RINSPIRATION SYSTEM

K041291 · Kerberos Proximal Solutions, Inc. · DQO · May 21, 2004 · Cardiovascular

Device Facts

• Record ID: K041291
• Device Name: RINSPIRATION SYSTEM
• Applicant: Kerberos Proximal Solutions, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: May 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.

Device Story

KPS Rinspiration™ System consists of multi-lumen catheter and hand-activated mechanical Rinspirator™ unit. Catheter features distal perforations for fluid infusion; placed in peripheral vasculature over guide wire. Rinspirator™ connects to catheter hub; activates two syringes to perform simultaneous irrigation and aspiration of treatment site. Used in clinical setting by healthcare professionals. Output is mechanical fluid exchange at treatment site; facilitates localized infusion and aspiration. Benefits include targeted treatment of peripheral vasculature.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1.

Technological Characteristics

Multi-lumen catheter with distal perforations; hand-activated mechanical syringe-based pump. Biocompatible materials per ISO 10993-1. No electronic components, software, or external energy sources.

Indications for Use

Indicated for infusion and aspiration in the peripheral vasculature. No specific patient population, age, or contraindications provided.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Rinspiration System (K031485)

Submission Summary (Full Text)

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# MAY 2 1 2004

## 8.0 APPENDIX A: 510(K) SUMMARY

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: May 13, 2004

| 510(k) number: | k04129 |
|----------------|--------|
|----------------|--------|

## Applicant Information:

Kerberos Proximal Solutions, Inc. 1400 Terra Bella Ave Suite K Mountain View, CA 94043

| Contact Person: | Tom Mason, VP, Regulatory Affairs and Quality Assurance |
|-----------------|---------------------------------------------------------|
| Phone Number: | [phone] |
| FAX Number: | [phone] |

#### Device Information:

Classification: Class II Trade Name: KPS Rinspiration™ System Classification Name: Catheters, Intravascular, Diagnostic (21 CFR 870.1200)

#### Cleared Device:

The subject device is identical in intended use and method of operation to the currently cleared Rinspiration System (K031485).

#### Intended Use:

The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.

## Device Description:

The system consists of a Rinspiration™ Catheter and a KPS Rinspirator™ with accessories. The KPS Rinspiration™ Catheter is a multi-lumen catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration™ Catheter will be placed in the peripheral vasculature of a patient over a quide wire. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ with accessories is a hand activated mechanical device that connects to the hub of the catheter. It allows for simultaneous irrigation and aspiration of the treatment site. The device activates two syringes for infusion and aspiration. This action is known as "Rinspiration™ ,"

#### Verification Test Results:

Results of bench testing demonstrate that the KPS Rinspiration™ System is safe and effective for its intended use.

#### Biocompatibility:

The materials used in the KPS Rinspiration™ System have been shown to be biocompatible when tested in accordance with ISO 10993-1 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing requirements.

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# Summary:

Based on the intended use, product performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to currently marketed Rinspiration System.

、

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2004

Kerberos Proximal Solutions c/o Mr. Tom Mason 1400 Terra Bella, Suite K Mountain View, CA 94043

Re: K041291 KPS Rinspiration™ System Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter. Intravascular, Diagnostic Regulatory Class: Class II (two) Product Code: DQO Dated: May 13, 2004 Received: May 14, 2004

Dear Mr. Mason:

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 Codc 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. Tom Mason

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase oc advised that I Dri 3 ibsudice Cr our device complies with other requirements of the Act that 1DA has made a acterimations administered by other Federal agencies. You must or any I coccar statutes and regerients, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CIN Fart 607), labeling (21 CFR Part 820), good if applicable, the electronic form in the quality by events (Sections 531-542 of the Act); 21 CFR 1000-1050. product familion only of provisions (2006) every of the end in your Section 510(k) I this letter writi anow you to organ maine of substantial equivalence of your device to a legally prematics notification. The promotion 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 [phone]. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

Dona R. lochner

(J.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

K041291 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:_ KPS Rinspiration™ System

Indications For Use:

The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral 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)

D'Nura R. kline 1
Division Sign-Off

sion of Cardiovascular Devices

012:01 number K041291