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.
1. To help re-establish and maintain normal intra-thoracic pressure gradients.
1. 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.

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-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.

AI/ML Overview

Acceptance Criteria and Device Performance for Pleur-evac Autotransfusion Systems

This document describes the acceptance criteria and the studies performed to demonstrate that the Pleur-evac Autotransfusion Systems meet these criteria. The information is extracted from the provided 510(k) summary (K120953).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document primarily focuses on verifying the performance of the modified components of the Pleur-evac Autotransfusion Systems and demonstrating their substantial equivalence to predicate devices, rather than establishing new, quantitative acceptance criteria for overall system performance. The "acceptance criteria" are implied by successful completion of various tests and verification activities, ensuring the modified components perform as intended and do not negatively impact the device's safety or effectiveness.

Therefore, the table below lists the performance tests conducted on the modified components and the reported results, implicitly indicating that these results met the pre-established internal acceptance criteria for each test.

Performance Test	Summary (Acceptance Criteria Implicit in Test Design)	Reported Device Performance
For general tubing (new material/manufacturing process):
Kink Resistance	Visually inspect proposed and predicate patient tubing for kink resistance under simulated various radiuses during coiling/packaging.	The proposed patient tubing has a greater ability to withstand kinking. (This implies it met or exceeded the predicate's performance, which was the implicit acceptance criterion).
Leak Integrity	Subject proposed tubing to positive and negative pressures to determine capability of withstanding leakage.	The proposed tubing passed the leak integrity test with no leaks at tubing joints. (Implicit acceptance criterion: no leaks).
Tubing Clamp Leak	Subject proposed tubing in a clamped configuration to positive and negative pressures to determine capability of withstanding leakage.	The proposed tubing passed the leak test with no leaks at the clamp. (Implicit acceptance criterion: no leaks).
Tubing Collapse	Expose proposed and predicate patient tubing to a high amount of negative pressure and visually inspect for tubing collapse.	All units passed the tubing collapse test - the proposed tubing did not collapse under imposed high pressure condition. (Implicit acceptance criterion: no collapse under high negative pressure).
ATS Connector Pull Test	Require the ATS Connector to withstand a minimum amount of force without separating from the proposed tubing.	The proposed tubing withstood the minimum amount of force applied without separation from the ATS Connector. (Implicit acceptance criterion: withstand minimum specified force).
Back Port Pull Test	Require the proposed tubing to withstand a minimum amount of force without separating from the Back Port of the unit.	The proposed tubing withstood the minimum amount of force applied without separation from the Back Port. (Implicit acceptance criterion: withstand minimum specified force).
Universal Connector Pull Test	Require the Universal Connector to withstand a minimum amount of force without separating from the proposed tubing.	The proposed tubing withstood the minimum amount of force applied without separation from the Universal Connector. (Implicit acceptance criterion: withstand minimum specified force).
For specific device modifications (Material/Process/Mold Changes):
Material Change: Autotransfusion Bag - Top Plate (Rigid PVC)	Assess Radio Frequency weld strength, Pressure/Decay, Tensile, Burst, and Stress attributes of the new material. All biocompatibility testing according to ISO 10993-1 and USP <181>.	All testing passed minimum requirements. All biocompatibility testing was completed according to specified standards. (Implicit acceptance criteria: meet minimum specified values for mechanical tests, conform to biocompatibility standards).
Material Change: Autotransfusion Bag - IV Strap	Validate through a study to ensure the IV strap material met visual acceptance criteria after aging. (Non-patient contacting material).	The change was validated through a validation study to ensure that the IV strap material met visual acceptance criteria after aging. (Implicit acceptance criterion: meet visual acceptance criteria after aging).
Supplier Process Change: Header Bags sterile barrier	Investigate three packaging criteria: seal strength, seal width, and seal visual defects (outlined in Purchasing Specification). (Non-patient contacting process change).	All pre-established specifications were met. (Implicit acceptance criteria: meet specified values for seal strength, width, and visual defects).
Modification: Replacement of Sterile Water Bottle with Syringe	Design verification activities including ship testing, syringe position, tip cover attachment, syringe leakage. Study for EtO and Ethylene Chlorohydrin residuals after double sterilization. (Non-patient contacting material).	Four different tests (ship testing, syringe position, tip cover attachment, syringe leakage) were performed to assure safety and performance. A study was performed to measure EtO and Ethylene Chlorohydrin after double sterilization. All results passed. (Implicit acceptance criteria: satisfactory performance in tests, acceptable residual levels).
New Mold: Swabbable Stem (ATS Connector component)	Functional tests: leak testing and needle injection after assembly. Dimensional inspection to meet drawing dimensions. (Patient contacting material and function unchanged).	The functional tests performed include leak testing and needles injection after the swabbable stem was assembled. A dimensional inspection was also performed. All results passed. (Implicit acceptance criteria: no leaks, proper needle injection, meet dimensional specifications).
Modification: Male ATS Connector	Functional tests: finger engagement, disengagement force, disengagement clearance, separation force. Dimensional inspection to meet drawing dimensions. (Patient contacting material and function unchanged).	The functional tests included finger engagement, disengagement force, Male ATS connector disengagement clearance and ATS connector separation force. A dimensional inspection was also performed. All results passed. (Implicit acceptance criteria: proper engagement/disengagement force/clearance, meet dimensional specifications).
Mold Location and Manufacturer Change: Air Flow Meter	Functional tests: correct flow path, no leaks through front, air flow measurement. Dimensional inspection. (Non-patient contacting component).	The functional tests included correct flow path, no leaks through front of air flow meter and air flow measurement. A dimensional inspection was performed. All results passed. (Implicit acceptance criteria: correct flow, no leaks, meet dimensional specifications).
Material and Mold Location Change: Slide Clamp	Dimensional inspection on all mold cavities. Functional testing to determine if tubing leaked while clamped. (Non-patient contacting component).	The design verification activities included dimensional inspection on all mold cavities and functional testing to determine if the tubing leaked while clamped. All results passed. (Implicit acceptance criteria: no leaks when clamped, meet dimensional specifications).
Mold Location Change: Hanger	Functional testing: verify hanger fit and form, hanger strength. Dimensional measurements (first article inspection). (Non-patient contacting component).	Functional testing consisted of verifying hanger fit and form, and hanger strength. Dimensional measurements were executed as part of a first article inspection. All results passed. (Implicit acceptance criteria: proper fit/form/strength, meet dimensional specifications).
Mold Location Change: Swivel Arm	Functional testing: verify swivel arm deflection, lock override, removal force, actuation force and rotational resistance. Dimensional measurements (first article inspection, critical dimension study). (Non-patient contacting component).	Functional testing consisted of verifying swivel arm deflection, lock override, removal force, actuation force and rotational resistance. Dimensional measurements were executed as part of a first article inspection and critical dimension study. All results passed. (Implicit acceptance criteria: proper deflection/force/resistance, meet dimensional specifications).
Material Change: Swivel Arm	Functional testing: verify swivel arm deflection, lock override, removal force, actuation force and rotational resistance. Dimensional measurements (first article inspection, critical dimension study). (Non-patient contacting component).	Functional testing consisted of verifying swivel arm deflection, lock override, removal force, actuation force and rotational resistance. Dimensional measurements were executed as part of a first article inspection and critical dimension study. All results passed. (Implicit acceptance criteria: proper deflection/force/resistance, meet dimensional specifications).
Material/Biocompatibility/Sterilization/Packaging Compliance:
Patient Contacting Materials	Compliance with ISO10993-1.	All patient contacting materials are in compliance with ISO10993-1.
Sterilization Cycle Validation	Meet requirements of AAMI/ANSI/ISO 11135-1:2007, AAMI/ANSI/ISO 11737-1:2006, AAMI/ANSI/ISO 10993-7:2008.	The sterilization cycle has been validated to meet the requirements of the listed standards.
Biological Evaluation	Meet requirements of AAMI/ANSI/ISO 10993-1:2009, ISO10993-4 AMD1:2006, AAMI/ANSVISO 10993-5:2009, AAMI/ANSVISO 10993-10:2007, AAMI/ANSI/ISO 10993-11:2006, AAMI/ANSI/ISO 10993-12:2007, AAMI ST72:2002, ASTM F-2382-04:2009, ASTM F-756-08:2009, ASTM F2148-07:2007, USP 35 (2012) <151> Pyrogen Test.	The Biological Evaluation of the devices met the requirements of the listed standards.
Packaging and Shelf Life Validation	Meet requirements of ISO 11607-1:2006, AAMI/ANSI/ISO 11607-2:2006, ASTM F1980-07, ASTM D4169:2009, ASTM D999:2008, ASTM D5276.	The packaging and shelf life has been validated to meet the requirements of the listed standards.

Study Proving Acceptance Criteria Met:

The primary study type represented in this document is a series of bench tests and design verification activities to demonstrate the substantial equivalence of the modified Pleur-evac Autotransfusion Systems to previously cleared predicate devices. The modifications primarily involved changes in material, manufacturing processes, and mold locations for various components, but without technological changes to the proposed device.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not explicitly state the numerical sample size for each bench test conducted. Phrases like "All units passed," "The proposed tubing passed," "All results passed" indicate that a sufficient number of samples were tested to demonstrate compliance, but the exact count is not provided.
Data Provenance: The data provenance is retrospective/internal bench testing. All tests were conducted by Teleflex Medical, Inc. (the manufacturer) as part of their design verification and validation activities for the 510(k) submission. There is no indication of external data sources or clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not Applicable. For this type of bench testing and substantial equivalence submission focused on device modifications and material properties, "ground truth" established by external experts (e.g., radiologists, pathologists) is not relevant. The ground truth for these tests is defined by engineering specifications, material standards (e.g., ISO, ASTM, AAMI), and the performance of the predicate device.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or diagnostic outputs where expert consensus is needed to establish ground truth in the presence of observer variability. This document describes objective bench testing against engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (autotransfusion apparatus) and its modifications, not a diagnostic imaging algorithm requiring human reader performance analysis. Therefore, there is no mention of human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone (algorithm only) performance study was not done. This device is a passive mechanical system for blood collection and reinfusion, not an AI or algorithmic device.

7. The Type of Ground Truth Used:

The "ground truth" for the tests reported in this document is based on:

Engineering Specifications and Design Requirements: For mechanical tests like pull strength, leak integrity, kink resistance, and dimensional accuracy, the ground truth is the predefined acceptable range or minimum/maximum limits established in the device's design specifications.
Performance of Predicate Devices: For tests like kink resistance and tubing collapse, the performance of the predicate device serves as a benchmark for substantial equivalence.
International and National Standards: For biocompatibility, sterilization, and packaging, the ground truth is established by adherence to recognized consensus standards (e.g., ISO 10993, AAMI/ANSI/ISO 11135, ASTM standards).

8. The Sample Size for the Training Set:

Not Applicable. This submission does not involve an AI or machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no training set, this question is not relevant.

Summary

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/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

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.

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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.

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
1. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum.
1. To help re-establish and maintain normal intra-thoracic pressure gradients.
1. To facilitate complete lung re-expansion to restore normal breathing dynamics.

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

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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 PlusContinuous ReinfusionAutotransfusion System	Genzyme Biosurgery	K031554	July 25, 2003
Pleur-evac® SaharaAdult/Sahara Chest DrainageSystem Models S-1100, S-1200,S-2100 and S-2200 with ModelS-100 Autotransfusion Bag	Deknatel DSPWorldwideIncorporated	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. .

PerformanceTest	Summary	Result
Kink Resistance	The proposed and predicate patienttubing were visually inspected forkink resistance. This test simulatedthe various radiuses the tubing couldbe subjected to during coiling and/orpackaging.	The results showed thatthe proposed patienttubing has a greaterability to withstandkinking.

A Summary of the performance testing completed is shown below:

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PerformanceTest	Summary	Result
Leak Integrity	The proposed tubing was subjectedto positive and negative pressures todetermine the capability ofwithstanding leakage.	The proposed tubingpassed the leak integritytest with no leaks attubing joints.
Tubing ClampLeak	The proposed tubing in a clampedconfiguration was subjected topositive and negative pressures todetermine the capability ofwithstanding leakage.	The proposed tubingpassed the leak test withno leaks at the clamp.
Tubing Collapse	The proposed and predicate patienttubing was exposed to a highamount of negative pressure andvisually inspected for tubingcollapse.	All units passed thetubing collapse test - theproposed tubing did notcollapse under imposedhigh pressure condition.
ATS ConnectorPull Test	The pull test required that the ATSConnector be able to withstand aminimum amount of force withoutbeing separated from the proposedtubing.	The proposed tubingwithstood the minimumamount of force appliedwithout separation fromthe ATS Connector.
Back Port PullTest	The pull test required that theproposed tubing be able to withstanda minimum amount of force withoutbeing separated from the Back Portof the unit.	The proposed tubingwithstood the minimumamount of force appliedwithout separation fromthe Back Port.
UniversalConnector PullTest	The pull test required that theUniversal Connector be able towithstand a minimum amount offorce without being separated fromthe proposed tubing.	The proposed tubingwithstood the minimumamount of force appliedwithout separation fromthe 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

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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:

DeviceModification	Description of Modification	Summary of Performance Testing
MaterialChange:AutotransfusionBag - Top Plate	The design of theAutotransfusion Bag includes arigid PVC top plate assembledonto the top of a vinyl, flexiblebag. The rigid PVC wascomposed of a copolymer andthe manufacturer discontinuedthe resin. The replacementmaterial (resin) was ahomopolymer that was one ofthe components of thecopolymer.	Performance testing was completed toassess the Radio Frequency weldstrength, Pressure/Decay, Tensile, Burstand Stress. All testing passed minimumrequirements.All biocompatibility testing wascompleted according to ISO 10993-1and USP <181>.
DeviceModification	Description of Modification	Summary of Performance Testing
MaterialChange: Autotransfusion Bag- IV Strap	The hanger strap material waschanged due to suppliermaterial obsolesces. This is anon-patient contactingmaterial.	The change to the top plate wasvalidated through a validation study toensure that the IV strap material metvisual acceptance criteria after aging.
Supplier ProcessChange: HeaderBags sterilebarrier fortransportation	Sealing of the header bagschanged from an impulsesealer to a hot bar sealer. Thisis a non-patient contactingprocess change.	The study investigated three packagingcriteria, seal strength, seal width, andseal visual defects that are outlined inPurchasing Specification. All pre-established specifications were met.
Modification:Replacement ofSterile WaterBottle withSterile WaterSyringe	Changed water delivery from abottle of sterile water to asyringe. This is a non-patientcontacting material.	The component change was validatedthrough design verification activitieswhere four different tests (ship testing,syringe position, tip cover attachment,syringe leakage) were performed toassure safety and performance. Toensure that the prefilled syringe was notnegatively impacted by Ethylene Oxide(EtO) a study was performed to measurethe amounts of EtO and EthyleneChlorohydrin after the syringe wassterilized twice. All results passed.
New Mold:Swabbable Stem(ATS Connectorcomponent)	New mold for swabbable stemcomponent which results indimensional changes. Thepatient contacting material andfunction of the component wasunchanged.	The functional tests performed includeleak testing and needles injection afterthe swabbable stem was assembledwithin the ATS connector assembly. Adimensional inspection of swabbablestems was also performed to determinewhether the new components producedby the mold met drawing dimensions.All results passed.
DeviceModification	Description of Modification	Summary of Performance Testing
Modification:Male ATSConnector	Change in component design.The patient contacting materialand function of the componentwas unchanged.	The functional tests included fingerengagement, disengagement force, MaleATS connector disengagement clearanceand ATS connector separation force. Adimensional inspection was alsoperformed to determine whether the newcomponents produced by the mold metdrawing dimensions. All results passed.
Mold LocationandManufacturerChange: AirFlow Meter	Mold location change due tocost savings efforts toconsolidate molding supplier.This is a non-patient contactingcomponent.	The functional tests included correctflow path, no leaks through front of airflow meter and air flow measurement. Adimensional inspection was performedto determine whether the newcomponents produced by the mold metdrawing dimensions. All results passed.
Material andMold LocationChange: SlideClamp	Mold location change due tocost savings efforts toconsolidate molding supplier.Material change due to suppliermaterial obsolesces. This is anon-patient contactingcomponent.	The design verification activitiesincluded dimensional inspection on allmold cavities and functional testing todetermine if the tubing leaked whileclamped. All results passed.
Mold LocationChange: Hanger	Mold location change due tocost savings efforts toconsolidate molding supplier.This is a non-patient contactingcomponent.	Functional testing consisted of verifyinghanger fit and form, and hanger strength.Dimensional measurements wereexecuted as part of a first articleinspection. All results passed.
Mold LocationChange: SwivelArm	Mold location change due tocost savings efforts toconsolidate molding supplier.This is a non-patient contactingcomponent.	Functional testing consisted of verifyingswivel arm deflection, lock override,removal force, actuation force androtational resistance. Dimensionalmeasurements were executed as part of afirst article inspection and criticaldimension study. All results passed.
MaterialChange: SwivelArm	Mold location change due tocost savings efforts toconsolidate molding supplier.This is a non-patient contactingcomponent.	Functional testing consisted of verifyingswivel arm deflection, lock override,removal force, actuation force androtational resistance. Dimensionalmeasurements were executed as part of afirst article inspection and criticaldimension study. All results passed.

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Pleur-evac® Autotransfusion Systems

Traditional 510(k) Section 8 - Summary of Safety and Effectiveness

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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.

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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

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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

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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.
1. To help re-establish and maintain normal intra-thoracic pressure gradients.
1. 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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K120953

Teleflex Medical, Inc.

Regulation Number and Section

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).