ENCORE 26 ADVANTAGE KIT

K123214 · Boston Scientific Corp · MAV · Nov 13, 2012 · Cardiovascular

Device Facts

• Record ID: K123214
• Device Name: ENCORE 26 ADVANTAGE KIT
• Applicant: Boston Scientific Corp
• Product Code: MAV · Cardiovascular
• Decision Date: Nov 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Encore™ 26 Advantage Kits are intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They create and monitor balloon inflation and facilitate wire introduction and control. Individual Device Intended Use: - Encore™ 26 Inflation Device: Used with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. - GateWay™ Plus Y-Adapter: Used for providing hemostasis around guidewires, balloon dilatation catheters, and other therapeutic devices - Torque Device: Used for guidewire manipulation during general intravascular procedures. - Guidewire Insertion Tool: Used for percutaneous introduction and placement of guidewires in vascular procedures.

Device Story

Encore™ 26 Advantage Kit is a sterile, disposable accessory kit for PTCA procedures. Components include an inflation device for balloon pressure monitoring/inflation/deflation; a Y-adapter for hemostasis around catheters/wires; a torque device for guidewire manipulation; and an insertion tool for guidewire placement. Used in clinical settings by physicians during vascular interventions. The device facilitates mechanical control of balloon catheters and guidewires, aiding in the successful delivery and operation of therapeutic devices within the vasculature.

Clinical Evidence

No clinical data. Clinical evaluation was not required for this device; substantial equivalence was established through design verification and sterility testing.

Technological Characteristics

Kit of sterile, disposable accessories for PTCA. Includes inflation device, Y-adapter, torque device, and guidewire insertion tool. Mechanical operation for pressure monitoring and device manipulation. No electronic or software components.

Indications for Use

Indicated for patients undergoing percutaneous coronary angiography (PTCA) or general intravascular procedures requiring balloon inflation, hemostasis around therapeutic devices, guidewire manipulation, or guidewire introduction.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Encore™ 26 Advantage Kit (K120694)

Reference Devices

• Torque Device (K123024)

Submission Summary (Full Text)

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K 123214 Page 1 of 1.

# 510(k) Summary per 21 CFR §807.92

| Sponsor: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick MA 01760 | NOV 1 3 2012 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Rachel Owens | |
| Phone Number: | 763-494-1491 | |
| Fax Number: | 763-494-2222 | |
| Prepared: | 12 October 2012 | |
| Trade Name: | Encore™ 26 Advantage Kit | |
| Common Name: | Balloon Inflation Kit<br>Common name of the kit components:<br>Inflation device, insertion tool, Y-adaptor and torque device | |
| Classification: | II | |
| Product Code: | MAV<br>21 CFR 870.1650 | |
| Predicate Device: | Encore™ 26 Advantage Kit (K120694, 03 April 2012). | |

#### Device Description:

The Encore™ Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.

## Intended Use

The Encore™ 26 Advantage Kits are intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They create and monitor balloon inflation and facilitate wire introduction and control.

Individual Device Intended Use:

- Encore™ 26 Inflation Device: Used with balloon dilation catheters to create and monitor . pressure in the balloon, and to deflate the balloon.
- GateWay™ Plus Y-Adapter: Used for providing hemostasis around guidewires, balloon . dilatation catheters, and other therapeutic devices
- Torque Device: Used for guidewire manipulation during general intravascular procedures. .
- Guidewire Insertion Tool: Used for percutaneous introduction and placement of guidewires . in vascular procedures.

#### Substantial Equivalence

The proposed Encore ™ 26 Advantage Kit design, materials, manufacturing process and intended use are substantially equivalent to the currently marketed Encore ™ 26 Advantage Kit (K120694).

#### Summary of Non-Clinical Testing

Design verification was performed to verify the performance and usability of the Torque Device remains substantially equivalent to the predicate device via K123024. No additional testing was required for kit inclusion. Sterility testing was performed to verify the overall substantial equivalence to the predicates. No additional biocompatibility testing was required.

#### Summary of Clinical Testing

Clinical Evaluation was not required for this device.

Boston Scientific Corporation Premarket Notification - Special 510(k) Encore™ 26 Advantage Kit

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Boston Scientific Corporation Ms. Rachel Owens Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K123214

Trade Name: Encore™ 26 Advantage Kit Regulation Number: 21 CFR 870.1650 Regulation Name: Syringe, balloon Inflation Regulatory Class: Class II Product Code: MAV Dated: October 12, 2012 Received: October 15, 2012

Dear Ms. Owens:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., untinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these and farmer provents in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.

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

NOV 1 3 2012

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Page 2 - Ms. Owens

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 (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/ReportalProblem/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.

Mrs. Miller

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

510(k) Number (if known): 14232 14

Device Name: Encore™ 26 Advantage Kit

Indications For Use:

The Encore™ 26 Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.

Individual Device Intended Use:

- Encore™ 26 Inflation Device: Inflation device are indicated for use with balloon . dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
- GateWay™ Plus Y-Adapter: Used for providing hemostasis around quidewires, . balloon dilatation catheters, and other therapeutic devices
- Torque Device: Used for guidewire manipulation during general intravascular . procedures.
- Guidewire Insertion Tool: Used for percutaneous introduction and placement of . guidewires in vascular procedures.

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

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)

My weleh

(Division Sign-Off)
Division of Cardiovascular Devices

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510(k) Number K123214