The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.

Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

Device Description

The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.

The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and is compatible with a 0.014" guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wall thickness and tapers to the catheter is available in lengths of 135 cm and 150 cm in length to facilitate access to various target sites.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Surmodics Microcatheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting effectiveness studies akin to AI/ML device studies. Therefore, many of the requested elements for AI/ML device evaluations (such as human readers, ground truth establishment, training set details, or comparative effectiveness studies with AI assistance) are not applicable or not present in this document.

However, I can extract and structure the available information regarding acceptance criteria and testing:

Acceptance Criteria and Device Performance Study for Surmodics Microcatheter (K173560)

This submission establishes substantial equivalence to a predicate device (ASAHI Caravel, K152447) based on design, intended use, principles of use, materials, sizes, and sterility. The "acceptance criteria" here refer to the performance thresholds met during design verification and biocompatibility testing. The "study" refers to the conducted design verification tests and biocompatibility assessments.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." Specific quantitative performance values or detailed acceptance criteria are not provided in this regulatory document. The table below lists the types of tests performed.

Acceptance Criteria Category	Specific Tests Performed
Design Verification	- Visual inspections
- Dimensional evaluations
- Radiopacity
- Tensile strength
- Freedom from liquid leakage
- Hub/Luer connector compatibility
- Simulated use
- High pressure injection
- Particulate
- Flow Rate
- Kink resistance
- Tracking forces
- Torque strength
- Torque transmission
- Hydrophilic coating testing
- Freedom from air leakage
- Push transmittance
- 3 point bend
- Coating Integrity
- Package Performance Testing
Biocompatibility (ISO 10993-1)	- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous Reactivity ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Systemic toxicity (acute) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Hemocompatibility ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Pyrogenicity
Reported Performance	"All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." This indicates successful performance against the established criteria for each test listed above.

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

The document does not specify the sample sizes for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). These details are typically contained in the full test reports referenced in such a submission, but not in the summary provided.

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

Not applicable. For a 510(k) submission for a non-AI/ML device, "ground truth" as typically understood in AI/ML performance evaluation (e.g., expert consensus on medical images) is not established. Device performance is assessed against engineering specifications, material properties, and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML device and does not involve adjudication of expert interpretations for a test set.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed. This is a 510(k) submission for a microcatheter, not an AI/ML device, and thus does not involve human readers or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

Not applicable. This is not an AI/ML algorithm. The device performance testing is akin to "standalone" in the sense that the device's physical and functional characteristics are tested directly without human intervention in the device's core function.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, material science standards, and regulatory requirements (e.g., ISO standards) for medical devices. For example, a "tensile strength" test has a defined pass/fail criterion based on mechanical properties required for the device's intended use. Similarly, biocompatibility tests are assessed against established biological response limits.

8. The Sample Size for the Training Set

Not applicable. This is a conventional medical device; there is no "training set" in the context of machine learning. The device design is based on engineering principles and iterative development, not data-driven machine learning training.

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

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

January 12, 2018

Surmodics, Inc. Sherri Mellingen Senior Regulatory Associate 9924 W 74th St Eden Prairie, Minnesota 55344

Re: K173560

Trade/Device Name: Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 16, 2017 Received: November 17, 2017

Dear Sherri Mellingen:

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 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);

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Page 2 - Sherri Mellingen

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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	DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
	Food and Drug Administration	Expiration Date: January 31, 2017
	Indications for Use	See PRA Statement below.
510(k) Number (if known)
K173560
Device NameMicrocatheter

Indications for Use (Describe)
	The Surmodics Microcatheter is intended to provide support to facement of guidewires in the coronary andperipheral vasculatures and can be used to exchange one guidevire for another. This microcatheter is also intended toassist in the delivery of contrast media into the coronary and peripheral vasculatures.
	Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.






















	[X] Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
	CONTINUE ON A SEPARATE PAGE IF NEEDED.
	This section applies only to requirements of the Paperwork Reduction Act of 1995.
	*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
Type of Use (Select one or both, as applicable)	The burden time for this collection of information is estimated to average 79 hours per response, including the
	time to review instructions, search existing data sources, gather and maintain the data needed and complete
	and review the collection of information. Send comments regarding this burden estimate or any other aspect
	of this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human Services
	Food and Drug Administration
	Office of Chief Information Officer
	Paperwork Reduction Act (PRA) Staff
	PRAStaff@fda.hhs.gov
	"An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number."

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510(K) Summary SURMODICS

Date Prepared: 11/16/2017

Submitters Name / Contact Person

510k Submitter Address

Surmodics, Inc. 9924 W 74th St Eden Prairie MN 55344 Phone - (952) 500 - 7528 Fax - (763) 557-6674

Contact for Official/Routine Correspondence

Sherri Mellingen Senior Regulatory Associate 9924 W 74th St, Eden Prairie, MN 55344 Phone - (952) 500 - 7081 Fax - (763) 557-6674

General Information
Trade Name:	Microcatheter
Common / Usual Name:	Microcatheter
Classification:	Class 2 per 21 CFR 870.1250
Product Code:	DQY - Catheter, Percutaneous
Predicate Device:	ASAHI Caravel (K152447)

Device Description

Intended Use / Indications

Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

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Comparison of Technological Characteristics

The Surmodics Microcatheter device is substantially similar to the legally marketed predicate device in design, intended use, principles of use, materials, sizes and sterility. The Surmodics Microcatheter and the predicate device are intended to access discrete regions of the coronary and peripheral vasculature to facilitate the placement of or exchange of guidewires or to deliver contrast media. Both devices have similar dimensions and similar accessory compatibility. The devices are made from similar materials and both have a lubricious coating.

Substantial Equivalence and Summary of Studies

Results of design verification testing demonstrate that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device. The microcatheter is substantially equivalent to the predicate device based on intended use/indications for use and technological characteristics. The subject device has been evaluated through the following tests:

. Visual inspections
Dimensional evaluations
Radiopacity ●
Tensile strength ●
Freedom from liquid leakage ●
Hub/Luer connector compatibility ●
. Simulated use
High pressure injection .
Particulate
Flow Rate .
. Kink resistance
Tracking forces
Torque strength .
Torque transmission ●
Hydrophilic coating testing ●
Freedom from air leakage
Push transmittance ●
. 3 point bend
Coating Integrity
Package Performance Testing ●

The following biocompatibility tests were performed in accordance with ISO 10993-1:

. Cytotoxicity
. Sensitization
. Irritation/Intracutaneous Reactivity
. Systemic toxicity (acute)
Hemocompatibility
. Pyrogenicity

All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness. The Surmodics Microcatheter is substantially equivalent to the predicate device.

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).