(84 days)
No
The summary describes a mechanical catheter for drug delivery and does not mention any AI/ML components or functionalities.
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 is an infusion catheter intended for the delivery of diagnostic and therapeutic agents, not for diagnosing. While it delivers diagnostic agents, it is a delivery tool, not a diagnostic tool itself.
No
The device description clearly describes a physical catheter with mechanical components (microneedle delivery port, balloon actuator, guidewire) and mentions testing of mechanical and fluid delivery performance, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the infusion of diagnostic and therapeutic agents into the body (vessel wall, perivascular area, or intraluminally). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The device is a catheter designed for insertion into blood vessels. This further supports its use within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (e.g., blood, urine, tissue samples) to provide information about a patient's health.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose diseases or conditions. This device is designed to deliver substances into the body.
N/A
Intended Use / Indications for 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 vessel wall or perivascular area. The MicroSyringe II Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
Product codes
KRA
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.
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
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
K040139, K932616, K914751, K913517
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
$\qquad 1062752$
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.D
President and Chief Technology Officer
Mercator MedSystems, Inc.
3077 Teagarden Street
San Leandro, CA 94577
Telephone: 510 614-4550
Facsimile: 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 Catheter
Manufactured by Mercator MedSystems, Inc. | K040139 |
| | Dispatch Coronary Infusion Catheter
Manufactured by SCIMED® Life Systems, Inc. | K932616 |
| | Selective Infusion II Catheter
Manufactured by ACS®/Guidant, Inc. | K914751 |
| | Isolate Infusion Catheter System
Manufactured 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.
1
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.
2
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.
3
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
4
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:
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.
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