MODIFIED ACUMEN SHEATH, MODEL TTW 10-65

K051515 · Acumen Medical, Inc. · DYB · Sep 1, 2005 · Cardiovascular

Device Facts

• Record ID: K051515
• Device Name: MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
• Applicant: Acumen Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 1, 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

The Acumen Sheath is a medical device designed for the introduction of pacing or defibrillator leads and catheters. It features a guidewire lumen and a secondary lumen for lead/catheter passage. The sheath is engineered to be slittable, allowing for its removal from the lead after placement; a slitter tool is provided with the device. It is intended for use by clinicians in a medical setting. The device facilitates the placement of cardiac leads, potentially benefiting patients requiring pacing or defibrillation therapy.

Clinical Evidence

Bench testing only. All components, subassemblies, and full devices met required specifications.

Technological Characteristics

The device is a slittable sheath with a guidewire lumen and a lead/catheter lumen. Materials are stated to be suitable for use and previously cleared in other products. No specific ASTM standards or energy sources are mentioned. The device is a mechanical introducer.

Indications for Use

Indicated for the introduction of pacing or defibrillator leads and catheters into the patient's vasculature.

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, TTW 0767 (K050015)

Submission Summary (Full Text)

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Acumen Medical, Inc.

K051515

## SEP - 1 2005

#### 510(k) Summary

| General Information | |
|---------------------|-----------------------------------------------------------------------------------|
| Date Compiled | June 7, 2005 |
| Classification | Class II |
| Trade Name | Modified Acumen Sheath<br>Model TTW 10-65 |
| Submitter | Acumen Medical, Inc.<br>1400 Terra Bella Ave., Suite A<br>Mountain View, CA 94043 |
| Contact | Marybeth Gamber<br>Director, Regulatory Affairs |
| | tel: [phone], ext. 226 |
| | fax: [phone] |

#### Intended Use

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

Predicate Devices Acumen Sheath, TTW 0767 Manufactured by Acumen Medical, Inc.

K050015

#### Device Description

Device Dossellibrient 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 I he reading or defibrillator leads and catheters. The sheath is designed to be slittable, 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

Summary or Duestantial Dollywers 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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SEP - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051515 Modified Acumen Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: August 4, 2005 Received: August 5, 2005

Dear Ms. Gamber:

We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 910(x) premained is substantially equivalent (for the indications ferenced above and nave determined the arredicate devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Devices Amendmants for use stated in the encrosule) to regary manced promotical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior to May 20, 1770, the characted in accordance with the provisions of the Federal Food, Drug, devices that have been recassince in accerdance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premisions of the Act. and Cosment Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the devices, belyer to the manual registration, listing of general controls provisions of the fret meride sequences against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controlls) or class III (PMA), it If your device is classified (sec above) this exist on the sifecting your device can
may be subject to such additional controls. Existing major regulations EDA may may be subject to such adultional controller. Extrong may be of 898. In addition, FDA may be found in the Ood of receits 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 1000-100. 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 to regarity 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" (2125) Pro 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 the Division of Sillan
[phone] [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. Vochner

A 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

# Ko51515

| 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number k051515