(13 days)
Not Found
No
The description focuses on mechanical components and their function, with no mention of AI or ML.
Yes.
The device is used during cardiothoracic surgical procedures to remove clots and evacuate blood and fluid from the operative site. These actions directly contribute to the patient's treatment and recovery.
No
The device is described as a system for clearing clots from chest tubes after cardiothoracic surgical procedures and chest trauma, designed to prevent or minimize chest tube occlusion and facilitate fluid evacuation. Its function is to maintain patency of the chest tube, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines physical components like a Chest Tube, Clearance Apparatus, Guide Tube, PTFE-coated Clearance Wire, and a magnetic shuttle. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used during surgical procedures and for chest trauma to actively clear clots from a chest tube. This is a direct intervention on the patient's body to maintain drainage, not a test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: The description details a physical system involving a chest tube and a clearance apparatus with a wire and loop. This is a mechanical device designed for drainage and clearance within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, fluid, tissue), reagents, or any diagnostic testing being performed by the device.
The device is a therapeutic and drainage device used in a clinical setting, not a diagnostic device used to analyze samples for medical information.
N/A
Intended Use / 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.
Product codes
OTK, GBX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest cavity
Indicated Patient Age Range
adult and pediatric patients including infant, preadolescent and adolescent patients
Intended User / Care Setting
clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The performance of the new models PFFG-20 XDL and PFFG-24 XDL 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: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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)
Page 1 of __1
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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 E | |
| Anaheim CA 92806 | |
| Primary Contact Person: | Dov Gal, DVM |
| ClearFlow, Inc. | |
| 1630 S. Sunkist St., Suite E | |
| Anaheim CA 92806 | |
| Phone: 714-916-5014 | |
| Fax: 714-916-5019 | |
| Email: dgal@clearflow.com | |
| CEO/President: | Paul Molloy |
| ClearFlow, Inc. | |
| 1630 S. Sunkist St., Suite E | |
| Anaheim CA 92806 | |
| Phone: 714-905-5271 | |
| Fax: 714-916-5019 | |
| Email: 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) by |
| ClearFlow, Inc. | |
| Device Description: | 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. | |
| Indication 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 |
4
5
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
6
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.