Quantum Perfusion Blood Oxygenator ECC VT200-E1 and Quantum Perfusion Blood Oxygenator ECC VT160-E1 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use.

Quantum Perfusion Blood Oxygenator ECC VT200-E2 and Quantum Perfusion Blood Oxygenator ECC VT160-E2 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use.

Devices are intended for adult patients.

Device Description

The Quantum Perfusion Blood Oxygenator ECC (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours..

Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethy|pentene (PMP). In this chamber, carbon dioxide moves from the blood to the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator.

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box.

All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the Quantum Perfusion Blood Oxygenator ECC (various models). It details the device's characteristics, intended use, and comparison to predicate devices for demonstrating substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a detailed quantitative manner for all parameters. Instead, it states that "All testing passed by meeting the established requirements set for the devices." The performance data is summarized under "NON-CLINICAL TESTING" as a list of tests performed.

However, we can infer some of the performance characteristics from "Table 5-1 —Main characteristics" on page 7 and "Table 5-2 – Comparative Data" on page 9-10, which provide technical specifications of the device and its comparison to predicate devices. These act as the de facto acceptance criteria and reported performance values.

Here's an attempt to construct a table based on the provided information, noting that specific "acceptance criteria" values are often inferred from the device's technical specifications and the predicate device's characteristics, which the new device aims to match or perform similarly to. The "Reported Device Performance" here are the self-declared specifications of the applicant's device.

Characteristic / Performance Parameter	Acceptance Criteria (Inferred/Predicate Value)	Reported Device Performance (Quantum Perfusion Blood Oxygenator ECC)
Max Operating Pressure - Blood Side	760 mmHg / 100 kPa / 1 bar / 14.5 psi (This is a maximum limit, implying the device must withstand at least this)	760 mmHg / 100 kPa / 1 bar / 14.5 psi
Static Priming Volume (VT200-E1, VT200-E2)	Predicate: 215 ml	195 ml
Static Priming Volume (VT160-E1, VT160-E2)	Reference Predicate: 150 ml	160 ml
Exchange Surface Area (VT200-E1, VT200-E2)	Predicate: 1.8 m²	1.75 m²
Exchange Surface Area (VT160-E1, VT160-E2)	Reference Predicate: 1.2 m²	1.45 m²
Blood Flow (VT200-E1, VT200-E2)	Predicate: 7 l/min	1-7 l/min
Blood Flow (VT160-E1, VT160-E2)	Reference Predicate: 5 l/min	0.5-5 l/min
Maximum Gas Flow	Not explicitly stated for predicate; device has a max gas flow.	10 l/min
Connections - Blood Side (IN/OUT)	Predicate: 3/8" (9.525mm)	3/8" (9.525mm)
Temperature Probe - Blood OUT (VT200-E1, VT160-E1)	Not explicitly stated for predicate; device has this feature.	YSI 400
Blood OUT Pressure Sensor - Range	Not explicitly stated for predicate; device has this feature.	-200 to 600 mmHg / -27 to 80 KPa / -0.27 to 0.8 bar / -3.8 to 11.6 psi
Material - Fiber	Predicate/Reference: Polymethylpentene (PMP)	Polymethylpentene (PMP)
Material - Coating	Predicate: Softline (synthetic polymer-based); Reference: Phosphorylcholine	Phosphorylcholine
Material - Housing	Predicate: Polycarbonate (PC); Reference: Polycarbonate	Tritan copolyester
Single-use	Predicate: Yes	Yes
Sterile Condition	Predicate: EtO Sterile	EtO Sterile
Biocompatibility	Complies with ISO 10993-1:2018 guidance	Evaluation performed, meets standard.
Mechanical Integrity	Established requirements met through testing.	Testing passed.
Mechanical Resistance of Connectors	Established requirements met through testing.	Testing passed.
Coating Coverage and Durability	Established requirements met through testing.	Testing passed.
Operating Priming Volume	Established requirements met through testing.	Testing passed.
Device Pressure Drop	Established requirements met through testing.	Testing passed.
Gas Transfer Performances	Established requirements met through testing.	Testing passed.
Mechanical Blood Cell Damage	Established requirements met through testing.	Testing passed.
Ease of Prime and Air Handling	Established requirements met through testing.	Testing passed.
Filtration Efficiency	Established requirements met through testing.	Testing passed.
Temperature Probe and Pressure Sensor Verification	Established requirements met through testing.	Testing passed.
Product Shelf Life	Complies with EP/UPS requirements.	Evaluation performed, meets standard.
EtO Sterilization Process Validation	Complies with ISO 11135:2014.	Validation performed, meets standard.
Packaging Validation	Complies with ISO 11607-1:2019.	Validation performed, meets standard.

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

The document does not specify the sample sizes for the non-clinical tests (e.g., how many devices were tested for priming volume, pressure drop, etc.). It mentions that in-vitro testing was performed.

Data Provenance: The manufacturer is Qura S.r.l. in Mirandola, Modena, Italy. The testing was non-clinical (in-vitro), so there is no patient data provenance in terms of country or retrospective/prospective nature. The tests were performed to demonstrate compliance with international standards (ISO, EP/UPS) and FDA guidance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the studies described are non-clinical, in-vitro performance, and biocompatibility tests for medical devices, not diagnostic studies requiring expert adjudication of images or patient outcomes. The "ground truth" here is defined by physical and chemical measurements against engineering specifications and international standards.

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

This is not applicable as there is no human-in-the-loop diagnostic task or medical imaging analysis requiring adjudication. Adjudication methods are typically used in clinical studies or expert reviews of diagnostic interpretations.

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 is not applicable. The device is a blood oxygenator, not an AI-powered diagnostic tool. No MRMC study was performed or is relevant for this type of device. The submission explicitly states: "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate devices."

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

This is not applicable as the device is not an algorithm or AI system. Its "performance" is mechanical, physical, and biological (biocompatibility, gas exchange efficiency). These were tested in a standalone (device-only) manner as non-clinical, in-vitro tests, as described in the "NON-CLINICAL TESTING" section.

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

The "ground truth" for this device's performance evaluation is established through:

Engineering specifications and design parameters.
Relevant international standards (e.g., ISO 7199 for oxygenators, ISO 11135 for sterilization, ISO 11607-1 for packaging, ISO 10993-1 for biocompatibility).
FDA guidance documents specific to cardiopulmonary bypass oxygenators.
Performance characteristics of the predicate and reference devices, against which substantial equivalence is claimed.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This is not applicable for the reason stated in point 8.

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). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

December 17, 2021

Qura S.r.1. Raffaella Tommasini QA&RA Director Via di Mezzo, 23 Mirandola, Modena 41037 Italy

Re: K203424

Trade/Device Name: Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: November 18, 2021 Received: November 22, 2021

Dear Raffaella Tommasini:

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

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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,

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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Indications for Use

510(k) Number (if known) K203424

Device Name

Quantum Perfusion Blood Oxygenator ECC VT200-E2

Indications for Use (Describe)

Quantum Perfusion Blood Oxygenator ECC VT200-E2 is a diffusion membrane oxygenator, designate and remove carbon dioxide from venous blood during cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use.

Devices are intended for adult patients.

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."

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

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Indications for Use

510(k) Number (if known) K203424

Device Name

Quantum Perfusion Blood Oxygenator ECC VT200-E1

Indications for Use (Describe)

Quantum Perfusion Blood Oxygenator ECC VT200-E1 is a diffusion membrane oxygenator, designate and remove carbon dioxide from venous blood during cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use.

Devices are intended for adult patients.

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.

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."

er aspect

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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Indications for Use

510(k) Number (if known) K203424

Device Name

Quantum Perfusion Blood Oxygenator ECC VT160-E2

Indications for Use (Describe)

Quantum Perfusion Blood Oxygenator ECC VT160-E2 is a diffusion membrane oxygenator, designate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use.

Devices are intended for adult patients.

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.

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."

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

PSC Publishing Services (301) 443-6740 EF

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Indications for Use

510(k) Number (if known) K203424

Device Name

Quantum Perfusion Blood Oxygenator ECC VT160-E1

Indications for Use (Describe)

Quantum Perfusion Blood Oxygenator ECC VT160-E1 is a diffusion membrane oxygenator, designate and remove carbon dioxide from venous blood during cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use.

Devices are intended for adult patients.

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.

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."

ed to oxygenate and

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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510(K) SUMMARY

SUBMITTER

Submitter Name:	Qura S.r.l.
Submitter Address:	Via di Mezzo, 23 41037 Mirandola (MO) Italy
Contact Person:	Raffaella Tommasini, QA&RA Director – Qura s.r.l.
Phone:	+39 0535 1803050
e-mail:	raffaella.tommasini@quramed.com
Fax:	+39 0535 1803051
Date Summary Prepared:	December 17th, 2021

II. DEVICE	Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion BloodOxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1Quantum Perfusion Blood Oxygenator ECC VT160-E2
Proprietary Name:
Common Name:	Blood Oxygenator
Common Name:	Blood Oxygenator
Classification Name:	Oxygenator, Cardiopulmonary Bypass
Regulatory Class:	II
Product Code:	DTZ
Panel:	Cardiovascular Devices, Office of Health Technology 2 (OHT2) / Division of HealthTechnology 2 B (Circulatory Support, Structural and Vascular Devices)

PREDICATE AND REFERENCE DEVICES ==

Predicate device:
Trade Name:	QUADROX-iD Adult
Registered Establishment Name:	MAQUET CARDIOPULMONARY AG
Regulation Number:	870.4350
Regulation Name:	Cardiopulmonary Bypass Oxygenator
Regulatory Class:	II
Product Code:	DTZ
510(k) Number	K150267

Reference device:

Trade Name:	EOS PMP
Registered Establishment Name:	Sorin Group Italia S.r.l.
Regulation Number:	870.4350
Regulation Name:	Cardiopulmonary Bypass Oxygenator
Regulatory Class:	II
Product Code:	DTZ
510(k) Number	K150489

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IV. DEVICE DESCRIPTION

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box.

All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.

	CODE
Characteristics	VT200-E1	VT200-E2	VT160-E1	VT160-E2
Blood contact materials	Tritan copolyesterPolymethylpentene (PMP)Polyurethane (PU)Coating: phosphorylcholine
Maximum operating pressure - blood side	760 mmHg / 100 kPa / 1 bar / 14.5 psi
Static priming volume (ml)	195		160
Exchange surface area (m²)	1.75		1.45
Blood flow (l/min)	1-7		0.5-5
Maximum gas flow (l/min)		10		10
Connections - blood side (IN/OUT)	3/8" (9.525mm)		3/8" (9.525mm)
Arterial sampling	Luer Lock		Luer Lock
Purge line	Luer Lock		Luer Lock
Connections - gas sideIN		CPC APC profile		CPC APC profile
Connections - gas sideOUT		1/4" (6.35mm) and Luer Lock		1/4" (6.35mm) and Luer Lock
Temperature probe - Blood OUT	YSI 400	NA	YSI 400	NA
Blood OUT pressure sensor - Range	-200 to 600 mmHg / -27 to 80 KPa / -0.27 to 0.8 bar / -3.8 to 11.6 psi

Significant physical and performance characteristics:

Table 5-1 —Main characteristics

Additional information have been provided in Section 10 of K203424 submission.

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INTENDED USE / INDICATIONS FOR USE V.

Devices are intended for adult patients.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

An extensive and complete comparison between Quantum Perfusion Blood Oxygenator ECC (all variants) and the predicate device has been conducted. Based on the safety, performance data, technological characteristics, and the indications for use of the predicate device:

l Quantum Perfusion Blood Oxygenator ECC (all variants) are considered substantially equivalent to the legally marketed predicate device QUADROX-iD Adult Oxygenator (K150267) since the intended use, main blood-contact materials and technological characteristics are the same.
In addition, in terms of performance:
. VT200-E1 and VT200-E2 devices are considered substantially equivalent to the legally marketed predicate device QUADROX-iD Adult Oxygenator (K150267).
. VT160-E1 and VT160-E2 devices are considered substantially equivalent to the legally marketed reference predicate device EOS-PMP (K150489).

A summary of the technological characteristics of Quantum Perfusion Blood Oxygenator ECC to those of the predicate/reference device has been given in table below.

Additional information have been provided in Section 12 of K203424 submission.

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Device	Proposed Device - QuantumPerfusion Blood OxygenatorECC	Predicate Device –Maquet Quadrox-iD AdultOxygenator	Reference Predicate Device– Sorin Group Italia EOSPMP
Name	Quantum Perfusion BloodOxygenator ECC VT200-E1Quantum Perfusion BloodOxygenator ECC VT200-E2	QUADROX-iD Adult	EOS PMP
	Quantum Perfusion BloodOxygenator ECC VT160-E1Quantum Perfusion BloodOxygenator ECC VT160-E2
510(k) Number	K203424	K150267	K150489
Regulation #		870.4350
Regulation Name	Cardiopulmonary Bypass Oxygenator
Product Code	DTZ
Classification	II
Indication for Use	Quantum Perfusion BloodOxygenator ECC VT200-E1 andQuantum Perfusion BloodOxygenator ECC VT160-E1 arediffusion membraneoxygenators, designed tooxygenate and remove carbondioxide from venous bloodblood during cardiac surgeryrequiring cardiopulmonarybypass and to measure bloodpressure and temperatureduring the procedure. Thedevice is limited to 6 hours ofuse.Quantum Perfusion BloodOxygenator ECC VT200-E2 andQuantum Perfusion BloodOxygenator ECC VT160-E2 arediffusion membraneoxygenators, designed tooxygenate and remove carbondioxide from venous bloodduring cardiac surgery requiringcardiopulmonary bypass and tomeasure blood pressure duringthe procedure. The device islimited to 6 hours of use.Devices are intended for adultpatients.	The QUADROX-iD Adultoxygenator is intended foruse in an extracorporealcirculation duringcardiopulmonary bypass incardiac surgery. Within thespecified flow rate range,the device oxygenates theblood, removes carbondioxide from the blood andregulates the bloodtemperature. Theapplication duration islimited to 6 hours.Responsibility for decidingwhether to use anoxygenator rests solelywith the attendingphysician.	The device is intended for usein patients who undergocardiopulmonary bypasssurgery requiringextracorporeal circulationwith a maximum blood flowrate of 5 liters/minute. Itprovides oxygenation andcarbon dioxide removal fromvenous blood. The integratedheat exchanger providesblood temperature controland allows the use ofhypothermia or aids in themaintenance ofnormothermia duringsurgery. The device isintended to be used for 6hours or less.
Main ContactingMaterials	Fiber: Polymethylpentene(PMP)Coating: PhosphorylcholineHousing: TritanSensor: Polycarbonate andsilicone based protective gel	Fiber: Polymethylpentene(PMP)Coating: Softline (syntheticpolymer-based coating)Housing: Polycarbonate(PC)	Fiber: Polymethylpentene(PMP)Coating: PhosphorylcholineHousing: PolycarbonateHeat exchanger: Stainlesssteel
Device	Proposed Device – QuantumPerfusion Blood OxygenatorECC	Predicate Device –Maquet Quadrox-iD AdultOxygenator	Reference Predicate Device– Sorin Group Italia EOSPMP
		Heat exchanger:thermoplasticpolyurethane (TPU)
Blood side ConnectorType		3/8" (9.525mm)
Max flow rate [l/min]
VT200-E1, VT200-E2	7	7
VT160-E1, VT60-E2	5		5
Exchange surface [m²]
VT200-E1, VT200-E2	1.75	1.8
VT160-E1, VT60-E2	1.45		1.2
Static PrimingVolume [ml]	195	215
	160		150
Presence of sensor	Pressure sensors locatedintegrated in the blood outconnector.	Not present	Not present
Single-use	Yes	Yes
Sterile Condition	EtO Sterile	EtO Sterile

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Table 5-2 – Comparative Data

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VIII. PERFORMANCE DATA

NON-CLINICAL TESTING

In-vitro testing was performed to demonstrate the product's substantial equivalence with the predicate device and also to comply with user needs and safety and effectiveness requirements. Testing supplied in the 510(k) Notification includes biocompatibility evaluation, mechanical and performance verification, labeling and Instructions for Use (IFU), verification and validation tests.

All testing passed by meeting the established requirements set for the devices. The following data were provided:

-Performance tests, according to applicable special controls according to ISO 7199, 21 CFR §870.4350 and "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff", dated November 13, 2000:
- o Operating priming volume;
- O Device pressure Drop;
- Gas Transfer Performances; O
- O Mechanical Blood Cell Damage;
- Ease of Prime and Air handling; O
- O Filtration efficiency;
- O Temperature probe and Pressure sensor verification;
- Mechanical Integrity; O
- o Mechanical resistance of connectors;
- O Coating coverage and durability.
Evaluation of product shelf life, including product's sterility according to EP/UPS requirements; -
-Validation of the EtO Sterilization process, according to ISO 11135:2014 [Recognition Nr.: 14-452];
-Packaging Validation tests according to ISO 11607-1:2019 [Recognition Nr.: 14-530];
-Biocompatibility of the finished product, according to International Standard ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

Animal Study

No animal studies have been performed except for mandatory biocompatibility tests according to International Standard ISO 10993-1:2018 |Recognition Nr. 2-258| and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

CLINICAL TESTING

No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate devices.

VIII. CONCLUSIONS

Based on the indications for use, main technological characteristics and results of non-clinical testing, the subject devices have been demonstrated to be appropriate for their intended use and are considered substantially equivalent to legally marketed predicate (K150267) and reference (K150489) devices.

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.”