(145 days)
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.
Device is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).
Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.
Devices is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).
Quantum Perfusion Blood Oxygenator devices, VT75-C1U and VT75-C2U, consist of an oxygenator with an integrated arterial filter. The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surqical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.
The provided text describes a 510(k) premarket notification for a medical device, the "Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U" and "Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U". This document outlines the device's characteristics, intended use, and comparison to predicate devices. It states that the submission does not include clinical data and relies on non-clinical testing to demonstrate substantial equivalence.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device, particularly those related to human-in-the-loop performance, expert ground truth, and training sets, are not applicable to this submission. This device is a traditional medical device (oxygenator), not an AI/ML-powered diagnostic or therapeutic tool.
Here's a breakdown of the requested information based on the provided document, highlighting what is present and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, but does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for the device alongside those criteria. It only states that "all testing passed by meeting the established requirements."
| Test Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Gas Exchange testing | "meeting the established requirements" (not specified quantitatively) | "all testing passed" |
| Mechanical Hemolysis | "meeting the established requirements" (not specified quantitatively) | "all testing passed" |
| Leakage testing | "meeting the established requirements" (not specified quantitatively) | "all testing passed" |
| Filtration efficiency | "meeting the established requirements" (not specified quantitatively) | "all testing passed" |
| Pressure drop testing | "meeting the established requirements" (not specified quantitatively) | "all testing passed" |
| Priming volume characterization | "meeting the established requirements" (not specified quantitatively) | "all testing passed" |
| Biocompatibility | According to ISO 10993-1: 2018 and FDA Guidance | Animal studies performed for mandatory biocompatibility tests, passed. (Specific results not detailed) |
2. Sample sizes used for the test set and the data provenance
The document does not specify sample sizes for the non-clinical performance tests (e.g., how many oxygenators were tested for gas exchange). The tests are described as "non-clinical testing" and appear to be laboratory or bench testing. Data provenance is not applicable in the sense of patient data; it's device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an oxygenator, not an AI/ML diagnostic. Ground truth would be defined by engineering specifications and physical measurements, not expert consensus on medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to human review of ground truth in AI/ML performance studies, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device. The submission explicitly states "No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The performance tests mentioned (gas exchange, hemolysis, etc.) are inherent performance characteristics of the physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of traditional medical device, "ground truth" for performance relates to:
- Engineering specifications and standards: Adherence to established performance parameters outlined in standards like ISO 7199 for Cardiopulmonary Bypass Oxygenators.
- Physical and chemical measurements: Examples include flow rates, pressure drops, gas transfer rates (O2 and CO2), and hemolysis rates.
- Biocompatibility testing results: As per ISO 10993.
8. The sample size for the training set
Not applicable. This is not an AI/ML-powered device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML-powered device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
November 8, 2023
Qura S.r.1. Raffaella Tommasini QA&RA Director Via di Mezzo 23 Mirandola, Modena 41037 Italy
Re: K231773
Trade/Device Name: Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: October 10, 2023 Received: October 10, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K231773
Device Name
Quantum Perfusion Blood Oxygenator with Intgrated AF and Sensor VT75-C1U
Indications for Use (Describe)
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.
Device is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known) K231773
Device Name
Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U
Indications for Use (Describe)
Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.
Devices is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/5/Picture/0 description: The image is a logo for Qura Advanced Medical Solutions. The logo features a stylized human figure inside of an oval shape. The text "QURA" is in bold, blue letters, and below it, in smaller letters, is the phrase "advanced medical solutions."
510(K) SUMMARY
| I.SUBMITTER | |
|---|---|
| Submitter Name: | Qura S.r.l. |
| Submitter Address: | Via di Mezzo, 23 41037 Mirandola (MO) Italy |
| Contact Person: | Raffaella Tommasini, QA&RA Director - Qura s.r.l. |
| Phone: | +39 0535 1803050 |
| e-mail: | raffaella.tommasini@quramed.com |
| Fax: | +39 0535 1803051 |
| Date Summary Prepared: | October 10th, 2023 |
| II.DEVICE | |
| Proprietary Name: | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U |
| Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U | |
| Common Name: | Blood Oxygenator |
| Classification Name: | Oxygenator, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DTZ |
| Panel: | Cardiovascular Devices, Office of Health Technology 2 (OHT2) / Division ofHealth Technology 2 B (Circulatory Support, Structural and Vascular Devices) |
| III.PREDICATE AND REFERENCE DEVICES | |
| Predicate Device | |
| Proprietary Name: | D101 Kids Infant Hollow Fiber Membrane Oxygenator With IntegratedHardshell Cardiotomy/Venous Reservoir |
| Common Name: | Hollow Fiber Membrane Oxygenator with Hardshell Cardiotomy/VenousReservoir |
| Classification Name: | Oxygenator, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DTZ |
| 510(k) Number: | K072091 |
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Image /page/6/Picture/0 description: The image is a logo for Qura Advanced Medical Solutions. The logo features a stylized human figure inside of an orbital shape. To the right of the figure is the word "QURA" in a bold, sans-serif font. Below the word "QURA" is the phrase "advanced medical solutions" in a smaller, sans-serif font.
Reference Device
| Proprietary Name: | Quantum Perfusion Blood Oxygenator devices |
|---|---|
| Common Name: | Blood Oxygenator |
| Classification Name: | Oxygenator, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DTZ |
| 510(k) Number: | K212341 |
IV. DEVICE DESCRIPTION
Quantum Perfusion Blood Oxygenator devices, VT75-C1U and VT75-C2U, consist of an oxygenator with an integrated arterial filter. The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surqical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.
V. INTENDED USE / INDICATIONS FOR USE
Quantum Perfusion Blood Oxyqenator with Integrated AF and Sensor VT75-C1U
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.
Devices are intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years of age).
Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U
Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.
Devices are intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years of age).
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Image /page/7/Picture/0 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched, enclosed within a curved line. 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 DEVICE VI.
A comparison between Quantum Perfusion Blood Oxygenator devices, VT75-C1U and VT75-C2U, and the prodicate and reference devices has been conducted.
Quantum Perfusion Blood Oxygenator devices have the same operating principle and intended and reference devices.
Quantum Perfusion Blood Oxygenator VT75-C2U devices and primary predicate device have both an intended population regarding pediatric patients. The target population of the D101 Kids device is specific to infants (i.e., from 29 days to 2 years of age) and therefore falls in a more critical threshold respect to identified category for subject devices (i.e. Adolescent and Transitional Adolescent, from 12 to 21 years of age).
A summary of the technological characteristics of Quantum Perfusion Blood Oxygenator devices and reference devices has been given in table below. Additional information are available in Attacher Comparison" of present "Additional Information" required by the Agency.
| Device | Proposed Devices – | Predicate Device - | Reference Devices – QuantumPerfusion Blood Oxygenator Devices |
|---|---|---|---|
| Name | Quantum Perfusion Blood Oxygenatorwith Integrated AF and SensorVT75-C1UQuantum Perfusion Blood Oxygenatorwith Integrated AFVT75-C2UQura S.r.l. | D101 KidsSorin Group Italia S.r.I. | Qura S.r.l. |
| Quantum Perfusion Blood Oxygenatorwith Integrated AF and Sensor VT75-C1UQuantum Perfusion Blood Oxygenatorwith Integrated AF VT75-C2U | D101 Kids Infant Hollow FiberMembrane Oxygenator With IntegratedHardshell Cardiotomy/VenousReservoir | Quantum Perfusion Blood Oxygenatorwith Integrated AF and Sensor VT160-C1UQuantum Perfusion Blood Oxygenatorwith Integrated AF VT160-C2U | |
| 510(k) Number | K231773 | K072091 | K212341 |
| Device description | The Quantum Perfusion BloodOxygenator device (acronym VT-C) isdesigned to oxygenate blood andremove carbon dioxide from venousblood during cardiac surgicalprocedures requiring cardiopulmonary | The D101 KIDS Hollow Fiber MembraneOxygenator With Integrated HardshellCardiotomy/Venous Reservoir withphosphorylcholine coating (hereafterreferred to as the D101 KIDS) is a highefficiency infant microporous hollowfiber membrane oxygenator integrated | The Quantum Perfusion BloodOxygenator device (acronym VT-C) isdesigned to oxygenate blood andremove carbon dioxide from venousblood during cardiac surgicalprocedures requiring cardiopulmonary |
| Device | Proposed Devices - | Predicate Device - | Reference Devices – Quantum |
| Quantum Perfusion Blood Oxygenator | D101 Kids | Perfusion Blood Oxygenator Devices | |
| with Integrated AF and Sensor | Sorin Group Italia S.r.l. | Qura S.r.l. | |
| VT75-C1U | |||
| Quantum Perfusion Blood Oxygenator | |||
| with Integrated AF | |||
| VT75-C2U | |||
| Qura S.r.l. | |||
| bypass for a maximum duration of 6 | with an heat exchanger and connected | bypass for a maximum duration of 6 | |
| hours. | to an hardshell cardiotomy/venous | hours. | |
| The Quantum Perfusion Blood | reservoir. | The Quantum Perfusion Blood | |
| Oxygenator device has an integrated | Oxygenator device has an integrated | ||
| arterial filter and can be operated up to2,5 liters per minutes. | arterial filter and can be operated up to6 liters per minutes (VT160 variants). | ||
| Regulation # | 21 CFR §870.4350 | 21 CFR §870.4350 | 21 CFR §870.4350 |
| Regulation Name | Cardiopulmonary Bypass Oxygenator | Cardiopulmonary Bypass Oxygenator | Cardiopulmonary Bypass Oxygenator |
| Product Code | DTZ | DTZ | DTZ |
| Classification | II | II | II |
| Indication for Use | VT75-C1U | The D101 KIDS Infant Hollow Fiber | VT160-C1U |
| Quantum Perfusion Blood Oxygenator | Membrane Oxygenator is intended for | Quantum Perfusion Blood Oxygenator | |
| with Integrated AF and Sensor VT75- | use in infants who undergo | with Integrated AF and Sensor VT160- | |
| C1U is a diffusion membrane | cardiopulmonary bypass surgery | C1U is a diffusion membrane | |
| oxygenator, designed to provide gas | requiring extracorporeal circulation | Oxygenator, designed to provide gas | |
| exchange during cardiac surgery | with a maximum blood flow rate of 2.5 | exchange during cardiac surgery | |
| requiring cardiopulmonary bypass, to | liters/minute. It provides oxygenation | requiring cardiopulmonary bypass, to | |
| measure blood pressure and | and carbon dioxide removal from | measure blood pressure and | |
| temperature during the procedure. The | venous or suctioned blood. The | temperature during the procedure. The | |
| integrated arterial filter provides | integrated heat exchanger provides | integrated arterial filter provides | |
| additional protection against air and | blood temperature control and allows | additional protection against air and | |
| solid emboli. The device is limited to 6 | the use of hypothermia or aids in the | solid emboli. The device is limited to 6 | |
| hours of use. | maintenance of normothermia during surgery. The venous reservoir is | hours of use. | |
| intended to collect blood aspirated | |||
| VT75-C2U | from the operating field during surgical | VT160-C2U | |
| Quantum Perfusion Blood Oxygenator | procedures and blood from patient's | Quantum Perfusion Blood Oxygenator | |
| with Integrated AF VT75-C2U is a | with Integrated AF VT160-C2U is a |
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Image /page/8/Picture/0 description: The image is a logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with outstretched arms, enclosed within a blue arc. To the right of the figure, the word "QURA" is written in bold, blue letters. Below "QURA", the words "advanced medical solutions" are written in a smaller font.
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Image /page/9/Picture/0 description: The image is a logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with outstretched arms, enclosed within a blue arc. To the right of the figure, the word "QURA" is written in bold, blue letters, with the words "advanced medical solutions" written in smaller letters underneath.
| Device | Proposed Devices –Quantum Perfusion Blood Oxygenatorwith Integrated AF and SensorVT75-C1UQuantum Perfusion Blood Oxygenatorwith Integrated AFVT75-C2UQura S.r.l. | Predicate Device –D101 KidsSorin Group Italia S.r.I. | Reference Devices - QuantumPerfusion Blood Oxygenator DevicesQura S.r.l. |
|---|---|---|---|
| diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use. | veins (gravity or vacuum assisted) during normal operation, to always assure the proper oxygenation capability of the device.The D101 KIDS should not be used longer than 6 hours. Contact with blood for longer periods is not advised. The blood to be treated should contain anticoagulant. | diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use. | |
| Target population | Adolescent/transitional adolescent(from 12 to 21 years of age) | Infant | Adult |
| Target User | Perfusionist | Perfusionist | Perfusionist |
| Main Contacting Materials | Fiber: polypropylene (PP)Coating: PhosphorylcholineArterial filter: polyester (PET)Housing: TritanSensor: Polycarbonate and silicone-based protective gel | Fiber: polypropylene (PP)Coating: PhosphorylcholineArterial filter: polyester (PET)Housing: Polycarbonate | Fiber: polypropylene (PP)Coating: PhosphorylcholineArterial filter: polyester (PET)Housing: TritanSensor: Polycarbonate and silicone-based protective gel |
| Blood side Connector Type | 1/4" (0.635 mm) | 1/4" (0.635 mm) | 3/8" (9.525 mm) |
| Max flow rate [I/min]Nominal flow rate [I/min]Min flow rate [l/min] | 2.5 | 2.5 | 6 |
| Exchange surface [m²] | 0.80 | 0.61 | 1.5 |
| Priming Volume [ml] | 75 | 87 | 145 |
| Single-use | Yes | Yes | Yes |
| Sterile Condition | EtO Sterile | EtO Sterile | EtO Sterile |
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Image /page/10/Picture/0 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. The text "QURA" is written in a bold, sans-serif font, with the words "advanced medical solutions" appearing in a smaller font size below it. The color scheme is primarily blue.
VII. PERFORMANCE DATA
NON-CLINICAL TESTING
The following activities were performed to demonstrate product safety and effectiveness requirements and all testing passed by meeting the established requirements set for the use of the devices.
The following data have been provided as requested by FDA in its letter dated August 15, 2023:
- Performance tests, according to applicable special controls according to ISO 7199 [Recognition Nr. 3--150], 21 CFR §870.4350 and "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for industry and FDA Staff", dated November 13, 2000:
- Gas Exchange testing; o
- Mechanical Hemolysis; O
- Leakage testing; O
- Filtration efficiency; O
- Pressure drop testing; O
- Priming volume characterization. O
Further this, Qura S.r.l. has updated labeling and Instruction for Use (IFU) according to ISO 15223-11. 2021 Medical Devices – symbols to be used with Medical Device Labelling and Information to Be Supplied – Part 1: General Requirements [Recognition Nr. 5-134].
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 510(k) submission to support substantial equivalence to legally marketed predicate devices.
VIII. CONCLUSIONS
Based on the Indication for use, technological characteristics, results of non - clinical testing, and comparison to predicate device, Quantum Perfusion Blood Oxygenators have been shown to be substantially equivalent to predicate device Sorin Group Italia S.r.l. Kids D101 (K072091) and reference Qura's own marketed Quantum Perfusion Blood Oxygenator devices (K212341).
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”