CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508

K042381 · Acumen Medical, Inc. · DQY · Dec 28, 2004 · Cardiovascular

Device Facts

• Record ID: K042381
• Device Name: CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
• Applicant: Acumen Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Acumen Coronary Sinus Visualization System is intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

Device Story

Steerable angioscopic catheter with distal silicone balloon; used to displace blood for visualization and provide temporary occlusion during venograms. Includes integrated light source and camera providing NTSC video output. Used in clinical settings by physicians to navigate coronary sinus and coronary vasculature. Provides pathway for delivery of transvenous devices. Output viewed by clinician to guide procedures; aids in visualization of cardiac anatomy; facilitates device placement.

Clinical Evidence

In-vitro and in-vivo testing performed; all components and subassemblies met required specifications. No clinical trial data provided.

Technological Characteristics

Steerable angioscopic catheter; silicone balloon; integrated light source; CCD solid state video camera; NTSC video output. Materials are biocompatible and previously cleared in other devices.

Indications for Use

Indicated for patients requiring visualization of the coronary sinus, temporary occlusion during venography, and delivery of transvenous devices to the coronary sinus and coronary vasculature.

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

• Attain™ Prevail® Left Heart Delivery System (K032622)
• Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter (K973298)
• ImagCath™ Coronary Angioscope (K952638)
• CCD Solid State Video Camera (K855529)
• Battery Powered Endoscopic Light Source (K960081)

Submission Summary (Full Text)

{0}------------------------------------------------

# DEC 2 8 2004

#### 510(k) Summary

General Information

Date Compiled

Classification

Class II

August 30, 2004

Trade Name

Submitter

Coronary Sinus Visualization System

Acumen Medical, Inc. 1400 Terra Bella Blvd. Suite A Mountain View, CA 94043

Tel: [phone] Fax: [phone]

Contact

Marybeth Gamber Director, Regulatory Affairs

Intended Use

The Acumen Coronary Sinus Visualization System is intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

", : ,

### Predicate Devices

| Attain™ Prevail® Left Heart Delivery System<br>Manufactured by Medtronic Inc. | K032622 |
|--------------------------------------------------------------------------------------------|---------|
| Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter<br>Manufactured by Cardima Inc. | K973298 |
| ImagCath™ Coronary Angioscope<br>Manufactured by Baxter Healthcare Corp. | K952638 |
| CCD Solid State Video Camera<br>Manufactured by Medical Dynamics, Inc. | K855529 |
| Battery Powered Endoscopic Light Source<br>Manufactured by Mitsubishi Cable America Inc. | K960081 |

{1}------------------------------------------------

#### Device Description

Device Description The Acumen Coronary Sinthe visualization of the coronary sinus, provide temporary cancer intended to and mi the model provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

The CSVS is a steerable angioscopic catheter with a silicone balloon on the distal end. The balloon is intended to displace blood flow to aid in visualization and to provide temporary occlusion during a venogram. The CSVS includes an integrated light source and a camera providing NTSC video output.

#### Materials

All materials used in the manufacture of the CSVS are suitable for this use and have been used in numerous previously cleared products.

#### Testing

In-vitro and in-vivo testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.

#### Summary of Substantial Equivalence

Acumen Medical believes the CSVS is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.

{2}------------------------------------------------

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 contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2004

Acumen Medical, Inc. c/o Ms. Marybeth Gamber 1400 Terra Bella Blvd. Mountain View, CA 94043-1884

Re: K042381

Trade Name: Coronary Sinus Visualization System, model CSVS 5508 Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: II (two) Product Code: DQY Dated: August 30th, 2004 Received: September 1st, 2004

Dear Ms. Gamber:

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.

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

{3}------------------------------------------------

Page 2 - Ms. Marybeth Gamber

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 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

Sincerely yours,

Mepremp

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

Enclosure

{4}------------------------------------------------

Acumen Medical, Inc.

## Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

This application

Acumen Coronary Sinus Visualization System

The Acumen Coronary Sinus Visualization System is intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mesa Maya

on Slan-C Division of Cardiovascular Devices KO42381 510(k) Number

Confidential