(30 days)
No
The summary describes a mechanical blood pump with integrated pressure sensors. There is no mention of AI/ML terms, image processing, or data analysis beyond basic pressure monitoring. The performance studies focus on labeling updates and comparison to predicate devices, not AI/ML model validation.
Yes
The device is intended to pump blood through an extracorporeal circuit during procedures like cardiopulmonary bypass or temporary circulatory bypass, which are therapeutic interventions.
No
The device is a blood pump used in extracorporeal circuits for procedures like cardiopulmonary bypass, which is a therapeutic function, not a diagnostic one. While it monitors pressure, this is for operational safety and control during the bypass, not to diagnose a patient's condition.
No
The device description explicitly states it is a "standalone single use device intended to pump blood" and is "equipped with two sensors integrated in the blood inlet and outlet connectors," indicating it is a physical 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 used to "pump the blood through an extracorporeal circuit" and "monitor pressure" during surgical procedures. This is a mechanical function related to supporting circulation, not analyzing biological samples in vitro (outside the body).
- Device Description: The description focuses on the physical components and function of pumping blood and monitoring pressure. There is no mention of analyzing blood components or performing any diagnostic tests on the blood itself.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis.
The device is a medical device used for extracorporeal circulation support during surgery, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either:
(i) Full of 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.
Devices are intended for adult patients.
Product codes
KFM
Device Description
The Quantum Perfusion Centrifugal Blood Pump with Integrated Sensors is a standalone single use device intended to pump blood into the extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours. The device is equipped with two sensors integrated in the blood inlet and outlet connectors.
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
Adult patients
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
NON-CLINICAL TESTING
The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact:
- Update of labeling and Instructions for Use (IFU) according to ISO 15223-1:2021 -Medical Devices - Symbols to Be Used with Medical Device Labels, Labelling, And Information to Be Supplied - Part 1: General Requirements [Recognition Nr. 5-134];
- Review and Assessment of data available on predicate( K201320) and reference (K202169) devices submission and applicability to new variant introduced in the product family portfolio.
Animal Study
No animal studies have been performed to support changes object of the present Special 510(k).
CLINICAL TESTING
No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 26, 2023
Qura S.r.1. Raffaella Tommasini QA&RA Director Via di Mezzo, 23 Mirandola, MO 41037 Italy
Re: K233091
Trade/Device Name: Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type blood pump Regulatory Class: Class II Product Code: KFM Dated: September 26, 2023 Received: September 26, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Eric E. Richardson -S
for Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known) K233091
Device Name
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors
Indications for Use (Describe)
The Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either:
(i) Full of 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.
Devices are intended for adult patients.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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 partial blue circle. To the right of the figure, the word "QURA" is written in a bold, blue font. Below "QURA", the phrase "advanced medical solutions" is written in a smaller, lighter blue font.
510(K) SUMMARY
SUBMITTER l.
| 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: | September 26th, 2023 |
DEVICE II.
| Proprietary Name: | Quantum Perfusion Centrifugal Blood Pump CP37 with
Integrated Sensors |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Centrifugal Blood Pump with Integrated Sensors |
| 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 AND REFERENCE DEVICES
Predicate device:
| Proprietary Name: | Quantum Perfusion Centrifugal Blood Pump CP22 with
Integrated Sensors |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Centrifugal Blood Pump CP22 with Integrated Sensors |
| 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) |
| 510(k) Number: | K201320 |
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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 with arms outstretched, enclosed within a curved line. The text "QURA" is written in a bold, sans-serif font, with the words "advanced medical solutions" in a smaller font below it. The logo is blue.
Reference device:
| Proprietary Name: | Quantum Perfusion Centrifugal Blood Pump CP37 |
|---|---|
| Common Name: | Centrifugal Blood Pump CP37 |
| 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) | |
| 510(k) Number: | K202169 |
DEVICE DESCRIPTION IV.
The Quantum Perfusion Centrifugal Blood Pump with Integrated Sensors is a standalone single use device intended to pump blood into the extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours. The device is equipped with two sensors integrated in the blood inlet and outlet connectors.
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 Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, are intended to pump the blood through an extracorporeal circuit and to monitor pressure 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.
Devices are intended for adult patients.
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 arms outstretched, enclosed in a partial orbit shape. To the right of the figure is the word "QURA" in a bold, sans-serif font. Below "QURA" is the text "advanced medical solutions" in a smaller, lighter font.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
One additional device model has been introduced in the Centrifugal Blood Pump with Integrated Sensors product family in order to provide to clinicians/users an additional option to perform cardiopulmonary bypass procedures.
New REF code introduced in the portfolio for Quantum Perfusion Centrifugal Blood Pump with Integrated Sensors product family is aligned with information provided in original submission K201320 in terms of general structure (including packaging configuration), principle of operation, intended use , manufacturing and sterilization processes.
Technical specifications have been verified through testing activities performed according to the same internal applicable standards/protocols of the original cleared devices.
Applicable testing activities demonstrated that the proposed device model does not raise any issues of safety and effectiveness as compared to the currently cleared predicate and reference product.
VII. PERFORMANCE DATA
NON-CLINICAL TESTING
The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact:
- Update of labeling and Instructions for Use (IFU) according to ISO 15223-1:2021 -Medical Devices - Symbols to Be Used with Medical Device Labels, Labelling, And Information to Be Supplied - Part 1: General Requirements [Recognition Nr. 5-134];
- Review and Assessment of data available on predicate( K201320) and reference (K202169) devices submission and applicability to new variant introduced in the product family portfolio.
Animal Study
No animal studies have been performed to support changes object of the present Special 510(k).
CLINICAL TESTING
No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate devices.
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Image /page/7/Picture/0 description: The image is a logo for Qura Advanced Medical Solutions. The logo features a stylized human figure inside of a partial circle. The text "QURA" is to the right of the figure, and below that is the text "advanced medical solutions" in a smaller font.
VIII. CONCLUSIONS
Considering all changes performed on original devices cleared K201320 as described in Section "Device Description" of current submission, it could be stated that devices under evaluation are identical in terms of intended use and applicable medical technique.
Based on the testing activities, technological characteristics and the indications for use, the proposed devices have been demonstrated to be appropriate for their intended use and are considered substantially equivalent to Qura's own original devices.