(193 days)
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.
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.
This document is a 510(k) summary for the Quantum SuperPAC Tubing Set and Quantum SuperPAC Cardioplegia Set. It details the device's intended use, comparison to predicate devices, and performance testing. However, it does not contain information regarding studies that establish acceptance criteria for device performance in the manner of an AI/ML algorithm's effectiveness in diagnostic tasks, nor does it provide details on sample sizes, ground truth establishment, or expert adjudication typical for such studies.
Instead, this document focuses on demonstrating substantial equivalence to existing medical devices through non-clinical performance and biocompatibility testing for a medical device (tubing sets) rather than a diagnostic AI system.
Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary, as it pertains to a physical medical device.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside reported device performance in the context of an AI/ML diagnostic system. Instead, it states that "All testing passed by meeting the established requirements set for the devices." The performance tests conducted are listed as:
- Operating Parameters
- Mechanical Integrity
- Device pressure drop
- Spallation and Tubing Life
- Connection strength
These tests were mainly performed according to ISO 15676. Additional tests included:
- Evaluation of product shelf life (according to EP/UPS requirements)
- Validation of EtO Sterilization process (according to ISO 11135:2014)
- Packaging Validation tests (according to ISO 11607-1:2019, ASTM F1886/F1886M-16, EN 868-5 and ASTM F1929-15)
- Biocompatibility (according to ISO 10993-1:2018 and FDA Guidance)
The document asserts that the devices met these established requirements, implying that the acceptance criteria were defined by these standards and the device's performance aligned with them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system requiring a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical performance testing for a physical medical device.
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
This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable for the type of device described. The "ground truth" for this device would be its adherence to performance specifications and safety standards as determined by the listed non-clinical tests (e.g., mechanical integrity tests, biocompatibility tests).
8. The sample size for the training set
This information is not applicable as the document describes a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable as the document describes a physical medical device, not a machine learning model.
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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.
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
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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
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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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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) 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."
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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 setQuantum SuperPAC Cardioplegia set |
| Common Name: | Tubing setCardioplegia set |
| Classification Name: | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Regulatory Class: | II |
| Product Code: | DWF |
| Panel: | CardiovascularMedical Specialty 74 - 21 CFR Part 870Office 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 |
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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.
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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 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– CobeCardiovascular IncCOBE SMARXTTubing andConnectors | Reference Device– Medtronic, Inc.MYOtherm XPCardioplegiaDelivery System |
|---|---|---|---|---|
| – QuantumSuperPAC TubingSet | ||||
| Quantum | ||||
| SuperPACCardioplegia set | ||||
| Name | QuantumSuperPAC TubingSetQuantumSuperPACCardioplegiaTubing Set | Tubing,Connectors andAccessories | COBE SMARXTTubing andConnectors | MYOtherm XPCardioplegiaDelivery SystemWith CortivaBioActive Surface,MYOtherm XPCardioplegiaDelivery SystemWith CortivaBioActive Surface(Bridge System) |
| 510(k) Number | N.A. | K171979 | K981613 | K162774 |
| Device description | QuantumSuperPAC TubingSet is a tubing andcomponents setconnectingdifferent medicaldevices usedduring theextracorporealprocedure up tosix hours.QuantumSuperPACCardioplegiaTubing Set is a | Medtronic TubingPacks consist ofcoated anduncoated tubing,connectors andvarious medicaldevices that arepre-assembledinto user-specifiedextracorporealcardiopulmonarybypass perfusioncircuits. TubingPacks areintended for usewithin the | The COBE SMARTTubing andConnectors areused in connectingoxygenators,reservoirs, filtersand othercardiopulmonarybypasscomponents intocircuits used insurgicalproceduresrequiringextracorporealsupport | The MYOtherm XPcardioplegiadelivery systemwith Cortivabioactive surface iscomprised ofpolycarbonatehousing and comespreconnected totubing andconnectorcomponentscomprised ofpolycarbonate,polyvinyl chlorideand plastisolmaterials and |
| Device | Proposed Devices- QuantumSuperPAC TubingSetQuantumSuperPACCardioplegia settubing andcomponents setused duringextracorporealcirculation toinfusecardioplegia/physiologic fluidssolution up to sixhours. | Predicate Device –Medtronic, Inc.Tubing Packextracorporealblood pathwayduringcardiopulmonarybypass surgicalprocedures. | Reference Device– CobeCardiovascular IncCOBE SMARXTTubing andConnectors | Reference Device– Medtronic, Inc.MYOtherm XPCardioplegiaDelivery Systemprovided in Y-type,straight, reducerand tubingconfigurations. |
| Regulation # | 870.4210 | 870.4210 | 870.4390 | 870.4240 |
| Regulation Name | Cardiopulmonarybypass vascularcatheter, cannula,or tubing | Cardiopulmonarybypass vascularcatheter, cannula,or tubing | Cardiopulmonarybypass pumptubing | Cardiopulmonarybypass heatexchanger. |
| Product Code | DWF | DWF | DWE | DTR |
| Classification | II | II | II | II |
| Indication for Use | QuantumSuperPAC tubingset is a set oftubing intendedfor use duringextracorporealcirculation for aduration up to 6hours.QuantumSuperPACCardioplegia Set isa tubing set usedfor the infusion ofcardioplegiasolutions andphysiological fluidsduring cardiacsurgeryprocedures on theheart and greatvessels for up tosix hours. | The MedtronicTubing Pack isindicated for use inthe extracorporealcircuit duringcardiopulmonarybypass (CPB)surgicalprocedures. | The COBE SMARTTubing andConnectors areintended to beused in surgicalproceduresrequiringextracorporealsupport for periodsof up to six hours | The MYOtherm XPwith Cortivabioactive surface isa device intendedfor the mixing,warming/coolingand delivery ofoxygenatedblood/cardioplegiasolution in apredeterminedratio duringroutinecardiopulmonarybypass (CPB)procedures up to 6hours in duration.Blood/cardioplegiasolution isdelivered to thepatient throughthe cardioplegiadelivery systemand appropriatecannula by theoperation of a |
| Device | Proposed Devices- QuantumSuperPAC TubingSetQuantumSuperPACCardioplegia set | Predicate Device –Medtronic, Inc.Tubing Pack | Reference Device- CobeCardiovascular IncCOBE SMARXTTubing andConnectors | Reference Device- Medtronic, Inc.MYOtherm XPCardioplegiaDelivery System |
| single occlusiveroller pump. | ||||
| Target population | Patient requiringextracorporealcirculationprocedures forperiod up to 6hours | Patient requiringCPB procedures forperiod up to 6hours | Patient requiringsurgicalproceduresrequiringextracorporealsupport for periodsof up to six hours | Patient requiringcardiopulmonarybypass (CPB)procedures up to 6hours in duration. |
| Target User | Perfusionist | Perfusionist | Perfusionist | Perfusionist |
| BiocompatibilityRequirements | In compliance withISO 10993 series | In compliance withISO 10993 series | In compliance withISO 10993 series | In compliance withISO 10993 series |
| MainContactingMaterials | DOP-free polyvinylchloride (PVC)Polycarbonate (PC)Phosphorylcholinecoating | DOP-free polyvinylchloride (PVC)Polycarbonate (PC)Cortiva, Trilliumand Balancecoating | DOP-free polyvinylchloride (PVC)Polycarbonate (PC)SMART coating | Polyvinyl chloride(PVC)Polycarbonate (PC)Plastisol materials |
| Blood sideConnection Type | 3/8x3/32"1/2x3/32"1/4x1/16"3/16x1/16" | 0.085x.062 mm0.107x.040mm1/2X1/8"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 thesterilizationmethod | EtO sterilizationprocess | EtO sterilizationprocess | EtO sterilizationprocess | EtO sterilizationprocess |
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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.
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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 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
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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.
§ 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).