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.

AI/ML Overview

The provided text describes the 510(k) Summary for the Merit Medical Systems, Inc. Concierge® Guiding Catheter, which is a medical device and not an AI/ML powered device. Therefore, the information required, such as acceptance criteria in the context of AI/ML performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, and ground truth establishment, is not applicable to this document.

The document discusses the substantial equivalence of the subject device to a predicate device based on its design, intended use, and conventional safety and performance tests. It doesn't involve any AI/ML components or their evaluation.

Here's an analysis of the provided text in the context of the requested information, highlighting why most of it is not relevant:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: The document lists various tests performed (Device Testing, Packaging Testing, Biocompatibility Testing) based on international standards (e.g., ISO 10555-1, ISO 10993-1). The acceptance criteria for these tests are implied to be compliance with these standards and the successful achievement of pre-determined criteria.
- Examples of tests: Dimensions, Air Leak, Liquid Leak, Catheter Tip Support and Attachment, Tensile, Shaft Kink, Shaft Stiffness, Simulated use testing, Visual Inspection (packaging), Dye Penetration (packaging), Cytotoxicity, Hemocompatibility, Chemical Characterization.
Reported Device Performance: The document states, "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." Specific numerical performance metrics for each test (e.g., exact tensile strength achieved, precise leak rate) are not provided in this summary.

2. Sample sizes used for the test set and the data provenance:

Not Applicable: This type of information (sample size for test sets, data provenance like country of origin, retrospective/prospective) is relevant for AI/ML model validation using datasets. For a physical medical device like a guiding catheter, "sample size" would refer to the number of catheters tested for each physical or biological property, which is not detailed in this summary. The "data provenance" refers to the origin of the test results from the manufacturer's internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: "Ground truth" established by experts is a concept pertinent to AI/ML model evaluation against human interpretations (e.g., radiologists labeling images). For a physical medical device, "ground truth" is typically defined by engineering specifications, material properties, and established medical standards. The testing is performed by engineers/technicians according to established protocols, not by clinical "experts" establishing a "ground truth" in the AI sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable: Adjudication methods are used in AI/ML validation to resolve disagreements among human annotators or model predictions. This concept does not apply to the direct physical and biological testing of a medical device.

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:

Not Applicable: MRMC studies are specifically designed to evaluate the impact of AI on human reader performance for diagnostic tasks. This device is a physical catheter, not an AI diagnostic tool, so an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable: This applies to AI algorithms. The device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable in the AI/ML sense: For a physical device, ground truth is based on engineering specifications, physical/chemical properties, and established biological safety standards (e.g., ISO standards for biocompatibility, ASTM for material properties and packaging). There's no "expert consensus" on an image or pathology slide involved.

8. The sample size for the training set:

Not Applicable: There is no "training set" for a physical medical device like this, as it does not involve machine learning.

9. How the ground truth for the training set was established:

Not Applicable: As there is no training set, this question is not relevant.

In summary, the provided document describes the safety and performance testing of a physical medical device (Concierge® Guiding Catheter) for regulatory submission, focusing on its substantial equivalence to a predicate device. The framework of acceptance criteria and study design requested is primarily applicable to Artificial Intelligence and Machine Learning (AI/ML) powered medical devices, which is not what this document describes.

Summary

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K132409

Section 5

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510(k) Summary ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

GeneralProvisions	Submitter Name: Merit Medical Systems, Inc.Address: 1600 West Merit ParkwaySouth Jordan, UT 84095Telephone Number: (801) 208-4160Fax Number: (801) 826-4171Contact Person: Vicki GodwinDate of Preparation: August 1,2013Registration Number: 1721504AUG 2 9 2013
SubjectDevice	Trade Name: Concierge® Guiding CatheterCommon/Usual Name: Guiding CatheterClassification Name: Percutaneous Catheter
PredicateDevice	Trade Name: Concierge® Guiding CatheterClassification Name: Percutaneous CatheterPremarket Notification: K121051Manufacturer: Merit Medical Systems, Inc.
Classification	Class II21 CFR § 870.1250FDA Product Code: DQYReview 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.
DeviceDescription	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 toPredicateDevice	The technological characteristics of the subject Concierge GuidingCatheters are substantially equivalent to those of the predicatedevice. The 5F, 7F and 8F Concierge Guiding Catheter sizes aremodifications of the predicate 6F Concierge Guiding Catheter. Inaddition, changes were made to the device material and packaging
Safety &PerformanceTests	No performance standards have been established under Section 514of the Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject Concierge Guiding Catheter was conductedbased on the risk analysis and based on the requirements of thefollowing international standards:ISO 10555-1:1995, Sterile, single-use intravascularcatheters - Part 1: General requirements ISO 10555-2:1996, Sterile, single-use intravascularcatheters - Part 2: Angiographic catheters ISO 11135-1: 2007, Sterilization of health care products- Ethylene oxide - Part 1: Requirements fordevelopment, validation and routine control of asterilization process for medical devices ISO 10993-1: 2009, Biological Evaluation of MedicalDevices Part-1: Evaluation and Testing within a riskmanagement process ISO 10993-5: 2009, Biological Evaluation of MedicalDevices Part-5: Tests for In Vitro Cytotoxicity ISO 10993-7: 2008, Biological Evaluation of MedicalDevices Part-7 Ethylene Oxide Sterilization Residuals ISO 10993-17: 2002, Biological Evaluation of MedicalDevices - Part 17: Establishment of allowable limits forleachable substances ISO 10993-18: 2005, Biological Evaluation of MedicalDevices - Part 18: Chemical Characterization ofMaterials ISO 2233: 2000: Packaging - complete, filled transportpackages and unit loads - conditioning and testing BS EN ISO 11607: 2009, Packaging for terminallysterilized medical devices Part 1: Requirements formaterials, sterile barrier systems and packaging systems(ISO 11607-1:2006) ASTM D4169-09: 2009, Standard practice forperformance testing of shipping containers and systems ASTM F756-08, 2008: Standard Practice forAssessment of Hemolytic Properties of Materials ASTM F1929-98(2004): 1998, Standard test method fordetecting seal leaks in porous medical packaging by dyepenetration

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).