(193 days)
No
The device description and performance studies focus on the physical properties and functionality of tubing sets for cardiopulmonary bypass, with no mention of AI or ML.
No
The device is a tubing set used for connecting other devices in a cardiopulmonary bypass circuit or for delivering cardioplegia solutions. It does not directly provide therapy but enables other therapeutic interventions.
No
Explanation: The device is described as a tubing set for cardiopulmonary bypass and cardioplegia infusion, which are therapeutic and support functions, not diagnostic ones. It is used to connect other devices but does not itself perform any diagnostic measurements or analyses.
No
The device description explicitly states it is a "set of tubing" and describes physical components like "polyvinyl chloride (PVC) DOP free tubing and additional components composing the set." The performance studies also detail testing of physical properties like "Mechanical Integrity," "Device pressure drop," and "Connection strength." This indicates a hardware-based medical device, not software-only.
Based on the provided information, the Quantum SuperPAC Tubing set and Quantum SuperPAC Cardioplegia Set are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that these devices are tubing sets used during cardiopulmonary bypass and for the infusion of solutions during cardiac surgery. This involves direct interaction with the patient's circulatory system and the delivery of fluids into the body.
- Device Description: The description details the components of the tubing sets and their function in connecting other devices for extracorporeal support and fluid delivery. This is a mechanical function related to surgical procedures.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of patient samples or diagnostic purposes.
Therefore, these devices fall under the category of medical devices used in surgical procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Quantum SuperPAC Tubing Set is a set of tubing intended for use during cardiopulmonary bypass for a duration up to 6 hours.
Quantum SuperPAC Cardioplegia Set is a tubing set used for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.
Product codes
DWF
Device Description
Quantum SuperPAC Tubing set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set such as oxygenators, pumps, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support, for a maximum duration of 6 hours.
Quantum SuperPAC Cardioplegia set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.
Quantum SuperPAC devices (all variants) are non-toxic, non-pyrogenic, and sterilized by ethylene oxide. Devices are intended for single use only and are not to be resterilized by the user.
All the device surfaces in contact with blood are treated with a phosphorylcholine-based coating.
Quantum SuperPAC devices (all variants) are mainly constituted of polyvinyl chloride (PVC) DOP free tubing and additional components composing the set; different variants are available, varying for tubing dimension and set configuration in order to address customer and surgical procedure specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart and great vessels
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed including 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, mainly related to:
- Operating Parameters,
- Mechanical Integrity,
- Device pressure drop,
- Spallation and Tubing Life,
- Connection strength,
and mainly performed according to ISO 15676.
- 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 [Previous Edition Recognition Nr. 14-454], ASTM F1886/F1886M-16 [Recognition Nr. 14-501], EN 868-5 and ASTM F1929-15 [Recognition Nr. 14-484],
- 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".
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 ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
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.
May 20, 2022
Qura S.r.1. Raffaella Tommasini QA&RA Director Via di Mezzo, 23 Mirandola, Modena 41037 Italy
Re: K213540
Trade/Device Name: Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: April 20, 2022 Received: April 22, 2022
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 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
1
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
Enclosure
2
Indications for Use
510(k) Number (if known) K213540
Device Name Quantum SuperPAC Tubing Set
Indications for Use (Describe)
Quantum SuperPAC Tubing Set is a set of tubing intended for use during cardiopulmonary bypass for a duration up to 6 hours.
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."
3
Indications for Use
510(k) Number (if known) K213540
Device Name Quantum SuperPAC Cardioplegia Set
Indications for Use (Describe)
Quantum SuperPAC Cardioplegia Set is a tubing set used for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.
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/0 description: The image shows the logo for Qura advanced medical solutions. The logo features a stylized human figure with outstretched arms, enclosed within a curved line. 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
| 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: | April 20th, 2022 |
| II. DEVICES | |
| Proprietary Name: | Quantum SuperPAC Tubing set |
| Quantum SuperPAC Cardioplegia set | |
| Common Name: | Tubing set |
| Cardioplegia set | |
| Classification Name: | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DWF |
| 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) |
III. PREDICATE AND REFERENCE DEVICES
Predicate device:
| Trade Name: | Tubing Pack |
|---|---|
| Registered Establishment Name: | Medtronic, Inc. |
| Regulation Number: | 870.4210 |
| Regulation Name: | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DWF |
| 510(k) Number | K171979 |
5
Image /page/5/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 blue arc. To the right of the figure is the word "QURA" in bold, blue letters, with the words "advanced medical solutions" in smaller font underneath.
Reference devices:
| For Quantum SuperPAC Tubing set: | |
|---|---|
| Trade Name: | COBE SMARXT TUBING AND CONNECTORS |
| Registered Establishment Name: | COBE CARDIOVASCULAR, INC |
| Regulation Number: | 870.4390 |
| Regulation Name: | Tubing, Pump, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DWE |
| 510(k) Number | K981613 |
For Quantum SuperPAC Cardioplegia set:
| Trade Name: | MYOtherm XP Cardioplegia Delivery System With Cortiva BioActive Surface,
MYOtherm XP Cardioplegia Delivery System With Cortiva BioActive Surface
(Bridge System) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registered Establishment Name: | Medtronic, Inc |
| Regulation Number: | 870.4240 |
| Regulation Name: | Cardiopulmonary Bypass Heat Exchanger |
| Regulatory Class: | II |
| Product Code: | DTR |
| 510(k) Number | K162774 |
IV. DEVICE DESCRIPTION
Quantum SuperPAC Tubing set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set such as oxygenators, pumps, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support, for a maximum duration of 6 hours.
Quantum SuperPAC Cardioplegia set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.
Quantum SuperPAC devices (all variants) are non-toxic, non-pyrogenic, and sterilized by ethylene oxide. Devices are intended for single use only and are not to be resterilized by the user.
All the device surfaces in contact with blood are treated with a phosphorylcholine-based coating.
Quantum SuperPAC devices (all variants) are mainly constituted of polyvinyl chloride (PVC) DOP free tubing and additional components composing the set; different variants are available, varying for tubing dimension and set configuration in order to address customer and surgical procedure specifications.
6
Image /page/6/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 curved line, next to the word "QURA" in a bold, sans-serif font. Below "QURA" are the words "advanced medical solutions" in a smaller, lighter font.
V. INTENDED USE / INDICATIONS FOR USE
-
l Quantum SuperPAC Tubing set:
Quantum SuperPAC tubing set is a set of tubing intended for use during cardiopulmonary bypass for a duration up to 6 hours. -
Quantum SuperPAC Cardioplegia set:
Quantum SuperPAC Cardioplegia Set is a tubing set used for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
An extensive and complete comparison between Quantum SuperPAC Tubing set and Quantum SuperPAC Cardioplegia set devices and the predicate/reference devices has been conducted. Devices has the same intended use and operating principle as the predicate and reference devices.
| Device | Proposed Devices | Predicate Device –
Medtronic, Inc.
Tubing Pack | Reference Device
– Cobe
Cardiovascular Inc
COBE SMARXT
Tubing and
Connectors | Reference Device
– Medtronic, Inc.
MYOtherm XP
Cardioplegia
Delivery System |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | – Quantum
SuperPAC Tubing
Set | | | |
| | Quantum | | | |
| | SuperPAC
Cardioplegia set | | | |
| Name | Quantum
SuperPAC Tubing
Set
Quantum
SuperPAC
Cardioplegia
Tubing Set | Tubing,
Connectors and
Accessories | COBE SMARXT
Tubing and
Connectors | MYOtherm XP
Cardioplegia
Delivery System
With Cortiva
BioActive Surface,
MYOtherm XP
Cardioplegia
Delivery System
With Cortiva
BioActive Surface
(Bridge System) |
| 510(k) Number | N.A. | K171979 | K981613 | K162774 |
| Device description | Quantum
SuperPAC Tubing
Set is a tubing and
components set
connecting
different medical
devices used
during the
extracorporeal
procedure up to
six hours.
Quantum
SuperPAC
Cardioplegia
Tubing Set is a | Medtronic Tubing
Packs consist of
coated and
uncoated tubing,
connectors and
various medical
devices that are
pre-assembled
into user-
specified
extracorporeal
cardiopulmonary
bypass perfusion
circuits. Tubing
Packs are
intended for use
within the | The COBE SMART
Tubing and
Connectors are
used in connecting
oxygenators,
reservoirs, filters
and other
cardiopulmonary
bypass
components into
circuits used in
surgical
procedures
requiring
extracorporeal
support | The MYOtherm XP
cardioplegia
delivery system
with Cortiva
bioactive surface is
comprised of
polycarbonate
housing and comes
preconnected to
tubing and
connector
components
comprised of
polycarbonate,
polyvinyl chloride
and plastisol
materials and |
| Device | Proposed Devices
- Quantum
SuperPAC Tubing
Set
Quantum
SuperPAC
Cardioplegia set
tubing and
components set
used during
extracorporeal
circulation to
infuse
cardioplegia/physi
ologic fluids
solution up to six
hours. | Predicate Device –
Medtronic, Inc.
Tubing Pack
extracorporeal
blood pathway
during
cardiopulmonary
bypass surgical
procedures. | Reference Device
– Cobe
Cardiovascular Inc
COBE SMARXT
Tubing and
Connectors | Reference Device
– Medtronic, Inc.
MYOtherm XP
Cardioplegia
Delivery System
provided in Y-type,
straight, reducer
and tubing
configurations. |
| Regulation # | 870.4210 | 870.4210 | 870.4390 | 870.4240 |
| Regulation Name | Cardiopulmonary
bypass vascular
catheter, cannula,
or tubing | Cardiopulmonary
bypass vascular
catheter, cannula,
or tubing | Cardiopulmonary
bypass pump
tubing | Cardiopulmonary
bypass heat
exchanger. |
| Product Code | DWF | DWF | DWE | DTR |
| Classification | II | II | II | II |
| Indication for Use | Quantum
SuperPAC tubing
set is a set of
tubing intended
for use during
extracorporeal
circulation for a
duration up to 6
hours.
Quantum
SuperPAC
Cardioplegia Set is
a tubing set used
for the infusion of
cardioplegia
solutions and
physiological fluids
during cardiac
surgery
procedures on the
heart and great
vessels for up to
six hours. | The Medtronic
Tubing Pack is
indicated for use in
the extracorporeal
circuit during
cardiopulmonary
bypass (CPB)
surgical
procedures. | The COBE SMART
Tubing and
Connectors are
intended to be
used in surgical
procedures
requiring
extracorporeal
support for periods
of up to six hours | The MYOtherm XP
with Cortiva
bioactive surface is
a device intended
for the mixing,
warming/cooling
and delivery of
oxygenated
blood/cardioplegia
solution in a
predetermined
ratio during
routine
cardiopulmonary
bypass (CPB)
procedures up to 6
hours in duration.
Blood/cardioplegia
solution is
delivered to the
patient through
the cardioplegia
delivery system
and appropriate
cannula by the
operation of a |
| Device | Proposed Devices
- Quantum
SuperPAC Tubing
Set
Quantum
SuperPAC
Cardioplegia set | Predicate Device –
Medtronic, Inc.
Tubing Pack | Reference Device - Cobe
Cardiovascular Inc
COBE SMARXT
Tubing and
Connectors | Reference Device - Medtronic, Inc.
MYOtherm XP
Cardioplegia
Delivery System |
| | | | | single occlusive
roller pump. |
| Target population | Patient requiring
extracorporeal
circulation
procedures for
period up to 6
hours | Patient requiring
CPB procedures for
period up to 6
hours | Patient requiring
surgical
procedures
requiring
extracorporeal
support for periods
of up to six hours | Patient requiring
cardiopulmonary
bypass (CPB)
procedures up to 6
hours in duration. |
| Target User | Perfusionist | Perfusionist | Perfusionist | Perfusionist |
| Biocompatibility
Requirements | In compliance with
ISO 10993 series | In compliance with
ISO 10993 series | In compliance with
ISO 10993 series | In compliance with
ISO 10993 series |
| Main
Contacting
Materials | DOP-free polyvinyl
chloride (PVC)
Polycarbonate (PC)
Phosphorylcholine
coating | DOP-free polyvinyl
chloride (PVC)
Polycarbonate (PC)
Cortiva, Trillium
and Balance
coating | DOP-free polyvinyl
chloride (PVC)
Polycarbonate (PC)
SMART coating | Polyvinyl chloride
(PVC)
Polycarbonate (PC)
Plastisol materials |
| Blood side
Connection Type | 3/8x3/32"
1/2x3/32"
1/4x1/16"
3/16x1/16" | 0.085x.062 mm
0.107x.040mm
1/2X1/8"
1/2x3/32"
1/4X1/16"
3/16x1/16"
5/16x3/32" | From 0.075x0.028"
to 5/8x1/8" | 3/8" - 3/16" |
| Single-use | Yes | Yes | Yes | Yes |
| Sterile Condition | Sterile | Sterile | Sterile | Sterile |
| Description of the
sterilization
method | EtO sterilization
process | EtO sterilization
process | EtO sterilization
process | EtO sterilization
process |
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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, blue line. To the right of the figure is the word "QURA" in bold, blue letters, with the words "advanced medical solutions" in smaller font underneath.
8
Image /page/8/Picture/0 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 line. 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, sans-serif font.
Table 5-1 – Comparative Data
9
Image /page/9/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.
VII. PERFORMANCE DATA
NON-CLINICAL TESTING
The following non-clinical testing was performed to support the substantial equivalence Quantum SuperPAC Tubing set and Quantum SuperPAC Cardioplegia set devices 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, mainly related to: -
- Operating Parameters, O
- Mechanical Integrity, O
- o Device pressure drop,
- O Spallation and Tubing Life,
- Connection strength, o
and mainly performed according to ISO 15676.
- -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 [Previous Edition Recognition Nr. 14-454], ASTM F1886/F1886M-16 [Recognition Nr. 14-501], EN 868-5 and ASTM F1929-15 [Recognition Nr. 14-484],
- -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".
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 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, technological characteristics, results of non-clinical testing, and comparison to predicate and reference devices, Quantum SuperPAC Tubing set and Quantum SuperPAC Cardioplegia set devices have been shown to be substantially equivalent to legally marketed predicate and reference devices.