(30 days)
The Quantum PureFlow Centrifugal Blood Pump CP22 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
The Quantum PureFlow Centrifugal Blood Pump CP37 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical (i) procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
The Quantum PureFlow Centrifugal Blood Pump CP22/Quantum PureFlow Centrifugal Blood Pump CP37 is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circulation circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circuits for periods lasting up to 6 hours. The pump is designed to allow the passage of blood through an impeller rotating around its axis.
The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.
Here's a breakdown of the acceptance criteria and study information for the Quantum PureFlow Centrifugal Blood Pump CP22 and CP37, based on the provided FDA 510(k) summary:
The primary purpose of this 510(k) submission is to document a change in labeling regarding the removal of a warning and a package symbol related to DEHP content. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that this labeling change does not negatively impact the safety or effectiveness, and that the device remains substantially equivalent to its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Safety | Device materials meet biocompatibility standards, specifically regarding DEHP content. | Evaluation of DEHP performed according to ISO 10993-18. The change is the removal of DEHP-related labeling, implying that the device either no longer contains DEHP or that prior labeling was updated based on current standards. The document states "no changes are present related to general structure and components... all information contained in original K192850 submission could be considered as still valid," implying the material composition (and thus DEHP status) has been appropriately addressed. |
| Labeling Compliance | Labeling and Instructions for Use (IFU) comply with relevant standards. | Update of labeling and Instructions for Use (IFU) performed according to ISO 15223-1:2016. The specific change is the removal of a warning and a package symbol related to DEHP content. |
| Technological Equivalence | The proposed device maintains the same technological characteristics, intended use, and principle of operation as the predicate device. | "There have been no design changes between the originally cleared device and the proposed device." "The only change involves the removal of a warning and a package symbol related to DEHP content from the product labeling." "Thus, the two devices have the same intended use, principle of operation, and technological characteristics." "Applicable testing has demonstrated that the proposed devices do not raise any new issues of safety and effectiveness as compared to the currently cleared predicate products." |
| Functional Performance | The device's fundamental function (pumping blood through an extracorporeal circuit) remains unchanged and safe. | Not explicitly re-tested for this specific 510(k) due to no design changes. The submission relies on the original K192850 clearance's performance data. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the traditional sense for this submission. The "test set" here refers to the review of standards compliance and labeling changes. No new physical device testing with a specific sample size is detailed.
- Data Provenance: The referenced standards (ISO 10993-18, ISO 15223-1:2016) are international standards. The evaluation of DEHP compliance and labeling update would have been conducted by Qura S.r.l. internally, likely using existing device specifications and documentation. The data is retrospective in that it refers to the original device design and its compliance with updated labeling and material standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The activities performed were:
- DEHP evaluation: This is typically performed by specialists in material science, biocompatibility, and regulatory affairs, often with expertise in ISO 10993 series standards.
- Labeling and IFU update: This would involve quality assurance and regulatory affairs personnel with expertise in medical device labeling regulations (e.g., ISO 15223-1:2016) and FDA requirements. The contact person is Raffaella Tommasini, QA&RA Director.
4. Adjudication Method for the Test Set
- Not applicable. This submission is about a labeling update and demonstrating continued substantial equivalence based on no design changes. It does not involve a "test set" in the context of clinical or performance data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This device is a blood pump, not an AI/imaging diagnostic tool, so MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This device is a physical medical device (blood pump), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" here is compliance with established international standards for biocompatibility (ISO 10993-18) and medical device symbols/information (ISO 15223-1:2016), as well as the device's original design specifications from K192850. The "truth" is that the device's fundamental design and performance characteristics have not changed, and the labeling updates align with current regulatory expectations.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
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September 2, 2020
Qura S.r.l Raffaella Tommasini QA&RA Director Via di Mezzo, 23 Mirandola, Modena 41037 Italy
Re: K202169
Trade/Device Name: Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-Type Blood Pump Regulatory Class: Class II Product Code: KFM Dated: July 31, 2020 Received: August 3, 2020
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.
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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
for Fernando Aguel 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) K202169
Device Name
QuantumPureFlow Centrifugal Blood Pump CP22
Indications for Use (Describe)
The Quantum PureFlow Centrifugal Blood Pump CP22 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
| 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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Indications for Use
510(k) Number (if known) K202169
Device Name
QuantumPureFlow Centrifugal Blood Pump CP37
Indications for Use (Describe)
The Quantum PureFlow Centrifugal Blood Pump CP37 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
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 onlyto 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 estimatedto average 79 hours per response, includingthe time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regardingthis 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 is a logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched, enclosed within a circular shape. To the right of the figure, the word "QURA" is written in a bold, sans-serif font. Below "QURA", the words "advanced medical solutions" are written in a smaller, lighter font.
510(K) SUMMARY Section 5.0
l. 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: | 31 July 2020 |
II. DEVICE
| Proprietary Name: | Quantum PureFlow Centrifugal Blood Pump CP22, Quantum PureFlowCentrifugal Blood Pump CP37 |
|---|---|
| Common Name: | Centrifugal Blood Pump |
| Classification Name: | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
| Regulatory Class: | II |
| Product Code: | KFM |
| Panel: | Cardiovascular Devices, Office of Health Technology 2 (OHT2) / Division ofHealth Technology 2 B (Circulatory Support, Structural and Vascular Devices) |
lll. PREDICATE DEVICE
| Trade Name: | Quantum PureFlow Centrifugal Blood Pump |
|---|---|
| Registered Establishment Name: | Qura S.r.l. |
| Regulation Number: | 21 CFR §870.4360 |
| Regulation Name: | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
| Regulatory Class: | II |
| Product Code: | KFM |
| 510(k) Clearance: | K192850 |
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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 a circle on the left side of the image. 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.
IV. DEVICE DESCRIPTION
The Quantum PureFlow Centrifugal Blood Pump CP22/Quantum PureFlow Centrifugal Blood Pump CP37 is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circulation circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circuits for periods lasting up to 6 hours. The pump is designed to allow the passage of blood through an impeller rotating around its axis.
The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.
Within the scope of present Special 510(k) submission, no changes are present related to general structure and components, intended use, available variants and principle of operation; all information contained in original K192850 submission could be considered as still valid.
V. INTENDED USE / INDICATIONS FOR USE
The Quantum PureFlow Centrifygal Blood Pump CP22 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
- (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
- (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
The Quantum PureFlow Centrifugal Blood Pump CP37 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
- Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical (i) procedures on the heart or great vessels; or
- (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
There have been no design changes between the originally cleared device and the proposed device. The only change involves the removal of a warning and a package symbol related to DEHP content from the product labeling.
Thus, the two devices have the same intended use, principle of operation, and technological characteristics. Applicable testing has demonstrated that the proposed devices do not raise any new issues of safety and effectiveness as compared to the currently cleared predicate products.
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Image /page/6/Picture/0 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with outstretched arms and legs, enclosed within a curved shape. To the right of the figure is the word "QURA" in a bold, sans-serif font, with the words "advanced medical solutions" in a smaller font underneath.
VII. PERFORMANCE DATA
NON-CLINICAL TESTING
The following activities were performed to demonstrate the substantially equivalent to the predicate device:
- evaluation of DEHP according to ISO 10993-18 [FDA Recognition Nr. 2-276;
- update of labeling and Instructions for Use (IFU) according to ISO 15223-1:2016 [FDA Recognition Nr. 5-117].
Animal Study
No animal studies have been performed to support changes object of the present Special 510(k).
CLINICAL TESTING
No clinical testing activities have been performed to support changes object of the present Special 510(k).
VIII. CONCLUSIONS
Considering all changes performed on original devices cleared by K192850, it could be stated that devices under evaluation are identical in terms of intended use, indications for use and applicable medical technique.
Based on the testing activities, technological characteristics and the indications for use, the proposed Centrifugal Blood Pump devices have been demonstrated to their intended use and are considered substantially equivalent to Qura's own original devices.
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.