MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59

K083855 · Acumen Medical, Inc. · DYB · Feb 17, 2009 · Cardiovascular

Device Facts

• Record ID: K083855
• Device Name: MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
• Applicant: Acumen Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 17, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The SPIRIT™ Navigable Lead Delivery Catheter is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Device Story

SPIRIT Navigable Lead Delivery Catheter is a single-use percutaneous device for introducing pacing or defibrillator leads/catheters. Device features a guidewire lumen and is packaged with stylets (Distal Control Devices) to assist in navigation and positioning within the vasculature. Operated by clinicians in a procedural setting. Provides a pathway for lead placement; facilitates precise positioning of cardiac leads. Benefits include improved maneuverability during lead delivery procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Single-use percutaneous catheter with guidewire lumen. Includes stylets (Distal Control Devices) for positioning. Materials meet ISO 10993-1 biocompatibility requirements. No software or electronic components.

Indications for Use

Indicated for the introduction of pacing or defibrillator leads and catheters into the vasculature. Patient population not specified.

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 with Stylet (K070197)

Submission Summary (Full Text)

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1083855

### 510(k) Summary

### General Information

Date Compiled Classification

Trade Name

Submitter

December 18, 2008

FEB 1 7 2009

Class II,

SPIRITTM Navigable Lead Delivery Catheter

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

Tel: [phone] Fax: [phone]

Contact

Kevin MacDonald Tel. [phone]

#### Intended Use

The SPIRIT™ Navigable Lead Delivery Catheter is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Predicate Devices Acumen Lead Delivery Sheath with Stylet Manufactured by Acumen Medical, Inc.

K070197

#### Device Description

The SPIRIT™ Navigable Lead Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of pacing or defibrillator leads and catheters. The Modified Acumen Lead Delivery Sheath with Stylet has a guidewire lumen for introduction of leads. The Modified Acumen Lead Delivery Sheath with Stylet will be packaged with stylets, also referred to as Distal Control Devices (DCDs), to aid in positioning of the device in the vasculature.

#### Materials

All materials used in the manufacture of the SPIRIT™ Navigable Lead Delivery Catheter are suitable for this use, meet the biocompatibility requirements per ISO 10993-1, 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 SPIRIT™ Navigable Lead Delivery Catheter 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2009

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

Re: K083855

Trade/Device Name: SPIRITTM Navigable Lead Delivery Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 26, 2009 Received: January 29, 2009

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 Hederal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (EMA). 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 -- Mr. Kevin MacDonald

Enclosure

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 Biometrics' (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, M.D.

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

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# Indications for Use Statement

510(k) Number (if known):

Device Name:

SPIRIT

K083855

Indications for Use:

SPIRIT™ Navigable Lead Delivery Catheter

The SPIRIT™ Navigable Lead Delivery Catheter 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oomlee

(Division Sign-Off) Division of Cardiovascular Devices KOB3855 510(k) Number