(130 days)
No
The description focuses on the mechanical and hydraulic operation of the device for targeted infusion, with no mention of AI or ML capabilities.
Yes
The device is intended for the "infusion of diagnostic and therapeutic agents."
No
Explanation: The device is intended for the infusion of diagnostic and therapeutic agents, not for diagnosing conditions itself.
No
The device description clearly outlines a physical, wire-guided endovascular catheter with a microneedle, actuator balloon, and stabilizing balloon. This is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "infusion of diagnostic and therapeutic agents" into the vessel wall, perivascular area, or intraluminally. This describes a device used in vivo (within the living body) for delivering substances, not for testing samples in vitro (outside the living body).
- Device Description: The description details a catheter with a microneedle and balloons designed for insertion into blood vessels and delivering substances directly into tissues. This is consistent with an in vivo delivery system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing samples outside the body.
Therefore, the Bullfrog Micro-Infusion Device is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
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 in selective areas of peripheral and coronary vessels. The Bullfrog Micro-Infusion Device is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
Product codes
KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three faces in profile, one behind the other, with flowing lines representing the body.
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
1
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:
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.
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
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.
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
4
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.