RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703

K041123 · Kerberos Proximal Solutions, Inc. · DQO · Aug 26, 2004 · Cardiovascular

Device Facts

• Record ID: K041123
• Device Name: RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
• Applicant: Kerberos Proximal Solutions, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Aug 26, 2004
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kerberos Proximal Solutions Rinspiration System is intended to infuse and aspirate physician specified fluid in the coronary and peripheral vasculature.

Device Story

The Rinspiration System is a mechanical, hand-activated device used in coronary and peripheral vasculature. It consists of a multi-lumen catheter with distal perforations and a Rinspirator unit. The catheter is placed over a guidewire; it features radiopaque markers for positioning. The Rinspirator connects to two syringes, enabling simultaneous infusion and aspiration of fluids at the treatment site. Operated by a physician, the device allows for localized fluid delivery and removal. It is a sterile, single-use device. The system is not indicated for thrombectomy or embolic protection; use for these purposes is contraindicated due to risks of death or permanent impairment.

Clinical Evidence

Bench testing only. Functional testing performed per ISO 10555 (Sterile, Single Use Intravascular Catheters). Biocompatibility testing performed per ISO 10993-1. Sterilization validation performed per ISO 11135 to ensure a sterility assurance level (SAL) of 10^-6.

Technological Characteristics

Multi-lumen catheter with distal perforations and radiopaque marker bands. Hand-activated mechanical Rinspirator unit for simultaneous dual-syringe infusion/aspiration. Sterile, single-use. Sterilization via Ethylene Oxide (ISO 11135). Complies with ISO 10555 for intravascular catheters and ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for infusion and aspiration of physician-specified fluids within the coronary and peripheral vasculature. For prescription use only.

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

• Kerberos Proximal Solutions Rinspiration System (Peripheral) (K031485)
• Cordis Neurovascular, Inc., PROWLER® SELECT 10 and 14 Infusion Catheters (K020680)
• Precision Vascular, PVS 1700 Steerable Delivery System®-10 (K032494)
• Micro Therapeutics, Inc., TruLine™ Reinforced Valved Infusion Catheter (K021139)
• eMed Corp., Microfuse Membrane Infusion Catheter (K971619)
• Vascular Solutions, Inc., PRONTO Extraction Catheter (K032763)
• Lucas Medical, Inc., LMI Irrigation Catheter (K972623)
• Atrium Medical Corporation, Atrium Clearway PTFE Balloon Cathefer (K020634)

Submission Summary (Full Text)

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#### SECTION 8

# K041123

## AUG 2 6 2004

## 510(k) Summary of Safety and Effectiveness

This 510(k) summary for the KPS Rinspiration System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## Applicant Information

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

| Contact Person: | Tom Mason |
|-----------------|----------------|
| Phone Number: | [phone] |
| FAX Number: | [phone] |

## Device Information

Classification: Class II KPS Rinspiration™ System Trade Name: Generic/Common Name: Catheter, Intravascular, Diagnostic (21 CFR 870.1200)

## Predicate Devices

The subject device is substantially equivalent in intended use and/or method of operation to the following cleared devices.

- Kerberos Proximal Solutions Rinspiration System (Peripheral) K031485 (1)
- Cordis Neurovascular, Inc., PROWLER® SELECT 10 and 14 Infusion Catheters (2) K020680
- Precision Vascular, PVS 1700 Steerable Delivery System®-10 K032494 (3)
- Micro Therapeutics, Inc., TruLine™ Reinforced Valved Infusion Catheter K021139 (4)
- eMed Corp., Microfuse Membrane Infusion Catheter K971619 (5)
- Vascular Solutions, Inc., PRONTO Extraction Catheter K032763 (6)
- Lucas Medical, Inc., LMI Irrigation Catheter K972623 (7)
- Atrium Medical Corporation, Atrium Clearway PTFE Balloon Cathefer K020634 (8)

## Intended Use

The Kerberos Proximal Solutions Rinspiration System is intended to infuse and aspirate physician specified fluid in the coronary and peripheral vasculature.

## Device Description

The system consists of a Rinspiration™ Catheter, and a Rinspirator™ with accessories, The Rinspiration Catheter is a multi-lumen, rail configuration 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 vasculature of a patient over a quide wire. The Rinspiration Catheter is offered with a standard tip and a short tip. The catheter includes a radiopaque marker band at the distal tip and two radiopaque marker bands designating the infusion portion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The Rinspirator and accessories is a sterile, single-use mechanical device. This hand activated device allows for simultaneous infusion and aspiration of fluids at the treatment site. The device activates two syringes, one for infusion and one for aspiration. This simultaneous infusion and aspiration action is known as "Rinspiration."

Kerberos Proximal Solutions

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## Substantial Equivalence

The KPS Rinspiration System is substantially equivalent to the predicate devices with regard to intended use, function, materials, and sterilization method.

All necessary testing was performed on the KPS Rinspiration System to ensure the product is substantially equivalent to the predicate devices and to ensure that the KPS Rinspiration System does not have any differences that have a significant effect on safety or effectiveness.

## Functional Test Results

Functional testing was conducted on the KPS Rinspiration System to ensure that the product will function according to its Instructions for Use. This functional testing was performed per KPS protocol and referenced International Standard ISO 10555, Sterile, Single Use Intravascular Catheters - Part 1. All testing conducted confirmed the acceptability of the KPS Rinspiration System to perform as intended.

## Biocompatibility and Sterility

Biocompatibility testing was conducted on the KPS Rinspiration System materials to ensure acceptability when used as directed. The KPS Rinspiration System materials passed the necessary biocompatibility tests, complying with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing requirements.

Sterilization Validation was conducted according to ISO 11135. Industrial Ethylene Oxide Sterilization. Validation and Routine Control, on the KPS Rinspiration System to assure a sterility assurance level (SAL) of 106.

### Summarv

Based on the intended use, product performance and biocompatibility information provided in this notification, the subject device is safe and effective when used in accordance with its Instructions for Use and has been shown to be substantially equivalent to currently marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle or bird, with three curved lines representing its wings or feathers. The logo is black and white.

Public Health Service

AUG 2 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kerberos Proximal Solutions Mr. Tom Mason Vice President, Regulatory Affairs and Quality Assurance 1400 Terra Bella, Suite K Mountain View, CA 94043

Re: K041123 Trade/Device Name: Catheter, Intravascular, Diagnostic Regulation Number: 870.1200 Regulation Name: Kerberos Proximal Solutions Rinspiration System Regulatory Class: II Product Code: DQO Dated: July 28, 2004 Received: July 29, 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

In bold and first to appear in the Warnings section:

#### WARNINGS:

The safety and effectiveness of the Kerberos Proximal Solutions Rinspiration System have NOT been established for use as thrombectomy or embolic protection. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention.

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Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Sincerely yours,

Donna Rea Tillman, Ph.D.

lman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K041123

Device Name: Kerberos Proximal Solutions Rinspiration System

.

Indications for Use:

The Kerberos Proximal Solutions Rinspiration System is intended to infuse and aspirate physician specified fluid in the coronary and peripheral vasculature.

× Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (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)

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen

Donny R. Vochner

(Division Sian-C Division of Cardiovascular Devices

510(k) Number k 041123

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