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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Fluent Inflation Device." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on bench testing. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving those criteria are met in the format of a clinical or AI-based diagnostic study.

Here's an analysis of what can be extracted and what information is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (General)	Reported Device Performance (General)
Specified acceptance criteria for bench tests	Results of verification tests met the specified acceptance criteria

Missing Specifics: The document states that "results of the verification tests met the specified acceptance criteria," but it does not provide the specific quantitative acceptance criteria (e.g., "pressure retention for X minutes with < Y% drop") nor the specific quantitative performance results (e.g., "achieved X PSI and maintained for Y minutes with Z% drop").

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the tests.
Data Provenance: Not specified. This typically refers to a clinical study, but the document only mentions "bench tests."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: This device is a mechanical inflation device, not a diagnostic imaging or AI device that relies on expert interpretation for ground truth. The "ground truth" for this device would be based on engineering specifications and physical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: Adjudication methods are typically used in clinical trials or AI studies where human interpretation or consensus is required. For bench testing of a mechanical device, performance is typically measured against pre-defined engineering specifications.

5. If a multi reader multi case (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

No, not done: This is a mechanical device, not an AI or diagnostic imaging device. An MRMC study is irrelevant to this submission.

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

Not Applicable: This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Engineering Specifications/Physical Measurements: The "ground truth" for a device like this would be its ability to physically perform to its engineering specifications (e.g., maintaining pressure, ease of use measurements, torque values).

8. The sample size for the training set

Not Applicable: This is a mechanical device, not an AI device that requires a training set.

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

Not Applicable: No training set or associated ground truth for this type of device.

Summary of what the document does provide regarding the "study":

The study referenced is a series of "bench tests" to evaluate the modified Fluent inflation device's functionality and technological characteristics. The tests performed include:

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

Conclusion:

The provided document is a 510(k) submission for a mechanical inflation device. It describes "bench tests" to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed clinical or AI-related study information, acceptance criteria specifics, or sample sizes as requested in your prompt. The questions you've posed are largely applicable to AI/diagnostic imaging devices, whereas this submission pertains to a physical, mechanical medical device.

Summary

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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 (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,

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: 763-656-4300
Establishment Registration # 2134812	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 Device	K152387 - Fluent inflation device (Vascular Solutions, Inc.)

Device Description

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.

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.