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K Number
K120953
Device Name
PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
Manufacturer
TLELFLEX MEDICAL, INC.
Date Cleared
2012-12-10

(255 days)

Product Code
CAC
Regulation Number
868.5830
Type
Traditional
Panel
AN
Reference & Predicate Devices
K031554,K962856
Predicate For
K130043
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

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 TestSummary (Acceptance Criteria Implicit in Test Design)Reported Device Performance
For general tubing (new material/manufacturing process):
Kink ResistanceVisually 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 IntegritySubject 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 LeakSubject 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 CollapseExpose 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 TestRequire 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 TestRequire 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 TestRequire 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 .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 StrapValidate 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 barrierInvestigate 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 SyringeDesign 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 ConnectorFunctional 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 MeterFunctional 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 ClampDimensional 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: HangerFunctional 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 ArmFunctional 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 ArmFunctional 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 MaterialsCompliance with ISO10993-1.All patient contacting materials are in compliance with ISO10993-1.
Sterilization Cycle ValidationMeet 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 EvaluationMeet 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) Pyrogen Test.The Biological Evaluation of the devices met the requirements of the listed standards.
Packaging and Shelf Life ValidationMeet 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.

§ 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).