------------------ {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is likely part of a document or sign. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUN 1 3 2012 Merit Medical Systems, Inc. c/o Ms. Michaela Rivkowich Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095 Re: K121051 Trade/Device Name: 6 French Concierge Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 10, 2012 Received: May 14, 2012 Dear Ms. Rivkowich: 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 {4}------------------------------------------------ Page 2 - Ms. Michaela Rivkowich 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/CDRH0ffices/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/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 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 yours, Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Concierge® Guiding Catheter Section 4, Indications for Use Special Premarket Notification 510(k) ## Section 4 ## Indications for Use K121051 . 510(k) Number (if known): Device Name: 6 French Concierge® Guiding Catheter Indications for Use: The Concierge® Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. Prescription Use _ X ____ AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (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) (Division Sign-Off) Division of Cardiovascular Devices 21051 5 . k) Numbe