ACUITY PRO LEAD DELIVERY SYSTEM

K132914 · Boston Scientific · DQY · Apr 3, 2014 · Cardiovascular

Device Facts

• Record ID: K132914
• Device Name: ACUITY PRO LEAD DELIVERY SYSTEM
• Applicant: Boston Scientific
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ACUITY™ Pro Lead Delivery System is intended to access the coronary venous system, and may be used alone (9F) or in a dual catheter delivery (9F with 7F). The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

Device Story

ACUITY™ Pro Lead Delivery System is a percutaneous guide catheter used to access coronary venous system for delivery of contrast medium and implantable coronary venous leads; supports single (9F) or dual (9F with 7F) catheter delivery. Device consists of catheter shaft with PTFE inner liner, stainless steel braid reinforcement, and outer polymer jacket; distal end features radiopaque polymer tip; proximal end includes hub with flush luer fitting. Used in clinical settings by physicians to facilitate CRT lead placement. System includes accessories: guidewire introducer, guidewire torquer, venous access dilator, universal cutter, and transvalve introducer tool. Provides conduit for lead placement; aids in selective positioning within cardiac vasculature.

Clinical Evidence

No clinical data. Bench testing only, including mechanical verification (tensile, pushability, stiffness, torque, kink resistance, radiopacity, hub integrity) and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility).

Technological Characteristics

Catheter shaft: PTFE inner liner, stainless steel braid reinforcement, outer polymer jacket. Radiopaque polymer tip. 9F (45-54cm) and 7F (60-69cm) designs. Hub with flush luer fitting. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring access to the coronary venous system for the delivery of contrast medium and implantable coronary venous leads. Used by clinicians for cardiac resynchronization therapy (CRT) lead placement.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• ACUITY Break-Away™ Guide Catheters (K093969)
• ACUITY Cut-Away™ Guide Catheters (K111252)

Submission Summary (Full Text)

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# 510(k) Summary per 21 CFR §807.92

| Sponsor: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick MA 01760 |
|-----------------|---------------------------------------------------------------------------------|
| Contact Person: | Holly Ramirez |
| Phone Number: | 763-494-2113 |
| Fax Number: | 763-494-2222 |
| Prepared: | September 16, 2013 |
| Trade Name: | ACUITY™ Pro Lead Delivery System |
| Common Name: | Percutaneous Guide Catheter |
| Classification: | II |
| Product Code: | DQY<br>21 CFR 870.1250 |

#### Predicate Device:

ACUITY Break-Away™ Guide Catheters (K093969; March 05, 2010) and ACUITY Cut-Away™ Guide Catheters (K111252, June 02, 2011).

#### Device Description:

The ACUITY™ Pro Lead Delivery System is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are comprised of a PTFE inner iner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer .

The approximate working lengths of the catheters are 45-54cm for the 9F design and 60-69 cm for the 7F design.

The ACUITY Pro 9F is provided with the following accessories:

Guidewire Introducer Guidewire Torquer

Venous Access Dilator ACUITY™ Universal Cutter

Transvalve Introducer Tool (2)

#### Intended Use:

The ACUITY™ Pro Lead Delivery System is intended to access the coronary venous system, and may be used alone (9F) or in a dual catheter delivery (9F with 7F). The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

#### Substantial Equivalence:

The ACUITY™ Pro Lead Delivery System design, materials, manufacturing process and intended use are substantially equivalent to the ACUITY Break-Away™ Guide Catheter (K093969) and the ACUITY Cut-Away™ Guide Catheter (K111252).

### Summary of Non-Clinical Testing:

Design verification and validation testing, including mechanical bench testing, was performed to verify that the performance and usability of the ACUITY™ Pro Lead Delivery System remains substantially equivalent to both predicate devices. Biocompatibility, and packaging testing were also performed to verify the overall safety and efficacy of the device.

Boston Scientific Corporation Premarket Notification - Traditional 510(k) ACUITY™ Pro Lead Delivery System

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Specifically the following design verification and validation testing was performed:

- � Dimensional Verification
- Tensile �
- � Pushability and Shaft Stiffness
- � Shaft Cutting
- � Kink Resistance
- � Curve Shape
- � Radiopacity
- � Curve Shape
- � Tip Deflection
- Torque Strength �
- � Hub Leak
- � Hub Separation
- � Hub Cutting /Catheter Removal
- � Compatibility With Accessories And Adjunctive Devices
- Lead Passage �
- � Product Marking And Identification
- � Product Integrity
- � Ease Of Removal Of Device And Accessories From Packaging
- � Particulates
- Microbiology Endotoxin �
- EO Residuals �
- Biocompatibility Testing �
- Cytotoxicity o
- Sensitization O
- Irritation Or Intracutaneous O Reactivity
- Systemic Toxicity (Acute) ಂ
- Hemocompatibility 0
- Latex ೧
- USP Physicochemical O

## Summary of Clinical Testing:

Clinical Evaluation was not required for these devices.

Boston Scientific Corporation Premarket Notification - Traditional 510(k) ACUITY™ Pro Lead Delivery System

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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April 3, 2014

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Boston Scientific Corporation % Holly Ramirez Sr. Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K132914

> Trade/Device Name: ACUITY™ Pro Lead Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: March 27, 2014 Received: March 28, 2014

Dear Holly Ramirez,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 that I Driver Inatutes 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

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Page 2 - Holly Ramirez

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Bram D. Zuckerman -S

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

510(k) Number (if known): K132914 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name:

ACUITY Pro Lead Delivery System

Indications for Use:

The ACUITY™ Pro Lead Delivery System is intended to access the coronary venous system, and may be used alone (9F) or in a dual catheter delivery (9F with 7F). The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bram D. Zuckerm 2014.04.03 13