The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for six hours or less with a maximum blood flow rate of 1.5 liters/minute. PATIENT POPULATION: Infants.

Device Description

AMG PMP INFANT is an oxygenator used to exchange gases between blood and gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. It is composed by PMP (Polymethylpentene) hollow fiber membrane with an integrated heat exchanger. It is provided together with the accessories that are the gas line and the convenience kit. Oxygenator module, AMG PMP INFANT consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the blood temperature control and gas exchange. The device center consists stainless steel tubes that allow the control of the temperature of the blood. The exchange of heat is between the water (with controlled temperature) that flows outside of steel tubes and the blood that flows inside the steel tubes. The device center is surrounded by an outer compartment that contains a microporous membrane of Polymethylpentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air form the gas mixer rich in O2 follows the gas path: is insufflated through the gas inlet port on the top of the device, goes through microporous PMP fibers and exit from gas escape port, at the same time blood go outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator centers allows making a biologically inert surface capable of achieving the desired rate of heat exchange, without producing any localized overheating of the blood.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "AMG PMP INFANT," which is a cardiopulmonary bypass oxygenator. It assesses the substantial equivalence of this new device to previously cleared predicate devices.

The document discusses performance testing, but it fundamentally does not contain the level of detail requested for acceptance criteria and the specifics of a study proving a device meets those criteria for human clinical/AI related outcomes. The performance data section broadly lists the types of tests performed (e.g., Blood cell damage, Gas transfer rate & pressure drop, Heat exchanger performance evaluation), stating that the device "met the safety and performance requirements as per its indication for use." However, it does not provide numerical acceptance criteria or the specific results obtained for each criterion.

Furthermore, the nature of the device (a cardiopulmonary bypass oxygenator) means that the "performance data" refers to hardware performance specifications (e.g., flow rates, pressure drops, gas transfer efficiency, material compatibility, biological safety) rather than the kind of AI-driven diagnostic or prognostic performance (e.g., sensitivity, specificity, AUC) that would involve human readers, ground truth consensus, or large datasets of medical images.

Therefore, I cannot extract the requested information regarding:

A table of acceptance criteria and the reported device performance (with numerical values): The document only lists the categories of tests.
Sample size used for the test set and the data provenance: Not applicable in the context of this device's testing. The "test set" here refers to the physical devices undergoing engineering and biological performance evaluations, not a dataset of patient cases.
Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for this device is based on physical and chemical measurements against established engineering standards and biological safety guidelines, not expert human interpretation of data.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device is not an AI diagnostic/prognostic tool.
Standalone (algorithm only without human-in-the-loop performance): Not applicable.
The type of ground truth used: Indirectly, the ground truth is established regulatory standards (e.g., ISO 7199:2016, FDA Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions) and internal engineering specifications, rather than clinical outcomes or expert consensus on patient data.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

The document explicitly states: "A program of design verification and validation testing was performed according to the standards 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000'; and ISO 7199:2016 'Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)'." This indicates that the "acceptance criteria" are derived from these established regulatory and international standards for medical device performance and safety, and the "study" is the verification and validation testing against these standards. However, the specific numerical results of these tests are not included for public dissemination in this summary document.

In summary, the provided document details the regulatory clearance process for a traditional medical device (oxygenator), focusing on its substantial equivalence to predicate devices based on engineering and biological performance testing, rather than the AI/software-as-a-medical-device (SaMD) type of study that would involve expert interpretation of data or patient outcomes.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 10, 2021

Eurosets S.r.l. Katia Vescovini RA/QA/CQ Manager Strada Statale 12, nº 143 Medolla, Modena I-41036 Italy

Re: K202510

Trade/Device Name: AMG PMP Infant Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: October 20, 2021 Received: October 25, 2021

Dear Katia Vescovini:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202510

Device Name AMG PMP INFANT

Indications for Use (Describe)

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) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

1. General Information

Submitter :

EUROSETS Srl Strada Statale 12, nº 143 41036 Medolla (MO) - ITALY Tel.: +39 0535 660311 Fax +39 0535 51248

Establishment Registration Number: 3003752502

Contact:

Dr. Katia Vescovini Tel.: +39 0535 660311 Email: kvescovinirequlatory@eurosets.com

Summary Preparation Date:	April 12, 2021
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2. Name & Classification

Device Name: Regulation Name: Regulation Number: Product Code: CLASS:

AMG PMP INFANT Cardiopulmonary bypass oxygenator 870.4350 DTZ ll

3. Predicate Devices

The AMG PMP INFANT device is substantially equivalent to the following devices:

Applicant	Device name	510(k) Number
Sorin Group Italia S.r.I.	Lilliput PMP, Lilliput PMP Integrated	K151713Primary predicate Dev.
Eurosets	A.M.G. MODULE PMP NO T.P. STERILE	K141492

4. Indications for Use

5. Device Description

Oxygenator module, AMG PMP INFANT consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the blood temperature control and gas exchange. The device center consists stainless steel tubes that allow the control of the temperature of the blood. The exchange of heat is between the water (with controlled temperature) that flows outside of steel tubes and the blood that flows inside the steel tubes. The device center is surrounded by an outer compartment that contains a microporous membrane of Polymethylpentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air form the gas mixer rich in O2 follows the gas path: is insufflated through the gas inlet port on the top of the device, goes through microporous PMP fibers and exit from gas escape port, at the same time blood go outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator centers allows making a biologically inert surface capable of achieving the desired rate of heat exchange, without producing any localized overheating of the blood.

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6. Comparison with the predicate devices

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	SECONDARY PREDICATE DEVICE
MODEL NAME:	AMG PMP INFANT	K151713Lilliput PMP	K141492A.M.G. MODULE PMP NO T.P.STERILE
APPLICANT:	Eurosets S.r.l.	Sorin Group Italia S.r.l.	Eurosets S.r.l.
		CLASSIFICATION
CLASS:	II	II	II
REGULATIONNUMBER:	870.4350	870.4350	870.4350
PRODUCTCODE	DTZ	DTZ	DTZ
REGULATIONNAME:	Cardiopulmonary BypassOxygenator	Cardiopulmonary Bypass Oxygenator	Cardiopulmonary BypassOxygenator
		INTENDED USE & PATIENT POPULATION
INTENDED USE:	The device is indicated forpatients who undergocardiopulmonary bypasssurgery requiringextracorporeal circulation forsix hours or less with amaximum blood flow rate of1.5 liters/minute.	The device is intended for use in infantsnot exceeding 20 kg (44lb) whoundergo cardiopulmonary bypasssurgery requiring extracorporealcirculation. It provides oxygenation andcarbon dioxide removal from venousblood. The integrated heat exchangerprovides blood temperature control andallows the use of hypothermia or aids inthe maintenance of normothermiaduring surgery. The venous reservoir isintended to collect blood during normaloperation, to always assure the properoxygenation capability of the device.The device should not be used longerthan 6 hours. Contact with blood forlonger periods is not advised.	Is intended in surgical procedurerequiring extracorporeal gasexchange support and bloodtemperature control for periodsof up to 6 hours.The advanced Membrane GasExchange for extracorporealcirculation is a microporoushollow-fiber oxygenator with anintegral heat exchanger used toperform cardiopulmonary bypass.It includes a detachable 4.5 literblood reservoir.
PATIENTPOPULATION:	Infants	Infants not exceeding 20Kg (44lbs).	Adults
		TECHNICAL FEATURES
MINBLOODFLOW:	0,2	/	1l/min
MAXBLOODFLOW:	1,5l/min	2,3l/min	7l/min
KIND OF FIBEROXYGENATOR:	Polymethylpentene (PMP)	Polymethylpentene (PMP)	Polymethylpentene (PMP)
MEMBRANESURFACEAREA:	0,69m²	0,80m²	1,81m²
HEATEXCAHNGER:	integrated	integrated	integrated
HEAT EXHANGESURFACEAREA:	0,04m²	0,02m²	0,08m²
STATICPRIMINGVOLUME:	90ml	<140ml	220ml
COATING:	Phosphorylcholine	Phosphorylcholine	Phosphorylcholine
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	SECONDARY PREDICATE DEVICE
MODEL NAME:	AMG PMP INFANT	K151713Lilliput PMP	K141492A.M.G. MODULE PMP NO T.P.STERILE
Materials	Polycarbonate (PC)Polyurethane resinStainless SteelSiliconePolyvinyl Chloride (PVC)Polypropylene (PP)High Density Polyethylene(HDPE)Low Density Polyethylene(LDPE)Thermoplastic Elastomer -Styrene-Ethylene-Butylene-Styrene (SEBS)Hydrophobic Acrylic CopolymerAcrylonitrile-Butadiene-Styrene(ABS)PolyTetraFluoroEthylene (PTFE)	unknown	Polycarbonate (PC)Polyurethane resinStainless SteelSiliconePolyvinyl Chloride (PVC)Polypropylene (PP)High Density Polyethylene (HDPE)Low Density Polyethylene (LDPE)Thermoplastic Elastomer -Styrene-Ethylene-Butylene-Styrene (SEBS)Hydrophobic Acrylic CopolymerAcrylonitrile-Butadiene-Styrene(ABS)PolyTetraFluoroEthylene (PTFE)
OXYGENATOR CONNECTIONS
VENOUS INLET:	1/4" (6,35mm)	1/4" (6,35mm)	3/8" (9,53mm)
ARTERIALOUTLET:	1/4" (6,35mm)	1/4" (6,35mm)	3/8" (9,53mm)
GAS INLET:	1/4" (6,35mm)	1/4" (6,35mm)	1/4" (6,35mm)
STANDARDS
BIOLOGICALSTANDARDS:	ISO 10993-1 BiologicalEvaluation of Medical DevicesPart 1: Evaluation and Testing;	ISO 10993-1 Biological Evaluation ofMedical Devices Part 1: Evaluation andTesting;	ISO 10993-1 Biological Evaluationof Medical Devices Part 1:Evaluation and Testing;
PRODUCTSPECIFICSTANDARDS:	Guidance for CardiopulmonaryBypass Oxygenators 510(k)Submissions; Final Guidance forIndustry and FDA Staff,November 13, 2000;ISO 7199:2016 Cardiovascularimplants and artificial organs -Blood-gas exchangers(oxygenators);	Guidance for Cardiopulmonary BypassOxygenators 510(k) Submissions; FinalGuidance for Industry and FDA Staff,November 13, 2000	Guidance for CardiopulmonaryBypass Oxygenators 510(k)Submissions; Final Guidance forIndustry and FDA Staff, November13, 2000;

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As can be seen from the table in the underlined parts, the Indications for Use of the AMG PMP INFANT and the predicate devices (K151713, K141492) are fundamentally the same with only some additional details provided for the predicate devices that do not affect the intended use of the subject device.

7. Performance Data

A program of design verification and validation testing was performed according to the standards "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000"; and ISO 7199:2016 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)" .

This design verification and validation testing and includes the following tests:

Blood cell damage ●
Gas transfer rate & pressure drop ●
Blood pathway integrity ●
Heat exchanger fluid pathway integrity ●
. Gas pathway integrity
Blood volume capacity (static priming volume) .
Residual blood volume .
Blood pathway connectors (tensile strength test) ●
Gas pathway connectors integrity (tensile strength test) ●
Heat exchanger fluid pathway connectors ●

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Heat exchanger performance evaluation ●

8. Summary

Results of these performance tests allow to demonstrate that the subject device AMG PMP INFANT met the safety and performance requirements as per its indication for use and that AMG PMP INFANT subject device is substantially equivalent with the LILLIPUT PMP predicate devices, proving that the AMG PMP INFANT is as safe, as effective, and performs as well as the LILLIPUT PMP.

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.”