PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 21, 2014 Teleflex Medical, Inc. % Ms. Holly Hallock Regulatory Affairs Specialist 2917 Weck Dr. Po Box 12600 Research Triangle Park, North Carolina 27709 Re: K140197 > Trade/Device Name: Pleur-evac Plus Continuous Reinfusion And Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: September 9, 2014 Received: September 10, 2014 Dear Ms. Hallock, 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 {1}------------------------------------------------ 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 the quality systems (OS) 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, M.A. Hillebrand for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Page 1 of 1 #### 510(k) Number: K140197 Device Name: Pleur-evac® Plus Continuous Reinfusion Autotransfusion System #### Indications for Use: - . For the collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations, - To evacuate air and/or fluid from the chest cavity or mediastinum, - To help prevent air and/or fluid from re-accumulating in the chest cavity or ● mediastinum, - To help re-establish and maintain normal intra-thoracic pressure gradients, ● - o To facilitate complete lung re-expansion to restore normal breathing dynamics. Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR Over-the-counter use ___ (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) {3}------------------------------------------------ # 510(k) SUMMARY #### Pleur-evac® Plus Continuous Reinfusion Autotransfusion System #### A. Name, Address, Phone and Fax Number of Applicant Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-4918 Fax: 919-433-4996 #### B. Contact Person Holly Kornegay Regulatory Affairs Specialist #### C. Date Prepared January 24, 2014 #### D. Device Name | Trade Name: | Pleur-evac® Plus Continuous Reinfusion<br>Autotransfusion System | |----------------------------|------------------------------------------------------------------| | Common Name: | Autotransfusion Apparatus | | Regulatory Classification: | Class II | | Regulation Number: | 21 CFR 868.5830 | | Product Code: | CAC | ## E. Device Description Provided as a sterile unit and intended for single patient use, the A-9250LF Pleurevac® Plus Continuous Reinfusion Autotransfusion System is a three-chamber, collection/reinfusion system used for the collection and continuous reinfusion of autologous blood. By attaching a blood transfer bag, which is available as an accessory item, the A-9250LF Pleur-evac® Plus serves as a bag reinfusion system with a non-pyrogenic fluid path. When autotransfusion is complete, the A-9250LF Pleur-evac® Plus can serve as a water seal/dry suction chest drainage collection unit. #### F. Indications for Use Pleur-evac® Plus Continuous Reinfusion Autotransfusion Systems are indicated for: - For the collection of autologous blood from the patient's pleural cavity or mediastinal ● area for reinfusion purposes in trauma and post-operative situations, {4}------------------------------------------------ - To evacuate air and/or fluid from the chest cavity or mediastinum, ● - To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum, ● - To help re-establish and maintain normal intra-thoracic pressure gradients, . - To facilitate complete lung re-expansion to restore normal breathing dynamics. . ## G. Contraindications Pleur-evac® Plus Continuous Reinfusion Autotransfusion Systems are contraindicated for: - · Pericardial, mediastinal, or systemic infections, - · Pulmonary and respiratory infection or infestation, - · Presence of malignant neoplasms. - · Coagulopathies, - · Suspected thoraco-abdominal injuries with possible enteric contamination, - · Impaired renal function, - · Intraoperative thoracic or mediastinal cavity use of topical thrombin, microfibrillar hemostatic agents or providine-iodine antiseptic gels or solutions and non I.V. compatible antibiotics. ## H. Substantial Equivalence The proposed Pleur-evac® Plus Continuous Reinfusion Autotransfusion System is substantially equivalent to the predicate device: | Predicate Device | Manufacturer | 510(k) No. | Date Cleared | |-------------------------------------------------------------------------------------|-----------------------------------------|------------|-----------------| | Deknatel® A-9150 Pleur-evac®<br>Plus Continuous Reinfusion &<br>Autoinfusion System | Pfizer Hospital<br>Products Group, Inc. | K911656 | August 13, 1991 | ## I. Comparison to Predicate Devices The Pleur-evac® Plus Continuous Reinfusion Autotransfusion System has the same indication for use and functional characteristics as the predicate system. The proposed modifications are changes in the material and manufacturing process of the collection tubing and in the material of the high negative pressure relief valve (HNRV) filter. Additionally, there are proposed changes to the material of the faceplate, the back and the universal connector. # J. Materials All patient contacting materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1. ## K. Technological Characteristics {5}------------------------------------------------ A comparison of the technological characteristics of the proposed Pleur-evac® Plus Continuous Reinfusion Autotransfusion System and the predicate has been performed. The results of this comparison demonstrate that the Pleur-evac® Plus Continuous Reinfusion Autotransfusion System collection tubing, HNRV filter, faceplate, back and universal connector are equivalent to the marketed predicate device in technological characteristics. A summary of these comparisons is included in the table below. For a complete comparison chart, please refer to Section 16. | Technological<br>Characteristics | Predicate Device, A-9150 | Proposed Device, A-9250LF | Comparison | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Indications for<br>Use | For the collection of<br>autologous blood from<br>the patient's pleural<br>cavity or mediastinal<br>area for reinfusion<br>purposes in trauma and<br>post-operative<br>situations, To evacuate air and/or<br>fluid from the chest<br>cavity or mediastinum, To help prevent air<br>and/or fluid from re-<br>accumulating in the<br>chest cavity or<br>mediastinum, To help re-establish<br>and maintain normal<br>intra-thoracic pressure<br>gradients, To facilitate complete<br>lung re-expansion to<br>restore normal<br>breathing dynamics. | For the collection of<br>autologous blood from the<br>patient's pleural cavity or<br>mediastinal area for<br>reinfusion purposes in<br>trauma and post-operative<br>situations, To evacuate air and/or fluid<br>from the chest cavity or<br>mediastinum, To help prevent air and/or<br>fluid from re-accumulating<br>in the chest cavity or<br>mediastinum, To help re-establish and<br>maintain normal intra-<br>thoracic pressure gradients, To facilitate complete lung<br>re-expansion to restore<br>normal breathing dynamics. | Same | | Collection | Yes, the A-9150 featured a<br>collection compartment for<br>either gravity or suction<br>drainage and collection. | Yes, the A-9250LF features a<br>collection compartment for<br>either gravity or suction drainage<br>and collection. | Same | | Reinfusion | Yes, when connected to an<br>accessory bag, the A-9150<br>was capable of reinfusion<br>and autotransfusion via a<br>reinfusion port in the<br>collection chamber base. | Yes, when connected to an<br>accessory bag, the A-9250LF is<br>capable of reinfusion and<br>autotransfusion via a reinfusion<br>port in the collection chamber<br>base. | Same | # L. Performance Data {6}------------------------------------------------ Teleflex has performed bench testing to verify that the performance of the proposed Pleur-evac® Plus Continuous Reinfusion Autotransfusion System is substantially equivalent to that of the predicate device and that the Pleur-evac® Plus Continuous Reinfusion Autotransfusion System is seamlessly interchangeable with the predicate device. Various functionality tests were performed to ensure that the collection tubing, HNRV filter, faceplate, back and universal connector will perform as intended. The test results are summarized below. For more details, please refer to Section 23. | Product<br>Description | Quantity | Test Parameters | Results | |---------------------------------------------|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Kink | 300 | A visual inspection must be<br>performed to ensure that all<br>pouched tubing is coiled<br>correctly without kinks. | Pass | | Tubing Clamp<br>Leak | 60 | No leaks in the tubing when<br>clamped at 60 cm H2O for<br>vacuum and at 4 cm H2O<br>positive pressure minimum. | Pass | | Tubing Collapse | 300 | No tubing collapse at 340<br>cm H2O negative pressure. | Pass | | ATS Connector<br>Pull Test | 60 | Separation force of ATS<br>Connector from tubing. | Pass | | Inter- Chamber<br>Leak Test | 60 | All compartments must<br>hold the indicated volumes<br>with liquid spillover<br>occurring only at the<br>spillover level. | Pass | | Leak Integrity Test | 60 | The unit shall be airtight<br>when operated at negative<br>pressure 60 cm H2O | Pass | | Burst Test | 60 | The unit shall have a<br>minimum burst strength of<br>5 psig (PSI Gauge) at<br>welded joints with all<br>openings to atmosphere<br>sealed | Pass | | Reinfusion Tube<br>Separation Force<br>Test | 60 | The separation force of the<br>tube and spring from the<br>reinfusion port and the<br>tube from the spike port<br>shall be a minimum of 10<br>lbs axially | Pass | # M. Conclusion Based upon the comparative test results, the proposed Pleur-evac® Plus Continuous Reinfusion Autotransfusion System is substantially equivalent to the predicate device cleared to market via 510(k) K911656. The modifications made to the proposed {7}------------------------------------------------ Pleur-evac® Plus Continuous Reinfusion Autotransfusion System do not introduce any new issues of safety and effectiveness.