Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors

K220842 · Qura S.R.L · KFM · May 19, 2023 · Cardiovascular

Device Facts

• Record ID: K220842
• Device Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
• Applicant: Qura S.R.L
• Product Code: KFM · Cardiovascular
• Decision Date: May 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 up to 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 up to 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).

Device Story

Standalone, single-use centrifugal blood pump; moves blood through extracorporeal circuit; CP20 with Integrated Sensors variant includes inlet/outlet pressure monitoring. Operated by perfusionists in clinical settings (e.g., OR). Device uses magnetically suspended impeller to generate centrifugal force. Blood-contacting surfaces feature phosphorylcholine-based biocompatible coating to reduce platelet activation. Output (flow/pressure) used by perfusionists to manage bypass support; aids in maintaining circulatory function during cardiac/vascular surgery. Benefits include temporary circulatory support during planned surgical disruptions.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical bench testing, including operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, durability, shelf life, sterilization (ISO 11135), packaging (ISO 11607-1), and biocompatibility (ISO 10993-1).

Technological Characteristics

Polycarbonate construction; phosphorylcholine-based biocompatible coating. CP20 with Integrated Sensors includes polycarbonate/silicone-based pressure sensors. Centrifugal pumping via magnetically suspended impeller. Priming volume: 20 ml. Max flow: 1.5 L/min. Max pressure: 550 mmHg. EtO sterilized. Single-use. Complies with ISO 18242.

Indications for Use

Indicated for adolescent patients (12-21 years) requiring full/partial cardiopulmonary bypass or temporary circulatory bypass during open surgical procedures on the heart, great vessels, aorta, or vena cava. Use limited to <6 hours. Must be used with Spectrum Medical Quantum Centrifugal Drive.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Levitronix PediMag Blood Pump (K090051)

Reference Devices

• Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (K201320)

Submission Summary (Full Text)

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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.

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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K220842

Device Name

Quantum Perfusion Centrifugal Blood Pump CP20

Indications for Use (Describe)

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)

| 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.

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### *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:

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# Indications for Use

510(k) Number (if known) K220842

Device Name

Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors

Indications for Use (Describe)

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)

| 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."

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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: | [phone] |
| e-mail: | [e-mail] |
| Fax: | [phone] |
| 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 870<br>Office of Product Evaluation and Quality / Office of Health<br>Technology 2 (OHT2 Cardiovascular Devices) / Division of<br>Health Technology 2B (Circulatory Support, Structural and<br>Vascular Devices) |

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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-Roller<br>Type |
| Regulatory Class: | II |
| Product Code: | KFM |
| 510(k) Number: | K090051 |

### Reference device:

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

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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 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.

#### INTENDED USE / INDICATIONS FOR USE V.

# Quantum Perfusion Centrifugal Blood Pump CP20

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 up to 6 hours for the purpose of providing either:

- 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

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 up to 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).

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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 Perfusion<br>Centrifugal Blood Pump CP20 | Levitronix PediMag Blood<br>Pump | Quantum Perfusion<br>Centrifugal Blood Pump<br>CP22 with Integrated<br>Sensors |
| | Quantum Perfusion<br>Centrifugal Blood Pump CP20<br>with Integrated Sensors | | |
| 510(k) Number | K220842 | K090051 | K201320 |
| Device | Devices have been designed<br>to pump blood into the<br>extracorporeal circulation<br>circuit. Quantum Perfusion<br>Centrifugal Blood Pump CP20<br>with Integrated Sensors is<br>equipped with two sensors<br>positioned on the blood inlet<br>and outlet connectors. Both<br>sensors are able to measure<br>the pressure at the same time.<br>All the device surfaces in<br>contact with blood are treated<br>with a phosphorylcholine-<br>based biocompatible coating.<br>Contact with blood for a<br>period of more than 6 hours is<br>not allowed. | The PediMag Blood Pump<br>is a sterile, single-use,<br>disposable, non-coated,<br>polycarbonate centrifugal<br>blood pump. The pump<br>has a 14 ml priming<br>volume.<br>The pump inlet is on the<br>rotational axis of the<br>impeller whereas the<br>pump outlet is<br>perpendicular to the inlet<br>and tangent to the outer<br>diameter. Both the inlet<br>and outlet ports include<br>standard 1/4 inch barbed<br>connectors for easy<br>mating to standard<br>medical grade 1/4 inch<br>tubing. The Pump is<br>designed to move blood<br>by centrifugal force<br>created by the<br>magnetically suspended<br>rotating impeller. | The device has been<br>designed to pump blood<br>into the extracorporeal<br>circulation circuit. The<br>device is equipped with two<br>sensors positioned on the<br>blood inlet and outlet<br>connectors. Both sensors<br>are able to measure the<br>pressure at the same time.<br>All the device surfaces in<br>contact with blood are<br>treated with a<br>phosphorylcholine-based<br>biocompatible coating.<br>Contact with blood for a<br>period of more than 6<br>hours is not allowed. |
| Regulation # | 21 CFR §870.4360 | 21 CFR §870.4360 | 21 CFR §870.4360 |
| Device | Proposed Devices | Predicate Device –<br>Levitronix PediMag Blood<br>Pump | Reference Device –<br>Quantum Perfusion<br>Centrifugal Blood Pump<br>CP22 with Integrated<br>Sensors |
| Regulation<br>Name | Nonroller-type<br>cardiopulmonary bypass<br>blood pump | Nonroller-type<br>cardiopulmonary bypass<br>blood pump | Nonroller-type<br>cardiopulmonary bypass<br>blood pump |
| Product Code | KFM | KFM | KFM |
| Classification | II | II | II |
| Indication for<br>Use | Quantum Perfusion<br>Centrifugal Blood Pump CP20<br>The Quantum Perfusion<br>Centrifugal Blood Pump CP20,<br>indicated for use exclusively<br>with Quantum Centrifugal<br>Drive of Spectrum Medical, is<br>intended to pump the blood<br>through an extracorporeal<br>circuit for periods up to 6<br>hours for the purpose of<br>providing either:<br>(iii) Full or partial<br>cardiopulmonary bypass<br>(i.e., circuit includes an<br>oxygenator) during open<br>surgical procedures on<br>the heart or great vessels;<br>or<br>(iv) Temporary circulatory<br>bypass for diversion of<br>flow around a planned<br>disruption of the<br>circulatory pathway<br>necessary for open<br>surgical procedures on<br>the aorta or vena cava.<br>Device is intended for<br>adolescent patients (i.e.<br>patients greater than 12<br>through 21 years of age).<br>Quantum Perfusion<br>Centrifugal Blood Pump CP20<br>with Integrated Sensors<br>The Quantum Perfusion<br>Centrifugal Blood Pump CP20<br>with Integrated Sensors | The PediMag Blood Pump<br>is indicated for use with<br>the CentriMag Circulatory<br>Support System console<br>and motor to pump blood<br>through the<br>extracorporeal bypass<br>circuit for extracorporeal<br>circulatory support for<br>periods appropriate to<br>cardiopulmonary bypass<br>(up to six hours) for<br>surgical procedures such<br>as mitral valve<br>reoperation. It is also<br>indicated for use in<br>extracorporeal support<br>systems (for periods up to<br>six hours) not requiring<br>complete<br>cardiopulmonary bypass<br>(e.g. valvuloplasty,<br>circulatory support during<br>mitral valve reoperation,<br>surgery of the vena cava<br>or aorta, liver transplants<br>etc.).<br><br>The PediMag Pump can<br>generate a maximum<br>pump flow equal to 1.5<br>liters per minute, limiting<br>its use to pediatric<br>patients.<br><br>The PediMag Blood Pump<br>is indicated for use only<br>with the CentriMag | The Quantum Perfusion<br>Centrifugal Blood Pump<br>with Integrated Sensors<br>indicated for use exclusively<br>with Quantum Centrifugal<br>Drive of Spectrum Medical is<br>intended to pump the<br>blood through an<br>extracorporeal circuit and<br>to monitor pressure for<br>periods lasting less than 6<br>hours for the purpose of<br>providing either:<br>(i) Full or partial<br>cardiopulmonary<br>bypass (i.e., circuit<br>includes an oxygenator)<br>during open surgical<br>procedures on the<br>heart or great vessels<br>or<br>(ii) Temporary circulatory<br>bypass for diversion of<br>flow around a planned<br>disruption of the<br>circulatory pathway<br>necessary for open<br>surgical procedures on<br>the aorta or vena cava. |
| Device | Proposed Devices<br>Quantum Perfusion<br>Centrifugal Blood Pump CP20<br>Quantum Perfusion<br>Centrifugal Blood Pump CP20<br>with Integrated Sensors | Predicate Device –<br>Levitronix PediMag Blood<br>Pump | Reference Device –<br>Quantum Perfusion<br>Centrifugal Blood Pump<br>CP22 with Integrated<br>Sensors |
| | indicated for use exclusively<br>with Quantum Centrifugal<br>Drive of Spectrum Medical, is<br>intended to pump the blood<br>through an extracorporeal<br>circuit and to monitor<br>pressure for periods up to 6<br>hours for the purpose of<br>providing either:<br>(iii) Full or partial<br>cardiopulmonary bypass<br>(i.e., circuit includes an<br>oxygenator) during open<br>surgical procedures on<br>the heart or great vessels;<br>or<br>(iv) Temporary circulatory<br>bypass for diversion of<br>flow around a planned<br>disruption of the<br>circulatory pathway<br>necessary for open<br>surgical procedures on<br>the aorta or vena cava.<br>Device is intended for<br>adolescent patients (i.e.,<br>patients greater than 12<br>through 21 years of age). | Console and Motor. | |
| Target<br>population | Adolescent patients (i.e.<br>patients greater than 12<br>through 21 years of age) | Pediatric population | Adult population |
| Target User | Perfusionist | Perfusionist | Perfusionist |
| Main<br>Contacting<br>Materials | Polycarbonate<br>Coating: Phosphorylcholine<br><br>Variant with integrated<br>sensor:<br>Sensor made with<br>polycarbonate and silicone-<br>based protective gel | Polycarbonate | Polycarbonate<br>Coating: Phosphorylcholine<br><br>Sensor: polycarbonate and<br>silicone-based protective<br>gel |
| Priming Volume | 20 ml | 14 ml | 22 ml…