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 S-1150-08LF Pleurevac Sahara® Plus Continuous Reinfusion Autotransfusion System is a threechamber, 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 S-1150-08LF Pleur-evac Sahara® Plus serves as a bag reinfusion system with a non-pyrogenic fluid path. When autotransfusion is complete, the S-1150-08LF Pleur-evac Sahara® Plus can serve as a dry seal/dry suction chest drainage collection unit.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a medical device called the "Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System." It discusses the device's indications for use, comparison to a predicate device, and performance data to establish substantial equivalence, NOT acceptance criteria or a study proving a device meets acceptance criteria.

Therefore, the requested information (1-9) about acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, and MRMC studies or standalone algorithm performance cannot be extracted from this document. The document describes bench testing for mechanical properties and integrity, not clinical performance or diagnostic accuracy typically associated with acceptance criteria in the context of AI/algorithms.

However, I can extract the information provided about the device's performance testing as described in the summary:

The Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System did not undergo a study that establishes acceptance criteria in the typical sense for diagnostic or AI devices, nor does it have acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. It underwent bench testing to demonstrate substantial equivalence to a predicate device for mechanical and functional integrity.

Here's what can be extracted:

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

Test Parameters	Acceptance Criteria (Implicit)	Reported Device Performance
Inter-Chamber Leak Test	All compartments must hold the indicated volumes with liquid spillover occurring only at the spillover level.	Pass
Leak Integrity Test	The unit shall be airtight when operated at negative pressure 60 cm H20.	Pass
Burst Test	The unit shall have a minimum burst strength of 5 psig (PSI Gauge) at welded joints with all openings to atmosphere sealed.	Pass
Reinfusion Tube Separation Force 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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The tests were bench tests, not clinical studies involving patient data.

Sample size for each test: 60 units.
Data provenance: Not applicable in the context of clinical or diagnostic data. These are results from internal bench testing of the device hardware.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. These are engineering/mechanical pass/fail tests, not based on expert-adjudicated ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The tests are objective measurements against defined engineering specifications.

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 an autotransfusion system, not a diagnostic or AI-driven decision support tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for these tests is the physical measurement of the device's performance against engineering specifications (e.g., whether it leaks, bursts at a certain pressure, or tube separates with a specific force).

8. The sample size for the training set:
Not applicable. This device does not use a training set as it is not a machine learning or AI algorithm.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces suggesting community and support.

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

October 23, 2014

Teleflex Medical, Inc. % Ms. Holly Hallock Regulatory Affairs Specialist 2917 Weck Dr. P.O. Box 12600 Research Triangle Park, North Carolina 27709

Re: K140205

Trade/Device Name: Pleur-evac Sahara 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:

K140205

Device Name:

Pleur-evac Sahara® 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 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: 919-433-4918 Fax: 919-433-4996

B. Contact Person

Holly Kornegay Regulatory Affairs Specialist

Lorraine DeLong RA/QE Manager - Surgical

C. Date Prepared

January 24, 2014

D. Device Name

Trade Name:	Pleur-evac Sahara® Plus Continuous ReinfusionAutotransfusion System
Common Name:	Autotransfusion Apparatus
Regulatory Classification:	Class II
Regulation Number:	21 CFR 868.5830
Product Code:	CAC

E. Device Description

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F. Indications for Use

Pleur-evac Sahara® 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,
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 Sahara® 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 Sahara® Plus Continuous Reinfusion Autotransfusion System is substantially equivalent to the predicate device:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
S-1150-08LF Pleur-evacSahara® Plus ContinuousReinfusion AutoransfusionSystem	Teleflex Medical	K130043	February 12, 2013

I. Comparison to Predicate Devices

The Pleur-evac Sahara® 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 of the faceplate and the universal connector.

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J. Materials

All patient contacting materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1.

K. Technological Characteristics

A comparison of the technological characteristics of the proposed Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System and the predicate has been performed. The results of this comparison demonstrate that the Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System faceplate 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,S-1150-08LF	Proposed Device,S-1150-08LF	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 predicate featured acollection compartment foreither gravity or suctiondrainage and collection.	Yes, the proposed S-1150-08LFfeatures a collectioncompartment for either gravityor suction drainage andcollection.	Same
Reinfusion	Yes, when connected to anaccessory bag, the predicate	Yes, when connected to anaccessory bag, the proposed S-	Same

Teleflex Medical, Inc.

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L. Performance Data

Teleflex has performed bench testing to verify that the performance of the proposed Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System is substantially equivalent to the predicate device, and that the Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System is seamlessly interchangeable with the predicate device. Various functionality tests were performed to ensure that the faceplate 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
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 H20	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 Sahara® Plus Continuous Reinfusion Autotransfusion System is substantially equivalent to the predicate device cleared to market via 510(k) K130043. The modifications made to the proposed Pleur-evac Sahara® 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).