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 4 liters/minute. PATIENT POPULATION: Pediatric / small adults.

Device Description

AMG PMP PEDIATRC 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 PEDIATRIC consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the bloodtemperature 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 is surrounded by an outer compartment that contains a microporous membrane of Polymethy|pentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air from the gas mixer is rich in O2 and follows the gas path. It enters through the gas inlet port on the top of the device, goes through microporous PMP fibers and exits from gas escape port, at the same time blood flows outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator utilizes a biologically inert surface to achieve the desired rate of heat exchange without producing any localized overheating of the blood.

AI/ML Overview

The provided text is a 510(k) Summary for the AMG PMP PEDIATRIC device and primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study proving the device meets acceptance criteria. However, it does list the types of performance tests conducted and states that the device met safety and performance requirements.

Here's an attempt to derive the requested information based on the provided text, acknowledging that much of it is not explicitly stated in detail:

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

The document does not provide a table with specific numerical acceptance criteria and corresponding reported device performance values. It generally states that the device "met the safety and performance requirements." It does, however, indirectly compare some technical features to predicate devices, which implies an expectation for performance within a similar range.

Performance Characteristic	Acceptance Criteria (Implied/General)	Reported Device Performance (Implied/General)
Blood cell damage	Acceptable levels (as per ISO 7199 & FDA guidance)	Met safety and performance requirements
Gas transfer rate	Acceptable levels (as per ISO 7199 & FDA guidance)	Met safety and performance requirements
Pressure drop	Acceptable levels (as per ISO 7199 & FDA guidance)	Met safety and performance requirements
Blood pathway integrity	Maintain integrity (as per ISO 7199 & FDA guidance)	Met safety and performance requirements
Heat exchanger fluid pathway integrity	Maintain integrity (as per ISO 7199 & FDA guidance)	Met safety and performance requirements
Gas pathway integrity	Maintain integrity (as per ISO 7199 & FDA guidance)	Met safety and performance requirements
Blood volume capacity (static priming volume)	Comparable to predicate devices (e.g., ≤200ml for EOS PMP)	190ml (within comparable range, implying acceptance)
Residual blood volume	Acceptable levels (as per ISO 7199 & FDA guidance)	Met safety and performance requirements
Blood pathway connectors (tensile strength)	Sufficient strength (as per ISO 7199 & FDA guidance)	Met safety and performance requirements
Heat exchanger fluid pathway connectors	Maintain integrity (as per ISO 7199 & FDA guidance)	Met safety and performance requirements
Heat exchanger performance evaluation	Efficient heat exchange (as per ISO 7199 & FDA guidance)	Met safety and performance requirements
Gas pathway connectors integrity (tensile strength)	Sufficient strength (as per ISO 7199 & FDA guidance)	Met safety and performance requirements

Study details are not provided in the document for any specific study proving these criteria. The document only lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "design verification and validation testing" but does not detail the sample sizes, data provenance, or study design (retrospective/prospective) for these tests.

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)

This information is not provided in the document. The device is a cardiopulmonary bypass oxygenator, not an imaging or diagnostic AI device that would typically involve human expert consensus for "ground truth" in the way described. Its performance is evaluated through engineering and biocompatibility tests against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided as the performance evaluation is based on objective measurements against engineering and biological standards, not on subjective interpretations requiring 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/not provided. The device is a medical device for extracorporeal circulation, not an AI-assisted diagnostic tool involving human readers.

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

This information is not applicable/not provided. The device is an oxygenator, not an algorithm. Its performance is inherent to its physical design and materials, not software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance evaluation would be established by objective measurements against the requirements set by recognized standards like ISO 7199:2016 and the "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000." These standards specify methodologies and acceptance criteria for measuring parameters like gas transfer, pressure drop, blood cell damage, priming volume, etc.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable/not provided for the same reason as above.

Summary

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April 1, 2021

Image /page/0/Picture/1 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 in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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

Re: K202206

Trade/Device Name: AMG PMP Pediatric Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: March 1, 2021 Received: March 4, 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,

for Fernando Aguel 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202206

Device Name AMG PMP PEDIATRIC

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995.

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510(k) Summary

1. General Information

Submitter :

EUROSETS Sri

Strada Statale 12, n° 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: kvescoviniregulatory@eurosets.com

Summary Preparation Date:	March 31. 2021.
---------------------------	-----------------

2. Name & Classification

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

AMG PMP PEDIATRIC Cardiopulmonary bypass oxygenator 870.4350 DTZ ll

3. Predicate Devices

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

Applicant	Device name	510(k) Number
Sorin Group ItaliaS.r.l.	EOS PMP, EOS PMP Integrated	K150489Primary predicate Dev.
Eurosets	A.M.G. MODULE PMP NO T.P. STERILE	K141492

4. Indications for Use

5. Device Description

Oxygenator module, AMG PMP PEDIATRIC consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the bloodtemperature 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 is surrounded by an outer compartment that contains a microporous membrane of Polymethy|pentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air from the gas mixer is rich in O2 and follows the gas path. It enters through the gas inlet port on the top of the device, goes through microporous PMP fibers and exits from gas escape port, at the same time blood flows outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator utilizes a biologically inert surface to achieve 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 PEDIATRIC	K150489EOS 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
PRODUCT CODE	DTZ	DTZ	DTZ
REGULATIONNAME:	Cardiopulmonary Bypass Oxygenator	Cardiopulmonary Bypass Oxygenator	Cardiopulmonary Bypass Oxygenator
	INDICATIONS FOR USE & PATIENT POPULATION
		The device is intended for use in
INDICATIONSFOR USE:	The device is indicated for patientswho undergo cardiopulmonary bypasssurgery requiring extracorporealcirculation for six hours or less with amaximum blood flow rate of 4liters/minute.	patients who undergocardiopulmonary bypass surgeryrequiring extracorporeal circulationwith a maximum blood flow rate 5liters/minute. It provides oxygenationand carbon dioxide removal fromvenous blood. The integrated heatexchanger provides bloodtemperature control and allows theuse of hypothermia or aids in themaintenance of normothermia duringsurgery. The device is intended to beused for 6 hours or less.	Is intended in surgical procedurerequiring extracorporeal gas exchangesupport and blood temperature controlfor periods of up to 6 hours.The advanced Membrane Gas Exchangefor extracorporeal circulation is amicroporous hollow-fiber oxygenatorwith an integral heat exchanger used toperform cardiopulmonary bypass. Itincludes a detachable 4.5 liter bloodreservoir.
PATIENTPOPULATION:	Pediatric / small adults	Pediatric / small adults	Adults
		TECHNICAL FEATURES
MINBLOODFLOW:	0,5l/min	0,5l/min	1l/min
MAXBLOODFLOW:	4l/min	5l/min	7l/min
KIND OF FIBEROXYGENATOR:	Polymethylpentene (PMP)	Polymethylpentene (PMP)	Polymethylpentene (PMP)
MEMBRANESURFACE AREA:	1,35m²	1,4m²	1,81m²
HEATEXCAHNGER:	integrated	integrated	integrated
HEAT EXHANGESURFACE AREA:	0,08m²	0,15m²	0,08m²
STATIC PRIMINGVOLUME:	190ml	≤200ml	220ml
COATING:	Phosphorylcholine	Phosphorylcholine	Phosphorylcholine
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:	3/8" (9,53mm)	3/8" (9,53mm)	3/8" (9,53mm)
ARTERIALOUTLET:	3/8" (9,53mm)	3/8" (9,53mm)	3/8" (9,53mm)
GAS INLET:	1/4" (6,35mm)	1/4" (6,35mm)	1/4" (6,35mm)
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	SECONDARY PREDICATE DEVICE
MODEL NAME:	AMG PMP PEDIATRIC	K150489EOS PMP	K141492A.M.G. MODULE PMP NO T.P. STERILE
STANDARDS
BIOLOGICALSTANDARDS:	ISO 10993-1 Biological Evaluation ofMedical Devices Part 1: Evaluation andTesting;	ISO 10993-1 Biological Evaluation ofMedical Devices Part 1: Evaluation andTesting;	ISO 10993-1 Biological Evaluation ofMedical Devices Part 1: Evaluation andTesting;
PRODUCTSPECIFICSTANDARDS:	Guidance for Cardiopulmonary BypassOxygenators 510(k) Submissions; FinalGuidance for Industry and FDA Staff,November 13, 2000;ISO 7199:2016 Cardiovascular implantsand artificial organs - Blood-gasexchangers (oxygenators);	Guidance for Cardiopulmonary BypassOxygenators 510(k) Submissions; FinalGuidance for Industry and FDA Staff,November 13, 2000	Guidance for Cardiopulmonary BypassOxygenators 510(k) Submissions; FinalGuidance for Industry and FDA Staff,November 13, 2000;

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As can be seen from the table in the underlined parts, the Indications for Use of the AMG PMP PEDIA TRC and the predicate devices (K150489, 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)
. Heat exchanger fluid pathway connectors
. Heat exchanger performance evaluation
Gas pathway connectors integrity (tensile strength test) .

8. Summary

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