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

Device Description

The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, singleoperator, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a semi-rigid polymer actuator balloon. The device is designed to be advanced to target vasculature and hydraulically actuated to move the microneedle through the external elastic lamina to deliver substances to adventitial and perivascular tissues. A compliant stabilizing balloon inflates with the actuator to provide a force opposite the needle tip for proper seating of the needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bullfrog Micro-Infusion Device, based only on the input you provided.

Note: The provided document is a 510(k) summary for a medical device. These summaries typically highlight that performance tests were done and met criteria, but they do not usually contain the detailed acceptance criteria or the full study results that would be found in a complete test report or clinical study report. Therefore, much of the requested information (especially specific numerical acceptance criteria, detailed study parameters, and specific quantitative results) is not present in this document.

While the document states that performance testing, biocompatibility, sterilization validation, and in-vivo safety and effectiveness studies were conducted and all tests met pre-determined specifications and acceptance criteria, it does not provide the specific acceptance criteria or the detailed results of these studies. It also explicitly states "N/A" for "Indications for Use" under a section heading, which is likely a formatting error as it also lists indications for use earlier in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Not provided in detail)	Reported Device Performance (Summary)
Mechanical Performance	Pre-determined specifications and acceptance criteria (details not provided)	All tests met the pre-determined specifications and acceptance criteria. (General statement)
Fluid Delivery Performance	Pre-determined specifications and acceptance criteria (details not provided)	All tests met the pre-determined specifications and acceptance criteria. (General statement)
Biocompatibility	In accordance with ISO 10993, Biological Evaluation of Medical Devices. (Specific criteria not provided)	The biocompatibility assessment was conducted in accordance with ISO 10993. (General statement implying compliance)
Sterilization Validation	Pre-determined specifications and acceptance criteria (details not provided)	All tests met the pre-determined specifications and acceptance criteria. (General statement)
In-Vivo Safety	Pre-determined specifications and acceptance criteria (details not provided)	All tests met the pre-determined specifications and acceptance criteria. (General statement). Labeling contains instructions, cautions, and warnings for safe and effective use.
In-Vivo Effectiveness	Pre-determined specifications and acceptance criteria (details not provided)	All tests met the pre-determined specifications and acceptance criteria. (General statement)
Risk Profile Comparison	Same risk profile as the predicate device (qualitative)	Risk analysis has shown that the Bullfrog Micro-Infusion Device has the same risk profile as the predicate.

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

The document does not explicitly state the sample sizes used for any specific test sets (e.g., for mechanical, fluid delivery, or in-vivo studies). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "in-vivo safety and effectiveness studies" without details.

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

This information is not provided in the document. The document describes a medical device, and the "ground truth" concept as usually applied to AI algorithms (e.g., expert consensus on images) is not applicable or detailed here. For device performance, the "ground truth" would typically be defined by the physical or biological reality measured during testing against defined specifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No MRMC comparative effectiveness study is mentioned for the Bullfrog Micro-Infusion Device. This type of study is typically associated with diagnostic imaging or AI algorithms, not directly with a physical interventional medical device as described here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The Bullfrog Micro-Infusion Device is a physical interventional medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable in this context.

7. The Type of Ground Truth Used

For a physical device, the "ground truth" is established through engineering specifications, physical measurements, chemical analyses (biocompatibility), and biological outcomes (in-vivo studies, safety/effectiveness). The document generally states that tests met "pre-determined specifications and acceptance criteria," which implies that these specifications serve as the "ground truth" against which performance was measured. No specific mention of expert consensus, pathology, or outcomes data as a distinct ground truth source (like in imaging studies) is given for the device's technical performance.

8. The Sample Size for the Training Set

This information is not applicable. The Bullfrog Micro-Infusion Device is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable, as it is a physical device and not an AI algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 15, 2016

Mercator Medsystems, Inc. % Adam Harris Senior Regulatory Manager Target Health, Inc. 261 Madison Avenue 24th Floor New York, New York 10016

Re: K153501

Trade/Device Name: Bullfrog Micro-infusion Device Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: March 16, 2016 Received: March 17, 2016

Dear Adam Harris:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

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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4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K153501

Device Name: Mercator MedSystems Bullfrog® Micro-Infusion Device

Indications For Use:

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

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)

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5. 510(K) SUMMARY

510(k) Applicant Mercator MedSystems, Inc. 2200 Powell Street, Suite 530 Emeryville, CA 94608 Telephone: (510) 614-4550 Facsimile: (510) 614-4560 Contact Person: Adam Harris, Target Health Phone: (646) 218-2009 Email: aharris@targethealth.com Date of Summary: 30 November 2015 Device Overview Bullfrog® Micro-Infusion Device Trade Name: Common Name: Continuous Flush Infusion Catheter (per 21 CFR 870.1210) Classification: Continuous Flush Infusion Catheter 21 CFR 870.1210 Product Code KRA Panel: Cardiovascular

Predicate Devices

510(k)Number	Trade or Proprietary or Model Name	Manufacturer
K062752	Mercator MicroSyringe II Infusion Catheter	Mercator MedSystems

Device Description

Intended Use

In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents that are indicated for

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delivery into the vessel wall or perivascular area. The Bullfrog Micro-Infusion Device is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

Indications for Use

N/A

Technological Characteristics

All materials used in the manufacture of the Bullfrog Micro-Infusion Device are suitable for this use and have been used in several previously cleared products.

Performance Data

Performance testing of the Bullfrog Micro-Infusion Device included mechanical and fluid delivery performance, biocompatibility, sterilization validation, in-vivo safety and effectiveness studies. All tests met the pre-determined specifications and acceptance criteria.

Safety and Effectiveness

The Bullfrog Micro-Infusion Device labeling contains instructions for use and any necessary cautions and warnings to assure safe and effective use of the device. The biocompatibility assessment was conducted in accordance with ISO 10993, Biological Evaluation of Medical Devices.

Comparison to Predicate Devices

The Bullfrog Micro-Infusion Device is substantially equivalent to the predicate. The Bullfrog Micro-Infusion Device has the same intended use, design and materials, mechanical safety, methods of introduction and methods of operation as the MicroSyringe II/Bullfrog Micro-Infusion Device from K062752. The Bullfrog Micro-Infusion Device has new technological characteristics related to currently available model sizes, in comparison to the predicate. The Bullfrog Micro-Infusion Device is available in three model sizes (2-4 mm, 3-6 mm and 4-8 mm), while the MicroSyringe II/Bullfrog Micro-Infusion Device from K062752 was cleared with data from only one model size (3-6 mm). Risk analysis has shown that the Bullfrog Micro-Infusion Device has the same risk profile as the predicate.

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).