basixTOUCH40 Inflation Syringe

K153672 · Merit Medical Systems, Inc. · MAV · Jan 20, 2016 · Cardiovascular

Device Facts

• Record ID: K153672
• Device Name: basixTOUCH40 Inflation Syringe
• Applicant: Merit Medical Systems, Inc.
• Product Code: MAV · Cardiovascular
• Decision Date: Jan 20, 2016
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The basixTOUCH40 Inflation Syringe is used to inflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

Device Story

The basixTOUCH40 is a 30mL disposable inflation syringe featuring a threaded plunger assembly and a flexible high-pressure extension tube. Operated by clinicians in interventional settings, it generates positive and negative pressure to inflate/deflate balloons and monitors positive pressure from 0 to 40 ATM (0 to 588 PSI). The device utilizes a snap-fit connection between the gauge and syringe barrel, replacing the previous brass-fit design. By providing controlled pressure delivery and real-time pressure monitoring, the device assists clinicians in performing angioplasty or other interventional procedures, ensuring the balloon reaches the required pressure for effective treatment.

Clinical Evidence

Bench testing only. Performance data included fluid functional use, vertical and horizontal gauge tensile strength, vacuum capability, gauge accuracy, retainer cap bond torque, and tip adapter/tip securement. Results met all predetermined acceptance criteria. Biocompatibility testing was not required as the device does not have patient contact per ISO 10993-1:2009.

Technological Characteristics

30mL disposable inflation syringe; threaded plunger; flexible high-pressure extension tube; snap-fit gauge-to-barrel connection (plastic molded component with o-ring); pressure range 0 to 40 ATM. No patient-contacting materials.

Indications for Use

Indicated for inflation and deflation of angioplasty balloons or other interventional devices and pressure measurement within the balloon in patients undergoing 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

• BasixTOUCH Inflation Syringe (K130566)

Submission Summary (Full Text)

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

January 20, 2016

Merit Medical Systems, Inc. Dan Lindsay Project Manager, Regulatory Affairs 1600 West Merit Pkwy. South Jordan, Utah 84095

Re: K153672

Trade/Device Name: basixTOUCH40 Inflation Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: MAV Dated: December 18, 2015 Received: December 21, 2015

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. Please note: 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.

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

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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 (OS) 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 [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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Kenneth J. Cavanaugh -S

for

Bram 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) K153672

Device Name basixTOUCH40 Inflation Syringe

Indications for Use (Describe)

The basixTOUCH40 Inflation Syringe is used to inflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

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)

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| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date Prepared:<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>December 18, 2015<br>1721504 |
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| Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Review Panel: | basixTOUCH40 Inflation Syringe<br>Inflation Syringe<br>Angiographic injector and syringe<br>Class II<br>MAV<br>870.1650<br>74 Cardiovascular |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | BasixTOUCH Inflation Syringe<br>Angiographic injector and syringe<br>K130566<br>Merit Medical Systems, Inc.<br>This predicate has not been subject to a design-related recall |
| Device<br>Description | The basixTOUCH40TM Inflation Syringe by Merit Medical is a 30mL<br>disposable device with a threaded plunger assembly, a flexible high<br>pressure extension tube. The basixTOUCH40TM is designed to<br>generate positive and negative pressure, and monitor positive<br>pressures over a range of zero to +40ATM/BAR (zero to 588 PSI). | |
| Indications for<br>Use | The basixTOUCH40 Inflation Syringe is used to inflate and deflate an<br>angioplasty balloon or other interventional device, and to measure the<br>pressure within the balloon.<br>There is no change in the Indications for Use Statement from the<br>predicate to the subject device. | |

## 5.0 510(k) Summary

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The Technological characteristics of the subject basixTOUCH40 inflation syringe are considerably equivalent to those of the predicate, the Merit BasixTOUCH Inflation Syringe. The basixTOUCH40 generates higher pressure than the Predicate. Specifically, the predicate maximum pressure is 35 ATM while the subject maximum Comparison to pressure is 40 ATM. Predicate Device The connection between the gauge and the syringe barrel was modified from a brass-fit connection to a snap-fit connection. The predicate used brass and adhesive to attach the gauge to the syringe barrel; the subject device uses a plastic molded component and o-ring to connect the gauge to the syringe barrel. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject basixTOUCH40 Inflation Syringe was conducted based on the risk analysis. The following performance data were provided in support of the substantial equivalence determination. Biocompatibility testing Based on the categorization of the device with regard to patient contact and duration, biocompatibility testing is not required. Devices that do not have patient contact are not included in the scope of ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Performance Medical Devices, May 1, 1995 (FDA Bluebook Memo G95-1). Data Performance Testing ● Fluid Functional Use Vertical Gauge Tensile ● Horizontal Gauge Tensile ● Vacuum Capability ● Gauge Accuracy ● Retainer Cap Bond Torque ● Tip Adapter Securement and Tip Securement ● The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device.

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| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, safety and performance<br>testing, the subject basixTOUCH40 Inflation Syringe meets the<br>requirements that are considered essential for its intended use and is<br>substantially equivalent to the predicate device, the BasixTOUCH<br>Inflation Syringe, K130566 manufactured by Merit Medical Systems,<br>Inc. |
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