MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45

K070396 · Acumen Medical, Inc. · DYB · May 22, 2007 · Cardiovascular

Device Facts

• Record ID: K070396
• Device Name: MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45
• Applicant: Acumen Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 22, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

Modified Acumen Single-Lumen Delivery Sheath; designed to aid introduction of pacing/defibrillator leads and catheters. Device includes slittable sheath and dilator; available in 4F to 6F inner diameters. Used by clinicians in clinical settings to facilitate lead/catheter placement. Mechanical device; no electronic or software components.

Clinical Evidence

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

Technological Characteristics

Single-lumen delivery sheath with dilator; slittable design. Available in 4F to 6F inner diameters. Materials identical to predicate device. Mechanical device; 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 Single-Lumen Delivery Sheath (K053400)

Submission Summary (Full Text)

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# 5. 510(k) Summary

General Information

| Date Compiled | February 9, 2007 | MAY 22 2007 |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Classification | Class II | |
| Trade Name | Modified Acumen Single-Lumen Delivery Sheath | |
| Submitter | Acumen Medical, Inc.<br>275 Santa Ana Court<br>Sunnyvale CA 94085<br>Tel: [phone]<br>Fax: [phone] | |
| Contact | Marybeth Gamber | |
| Intended Use | The Modified Acumen Single-Lumen Delivery Sheath is indicated for the introduction of various<br>types of pacing or defibrillator leads and catheters. | |

Predicate Devices Acumen Single-Lumen Delivery Sheath Manufactured by Acumen Medical, Inc.

K053400

### Device Description

The Modified Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable. The Modified Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 6F.

### Materials

All materials used in the manufacture of the Acumen Single-Lumen Delivery Sheath are identical to the predicate device.

### Testing

In-vitro 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 Single-Lumen Delivery Sheath is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to cxisting legally marketed predicate products.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2007

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

Re: K070396

Trade/Device Name: Acumen Single-Lumen Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 11, 2007 Received: May 14, 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, 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. 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 promated 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,

Brimmer for

Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 4. Indications for Use Statement

| 510(k) Number (if known): | K070396 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Modified Acumen Single-Lumen Delivery Sheath |
| Indications for Use: | The Modified Acumen Single-Lumen Delivery Sheath is<br>intended for the introduction of various types of pacing c<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)

Bhimma

(Division Sign-Om) Division of Cardlov 510(k) Number