MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90

K062145 · Acumen Medical, Inc. · DYB · Aug 23, 2006 · Cardiovascular

Device Facts

• Record ID: K062145
• Device Name: MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90
• Applicant: Acumen Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 23, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

Modified Acumen Lead Delivery Sheath is a single-use percutaneous catheter; features guidewire lumen and lead introduction lumen. Used by clinicians to facilitate placement of pacing or defibrillator leads and catheters. Device provides a pathway for lead delivery; assists in cardiovascular procedures. Benefits include simplified lead introduction.

Clinical Evidence

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

Technological Characteristics

Single-use percutaneous catheter; includes guidewire lumen and lead introduction lumen. Materials are biocompatible and consistent with previously cleared products. 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

• Acumen Lead Delivery Sheath (K051515)

Submission Summary (Full Text)

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# AUG 2 3 2006

K062145

#### 5. 510(k) Summary General Information

Date Compiled

Classification

Trade Name

Submitter

July 26, 2006 Class II

Orion 11

Modified Acumen Lead Delivery Sheath

Models: LDS-10-57, LDS-10-64, LDS-10-57-90, and LDS-10-64-90

Acumen Medical, Inc. 275 Santa Ana Court Sunnyvale, CA 94085

Tel: [phone] Fax: [phone]

Contact

Marybeth Gamber Director, Regulatory Affairs

### Intended Use

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

Predicate Devices

Acumen Lead Delivery Sheath Manufactured by Acumen Medical, Inc. K051515

#### Device Description

The Acumen Lead Delivery Sheath (LDS) is a single-use perculaneous catheter intended (1) introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen LDS has a guidewire lumen and a lumen for introduction of leads.

#### Matcrials

All materials used in the manufacture of the Modified Acumen LDS 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 Modified Acumen Lead Delivery Sheath is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are cither identical or substantially equivalent to existing legally marketed predicate product.

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2006

Acumen Medical, Inc. c/o Ms. Marybeth Gamber Director, Regulatory Affairs 275 Santa Ana Court Sunnyvale, CA 94085

Re: K062145

Trade/Device Name: Modified Acumen Lead Delivery Sheath Regulation Number: 21 CFR §870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 26, 2006 Received: July 27, 2006

Dear Ms. Marybeth 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.

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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 [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,

B/Summner 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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#### Indications for Use Statement 4.

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

Device Namc: Modified Acumen Lead Delivery Sheath

Indications for Use:

.

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

Prescription Use _X (Pcr 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Pcr 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummina
(Division Sign-Off)

Division of Cardiovascular Devices
510(k) Number k060145