Who is the manufacturer of DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

Merit Medical Systems, Inc. filed the 510(k) submission for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe (K160107).

What is the FDA product code for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

DXT. It is classified under 21 CFR 870.1650 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

Monarch Inflation Syringe; Universal Fluid Dispensing Syringe (K011811).

Who can help prepare an FDA 510(k) submission like DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe

K160107 · Merit Medical Systems, Inc. · DXT · Jul 29, 2016 · Cardiovascular

Device Facts

Record ID	K160107
Device Name	DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
Applicant	Merit Medical Systems, Inc.
Product Code	DXT · Cardiovascular
Decision Date	Jul 29, 2016
Decision	SESK
Submission Type	Traditional
Regulation	21 CFR 870.1650
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The DiamondTOUCH Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid.

Device Story

Disposable 30mL inflation syringe with integral pressure transducer, microcomputer, and back-lit LCD; features threaded plunger assembly with lock/release trigger, flexible high-pressure extension tube, and three-way stopcock. Operated manually by clinician via rotating handle to generate positive/negative pressure (-0.4 to +35 ATM/BAR). Digital gauge displays real-time pressure and inflation duration. Used in clinical settings for interventional procedures; provides visual feedback during inflation to assist clinician in monitoring balloon pressure and time. Benefits include precise pressure control and monitoring during angioplasty or fluid dispensing.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included vacuum leak, syringe tolerance, pressure testing, gauge housing integrity, force, accuracy, tubing tensile retention, display functionality, and battery life. Biocompatibility testing (cytotoxicity) performed per ISO 10993-1. Electrical safety and EMC testing conducted per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

30mL disposable syringe; integral pressure transducer; microcomputer; back-lit LCD; threaded plunger with lock/release trigger; flexible high-pressure extension tube; three-way stopcock. Pressure range: -0.4 to +35 ATM/BAR. Standards: AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 62366, IEC 60601-1-6, ISO 10993-1, ISO 10993-5, ISO 594-2 (Luer lock).

Indications for Use

Indicated for inflation and deflation of balloon angioplasty catheters or other interventional devices, measurement of inflation pressure and time, and dispensing/monitoring of fluids in the body 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

Monarch Inflation Syringe; Universal Fluid Dispensing Syringe (K011811)

Reference Devices

basixTOUCH (K130566)
Monarch COMPAK Inflation Syringe and Universal Fluid Dispensing Syringe (K083523)

Related Devices

K122321 — BASIXCONPAK ANALOG INFLATION SYRINGE · Merit Medical Ireland, Ltd. · Dec 19, 2012
K083523 — MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE · Merit Medical Systems, Inc. · Feb 4, 2009
K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE · Beijing Demax Medical Technology Co.,Ltd · Mar 5, 2015
K130566 — BASIXTOUCH · Merit Medical Systems, Inc. · Jun 19, 2013
K122152 — OXTI INFLATION DEVICE · Oxti Corporation · Dec 14, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring a series of overlapping human profiles facing to the right, creating a sense of depth and continuity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 29, 2016 Merit Medical Systems, Inc. Dan W. Lindsay Project Manager, Regulatory Affairs 1600 West Merit Parkway South Jordan. Utah 84095 Re: K160107 Trade/Device Name: DiamondTOUCH Inflation Device and Fluid Dispensing Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT, MAV Dated: June 27, 2016 Received: June 28, 2016 Dear Dan 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. 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. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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. {1}------------------------------------------------ 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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Brian D. Pullin -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K160107 #### Device Name DiamondTOUCH™M Inflation Device and Fluid Dispensing Syringe Indications for Use (Describe) The DiamondTOUCH Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary - K160107 | General Provisions | Submitter Name: Address: Telephone Number: Fax Number: Contact Person: Date Prepared: Registration Number: | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 801-208-4408 801-253-6945 Dan W. Lindsay January 15, 2016 1721504 | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device | Trade Name: Common/Usual Name: Classification Name: Regulatory Class: Product Code: Subsequent Product Code: 21 CFR §: Review Panel: | DiamondTOUCH™ Inflation Device and Fluid Dispensing Syringe Inflation Syringe Angiographic injector and syringe Class II DXT MAV 870.1650 74 Cardiovascular | | Predicate Device | Trade Name: Classification Name: Subsequent Classification Name: Premarket Notification: Manufacturer: | Monarch Inflation Syringe; Universal Fluid Dispensing Syringe Injector and Syringe, Angiographic (DXT) Syringe, Balloon Inflation (MAV) K011811 Merit Medical Systems, Inc. This predicate has not been subject to a design-related recall | | Reference Devices | Trade Name: Classification Name: Premarket Notification: Manufacturer: | basixTOUCH Syringe, Balloon Inflation (MAV) K130566 Merit Medical Systems, Inc. | | | Trade Name: Classification Name: Premarket Notification: Manufacturer: | Monarch COMPAK Inflation Syringe and Universal Fluid Dispensing Syringe Injector and Syringe, Angiographic (DXT) K083523 Merit Medical Systems, Inc. | | Device Description | The DiamondTOUCH™ Inflation Device and Fluid Dispensing Syringe by Merit Medical is a 30mL disposable device with an integral pressure transducer, microcomputer, back-lit LCD, threaded plunger assembly with lock/release bar, a flexible high pressure extension tube, and a three-way stopcock. The DiamondTOUCH™ is designed to generate positive and negative pressure, and monitor positive pressures over a range of -0.4 ATM/BAR to +35ATM/BAR (-6 PSI to 514 PSI). | | | Indications for Use | The DiamondTOUCH Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid. | | | Comparison to Predicate Device | At a high level, the subject and predicate devices are based on the following same technological elements: Same basic design with the same principle of operation. Manual operated by manipulation of a rotating handle. The plunger threads of both syringes can be locked or retracted by using the trigger of the handle. This action allows the plungers to be advanced or withdrawn or locked within the barrel. When the trigger is released, the syringes both generate pressure by rotating the handle with the same clockwise motion. Digital gauge that presents pressure and time of inflation. The following technological differences exist between the subject and predicate devices: The subject device has a larger volume (30ml verses 20ml). The subject device has a higher pressure capability (35 ATM verses 30 ATM). The digital display is larger with a visual representation of during inflation like an analog needle gauge. The handle design was revised to incorporate a one handed preparation capability. | | | Performance Data | No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject DiamondTOUCH Inflation Syringe was conducted based on the risk analysis and based on the requirements of the following international standards: AAMI ANSI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment: Part I: General | | {4}------------------------------------------------ {5}------------------------------------------------ - IEC 60601-1-2 Medical electrical equipment. General requirements . for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests (19-1) - IEC 62366:2008+A1: 2015 Medical devices Application of . usability engineering to medical devices (5-95) - IEC 60601-1-6 Edition 3.1:2012 Medical electrical equipment: Part . 1-6: General requirements for basic safety and essential performance Collateral standard: Usability (5-89) - . 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. (2-156) - AAMI / ANSI / ISO 10993-5:2009/(R) 2014, biological evaluation of ● medical devices -- part 5: tests for in vitro cytotoxicity. (2-153) - ISO 594-2 Second edition 1998-09-01 Conical Fittings with a 6% . (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings (6-129) The following performance data were provided in support of the substantial equivalence determination. ## Biocompatibility Testing The biocompatibility evaluation for the DiamondTOUCH Inflation Syringe was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. As a result of the evaluation, a Cytotoxicity test was performed. The DiamondTOUCH Inflation Syringe is considered an externally communicating device with indirect blood contact for a limited (≤ 24 hours) duration. ## Electrical Safety and Electromagnetic Compatibility (EMC) Electrical safety and EMC testing were conducted on the DiamondTOUCH Inflation Syringe, consisting of the digital gauge, The system complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC. ## Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator. {6}------------------------------------------------ | | Performance Testing | | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Performance Data cont. | • Vacuum Leak • Syringe Tolerance • Pressure Test • Gauge Housing Integrity • Force | • Accuracy Test • Tubing Tensile Retention • Display Functionality • Battery Life | | Summary of Substantial Equivalence | Based on the indications for use, design, safety and performance testing, the subject DiamondTOUCH Inflation Syringe meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Monarch Inflation Syringe; Universal Fluid Dispensing Syringe, K011811. | |