Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.

Device Description

The Impress Angiographic Catheter with Hydrophilic Coating is an intravascular diagnostic catheter intended for the administration of contrast for conducting fluoroscopic studies. The catheter is available in a variety of 5F braided configurations including lengths from 40 cm to 125 cm, with or without marker bands and with hydrophilic coating. The device is available in variety of tip shapes to cater to variation in physician preference and patient anatomy. The device is intended for single use only and is supplied in a sterile configuration.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Impress Angiographic Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or conducting extensive clinical trials as might be seen for entirely new technologies.

Therefore, the acceptance criteria and study described are primarily focused on verifying that the new device performs comparably to the predicate and meets established safety standards for its type. The document does not describe an AI device, so information related to human readers, AI assistance, effect size, or standalone algorithm performance is not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (angiographic catheter), the "acceptance criteria" are not performance metrics in the way one might think for software or AI (e.g., sensitivity, specificity). Instead, they are related to established international and internal standards for medical device design, manufacturing, and safety. The reported device performance is that it met these standards and was found substantially equivalent.

Acceptance Criteria (Standards & Tests)	Reported Device Performance
Biocompatibility Testing:	The Impress Angiographic Catheter met the requirements for biocompatibility based on FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
- Cytotoxicity	Performed and met standards.
- Hemolysis	Performed and met standards.
Bench Testing:	The Impress Angiographic Catheter met the specified requirements for all bench tests.
- Marker band radiopacity, position, width, integrity	Performed and met standards.
- Tensile (shaft at marker band and tip to shaft bond)	Performed and met standards.
- Shaft ID/OD, Catheter length	Performed and met standards.
- Catheter stiffness, Kink resistance	Performed and met standards.
- Hydrophilic coating lubricity and coating integrity friction testing	Performed and met standards.
- Tip length, Burst pressure rating, Flow rate	Performed and met standards.
Design Validation:	The Impress Angiographic Catheter met the specified requirements for all design validation tests.
- Marker band size, shape, location, surface profile, radiopacity	Performed and met standards.
- Distal Tip Inspection, Guidewire compatibility	Performed and met standards.
- Catheter push-ability, track-ability, torque-ability, withdrawal	Performed and met standards.
- Kink resistance, Catheter stiffness, Curve retention	Performed and met standards.
International Consensus Standards:	The device was tested and found compliant with these standards.
- ISO 10555-1:2013 (Intravascular catheters - General requirements)	Met
- ISO 594-1:1986, ISO 594-2:1998 (Conical Fittings with 6% Luer Taper)	Met
- ASTM F640-12 (Radiopacity for Medical Use)	Met
- ANSI/AAMI/ISO 11135:2014 (Sterilization - Ethylene oxide)	Met
- ISO 10993-1, -4, -5, -10, -11 (Biological Evaluation of Medical Devices)	Met
- United States Pharmacopeia 41-NF36:2018, <151> Pyrogen Test	Met
- ASTM F756-13 (Hemolytic Properties of Materials)	Met
Overall Substantial Equivalence to K093004 Impress Angiographic Catheter	The subject device is substantially equivalent based on identical indications for use, basic performance and safety profile, principle of operation, fundamental design principles, materials, and manufacturing technology. The addition of a marker band did not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The text describes various bench and design validation tests for the physical properties and functionality of the catheter. It does not refer to a "test set" of patient data or studies in the typical sense of evaluating AI or diagnostic software.

Sample Size: Not explicitly stated as a single "sample size." The testing involves components and finished devices, and the number of units tested for each specific criterion (e.g., tensile strength, burst pressure) would be determined by internal quality control and standard methods specified in the cited ISO/ASTM standards.
Data Provenance: The data provenance is from laboratory testing performed by Merit Medical Systems, Inc. (the manufacturer). This is not retrospective or prospective patient data, but rather controlled engineering and biological compatibility testing of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes the testing of a physical medical device. There is no "ground truth" derived from expert consensus on medical images or patient outcomes for this type of submission. The ground truth refers to the objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., reading medical images). Here, the testing involves objective measurements and adherence to specified limits within the cited standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This device is a physical angiographic catheter, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm study was not done. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" used for this device's evaluation is based on:

Established engineering standards: Specifications for physical properties like dimensions, strength, flow rate, stiffness, etc., as outlined in ISO and ASTM standards.
Biocompatibility standards: Criteria defined by ISO 10993 series and FDA guidance for evaluating biological response (e.g., cytotoxicity, hemolysis).
Predicate device's performance: The previous version of the Impress Angiographic Catheter (K093004) served as the benchmark for demonstrating substantial equivalence. The new device must perform at least as well and not introduce new safety concerns.

8. Sample Size for the Training Set

There is no training set as this is not an AI/machine learning device. The device itself is manufactured based on established designs and processes and then verified through testing.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set mentioned in the context of this device's submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 16, 2019

Merit Medical Systems, Inc. Luke Meidell Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095

Re: K191608

Trade/Device Name: Impress Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: June 14, 2019 Received: June 17, 2019

Dear Mr. Meidell:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gregory O'Connell Assistant Director Plaque Modification Devices Team DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191608

Device Name Impress Angiographic Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary – K191608

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date Prepared:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4623(801) 826-4174Luke MeidellJune 13, 20191721504
Subject Device	Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel:	Impress Angiographic CatheterAngiographic CatheterDiagnostic intravascular catheter2DQO870.1200Cardiovascular
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Regulatory Class:Product Code:21 CFR §:Manufacturer:	Impress Angiographic CatheterDiagnostic intravascular catheterK0930042DQO870.1200Merit Medical Systems, Inc.
DeviceDescription	The Impress Angiographic Catheter with Hydrophilic Coating is anintravascular diagnostic catheter intended for the administration ofcontrast for conducting fluoroscopic studies. The catheter is available ina variety of 5F braided configurations including lengths from 40 cm to125 cm, with or without marker bands and with hydrophilic coating. Thedevice is available in variety of tip shapes to cater to variation inphysician preference and patient anatomy. The device is intended forsingle use only and is supplied in a sterile configuration.
Indications forUse		Angiographic catheters are designed to be used for deliveringradiopaque media to selected sites in the vascular system inconjunction with routine diagnostic procedures. Angiographic catheterswith marker bands may also be used for anatomical measurements.
Comparison toPredicateDevice	The subject device is substantially equivalent to the predicate devicebased on identical indications for use statement, and same basicperformance and safety profile, principle of operation, fundamentaldesign principles, materials and manufacturing technology. The primaryreason for submitting this special 510(k) is the addition of a markerband on the current Impress Angiographic Catheter with HydrophilicCoating cleared under K093004.

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Note: There is no change in the Indications for Use Statement from the predicate to the subject device.

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Impress Angiographic Catheter with Hydrophilic Coating was conducted based on the risk analysis and based on the requirements of the following international consensus standards:

. ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
ISO 594-1:1986, Conical Fittings with 6% (Luer) Taper for . Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements.
ISO 594-2:1998, Conical Fittings with 6% (Luer) Taper for ● Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock fittings.
ASTM F640-12, Standard Test Methods for Determining . Radiopacity for Medical Use
Safetv & Performance Tests
ANSI/AAMI/ISO 11135:2014, Sterilization of health care products. ● Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices.
ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (2016).
ISO 10993-4:2017, Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions 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 10993-11:2017, Biological evaluation of medical devices -● Part 11: Tests for systemic toxicity
United States Pharmacopeia 41-NF36:2018, <151> Pyrogen Test ●
ASTM F756-13, Standard Practice for Assessment of Hemolytic ● Properties of Materials

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The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Impress Angiographic Catheter with Hydrophilic Coating was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following testing was conducted for the catheter:

Cytotoxicity ●
Hemolysis .

The Impress Angiographic Catheter with Hydrophilic Coating is considered to be an externally communicating device with circulating blood contact for a limited (≤ 24 hours) duration.

Bench Testing

Marker band radiopacity
Marker band position ●
Marker band width ●

Safety & Performance

Tests

Marker band integrity ● Tensile – shaft at marker band and tip to shaft bond ●
Shaft ID/OD
Catheter length .
Catheter stiffness
Kink resistance ●
Hydrophilic coating lubricity and coating integrity friction testing ●
Tip length ●
Burst pressure rating ●
Flow rate ●

Design Validation

Marker band size, shape, location, surface profile, and ● radiopacity
Distal Tip Inspection ●
Guidewire compatibility ●
Catheter push-ability ●
Catheter track-ability
Kink resistance ●
Catheter stiffness
Catheter torque-ability ●
Curve retention ●

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Catheter withdrawal ●

The results of the testing do not bring up new questions of safety or effectiveness.

Based on the indications for use, design, safety and performance testing, the subject Impress Angiographic Catheter with Hydrophilic Summary of Substantial Coating meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Equivalence Impress Angiographic Catheter, K093004 manufactured by Merit Medical Systems, Inc.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).