ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY

K070197 · Acumen Medical, Inc. · DYB · Feb 23, 2007 · Cardiovascular

Device Facts

• Record ID: K070197
• Device Name: ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
• Applicant: Acumen Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 23, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

The Acumen Lead Delivery Sheath with Stylet is a single-use percutaneous catheter designed to facilitate the introduction of pacing or defibrillator leads and catheters into the vasculature. The device features a guidewire lumen and a dedicated lumen for lead introduction. It is packaged with a stylet to assist the clinician in positioning the device within the patient's vasculature. The device is intended for use by healthcare professionals in a clinical setting.

Clinical Evidence

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

Technological Characteristics

Single-use percutaneous catheter; includes guidewire lumen and lead introduction lumen; packaged with a stylet for positioning. 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 Lead Delivery Sheath (K062145)

Submission Summary (Full Text)

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K070197

FEB 2 3 2007

Acumen Lead Delivery Sheath January 19, 2007

Acumen Medical, Inc.

#### 510(k) Summary 5.

General Information

| Date Compiled | January 19 2007 |
|----------------|-----------------------------------------|
| Classification | Class II, |
| Trade Name | Acumen Lead Delivery Sheath with Stylet |
| Submitter | Acumen Medical, Inc. |

275 Santa Ana Court Sunnyvale, CA 94085

Tel: [phone] Fax: [phone]

Contact

Marybeth Gamber Director, Regulatory Affairs

### Intended Use

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

| Predicate Devices | |
|--------------------------------------|---------|
| Acumen Lead Delivery Sheath | K062145 |
| Manufactured by Acumen Medical, Inc. | |

## Device Description

The Acumen Lead Delivery Sheath with Stylet is a single-use percutaneous catheter intended to The Acumen Lead Delivery Birean West villator leads and catheters. The Acumen Lead Delivery Sheath with Stylet has a guidewire lumen and a lumen for introduction of leads. The Acumen Silean with Stylet was a gurdential be packaged with a stylet to aid in positioning of the device in the vasculature.

### Materials

MI materials used in the manufacture of the Acumen Lead Delivery Sheath with Stylet are suitable for this use and have been used in numerous previously cleared products.

## Testing

Appropriate 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, Inc. believes the Acumen Lead Delivery Sheath with Stylet is substantially equivalent to the predicate product. The intended use, method of operation, methods of ounstruction 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 shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with three lines forming its body and wings, and a wavy line representing its tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2007

Acumen Medical, Inc. C/O Marybeth Gamber 275 Santa Ana Court Sunnyville, CA 94085

Re: K070197

Trade/Device Name: Acumen Lead Delivery Sheath with Stylet Regulation Number: 21 CFR 870.1340 Regulation Name: Regulatory Class: Class II Product Code: DYB Dated: January 19, 2007 Received: January 23, 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. Iisting 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. 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 [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,

BHummar fr

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.

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

Acumen Lead Delivery Sheath with Stylet Device Name:

Indications for Use:

The Acumen Lead Delivery Sheath with Stylet is indicated 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Hummer

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ 270197

Confidential