The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter. The sidearm extension tubing is intended to provide a sterile fluid pathway between two devices.

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 male luer lock. The manometer is graduated between vacuum and 30 atm. The extension tubing is a plastic tube with plastic luer lock connector hubs (one male and one female) at either end. It is available in 25 cm and 50 cm lengths.

AI/ML Overview

This document describes the Fluent inflation device, intended for use during cardiovascular procedures, and its substantial equivalence to predicate devices. It does not contain information about an AI-powered device or a study involving human readers or AI assistance. Therefore, I cannot provide the requested information regarding acceptance criteria and study details related to AI performance.

However, based on the provided text, I can extract the acceptance criteria and the study that proves the Fluent inflation device meets these criteria. Please note that this is NOT an AI device, and therefore several requested sections of your prompt will be marked as "N/A" (Not Applicable).

Here is the information from the provided text about the Fluent inflation device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria or detailed reported device performance values in a table format. Instead, it states that the design verification tests "met the specified acceptance criteria" and "passed" the biocompatibility tests.

Acceptance Criteria Category	Reported Device Performance Summary (Qualitative)
Fluent Inflation Device Design Verification Tests
Ease of Use	Met specified acceptance criteria
Pressure	Met specified acceptance criteria
Force	Met specified acceptance criteria
Plunger Torque	Met specified acceptance criteria
Tensile	Met specified acceptance criteria
Fluid Capacity	Met specified acceptance criteria
Luer Compatibility	Met specified acceptance criteria
Extension Tubing Design Verification Tests
Luer Compatibility	Met specified acceptance criteria
Pressure	Met specified acceptance criteria
Biocompatibility Tests (for both Fluent inflation device and extension tubing)
Cytotoxicity	Passed (required by ISO 10993-1)
Sensitization	Passed (required by ISO 10993-1)
Irritation/Intracutaneous Reactivity	Passed (required by ISO 10993-1)
Acute Systemic Toxicity	Passed (required by ISO 10993-1)
Material Mediated Pyrogenicity	Passed (required by ISO 10993-1)
ASTM Hemolysis	Passed (required by ISO 10993-1)
Complement Activation	Passed (required by ISO 10993-1)
Coagulation	Passed (required by ISO 10993-1)
In Vitro Hemocompatibility	Passed (required by ISO 10993-1)
Thrombogenicity (extension tubing only)	Passed (required by ISO 10993-1)

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "samples" of the device and extension tubing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This is a medical device, not an AI model that requires expert annotation for ground truth. The 'ground truth' for device performance is established by meeting predefined engineering and biological specifications through testing.

4. Adjudication method for the test set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers or AI systems to resolve discrepancies in diagnoses or interpretations. This is a physical medical device.

5. If a multi-reader multicase (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This document describes a physical medical device, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This document describes a physical medical device, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on predefined engineering specifications, international standards (like ISO 10993-1 for biocompatibility), and regulatory requirements for medical devices of its type. The device's functionality and safety are evaluated against these objective criteria rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set

N/A. This document describes a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

N/A. This document describes a physical medical device, not an AI model.

Summary

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

December 18, 2015

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

Re: K152387

Trade/Device Name: Fluent Inflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II Product Code: MAV Dated: November 12, 2015 Received: November 16, 2015

Dear Beka 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. 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. 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. 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 device-related 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 (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" (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 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,

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

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Indications for Use

510(k) Number (if known): K152387

Device Name: Fluent inflation device

Indications for Use: The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter. The sidearm extension tubing is intended to provide a sterile fluid pathway between two devices.

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)

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510(k) Summary

[As required by 21 CFR 807.92] Date Prepared: August 20, 2015 510(k) Number: K152387

Submitter's Name / Contact Person

Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Beka Vite Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-656-4253

General Information

Trade Name	Fluent inflation device
Common / Usual Name	Inflation device
Classification Name	21 CFR 870.1650, MAV – Syringe, balloon inflation
Predicate Devices	K082755 - Sedat Flamingo (Sedat)
	K963749 - High Pressure Injection Lines (Maxxim Medical)

Device Description

Indications for Use

Technological Characteristics Comparison

The Fluent inflation device and the sidearm extension tubing are similar in design and intended use to their respective predicate devices. The Fluent and its predicate 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. The extension tubing and its predicate are both plastic tubes with plastic luer lock connector hubs (one male and one female) at either end.

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Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through biocompatibility and mechanical tests, and results did not raise new issues of safety or effectiveness. The Fluent inflation device and extension tubing are substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The Fluent inflation device design has been verified through the following tests:

Ease of Use
Pressure ●
Force
. Plunger Torque
Tensile ●
. Fluid Capacity
Luer Compatibility ●

The extension tubing design has been verified through the following tests:

Luer Compatibility
Pressure

Fluent inflation device and extension tubing samples passed the following biocompatibility tests required by ISO 10993-1:

. Cytotoxicity
. Sensitization
. Irritation/Intracutaneous Reactivity
Acute Systemic Toxicity ●
Material Mediated Pyrogenicity .
. ASTM Hemolysis
Complement Activation ●
Coagulation
In Vitro Hemocompatibility ●
Thrombogenicity (extension tubing only) .

The results of the design verification tests met the specified acceptance criteria and did not raise new questions of safety and effectiveness. Therefore, the Fluent inflation device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.