ACUMEN SINGLE-LUMEN DELIVERY SHEATH

K053400 · Acumen Medical, Inc. · DYB · Jun 19, 2006 · Cardiovascular

Device Facts

• Record ID: K053400
• Device Name: ACUMEN SINGLE-LUMEN DELIVERY SHEATH
• Applicant: Acumen Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Device Story

Single-lumen delivery sheath; includes dilator; slittable design. Used by physicians to facilitate percutaneous introduction of pacing/defibrillator leads and catheters into the vasculature. Operates as a mechanical conduit for lead/catheter placement. Benefits include simplified access and delivery of cardiac rhythm management devices.

Clinical Evidence

In-vitro and animal testing performed. All components, subassemblies, and full devices met required specifications. No human clinical data provided.

Technological Characteristics

Single-lumen delivery sheath with dilator; slittable construction. Materials are biocompatible and consistent with previously cleared devices. Mechanical device; no energy source or software.

Indications for Use

Indicated for the introduction of pacing or defibrillator leads and catheters in patients requiring such devices.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• SafeSheath (K003731)
• Attain Access 6216 Left Heart Delivery System (K012130)
• Attain Access 6218 Left Heart Delivery System (K012083)

Submission Summary (Full Text)

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General Information

510(k) Summary

5.

JUN 19 2006

K053400
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| Date Compiled | December 1, 2005 |
|----------------|-------------------------------------------------------------------------------------------------------------|
| Classification | Class II |
| Trade Name | Acumen Single-Lumen Delivery Sheath |
| Submitter | Acumen Medical, Inc.<br>275 Santa Ana Court<br>Sunnyvale CA 94085<br>Tel: [phone]<br>Fax: [phone] |
| Contact | Marybeth Gamber<br>E-mail: [e-mail] |

Intended Use

The Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Predicate Devices

| SafeSheath | K003731 |
|----------------------------------------------------------------------------------|-----------------------------------------|
| | Manufactured by Thomas Medical Products |
| Attain Access 6216 Left Heart Delivery System<br>Manufactured by Medtronic, Inc. | K012130 |

### Attain Access 6218 Left Heart Delivery System K012083 Manufactured by Medtronic, Inc.

# Device Description

The Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable.

#### Materials

All materials used in the manufacture of the Acumen Single-Lumen Delivery Sheath are suitable for this use and have been used in numerous previously clearcd products.

# Testing

In-vitro and animal testing has been performed and all components, subassemblics, and/or fuil devices met the required specifications for the completed tests.

# Summary of Substantial Equivalence

Acumen Medical, Inc. believes the Acumen Single-Lumen Delivery Sheath is substantially equivalent to the predicate products. The intended use, method of operation, methods of

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Acumen Medical, Inc.

053400
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construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.

(Division Sign-Off)
Division of Cardiovascular
510(k) Number
E053/80

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines representing the wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Acumen Medical, Inc c/o Ms. Marybeth Gamber Director, Regulatory Affairs

275 Santa Ana Court Sunnyvale, CA 94085

Re: K053400

Device Name: Acumen Single-Lumen Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: June 7, 2006 Received: June 8, 2006

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.

JUN 19 2006

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- 1020. 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 yours,

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 Statement 4.

510(k) Number (if known): This application

Device Name: Acumen Single-Lumen Delivery Sheath

Indications for Use:

The Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.

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)

Rhummunon
(Division Sign-Off)

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