The FlowMedica Benephit® Infusion Systems are intended to facilitate targeted renal therapy, or TRT®, the delivery of physician-specified agents to the kidneys via the renal arteries. The Benephit® Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit® Infusion Systems are also indicated to facilitate TRT® in patients who have demonstrated symptoms of acute kidney injury, and in whom arterial catheterization for TRT® is feasible.

Device Description

The Benephit® family of infusion systems comprises the Benephit® CV, Benephit® PV, Benephit® PVMini, Benephit® PVSolo, and Benephit® XT systems. Each system includes a bifurcated infusion catheter and a vascular introducer sheath with dilator.

Each Benephit® Infusion System consists of a bifurcated infusion catheter and a vascular introducer sheath with dilator. The bifurcated infusion catheter in each of the Benephit® systems is a single-lumen infusion catheter with a bifurcated distal end that allows access to two locations (e.g., two renal arteries) for infusion simultaneously. Each system's introducer sheath is a PTFE-lined, coil reinforced polymer sheath with matching radiopaque dilator.

The Benephit® CV system comprises a 2.4 Fr. bifurcated infusion catheter, utilizing a nitinol hypo tube shaft, and an 8 Fr. compatible introducer sheath with a unique Y-hub design.

AI/ML Overview

The provided text describes a 510(k) submission for the FlowMedica Benephit® Infusion Systems. This submission is for a change in the indications for use of an already cleared medical device, not for a new device requiring extensive performance testing against acceptance criteria in the typical sense of a diagnostic AI algorithm.

Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truthing, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in submissions for AI/ML-powered diagnostic devices, is not present in this document.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for the modified indications for use.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in the traditional sense for this submission. This submission is for a change in Indications for Use for already cleared devices. The acceptance criteria relate to demonstrating substantial equivalence for the modified indications, rather than meeting specific performance metrics for a novel diagnostic.
The document states: "An evaluation of data gained through normal post-production monitoring and from a FlowMedica-sponsored post-market customer preference study provides support for the new indication proposed. These data show that the Benephit devices perform as intended, and are safe and effective for their intended use and for the new label indication as proposed."
No specific quantitative acceptance criteria or corresponding device performance metrics (e.g., sensitivity, specificity, accuracy) are presented because the device is not a diagnostic tool and the submission is not for initial market clearance with novel performance claims.

2. Sample size used for the test set and the data provenance:

Not applicable. No dedicated "test set" for performance evaluation of an AI/ML algorithm is described. The support for the new indication comes from "normal post-production monitoring" and a "FlowMedica-sponsored post-market customer preference study." No specific sample size or data provenance details for these are provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth establishment for a test set is described, as the submission does not involve a diagnostic algorithm requiring such validation.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication method is described.

5. 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:

No. This document does not describe an MRMC study. The device is an infusion system, not an AI-powered diagnostic aide for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a hardware infusion system, not a standalone algorithm.

7. The type of ground truth used:

Not applicable. The submission does not involve a diagnostic algorithm requiring ground truth. The "data" used to support the new indication are related to the device's performance in its existing and proposed intended uses, likely focusing on safety and effectiveness in a clinical context, rather than diagnostic accuracy.

8. The sample size for the training set:

Not applicable. No training set for an AI/ML algorithm is described.

9. How the ground truth for the training set was established:

Not applicable. No training set or ground truth establishment for it is described.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this document):

The "study" or evidence provided to support the new indication and substantial equivalence is described as:

"An evaluation of data gained through normal post-production monitoring"
"from a FlowMedica-sponsored post-market customer preference study"

These evaluations collectively demonstrated that "the Benephit devices perform as intended, and are safe and effective for their intended use and for the new label indication as proposed."

The core argument for acceptance is substantial equivalence to predicate devices (K033569 and K050205) because the proposed change is only in the indications for use, and not in the design, materials, processing, or technological characteristics of the devices themselves. The new indications clarify specific settings for the devices but do not alter their fundamental intended use (targeted renal therapy).

Summary

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510(k) Summary FlowMedica, Inc. Benephit® Infusion Systems

OCT 2 9 2008

510(k) Notification: K_088103

GENERAL INFORMATION

Manufacturer:

FlowMedica, Inc. 46563 Fremont Blvd Fremont, CA 94538 USA (510) 252-9500 Tel: (510) 252-9515 Fax:

Contact Person:

Jeff Elkins President & CEO

Date Prepared:

Monday, July 28, 2008

DEVICE DESCRIPTION

Classification:

Continuous flush catheter, 21 CFR 870.1210, class II

Catheter introducer, 21 CFR 870.1340, class II

Trade Name:

FlowMedica Benephit® CV Infusion System

FlowMedica Benephit® PV Infusion System

FlowMedica Benephit® PVMini Infusion System

FlowMedica Benephit® PVSolo Infusion System

FlowMedica Benephit® XT Infusion System

Generic/common name:

Continuous flush catheter

Catheter introducer

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KC52163 Page 2013

7/28/2008

PREDICATE DEVICES

The FlowMedica Benephit® Infusion Systems, each being a legally marketed device per 21 CFR 807.92(a)(3), serve as their own predicates. Reference original 510(k) submissions K033569 (cleared January 13, 2004) and K050205 (cleared March 4, 2005).

INTENDED USE

PRODUCT DESCRIPTIONS

The Benephit® CV system comprises a 2.4 Fr. bifurcated infusion catheter, utilizing a nitinol hypo tube shaft, and an 8 Fr. compatible introducer sheath with a unique Y-hub design. The Y-hub allows for introduction of the bifurcated infusion catheter and another interventional vascular device (up to 6 Fr. OD) simultaneously. This allows for targeted renal therapy (TRT) to be performed in conjunction with another interventional procedure through a single vascular access.

The Benephit® PV, PVMini, PVSolo, and XT systems comprise a 4.8 Fr. bifurcated catheter utilizing a braid reinforced polymer shaft and a 5 Fr. compatible introducer sheath with a standard single hemostasis valve configuration. These systems provide a smaller vascular access to allow stand-alone TRT procedures or TRT in conjunction with non-interventional procedures (e.g., open surgery), or they may be used in conjunction with other interventional procedures via separate vascular access. In the case of the PVSolo uniquely, only a single infusion branch is active for infusion, allowing for TRT to a single renal artery when this is desired.

SUBSTANTIAL EQUIVALENCE

The Benephit® systems covered in this submission are identical in design, materials, processing, and technological characteristics as their predicate devices, and as such are substantially equivalent in those regards. The proposed change in this submission is in the indications for use only. The change in label indications reflects specific settings for

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K082103 Puyi 303

7/28/2008

the devices but does not alter their intended use, which is to provide targeted renal therapy, or TRT®. Because the intended use of the devices is not being changed, they are deemed substantially equivalent to their predicate devices.

SUPPORT FOR NEW INDICATION & SUBSTANTIAL EQUIVALENCE

An evaluation of data gained through normal post-production monitoring and from a FlowMedica-sponsored post-market customer preference study provides support for the new indication proposed. These data show that the Benephit devices perform as intended, and are safe and effective for their intended use and for the new label indication as proposed. Thus the Benephit devices with the proposed label indication change are substantially equivalent to the predicate devices.

SUMMARY

The Benephit® CV, PV, PVMini, PVSolo, and XT Infusion Systems with modified indications for use as proposed here are substantially equivalent to their predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2008

FlowMedica, Inc. c/o Mr. Jeff Elkins President & CEO 46563 Fremont Blvd. Fremont, CA 94538

Re: K082163

FlowMedica Benephit® CV Infusion System, FlowMedica Benephit® PV Infusion System, FlowMedica Benephit® PVMini Infusion System, FlowMedica Benephit® PVSolo Infusion System, FlowMedica Benephit® XT Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA; DYB Dated: July 28, 2008 Received: July 31, 2008

Dear Mr. Elkins:

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.

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, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Jeff Elkins

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) promarket 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, plcase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

$\rho$

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FlowMedica, Inc., 510(k) Submission

7/28/2008

CONFIDENTIAL

FlowMedica, Inc. 46563 Fremont Blvd. Fremont, CA 94538

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):	K082163
Device Name	FlowMedica Benephit ® CV Infusion System
	FlowMedica Benephit ® PV Infusion System
	FlowMedica Benephit ® PVMini Infusion System
	FlowMedica Benephit ® PVSolo Infusion System
	FlowMedica Benephit ® XT Infusion System
Indications for Use:	The FlowMedica Benephit® Infusion Systems are intended to facilitate targeted renal therapy, or TRT®, the delivery of physician-specified agents to the kidneys via the renal arteries. The Benephit® Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit® Infusion Systems are also indicated to facilitate TRT® in patients who have demonstrated symptoms of acute kidney injury, and in whom arterial catheterization for TRT® is feasible.
Prescription Use	X
	or
	Over-the-counter Use

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:	K082163
----------------	---------

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).