PleuraFlow System by CLEARFLOW, INC.

The PleuraFlow System is indicated 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.

Device Description

The PleuraFlow System is comprised of a silicone Chest Tube and a Clearance Apparatus. Currently the PleuraFlow Chest Tube is available in four (4) models with standard sizes (20FR, 24FR, 28FR and 32FR). The Chest Tubes of currently marketed and above-references PleuraFlow System models include six (6) eyelets distributed along an Effective Drainage Length of 4 inches (10.2 cm). The Effective Drainage Length is defined as the length of the Chest Tube having eyelets for the influx of fluid. The current Chest Tube models are available with a Cut Length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet. Each Chest Tube has a barium stripe to facilitate visualization. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister.

The new PleuraFlow System model is similar to the current models except for the Chest Tube, which has four eyelets instead of 6 eyelets. The short Effective Drainage length is only available with a 20FR Chest Tube identifies as: Short Effective Drainage Length (SEDL). This model has four (4) eyelets distributed along an Effective Drainage Length of 2 inches (5.1 cm). This Chest Tube model has a Cut Length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet and a barium stripe to facilitate visualization, as all of the currently marketed Chest Tubes have. Same as the marketed models, the 20FR SEDL 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 20FR SEDL Chest Tube is same as the predicate. It consists of a Guide Tube and a PTFE-coated Clearance Wire with a Loop set on its distal end, bent at a 105-degree angle. 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 Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube open.

The PleuraFlow System with 20FR Short Effective Drainage Length (SEDL) Chest Tube can be used when the surgeon determines that a chest tube with a shorter length of drainage holes, 2" (5.1 cm) is needed. This includes patients having smaller dimension chests (length of torso) that cannot accommodate Chest Tubes with longer EDLs.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PleuraFlow® System with Short Effective Drainage Length (SEDL) Chest Tube. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to present a de novo study proving the device meets specific acceptance criteria through a comprehensive clinical trial with a defined sample size, expert ground truth, or MRMC studies for AI devices.

Instead, this document focuses on demonstrating that a modified PleuraFlow System (with a shorter effective drainage length) is substantially equivalent to a previously cleared PleuraFlow System and its predicate. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of safety and effectiveness through mechanical testing and reliance on prior clearances, rather than specific performance metrics against clinical endpoints in a novel study for this particular modification.

Here's a breakdown of the information requested, based on the provided text:

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

Since this is a substantial equivalence submission for a modification, the "acceptance criteria" are not explicitly defined as performance targets for a new study, but rather the demonstration of equivalence through mechanical testing and leverage of prior clearances.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Demonstrated under predicate 510(k) K093565, in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
Flow Rate	Mechanical testing performed to establish substantial equivalence to predicate 510(k) K093565 (in accordance with BS EN 1617:1997).
Tensile Strength	Mechanical testing performed to establish substantial equivalence to predicate 510(k) K093565 (in accordance with BS EN 1618:1997).
Safety & Effectiveness (Overall)	Previously demonstrated through design validation and verification cleared under K093565 and K150042. Post-market data published in the Journal of Thoracic and Cardiovascular Surgery (Sirch et al. 2015) also cited.
Indication for Use	Same as the predicate device.

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

Sample Size for Test Set: Not applicable in the context of a new comprehensive study for this 510(k) submission. The testing mentioned (mechanical) would have been performed on a sample of the modified device. The document does not specify the exact number of units tested for mechanical properties.
Data Provenance: The document refers to mechanical testing standards (BS EN 1617:1997 and BS EN 1618:1997) which are European standards. The post-market data cited (Sirch et al. 2015) is a journal publication, but its specific provenance (country, retrospective/prospective) is not detailed in this 510(k) summary.

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 submission relies on mechanical testing against established standards and prior regulatory clearances, not expert review of a test set in the same way an AI device might.

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

Not applicable. This is not a study requiring adjudication of clinical data.

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

Not applicable. The PleuraFlow System is a medical device for drainage, not an AI diagnostic tool that assists human readers.

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

Not applicable. The PleuraFlow System is a physical medical device, not an algorithm.

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

For the mechanical testing mentioned, the "ground truth" would be the specifications and requirements defined by the BS EN 1617:1997 (flow rate) and BS EN 1618:1997 (tensile strength) standards. For the overall safety and effectiveness, the ground truth refers to the previously established clearances for the predicate devices and general medical device standards. The cited post-market data (Sirch et al. 2015) would relate to clinical outcomes data (e.g., "reduces retained blood"), but the details are not described in this 510(k) summary.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. See #8.

Summary

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Public Health Service

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

January 20, 2016

Clearflow Incorporated Mr. Dov Gal Vice President Regulatory Affairs and Quality Assurance 1630 South Sunkist St, Suite E Anaheim, California 92806

Re: K153681

Trade/Device Name: PleuraFlow® System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OTK, GBX Dated: September 17, 2015 Received: September 18, 2015

Dear Mr. Gal:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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 yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

K153681 510(k) Number:

PleuraFlow® System Device Name:

Indications for Use: The PleuraFlow System is indicated 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.

Prescription Use X	AND/OR	Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)		(21 CFR 807 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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Section 5: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for PleuraFlow® System with Short Effective Drainage Length (SEDL) Chest Tube 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:	December 21, 2015
Applicant:	ClearFlow, Inc.1630 S. Sunkist St., Suite EAnaheim CA 92806
Primary Contact Person:	Dov Gal, DVMClearFlow, Inc.1630 S. Sunkist St., Suite EAnaheim CA 92806Phone: 714-916-5014Fax: 714-916-5019Email: dgal@clearlflow.com
CEO/President:	Paul MolloyClearFlow, Inc.1630 S. Sunkist St., Suite EAnaheim CA 92806Phone: 714-905-5271Fax: 714-916-5019Email: pmolloy@clearlflow.com
Device Proprietary Name:	PleuraFlow® System

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Introduction/drainage; wound drain catheter system. Device Common Name:

Regulatory Class and Name: Class II, Powered Suction Pump

Product Codes: OTK and GBX

Indication For Use: The PleuraFlow System is indicated 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.

Predicate Device: Predicate device is the PleuraFlow System (K150042) by ClearFlow, Inc.

Device Description: The PleuraFlow System is comprised of a silicone Chest Tube and a Clearance Apparatus. Currently the PleuraFlow Chest Tube is available in four (4) models with standard sizes (20FR, 24FR, 28FR and 32FR). The Chest Tubes of currently marketed and above-references PleuraFlow System models include six (6) eyelets distributed along an Effective Drainage Length of 4 inches (10.2 cm). The Effective Drainage Length is defined as the length of the Chest Tube having eyelets for the influx of fluid. The current Chest Tube models are available with a Cut Length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet. Each Chest Tube has a barium stripe to facilitate visualization. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister.

The new PleuraFlow System model is similar to the current models except for the Chest Tube, which has four eyelets instead of 6 eyelets. The short Effective Drainage length is only available with a 20FR Chest Tube identifies as: Short Effective Drainage Length (SEDL). This

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model has four (4) eyelets distributed along an Effective Drainage Length of 2 inches (5.1 cm). This Chest Tube model has a Cut Length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet and a barium stripe to facilitate visualization, as all of the currently marketed Chest Tubes have. Same as the marketed models, the 20FR SEDL 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 20FR SEDL Chest Tube is same as the predicate. It consists of a Guide Tube and a PTFE-coated Clearance Wire with a Loop set on its distal end, bent at a 105-degree angle. 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 Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube open.

Performance Data: The safety and effectiveness of the PleuraFlow System has been previously demonstrated through design validation and verification that were cleared under 510(k) premarket notification K093565 and K150042. The biocompatibility evaluation for the PleuraFlow System was conducted under predicate 510(k) K093565, in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1.
Mechanical testing was performed to establish substantial equivalence to the predicate 510(k) K093565. Testing was performed in accordance with BS EN 1617:1997 and BS EN 1618:1997. These included flow rate and tensile strength testing.

Device performance has been further demonstrated through post-

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market data published in the Journal of Thoracic and Cardiovascular Surgery [Sirch J, Ledwon M, Püski T, Grossmann I, Boyle EM, Pfeiffer S, Fischlein T. Active Clearance of Chest Drainage Catheters Reduces Retained Blood. J Thorac Cardiovasc Surg. 2015 Oct 22. pii: S0022-5223(15)01970-4. doi: 10.1016/j.jtcvs.2015.10.015].

Conclusion: The device Indication for Use is same as the predicate. The evaluation of the PleuraFlow System does not raise any additional concerns regarding safety and effectiveness and may be considered substantially equivalent to the predicate device.

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.