The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir.

Device Description

The Advanced Membrane Gas Exchange and accessories PMP STERILE (A.M.G. PMP STERILE) is a microporous hollow-fiber oxygenator with an integral heat exchanger, used to perform cardiopulmonary bypass or surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. It includes a detachable 4.5 liter blood reservoir.
The A.M.G. PMP STERILE is equipped with polymethyl pentene fibres, more hydrophobic than the polyethylene used for the predicate device and so considered a more reliable barrier between the blood pathway and gas pathway of the oxygenator.
The A.M.G. PMP STERILE is provided in different configurations:

microporous hollow-fiber oxygenator with temperature probe and pre-connected venous cardiotomy reservoir (“A.M.G. PMP STERILE”),
microporous hollow-fiber oxygenator with temperature probe and without pre-connected venous cardiotomy reservoir (“A.M.G. MODULE PMP STERILE”),
microporous hollow-fiber oxygenator without temperature probe and without pre-connected venous cardiotomy reservoir (“A.M.G. MODULE PMP NO TP STERILE”),
Venous Cardiotomy Reservoir 4500 PMP (“VCR 4500 PMP STERILE”).
The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood. The device can be use with adult patients.

AI/ML Overview

The provided text describes the 510(k) summary for the "Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE)" device. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a standalone study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, the requested information elements related to AI device performance are not applicable to this document. This document describes a medical device, specifically a cardiopulmonary bypass oxygenator, and its regulatory submission for market clearance. It does not involve an AI/ML algorithm or a study demonstrating the performance of such an algorithm.

However, I can extract the acceptance criteria and a summary of the performance testing for the manufacturing and functional aspects of the described medical device:

1. Table of acceptance criteria and reported device performance:

The document states that the new device, "Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE)," met the acceptance criteria defined in the product specification and performed comparably to the predicate device. While specific quantitative acceptance criteria are not detailed in this summary, the areas tested and successfully met are listed.

Acceptance Criteria Area / Parameter Tested	Reported Device Performance
Gas Transfer and Pressure Drop	Met acceptance criteria; performed comparably to predicate.
Fiber Hydrophilization	Met acceptance criteria; performed comparably to predicate.
Cracking test external body	Met acceptance criteria; performed comparably to predicate.
Coating Uniformity	Met acceptance criteria; performed comparably to predicate.
Plasma hemoglobin concentration	Met acceptance criteria; performed comparably to predicate.
Heat exchanger Efficiency and Filling Volume	Met acceptance criteria; performed comparably to predicate.
Seal Connection	Met acceptance criteria; performed comparably to predicate.
Structural and Mechanical Integrity	Met acceptance criteria; performed comparably to predicate.
Bioburden tests	Met acceptance criteria.
Sterility tests	Met acceptance criteria.
LAL-test	Met acceptance criteria.
Validation of the EtO Sterilization process	Met acceptance criteria.
EtO Residual (according to EN ISO 10993-7)	Met acceptance criteria.
Biocompatibility (according to ISO 10993 series requirements)	Met acceptance criteria.
Packaging evaluation	Met acceptance criteria.
Labelling evaluation	Met acceptance criteria.

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The document refers to "in vitro bench tests" but does not specify the sample sizes (e.g., number of devices tested) or the provenance of any data used (as it's bench testing, not clinical data from patients or countries).

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 as the document describes bench testing for a physical medical device, not an AI model or a dataset requiring expert ground truth labeling.

4. Adjudication method for the test set:

This information is not applicable as the document describes bench testing for a physical medical device, not an AI model or a dataset requiring expert adjudication.

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:

This information is not applicable as the document describes a physical medical device (oxygenator) and not an AI/ML algorithm.

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

This information is not applicable as the document describes a physical medical device (oxygenator) and not an AI/ML algorithm.

7. The type of ground truth used:

This information is not applicable as the document describes bench testing against predefined product specifications and regulatory standards for a physical medical device, not against "ground truth" in the context of AI model evaluation (e.g., pathology, expert consensus on images).

8. The sample size for the training set:

This information is not applicable as the document describes a physical medical device and its manufacturing/functional testing, not an AI/ML model that undergoes "training."

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

This information is not applicable as the document describes a physical medical device and its manufacturing/functional testing, not an AI/ML model.

Summary

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Public Health Service

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

February 6, 2015

EUROSETS s.r.1. % Mario Gennari Official Correspondent, Gemar s.r.1. Via G. Puccini, 1 Medolla, Modena, IT I-43036

Re: K141492

Trade/Device Name: Advanced Membrane Gas Exchange PMP Sterile (A.M.G. PMP Sterile) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: December 4, 2014 Received: January 14, 2015

Dear Mario Gennari,

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

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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 of medical devicerelated 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 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. 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

510(k) Number (if known) K141492

Device Name

Advanced Membrane Gas Exchange PMP (A.M.G. PMP STERILE)

Indications for Use (Describe)

The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY, AS REQUIRED BY 21 CFR 807.92

Submitter's Name	Eurosets s.r.l.
Address	Strada Statale 12, nº14341036 Medolla (MO) Italy
EstablishmentRegistration Number	3003752502
SummaryPreparation Date	Feruary 05, 2015
Contact PersonTelephone NumberFax Number	Dr. Katia Vescovini, Regulatory Affairs Manager0039 05356603340039 0535 51248
Name of the Device	Advanced Membrane Gas Exchange PMP STERILE (A.M.G.PMP STERILE)
Name of theOxygenating module	A.M.G. MODULE PMP STERILEA.M.G. MODULE PMP NO T.P. STERILE
Name of theCardiotomyreservoir	VCR 4500 PMP STERILE
Common name ofthe device	Advanced Membrane Gas Exchange and Accessories A.M.G.PMP STERILE
Common name ofthe Oxygenatingmodule	A.M.G. MODULE PMP STERILEA.M.G. MODULE PMP NO T.P. STERILE
Common name ofthe Cardiotomyreservoir	Venous Cardiotomy Reservoir 4500 PMP STERILE
Classification Name	Cardiopulmunary deviceClassification Name: Advanced membrane gas exchangeDevice Class: IIProduct Code: DTZRegulation Number: 21 CFR §870.4350
PerformanceStandards	No performance standards applicable to Advanced MembraneGas Exchange PMP STERILE (A.M.G. PMP STERILE) havebeen established by the FDA

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510(k) SUMMARY, continued

DESCRIPTION:	The Advanced Membrane Gas Exchange and accessories PMPSTERILE (A.M.G. PMP STERILE) is a microporous hollow-fiberoxygenator with an integral heat exchanger, used to performcardiopulmonary bypass or surgical procedures requiringextracorporeal gas exchange support and blood temperaturecontrol for periods of up to 6 hours. It includes a detachable 4.5liter blood reservoir.The A.M.G. PMP STERILE is equipped with polymethyl pentenefibres, more hydrophobic than the polyethylene used for thepredicate device and so considered a more reliable barrierbetween the blood pathway and gas pathway of the oxygenator.The A.M.G. PMP STERILE is provided in different configurations:- microporous hollow-fiber oxygenator with temperature probeand pre-connected venous cardiotomy reservoir (“A.M.G. PMPSTERILE”),- microporous hollow-fiber oxygenator with temperature probeand without pre-connected venous cardiotomy reservoir(“A.M.G. MODULE PMP STERILE”),- microporous hollow-fiber oxygenator without temperatureprobe and without pre-connected venous cardiotomy reservoir(“A.M.G. MODULE PMP NO TP STERILE”),- Venous Cardiotomy Reservoir 4500 PMP (“VCR 4500 PMPSTERILE”).The device is used to temporarily substitute the functions of the
	lung as it supplies oxygen and removes carbon dioxide from theblood. The device can be use with adult patients.
Indications for Use	The Advanced Membrane Gas Exchange PMP STERILE (A.M.G.PMP STERILE) is intended for use in adult Surgical proceduresrequiring extracorporeal gas exchange support and bloodtemperature control for periods of up to 6 hours.The Advanced Membrane Gas Exchange PMP STERILE (A.M.G.PMP STERILE) for extracorporeal circulation is a microporoushollow-fiber oxygenator with an integral heat exchanger used toperform cardiopulmonary bypass.It includes a detachable 4.5 liter blood reservoir.
Identification ofPredicate Device	Proprietary Name: AMGClassification Name: 21 CFR 870.4350, Oxygenator,Cardiopulmonary BypassRegistered Establishment Name:Eurosets srlStrada Statale 12, n. 14341036 Medolla (MO) Italy
Registered Establishment Number:	3003752502Owner/Operator: Eurosets srlEstablishment Operations: Manufacturer510 (k): K102109Device Name: A.M.G. advanced membrane gas exchange andaccessoriesApplicant: Eurosets srl
	Please note that regarding the polymethyl pentene fibres used bythe A.M.G. PMP STERILE, Eurosets will refer to the followingpredicate device:
	Proprietary Name: MEDOS HILITE 7000 & 7000 LT Hollow FiberOxygenator
	Classification Name: 21 CFR 870.4350, Oxygenator,Cardiopulmonary BypassRegistered Establishment Name: GISH BIOMEDICAL, INC.
	Registered Establishment Number: 3002845651Owner/Operator: GISH BIOMEDICAL, INC.Owner/Operator Number: 3002845651Establishment Operations: Manufacturer 510 (k): K082403
	Device Name: 7000 LT Hollow Fiber Oxygenator (K082403)
	Applicant: GISH BIOMEDICAL, INC.
Common name ofthe predicate devicefor principles ofoperatations	A.M.G. advanced membrane gas exchange and accessories
Classification Nameof the device	Oxygenator, Cardiopulmonary Bypass
Classification Nameof the Oxygenatingmodule	Device Class: IIProduct Code: DTZRegulation Number: 21 CFR §870.4350Oxygenator cardiopulmonary bypass CardiovascularDevice Class: IIProduct Code: DTZ
Classification Nameof the Cardiotomyreservoir	Regulation Number: 21 CFR §870.4350Hard shell Venous/cardiotomy reservoir CardiovascularDevice Class: IIProduct Code: DTZRegulation Number: 21 CFR §870.4350
Applicant name andaddress:	Eurosets s.r.l.Strada Statale 12, n°14341036 Medolla (MO) Italy
	MEDOS MEDIZINTECHNIK AGObere Steinfurt 8-10
Comparison ofTechnologicalCharacteristics	In vitro bench testing was performed to support a determination ofsubstantial equivalence (refer to performance testing below)between the new Advanced Membrane Gas Exchange PMPSTERILE (A.M.G. PMP STERILE) and the predicate.The results of these tests provide reasonable assurance that theproposed device has been designed and tested to assureconformance to the requirements for its intended use andperforms comparably to the existing predicate devices.
PerformanceTesting (non-clinical)	In vitro bench tests were carried out to demonstrate equivalence,according to the requirements of FDAs document "Guidance forCardiopulmunary Bypass Oxygenators 510(k) Submission",issued on November 13, 2000, the ISO 7199:2009 and of the EN12022:1998 "Blood-gas exchangers".The following areas have been tested and/or evaluated:- Gas Transfer and Pressure Drop,- Fiber Hydrophilization,- Cracking test external body,- Coating Uniformity,- Plasma hemoglobin concentration,- Heat exchanger Efficiency and Filling Volume,- Seal Connection,- Structural and Mechanical Integrity,- Bioburden tests,- Sterility tests,- LAL-test,- Validation of the EtO Sterilization process,- Sterility tests,- Packaging evaluation,- Labelling evaluation,- EtO Residual, according to EN ISO 10993-7,- Biocompatibility, according to ISO 10993 seriesrequirements.The results from these performance evaluations demonstratedthat the AMG PMP STERILE met the acceptarfce criteria definedin the product specification and performed comparably to thepredicate device.
SUBSTANTIALEQUIVALENCE:	The A.M.G PMP STERILE are identical to the predicate device interms of intended use, indications for use and surgical technique.Based on the safety and performance testing, technologicalcharacteristics and the indications for use for the device, theproposed A.M.G PMP STERILE has been demonstrated to beappropriate for its intended use and is considered substantiallyequivalent to the previously cleared A.M.G. advanced membranegas exchange and accessories (K102109).

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Stolberg, GERMANY 52222

Regulation Number and Section

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”