(193 days)
Not Found
No
The summary describes a mechanical blood pump and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is intended to pump blood through an extracorporeal circuit for cardiopulmonary or circulatory bypass during surgical procedures, which directly treats a medical condition.
No
The device is described as a blood pump intended to move blood through an extracorporeal circuit for procedures like cardiopulmonary bypass or temporary circulatory bypass. Its function is to facilitate blood flow, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description clearly describes a physical, single-use blood pump with an impeller, designed to move blood through an extracorporeal circuit. It mentions materials, sterilization, and packaging, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is intended to pump blood through an extracorporeal circuit for the purpose of providing cardiopulmonary bypass or temporary circulatory bypass during surgical procedures. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of the pump (moving blood by centrifugal force) and its physical characteristics (single-use, sterilized, coated surfaces). There is no mention of analyzing blood samples or providing diagnostic information.
- Lack of Diagnostic Elements: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device's function is to support circulation during surgery, which falls under the category of medical devices used for treatment or support, not diagnosis.
N/A
Intended Use / Indications for Use
The Quantum PureFlow Centrifugal Blood Pump 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.
Product codes
KFM
Device Description
The Quantum PureFlow Centrifygal Blood Pump is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circulation 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart or great vessels; aorta or vena cava
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
In-vitro testing was performed to demonstrate product substantial equivalence with the predicate devices and also to comply with user needs and safety and effectiveness requirements. Testing supplied in the 510(k) Notification includes biocompatibility evaluation, mechanical and performance verification, labeling and Instructions for Use (IFU), verification and validation tests. All testing passed by meeting the established requirements set for the use of Quantum PureFlow Centrifugal Blood Pump.
The following data were provided:
- Evaluation of devices' performances:
- Operating Parameters
- Dynamic Blood Damage
- Heat Generation
- Air Entrapment
- Mechanical Integrity
- Durability/Reliability
- Evaluation of Hemolysis according to ASTM F1841-97 (Reaproved 2017) [Recognition Nr. 3-56] and ASTM F1830-97 (Reapproved 2017) [Recognition Nr. 3-55]
- Validation of the EtO Sterilization process, according to ISO 11135:2014 [Recognition Nr.: 14-452]
- Packaging Validation tests according to ISO 11607-1:2019 [Previous Edition Recognition Nr. 14-454]
- Biocompatibility of the finished product (worst case condition), 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 on the Quantum PureFlow Centrifugal Blood Pump have been included in the current Traditional 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 13, 2020
Qura S.r.1. Raffaella Tommasini QA&RA Manager Via di Mezzo, 23 Mirandola, 41037 It
Re: K192850
Trade/Device Name: Ouantum PureFlow Centrifugal Blood Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-Type Blood Pump Regulatory Class: Class II Product Code: KFM Dated: April 7, 2020 Received: April 9, 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/cdrl/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
1
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-devices/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 (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,
Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192850
Device Name Quantum PureFlow Centrifugal Blood Pump
Indications for Use (Describe)
The Quantum PureFlow Centrifugal Blood Pump 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 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) |
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Image /page/3/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 partial circle. 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
| I. SUBMITTER |
|---|
| Submitter Name: | Qura S.r.l. |
|---|---|
| Submitter Address: | Via di Mezzo, 23 41037 Mirandola (MO) Italy |
| Contact Person: | Raffaella Tommasini, QA&RA Manager – Qura s.r.l. |
| Phone: | +39 0535 1803050 |
| e-mail: | raffaella.tommasini@quramed.com |
| Fax: | +39 0535 1803051 |
| Date Summary Prepared: | April 10, 2020 |
II. DEVICE
| Proprietary Name: | Quantum PureFlow Centrifugal Blood Pump |
|---|---|
| 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 of |
| Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) |
III. PREDICATE DEVICE
| Proprietary Name: | COBE Cardiovascular Revolution Centrifugal Blood Pump with PC Coating (at
time of 510(k) submission, now under Sorin Group Italia S.R.L. responsibility,
identified as "Revolution Centrifugal Blood Pump") |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registered Establishment Name: | SORIN GROUP ITALIA S.R.L. |
| Common Name: | Centrifugal Blood Pump |
| Classification Name: | Nonroller-type cardiopulmonary bypass blood pump |
| Regulatory Class: | II |
| Product Code: | KFM |
| 510(k) Number: | K030462 |
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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 inside of an oval shape. The text "QURA" is in bold, blue letters, and below it, in smaller letters, is the text "advanced medical solutions."
IV. DEVICE DESCRIPTION
The Quantum PureFlow Centrifygal Blood Pump is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circulation 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.
V. INTENDED USE / INDICATIONS FOR USE
The Quantum PureFlow Centrifugal Blood Pump 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Quantum PureFlow Centrifygal Blood Pump has the same intended use and operating principle as the predicate device (COBE Cardiovascular Revolution Centrifygal Blood Pump with PC Coating, K030462, now under Sorin Group Italia S.R.L. responsibility, identified as "Revolution Centrifugal Blood Pump").
In-vitro performance tests have been performed in order to support claimed substantial equivalence determining that proposed devices do not raise any new issues in terms of product's safety or effectiveness if compared to currently cleared predicate products.
Quantum PureFlow Centrifugal Blood Pump can be therefore considered as substantially equivalent to predicate device (COBE Cardiovascular Revolution Centrifugal Blood Pump with PC Coating, K030462), according to FDA's Guidance "Evaluating Substantial Equivalence in Premarket Notifications [510(k)]," issued July 28, 2014.
VII. PERFORMANCE DATA
NON-CLINICAL TESTING
In-vitro testing was performed to demonstrate product substantial equivalence with the predicate devices and also to comply with user needs and safety and effectiveness requirements. Testing supplied in the 510(k) Notification includes biocompatibility evaluation, mechanical and performance verification, labeling and Instructions for Use (IFU), verification and validation tests.
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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 partial elliptical shape. The text "QURA" is prominently displayed in a bold, sans-serif font, with the words "advanced medical solutions" written in a smaller font size underneath.
All testing passed by meeting the established requirements set for the use of Quantum PureFlow Centrifugal Blood Pump.
The following data were provided:
- Evaluation of devices' performances: -
- Operating Parameters; O
- Dynamic Blood Damage; O
- Heat Generation; O
- Air Entrapment; O
- O Mechanical Integrity;
- o Durability/Reliability;
- -Evaluation of Hemolysis according to ASTM F1841-97 (Reaproved 2017) [Recognition Nr. 3-56] and ASTM F1830-97 (Reapproved 2017) [Recognition Nr. 3-55];
- -Validation of the EtO Sterilization process, according to ISO 11135:2014 [Recognition Nr.: 14-452],
- -Packaging Validation tests according to ISO 11607-1:2019 [Previous Edition Recognition Nr. 14-454];
- -Biocompatibility of the finished product (worst case condition), 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 on the Quantum PureFlow Centrifugal Blood Pump have been included in the current Traditional 510(k) submission.
VIII. CONCLUSIONS
Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to the predicate device, the Quantum PureFlow Centrifygal Blood Pump has been shown to be substantially equivalent to a legally marketed predicate device.