ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F

K111252 · Boston Scientific Corp · DQY · Jun 2, 2011 · Cardiovascular

Device Facts

• Record ID: K111252
• Device Name: ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
• Applicant: Boston Scientific Corp
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 2, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ACUITY™ Cut-Away™ catheters are intended to access the coronary venous system, and may be used in dual-catheter delivery. 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™ Cut-Away™ Guide Catheter is a percutaneous venous catheter used to access the coronary venous system for CRT lead delivery. Device acts as a conduit for contrast media and implantable leads; supports single or dual-catheter delivery. Operated by physicians in clinical settings. Construction features PTFE inner liner, 304V stainless steel braid reinforcement, and radiopaque bismuth subcarbonate-loaded PEBAX outer jacket. Stiffness varies along shaft length for pushability, steerability, and kink resistance. Radiopaque tip facilitates visualization. Hub design allows curve orientation. Device provides mechanical access to cardiac vasculature; output is the successful placement of venous leads. No software or algorithmic components.

Clinical Evidence

No clinical data. Evidence consists of design verification and validation testing, including mechanical bench testing (hub separation, diameter, particulates, torquability, pushability, radiopacity) and animal testing. Biocompatibility, sterility, and packaging integrity were verified.

Technological Characteristics

Materials: PTFE inner liner, 304V stainless steel braid, bismuth subcarbonate-loaded PEBAX outer jacket, tungsten/bismuth-loaded PEBAX tip. Dimensions: 69-74 cm working length. Principle: Mechanical conduit for venous access. Energy: None. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for accessing the coronary venous system for the delivery of contrast medium and implantable coronary venous leads. May be used as a single catheter (8F or 6F) or in a dual-catheter delivery system (8F and 6F). Prescription use only.

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 Catheter (K093969)
• RAPIDO Cut-Away Guiding Catheter (K031459)

Submission Summary (Full Text)

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KIII 252

# JUN - 2 2011

## 510(k) Summary per 21 CFR §807.92

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| 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: | May 2, 2011 |
| Trade Name: | ACUITY™ Cut-Away™ Guide Catheter |
| Common Name: | Percutaneous Guide Catheter |
| Classification: | II |
| Product Code: | DQY<br>21 CFR 870.1250 |

ACUITY™ Break-Away™ Guide Catheters (K093969; March 05, 2010) Predicate Device: and RAPIDO Cut-Away Guiding Catheter (K031459, July 23, 2003).

#### Device Description:

The ACUITY™ Cut-Away™ Guide Catheters are 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 an inner liner of polytetrafluoroethylene (PTFE), a reinforcing layer of 304V stainless steel braid, and an outer jacket of radiopaque bismuth subcarbonate-loaded polvether block amide (PEBAX). This construction creates a thin catheter wall that is pushable, steerable, and kink-resistant. The stiffness of the PEBAX jacket changes along the catheter from more stiffness proximally to less distally.

A radiopaque PEBAX tip is thermally attached to the distal end of the quide catheter shaft. This tip consists of a layer of tungsten loaded PEBAX co-extruded with an outer layer of bismuth subcarbonate-loaded PEBAX.

A PEBAX hub is attached to the proximal end of the shaft. One wing of the hub is used for the orientation of the curve shape relative to the hub.

The approximate working length of the catheter is 69-74 cm.

#### Intended Use

The ACUITY™ Cut-Away™ catheters are intended to access the coronary venous system, and may be used in dual-catheter delivery. 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™ Cut-Away™ Guide Catheter design, materials, manufacturing process and intended use are substantially equivalent to the ACUITY™ Break-Away™ Guide Catheter (K093969) and the RAPIDO™ Cut-Away Guiding Catheter (K031459).

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### Summary of Non-Clinical Testing

Design verification and validation testing, including mechanical bench testing, and animal testing, was performed to verify the performance and usability of the ACUITY™ Cut-Away™ Guide Catheter remains substantially equivalent to both predicate devices. Biocompatibility, sterility, and packaging testing were also performed to verify the overall safety and efficacy of the device. Specifically the following design verification and validation testing was performed.

- � Hub Separation
- � Hub Cutting
- � Hub Internal Diameter
- � Particulates
- � Biocompatibility Testing
- Cytotoxicity O
- Sensitization o
- Irritation Or Intracutaneous o Reactivity
- Systemic Toxicity (Acute) O
- Hemocompatibility o
- Latex 0
- USP Physicochemical O

- � Usability Of Multiple Catheter Shapes And Lengths
111 252

- � Compatibility With Accessories And Adjunctive Devices
- Torquability �
- � Pushability & Shaft Stiffness
- � Product Marking And Identification
- � Catheter Removal
- Product Integrity �
- Radiopacity �
- � Ease Of Removal Of Device And Accessories From Packaging

### Summary of Clinical Testing

Clinical Evaluation was not required for these devices.

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

Boston Scientific Corporation c/o Ms. Holly Ramirez Regulatory Affairs Specialist One Boston Scientific Place Natick, MA 01760

JUN - 2 2011

Re: K111252

Trade/Device Name: ACUITYTM Cut-Away™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 2, 2011 Received: May 3, 2011

Dear Ms. 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.

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.

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Page 2 - Ms. Holly Ramirez

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); medical device reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

M. A. Willian

Sam 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

510(k) Number (if known): KI||252

Device Name: ACUITY™ Cut-Away™ Guide Catheter

Indications For Use:

The ACUITY™ Cut-Away™ Lead Delivery System is intended to access the coronary venous system and may be used alone (8F or 6F) or in a dual catheter delivery (8F and 6F). The system 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

.g.killem

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ K 11 | 25 Z

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