(13 days)
The PleuraFlow® System with FlowGlide® XDL 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.
The PleuraFlow® System with FlowGlide® XDL is an extension of the PleuraFlow® System with FlowGlide® (predicate). The primary components of the System are the Chest Tube and the Clearance Apparatus. The PleuraFlow System with FlowGlide XDL includes two (2) models: PFFG-20 XDL, and PFFG-24 XDL. Each model includes a Chest Tube with a cut length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet. Each of these Chest Tubes has 15 eyelets distributed along an Effective Drainage Length of 10 inches (25.4 cm). The Effective Drainage Length is defined as the length of the Chest Tube having eyelets for the influx of fluid. Each Chest Tube has a barium stripe to facilitate visualization in the chest cavity under X-ray. Both models include a Chest Tube with FlowGlide applied to the internal and external surfaces to reduce friction and allow easier sliding of the Clearance Wire assembly. 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 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 open.
This document describes the 510(k) premarket notification for the ClearFlow, Inc. PleuraFlow® System with FlowGlide® XDL, a device intended to proactively remove clots from chest tubes during cardiothoracic surgical procedures and chest trauma. The submission aims to demonstrate substantial equivalence to a predicate device, the PleuraFlow System with FlowGlide (K163139).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in terms of specific numerical thresholds. Instead, it describes various tests performed to demonstrate that the new models (PFFG-20 XDL and PFFG-24 XDL) are "substantially equivalent to the cleared models (predicate) through bench testing" and "suitable for the intended use." The performance is reported in a pass/fail manner, indicating that the new models met the requirements of these tests to demonstrate equivalence.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tensile strength / Force at break | Performance comparable to predicate device. | Verified (implied: met expectations for equivalence). |
| Kink testing | No unacceptable kinking that would impede function, comparable to predicate. | Verified (implied: met expectations for equivalence). |
| Force to actuate Clearance Wire and Loop through coated chest tube | Acceptable force for proper actuation and clot clearance, comparable to predicate. | Verified (implied: met expectations for equivalence). |
| Test for actuation and tracking of the Clearance Wire and Loop through the coated chest tube tortuous path | Smooth and effective movement of the clearance wire through complex paths, comparable to predicate. | Verified (implied: met expectations for equivalence). |
| Integrity / durability of the FlowGlide coating | Coating remains intact and functional over the expected usage duration, comparable to predicate. | Verified (implied: met expectations for equivalence). |
| Simulated use | Device performs as intended under simulated clinical conditions, comparable to predicate. | Verified (implied: met expectations for equivalence). |
| Biocompatibility (FlowGlide coating) | Met ISO 10993-1 standards for biological risk assessment. | Summary of test results provided in K163139 submission. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each bench test performed on the new models (PFFG-20 XDL and PFFG-24 XDL). The tests are described as "bench testing."
- Sample Size for Test Set: Not explicitly stated for the individual bench tests. It refers to "the new models PFFG-20 XDL and PFFG-24 XDL."
- Data Provenance: The data appears to be prospective as it involves new bench testing performed on the "new models" in support of the 510(k) submission. The country of origin for the data is not specified, but the applicant (ClearFlow, Inc.) is based in Anaheim, California, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the study described is a series of bench tests comparing a new device to a predicate, not a study involving human interpretation of data where "ground truth" would be established by experts (e.g., in medical image analysis). The "ground truth" for these engineering and performance tests would be the established specifications and performance characteristics of the predicate device and relevant industry standards.
4. Adjudication Method for the Test Set
- This information is not applicable for bench testing. Adjudication methods are typically used in clinical studies or studies involving human readers to resolve discrepancies in expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through bench testing, not on assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable as the PleuraFlow System is a medical device (a chest tube and clearance apparatus), not an AI algorithm.
7. The Type of Ground Truth Used
- For the bench testing described, the "ground truth" is based on the established performance specifications and characteristics of the legally marketed predicate device (PleuraFlow System with FlowGlide, K163139) and relevant engineering/performance standards (e.g., for tensile strength, kink resistance, coating integrity, and simulated use). The biological risk assessment for the coating was based on ISO 10993-1 standards.
8. The Sample Size for the Training Set
- This information is not applicable as the described study involves bench testing of a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as above (not a machine learning model).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 14, 2018
ClearFlow, Inc. Dr. Dov Gal, DVM, MBA Vice President, Regulatory Affairs, Ouality Assurance and Clinical 1630 S. Sunkist St. Suite E Anaheim, California 92806
Re: K182067
Trade/Device Name: PleuraFlow System with FlowGlide Extra Drainage Length Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OTK, GBX Dated: July 25, 2018 Received: August 1, 2018
Dear Dr. 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
David Krause -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
| 510(k) Number: | 182067 |
|---|---|
| ---------------- | -------- |
PleuraFlow® System with FlowGlide® XDL Device Name:
Indications for Use: The PleuraFlow® System with FlowGlide® XDL 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 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 FlowGlide® XDL 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.
| 510(k) Number: | 182067 |
|---|---|
| Date of Submission: | July 30, 2018 |
| 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@clearflow.com |
| CEO/President: | Paul MolloyClearFlow, Inc.1630 S. Sunkist St., Suite EAnaheim CA 92806Phone: 714-905-5271Fax: 714-916-5019Email: pmolloy@clearflow.com |
| Device Proprietary Name: | PleuraFlow® System with FlowGlide® XDL |
| Device Common Name: | Introduction/drainage; wound drain catheter system. |
| Regulatory Class and Name: | Class II, Powered Suction Pump |
| Product Codes: | OTK and GBX |
| Predicate Device: | Predicate device is the PleuraFlow System with FlowGlide (K163139) byClearFlow, Inc. |
| Device Description: | The PleuraFlow® System with FlowGlide® XDL is an extension of thePleuraFlow® System with FlowGlide® (predicate). The primarycomponents of the System are the Chest Tube and the Clearance Apparatus.The PleuraFlow System with FlowGlide XDL includes two (2) models:PFFG-20 XDL, and PFFG-24 XDL. Each model includes a Chest Tubewith a cut length of 19 inches (48.3 cm) with graduated measurements incentimeters from the distal eyelet. Each of these Chest Tubes has 15eyelets distributed along an Effective Drainage Length of 10 inches (25.4cm). The Effective Drainage Length is defined as the length of the ChestTube having eyelets for the influx of fluid. Each Chest Tube has a bariumstripe to facilitate visualization in the chest cavity under X-ray. Bothmodels include a Chest Tube with FlowGlide applied to the internal andexternal surfaces to reduce friction and allow easier sliding of theClearance Wire assembly. The Chest Tube is connected to a ClearanceApparatus, which is connected to the tubing from the drainage canister.The Clearance Apparatus that is part of the PleuraFlow System withFlowGlide consists of a Guide Tube and a PTFE-coated Clearance Wirewith a Loop set on its distal end. The Clearance Apparatus is advancedinto the PleuraFlow Chest Tube using a magnetic shuttle. When indicated,the Clearance Wire and Loop is advanced and retracted within thePleuraFlow with FlowGlide Chest Tube to proactively prevent or break upand clear any tube obstructions or clogging to keep the tube open. |
| Indication For Use: | The PleuraFlow® System with FlowGlide® XDL is indicated for useduring cardiothoracic surgical procedures and chest trauma. Its ActiveClearance Technology proactively removes clots formed inside the chesttube to prevent or minimize chest tube occlusion with clot. A patent chesttube enables evacuation of blood and fluid from the operative site after |
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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.
The performance of the new models PFFG-20 XDL and PFFG-24 XDL Performance Data: was shown to be substantially equivalent to the cleared models (predicate) through bench testing.
Performance of the new models PFFG-20 XDL and PFFG-24 XDL was verified using the following testing summarized in the submission:
- . Tensile strength / Force at break
- Kink testing ●
- . Force to actuate Clearance Wire and Loop through coated chest tube
- Test for actuation and tracking of the Clearance Wire and Loop . through the coated chest tube tortuous path
- Integrity / durability of the FlowGlide coating .
- Simulated use .
A biological risk assessment for the addition of FlowGlide® coating to the Chest Tube was performed in accordance with ISO 10993-1, a summary of test results was provided in 510(k) K163139 submission.
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. Use of the predicate device over the past eight (8) years has shown that the product has significantly reduced the complications for patients recovering from heart surgery and who were treated with the PleuraFlow System with Active Clearance Technology® (ACT®) versus other conventional Chest Tubes.
Results from performance testing of the new models of PleuraFlow System with FlowGlide®, PFFG-20 XDL and PFFG-24 XDL, demonstrate that these are suitable for the
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intended use and did not raise new issues of safety and effectiveness when compared to the predicate models.
The Indication for Use of models PFFG-20 XDL and PFFG-24 XDL is Conclusion: the same as the predicate. The design and technological characteristics are same as the predicate. Risk benefit analysis, verification and validation and biocompatibility of the PleuraFlow System with FlowGlide® XDL models do not raise any additional concerns regarding safety and effectiveness and may be considered substantially equivalent to the predicate models.
§ 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.