K Number

Device Name

AMG PMP Pediatric

Manufacturer

Eurosets S.r.l.

Date Cleared

2021-04-01

(239 days)

Product Code

DTZ CLA

Regulation Number

870.4350

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K150489, K141492

Reference Devices

K150489, K141492

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical components and mechanisms of gas and heat exchange, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on standard physical and biological tests for oxygenators.

Therapeutic

Yes
The device, an oxygenator with an integrated heat exchanger, directly performs gas exchange and temperature control of a patient's blood during open-heart surgery, which is a therapeutic intervention.

Diagnostic

The device description indicates that the oxygenator is used to exchange gases and control blood temperature during open-heart surgery, which are therapeutic functions, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description clearly details a physical oxygenator with membranes, heat exchangers, and connectors, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that the device is an oxygenator used to exchange gases directly with the patient's blood during cardiopulmonary bypass surgery. It is a device that interacts directly with the patient's circulatory system, not a device that analyzes samples taken from the patient.
Intended Use: The intended use is for patients undergoing cardiopulmonary bypass surgery, which is a surgical procedure, not a diagnostic test.
Device Description: The description focuses on the physical components and how they facilitate gas and heat exchange with the blood flowing through the device. There is no mention of analyzing or testing blood samples.

Therefore, this device falls under the category of a therapeutic medical device used to support a patient's physiological function during surgery, not an in vitro diagnostic device used for testing samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DTZ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Pediatric / small adults.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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)

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, proving that the AMG PMP PEDIATRIC is as safe, as effective, and performs as well as the EOS PMP.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K150489, K141492

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.”

Summary

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

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

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 Italia
S.r.l.	EOS PMP, EOS PMP Integrated	K150489
Primary predicate Dev.
Eurosets	A.M.G. MODULE PMP NO T.P. STERILE	K141492

4. Indications for Use

5. Device Description

6. Comparison with the predicate devices

	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	SECONDARY PREDICATE DEVICE
MODEL NAME:	AMG PMP PEDIATRIC	K150489
EOS PMP	K141492
A.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
REGULATION
NUMBER:	870.4350	870.4350	870.4350
PRODUCT CODE	DTZ	DTZ	DTZ
REGULATION
NAME:	Cardiopulmonary Bypass Oxygenator	Cardiopulmonary Bypass Oxygenator	Cardiopulmonary Bypass Oxygenator
	INDICATIONS FOR USE & PATIENT POPULATION
		The device is intended for use in
INDICATIONS
FOR USE:	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.	patients who undergo
cardiopulmonary bypass surgery
requiring extracorporeal circulation
with a maximum blood flow rate 5
liters/minute. It provides oxygenation
and carbon dioxide removal from
venous blood. The integrated heat
exchanger provides blood
temperature control and allows the
use of hypothermia or aids in the
maintenance of normothermia during
surgery. The device is intended to be
used for 6 hours or less.	Is intended in surgical procedure
requiring extracorporeal gas exchange
support and blood temperature control
for periods of up to 6 hours.
The advanced Membrane Gas Exchange
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.
PATIENT
POPULATION:	Pediatric / small adults	Pediatric / small adults	Adults
		TECHNICAL FEATURES
MIN
BLOOD
FLOW:	0,5l/min	0,5l/min	1l/min
MAX
BLOOD
FLOW:	4l/min	5l/min	7l/min
KIND OF FIBER
OXYGENATOR:	Polymethylpentene (PMP)	Polymethylpentene (PMP)	Polymethylpentene (PMP)
MEMBRANE
SURFACE AREA:	1,35m²	1,4m²	1,81m²
HEAT
EXCAHNGER:	integrated	integrated	integrated
HEAT EXHANGE
SURFACE AREA:	0,08m²	0,15m²	0,08m²
STATIC PRIMING
VOLUME:	190ml	≤200ml	220ml
COATING:	Phosphorylcholine	Phosphorylcholine	Phosphorylcholine
Materials	Polycarbonate (PC)
Polyurethane resin
Stainless Steel
Silicone
Polyvinyl Chloride (PVC)
Polypropylene (PP)
High Density Polyethylene (HDPE)
Low Density Polyethylene (LDPE)
Thermoplastic Elastomer - Styrene-
Ethylene-Butylene-Styrene (SEBS)
Hydrophobic Acrylic Copolymer
Acrylonitrile-Butadiene-Styrene (ABS)
PolyTetraFluoroEthylene (PTFE)	Unknown	Polycarbonate (PC)
Polyurethane resin
Stainless Steel
Silicone
Polyvinyl Chloride (PVC)
Polypropylene (PP)
High Density Polyethylene (HDPE)
Low Density Polyethylene (LDPE)
Thermoplastic Elastomer - Styrene-
Ethylene-Butylene-Styrene (SEBS)
Hydrophobic Acrylic Copolymer
Acrylonitrile-Butadiene-Styrene (ABS)
PolyTetraFluoroEthylene (PTFE)
OXYGENATOR CONNECTIONS
VENOUS INLET:	3/8" (9,53mm)	3/8" (9,53mm)	3/8" (9,53mm)
ARTERIAL
OUTLET:	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	K150489
EOS PMP	K141492
A.M.G. MODULE PMP NO T.P. STERILE
STANDARDS
BIOLOGICAL
STANDARDS:	ISO 10993-1 Biological Evaluation of
Medical Devices Part 1: Evaluation and
Testing;	ISO 10993-1 Biological Evaluation of
Medical Devices Part 1: Evaluation and
Testing;	ISO 10993-1 Biological Evaluation of
Medical Devices Part 1: Evaluation and
Testing;
PRODUCT
SPECIFIC
STANDARDS:	Guidance for Cardiopulmonary Bypass
Oxygenators 510(k) Submissions; Final
Guidance for Industry and FDA Staff,
November 13, 2000;
ISO 7199:2016 Cardiovascular implants
and artificial organs - Blood-gas
exchangers (oxygenators);	Guidance for Cardiopulmonary Bypass
Oxygenators 510(k) Submissions; Final
Guidance for Industry and FDA Staff,
November 13, 2000	Guidance for Cardiopulmonary Bypass
Oxygenators 510(k) Submissions; Final
Guidance for Industry and FDA Staff,
November 13, 2000;

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

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.