ACUMEN SHEATH, MODEL TTW7807

K042376 · Acumen Medical, Inc. · DYB · Oct 26, 2004 · Cardiovascular

Device Facts

• Record ID: K042376
• Device Name: ACUMEN SHEATH, MODEL TTW7807
• Applicant: Acumen Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 26, 2004
• Decision: SESE
• Submission Type: Traditional
• 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

The Acumen Sheath is a single-use percutaneous catheter designed for the introduction of pacing or defibrillator leads and catheters. It features a guidewire lumen and a delivery lumen coated with a lubricious material to facilitate device passage. The sheath is designed to be splittable to allow for removal from the lead after placement; a slitter is provided with the device. It is intended for use by clinicians in a clinical setting to assist in the delivery of cardiac leads.

Clinical Evidence

Bench testing only. In-vitro and in-vivo testing performed; all components and subassemblies met required specifications.

Technological Characteristics

Single-use percutaneous catheter; includes guidewire lumen and delivery lumen with lubricious coating; splittable design with included slitter. 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

• SafeSheath Coronary Sinus Guide (K003731)

Submission Summary (Full Text)

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OCT 2 6 2004

K042376
page 1 of 2

### 510(k) Summary

General Information

| Date Compiled | August 30, 2004 |
|----------------|-----------------------------------------------------------------------------------------------------|
| Classification | Class II |
| Trade Name | Acumen Sheath |
| Submitter | Acumen Medical, Inc.<br>1400 Terra Bella Blvd.<br>Suite A<br>Mountain View, CA 94043 |
| Contact | Marybeth Gamber<br>Director, Regulatory Affairs<br>tel: [phone], ext. 226<br>fax: [phone] |

#### Intended Use

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

Predicate Devices SafeSheath Coronary Sinus Guide K003731 Manufactured by Pressure Products, Inc/Thomas Medical Products 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 and a lumen for the introduction of various types of pacing or defibrillator leads and catheters. The delivery lumen is coated with a lubricious coating to aid in device delivery. 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

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.

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042376
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# Summary of Substantial Equivalence

Summary of Substantial Equiralies
Acumen Medical believes the Acumen Sheath is substantially equivalent to the Acumen Medical believes the Noalien Streation, methods of construction predicale product. "The mended use, method or substantially equivalent to existing legally marketed predicate product.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2004

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

Re: K042376

Trade Name: Acumen Sheath, Model TTW 7807 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 30, 2004 Received: September 1, 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 for are waver 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 Cosmatic Act (Act). You may, therefore, market the device, subject to the general controls and Ooomette Free (110). - However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you ruer 20, 1973, and evice components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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### Page 2 - Ms. Marybeth Gamber

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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,

Bhummer 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

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

Bhummer

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