(422 days)
No
The provided text describes a centrifugal blood pump and its intended use, device description, and performance studies. There is no mention of AI or ML technology in any section. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
This device is a therapeutic device because its intended use is to pump blood through an extracorporeal circuit to provide cardiopulmonary bypass or temporary circulatory bypass during surgical procedures, which directly supports and maintains physiological functions.
No
The device is described as a "Quantum Perfusion Centrifugal Blood Pump" intended to "pump the blood through an extracorporeal circuit" for bypass procedures. While one version also monitors pressure, its primary function is circulatory support, not the diagnosis of a condition.
No
The device description explicitly states it is a "standalone single use device intended to pump blood" and mentions physical components like integrated sensors, connectors, and a biocompatible coating, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Quantum Perfusion Centrifugal Blood Pump CP20 is designed to pump blood through an extracorporeal circuit outside the body during surgical procedures. It's a mechanical device for circulating blood, not for analyzing it.
- Intended Use: The intended use clearly states its purpose is to provide cardiopulmonary bypass or temporary circulatory bypass during surgery. This is a therapeutic/supportive function, not a diagnostic one.
- Device Description: The description focuses on its mechanical function, sensors for pressure monitoring (which is related to the pumping function, not blood analysis), sterilization, and biocompatibility for blood contact. There is no mention of analyzing blood components or properties.
Therefore, the Quantum Perfusion Centrifugal Blood Pump CP20 falls under the category of a medical device used for extracorporeal circulation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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:
- 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).
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).
Product codes
KFM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart or great vessels; aorta or vena cava
Indicated Patient Age Range
Adolescent patients (i.e. patients greater than 12 through 21 years of age)
Intended User / Care Setting
Perfusionist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing was performed including:
- Performance tests, according to applicable special controls according to 21 CFR -870.4360 and ISO 18242. Tests are mainly related to: Operating Parameters; Dynamic Blood Damage; Heat Generation; Air Entrapment; Mechanical Integrity; Durability/Reliability; Evaluation of product shelf life.
- Validation of the EtO Sterilization process, according to ISO 11135.
- Packaging Validation tests, according to ISO 11607-1.
- Biocompatibility of the finished product, according to ISO 10993-1:2018 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 studies were limited to mandatory biocompatibility tests according to International Standard ISO 10993-1:2018 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".
- No clinical data were included.
Key results: Results of nonclinical testing demonstrated that the device does not raise any new issues in terms of product's safety or effectiveness as compared to predicate device and is appropriate for its intended use and considered substantially equivalent to legally marketed predicate and reference device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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.
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)
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."
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 870 |
| Office of Product Evaluation and Quality / Office of Health | |
| Technology 2 (OHT2 Cardiovascular Devices) / Division of | |
| Health Technology 2B (Circulatory Support, Structural and | |
| Vascular 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-Roller |
| Type | |
| Regulatory Class: | II |
| Product Code: | KFM |
| 510(k) Number: | K090051 |
Reference device:
| Trade Name: | Quantum Perfusion Centrifugal Blood Pump CP22 with
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
Type |
| 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 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).
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 Perfusion | ||
| Centrifugal Blood Pump CP20 | Levitronix PediMag Blood | ||
| Pump | Quantum Perfusion | ||
| Centrifugal Blood Pump | |||
| CP22 with Integrated | |||
| Sensors | |||
| Quantum Perfusion | |||
| Centrifugal Blood Pump CP20 | |||
| with Integrated Sensors | |||
| 510(k) Number | K220842 | K090051 | K201320 |
| Device | Devices have been designed | ||
| to pump blood into the | |||
| extracorporeal circulation | |||
| circuit. Quantum Perfusion | |||
| Centrifugal Blood Pump CP20 | |||
| with Integrated Sensors is | |||
| equipped with two sensors | |||
| positioned on the blood inlet | |||
| and outlet connectors. Both | |||
| sensors are able to measure | |||
| the pressure at the same time. | |||
| All the device surfaces in | |||
| contact with blood are treated | |||
| with a phosphorylcholine- | |||
| based biocompatible coating. | |||
| Contact with blood for a | |||
| period of more than 6 hours is | |||
| not allowed. | The PediMag Blood Pump | ||
| is a sterile, single-use, | |||
| disposable, non-coated, | |||
| polycarbonate centrifugal | |||
| blood pump. The pump | |||
| has a 14 ml priming | |||
| volume. | |||
| The pump inlet is on the | |||
| rotational axis of the | |||
| impeller whereas the | |||
| pump outlet is | |||
| perpendicular to the inlet | |||
| and tangent to the outer | |||
| diameter. Both the inlet | |||
| and outlet ports include | |||
| standard 1/4 inch barbed | |||
| connectors for easy | |||
| mating to standard | |||
| medical grade 1/4 inch | |||
| tubing. The Pump is | |||
| designed to move blood | |||
| by centrifugal force | |||
| created by the | |||
| magnetically suspended | |||
| rotating impeller. | The device has been | ||
| designed to pump blood | |||
| into the extracorporeal | |||
| circulation circuit. The | |||
| device is equipped with two | |||
| sensors positioned on the | |||
| blood inlet and outlet | |||
| connectors. Both sensors | |||
| are able to measure the | |||
| pressure at the same time. | |||
| All the device surfaces in | |||
| contact with blood are | |||
| treated with a | |||
| phosphorylcholine-based | |||
| biocompatible coating. | |||
| Contact with blood for a | |||
| period of more than 6 | |||
| hours is not allowed. | |||
| Regulation # | 21 CFR §870.4360 | 21 CFR §870.4360 | 21 CFR §870.4360 |
| Device | Proposed Devices | Predicate Device – | |
| Levitronix PediMag Blood | |||
| Pump | Reference Device – | ||
| Quantum Perfusion | |||
| Centrifugal Blood Pump | |||
| CP22 with Integrated | |||
| Sensors | |||
| Regulation | |||
| Name | Nonroller-type | ||
| cardiopulmonary bypass | |||
| blood pump | Nonroller-type | ||
| cardiopulmonary bypass | |||
| blood pump | Nonroller-type | ||
| cardiopulmonary bypass | |||
| blood pump | |||
| Product Code | KFM | KFM | KFM |
| Classification | II | II | II |
| Indication for | |||
| Use | 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: | |||
| (iii) Full or partial | |||
| cardiopulmonary bypass | |||
| (i.e., circuit includes an | |||
| oxygenator) during open | |||
| surgical procedures on | |||
| the heart or great vessels; | |||
| or | |||
| (iv) 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 | The PediMag Blood Pump | ||
| is indicated for use with | |||
| the CentriMag Circulatory | |||
| Support System console | |||
| and motor to pump blood | |||
| through the | |||
| extracorporeal bypass | |||
| circuit for extracorporeal | |||
| circulatory support for | |||
| periods appropriate to | |||
| cardiopulmonary bypass | |||
| (up to six hours) for | |||
| surgical procedures such | |||
| as mitral valve | |||
| reoperation. It is also | |||
| indicated for use in | |||
| extracorporeal support | |||
| systems (for periods up to | |||
| six hours) not requiring | |||
| complete | |||
| cardiopulmonary bypass | |||
| (e.g. valvuloplasty, | |||
| circulatory support during | |||
| mitral valve reoperation, | |||
| surgery of the vena cava | |||
| or aorta, liver transplants | |||
| etc.). |
The PediMag Pump can
generate a maximum
pump flow equal to 1.5
liters per minute, limiting
its use to pediatric
patients.
The PediMag Blood Pump
is indicated for use only
with the CentriMag | The Quantum Perfusion
Centrifugal Blood Pump
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:
(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 | Proposed Devices
Quantum Perfusion
Centrifugal Blood Pump CP20
Quantum Perfusion
Centrifugal Blood Pump CP20
with Integrated Sensors | Predicate Device –
Levitronix PediMag Blood
Pump | Reference Device –
Quantum Perfusion
Centrifugal Blood Pump
CP22 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:
(iii) Full or partial
cardiopulmonary bypass
(i.e., circuit includes an
oxygenator) during open
surgical procedures on
the heart or great vessels;
or
(iv) 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). | Console and Motor. | |
| Target
population | Adolescent patients (i.e.
patients greater than 12
through 21 years of age) | Pediatric population | Adult population |
| Target User | Perfusionist | Perfusionist | Perfusionist |
| Main
Contacting
Materials | Polycarbonate
Coating: Phosphorylcholine
Variant with integrated
sensor:
Sensor made with
polycarbonate and silicone-
based protective gel | Polycarbonate | Polycarbonate
Coating: Phosphorylcholine
Sensor: polycarbonate and
silicone-based protective
gel |
| Priming Volume | 20 ml | 14 ml | 22 ml |
| Device | Proposed Devices
Quantum Perfusion
Centrifugal Blood Pump CP20
Quantum Perfusion
Centrifugal Blood Pump CP20
with Integrated Sensors | Predicate Device -
Levitronix PediMag Blood
Pump | Reference Device -
Quantum Perfusion
Centrifugal Blood Pump
CP22 with Integrated
Sensors |
| Maximum
Blood Flow Rate | 1.5 l/min | 1.5 l/min | 7 l/min |
| Maximum
Pump Operating
Pressure | 550 mmHg | 540 mmHg | 550 mmHg |
| of
Presence
sensors | Yes
(Quantum
Perfusion
Centrifugal Blood Pump CP20
with Integrated Sensors only) | No | Yes |
| Single-use | Yes | Yes | Yes |
| Sterile
Condition | EtO Sterile | EtO Sterile | EtO Sterile |
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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.
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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.
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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.
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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".
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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).