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
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.

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

The Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System 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, the Pleurevac 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, structured to address your specific points:

The provided document describes a 510(k) submission for the Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System. This is a medical device, and the submission aims to demonstrate substantial equivalence to a predicate device, rather than proving efficacy in a clinical setting in the way an AI-powered diagnostic device might. Therefore, many of the questions related to AI-specific study design (like MRMC studies, AI assistance, ground truth for training sets, number of experts for ground truth, etc.) are not applicable to this type of device and submission.

The "study" described here is primarily bench testing to verify performance characteristics of a material change.

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Test Specification)	Reported Device Performance (Result)
Pressure Equalization Rate	PASS (All values tested allowed the pressure in a full collection chamber to rise from 17 cm H2O vacuum to 2 cm H2O vacuum between 1 second and 22 seconds.)
Filter Position Visual	PASS (All covers tested contacted the filter material on the entire cover retaining surface.)
Filter Visual	PASS (All Pleur-evac units tested contained a filter in the HNRV assembly.)
ASTM F1608-00(2009) (Bacterial Filter Efficacy)	PASS (All Pleur-evac units tested had an LRV > 4. This standard typically refers to the retention of bacteria/viruses, establishing sterility or barrier efficacy.)

Sample sizes used for the test set and the data provenance
- Sample Size: The document does not explicitly state the exact numerical sample size for each test ("All values tested," "All covers tested," "All Pleur-evac units tested"). However, it consistently refers to "All" units tested for each criterion, implying that every unit subjected to that specific test passed. In a 510(k), particularly for bench testing, this often means a statistically valid number of samples were tested to demonstrate consistent performance within a lot or production run, though the exact number isn't quantified in this summary.
- Data Provenance: The data is from bench testing conducted by the manufacturer, Teleflex Medical, Inc. The location of the testing is not specified, but the manufacturer's address is in Research Triangle Park, NC, USA. The data is prospective in the sense that the tests were performed specifically to validate the material change and support the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. As this is bench testing of physical device performance based on established engineering and material standards, expert clinical judgment for "ground truth" (as in image interpretation) is not applicable. The "ground truth" here is determined by objective measurements and visual inspections against predefined engineering specifications.
Adjudication method for the test set
- N/A. Adjudication methods (like 2+1 or 3+1) are typically used for subjectively assessed data, such as medical image interpretations, to establish a consensus ground truth. For objective bench tests, results are directly measured or visually verified against clear PASS/FAIL criteria, so an adjudication process is not relevant.
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. This is not an AI-powered diagnostic device. It's an autotransfusion system with a material change. Therefore, MRMC studies and AI assistance metrics are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm or software-based device. It's a hardware medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance validation is based on engineering specifications and established test methods (e.g., pressure equalization rate, visual inspection criteria, and the ASTM F1608-00(2009) standard which relates to bacterial filtration efficacy). It's objective, measurable performance against physical and material requirements, rather than clinical outcomes or interpretations.
The sample size for the training set
- N/A. There is no "training set" as this is not a machine learning/AI device.
How the ground truth for the training set was established
- N/A. There is no training set or associated ground truth establishment for this type of device validation.

Summary

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R 130043

Special 510(k) Pleur-evac Saḥara® Plus Continuous Reinfusion Autotransfusion System Section 8 - Summary of Safety and Effectiveness

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Pleur-evac Sahara® 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: 919-433-8049 919-433-4996 Fax:

B. Contact Person

Natalie Smith Regulatory Affairs Specialist

Lorraine DeLong Manager RA/QE Surgical

C. Date Prepared

January 7, 2013

D. Device Name

Trade Name: Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System

Common Name: Autotransfusion Apparatus

Classification Name: Autotransfusion Apparatus

E. Device Description

Teleflex Medical, Inc.

Page 8.1

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F. Indications for Use

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
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 Sahara® Plus Continuous Reinfusion Autotransfusion System is 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 Autotransfusion System is substantially equivalent to the predicate devices:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Pleur-evac® AutotransfusionSystems	Teleflex Medical,Inc.	K120953	December 10, 2012

I. Comparison To Predicate Devices

The proposed Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System has the same technology, indications for use and functional characteristics as

Teleflex Medical, Inc.

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the predicate system. The proposed modification is a change in material to an indirect patient contacting component, which was driven by supplier obsolescence.

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 Sahara® Plus Continuous Reinfusion Autotransfusion Systems and the predicate has been performed. The results of this comparison demonstrate that the Pleur-evac® High Negative Relief Valve filter is equivalent to the marketed predicate devices in performance characteristics.

L. Performance Data

The bench testing has been performed to verify that the performance of the proposed Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion Systems is substantially equivalent to the predicate device. The proposed filter material was validated according to test specifications and is summarized below.

Performance Data Results Summary
Response Type	Test Specification	Result
Quantitative	Pressure EqualizationRate	PASSAll values tested allowed the pressure in a fullcollection chamber to rise from 17 cm H2Ovacuum to 2 cm H2O vacuum between 1second and 22 seconds.
Qualitative(Pass, Fail)	Filter Position Visual	PASSAll covers tested contacted the filter materialon the entire cover retaining surface.
Qualitative(Pass, Fail)	Filter Visual	PASSAll Pleur-evac units tested contained a filter inthe HNRV assembly.
Quantitative	ASTM F1608-00(2009)	PASSAll Pleur-evac units tested had an LRV > 4.

L. Conclusion

Based upon the comparative test results, the proposed Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System is substantially equivalent in performance to the predicate devices cleared to market via 510(k) K120953. The modification made to the proposed Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System does not introduce any new issues of safety and effectiveness.

Teleflex Medical, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized graphic. The graphic consists of three curved lines that resemble a person embracing a stylized globe. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

FEB 1 2 2013

Teleflex Medical Incorporated c/o Ms. Natalie Smith Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709

Re: K130043

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: January 22, 2013 Received: January 23, 2013

Dear Ms. Smith:

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.

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Page 2 - Ms. Natalie Smith

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 vours.

Matthew G. Hillebrenner

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:

1413004380

Device Name:

Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System

Indications for Use:

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
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.

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)

Aflelel

(Division Sign-Off)
Division of Cardiovascular Devices

510(k)

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).