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.

Device Description

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).

AI/ML Overview

This is a 510(k) premarket notification for the Encore™ 26 Advantage Kit. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not involve a study of an AI/ML powered device. Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test and training sets, expert involvement, and comparative effectiveness studies are not applicable.

Here's an breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a device kit and not an AI/ML powered device with specific performance metrics like sensitivity or specificity, the "acceptance criteria" pertain to mechanical, biocompatibility, and sterility testing. The "reported device performance" indicates that these tests were performed and met the necessary standards for substantial equivalence.

Acceptance Criteria Category	Specific Test	Reported Device Performance
Mechanical Bench Testing	I.D. (Guidewire Compatibility)	Performed, verifying performance and usability of the guidewire insertion tool remains substantially equivalent to the predicate. (Specific numerical results are not provided in this summary but implied to meet requirements).
	Hub Tensile Strength	Performed, verifying performance and usability of the guidewire insertion tool remains substantially equivalent to the predicate. (Specific numerical results are not provided).
Biocompatibility Testing	Cytotoxicity	Performed, verifying overall safety and efficacy. (Implied to meet ISO or FDA biocompatibility standards).
	Sensitization	Performed, verifying overall safety and efficacy.
	Irritation Or Intracutaneous React	Performed, verifying overall safety and efficacy.
	Systemic Toxicity (Acute)	Performed, verifying overall safety and efficacy.
	Hemocompatibility	Performed, verifying overall safety and efficacy.
	Latex	Performed, verifying overall safety and efficacy.
	USP Physicochemical	Performed, verifying overall safety and efficacy.
Sterility Testing		Performed, verifying overall safety and efficacy. (Implied to meet relevant sterilization standards).
Packaging Testing		Performed, verifying overall safety and efficacy. (Implied to meet relevant packaging integrity standards).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as this is a non-clinical, bench-testing focused submission. For mechanical and biocompatibility testing, sample sizes would typically be determined by statistical methods for device testing, but this information is not provided in the summary.
Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Boston Scientific Corporation. This is not medical imaging data or patient data, so concepts like "country of origin" or "retrospective/prospective" in the typical sense do not apply.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Not Applicable. This submission does not involve expert review/ground truth establishment for clinical data as there was no clinical study. The "ground truth" for mechanical and biocompatibility testing would be defined by established engineering and biological standards, not human expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not Applicable. Since there's no diagnostic interpretation by experts, there's no adjudication method in the context of clinical or diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This was not an AI/ML powered device, and no clinical studies, including MRMC studies, were performed.
Effect size of human readers improve with AI vs without AI assistance: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable. This is a medical device kit, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" is based on established engineering standards, biocompatibility standards (e.g., ISO standards), and sterility validation criteria for medical devices. The testing verifies that the device meets these pre-defined physical, chemical, and biological requirements.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of AI/ML for this device. The development process would involve iterative design and testing, but not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set.

Summary

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K120694

APR - 3 2012

510(k) Summarv per 21 CFR §807.92

Sponsor:	Boston Scientific CorporationOne Boston Scientific PlaceNatick 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 KitCommon name of the kit components:'inflation device, insertion tool, Y-adaptor, and torque device
Classification:	II
Product Code:	MAV21 CFR Part 870.1650
Predicate Device:	Encore™ Advantage Kit (K951802; 21 July 1995)

Device Description:

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 (800) 638-2041 or (240) 276-3150 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: .

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

Page 1 of 1

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.