(29 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Encore™ 26 Advantage Kit. This submission details the device's intended use and claims substantial equivalence to a predicate device.
However, the document does not contain any information about acceptance criteria or a study proving that the device meets such criteria. The "Summary of Non-Clinical Testing" mentions that design verification was performed, and "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." The "Summary of Clinical Testing" explicitly states, "Clinical Evaluation was not required for this device."
Therefore, I cannot provide the requested information in a table or respond to the specific questions because the provided text does not contain any data related to acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for either test or training sets. This device was cleared based on substantial equivalence to an existing predicate device, not through a performance study against specific acceptance criteria.
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K 123214 Page 1 of 1.
510(k) Summary per 21 CFR §807.92
| Sponsor: | Boston Scientific CorporationOne Boston Scientific PlaceNatick 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 KitCommon name of the kit components:Inflation device, insertion tool, Y-adaptor and torque device | |
| Classification: | II | |
| Product Code: | MAV21 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 (800) 638-2041 or (301) 796-7100 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
Page 1 of 1
510(k) Number K123214
§ 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.