ENCORE 26 ADVANTAGE KIT

K120694 · Boston Scientific Corp · MAV · Apr 3, 2012 · Cardiovascular

Device Facts

• Record ID: K120694
• Device Name: ENCORE 26 ADVANTAGE KIT
• Applicant: Boston Scientific Corp
• Product Code: MAV · Cardiovascular
• Decision Date: Apr 3, 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 perculaneous 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 dilatation 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. - TD2® Torque Device: Used for guidewire manipulation. . - Guidewire Insertion Tool: Used for percutaneous introduction and placement of guidewires in . vascular procedures.

Device Story

Encore™ 26 Advantage Kit is a sterile, disposable procedural kit for PTCA. Components include an inflation device, Y-adaptor, torque device, and guidewire insertion tool. The inflation device creates, monitors, and releases pressure in balloon dilatation catheters; the Y-adaptor provides hemostasis; the torque device enables guidewire manipulation; the insertion tool facilitates percutaneous guidewire placement. Used in clinical settings by physicians during coronary procedures. The kit streamlines access to necessary accessories for balloon inflation and wire control, supporting successful catheterization and patient safety.

Clinical Evidence

No clinical data. Bench testing only, including mechanical verification (I.D. compatibility, hub tensile strength) and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility).

Technological Characteristics

Sterile, disposable kit containing mechanical accessories for PTCA. Components include inflation device, Y-adaptor, torque device, and insertion tool. Materials verified via biocompatibility testing (ISO/USP standards). No electronic or software components.

Indications for Use

Indicated for patients undergoing percutaneous coronary angiography (PTCA) procedures requiring balloon inflation and guidewire manipulation/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™ Advantage Kit (K951802)

Reference Devices

• Boston Scientific (BSC) Encore Inflation Device (K955869)
• BSC GateWay™ PLUS Y-Adaptor (K951089)
• Navilyst Medical TD2 Torque Device (K922706)
• NeedleTech Products, Inc. Guidewire Insertion Needle (K031173)

Submission Summary (Full Text)

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K120694

### APR - 3 2012

## 510(k) Summarv per 21 CFR §807.92

| Sponsor: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick MA 01760 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Adrienne Hotchkiss |
| Phone Number: | 763-255-0334 |
| Fax Number: | 763-494-2222 |
| Prepared: | 05 March 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 Part 870.1650 |
| Predicate Device: | Encore™ Advantage Kit (K951802; 21 July 1995) |

#### Device Description:

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.

The proposed Encore™ 26 Advantage Kit will include the following currently marketed devices: Boston Scientific (BSC) Encore Inflation Device (K955869); BSC GateWay™ PLUS Y-Adaptor (K951089); Navilyst Medical TD2 Torque Device (K922706); and NeedleTech Products, Inc. Guidewire Insertion Needle (K031173).

#### Intended Use

The Encore™ 26 Advantage Kits are intended for use as accessories for perculaneous 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 dilatation 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.
- TD2® Torque Device: Used for guidewire manipulation. .
- 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 I rre proposou invalent to the currently marketed Encore™ Advantage Kit (K951802).

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### Summary of Non-Clinical Testing

Design verification included mechanical bench testing was performed to verify the performance and usability of the guidewire insertion tool remains substantially equivalent to the guidewire insertion tool in the predicate kit. 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:

- I.D. (Guidewire Compatibility) �
- Hub Tensile Strength �
- � Biocompatibility Testing
- Cytotoxicity o
- Sensitization O
- Irritation Or Intracutaneous React o
- Systemic Toxicity (Acute) O
- O Hemocompatibility
- Latex o
- USP Physicochemical 0

### Summary of Clinical Testing

Clinical Evaluation was not required for these devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

APR - 3 2012

Boston Scientific Corporation c/o Ms. Adrienne Hotchkiss Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566

Re: K120694

Encore™ 26 Advantage Kit Regulation Number: 21 CFR 870.1650 Regulation Name: Syringe, balloon Inflation Regulatory Class: Class II Product Code: MAV Dated: March 5, 2012 Received: March 7, 2012

Dear Ms. Hotchkiss:

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 I ou may) incresy initions 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 friar oc subject to additions, 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. Adrienne Hotchkiss

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 (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 i [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Gram 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): K120694

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.

- Encore™ 26 Inflation Device: Inflation Devices are indicated for use with balloon . dilatation 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.
- TD2® Torque Device: Used for guidewire manipulation. ●
- Insertion Tool: Used for percutaneous introduction and placement of guidewires . in vascular procedures.

Prescription Use (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)

M.A. Kilbourne

(Division Sign-Off) Division of Cardiovascular Devices

K120694 510(k) Number

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