MODIFIED ACUMEN SHEATH, MODEL TTWO767

K050015 · Acumen Medical, Inc. · DYB · Feb 3, 2005 · Cardiovascular

Device Facts

• Record ID: K050015
• Device Name: MODIFIED ACUMEN SHEATH, MODEL TTWO767
• Applicant: Acumen Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 3, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

Modified Acumen Sheath is a single-use percutaneous introducer catheter; features a guidewire lumen for lead/catheter placement; designed to be splittable for removal from lead; includes a slitter tool. Used by clinicians in clinical settings for cardiovascular procedures. Device facilitates lead/catheter delivery; splittable design allows sheath removal while maintaining lead position.

Clinical Evidence

Bench testing only; all components and subassemblies met required specifications.

Technological Characteristics

Single-use percutaneous introducer catheter; splittable sheath design; includes slitter; guidewire lumen. Materials are biocompatible and consistent with previously cleared devices.

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

• Acumen Sheath (K042376)

Submission Summary (Full Text)

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Acumen Medical, Inc.

# FEB - 3 2005

### 510(k) Summary

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K050015

| General Information | |
|---------------------|-----------------------------------------------------------------------------------------------------|
| Date Compiled | January 3, 2004 |
| Classification | Class II |
| Trade Name | Modified Acumen Sheath |
| Submitter | Acumen Medical, Inc.<br>1400 Terra Bella Blvd., Suite A<br>Mountain View, CA 94043 |
| Contact | Marybeth Gamber<br>Director, Regulatory Affairs<br>tel: [phone], ext. 226<br>fax: [phone] |
| Intended Use | |

Intended Use

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

Predicate Devices Acumen Sheath K042376 Manufactured by Acumen Medical, Inc.

#### Device Description

The Acumen Sheath is a single-use percutaneous catheter indicated for the introduction of various types of pacing or defibrillator leads and catheters.

The Acumen Sheath has a guidewire lumen for the introduction of various types of pacing or defibrillator leads and catheters. The sheath is designed to be splittable, thereby allowing its removal from the lead, and a slitter is provided with the device.

Materials

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

#### Testing

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 Acumen Sheath 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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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.

Public Health Service

FEB = 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marybeth Gamber Director, Regulatory Affairs Acumen Medical, Inc. 1400 Terra Bella Blvd., Suite A Mountain View, CA 94043

Re: K050015

Trade/Device Name: Modified Acumen Sheath, Model TTWO 767 Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: II Product Code: DYB Dated: January 3, 3005 Received: January 4, 2005

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

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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/industry/support/index.html.

Sincerely yours,

Dinna R. Vochmer

- 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.

K050015

## Indications for Use

| 510(k) Number (if known): | This application |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Acumen Sheath |
| Indications for Use: | The Acumen Sheath is indicated for the introduction of various<br>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)

Dianna R. Vicluner

(Division Sign-Off) Division of Cardiovascular Devices

Confidential

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510(k) Number_Ko 5 (נוצ