The Quantum Perfusion Centrifugal Blood Pump CP20, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava

Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)

The Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either:

Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on (i) the heart or great vessels; or

Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava.

Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)

Device Description

Quantum Perfusion Centrifugal Blood Pump CP20 and Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors are standalone single use device intended to pump blood into the extracorporeal circulation circuit and to monitor pressure for periods lasting less than 6 hours.

Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors is equipped with two sensors integrated in the blood inlet and outlet connectors.

Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.

AI/ML Overview

This document describes the Qura S.r.l. Quantum Perfusion Centrifugal Blood Pump CP20 and CP20 with Integrated Sensors (K220842).

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" with numerical targets in a table format for each performance test. Instead, it lists the types of performance tests conducted to demonstrate substantial equivalence to the predicate and reference devices, implying that the acceptance criterion for each test was to perform comparably or within expected safety limits as per relevant standards and guidance.

Below is a table summarizing the reported device characteristics relevant to performance and the tests conducted. The "Acceptance Criteria" column will be inferred as "Compliance with applicable standards and demonstration of substantial equivalence to predicate/reference devices."

Performance Characteristic/Test Area	Acceptance Criteria (Inferred)	Reported Device Performance
Operating Parameters	Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference.	In-vitro performance tests performed. Device designed to pump blood, with CP20 with Integrated Sensors also monitoring pressure. Maximum blood flow rate: 1.5 L/min. Maximum pump operating pressure: 550 mmHg. (Compared favorably to predicate and reference)
Dynamic Blood Damage	Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference.	In-vitro performance tests performed. Blood contact surfaces coated with phosphorylcholine-based biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.
Heat Generation	Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference.	In-vitro performance tests performed.
Air Entrapment	Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference.	In-vitro performance tests performed.
Mechanical Integrity	Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference.	In-vitro performance tests performed.
Durability/Reliability	Compliance with applicable special controls per 21 CFR 870.4360 and ISO 18242; substantial equivalence to predicate/reference.	In-vitro performance tests performed. Intended for periods lasting less than 6 hours.
Product Shelf Life	Compliance with applicable standards and substantial equivalence to predicate/reference.	Evaluation performed.
Sterilization Process (EtO)	Validation per ISO 11135 (Recognition Nr.: 14-529).	Validation performed, device is EtO sterile.
Packaging Validation	Validation per ISO 11607-1 (Recognition Nr. 14-530).	Validation performed.
Biocompatibility	Compliance with ISO 10993-1:2018 (Recognition Nr. 2-258) and FDA Guidance "Use of International Standard ISO 10993-1..."	Evaluation performed, including mandatory animal tests. Devices are non-toxic.
Integrated Sensors (for CP20 with S.)	Ability to measure pressure at inlet and outlet; substantial equivalence to reference device (CP22 with Integrated Sensors).	Equipped with two sensors positioned on the blood inlet and outlet connectors, both able to measure pressure at the same time.
Priming Volume	Comparable to predicate device (14 mL for PediMag); appropriate for intended patient population.	20 mL.
Intended Use Duration	Less than 6 hours for cardiopulmonary bypass or temporary circulatory bypass. (Matches predicate and reference.)	< 6 hours.
Target Population	Adolescent patients (12-21 years of age). (Aligned with perceived need for a pump with 1.5 L/min flow rate, given predicate's pediatric use.)	Adolescent patients (greater than 12 through 21 years of age).

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical (in-vitro) performance tests. It states: "In-vitro testing was performed to comply with user needs and safety and effectiveness requirements and demonstrate substantial equivalence with the predicate and reference devices..."

Sample Size: The specific sample sizes for each in-vitro performance test (e.g., number of devices tested for durability, blood damage, etc.) are not specified in this summary.
Data Provenance: The tests are described as "in-vitro testing," meaning they were conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms typically apply to clinical studies rather than bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This section is not applicable as the studies are non-clinical (in-vitro performance tests). Ground truth, in the context of expert review, usually refers to the establishment of disease status or other clinical observations by human experts for comparison with AI or device performance in clinical settings. The document indicates that no clinical data was included in this 510(k) submission.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple human readers assess cases and discrepancies need to be resolved to establish a definitive "ground truth."

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:

No MRMC comparative effectiveness study was done. 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 and reference devices." The device is a centrifugal blood pump, not an AI or imaging diagnostic tool that would typically involve human readers.

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

The device is a medical pump, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance, which typically applies to AI diagnostics, is not applicable. The device's performance relies on its mechanical and physical properties when operated by a perfusionist with a centrifugal drive. The section on "Performance Data VII. NON-CLINICAL TESTING" details standalone performance in a laboratory setting against engineering, material, and safety standards.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is established by:

Compliance with recognized standards: ISO 18242 (for performance tests), ISO 11135 (for sterilization), ISO 11607-1 (for packaging), and ISO 10993-1:2018 (for biocompatibility).
Comparison to predicate and reference devices: The device demonstrates substantial equivalence in technological characteristics and performance to the Levitronix PediMag Blood Pump (K090051) and Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (K201320).
Physical measurements and laboratory analyses: These are used to determine operating parameters (flow rate, pressure), assess blood damage, heat generation, air entrapment, mechanical integrity, durability, and evaluate shelf life and biocompatibility.

There is no "expert consensus, pathology, or outcomes data" ground truth as this was a non-clinical submission.

8. The Sample Size for the Training Set:

Not applicable. This submission is for a medical device (blood pump), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI development.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As stated above, this is not an AI/ML device, so there is no training set or associated ground truth establishment for such a set.

Summary

{0}------------------------------------------------

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.

May 19, 2023

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

Re: K220842

Trade/Device Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type blood pump Regulatory Class: Class II Product Code: KFM Dated: April 13, 2023 Received: April 14, 2023

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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 (OS) 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 mediation-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).

Image /page/1/Picture/4 description: The image shows the end of a letter. The text reads "Sincerely, Kathleen M. Grunder -S". The text is in a simple, sans-serif font and is left-aligned. The letters "FDA" are faintly visible in the background.

Kathleen Grunder Acting 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220842

Device Name

Quantum Perfusion Centrifugal Blood Pump CP20

Indications for Use (Describe)

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava

Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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."

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K220842

Device Name

Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors

Indications for Use (Describe)

Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on (i) the heart or great vessels; or

Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava.

Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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."

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image contains the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with outstretched arms, enclosed within a circular design. To the right of the figure, the word "QURA" is written in a bold, sans-serif font. Below "QURA", the words "advanced medical solutions" are written in a smaller font.

510(K) SUMMARY

SUBMITTER l.

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:	April the 13th, 2023

ll. DEVICE

Proprietary Name:	Quantum Perfusion Centrifugal Blood Pump CP20
	Quantum Perfusion Centrifugal Blood Pump CP20 with
	Integrated Sensors
Common Name:	Centrifugal Blood Pump CP20
	Centrifugal Blood Pump CP20 with Integrated Sensors and
Classification Name:	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulatory Class:	II
Product Code:	KFM
Panel:	Cardiovascular Medical Specialty 74 - 21 CFR Part 870Office of Product Evaluation and Quality / Office of HealthTechnology 2 (OHT2 Cardiovascular Devices) / Division ofHealth Technology 2B (Circulatory Support, Structural andVascular Devices)

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image is a logo for Qura advanced medical solutions. The logo features a stylized human figure with arms outstretched, enclosed within a curved shape. To the right of the figure is the word "QURA" in a bold, sans-serif font. Below "QURA" are the words "advanced medical solutions" in a smaller font.

III. PREDICATE AND REFERENCE DEVICES

Predicate device:

Trade Name:	Levitronix PediMag Blood Pump
Registered Establishment Name:	LEVITRONIX LLC (now Thoratec Switzerland GMBH)
Common Name:	PediMag Blood Pump
Classification Name:	Pump, Blood, Cardiopulmonary Bypass, Non-RollerType
Regulatory Class:	II
Product Code:	KFM
510(k) Number:	K090051

Reference device:

Trade Name:	Quantum Perfusion Centrifugal Blood Pump CP22 withIntegrated Sensors
Registered Establishment Name:	Qura S.r.l.
Common Name:	Centrifugal Blood Pump CP22 with Integrated Sensors
Classification Name:	Pump, Blood, Cardiopulmonary Bypass, Non-RollerType
Regulatory Class:	II
Product Code:	KFM
510(k) Clearance:	K201320

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Qura advanced medical solutions. The logo features a stylized human figure with outstretched arms and legs, enclosed within a circular shape. To the right of the figure is the word "QURA" in bold, blue letters. Below "QURA" is the phrase "advanced medical solutions" in a smaller, lighter font.

DEVICE DESCRIPTION IV.

Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors is equipped with two sensors integrated in the blood inlet and outlet connectors.

INTENDED USE / INDICATIONS FOR USE V.

Quantum Perfusion Centrifugal Blood Pump CP20

Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) (i) during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava

Device is intended for adolescent patients (i.e. patients greater than 12 through 21 years of age).

Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Device is intended for adolescent patients (i.e. patients greater than 12 through 21 years of age).

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched, enclosed within a circular shape. To the right of the figure is the word "QURA" in a bold, sans-serif font, with the words "advanced medical solutions" in a smaller font underneath.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE AND REFERENCE DEVICE

A comparison between Quantum Perfusion Centrifugal Blood Pump CP20 and Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors and the predicate/reference devices has been conducted and provided in the following table.

Device	Proposed Devices	Predicate Device –	Reference Device –
	Quantum Perfusion	Levitronix PediMag Blood	Quantum Perfusion
	Centrifugal Blood Pump CP20	Pump	Centrifugal Blood Pump
	Quantum Perfusion		CP22 with Integrated
	Centrifugal Blood Pump CP20		Sensors
	with Integrated Sensors
Name	Quantum PerfusionCentrifugal Blood Pump CP20	Levitronix PediMag BloodPump	Quantum PerfusionCentrifugal Blood PumpCP22 with IntegratedSensors
	Quantum PerfusionCentrifugal Blood Pump CP20with Integrated Sensors
510(k) Number	K220842	K090051	K201320
Device	Devices have been designedto pump blood into theextracorporeal circulationcircuit. Quantum PerfusionCentrifugal Blood Pump CP20with Integrated Sensors isequipped with two sensorspositioned on the blood inletand outlet connectors. Bothsensors are able to measurethe pressure at the same time.All the device surfaces incontact with blood are treatedwith a phosphorylcholine-based biocompatible coating.Contact with blood for aperiod of more than 6 hours isnot allowed.	The PediMag Blood Pumpis a sterile, single-use,disposable, non-coated,polycarbonate centrifugalblood pump. The pumphas a 14 ml primingvolume.The pump inlet is on therotational axis of theimpeller whereas thepump outlet isperpendicular to the inletand tangent to the outerdiameter. Both the inletand outlet ports includestandard 1/4 inch barbedconnectors for easymating to standardmedical grade 1/4 inchtubing. The Pump isdesigned to move bloodby centrifugal forcecreated by themagnetically suspendedrotating impeller.	The device has beendesigned to pump bloodinto the extracorporealcirculation circuit. Thedevice is equipped with twosensors positioned on theblood inlet and outletconnectors. Both sensorsare able to measure thepressure at the same time.All the device surfaces incontact with blood aretreated with aphosphorylcholine-basedbiocompatible coating.Contact with blood for aperiod of more than 6hours is not allowed.
Regulation #	21 CFR §870.4360	21 CFR §870.4360	21 CFR §870.4360
Device	Proposed Devices	Predicate Device –Levitronix PediMag BloodPump	Reference Device –Quantum PerfusionCentrifugal Blood PumpCP22 with IntegratedSensors
RegulationName	Nonroller-typecardiopulmonary bypassblood pump	Nonroller-typecardiopulmonary bypassblood pump	Nonroller-typecardiopulmonary bypassblood pump
Product Code	KFM	KFM	KFM
Classification	II	II	II
Indication forUse	Quantum PerfusionCentrifugal Blood Pump CP20The Quantum PerfusionCentrifugal Blood Pump CP20,indicated for use exclusivelywith Quantum CentrifugalDrive of Spectrum Medical, isintended to pump the bloodthrough an extracorporealcircuit for periods up to 6hours for the purpose ofproviding either:(iii) Full or partialcardiopulmonary bypass(i.e., circuit includes anoxygenator) during opensurgical procedures onthe heart or great vessels;or(iv) Temporary circulatorybypass for diversion offlow around a planneddisruption of thecirculatory pathwaynecessary for opensurgical procedures onthe aorta or vena cava.Device is intended foradolescent patients (i.e.patients greater than 12through 21 years of age).Quantum PerfusionCentrifugal Blood Pump CP20with Integrated SensorsThe Quantum PerfusionCentrifugal Blood Pump CP20with Integrated Sensors	The PediMag Blood Pumpis indicated for use withthe CentriMag CirculatorySupport System consoleand motor to pump bloodthrough theextracorporeal bypasscircuit for extracorporealcirculatory support forperiods appropriate tocardiopulmonary bypass(up to six hours) forsurgical procedures suchas mitral valvereoperation. It is alsoindicated for use inextracorporeal supportsystems (for periods up tosix hours) not requiringcompletecardiopulmonary bypass(e.g. valvuloplasty,circulatory support duringmitral valve reoperation,surgery of the vena cavaor aorta, liver transplantsetc.).The PediMag Pump cangenerate a maximumpump flow equal to 1.5liters per minute, limitingits use to pediatricpatients.The PediMag Blood Pumpis indicated for use onlywith the CentriMag	The Quantum PerfusionCentrifugal Blood Pumpwith Integrated Sensorsindicated for use exclusivelywith Quantum CentrifugalDrive of Spectrum Medical isintended to pump theblood through anextracorporeal circuit andto monitor pressure forperiods lasting less than 6hours for the purpose ofproviding either:(i) Full or partialcardiopulmonarybypass (i.e., circuitincludes an oxygenator)during open surgicalprocedures on theheart or great vesselsor(ii) Temporary circulatorybypass for diversion offlow around a planneddisruption of thecirculatory pathwaynecessary for opensurgical procedures onthe aorta or vena cava.
Device	Proposed DevicesQuantum PerfusionCentrifugal Blood Pump CP20Quantum PerfusionCentrifugal Blood Pump CP20with Integrated Sensors	Predicate Device –Levitronix PediMag BloodPump	Reference Device –Quantum PerfusionCentrifugal Blood PumpCP22 with IntegratedSensors
	indicated for use exclusivelywith Quantum CentrifugalDrive of Spectrum Medical, isintended to pump the bloodthrough an extracorporealcircuit and to monitorpressure for periods up to 6hours for the purpose ofproviding either:(iii) Full or partialcardiopulmonary bypass(i.e., circuit includes anoxygenator) during opensurgical procedures onthe heart or great vessels;or(iv) Temporary circulatorybypass for diversion offlow around a planneddisruption of thecirculatory pathwaynecessary for opensurgical procedures onthe aorta or vena cava.Device is intended foradolescent patients (i.e.,patients greater than 12through 21 years of age).	Console and Motor.
Targetpopulation	Adolescent patients (i.e.patients greater than 12through 21 years of age)	Pediatric population	Adult population
Target User	Perfusionist	Perfusionist	Perfusionist
MainContactingMaterials	PolycarbonateCoating: PhosphorylcholineVariant with integratedsensor:Sensor made withpolycarbonate and silicone-based protective gel	Polycarbonate	PolycarbonateCoating: PhosphorylcholineSensor: polycarbonate andsilicone-based protectivegel
Priming Volume	20 ml	14 ml	22 ml
Device	Proposed DevicesQuantum PerfusionCentrifugal Blood Pump CP20Quantum PerfusionCentrifugal Blood Pump CP20with Integrated Sensors	Predicate Device -Levitronix PediMag BloodPump	Reference Device -Quantum PerfusionCentrifugal Blood PumpCP22 with IntegratedSensors
MaximumBlood Flow Rate	1.5 l/min	1.5 l/min	7 l/min
MaximumPump OperatingPressure	550 mmHg	540 mmHg	550 mmHg
ofPresencesensors	Yes(QuantumPerfusionCentrifugal Blood Pump CP20with Integrated Sensors only)	No	Yes
Single-use	Yes	Yes	Yes
SterileCondition	EtO Sterile	EtO Sterile	EtO Sterile

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched, enclosed within a partial circle. To the right of the figure is the word "QURA" in a bold, sans-serif font, with the words "advanced medical solutions" in a smaller font underneath.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched within a circular design, followed by the word "QURA" in a bold, sans-serif font. Below "QURA" are the words "advanced medical solutions" in a smaller, lighter font.

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with outstretched arms inside a circle on the left. To the right of the figure is the word "QURA" in a bold, sans-serif font, with the words "advanced medical solutions" in a smaller font underneath.

Table. 5-1 – Comparative Data

Based on the indications for use, main technological characteristics and results of nonclinical testing, subject device has been demonstrated to be appropriate for its intended use and is considered substantially equivalent to legally marketed predicate and reference device according to FDA's Guidance "Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," issued July 28, 2014.

Furthermore, in-vitro performance tests have been performed to demonstrate that the proposed device does not raise any new issues in terms of product's safety or effectiveness as compared to predicate device.

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image is a logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with outstretched arms, enclosed within a curved shape. To the right of the figure, the word "QURA" is written in a bold, sans-serif font, and below that, the words "advanced medical solutions" are written in a smaller font.

PERFORMANCE DATA VII.

NON-CLINICAL TESTING

In-vitro testing was performed to comply with user needs and safety and effectiveness requirements and demonstrate substantial equivalence with the predicate and reference devices with reference to FDA's document "Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s" and defined applicable standards for the products.

The following areas have been tested and/or evaluated:

Performance tests, according to applicable special controls according to 21 CFR -870.4360 and ISO 18242 [Recognition Nr. 3-163].
Tests are mainly related to:
o Operating Parameters;
Dynamic Blood Damage; O
Heat Generation; O
Air Entrapment; O
Mechanical Integrity; O
Durability/Reliability; o
Evaluation of product shelf life; -
-Validation of the EtO Sterilization process, according to ISO 11135 [Recognition Nr.: 14-529],
-Packaging Validation tests, according to according to ISO 11607-1 [Recognition Nr. 14-530],
-Biocompatibility of the finished product, according to 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".

{12}------------------------------------------------

Image /page/12/Picture/1 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with outstretched arms, enclosed within a circular shape. The text "QURA" is prominently displayed in a bold, sans-serif font, with the words "advanced medical solutions" appearing in a smaller font size beneath it.

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 and reference devices.

VIII. CONCLUSIONS

Based on the indications for use, main technological characteristics and results of nonclinical testing, the Quantum Perfusion Centrifugal Blood Pump CP20 and Quantum Perfusion Centrifygal Blood Pump CP20 with Integrated Sensors devices have been demonstrated to be appropriate for the intended use and are considered substantially equivalent to predicate device, Levitronix PediMag Blood Pump (K090051) and reference Qura's own marketed Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (K201320).

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

510(K) SUMMARY

SUBMITTER l.

ll. DEVICE

III. PREDICATE AND REFERENCE DEVICES

Predicate device:

Reference device:

DEVICE DESCRIPTION IV.

INTENDED USE / INDICATIONS FOR USE V.

Quantum Perfusion Centrifugal Blood Pump CP20

Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE AND REFERENCE DEVICE

PERFORMANCE DATA VII.

NON-CLINICAL TESTING

Animal Study

CLINICAL TESTING

VIII. CONCLUSIONS

§ 870.4360 Nonroller-type blood pump.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW