(184 days)
No
The document describes a mechanical device for gas exchange and filtration during cardiac surgery. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on physical and biological properties, not algorithmic performance.
Yes
The device is designed to provide gas exchange and measure blood pressure/temperature during cardiac surgery requiring cardiopulmonary bypass, which are therapeutic interventions.
No
The device is a blood oxygenator designed for gas exchange during cardiac surgery. While some models can measure blood pressure and temperature, these are parameters for monitoring the patient during the procedure, not for diagnosing a disease or condition. The primary function as described is therapeutic/life support, not diagnostic.
No
The device description clearly outlines a physical medical device (oxygenator with integrated arterial filter) made of materials like Polypropylene, designed for gas exchange during cardiac surgery. The performance studies also focus on physical and mechanical properties, not software validation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is designed to "provide gas exchange during cardiac surgery requiring cardiopulmonary bypass" and to "measure blood pressure and temperature during the procedure." This describes a device used in vivo (within the body) to support physiological function during surgery.
- Device Description: The description details how the device works by facilitating gas exchange through hollow fibers and filtering blood. This is consistent with an extracorporeal medical device used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, the Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor is a medical device used during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U and Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use.
Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U and Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use.
Product codes (comma separated list FDA assigned to the subject device)
DTZ
Device Description
Quantum Perfusion Blood Oxygenator devices (acronym VT-C) consist of an oxygenator with an integrated arterial filter.
The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours.
The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli.
Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange.
The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box.
All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed including:
- Performance tests: Operating priming volume, Device pressure Drop, Gas Transfer Performances, Mechanical Blood Cell Damage, Ease of Prime and Air handling, Filtration efficiency, Temperature probe and Pressure sensor verification, Mechanical Integrity, Mechanical resistance of connectors, Coating coverage and durability.
- Evaluation of product shelf life, including product's sterility according to EP/UPS requirements.
- Validation of the EtO Sterilization process, according to ISO 11135:2014.
- Packaging Validation tests according to ISO 11607-1:2019.
- Biocompatibility of the finished product, according to International Standard ISO 10993-1:2018.
All testing passed by meeting the established requirements set for the devices.
No animal studies were performed except for mandatory biocompatibility tests.
No clinical data were included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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.
January 28, 2022
Qura S.r.1. Raffaella Tommasini QA&RA Director Via di Mezzo, 23 Mirandola, Modena 41037 Italy
Re: K212341
Trade/Device Name: Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: December 23, 2021 Received: December 29, 2021
Dear Raffaella Tommasini:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
510(k) Number (if known) K212341
Device Name
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U
Indications for Use (Describe)
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.
Device is intended for adult patients.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K212341
Device Name
Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U
Indications for Use (Describe)
Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.
Device is intended for adult patients.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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
4
510(k) Number (if known) K212341
Device Name
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U
Indications for Use (Describe)
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.
Device is intended for adult patients.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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
5
510(k) Number (if known) K212341
Device Name
Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U
Indications for Use (Describe)
Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.
Device is intended for adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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
6
510(K) SUMMARY
I. SUBMITTER
| Submitter Name: | Qura S.r.l. |
|---|---|
| Submitter Address: | Via di Mezzo, 23 41037 Mirandola (MO) Italy |
| Contact Person: | Raffaella Tommasini, QA&RA Director – Qura s.r.l. |
| Phone: | +39 0535 1803050 |
| e-mail: | raffaella.tommasini@quramed.com |
| Fax: | +39 0535 1803051 |
| Date Summary Prepared: | December 23rd, 2022 |
II. DEVICES
Proprietary Name:
| | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor
VT160-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF and |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated |
| | AF VT160 – C2U, Quantum Perfusion Blood Oxygenator with Integrated
AF VT200-C2U. |
| Common Name: | Blood Oxygenator |
| Classification Name: | Oxygenator, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DTZ |
| Panel: | Cardiovascular Devices, Office of Health Technology 2 (OHT2) / Division of
Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) |
| 510(k) Number: | K212341 |
PREDICATE AND REFERENCE DEVICES lll.
Predicate device:
| Trade Name: | INSPIRE 8F M Hollow Fiber Oxygenator With Integrated Arterial Filter |
|---|---|
| Registered Establishment Name: | Sorin Group Italia S.r.l. |
| Regulation Number: | 870.4350 |
| Regulation Name: | Cardiopulmonary Bypass Oxygenator |
| Regulatory Class: | II |
| Product Code: | DTZ |
| 510(k) Number | K180448 |
Reference device:
| Trade Name: | INSPIRE 6F M Hollow Fiber Oxygenator With Integrated Arterial Filter |
|---|---|
| Registered Establishment Name: | Sorin Group Italia S.r.l. |
| Regulation Number: | 870.4350 |
| Regulation Name: | Cardiopulmonary Bypass Oxygenator |
| Regulatory Class: | II |
| Product Code: | DTZ |
| 510(k) Number | K180448 |
7
IV. DEVICE DESCRIPTION
Quantum Perfusion Blood Oxygenator devices (acronym VT-C) consist of an oxygenator with an integrated arterial filter.
The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours.
The device 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.
| Characteristics | CODE | |||
|---|---|---|---|---|
| VT200-C1U | VT200-C2U | VT160-C1U | VT160-C2U | |
| Blood contact materials | Tritan copolyester | |||
| Polypropylene (PP) | ||||
| Polyurethane (PU) | ||||
| Polyester (PET) | ||||
| Coating: phosphorylcholine | ||||
| Maximum operating pressure - blood side | 760 mmHg / 100 kPa / 1 bar / 14.5 psi | |||
| Static priming volume (ml) | 200 | 160 | ||
| Exchange surface area (m²) | 1.75 | 1.45 | ||
| Blood flow (l/min) | 1-8 | 0.5-6 | ||
| Maximum gas flow (l/min) | 10 | |||
| Connections - blood side (IN/OUT) | 3/8" (9.525mm) | |||
| Connections - gas side | ||||
| IN | CPC APC profile | |||
| OUT | 1/4" (6.35mm), cone and Luer Lock | |||
| Arterial sampling | Luer Lock | |||
| Purge line | Luer Lock | |||
| Cardioplegia connector | Pos Lock | |||
| Arterial filter size: | ||||
| Pore size (µm) | 40 | 40 | ||
| Filter surface area (cm²) | 78 | 60 | ||
| Temperature probe - Blood OUT | YSI 400 | |||
| Blood OUT pressure sensor - Range | -200 to 600 | |||
| mmHg | ||||
| -27 to 80 KPa | ||||
| -0.27 to 0.8 bar | / | -200 to 600 | ||
| mmHg | ||||
| -27 to 80 KPa | ||||
| -0.27 to 0.8 bar | / |
Significant physical and performance characteristics:
Table 5-1 —Main characteristics
8
INTENDED USE / INDICATIONS FOR USE V.
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U and Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use.
Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U and Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use.
Devices are intended for adult patients.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
An extensive and complete comparison between Quantum Perfusion Blood Oxygenator (all variants) and the predicate device has been conducted. Quantum Perfusion Blood Oxygenator devices has the same intended use and operating principle as the predicate and reference devices.
Based on the safety, performance data, technological characteristics, and the indications for use of the predicate device:
-
. Quantum Perfusion Blood Oxygenator (all variants) are considered substantially equivalent to the legally marketed predicate device INSPIRE 8F M (K180448) since the intended use, main blood-contact materials and technological characteristics are the same.
In addition, in terms of performance: -
l VT200-C1U and VT200-C2U devices are considered substantially equivalent to the legally marketed predicate device INSPIRE 8F M (K180448).
-
VT160-C1U and VT160-C2U devices are considered substantially equivalent to the legally marketed reference predicate device INSPIRE 6F M (K180448).
9
A summary of the technological characteristics of Quantum Perfusion Blood Oxygenators to those of the predicate/reference device has been given in table below.
| Device | Proposed Device - Quantum
Perfusion Blood Oxygenator | Predicate Device - Sorin
Group Italia Inspire 8F M | Reference Predicate Device
- Sorin Group Italia Inspire
6F M |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Quantum Perfusion Blood
Oxygenator with Integrated AF
and Sensor VT200-C1U
Quantum Perfusion Blood
Oxygenator with Integrated AF
VT200-C2U | INSPIRE 8F M Hollow Fiber
Oxygenator With
Integrated Arterial Filter | N.A. |
| | Quantum Perfusion Blood
Oxygenator with Integrated AF
and Sensor VT160-C1U
Quantum Perfusion Blood
Oxygenator with Integrated AF
VT160-C2U | | INSPIRE 6F M Hollow Fiber
Oxygenator With Integrated
Arterial Filter |
| 510(k) Number | K212341 | K180448 | |
| Regulation # | 870.4350 | 870.4350 | 870.4350 |
| Regulation Name | Cardiopulmonary Bypass
Oxygenator | Cardiopulmonary Bypass Oxygenator | |
| Product Code | DTZ | DTZ | |
| Classification | II | II | |
| Indication for Use | Quantum Perfusion Blood
Oxygenator with Integrated AF
and Sensor VT200-C1U and
Quantum Perfusion Blood
Oxygenator with Integrated AF
and Sensor VT160-C1U are
diffusion membrane
oxygenators, designed to
provide gas exchange during
cardiac surgery requiring
cardiopulmonary bypass, to
measure blood pressure and
temperature during the
procedure. The integrated
arterial filter provides
additional protection against
air and solid emboli. The
devices are limited to 6 hours of
use.
Quantum Perfusion Blood
Oxygenator with Integrated AF
VT200-C2U and Quantum
Perfusion Blood Oxygenator
with Integrated AF VT160-C2U
are diffusion membrane
oxygenators, designed to
provide gas exchange during
cardiac surgery requiring | The Inspire 8F M is
intended for use in adult
and small adult surgical
procedures requiring
cardiopulmonary bypass. It
provides gas exchange
support and blood
temperature control.
Inspire 8F M integrated
arterial filter provides
additional protection
against air and solid
emboli. Inspire 8F M is
intended to be used for 6
hours or less. | The Inspire 6F M is intended
for use in adult and small
adult surgical procedures
requiring cardiopulmonary
bypass. It provides gas
exchange support and blood
temperature control. Inspire
6F M integrated arterial filter
provides additional
protection against air and
solid emboli. Inspire 6F M is
intended to be used for 6
hours or less |
| Device | Proposed Device - Quantum Perfusion Blood Oxygenator | Predicate Device - Sorin Group Italia Inspire 8F M | Reference Predicate Device - Sorin Group Italia Inspire 6F M |
| | cardiopulmonary bypass, and measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use.
Devices are intended for adult patients. | | |
| Main Materials | Fiber: polypropylene (PP)
Coating: Phosphorylcholine
Arterial filter: polyester (PET)
Housing: Tritan
Sensor: Polycarbonate and silicone-based protective gel | Fiber: Polypropylene (PP)
Coating: Phosphorylcholine
Arterial filter: Polyester (PET)
Housing: Polycarbonate
Heat exchanger: Polyurethane (PU) | |
| Blood side Connector Type | 3/8" (9.525mm) | 3/8" (9.525mm) | |
| Max flow rate [l/min] | VT200-C1U - VT 200-C2U: 8
VT160-C1U - VT160-C2U: 6 | 8 | 6 |
| Exchange surface [m²] | VT200-C1U - VT 200-C2U: 1.75
VT160-C1U - VT160-C2U: 1.45 | 1.75 | 1.4 |
| Static Priming Volume [ml] | VT200-C1U - VT 200-C2U: 200
VT160-C1U - VT160-C2U: 160 | 351 | 284 |
| Arterial filter cut-off size [µm] | 40 | 38 | 38 |
| Presence of sensor | Pressure sensors located integrated in the blood out connector (C1U variants only) | Not present | Not present |
| Single-use | Yes | Yes | |
| Sterile Condition | EtO Sterile | EtO Sterile | |
10
Table 5-2 – Comparative Data
11
PERFORMANCE DATA VII.
NON-CLINICAL TESTING
The following non-clinical testing was performed to support the substantial equivalence of Quantum Perfusion Blood Oxygenators to the legally marketed predicate devices. This testing included biocompatibility evaluation, mechanical and performance verification, labeling and Instructions for Use (IFU), and verification and validation tests.
All testing passed by meeting the established requirements set for the devices. The following data were provided:
- Performance tests, according to applicable special controls according to ISO 7199 [Recognition Nr. 3-150], 21 CFR §870.4350 and "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff", dated November 13, 2000:
- o Operating priming volume;
- o Device pressure Drop;
- Gas Transfer Performances; O
- O Mechanical Blood Cell Damage;
- O Ease of Prime and Air handling;
- O Filtration efficiency;
- O Temperature probe and Pressure sensor verification;
- Mechanical Integrity; O
- o Mechanical resistance of connectors;
- O Coating coverage and durability.
- Evaluation of product shelf life, including product's sterility according to EP/UPS requirements; -
- -Validation of the EtO Sterilization process, according to ISO 11135:2014 [Recognition Nr.: 14-529];
- Packaging Validation tests according to ISO 11607-1:2019 [Recognition Nr.: 14-530]; -
- Biocompatibility of the finished product, according to International Standard ISO 10993-1:2018 -[Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Animal Study
No animal studies have been performed except for mandatory biocompatibility tests according to International Standard ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
CLINICAL TESTING
No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate devices.
VIII. CONCLUSIONS
Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, Quantum Perfusion Blood Oxygenators have been shown to be substantially equivalent to legally marketed predicate and reference devices (both covered by K180448).