MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7

K080500 · Acumen Medical, Inc. · DYB · Mar 13, 2008 · Cardiovascular

Device Facts

• Record ID: K080500
• Device Name: MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
• Applicant: Acumen Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 13, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

Modified Acumen Single-Lumen Delivery Sheath; slittable sheath used to aid introduction of pacing/defibrillator leads and catheters into vasculature. Available in 4F to 9F inner diameters; straight and curved configurations. Packaged with dilator. Used by clinicians in clinical settings. Device facilitates lead/catheter placement; provides access pathway. Materials identical to predicate.

Clinical Evidence

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

Technological Characteristics

Single-lumen slittable sheath; includes dilator. Available in 4F-9F diameters; straight and curved configurations. Materials identical to predicate device. No software or electronic components.

Indications for Use

Indicated for patients requiring the introduction of pacing or defibrillator leads and catheters.

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)
• Modified Acumen Single-Lumen Delivery Sheath (K070396)

Submission Summary (Full Text)

{0}------------------------------------------------

Kososcc

Acumen Medical, Inc. Premarket Notification - Special 510(k) Revision Date: February 21, 2008

## 5. 510(k) Summary General Information

| Date Compiled | February 21, 2008 | MAR 13 2008 |
|----------------|-------------------------------------------------------------------------------------------------------------|-------------|
| 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 | Kevin MacDonald (415-609-9875) | |

## Intended Use

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

## Predicate Devices

| Acumen Single-Lumen Delivery Sheath<br>Manufactured by Acumen Medical, Inc. | K053400 |
|--------------------------------------------------------------------------------------|---------|
| Modified Acumen Single-Lumen Delivery Sheath<br>Manufactured by Acumen Medical, Inc. | K070396 |

## 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 Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 9F. The Modified Acumen Single-Lumen Delivery Sheath is available in straight and multiple curved configurations.

### Materials

All materials used in the manufacture of the Modified 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 existing legally marketed predicate products.

{1}------------------------------------------------

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a stylized human figure, composed of three curved lines.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

Acumen Medical, Inc. c/o Mr. Kevin MacDonald Regulatory Consultant 275 Santa Ana Court Sunnydale, CA 94085

Re: K080500

Modified Acumen Single-Lumen Delivery Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: February 21, 2008 Received: February 25, 2008

Dear Mr. MacDonald:

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.

{2}------------------------------------------------

Page 2 - Mr. Kevin MacDonald

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

\$

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

Enclosure

{3}------------------------------------------------

# 4. Indications for Use Statement

| 510(k) Number (if known): | This application KO80500 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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)

2

(Division Sig

(Division Sig)
Division of Caraiova
510(k) Number K080500