KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES

K041151 · Kerberos Proximal Solutions, Inc. · DQY · Jul 22, 2004 · Cardiovascular

Device Facts

• Record ID: K041151
• Device Name: KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES
• Applicant: Kerberos Proximal Solutions, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Kerberos Proximal Solutions Occluding Guide Catheter and Accessories are intended to facilitate the use and guidance of intravascular catheters into selected blood vessels in the peripheral, cardiovascular and neurovascular systems. The balloon provides temporary vascular occlusion during these percutaneous procedures.

Device Story

Sterile, single-use percutaneous catheter; dual-lumen variable stiffness braided shaft; flush-mounted distal balloon. Operated by physicians in clinical settings (cardiovascular/neurovascular/peripheral). Guidance achieved via manual torque and guidewire tracking. Balloon provides temporary vascular occlusion to assist interventional procedures. Output is physical vessel access and flow control; enables physician to deliver therapeutic devices. Benefits include improved catheter navigation and localized flow management during minimally invasive interventions.

Clinical Evidence

Bench testing only. Evaluation included in vitro dimensional analysis, balloon performance, torque and kink resistance, leakage, bond strengths, and biocompatibility testing per FDA guidance for interventional cardiology devices. No clinical data presented.

Technological Characteristics

Dual-lumen variable stiffness braided shaft catheter; distal flush-mounted balloon. Mechanical device; no energy source or software. Biocompatible materials. Sterilized for single use.

Indications for Use

Indicated for patients requiring intravascular catheter guidance and temporary vascular occlusion during percutaneous procedures in peripheral, cardiovascular, and neurovascular systems.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Balloon Guide Catheter (K021899)
• LDOB Occlusion Balloon Catheter (K002286)
• 6F RunWay Guide Catheter (K033441)
• Commodore Temporary Occlusion Balloon Catheter (K984214)
• Vueport Balloon OGC (K973298)

Submission Summary (Full Text)

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#### 3. 510(k) SUMMARY

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

| 510(k) Number: | TBD K041151 |
|----------------|-------------|
|----------------|-------------|

#### Applicant Information:

| Date Prepared: | April 28, 2004 |
|-------------------|------------------------------------------------------------------------------|
| Name: | Kerberos Proximal Solutions, Inc. |
| Address: | 1400 Terra Bella, Suite E<br>Mountain View, CA 94043<br>650-254-1005 Ext 313 |
| Contact Person: | Michael A. Daniel |
| Phone Number: | Office: 925-254-5228 / Cell 415-407-0223 |
| Facsimile Number: | 925-254-5187 |

#### Device Information:

| Classification: | Class II Percutaneous Catheter / Vascular Clamp |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Kerberos Occluding Guide Catheter and Accessories |
| Common Name: | Percutaneous Catheter / Temporary Intravascular Occluding Catheter |
| Classification Name: | Catheter, Percutaneous 74 DQY /21 CFR 870.1250<br>Catheter, Intravascular Occluding, Temporary 74 MJN /21 CFR 870.4450 |

#### Predicate Devices:

The Kerberos Proximal Solutions Occluding Guide Catheter (OGC) and Accessories is substantially equivalent in intended use and method of operation to a combination of the following predicate devices:

- 1) K021899 -- Concentric Medical, Inc.; Balloon Guide Catheter
- 2) K002286 Cook Inc.; LDOB Occlusion Balloon Catheter
- 3) K033441 Boston Scientific Corporation; 6F RunWay Guide Catheter
- 4) K984214 Cordis; Commodore Temporary Occlusion Balloon Catheter
- 5) K973298 Cardima; Vueport Balloon OGC

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#### Device Description:

The Kerberos Proximal Solutions Occluding Guide Catheter (OGC) is a sterile single-use percutaneous catheter consisting of a dual lumen variable stiffness braided shaft catheter incorporating a flush mounted balloon at the distal tip. Guidance and tracking of the catheter through the coronary, neuro or peripheral vasculature is accomplished by torquing of the catheter and/or the use of a guide wire.

### Intended Use:

The Kerberos Proximal Solutions Occluding Guide Catheter and Accessories are intended to facilitate the use and guidance of intravascular catheters into selected blood vessels in the peripheral, cardiovascular and neurovascular systems. The balloon provides temporary vascular occlusion during these percutaneous procedures.

### Comparison to Predicate Device(s):

The Kerberos Proximal Solutions Occluding Guide Catheter and Accessories are substantially equivalent to a combination of the following devices in terms of indications for use, embodiment, shape, appearance and function:

- 1) K021899 Concentric Medical, Inc.; Balloon Guide Catheter
- 2) K002286 Cook Inc.; LDOB Occlusion Balloon Catheter
- 3) K033441 Boston Scientific Corporation; 6F RunWay Guide Catheter
- 4) K984214 Cordis; Commodore Temporary Occlusion Balloon Catheter
- 5) K973298 Cardima; Vueport Balloon OGC

## In Vitro, In Situ and In Vivo Test Data:

Design analysis, in vitro and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate device cited. Routine device evaluation consists of testing specified in FDA's "Draft Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Laser, Intravascular Stents" and included in vitro dimensional analysis, balloon performance, torque and kink resistance, leakage, bond strengths and biocompatibility tests. All data fell well within internal specification requirements, as well as external standard requirements and predicate performance expectations.

#### Summary:

Based upon the product technical information, intended use, performance, sterilization and biocompatibility information provided in this pre-market notification, the Kerberos Proximal Solutions Occluding Guide Catheter has been shown to be substantially equivalent to currently marketed predicate devices.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines representing movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 2004

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

Re: K041151

Kerberos Occluding Guide Catheter and Accessories Regulation Number: 21 CFR 870.1250 Regulation Name: Occluding Guide Catheter Regulatory Class: Class II Product Code: DQY Dated: April 28, 2004 Received: May 3, 2004

Dear Mr. Mason:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of 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). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains of the Act include requirements for annual registration, listing of genom controls provisions 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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease be advised that I Dr over device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must of ally it call 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 CITY art 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quanty bybeline (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro no begin marketing your device as described in your Section 510(k) I mis icter will anow yourse ough anding of substantial equivalence of your device to a legally premarket noticate 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 If you desire spoceine at [phone]. Also, please note the regulation entitled, Connact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

(901) 445 097 6ra . qov/cdrh/dsma/dsmamain.html

Sincerely yours,

uma R. Vochner

Image /page/3/Picture/5 description: The image shows a handwritten signature. The signature appears to be cursive and is written in black ink. The signature is illegible, but it appears to have a loop on the left side and a downward stroke on the right side.

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):_TBB KO 4 IIIS \

Device Name:_Kerberos Proximal Solutions Occluding Guide Catheter and Accessories

Indications For Use:

The Kerberos Proximal Solutions Occluding Guide Catheter (OCG) and Accessories are intended to facilitate the use and guidance of intravascular catheters into selected blood vessels in the peripheral, cardiovascular and neurovascular systems. The balloon provides temporary vascular occlusion during these percutaneous procedures.

Prescription Use X (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)

Duma R. Ve lines
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number

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