(27 days)
Not Found
No
The summary describes a physical medical device (a guiding catheter) and its materials, dimensions, and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as a guiding catheter used for the intravascular introduction of other interventional/diagnostic devices, which means it facilitates a procedure but doesn't in itself treat a disease or condition.
No
The intended use of the device is for the "intravascular introduction of interventional/diagnostic devices," meaning it facilitates the use of other devices, but it is not itself performing a diagnostic function.
No
The device description clearly outlines physical components like a Pebax body, stainless steel wire braid, PTFE inner lumen, and a radiopaque tip, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems." This describes a device used within the body to facilitate other procedures, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This is consistent with an interventional/diagnostic tool used in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This guiding catheter does not fit that description.
N/A
Intended Use / Indications for Use
The Concierge Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Product codes
DQY
Device Description
The Concierge Guiding Catheter is a single lumen catheter that incorporates a Pebax body reinforced with stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip. It is available in 5F, 6F, 7F and 8F sizes, 100cm long and is produced in a variety of shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular systems
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
Performance testing of the subject Concierge Guiding Catheter was conducted based on the risk analysis and based on the requirements of the following 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 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 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 10993-17: 2002, Biological Evaluation of Medical Devices - Part 17: Establishment of allowable limits for leachable substances ISO 10993-18: 2005, Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials ISO 2233: 2000: Packaging - complete, filled transport packages and unit loads - conditioning and testing BS EN ISO 11607: 2009, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) ASTM D4169-09: 2009, Standard practice for performance testing of shipping containers and systems ASTM F756-08, 2008: Standard Practice for Assessment of Hemolytic Properties of Materials ASTM F1929-98(2004): 1998, Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
The following is a list of all significant testing that was successfully completed: Device Testing - Dimensions, Air Leak, Liquid Leak, Catheter Tip Support and Attachment, Tensile, Shaft Kink, Shaft Stiffness, Simulated use testing; Packaging testing - Visual Inspection, Dye Penetration, Underwater Leak Test, Seal Peel Tensile Test, Burst Strength Test, Aseptic Peel Opening; Biocompatibility testing - Cytotoxicity, Hemocompatibility, Chemical Characterization. The results of the testing demonstrated that the subject Concierge Guiding Catheters met the pre-determined acceptance criteria applicable to the safety and efficacy of the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
K132409
Section 5
; (
4
510(k) Summary ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| General
Provisions | Submitter Name: Merit Medical Systems, Inc.
Address: 1600 West Merit Parkway
South Jordan, UT 84095
Telephone Number: (801) 208-4160
Fax Number: (801) 826-4171
Contact Person: Vicki Godwin
Date of Preparation: August 1,2013
Registration Number: 1721504
AUG 2 9 2013 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name: Concierge® Guiding Catheter
Common/Usual Name: Guiding Catheter
Classification Name: Percutaneous Catheter |
| Predicate
Device | Trade Name: Concierge® Guiding Catheter
Classification Name: Percutaneous Catheter
Premarket Notification: K121051
Manufacturer: Merit Medical Systems, Inc. |
| Classification | Class II
21 CFR § 870.1250
FDA Product Code: DQY
Review Panel: 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 Concierge Guiding Catheter is a single lumen catheter that incorporates a Pebax body reinforced with stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip. It is available in 5F, 6F, 7F and 8F sizes, 100cm long and is produced in a variety of shapes. |
| Comparison to
Predicate
Device | The technological characteristics of the subject Concierge Guiding
Catheters are substantially equivalent to those of the predicate
device. The 5F, 7F and 8F Concierge Guiding Catheter sizes are
modifications of the predicate 6F Concierge Guiding Catheter. In
addition, changes were made to the device material and packaging |
| 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 Concierge Guiding Catheter was conducted
based on the risk analysis and based on the requirements of the
following 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 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 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 10993-17: 2002, Biological Evaluation of Medical
Devices - Part 17: Establishment of allowable limits for
leachable substances ISO 10993-18: 2005, Biological Evaluation of Medical
Devices - Part 18: Chemical Characterization of
Materials ISO 2233: 2000: Packaging - complete, filled transport
packages and unit loads - conditioning and testing BS EN ISO 11607: 2009, Packaging for terminally
sterilized medical devices Part 1: Requirements for
materials, sterile barrier systems and packaging systems
(ISO 11607-1:2006) ASTM D4169-09: 2009, Standard practice for
performance testing of shipping containers and systems ASTM F756-08, 2008: Standard Practice for
Assessment of Hemolytic Properties of Materials ASTM F1929-98(2004): 1998, Standard test method for
detecting seal leaks in porous medical packaging by dye
penetration |
1
。 『
r
23
2
- ASTM F2096-11: 2011, Standard test method for ● detecting gross leaks in medical packaging by internal pressurization (bubble test)
- . ASTM F88/F88M-09: 2009 Standard test method for seal strength of flexible barrier materials
- ASTM F1140-07, Standard test methods for internal . pressurization failure resistance of unrestrained packages
The following is a list of all significant testing that was successfully completed:
Device Testing
- Dimensions ●
- Air Leak
- Liquid Leak .
- Catheter Tip Support and Attachment ●
- Tensile .
- Shaft Kink .
- . Shaft Stiffness
- . Simulated use testing
Packaging testing
- Visual Inspection .
- . Dye Penetration
- . Underwater Leak Test
- . Seal Peel Tensile Test
- Burst Strength Test �
- Aseptic Peel Opening .
Biocompatibility testing
- Cytotoxicity .
- Hemocompatibility
- . Chemical Characterization
The results of the testing demonstrated that the subject Concierge Guiding Catheters 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, safety and performance testing, the subject Concierge Guiding Catheters meet 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.
Safety & Performance Tests cont.
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of an eagle or bird with three wing-like shapes. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2013
Merit Medical Systems, Inc. c/o Vicki Godwin 1600 West Merit Parkway South Jordan, Utah 84095
Re: K132409
Trade/Device Name: Concierge Guiding Catheter Regulation Number: 21 CFR § 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 1, 2013 Received: August 2, 2013
Dear Ms. Godwin:
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 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.
4
Page 2 - Ms. Vicki Godwin
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M. L. Hillen
for Bram D. Zuckerman, M.D. Director of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4
Indications for Use
K132409 510(k) Number (if known):
Device Name: 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 × (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)
M. Z. Hilleman