BASIXTOUCH

K130566 · Merit Medical Systems, Inc. · MAV · Jun 19, 2013 · Cardiovascular

Device Facts

• Record ID: K130566
• Device Name: BASIXTOUCH
• Applicant: Merit Medical Systems, Inc.
• Product Code: MAV · Cardiovascular
• Decision Date: Jun 19, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The basixTOUCH Inflation Syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

Device Story

Single-use disposable inflation syringe; generates and monitors pressure for angioplasty or interventional devices. Features threaded plunger assembly with lock/release bar and flexible high-pressure extension tube. Used in clinical settings by physicians/technicians to inflate/deflate balloons; provides real-time pressure monitoring via integrated gauge. Enables controlled balloon expansion; assists in interventional decision-making during procedures.

Clinical Evidence

Bench testing only. No clinical data. Testing included fluid functional use, gauge accuracy, gauge tensile, retainer cap bond torque, tip adapter securement, tip securement, vacuum capability, and packaging integrity (visual, dye penetration, leak, burst strength).

Technological Characteristics

Single-use disposable inflation syringe. Features threaded plunger assembly, lock/release bar, and high-pressure extension tube. Sterilization via ethylene oxide (ISO 11135-1:2007). Biocompatibility per ISO 10993-1:2009 and FDA Memo G95-1. Packaging validated per ASTM F1980-07 and ASTM D4169-09.

Indications for Use

Indicated for inflation and deflation of angioplasty balloons or other interventional devices and pressure measurement within the balloon during interventional procedures.

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

• Merit basixCOMPAK™ Inflation Syringe (K122321)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the words "MERIT MEDICAL" in a bold, sans-serif font. The "M" in "MERIT" is solid black, while the rest of the letters in "MEDICAL" are outlined in black.

## JUN 1 9 2013

MERIT MEDICAL SYSTEMS, INC 1600 West Merit Parkway SOUTH JORDAN, UTAH 84095 PHONE [phone] FAX [phone] www.ment.com

| 1 510(k) Summary | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Correspondent Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>801-208-4408<br>801-253-6945<br>Dan W. Lindsay<br>March 1, 2013<br>1721504 |
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | basixTOUCH™<br>Inflation Syringe<br>MAV Balloon Inflation Syringe |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | Merit basixCOMPAK™ Inflation Syringe<br>MAV Balloon Inflation Syringe<br>K122321<br>Merit Medical Systems, Inc. |
| Classification | Class II<br>21 CFR § 870.1650, MAV<br>Division of Cardiovascular Devices | |
| Intended Use | The basixTOUCH Inflation Syringe is used to inflate and deflate an<br>angioplasty balloon or other interventional device, and to measure<br>the pressure within the balloon | |
| Device<br>Description | The basixTOUCH Inflation Syringe is a single use disposable device<br>capable of generating and monitoring pressure in angioplasty or<br>other similar interventional devices. It is fitted with a threaded<br>plunger assembly with lock/release bar, flexible high pressure<br>extension tube. | |

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Merit Medical Systems, Inc. basixTOUCH Inflation Syringe Premarket Notification 510(k)

- The Technological characteristics of the subject basixTOUCH inflation syringe are substantially equivalent to those of the predicate. Comparison to the Merit basixCOMPAK Inflation Syringe. The basixTOUCH Predicate generates higher pressure and is a larger volume syringe than the Predicate. No applicable mandatory performance standards or special controls have been established under Section 514 of the Food, Drug and Cosmetic Act for this device. However, a battery of tests was performed according to protocols based on the requirements of industry standards and guidance and the device met the acceptance criteria necessary to demonstrate the safety and efficacy of the device. Where appropriate, the tests were based on the requirements of the following documents: ISO 11135-1:2007 Sterilization of health care products -. Safety & Ethylene oxide - Part 1: Requirements for the development. Performance validation, and routine control of a sterilization process for Tests medical devices. . ISO 10993-7:2008 - Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals ASTM F1980-07 Standard Guide for Accelerated Aging of . Sterile Barrier Systems for Medical Devices. ASTM D4169 - 09 Standard Practice for Performance Testing . of Shipping Containers and Systems ISO 10993-1: 2009 Biological Evaluation of Medical Devices . Part 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.

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Merit Medical Systems, Inc. basixTOUCH Inflation Syringe Premarket Notification 510(k)

## K130566 3 of 3

Section 5 510(k) Summary

The following is a list of all significant performance testing that has been successfully completed for this device:

Device Testing

- Fluid Functional Use .
- � Gauge Accuracy
- Gauge Tensile ●
- Retainer Cap Bond Torque �
- Tip Adapter Securement ●
- Tip Securement ●
- . Vacuum Capability

Packaging Testing

- Visual Inspection .
- . Dye Penetration
- Underwater Leak Test ◆
- . Burst Strength Test

Summary of Substantial Equivalence

Based on the indications for use, design, safety, and performance testing, the subject basixTOUCH Inflation Device meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Merit basixCompak Analog Inflation Syringe (K122321) manufactured by Merit Medical Systems, Inc. Differences between the devices do not raise any different questions of safety or effectiveness.

Safety & Performance Tests

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars extending from the top of the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

June 19, 2013

Merit Medical Systems Dan Lindsay, RAC Regulatory Affairs Specialist III 2306 Sunnyside Avenue Salt Lake City, UT 84108

Rc: K130566

Trade/Device Name: BasixTOUCH Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: MAV Dated: May 23, 2013 Received: May 24, 2013

Dear Mr. Lindsay:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

Public Health Service

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

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Page 2 - Mr. Dan Lindsay

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 to!!-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.A. Hillerman

for Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Merit Medical Systems, Inc. basixTOUCH Inflation Syringe Premarket Notification 510(k)

Section 4 Indications for Use Statement

## 4 Indications for Use Statement

510(k) Number (if known):

Device Name: basixTOUCH™

Indications for Use:

The basixTOUCH inflation syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

K130566

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)

Image /page/5/Picture/12 description: The image shows the name "Bram D. Zuckerman - S" in large, bold font. Below the name is the date and time "2013.06.19 15:05:21 -04'00'" also in a large, bold font. In the background is a faded logo.