(178 days)
No
The summary describes a mechanical catheter device for drug delivery and does not mention any AI/ML components or capabilities.
Yes
The device is intended for the infusion of "diagnostic and therapeutic agents."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for the "infusion of diagnostic and therapeutic agents".
No
The device description clearly outlines a physical, endovascular catheter with mechanical components (microneedle, actuator balloon, stabilizing balloon) and hydraulic actuation, indicating it 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 describes the device as being used for the infusion of diagnostic and therapeutic agents into the vessel wall, perivascular area, or intraluminally. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test performed on samples like blood or tissue.
- Device Description: The description details a catheter with a microneedle and balloons designed for insertion into blood vessels and delivery of substances. This is consistent with an interventional medical device used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect analytes, or provide diagnostic information based on testing samples outside the body.
Therefore, the Bullfrog Micro-Infusion Device is an interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For Bullfrog devices capable of treating
§ 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).
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August 2, 2021
Mercator MedSystems, Inc. Kirk Seward President and Chief Science & Technology Officer 1900 Powell Street Suite 800 Emeryville, California 94608
Re: K210339
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: June 29, 2021 Received: July 1, 2021
Dear Kirk 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, 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 DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210339
Device Name Bullfrog Micro-Infusion Device
Indications for Use (Describe)
For Bullfrog devices capable of treating 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 of information unless it displays a currently valid OMB number."
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K210339 510(K) SUMMARY
510(k) Applicant Mercator MedSystems, Inc. 1900 Powell Street, Suite 800 Emeryville, CA 94608 Telephone: (510) 614-4550 Facsimile: (510) 614-4560
| Contact Person:
Phone:
Email: | Monica Barrett
(916) 849-5399
monica@mercatormed.com |
|-------------------------------------|---------------------------------------------------------------------------|
| Date of Summary: | 20 April 2021 |
| Device Overview
Trade Name: | Bullfrog® Micro-Infusion Device |
| 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 Device
| 510(k)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K161402 | Bullfrog® Micro-Infusion Device | Mercator MedSystems |
Reference Devices
| 510(k)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K153501 | Bullfrog® Micro-Infusion Device | Mercator MedSystems |
| K062752 | MicroSyringe II/Bullfrog Micro-Infusion | |
| Device | 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
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a force opposite the needle tip for proper seating of the needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.
Indications for Use
For Bullfrog devices capable of treating