Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical catheter for delivering substances and does not mention any AI/ML components or functions.

Therapeutic

Yes
The device is described as an "Infusion Catheter... intended for the infusion of diagnostic and therapeutic agents." The infusion of therapeutic agents directly implies a therapeutic purpose.

Diagnostic

No

The device is described as an "Infusion Catheter" intended for the "infusion of diagnostic and therapeutic agents". While it can infuse diagnostic agents, its primary function is delivery, not the act of diagnosing.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "wire-gulded endovascular catheter" with physical components like a "perpendicular microneedle delivery port" and a "semi-rigid polymer balloon actuator." The performance studies also focus on physical characteristics and performance of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use describes the device as being used for the "infusion of diagnostic and therapeutic agents" directly into the vessel wall, perivascular area, or intraluminally. This is a direct intervention within the body.
Device Description: The description details a catheter with a microneedle delivery port and balloon actuator, designed to be advanced into blood vessels. This is a medical device used for in-vivo procedures.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples.

Therefore, the uSyringe Infusion Catheter is a medical device used for therapeutic and diagnostic agent delivery within the body, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

In selective areas of 2.5 mm diameter peripheral and coronary vessels, the uSyringe 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 pSyringe Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

Product codes (comma separated list FDA assigned to the subject device)

KRA

Device Description

The EndoBionics uSyringe is a wire-gulded endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and contained within a semi-rigid polymer balloon actuator. The device is advanced over a 0.014" guidewire, using a single operator method, into the treatment vessel and hydraulically actuated to move the needle delivery port into the vessel in order to deliver substances to 2.5 min vascular structures.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral and coronary vessels; vessel wall or perivascular area; intraluminally

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The following testing was conducted to ensure the uSyringe met all specifications

Balloon Minimum Burst Strength .
Balloon Compliance (Distensibility) .
Balloon Inflation/Deflation Performance .
Balloon Fatigue .
Bond Strengths .
Catheter Diameter and Balloon Profile .
ア Tip Pull Test
Over-the-Arch Torque Strength Test *
Over-the-Arch Torque Response Test ◆
Balloon Preparation .
Catheter Body Burst Pressure 4
. Biocompatibility Testing
In-vivo Safety .

The results of the above tests demonstrated that the device is as safe and effective as the legally marketed predicate devices. All components, subassemblies and/or full devices met the required specifications for the above tests. Additional tests were performed to determine performance of the uSyringe in fluid delivery and integrity of device components.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K932616, K914751, K913517

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

FEB 1 8 2004

LO40139

510(k) Notification EndoBionics MicroSyringe™ Infusion Catheter February 9, 2004

Appendix E 510(k) Summary of Safety and Effectiveness

| Submitted by | Kirk Seward
Vice President and Chief Technology Officer
EndoBionics, Inc.
3077 Teagarden Street
San Leandro, CA 94577
Telephone: 510 614-4550
Facsimile: 510 667-0435 | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact Person | Same as above | |
| Date Summary Prepared | February 9, 2004 | |
| Trade Name | EndoBionics MicroSyringe ( $\mu$ Syringe) Infusion Catheter | |
| Common Name | Continuous Flush Infusion Catheter (per 21 CFR 870.1210) | |
| Performance Standards | Not promulgated for Continuous Flush Infusion Catheters | |
| PROCODE/Classification | KRA/Class II | |
| Panel | Cardiovascular | |
| Predicate Devices | 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 EndoBionics uSyringe is a wire-gulded endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and contained within a semi-rigid polymer balloon actuator. The device is advanced over a 0.014" guidewire, using a single operator method, into the treatment vessel and hydraulically actuated to move the needle delivery port into the vessel in order to deliver substances to 2.5 min vascular structures.

Intended Use

In selective areas of 2.5 mm diameter peripheral and coronary vessels, the pSyringe 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 uSyringe Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

1

41,139

510(k) Notification EndoBionics MicroSyringe™ Infusion Catheter February 9, 2004

Technological Characteristics

All materials used in the manyfacture of the uSyringe are suitable for this use and have been used in several previously cleared products.

Testing

The following testing was conducted to ensure the uSyringe met all specifications

Balloon Minimum Burst Strength .
Balloon Compliance (Distensibility) .
Balloon Inflation/Deflation Performance .
Balloon Fatigue .
Bond Strengths .
Catheter Diameter and Balloon Profile .
ア Tip Pull Test
Over-the-Arch Torque Strength Test *
Over-the-Arch Torque Response Test ◆
Balloon Preparation .
Catheter Body Burst Pressure 4
. Biocompatibility Testing
In-vivo Safety .

、

The results of the above tests demonstrated that the device is as safe and effective as the legally marketed predicate devices. All components, subassemblies and/or full devices met the required specifications for the above tests. Additional tests were performed to determine performance of the uSyringe in fluid delivery and integrity of device components.

2

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 18 2004

EndoBionics, Inc. c/o KEMA Quality B.V. Ms. Patricia L. Murphy 4377 County Line Road Chalfont, PA 18914

K040139 Re:

R0-01-9
Trade/Device Name: EndoBionics MicroSyringe (µSyringe) Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: January 20, 2004 Received: January 22, 2004

Dear Ms. Murphy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boodeermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enersburg to regars) the enactment date of the Medical Device Amendments, or to conninered pror to they 2011-11-11 de nees that hat e ocen that do not require approval of a premarket approval application (PMA). and Cosmetic Fee (i're, market the device, subject to the general controls provisions of the Act. The r ou may, morelore, mainer of the Act include requirements for annual registration, listing of general voltarely pro resuring 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 n your device is exaseries (controls. Existing major regulations affecting your device can may be subject to basil as a sublimations, 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 r lease to advisou that I Dr resum that your device complies with other requirements of the Act that I Dr Has made a wond regulations administered by other Federal agencies. You must or any I edetar statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

3

Page 2 - Ms. Patricia L. Murphy

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 premated 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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Dwane R. Vochner

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 EndoBionics MicroSyringe™ Infusion Catheter February 9, 2004

Appendix J Indications for Use Form

Indications for Use

510(k) Number (if known): 1940139

Device Name: EndoBionics MicroSyringe (μSyringe) Infusion Catheter

Indications For Use:

In selective areas of 2.5 mm diameter peripheral and coronary vessels, the uSyringe 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 pSyringe Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

Prescription Use X (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)

Muna R. Vachinel

(Division Sian-Off) Division of Cardiovascular Devices

510(k) Number K 040 | 39

Page 1 of __ 1 __ 1 __

Page 145 of 210