PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM

{0}------------------------------------------------ /20953 ## Pleur-evac® Autotransfusion Systems #### DEC 1 0 2012 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS #### Pleur-evac® Autotransfusion Systems #### A. Name, Address, Phone and Fax Number of Applicant Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8049 919-433-4996 Fax: #### B. Contact Person - Natalie Smith Regulatory Affairs Specialist Lorraine DeLong Manager RA/OE Surgical # C. Date Prepared March 28, 2012 #### D. Device Name Trade Name: Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System, Pleur-evac® Autotransfusion Bag, Pleur-evac® Sahara Autotransfusion Bag Common Name: Autotransfusion Apparatus Classification Name: Autotransfusion Apparatus #### E. Device Description Teleflex Medical offers a line of Chest Drainage and Autotransfusion Systems. This line includes Chest Drainage units with a variety of suction and seal technologies. The three lines are the Wet Suction/Wet Seal, Dry Suction/Wet Seal, and Dry Suction/Dry Seal technologies. The Dry Suction/Dry Seal are branded the Sahara Series. Each technology of Chest Drainage devices can be coupled with an Autotransfusion (ATS) Bag for reinfusion capability. In addition, there is the S-1150-08LF, Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System that can be reinfused from the Drainage Unit. This submission will cover the Sahara reinfusion unit and the ATS Bags that can be mated with the different technology Chest Drainage Units. The Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System (S-1150-08LF) is provided as a sterile unit intended for single patient use. The fluid path is non- Teleflex Medical, Inc. {1}------------------------------------------------ pyrogenic. The Pleur-evac Sahara Plus System is used for the collection and continuous reinfusion of autologous blood. By attaching the Pleur-evac Sahara Autotransfusion Bag (S-100-08LF), the Pleur-evac Sahara Plus System serves as a bag reinfusion system. When autotransfusion is completed, the Pleur-evac Sahara Plus System can serve as a chest drainage collection unit. The Autotransfusion(ATS) Bag is a sterile, non-pyrogenic, single-use, blood collection and reinfusion device intended for the post-surgical, chest-drainage market. The ATS Bag attaches to the appropriate Pleur-evac Chest Drainage System. The S-100-08LF attached to a Sahara branded Pleur-evac® unit and an A-1500-08LF attaches to a standard Pleur-evac® unit. #### F. Indications for Use #### AUTOTRANSFUSION - l . For the collection of autologuous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations #### CHEST DRAINAGE - 1. To evacuate air and/or fluid from the chest cavity or mediastinum - 2. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. - 3. To help re-establish and maintain normal intra-thoracic pressure gradients. - 4. To facilitate complete lung re-expansion to restore normal breathing dynamics. The Pleur-evac® Autotransfusion Bag is indicated as a sterile, single use device used for collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac® System. The fluid path is non-pyrogenic. #### G. Contraindications Pleur-evac® 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 {2}------------------------------------------------ ## H. Substantial Equivalence The proposed Pleur-evac® Plus Continuous Autotransfusion System is substantially equivalent to the predicate devices: | Predicate Device | Manufacturer | 510(k) No. | Date Cleared | |-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------|--------------------| | Pleur-evac® Sahara Plus<br>Continuous Reinfusion<br>Autotransfusion System | Genzyme Biosurgery | K031554 | July 25, 2003 | | Pleur-evac® Sahara<br>Adult/Sahara Chest Drainage<br>System Models S-1100, S-1200,<br>S-2100 and S-2200 with Model<br>S-100 Autotransfusion Bag | Deknatel DSP<br>Worldwide<br>Incorporated | K962856 | September 10, 1996 | ## I. Comparison To Predicate Devices The proposed Pleur-evac® Autotransfusion Systems have the same technology, indications for use and functional characteristics as the predicate systems. The proposed modification is a change in the material and manufacturing process of the collection tubing of the Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System. ## J. Materials All patient contacting materials are in compliance with ISO10993-1. #### K. Technological Characteristics A comparison of the technological characteristics of the proposed Pleur-evac® Autotransfusion Systems and the predicate has been performed. The results of this comparison demonstrate that the Pleur-evac® Autotransfusion System tubing is equivalent to the marketed predicate devices in performance characteristics. There were no technological changes made to the proposed device. #### L. Performance Data The bench testing has been performed to verify that the performance of the proposed Pleur-evac® Autotransfusion Systems are substantially equivalent to the predicate device, and that the Pleur-evac® Autotransfusion System tubing will perform as intended. . | Performance<br>Test | Summary | Result | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Kink Resistance | The proposed and predicate patient<br>tubing were visually inspected for<br>kink resistance. This test simulated<br>the various radiuses the tubing could<br>be subjected to during coiling and/or<br>packaging. | The results showed that<br>the proposed patient<br>tubing has a greater<br>ability to withstand<br>kinking. | A Summary of the performance testing completed is shown below: Teleflex Medical, Inc. {3}------------------------------------------------ | Performance<br>Test | Summary | Result | |-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Leak Integrity | The proposed tubing was subjected<br>to positive and negative pressures to<br>determine the capability of<br>withstanding leakage. | The proposed tubing<br>passed the leak integrity<br>test with no leaks at<br>tubing joints. | | Tubing Clamp<br>Leak | The proposed tubing in a clamped<br>configuration was subjected to<br>positive and negative pressures to<br>determine the capability of<br>withstanding leakage. | The proposed tubing<br>passed the leak test with<br>no leaks at the clamp. | | Tubing Collapse | The proposed and predicate patient<br>tubing was exposed to a high<br>amount of negative pressure and<br>visually inspected for tubing<br>collapse. | All units passed the<br>tubing collapse test - the<br>proposed tubing did not<br>collapse under imposed<br>high pressure condition. | | ATS Connector<br>Pull Test | The pull test required that the ATS<br>Connector be able to withstand a<br>minimum amount of force without<br>being separated from the proposed<br>tubing. | The proposed tubing<br>withstood the minimum<br>amount of force applied<br>without separation from<br>the ATS Connector. | | Back Port Pull<br>Test | The pull test required that the<br>proposed tubing be able to withstand<br>a minimum amount of force without<br>being separated from the Back Port<br>of the unit. | The proposed tubing<br>withstood the minimum<br>amount of force applied<br>without separation from<br>the Back Port. | | Universal<br>Connector Pull<br>Test | The pull test required that the<br>Universal Connector be able to<br>withstand a minimum amount of<br>force without being separated from<br>the proposed tubing. | The proposed tubing<br>withstood the minimum<br>amount of force applied<br>without separation from<br>the Universal Connector. | #### M. Pre-Clinical Testing The sterilization cycle has been validation to meet the requirements of AAMI/ANSI/ISO 11135-1:2007 Sterilization of health care products Ethylene Oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, AAMI/ANSI/ISO 11737-1:2006 Sterilization of medical devices – Microbiological methods – Part 1: Determination of the population of microorganisms on product, and AAMI/ANSI/ISO 10993-7:2008 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals. The Biological Evaluation of the devices met the requirements of AAMI/ANSI/ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing, ISO10993-4 AMD1:2006 Biological Evaluation of Medical Devices - Part {4}------------------------------------------------ 4: Selection of tests in interactions with blood AMENDMENT 1, AAMI/ANSVISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro 10993-512007 Diological Evaluation 1: 2006 Biological Evaluation of Medical Devices - Pat 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1, AAMI/ANSI/ISO 10993-11:2006 Biological Evaluation of Medical Devices – Part 11: Tests for systemic toxicity, AAMI/ANSI/ISO 10993-12 :2007 Biological Evaluation of Medical Devices – Part 12 Sample preparation and :2007 Divins - Taterials, AAMI ST72:2002/(R)2010 Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing, ASTM F-2382-04:2009 Standard Test Method for Assessment of Intravascular Medical Device 0 1:2009 Gainaardal Thromboplastin Time (PTT), ASTM F-756-08:2009 Guideline, Standard Practice for Assessment of Hemolytic Properties of Materials, ASTM F2148-07:2007 Standard Practice for Evaluation of Delayed Contact I LT 10 orsitivity using the Murine Local Lymph Node Assay (LLNA) and United States Pharmacopeia 35, National Formulary 30, 2012. <151> Pyrogen Test. The packaging and shelf life has been validated to meet the requirements of File packaging and 2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, AAMI/ANSI/ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes, ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers and Systems, ASTM D999:2008 Standard Test Methods for or Smipping Containers, and ASTM D5276 Standard Test Method for Drop Test for Loaded Containers by Free Fall. ## N. Summary of Letter to File Modifications Additional modifications were made to the device since the last clearance. These modifications and a summary of the performance testing are shown below: | Device<br>Modification | Description of Modification | Summary of Performance Testing | |---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material<br>Change:<br>Autotransfusion<br>Bag - Top Plate | The design of the<br>Autotransfusion Bag includes a<br>rigid PVC top plate assembled<br>onto the top of a vinyl, flexible<br>bag. The rigid PVC was<br>composed of a copolymer and<br>the manufacturer discontinued<br>the resin. The replacement<br>material (resin) was a<br>homopolymer that was one of<br>the components of the<br>copolymer. | Performance testing was completed to<br>assess the Radio Frequency weld<br>strength, Pressure/Decay, Tensile, Burst<br>and Stress. All testing passed minimum<br>requirements.<br>All biocompatibility testing was<br>completed according to ISO 10993-1<br>and USP <181>. | | Device<br>Modification | Description of Modification | Summary of Performance Testing | | Material<br>Change: Auto<br>transfusion Bag<br>- IV Strap | The hanger strap material was<br>changed due to supplier<br>material obsolesces. This is a<br>non-patient contacting<br>material. | The change to the top plate was<br>validated through a validation study to<br>ensure that the IV strap material met<br>visual acceptance criteria after aging. | | Supplier Process<br>Change: Header<br>Bags sterile<br>barrier for<br>transportation | Sealing of the header bags<br>changed from an impulse<br>sealer to a hot bar sealer. This<br>is a non-patient contacting<br>process change. | The study investigated three packaging<br>criteria, seal strength, seal width, and<br>seal visual defects that are outlined in<br>Purchasing Specification. All pre-<br>established specifications were met. | | Modification:<br>Replacement of<br>Sterile Water<br>Bottle with<br>Sterile Water<br>Syringe | Changed water delivery from a<br>bottle of sterile water to a<br>syringe. This is a non-patient<br>contacting material. | The component change was validated<br>through design verification activities<br>where four different tests (ship testing,<br>syringe position, tip cover attachment,<br>syringe leakage) were performed to<br>assure safety and performance. To<br>ensure that the prefilled syringe was not<br>negatively impacted by Ethylene Oxide<br>(EtO) a study was performed to measure<br>the amounts of EtO and Ethylene<br>Chlorohydrin after the syringe was<br>sterilized twice. All results passed. | | New Mold:<br>Swabbable Stem<br>(ATS Connector<br>component) | New mold for swabbable stem<br>component which results in<br>dimensional changes. The<br>patient contacting material and<br>function of the component was<br>unchanged. | The functional tests performed include<br>leak testing and needles injection after<br>the swabbable stem was assembled<br>within the ATS connector assembly. A<br>dimensional inspection of swabbable<br>stems was also performed to determine<br>whether the new components produced<br>by the mold met drawing dimensions.<br>All results passed. | | Device<br>Modification | Description of Modification | Summary of Performance Testing | | Modification:<br>Male ATS<br>Connector | Change in component design.<br>The patient contacting material<br>and function of the component<br>was unchanged. | The functional tests included finger<br>engagement, disengagement force, Male<br>ATS connector disengagement clearance<br>and ATS connector separation force. A<br>dimensional inspection was also<br>performed to determine whether the new<br>components produced by the mold met<br>drawing dimensions. All results passed. | | Mold Location<br>and<br>Manufacturer<br>Change: Air<br>Flow Meter | Mold location change due to<br>cost savings efforts to<br>consolidate molding supplier.<br>This is a non-patient contacting<br>component. | The functional tests included correct<br>flow path, no leaks through front of air<br>flow meter and air flow measurement. A<br>dimensional inspection was performed<br>to determine whether the new<br>components produced by the mold met<br>drawing dimensions. All results passed. | | Material and<br>Mold Location<br>Change: Slide<br>Clamp | Mold location change due to<br>cost savings efforts to<br>consolidate molding supplier.<br>Material change due to supplier<br>material obsolesces. This is a<br>non-patient contacting<br>component. | The design verification activities<br>included dimensional inspection on all<br>mold cavities and functional testing to<br>determine if the tubing leaked while<br>clamped. All results passed. | | Mold Location<br>Change: Hanger | Mold location change due to<br>cost savings efforts to<br>consolidate molding supplier.<br>This is a non-patient contacting<br>component. | Functional testing consisted of verifying<br>hanger fit and form, and hanger strength.<br>Dimensional measurements were<br>executed as part of a first article<br>inspection. All results passed. | | Mold Location<br>Change: Swivel<br>Arm | Mold location change due to<br>cost savings efforts to<br>consolidate molding supplier.<br>This is a non-patient contacting<br>component. | Functional testing consisted of verifying<br>swivel arm deflection, lock override,<br>removal force, actuation force and<br>rotational resistance. Dimensional<br>measurements were executed as part of a<br>first article inspection and critical<br>dimension study. All results passed. | | Material<br>Change: Swivel<br>Arm | Mold location change due to<br>cost savings efforts to<br>consolidate molding supplier.<br>This is a non-patient contacting<br>component. | Functional testing consisted of verifying<br>swivel arm deflection, lock override,<br>removal force, actuation force and<br>rotational resistance. Dimensional<br>measurements were executed as part of a<br>first article inspection and critical<br>dimension study. All results passed. | Teleflex Medical, Inc. Page 8.5 {5}------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ · . . - {6}------------------------------------------------ Pleur-evac® Autotransfusion Systems ## Traditional 510(k) Section 8 - Summary of Safety and Effectiveness Teleflex Medical, Inc. Page 8.7 . {7}------------------------------------------------ ## O. Conclusion Based upon the comparative test results, the proposed Pleur-evac® Autotransfusion Systems are substantially equivalent in performance to the predicate devices cleared to market via 510(k) K031554 and K962856. The modifications made to the proposed Pleur-evac® Autotransfusion Systems do not introduce any new issues of safety and effectiveness. {8}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 DEC 10 2012 Teleflex Medical, Inc. C/O Ms. Lorraine DeLong 2917 Weck Drive, Research Triangle Park, NC 27709 Re: K120953 Trade/Device Name: Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: December 4, 2012 Received: December 4, 2012 Dear Ms. DeLong: 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 {9}------------------------------------------------ ## Page 2 - Ms. Lorraine DeLong or any Federal statutes and regulations administered by other Federal agencies. You must of any I cather state and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of it Fart 607); acceming (21 CFR 803); good manufacturing practice requirements as set forth in 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 11 you ucsite specific advice for your as ntess offices/CDRH/CDRHOffices/ucm115809.htm for go to mup/rww.ida:2017100di Boyical Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1807.97). 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 Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Bram D. Zuckerman Bram D. Zuckerman, MD Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ ## Indications for Use Page 1 of 1 510(k) Number: K120953 Device Name: Pleur-evac® Autotransfusion Systems Indications for Use: The Indications for Use Statements are as follows: AUTOTRANSFUSION - 1. For the collection of autologuous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations CHEST DRAINAGE . - 1. 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 2. mediastinum. - 3. To help re-establish and maintain normal intra-thoracic pressure gradients. - 4. To facilitate complete lung re-expansion to restore normal breathing dynamics. The Pleur-evac® Autotransfusion Bag is indicated as a sterile, single use device used for collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac® System. The fluid path is non-pyrogenic. 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) | (Division Sign-Off) | | |------------------------------------|---------| | Division of Cardiovascular Devices | | | 510(k) Number | K120953 | Teleflex Medical, Inc.