The FlowMedica Bifurcated Infusion System consists of the Bifurcated Infusion Catheter and the Introducer Sheath. It is intended for single-use only and is sterilized using ethylene oxide gas.

The Bifurcated Infusion Catheter functions by selectively delivering physician-specified agents directly to the peripheral vasculature. The Bifurcated Infusion Catheter contains a 77cm working length shaft/infusion lumen. It is bifurcated at the distal end, which is comprised of two identical metal-supported and braided polymer branches.

The Introducer Sheath provides for the introduction of two interventional devices through a single vessel access site, allowing for the introduction of the Bifurcated Infusion Catheter and the introduction of a standard coronary guiding or diagnostic catheter as may be required for a catheterization procedure. The Introducer Sheath, available in four lengths, is a polymer and metal coil reinforced sheath with two insertion ports in its integral Y hub assembly. The ports contain a hemostasis valve, designed for a 6Fr diagnostic or guiding catheter, and Touhy Borst valve used for the Bifurcated Infusion Catheter. A vessel diffator is supplied with the Introducer Sheath.

The FlowMedica Bifurcated Infusion Catheter is designed for use only with the FlowMedica Introducer Sheath. Each component is packaged separately and may be ordered and shipped separately; however, the Instructions for Use included with the Bifurcated Infusion Catheter specify exclusive usage with the FlowMedica Introducer Sheath.

AI/ML Overview

The provided document is a 510(k) summary for the FlowMedica Bifurcated Infusion System and its associated FDA clearance letter. It describes the device, its intended use, predicate devices, and testing conducted to support substantial equivalence.

However, the document does not contain information related to acceptance criteria, specific device performance metrics, or details of a clinical study with human subjects that would typically involve a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance.

The "Testing in Support of Substantial Equivalence Determination" section only lists categories of testing:

Design Verification Testing
Biocompatibility Testing
Animal Testing
Predicate Device Comparative Testing

It explicitly states: "Comparative bench testing demonstrates that the performance and safety of the FlowMedica Bifurcated Infusion Catheter is equivalent to that of the predicate devices." This indicates that the primary evidence for substantial equivalence came from bench (laboratory) and animal testing, not a clinical study involving a test set of human cases with expert-established ground truth.

Therefore, I cannot provide the requested information from the provided text. The device in question is a medical device (catheter and introducer sheath), and its clearance was based on substantial equivalence to existing predicate devices, supported by non-clinical testing.

The following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: No such table is present. The document generally states equivalence based on bench and animal testing.
Sample size used for the test set and the data provenance: No clinical test set involving human data is described. Animal testing is mentioned, but details on sample size or data provenance for that are not provided beyond the category.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with expert-established ground truth is described.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical device, not an AI or image-based diagnostic tool that would typically involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: For the non-clinical testing (bench, animal), the "ground truth" would be established by direct measurement of device properties or observed physiological effects in animals, compared against predicate device performance. No human clinical ground truth (e.g., pathology, outcomes data) is mentioned for a test set.
The sample size for the training set: Not applicable; this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary

FlowMedica, Inc.

Bifurcated Infusion System

510(k) Notification K_033569 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

GENERAL INFORMATION

Manufacturer:

FlowMedica, Inc.
46563 Fremont Boulevard	P: (510) 252-9500
Fremont, CA 94538	F: (510) 252-9515

Contact Person:

Jeff Elkins Vice President of R&D and COO

Date Prepared:

November 07, 2003

DEVICE DESCRIPTION

The FlowMedica Bifurcated Infusion System consists of the FlowMedica Bifurcated Infusion Catheter and the FlowMedica Introducer Sheath.

Classification:

Continuous Flush Catheter, 21 CFR Sec. 870.1210, Class II

Introducer, Catheter, 21 CFR Sec. 870.1340, Class II

Trade Name:

FlowMedica Bifurcated Infusion System:

FlowMedica Bifurcated Infusion Catheter

FlowMedica Introducer Sheath

Generic/Common Name:

Continuous Flush Catheter

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Introducer, Catheter

PREDICATE DEVICES

FlowMedica Bifurcated Infusion Catheter:

Boston Scientific Mewissen™ Catheter (K904788) Interventional Innovations Flower™ Infusion Catheter (K955525) EKOS Peripheral Infusion System (K030637) Boston Scientific Katzen™ Thrombolysis Wire (K883880) Boston Scientific Cragg FX™ Wire (K897152).

FlowMedica Introducer Sheath:

Cook Check-Flo® Performer® Introducer (unable to determine 510[k] reference) Cook Shuttle® SL Flexor® Tuohy-Borst Side Arm Introducer Set (unable to determine 510[k] reference)

Super Arrow-Flex® Percutaneous Sheath Introducer Set (K924607, K970229) Terumo Pinnacle™ Destination™ Renal Guiding Sheath (K012854)

INTENDED USE

The FlowMedica Bifurcated Infusion System is intended for the infusion of physicianspecified agents in the peripheral vasculature including but not limited to the renal arteries.

The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

PRODUCT DESCRIPTION

The FlowMedica Bifurcated Infusion System consists of the Bifurcated Infusion Catheter and the Introducer Sheath. It is intended for single-use only and is sterilized using ethylene oxide gas.

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SUBSTANTIAL EQUIVALENCE

The FlowMedica, Inc. Bifurcated Infusion System consists of the Bifurcated Infusion Catheter and the Introducer Sheath.

The FlowMedica Bifurcated Infusion Catheter has substantially equivalent indications for use, and/or technological characteristics as the Boston Scientific Mewissen™ Catheter (K904788), the Interventional Innovations Flower™ Infusion Catheter (K955525), the EKOS Peripheral Infusion System (K030637), the Boston Scientific Katzen™ Thrombolysis Wire (K883880), and the Boston Scientific Cragg FX™ Wire (K897152). Any differences in the technological characteristics do not raise any new issues of safety or efficacy. Comparative bench testing demonstrates that the performance and safety of the FlowMedica Bifurcated Infusion Catheter is equivalent to that of the predicate devices. Thus, it is substantially equivalent to the predicate devices.

The FlowMedica Introducer Sheath has substantially equivalent indications for use and and/or technological characteristics as the Cook Check-Flo® Performer® Introducer (unable to determine 510[k] reference), the Cook Shuttle® SL Flexor® Tuohy-Borst Side Arm Introducer Set (unable to determine 510[k] reference), the Super Arrow-Flex® Percutaneous Sheath Introducer Set (K924607 and K970229), and the Terumo Pinnacle™ Destination™ Renal Guiding Sheath (K012854). Any differences in the technological characteristics do not raise any new issues of safety or efficacy. Comparative bench testing demonstrates that the performance and safety of the FlowMedica Introducer Sheath is equivalent to that of the predicate devices. Thus, it is substantially equivalent to the predicate devices.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

The following testing has been conducted. The results of the testing demonstrate that the FlowMedica, Inc. Bifurcated Infusion System performs as designed, is suitable for its intended use, and that it is substantially equivalent to the predicate devices:

. Design Verification Testing
. Biocompatibility Testing
Animal Testing
Predicate Device Comparative Testing .

SUMMARY

The FlowMedica Bifurcated Infusion Catheter and the FlowMedica Introducer Sheath (the Bifurcated Infusion System) are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN 1 3 2004

FlowMedica, Inc. c/o Mr. Jeff Elkins Vice President R&D and COO 46563 Fremont Boulevard Fremont, CA 94538

Re: K033569

K033569
Trade/Device Name: FlowMedica Bifurcated Infusion System
Trade/Device Name: Flow Medica 1850, 21 CED 870, 1340 Trade/Device Name: 116w.hours: 21 CFR 870.1250; 21 CFR 870.1340 Regulation Numbers. 21 CFR 8707259, 2017
Regulation Names: Continuous Flush Catheter; Catheter Introducer Regulatory Class: Class II Product Codes: KRA; DYB Dated: November 11, 2003 Received: November 12, 2003

Dear Mr. Elkins:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) premaise is substantially equivalent (for the indications
referenced above and have determined the device is substantierted in interstat referenced above and have delemined the devices marketed in interstate for use stated in the enclosure) to the enatment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the provision of the Federal Fo commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance was archarded application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require apptoval or a pel. controls provisions of the Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject or the gential vannual registration, listing of
general controls provisions of the Act include requirements for amount misbrand general controls provisions of the Act Include requirements of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mio crime on regulations affecting your device can
may be subject to such additional controls. Existing major regulations alle addit may be subject to such additions: Entrois: Existing includes In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addition, be found in the Code of Pederal Regalations, our device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualited of a substitution with other requirements of the Act
that FDA has made a determination that your device also also as a concies. You m that FDA has made a determination that your are root by other Federal agencies. You must or any Federal statutes and regulations and mits of on timited to: registration and listing (21
comply with all the Act's requirements, including, but not one seguirements as comply with all the Act s requirements, meridanty, careforming practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirement

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Page 2 - Mr. Jeff Elkins

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 100-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1 product radiation control provisions (Declons over device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your This letter will anow you to oegin manoling of substantial equivalence of your deversite way day premarket notheation. The PDA mining of casification 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 If you desire specific advice for your ac not 60 % 0.0 % 0.0 % as note the regulation entitled, contact the Office of Comphalled as (Set notification" (21CFR Part 807.97). You may obtain " Misoranding by reference to premantonities under the Act from the Division of Small
on 1900 of Shall information on your responsibilities under the Act from the 1900 Call o other general information on your responsibility and 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,

Ashley B Braun

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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Indications for Use

510(k) Number (if known): K033569

Device Name: FlowMedica Bifurcated Infusion System

Indications For Use: Infusion of physician-specified agents in the peripheral vasculature including but not limited to the renal arteries.

The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

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)

Adeline B. Brown

Page 1 of

(Division Sign Division of Cardiovascular D

510(K) Number

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).