ISOFLOW INFUSION CATHETER by VASCULAR DESIGNS INC.

The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region.

The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.

Device Description

The 2.4F IsoFlow™ Infusion Catheter System is intended to be used with guide catheters 4F (0.050") and larger, along with a 0.010" guide wire for positioning the catheter in the desired region. A standard Y-adaptor RHV provides for guide wire entry and saline flush into the main guide wire / bypass lumen of the catheter. Radiopaque markers at the distal tip and between the two balloons allow for final position adjustment under fluoroscopy guidance.

The two compliant balloons are inflated simultaneously using radiopaque fluid delivered via a single inflation lumen.

Physician specified infusion fluid through either the labeled infusion lumen or the labeled guidewire lumen is delivered via the 1-way stopcock connection. The mixture of infusion and radiopaque agents is delivered directly to the target region between the balloons, or out the distal tip respectively.

For infusion out of the sideport holes, retracting the guide wire to the radiopaque marker band proximal to both balloons allows blood to bypass the isolated tarqet region via holes connecting the guide wire / bypass lumen with the catheter exterior. Complete removal of the guidewire allows delivery from the distal tip.

All components of the catheter system are provided sterile. Each device is intended for single use. Do not reuse or attempt to resterilize any component of the system.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria, device performance,
or a study comparing the device against specific criteria in the way typically found for AI/ML-based
medical devices. The document is a 510(k) summary for a physical medical device—the IsoFlow™
Infusion Catheter—seeking substantial equivalence to predicate devices.

Therefore, many of the requested categories (such as sample size for test set, number of experts,
adjudication method, MRMC study, standalone performance, training set details) are not applicable
to this type of submission and are not present in the provided text.

However, I can extract the information that is present concerning the device's characteristics and its
comparison to predicate devices, which forms the basis for its acceptance (i.e., substantial
equivalence) by the FDA.

Here's a summary based on the provided text, addressing the applicable points:

1. A table of acceptance criteria and the reported device performance

For a traditional medical device like the IsoFlow™ Infusion Catheter, "acceptance criteria" are
typically demonstrated through substantial equivalence to legally marketed predicate devices, along
with adherence to performance standards and safety testing (which are summarized, but not detailed
in a quantitative study in this specific 510(k) summary). The performance is shown by demonstrating
that the device's characteristics are "Substantially Equivalent" to the predicates.

Category	Acceptance Criteria (Demonstrated by Substantial Equivalence to Predicate Devices)	Reported Device Performance (IsoFlow™ Infusion Catheter)
Intended Use	Substantially Equivalent to predicate devices (K932616, K913517)	Substantially Equivalent
Physical Description	Substantially Equivalent to predicate devices (K932616, K913517)	Substantially Equivalent
Anatomical Sites	Substantially Equivalent to predicate devices (K932616, K913517)	Substantially Equivalent
Design	Substantially Equivalent to predicate devices (K932616, K913517)	Substantially Equivalent
Materials	Substantially Equivalent to predicate devices (K932616, K913517)	Substantially Equivalent
Primary Indication	Isolate a specific treatment region from blood flow while allowing infusion/perfusion.	Functionally meets this indication as stated.
Secondary Indication	Deliver physician specified fluids out the distal tip with or without inflation.	Functionally meets this indication as stated.

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

Not applicable. The document describes a 510(k) submission for a physical medical device (infusion
catheter), not an AI/ML device relying on a test set of data. The "study" here is the comparison of
the device's characteristics to predicate devices.

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

Not applicable. This information is typically relevant for AI/ML device evaluations. For this traditional
medical device, "ground truth" mainly refers to the functional and material specifications meeting
established medical device standards and being comparable to legally marketed devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not relevant for the type of device and submission 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

Not applicable. This type of study is for AI/ML-assisted diagnostic or therapeutic devices, not for
a physical infusion catheter.

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

Not applicable. This is for AI/ML devices. The IsoFlow™ Infusion Catheter is a physical device
used by a physician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of an AI/ML device. For this physical catheter, the "ground truth" for
its acceptance is established through:

Engineering design specifications and material science: Ensuring the catheter is constructed
from biocompatible materials and designed to safely perform its intended functions.
Comparison to predicate devices: Demonstration of substantial equivalence in intended use,
technological characteristics (physical description, anatomical sites, design, materials), and
performance. This implies that the predicate devices themselves have a history of safe and
effective use.
Performance testing: While not detailed in this summary, a 510(k) submission typically
includes bench testing (e.g., burst pressure, tensile strength, flow rates, balloon integrity),
biocompatibility testing, and sterilization validation to ensure safety and performance.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train for this device.

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

Not applicable. There is no AI/ML model to train for this device.

Summary

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5. 510(k) Summary

VascularDesigns™

MAY 2 9 2009

Kosjitt

Submitter's name: Address:

Vascular Designs Inc 5655 Silver Creek Valley Road #512 San Jose, CA 95138

Phone: Fax number: 408-230-5560 408-416-4116

Name of contact person:

Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821 Email: grace@regulatoryspecialists.com

Date the summary was prepared: April 16, 2008

Name of the device:	IsoFlow
Trade or proprietary name:	IsoFlow
Common or usual name:	Infusion catheter
Classification name:	Catheter, percutaneousContinuous flush catheter
CFR Classification Reference	870.1250870.1210
Class	Class II (two)
Product Code	DQYKRA

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

Predicate Device Name	Submitted By	510kReference #
DISPATCH™ Coronary InfusionCatheter	SCIMED	K932616
ISOLATE™ Infusion Catheter System	Lake Region Mfg. Co.Inc.	K913517

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Description of the device:

The two compliant balloons are inflated simultaneously using radiopaque fluid delivered via a single inflation lumen.

All components of the catheter system are provided sterile. Each device is intended for single use. Do not reuse or attempt to resterilize any component of the system.

Indications:

The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.

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Summary of characteristics of our device compared to the predicate device:

ISO Flow Catheter versus predicate devices
	DISPATCH™ CoronaryInfusion Catheter	ISOLATE™ InfusionCatheter System
Parameter	K932616	K913517
Intended Use	Substantially Equivalent	Substantially Equivalent
Physical Description	Substantially Equivalent	Substantially Equivalent
Anatomical Sites	Substantially Equivalent	Substantially Equivalent
Design	Substantially Equivalent	Substantially Equivalent
Materials	Substantially Equivalent	Substantially Equivalent

IsoFlow Catheter versus 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Designs C/O Regulatory Specialists, Inc. Ms. Grace Holland Regulatory Consultant 3722 Ave: Sausalito Irvine, CA 92606

MAY 2 9 2009

Re: K081147

Trade/Device Name: IsoFlow Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, DQY Dated: May 4, 2009 Received: May 6, 2009

Dear Ms. Holland:

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 intestate 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, IDA 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 nf 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

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please 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 Biometric's (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 yours,

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

Enclosure

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4. Indications for Use Statement Indications for Use

510(k) Number (if known): Koogli47

Device Name: IsoFlow

Indications for Use:

The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ==============================================================================================================================================================================

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-C Dill rdiovascular Devices

Page 1 of 1

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).