The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors indicated for use exclusively with Spectrum Medical Systems is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods up to 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.

Device is intended for adolescent (i.e., patients greater than 12 through 21 years of age).

Device Description

The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is a standalone, single-use device intended for use in medical procedures requiring extracorporeal circulation. The device is designed to pump blood via centrifugal force through an extracorporeal circuit for periods lasting up to six (6) hours.

The device is non-toxic, non-pyrogenic, EtO-sterilized, and packaged in a single blister. Blood contact surfaces are coated with a stable, biocompatible compound to reduce platelet activation and adhesion while preserving platelet function.

AI/ML Overview

This document describes the 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors. This is a medical device, not an AI/ML powered device, so several aspects of your request (e.g., number of experts, adjudication method, MRMC study, ground truth for AI/ML models) are not applicable.

Here's an analysis of the provided text in relation to your request, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a structured format as one might find for an AI/ML device where metrics like sensitivity, specificity, or AUC are reported against specific thresholds.

Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device (K220842) through non-clinical performance testing. The reported performance is an affirmation that the device met these implicit criteria by performing comparably to the predicate.

The non-clinical performance tests conducted to demonstrate this are listed:

Operating Parameters
Dynamic Blood Damage
Heat Generation
Air Entrapment
Mechanical Integrity
Durability/Reliability

The conclusion is that "Performance data confirmed that the subject device is equivalent to the predicate device and any differences in the device do not raise new questions of safety or effectiveness." This statement is the reported device performance in the context of a 510(k) for this type of device – it met the standards for substantial equivalence. No specific numerical thresholds or results are provided in this summary, as is common for non-AI/ML 510(k) submissions unless a specific performance standard requires it to be explicitly stated in the summary.

Acceptance Criteria (Implicit)	Reported Device Performance
Equivalent Operating Parameters to Predicate	Confirmed to be equivalent to predicate.
Equivalent Dynamic Blood Damage to Predicate	Confirmed to be equivalent to predicate.
Equivalent Heat Generation to Predicate	Confirmed to be equivalent to predicate.
Equivalent Air Entrapment to Predicate	Confirmed to be equivalent to predicate.
Equivalent Mechanical Integrity to Predicate	Confirmed to be equivalent to predicate.
Equivalent Durability/Reliability to Predicate	Confirmed to be equivalent to predicate.
Biocompatibility (via predicate data)	Validated by predicate device data (K220842).
Sterilization (via predicate data)	Validated by predicate device data (K220842).
Shelf-life (via predicate data)	Validated by predicate device data (K220842).
Packaging Validation (via predicate data)	Validated by predicate device data (K220842).

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

The document states "In vitro performance tests have been performed to support claimed substantial equivalence."

Sample Size: The document does not specify the exact sample sizes (e.g., number of pumps tested) for each of the non-clinical performance tests. This information is typically detailed in the full 510(k) submission, not necessarily in the public summary.
Data Provenance: The tests are described as "In vitro performance tests," implying laboratory-based testing. "Performance testing in accordance with the special controls of 21 CFR 870.4360 was performed with the subject device (CP20V-NG)." This is prospective testing performed on manufactured devices. The country of origin of the data is not specified, but the applicant company is located in Italy (Spectrum Medical S.r.l., Mirandola, Italy).

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

This question is not applicable. This is a physical medical device, not an AI/ML device that requires human expert annotation for ground truth. The "ground truth" for a device like this comes from standardized engineering and biocompatibility testing methods, not expert consensus on medical images or patient outcomes.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This question is not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Performance is measured against physical properties and engineering specifications.

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 question is not applicable. This is not an AI-powered diagnostic or assistive device. No MRMC study was conducted.

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

This question is not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is established through:

Engineering Specifications and Standards: The device's performance is measured against established engineering parameters and standards (e.g., relating to flow, pressure, heat, mechanical durability, blood damage).
Biocompatibility Standards (ISO 10993-1:2018): Ensuring the materials are safe for biological contact.
Sterilization Standards (ISO 11135:2014): Verifying the sterility of the device.
Packaging Standards (ISO 11607-1:2019): Ensuring the integrity of the packaging.
Regulatory Special Controls (21 CFR 870.4360): Specific performance requirements for nonroller-type blood pumps.

The "ground truth" is not based on expert consensus, pathology, or outcomes data in the traditional sense of an AI/ML diagnostic.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI/ML device that uses a "training set." The device is designed, manufactured, and tested, not "trained."

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

This question is not applicable. There is no "training set" or corresponding "ground truth" establishment in the context of this device.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 4, 2025

Spectrum Medical S.r.l.
Raffaella Tommasini
Spectrum Medical Group Regulatory and Quality Director
via di Mezzo, 23
Mirandola, Modena 41037
Italy

Re: K251762
Trade/Device Name: Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
Regulation Number: 21 CFR 870.4360
Regulation Name: Nonroller-Type Blood Pump
Regulatory Class: Class II
Product Code: KFM
Dated: June 9, 2025
Received: June 9, 2025

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"

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K251762 - Raffaella Tommasini
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(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).

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 QS 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K251762 - Raffaella Tommasini
Page 3

Sincerely,

Kathleen M. Grunder -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

Enclosure

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Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.

Please provide the device trade name(s).

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)

Please provide your Indications for Use below.

(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.

Device is intended for adolescent (i.e., patients greater than 12 through 21 years of age).

Please select the types of uses (select one or both, as applicable).

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors
Page 7 of 28

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510(K) SUMMARY

I. SUBMITTER

Submitter Name: Spectrum Medical S.r.l.
Submitter Address: Via di Mezzo, 23 41037 Mirandola (MO) Italy
Contact Person: Raffaella Tommasini, Spectrum Medical Group Regulatory and Quality Director
Phone: +39 0535 1803050
e-mail: raffaella.tommasini@spectrummedical.com
Fax: +39 0535 1803051
Date Summary Prepared: June 6th, 2025

II. DEVICE

Proprietary Name: Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors
Common Name: Centrifugal Blood Pump CP20NG 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: K251762

III. PREDICATE DEVICES

Proprietary Name: Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
Common Name: Centrifugal Blood Pump CP20 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: K220842

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IV. DEVICE DESCRIPTION

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.

Device is intended for adolescent (i.e., patients greater than 12 through 21 years of age).

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) has the same intended use, main technological characteristics, and operating principle as the predicate device (K220842). The design modifications characterizing the subject device are improvements to the rotor and housing of the centrifugal blood pump.

In vitro performance tests have been performed to support claimed substantial equivalence and confirm that any differences in the subject device do not raise any new issues related to product safety or effectiveness.

The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is therefore substantially equivalent to the predicate device per FDA's Guidance Evaluating Substantial Equivalence in Premarket Notifications [510(k)], issued July 28, 2014.

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VII. PERFORMANCE DATA

NON-CLINICAL TESTING

The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact:

Biocompatibility testing was performed in accordance with ISO 10993-1:2018 in a previous submission for the Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (K220842). The modifications to the subject device do not affect the materials, contact type, or contact duration; therefore, the biocompatibility data for the predicate device are valid for the subject device. Refer to K220842 for additional information.
Validation of the EtO sterilization process was performed in accordance with ISO 11135:2014 and provided in a previous submission for the Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (K220842). The modifications to the subject device do not affect the materials or sterilization process; therefore, the sterilization data for the predicate device is valid for the subject device. Refer to K220842 for additional information.
Validation of the product shelf-life was performed and provided in a previous submission for the Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (K220842). The modifications to the subject device do not affect the device materials; therefore, the shelf-life data for the predicate device are valid for the subject device. Refer to K220842 for additional information.
Packaging validation was performed in accordance with ISO 11607-1:2019 and provided in a previous submission for the Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (K220842). The modifications to the subject device do not affect the packaging of the device; therefore the packaging validation for the predicate device are valid for the subject device. Refer to K220842 for additional information.
Performance testing in accordance with the special controls of 21 CFR 870.4360 was performed with the subject device (CP20V-NG). Such testing included:
- Operating Parameters,
- Dynamic Blood Damage,
- Heat Generation,
- Air Entrapment,
- Mechanical Integrity, and
- Durability/Reliability.

Performance data confirmed that the subject device is equivalent to the predicate device and any differences in the device do not raise new questions of safety or effectiveness.

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Animal Study

No animal studies have been performed to support the substantial equivalence determination of this 510(k).

CLINICAL TESTING

No clinical studies have been performed to support the substantial equivalence determination of this 510(k).

VIII. CONCLUSIONS

Based on the intended use, main technological characteristics, and results of testing, the Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is substantially equivalent to the predicate device (K220842).

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.