The Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors indicated for use exclusively with the 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 or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava.

Device Description

The Quantum Perfusion Centrifygal Blood Pump CP22 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter and the 510(k) summary provided do not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance for each criterion. Instead, the document states that "All testing passed by meeting the established requirements set for the devices." and that the device "does not raise any new issues in terms of product's safety or effectiveness as compared to the currently cleared predicate device."

However, the document does list the types of performance tests conducted, which imply the areas for which acceptance criteria would have been established. Based on the provided information, a conceptual table can be created, though without specific numerical targets or results:

Acceptance Criterion Category	Performance Reported
Operating Parameters	Met established requirements. Implies successful operation within specified flow rates, pressures, and other operational limits.
Dynamic Blood Damage	Met established requirements. Implies minimal hemolysis or other blood component damage during operation.
Heat Generation	Met established requirements. Implies that the device does not generate excessive heat that could harm blood or patient.
Air Entrapment	Met established requirements. Implies that the device prevents or minimizes the entrapment of air in the blood path.
Mechanical Integrity	Met established requirements. Implies structural soundness and resistance to failure under expected operating conditions.
Durability/Reliability	Met established requirements. Implies the device maintains its performance and integrity over its intended use duration.
Product Shelf Life	Met established requirements (according to EP/UPS requirements). Implies the device remains sterile and functional for its specified shelf life.
Sterilization Process	Validation successful (according to ISO 11135:2014). Implies the ethylene oxide sterilization effectively renders the device sterile.
Packaging Validation	Validation successful (according to ISO 11607-1:2019). Implies the packaging maintains sterility and protects the device until point of use.
Biocompatibility	Met established requirements (according to ISO 10993-1:2018 and FDA Guidance). Implies the device materials are safe for blood contact and do not elicit adverse biological responses. This included mandatory biocompatibility animal tests.
Substantial Equivalence	Demonstrated. The device is considered substantially equivalent to the predicate device (Quantum PureFlow Centrifugal Blood Pump CP22, K202169) based on intended use, main technological characteristics, and results of non-clinical testing, raising no new safety or effectiveness issues compared to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of devices, number of repeated tests) for each in-vitro performance test. It broadly states that "In-vitro testing was performed."
Data Provenance: The tests were "In-vitro" (laboratory-based) and conducted by Qura S.r.l. in Italy, where the company is based. The nature of these tests suggests they are prospective, as they were specifically designed and executed to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the studies described. The performance data presented are from non-clinical (in-vitro) testing, not studies involving independent expert assessment of, for example, diagnostic images. The "ground truth" for these engineering and performance tests would be defined by established standards (e.g., ISO, EP/UPS, FDA guidance) and the physical or chemical properties measured.

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are non-clinical engineering and performance tests, not studies requiring expert adjudication of observations or diagnoses. The "adjudication" is essentially the comparison of measured results against pre-defined acceptance limits derived from standards and engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate device." This type of study is specifically for evaluating human reader performance, often with AI assistance, which is not relevant for this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable to the device described. The Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensors is a physical medical device (a centrifugal blood pump), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant. Its "standalone performance" refers to its operational performance as a device pumping blood and monitoring pressure, which was evaluated through the in-vitro tests listed.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on:

Established requirements/standards: Applicable special controls (21 CFR 870.4360), ISO standards (ISO 11135:2014, ISO 11607-1:2019, ISO 10993-1:2018), and European Pharmacopoeia/United States Pharmacopeia (EP/UPS) requirements.
Engineering specifications and design parameters: The device performance was measured against its own design specifications and intended performance characteristics.
Predicate device characteristics: Substantial equivalence was demonstrated by showing performance comparable to the predicate device, implying the predicate device's established performance serves as a benchmark.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The design and manufacturing process would involve training of personnel, but not a data training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device.

Summary

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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.

November 3, 2021

Qura S.r.1. Raffaella Tommasini QA&RA Director Via di Mezzo 23 Mirandola, Modena 41037 Italy

Re: K201320

Trade/Device Name: Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-Type Blood Pump Regulatory Class: Class II Product Code: KFM Dated: October 1, 2021 Received: October 4, 2021

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

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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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 Acting 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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Quantum Portugion Rentribeau Black Plann FRAG AND Sensors Food and Drug Administration

Indications for Use

510(k) Number (if known) K201320

Device Name

Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors

Indications for Use (Describe)

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava.

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)

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Image /page/3/Picture/0 description: The image shows the logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with outstretched arms inside of a blue circle. To the right of the figure is the word "QURA" in large, bold, blue letters. Below "QURA" is the phrase "advanced medical solutions" in smaller, lighter blue font.

Section 5.0 510(K) SUMMARY

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:	October 14th, 2020

II. DEVICES

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 ofHealth Technology 2 B (Circulatory Support, Structural and Vascular Devices)
510(k) Number:	K201320

lll. PREDICATE DEVICE

Trade Name:	Quantum PureFlow Centrifugal Blood Pump CP22
Registered Establishment Name:	Qura S.r.l.
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)
510(k) Number:	K202169

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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 circle. To the right of the figure is the word "QURA" in a bold, sans-serif font. Below "QURA" are the words "advanced medical solutions" in a smaller, lighter font.

DEVICE DESCRIPTION IV.

V. INTENDED USE / INDICATIONS FOR USE

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 Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors has the same intended use, main technological characteristics, and operating principle as the predicate device (Quantum PureFlow Centrifugal Blood Pump CP22, cleared by K202169).

In-vitro performance tests have been performed to support claimed substantial equivalence determining that the proposed device does not raise any new issues in terms of product's safety or effectiveness as compared to the currently cleared predicate device.

The Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors can therefore be considered substantially equivalent to the predicate device 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 the product's substantial equivalence with the predicate device 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 is a logo for Qura Advanced Medical Solutions. The logo features a stylized human figure with arms outstretched, enclosed within a partial oval 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, sans-serif font.

All testing passed by meeting the established requirements set for the devices. The following data were provided:

Performance tests, according to applicable special controls according to 21 CFR 870.4360:
- o Operating Parameters;
- o Dynamic Blood Damage;
- O Heat Generation;
- Air Entrapment; O
- O Mechanical Integrity;
- o Durability/Reliability;
-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.: 14-452];
-Packaging Validation tests according to ISO 11607-1:2019 [Recognition Nr.: 14-530];
-Biocompatibility of the finished product, 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 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 device.

VIII. CONCLUSIONS

Based on the indications for use, main technological characteristics and results of non-clinical testing, the Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors device has been demonstrated to be appropriate for its intended use and is considered substantially equivalent to Qura's own marketed predicate device, Quantum PureFlow Centrifugal Blood Pump CP22 (K202169).

Regulation Number and Section

§ 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.