ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM

K070051 · Acumen Medical, Inc. · DQY · Apr 6, 2007 · Cardiovascular

Device Facts

• Record ID: K070051
• Device Name: ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
• Applicant: Acumen Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, 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. The Insight is intended for use in the right heart only.

Device Story

Insight Endocardial Visualization System is a single-use percutaneous catheter; aids visualization of coronary sinus, foramen ovale, and venous/cardiac anatomy; provides temporary occlusion during venograms; serves as a delivery pathway for transvenous devices to coronary sinus and vasculature. Used in right heart only. Device design and materials are identical to previously cleared predicates; no new clinical or bench testing required for this submission.

Clinical Evidence

No clinical data provided. Bench testing not required due to identical design to predicate devices.

Technological Characteristics

Single-use percutaneous catheter. Materials are identical to predicate devices. Intended for right heart visualization and device delivery. No software or electronic components described.

Indications for Use

Indicated for patients requiring visualization of the coronary sinus, foramen ovale, and other venous/cardiac anatomy, temporary occlusion during venography, and a pathway for transvenous device delivery to the coronary sinus and coronary vasculature. Intended for right heart use only.

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

• Acumen Insight Endocardial Visualization System (K042381, K062084)
• AcuNav Diagnostic Ultrasound Catheter (K992631)

Submission Summary (Full Text)

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Insight™ Endocardial Visualization System, K070051

#### 510(k) Summary 5. General Information

| Date Compiled | April 5, 2007 |
|----------------|--------------------------------------------------------------------|
| Classification | Class II |
| Trade Name | Acumen Insight Endocardial Visualization System |
| Submitter | Acumen Medical, Inc.<br>275 Santa Ana Court<br>Sunnyvale, CA 94085 |
| | Tel: [phone]<br>Fax: [phone] |
| | Contact |

# Intended Use

The Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, 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. The Insight is intended for use in the right heart only.

| Predicate Devices | |
|-----------------------------------------------------------------------------------------|------------------|
| Acumen Insight Endocardial Visualization System<br>Manufactured by Acumen Medical, Inc. | K042381, K062084 |
| AcuNav Diagnostic Ultrasound Catheter<br>Manufactured by Acuson Corporation | K992631 |

# Device Description

The Acumen Insight Endocardial Visualization System (Insight) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus. foramen ovale and other venous side cardiac anatomy, 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.

# Materials

All materials used in the manufacture of the Acumen Insight Endocardial Visualization System are suitable for this use, are identical to the those used in the predicate devices, and have been used in numerous previously cleared products

# Testing

As there is no change in the design of the device, additional device testing was not required.

#### Summary of Substantial Equivalence

Acumen Medical, Inc. believes the Acumen Insight Endocardial Visualization System is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate product.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = \$ 2007

Acumen Medical, Inc. c/o Marybeth Gamber Director, Regulatory Affairs 275 Santa Ana Court Sunnyvale, CA 94085

Re: K070051

Trade/Device Name: Acumen Insight Endocardial Visualization System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: March 7, 2007 Received: March 8, 2007

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.

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Page 2 - Ms. Marybeth Gamber

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. 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 240-276-0120. 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/industry/support/index.html.

Sincerely vours.

Bfimmerman for

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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Acumen Medical, Inc.

#### Indications for Use Statement 4.

| 510(k) Number (if known): | K070051 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Acumen Insight Endocardial Visualization System |
| Indications for Use: | The Insight Endocardial Visualization System is intended to<br>aid in the visualization of the coronary sinus, foramen ovale<br>and other venous and cardiac anatomy, provide temporary<br>occlusion during a venogram, and to provide a pathway for<br>delivery of transvenous devices to the coronary sinus and<br>coronary vasculature of the heart. The Insight is intended for<br>use in the right heart only. |

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)

B.A.mumo