Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U and Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use.

Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U and Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use.

Devices are intended for adult patients.

Device Description

Quantum Perfusion Blood Oxygenator devices (acronym VT-C) consist of an oxygenator with an integrated arterial filter.

The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours.

The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli.

Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange.

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

The provided text describes a 510(k) premarket notification for a medical device, the "Quantum Perfusion Blood Oxygenator," and its various models. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving that the device meets specific numeric acceptance criteria for performance in an AI/data science context.

Therefore, the information required to answer your specific questions about AI/ML acceptance criteria and a study proving those criteria (such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not present in this document.

The document states:

"No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate devices."
"No animal studies have been performed except for mandatory biocompatibility tests..."

Instead, the submission relies on non-clinical bench testing to demonstrate performance and safety characteristics, comparing them to the properties of the predicate devices. The non-clinical tests listed are related to the physical and functional aspects of the oxygenator itself (e.g., priming volume, pressure drop, gas transfer, mechanical integrity, etc.), not the performance of an AI algorithm.

Here's what can be extracted, albeit not directly answering your AI/ML specific questions:

1. A table of acceptance criteria and the reported device performance:
* The document implies acceptance criteria by stating "All testing passed by meeting the established requirements set for the devices." However, the specific numerical acceptance criteria for each non-clinical test are not explicitly detailed in this summary. Instead, it refers to standards like ISO 7199 and FDA Guidance for Cardiopulmonary Bypass Oxygenators.
* The "reported device performance" are implied to have met these unspecified criteria, but no quantitative results for these tests are presented in this summary.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Meeting established requirements per ISO 7199, 21 CFR §870.4350, and FDA Guidance ("Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff") for:	"All testing passed by meeting the established requirements set for the devices." No quantitative data provided in this summary.
Operating priming volume	(Passed)
Device pressure Drop	(Passed)
Gas Transfer Performances	(Passed)
Mechanical Blood Cell Damage	(Passed)
Ease of Prime and Air handling	(Passed)
Filtration efficiency	(Passed)
Temperature probe and Pressure sensor verification	(Passed)
Mechanical Integrity	(Passed)
Mechanical resistance of connectors	(Passed)
Coating coverage and durability	(Passed)
Product shelf life & sterility (per EP/UPS)	(Passed)
EtO Sterilization process validation (per ISO 11135:2014)	(Passed)
Packaging Validation (per ISO 11607-1:2019)	(Passed)
Biocompatibility (per ISO 10993-1:2018 and FDA Guidance)	(Passed)

2. Sample sizes used for the test set and the data provenance:
* Not applicable/Not provided. The document describes non-clinical bench testing, not a clinical study with a test set of patient data for an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not provided, as there is no mention of an AI/ML algorithm requiring expert ground truth for its performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not provided.

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:
* Not applicable/Not provided. No AI component is described or evaluated in this medical device submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable/Not provided.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* Not applicable/Not provided for an AI/ML context. The "ground truth" for the non-clinical tests would be the established engineering and biological standards and measurements.

8. The sample size for the training set:
* Not applicable/Not provided. No AI/ML model training is described.

9. How the ground truth for the training set was established:
* Not applicable/Not provided.

In summary: This document is a regulatory submission for a physical medical device (blood oxygenator) seeking substantial equivalence based on its physical and functional characteristics and non-clinical bench testing. It does not involve AI or machine learning, and therefore the information you requested regarding AI/ML model evaluation is not present.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 28, 2022

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

Re: K212341

Trade/Device Name: Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: December 23, 2021 Received: December 29, 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.

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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.

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

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510(k) Number (if known) K212341

Device Name

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U

Indications for Use (Describe)

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.

Device is 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

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510(k) Number (if known) K212341

Device Name

Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U

Indications for Use (Describe)

Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.

Device is 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

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510(k) Number (if known) K212341

Device Name

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U

Indications for Use (Describe)

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.

Device is 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

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510(k) Number (if known) K212341

Device Name

Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U

Indications for Use (Describe)

Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.

Device is 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

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510(K) SUMMARY

I. 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 23rd, 2022

II. DEVICES

Proprietary Name:

	Quantum Perfusion Blood Oxygenator with Integrated AF and SensorVT160-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF and
	Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated
	AF VT160 – C2U, Quantum Perfusion Blood Oxygenator with IntegratedAF VT200-C2U.
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 ofHealth Technology 2 B (Circulatory Support, Structural and Vascular Devices)
510(k) Number:	K212341

PREDICATE AND REFERENCE DEVICES lll.

Predicate device:

Trade Name:	INSPIRE 8F M Hollow Fiber Oxygenator With Integrated Arterial Filter
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	K180448

Reference device:

Trade Name:	INSPIRE 6F M Hollow Fiber Oxygenator With Integrated Arterial Filter
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	K180448

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IV. DEVICE DESCRIPTION

Quantum Perfusion Blood Oxygenator devices (acronym VT-C) consist of an oxygenator with an integrated arterial filter.

The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours.

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.

Characteristics	CODE
	VT200-C1U	VT200-C2U	VT160-C1U	VT160-C2U
Blood contact materials	Tritan copolyesterPolypropylene (PP)Polyurethane (PU)Polyester (PET)Coating: phosphorylcholine
Maximum operating pressure - blood side	760 mmHg / 100 kPa / 1 bar / 14.5 psi
Static priming volume (ml)	200		160
Exchange surface area (m²)	1.75		1.45
Blood flow (l/min)	1-8		0.5-6
Maximum gas flow (l/min)		10
Connections - blood side (IN/OUT)		3/8" (9.525mm)
Connections - gas side
IN		CPC APC profile
OUT		1/4" (6.35mm), cone and Luer Lock
Arterial sampling		Luer Lock
Purge line		Luer Lock
Cardioplegia connector		Pos Lock
Arterial filter size:
Pore size (µm)	40		40
Filter surface area (cm²)	78		60
Temperature probe - Blood OUT		YSI 400
Blood OUT pressure sensor - Range	-200 to 600mmHg-27 to 80 KPa-0.27 to 0.8 bar	/	-200 to 600mmHg-27 to 80 KPa-0.27 to 0.8 bar	/

Significant physical and performance characteristics:

Table 5-1 —Main characteristics

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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 (all variants) and the predicate device has been conducted. Quantum Perfusion Blood Oxygenator devices has the same intended use and operating principle as the predicate and reference devices.

Based on the safety, performance data, technological characteristics, and the indications for use of the predicate device:

. Quantum Perfusion Blood Oxygenator (all variants) are considered substantially equivalent to the legally marketed predicate device INSPIRE 8F M (K180448) since the intended use, main blood-contact materials and technological characteristics are the same.
In addition, in terms of performance:
l VT200-C1U and VT200-C2U devices are considered substantially equivalent to the legally marketed predicate device INSPIRE 8F M (K180448).
VT160-C1U and VT160-C2U devices are considered substantially equivalent to the legally marketed reference predicate device INSPIRE 6F M (K180448).

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

Device	Proposed Device - QuantumPerfusion Blood Oxygenator	Predicate Device - SorinGroup Italia Inspire 8F M	Reference Predicate Device- Sorin Group Italia Inspire6F M
Name	Quantum Perfusion BloodOxygenator with Integrated AFand Sensor VT200-C1UQuantum Perfusion BloodOxygenator with Integrated AFVT200-C2U	INSPIRE 8F M Hollow FiberOxygenator WithIntegrated Arterial Filter	N.A.
	Quantum Perfusion BloodOxygenator with Integrated AFand Sensor VT160-C1UQuantum Perfusion BloodOxygenator with Integrated AFVT160-C2U		INSPIRE 6F M Hollow FiberOxygenator With IntegratedArterial Filter
510(k) Number	K212341	K180448
Regulation #	870.4350	870.4350	870.4350
Regulation Name	Cardiopulmonary BypassOxygenator	Cardiopulmonary Bypass Oxygenator
Product Code	DTZ	DTZ
Classification	II	II
Indication for Use	Quantum Perfusion BloodOxygenator with Integrated AFand Sensor VT200-C1U andQuantum Perfusion BloodOxygenator with Integrated AFand Sensor VT160-C1U arediffusion membraneoxygenators, designed toprovide gas exchange duringcardiac surgery requiringcardiopulmonary bypass, tomeasure blood pressure andtemperature during theprocedure. The integratedarterial filter providesadditional protection againstair and solid emboli. Thedevices are limited to 6 hours ofuse.Quantum Perfusion BloodOxygenator with Integrated AFVT200-C2U and QuantumPerfusion Blood Oxygenatorwith Integrated AF VT160-C2Uare diffusion membraneoxygenators, designed toprovide gas exchange duringcardiac surgery requiring	The Inspire 8F M isintended for use in adultand small adult surgicalprocedures requiringcardiopulmonary bypass. Itprovides gas exchangesupport and bloodtemperature control.Inspire 8F M integratedarterial filter providesadditional protectionagainst air and solidemboli. Inspire 8F M isintended to be used for 6hours or less.	The Inspire 6F M is intendedfor use in adult and smalladult surgical proceduresrequiring cardiopulmonarybypass. It provides gasexchange support and bloodtemperature control. Inspire6F M integrated arterial filterprovides additionalprotection against air andsolid emboli. Inspire 6F M isintended to be used for 6hours or less
Device	Proposed Device - Quantum Perfusion Blood Oxygenator	Predicate Device - Sorin Group Italia Inspire 8F M	Reference Predicate Device - Sorin Group Italia Inspire 6F M
	cardiopulmonary bypass, and measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use.Devices are intended for adult patients.
Main Materials	Fiber: polypropylene (PP)Coating: PhosphorylcholineArterial filter: polyester (PET)Housing: TritanSensor: Polycarbonate and silicone-based protective gel	Fiber: Polypropylene (PP)Coating: PhosphorylcholineArterial filter: Polyester (PET)Housing: PolycarbonateHeat exchanger: Polyurethane (PU)
Blood side Connector Type	3/8" (9.525mm)	3/8" (9.525mm)
Max flow rate [l/min]	VT200-C1U - VT 200-C2U: 8VT160-C1U - VT160-C2U: 6	8	6
Exchange surface [m²]	VT200-C1U - VT 200-C2U: 1.75VT160-C1U - VT160-C2U: 1.45	1.75	1.4
Static Priming Volume [ml]	VT200-C1U - VT 200-C2U: 200VT160-C1U - VT160-C2U: 160	351	284
Arterial filter cut-off size [µm]	40	38	38
Presence of sensor	Pressure sensors located integrated in the blood out connector (C1U variants only)	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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PERFORMANCE DATA VII.

NON-CLINICAL TESTING

The following non-clinical testing was performed to support the substantial equivalence of Quantum Perfusion Blood Oxygenators to the legally marketed predicate devices. This testing included biocompatibility evaluation, mechanical and performance verification, labeling and Instructions for Use (IFU), and 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 [Recognition Nr. 3-150], 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;
- O Ease of Prime and Air handling;
- 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.: 14-529];
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, technological characteristics, results of non-clinical testing, and comparison to predicate devices, Quantum Perfusion Blood Oxygenators have been shown to be substantially equivalent to legally marketed predicate and reference devices (both covered by K180448).

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.”