In selective areas of peripheral and coronary vessels, the MicroSyringe II Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The MicroSyringe II Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

Device Description

The Mercator MicroSyringe II is a wire-guided endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and consists of a semi rigid nolymor halless sollyery port, which is sheathed within a semi-rigid polymer balloon actuator with an integrated compliant low-pressure forcing balloon opposite the microneedle. The device is advanced over a 0.014" guidewire, using a single operator method. The device is advanced over a 0.014 guidewire, use the needle delivery port into the troutinent vossel and nythanically actualed to ctructures structures.

AI/ML Overview

The provided text is a 510(k) summary for the Mercator MicroSyringe II Infusion Catheter and does not contain the detailed information requested regarding acceptance criteria and a specific study proving device performance against those criteria in the context of an AI/ML model.

This document describes a medical device clearance for an infusion catheter, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML performance, ground truth, expert review, training sets, and comparative effectiveness studies are not applicable or detailed in this submission.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance	Met all required specifications for the tests.
Fluid Delivery Performance	Met all required specifications for the tests.
Biocompatibility	Met all required specifications for the tests. Materials used are suitable for this use and have been used in several previously cleared products.
Sterilization Validation	Met all required specifications for the tests.
In-vivo Safety	Met all required specifications for the tests.
Overall Safety and Effectiveness (vs. Predicates)	"The results of these tests demonstrated that the device is as safe and effective as the legally marketed predicate devices." This implies that the performance across the above categories was equivalent or superior to the predicate devices (Mercator MicroSyringe Infusion Catheter K040139, Dispatch Coronary Infusion Catheter K932616, Selective Infusion II Catheter K914751, Isolate Infusion Catheter System K913517). The specific quantitative metrics for "acceptance criteria" are not explicitly detailed beyond "met all required specifications."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes (e.g., number of units tested, number of in-vivo subjects) for the mechanical, fluid delivery, biocompatibility, sterilization, or in-vivo safety testing. It also does not state the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a medical device for infusion, not an AI/ML diagnostic or predictive device requiring expert-established ground truth in the context of image interpretation or similar. The "performance" assessment is based on engineering and biological testing.

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

Not applicable. This is not an AI/ML device requiring human adjudication of performance outcomes in that context. Device performance was likely assessed against engineering specifications and possibly animal studies in a direct, objective manner.

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. This is not an AI-assisted device, and no MRMC study information is provided.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance of this physical device would typically be defined by:

Engineering specifications and standards for mechanical and fluid delivery performance.
Relevant ISO standards and guidelines for biocompatibility and sterilization validation.
Pre-clinical (in-vivo animal) study results for safety.

The document states that "All components, subassemblies and/or full devices met the required specifications for the tests," implying these specifications served as the ground truth or target.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model.

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

Not applicable. This is a physical medical device, not an AI/ML model.

Summary

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$\qquad 1062752$

510(k) Notification Mercator MicroSyringe II Infusion Catheter August 15, 2006

Appendix A 510(k) Summary of Safety and Effectiveness

UEU = 7 2006

Submitted by	Kirk P. Seward, Ph.DPresident and Chief Technology OfficerMercator MedSystems, Inc.3077 Teagarden StreetSan Leandro, CA 94577Telephone: 510 614-4550Facsimile: 510 667-0435
Contact Person	Same as above
Date Summary Prepared	August 15, 2006
Trade Name	Mercator MicroSyringe II Infusion Catheter
Common Name	Continuous Flush Infusion Catheter (per 21 CFR 870.1210)
Performance Standards	Not promulgated for Continuous Flush Infusion Catheters
Classification	KRA/Class II
Panel	Cardiovascular
Predicate Devices
	Mercator MicroSyringe Infusion CatheterManufactured by Mercator MedSystems, Inc.	K040139
	Dispatch Coronary Infusion CatheterManufactured by SCIMED® Life Systems, Inc.	K932616
	Selective Infusion II CatheterManufactured by ACS®/Guidant, Inc.	K914751
	Isolate Infusion Catheter SystemManufactured by Lake Region, Inc.	K913517

Device Description

The Mercator MicroSyringe II is a wire-guided endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and consists of a
semi rigid nolymor halless sollyery port, which is sheathed within a semi-rigid polymer balloon actuator with an integrated compliant low-pressure forcing balloon opposite the microneedle. The device is advanced over a 0.014" guidewire, using a single operator method. The device is advanced over a 0.014 guidewire, use the needle delivery port into the troutinent vossel and nythanically actualed to
ctructures structures.

Intended Use

In selective areas of peripheral and coronary vessels, the MicroSyringe II Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the infaction of diagricult area. The MicroSyringe II Infusion Catheter is also internet was of diagnostic and therapeutic agents
infraluminally intraluminally.

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510(k) Notification Mercator MicroSyringe II Infusion Catheter August 15, 2006

Technological Characteristics

All materials used in the manufacture of the MicroSyringe II are suitable for this use and have been used in several previously cleared products.

Testing

Testing of mechanical and fluid delivery performance, biocompatibility, sterilization validation, and in-vivo safety were conducted to ensure the MicroSyringe II met all of its pre-determined specifications.

All components, subassemblies and/or full devices met the required specifications for the tests. The results of these tests demonstrated that the device is as safe and effective as the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mercator MedSystems, Inc. c/o Kirk P. Seward, Ph.D. President and Chief Technology Officer 3077 Teagarden Street San Leandro, CA 94577

DEC - 7 2006

Re: K062752

Mercator MicroSyringe II Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: November 20, 2006 Received: December 1, 2006

Dear Dr. Seward:

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, Orug, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, RDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Kirk P. Seward, Ph.D.

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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510(k) Notification Mercator MicroSyringe II Infusion Catheter August 15, 2006

Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Mercator MedSystems MicroSyringe II Infusion Catheter____________________________________________________________________________________________________________

Indications For Use:

Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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

510(k) Number K062752

Page 1 of 1

Page 4 of 181

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).