Fluent inflation device

K162272 · Vascular Solutions, Inc. · MAV · Oct 20, 2016 · Cardiovascular

Device Facts

• Record ID: K162272
• Device Name: Fluent inflation device
• Applicant: Vascular Solutions, Inc.
• Product Code: MAV · Cardiovascular
• Decision Date: Oct 20, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

Device Story

Fluent inflation device is a manual, single-use, sterile syringe-based tool used during cardiovascular procedures. It consists of a barrel, plunger, locking button, rotating handle, manometer, and high-pressure tube with a rotating luer lock. The operator (clinician) manually rotates the handle to inflate or deflate angioplasty balloon catheters; the locking mechanism maintains pressure or enables rapid deflation. The manometer provides real-time pressure monitoring (vacuum to 30 atm). The device assists clinicians in achieving precise balloon inflation, which is critical for successful angioplasty procedures.

Clinical Evidence

Bench testing only. Verification tests included pressure (hand pressurization, repeat, static), force (button lock/unlock), plunger torque, and ease of use. All results met specified acceptance criteria.

Technological Characteristics

Manual, single-use, sterile inflation device. Components: barrel, plunger, locking button, rotating handle, manometer (vacuum to 30 atm), high-pressure tube with rotating luer lock. Mechanical operation; no software or electronic components.

Indications for Use

Indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in balloon catheters. Prescription use only.

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

• Fluent inflation device (K152387)

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

October 20, 2016

Vascular Solutions, Inc. Ms. Beka Vite Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K162272

Trade/Device Name: Fluent Inflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: MAV Dated: September 28, 2016 Received: September 29, 2016

Dear Ms. Vite:

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 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.

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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,

# 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

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## Indications for Use

510(k) Number (if known)

K162272

Device Name Fluent inflation device

Indications for Use (Describe)

The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 2 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: August 11, 2016

510(k) Number:

### Submitter's Name / Contact Person

| Manufacturer | Contact Person |
|--------------------------------------|-----------------------------------|
| Vascular Solutions, Inc. | Beka Vite |
| 6464 Sycamore Court North | Sr. Regulatory Product Specialist |
| Minneapolis, MN 55369 USA | Tel: [phone] |
| Establishment Registration # 2134812 | Fax: [phone] |

#### General Information

| Trade Name | Fluent inflation device |
|---------------------|--------------------------------------------------------------|
| Common / Usual Name | Inflation device |
| Classification Name | 21 CFR 870.1650, MAV – Syringe, balloon inflation |
| Predicate Device | K152387 - Fluent inflation device (Vascular Solutions, Inc.) |

### Device Description

The Fluent inflation device consists of a barrel with a plunger, locking button, rotating handle, manometer, and high pressure tube with a rotating luer lock. The manometer is graduated between vacuum and 30 atm.

#### Intended Use

The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

### Technological Characteristics Comparison

The Fluent inflation device is similar in design and identical in intended use to the predicate device as they are both single-use, sterile inflation devices used to inflate, deflate, and measure the pressure in angioplasty balloon catheters. Both devices are manually operated by manipulation of a rotating handle, and both include a locking mechanism to maintain pressure or achieve rapid deflation.

### Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence that the modified Fluent inflation device is substantially

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equivalent to the predicate device. The modified Fluent inflation device is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The modified device design has been verified through the following tests:

- . Pressure (hand pressurization, repeat hand pressurization, static pressure)
- Force (button lock and unlock)
- Plunger Torque
- . Ease of Use

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Fluent inflation device is substantially equivalent to the predicate device.