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,
To facilitate complete lung re-expansion to restore normal breathing dynamics.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Pleur-evac® Plus Continuous Reinfusion And Autotransfusion System." The purpose of this notification is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device, the "Deknatel® A-9150 Pleur-evac® Plus Continuous Reinfusion & Autoinfusion System."

The document details performance data obtained from bench testing to verify this substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria / Test Parameters	Reported Device Performance
A visual inspection must be performed to ensure that all pouched tubing is coiled correctly without kinks.	Pass (Kink)
No leaks in the tubing when clamped at 60 cm H2O for vacuum and at 4 cm H2O positive pressure minimum.	Pass (Tubing Clamp Leak)
No tubing collapse at 340 cm H2O negative pressure.	Pass (Tubing Collapse)
Separation force of ATS Connector from tubing.	Pass (ATS Connector Pull Test)
All compartments must hold the indicated volumes with liquid spillover occurring only at the spillover level.	Pass (Inter-Chamber Leak Test)
The unit shall be airtight when operated at negative pressure 60 cm H2O.	Pass (Leak Integrity Test)
The unit shall have a minimum burst strength of 5 psig (PSI Gauge) at welded joints with all openings to atmosphere sealed.	Pass (Burst Test)
The separation force of the tube and spring from the reinfusion port and the tube from the spike port shall be a minimum of 10 lbs axially.	Pass (Reinfusion Tube Separation Force Test)

2. Sample sizes used for the test set and the data provenance

The sample sizes for the test set are provided in the "Quantity" column of the "Performance Data" table.

Kink: 300
Tubing Clamp Leak: 60
Tubing Collapse: 300
ATS Connector Pull Test: 60
Inter-Chamber Leak Test: 60
Leak Integrity Test: 60
Burst Test: 60
Reinfusion Tube Separation Force Test: 60

The data provenance is bench testing performed by Teleflex. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective, as these terms are typically associated with human or animal studies, not bench testing of a device's physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable (N/A) in this context. The "ground truth" for these performance tests is defined by the physical parameters and engineering specifications themselves, not by expert consensus or interpretations. For example, for the "Kink" test, the ground truth is simply the absence of kinks, which is determined by visual inspection against a predefined standard, not by expert interpretation. Similarly, for leak tests or burst strength tests, the ground truth is a measurable physical property that either meets or fails a numerical threshold.

4. Adjudication method for the test set

This information is not explicitly stated and is likely N/A for this type of bench testing. The tests involve objective measurements (e.g., pressure, force, visual inspection for kinks) against predefined criteria. An adjudication method, often used in clinical trials involving subjective assessments, would not typically apply here. The results are reported as "Pass," indicating compliance with the specified parameters.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a medical apparatus (Autotransfusion System), not an AI-powered diagnostic or interpretive tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

7. The type of ground truth used

The ground truth used for these tests is based on engineering specifications, physical measurements, and visual inspection against predetermined criteria.

For example, for "Tubing Clamp Leak," the ground truth is whether "No leaks in the tubing" are observed under specified pressure conditions.
For "Burst Test," the ground truth is whether the unit satisfies a "minimum burst strength of 5 psig."
For "Kink" test, the ground truth is a "visual inspection... to ensure that all pouched tubing is coiled correctly without kinks."

These are objective, measurable outcomes and not a "ground truth" established by expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This information is not applicable (N/A). The document describes a 510(k) submission for a physical medical device, not a machine learning or AI model that requires a training set. The device's performance is verified through bench testing of physical properties, not by training.

9. How the ground truth for the training set was established

This information is not applicable (N/A), as there is no training set for a machine learning model.

Summary

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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

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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

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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)

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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 ReinfusionAutotransfusion System
Common Name:	Autotransfusion Apparatus
Regulatory Classification:	Class II
Regulation Number:	21 CFR 868.5830
Product Code:	CAC

E. Device Description

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,

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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®Plus Continuous Reinfusion &Autoinfusion System	Pfizer HospitalProducts 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

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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.

TechnologicalCharacteristics	Predicate Device, A-9150	Proposed Device, A-9250LF	Comparison
Indications forUse	For the collection ofautologous blood fromthe patient's pleuralcavity or mediastinalarea for reinfusionpurposes in trauma andpost-operativesituations, To evacuate air and/orfluid from the chestcavity or mediastinum, To help prevent airand/or fluid from re-accumulating in thechest cavity ormediastinum, To help re-establishand maintain normalintra-thoracic pressuregradients, To facilitate completelung re-expansion torestore normalbreathing dynamics.	For the collection ofautologous blood from thepatient's pleural cavity ormediastinal area forreinfusion purposes intrauma and post-operativesituations, To evacuate air and/or fluidfrom the chest cavity ormediastinum, To help prevent air and/orfluid from re-accumulatingin the chest cavity ormediastinum, To help re-establish andmaintain normal intra-thoracic pressure gradients, To facilitate complete lungre-expansion to restorenormal breathing dynamics.	Same
Collection	Yes, the A-9150 featured acollection compartment foreither gravity or suctiondrainage and collection.	Yes, the A-9250LF features acollection compartment foreither gravity or suction drainageand collection.	Same
Reinfusion	Yes, when connected to anaccessory bag, the A-9150was capable of reinfusionand autotransfusion via areinfusion port in thecollection chamber base.	Yes, when connected to anaccessory bag, the A-9250LF iscapable of reinfusion andautotransfusion via a reinfusionport in the collection chamberbase.	Same

L. Performance Data

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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.

ProductDescription	Quantity	Test Parameters	Results
Kink	300	A visual inspection must beperformed to ensure that allpouched tubing is coiledcorrectly without kinks.	Pass
Tubing ClampLeak	60	No leaks in the tubing whenclamped at 60 cm H2O forvacuum and at 4 cm H2Opositive pressure minimum.	Pass
Tubing Collapse	300	No tubing collapse at 340cm H2O negative pressure.	Pass
ATS ConnectorPull Test	60	Separation force of ATSConnector from tubing.	Pass
Inter- ChamberLeak Test	60	All compartments musthold the indicated volumeswith liquid spilloveroccurring only at thespillover level.	Pass
Leak Integrity Test	60	The unit shall be airtightwhen operated at negativepressure 60 cm H2O	Pass
Burst Test	60	The unit shall have aminimum burst strength of5 psig (PSI Gauge) atwelded joints with allopenings to atmospheresealed	Pass
Reinfusion TubeSeparation ForceTest	60	The separation force of thetube and spring from thereinfusion port and thetube from the spike portshall be a minimum of 10lbs 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

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Pleur-evac® Plus Continuous Reinfusion Autotransfusion System do not introduce any new issues of safety and effectiveness.

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).