The PleuraFlow® System with FlowGlide® is indicated for use during cardical procedures and chest trauma. Its Active Clearance Technology® proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.

Device Description

The PleuraFlow® System with FlowGlide(R) PFFG3 iss a modification to our current PleuraFlow® System with FlowGlide(R) (predicate). The primary components of the System are the Chest Tube and the Clearance Apparatus. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister.

The Clearance Apparatus that is part of the PleuraFlow System with FlowGlide consists of a Guide Tube with a magnetic shuttle and a PTFE-coated Clearance Wire with a Loop set on its distal end. The Clearance Apparatus is advanced into the PleuraFlow with FlowGlide Chest Tube using a magnetic Shuttle. When indicated, the Clearance Wire and Loop is advanced and retracted within the PleuraFlow with FlowGlide Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube patent. The PleuraFlow System with FlowGlide, PFFG3, has a new shuttle design that includes a spring activated button to allow the user to increase the magnetic force when needed. The range of magnetic force is the same as predicate.

AI/ML Overview

This document, a 510(k) summary for the ClearFlow PleuraFlow® System with FlowGlide®, describes the device as a modification of a previously cleared device. Therefore, the information provided focuses on bench testing to demonstrate substantial equivalence to the predicate device, rather than a clinical study with human subjects.

As a result, there is no information to fulfill questions 1-9 regarding acceptance criteria and study proving device meets acceptance criteria in a clinical context, such as:

A table of acceptance criteria and reported device performance (in a clinical study)
Sample size used for the test set and data provenance
Number of experts and their qualifications for ground truth
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone (algorithm only) performance
Type of ground truth (expert consensus, pathology, outcomes data)
Sample size for the training set
How ground truth for the training set was established

The document explicitly states: "No clinical performance was deemed necessary according to Risk Management assessment and evaluation." and "The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device."

The acceptance criteria and "study" described are focused on engineering and functional performance bench tests to demonstrate the device performs as intended and is equivalent to the predicate.

Here's an interpretation of the "acceptance criteria" and "study" based only on the provided text, but it's important to understand this is not a clinical study:

Acceptance Criteria and Study for the ClearFlow PleuraFlow® System with FlowGlide® (Based on Bench Testing for Substantial Equivalence)

Since this is a 510(k) submission for a modified device, the "study" conducted for proving the device meets acceptance criteria is primarily bench testing to demonstrate substantial equivalence to a previously cleared predicate device.

1. Table of Acceptance Criteria and Reported Device Performance (Bench Testing):

Acceptance Criterion (Test Performed)	Reported Device Performance (Result)
Actuation and Tracking of Clearance Wire and Loop	Demonstrated successful actuation and tracking through the coated chest tube tortuous path.
Functional Testing of the Shuttle:	The new shuttle design with a spring-activated button allows the user to increase magnetic force when needed, while maintaining the same range of magnetic force as the predicate.
- Coupling Force Testing of Shuttle to Clearance Wire and Loop	Performed and results indicate proper coupling.
- Force to Actuate, Force to Move Shuttle along Guide Tube	Performed and results demonstrate appropriate force for actuation and movement while coupled to the Clearance Wire and Loop.
Magnetic Flux Testing (Magnetic Field in Proximity to Device)	Performed and results show the magnetic field is within acceptable parameters.
Button Cycle Testing (for Button Function after Repeated Uses)	Performed and results demonstrate the button functions effectively after repeated uses.
Force to Separate the Shuttle Enclosure	Performed and results indicate appropriate force.
Transportation Simulation	Performed and results demonstrate device integrity after simulated transportation.
Tensile Strength of Drain Tubing to Drain Barb	Performed and results demonstrate adequate tensile strength.
Biocompatibility of Materials	Materials remain the same as the predicate and meet ISO 10993-1 applicable requirements.
Sterility (Device Provided Sterile and Single Use)	Meets ISO 11135:2014 requirements.
Overall Safety and Effectiveness Comparison to Predicate Device	"Results from performance testing of the new models... demonstrates that these are suitable for the intended use and did not raise new issues of safety and effectiveness when compared to the predicate models." "The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device." "Risk assessment, verification and validation... do not raise any additional concerns regarding safety and effectiveness and they are substantially equivalent to the predicate system."

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

Sample Size: Not specified in terms of number of units tested for each bench test, but implies a sufficient number were tested to validate the design.
Data Provenance: The tests are described as bench testing done internally by the manufacturer (ClearFlow, Inc.) and are prospective in nature for the modified device. No external or historical data is explicitly mentioned for these specific tests.

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

Not Applicable. This was a series of engineering and functional bench tests, not a clinical study requiring expert review of patient data to establish ground truth. The "ground truth" here is adherence to engineering specifications and performance comparable to the predicate.

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

Not Applicable. As per point 3, this was not a clinical study involving human judgment on cases. Test results would likely be adjudicated against pre-defined engineering pass/fail criteria.

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. An MRMC study is not relevant to this type of device or its premarket notification, which relies on bench testing and substantial equivalence to a predicate. There is no AI or human reader component mentioned.

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

No. This device is a mechanical system, not an algorithm.

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

The "ground truth" for this submission is engineering specifications, functional performance requirements, and comparison to the known performance of the predicate device. This includes passing criteria for physical and mechanical tests, and compliance with standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135:2014 for sterilization).

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not a machine learning or AI device. The "training" for the device would be its engineering design and manufacturing processes.

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

Not Applicable. (As per point 8.) The design and functionality are based on established engineering principles and the existing predicate device's proven performance over "more than 10 years."

Summary

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March 2, 2021

ClearFlow, Inc, Serrah Namini VP RA/QA/CA 140 Technology Drive, Suite 100 Irvine, California 92618

Re: K203394

Trade/Device Name: PleuraFlow System with FlowGlide Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OTK, GBX Dated: February 3, 2021 Received: February 4, 2021

Dear Serrah Namini:

We have reviewed your Section 5100k) 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies_combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0990-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K203394

Device Name PleuraFlow® System with FlowGlide®

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter

Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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K203394

510(k) Summary (807.92(c))

The following information is provided as required by 21 CFR § 807.92(c) for PleuraFlow® System with FlowGlide™ 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Date of Submission:	Nov 17, 2020
Applicant:	ClearFlow, Inc.140 Technology Drive, Suite 100Irvine, CA 92618
Primary Contact Person:	Serrah NaminiClearFlow, Inc.140 Technology Drive, Suite 100Irvine, CA 92618Phone: 714-916-5014Fax: 714-916-5019Email: snamini@clearflow.com
CEO/President:	Paul MolloyClearFlow, Inc.Phone: 714-905-5271Fax: 714-916-5019Email: pmolloy@clearflow.com
Device Proprietary Name:	PleuraFlow® System with FlowGlide®
Device Common Name:	Wound drain catheter system
Regulatory Class and Name:	Class II, 878.4780 Powered suction pump
Product Codes:	OTK and GBX

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Predicate Device: Predicate device is the PleuraFlow Catheter System (K163139 and number K182067) as well as K191733 by ClearFlow, Inc.

The PleuraFlow® System with FlowGlide(R) PFFG3 iss a Device Description: modification to our current PleuraFlow® System with FlowGlide(R) (predicate). The primary components of the System are the Chest Tube and the Clearance Apparatus. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister.

The Clearance Apparatus that is part of the PleuraFlow System with FlowGlide consists of a Guide Tube with a magnetic shuttle and a PTFE-coated Clearance Wire with a Loop set on its distal end. The Clearance Apparatus is advanced into the PleuraFlow Chest Tube using a magnetic Shuttle. When indicated, the Clearance Wire and Loop is advanced and retracted within the PleuraFlow with FlowGlide Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube patent. The PleuraFlow System with FlowGlide, PFFG3, has a new shuttle design that includes a spring activated button to allow the user to increase the magnetic force when needed. The range of magnetic force is the same as predicate.

The PleuraFlow® System with FlowGlide™ is indicated for use Indication For Use: during cardiothoracic surgical procedures and chest trauma. Its Active Clearance Technology proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.

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K203394

Technological Characteristics and Performance Data:

The performance of the new models of the PleuraFlow System with FlowGlide® was shown to be substantially equivalent to the cleared models (predicate) through bench testing.

Performance of new configuration of the PleuraFlow System was verified using the following testing as summarized in the submission:

. Test for actuation and tracking of the Clearance Wire and Loop through the coated chest tube tortuous path
Functional Testing of the Shuttle o
o Coupling force testing of the Shuttle to Clearance Wire and Loop
Force to actuate, force to move the Shuttle along the guide tube o of the clearance apparatus while coupled to the Clearance Wire and Loop
Magnetic Flux testing, magnetic field in proximity to the device ●
Button cycle testing, test for button function after repeated uses ●
. Force to separate the shuttle enclosure
Transportation simulation. ●
Tensile strength of the drain tubing to drain barb o

The biocompatibility of materials remains the same and as such, the new device meets ISO 10993-1 applicable requirements. The new device is provided sterile and single use and meets ISO 11135:2014 requirements.

The safety and effectiveness of the predicate have been previously demonstrated through design validation and verification that were cleared under 510(k) premarket notification (K163139 and number K182067). No clinical performance was deemed necessary according to Risk Management

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assessment and evaluation. Use of the predicate devices for more than 10 years has demonstrated safety and effectiveness for patients recovering after surgery and who were placed with the PleuraFlow System with Active Clearance Technology® (ACT®). The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device

Results from performance testing of the new models of PleuraFlow System with FlowGlide® PFFG3, demonstrates that these are suitable for the intended use and did not raise new issues of safety and effectiveness when compared to the predicate models.

The Indication for Use for the new configurations is same as Conclusion: the predicate. The fundamental design and technological characteristics are the same as the predicate. Risk assessment, verification and validation of the PleuraFlow System with FlowGlide®, PFFG3, do not raise any additional concerns regarding safety and effectiveness and they are substantially equivalent to the predicate system.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.