The Quantum Pump Console is indicated for use for up to 6 hours in cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Device Description

The Quantum Pump Console is a configurable heart-lung machine consisting of various components controlled by a central workstation. The system is intended to be used in any surgery in which the patient's blood is being oxygenated extracorporeally. The modular system consists of a frame, power supply with battery backup, roller pumps, pump control module, diagnostic module and a central workstation with the user interface.

The roller pumps are available in three sizes (4", 6" and 8") and can be controlled via a centralized interface on the Quantum Workstation touchscreen or through the Quantum Pump Console, which contains five knobs and displays in one integrated console.

AI/ML Overview

This document is a 510(k) summary for the Quantum Pump Console, a heart-lung machine. It determines substantial equivalence to a predicate device, the Stöckert S5 System.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for a specific clinical or diagnostic task in the way one might expect for an AI/ML diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device.

The performance data presented is primarily focused on non-clinical testing to ensure the device performs safely and effectively in its intended function, similar to the predicate.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Safety and Effectiveness Equivalence: The Quantum Pump Console must demonstrate that differences in technological characteristics from the predicate device (Stöckert S5 System) do not raise new issues of safety or effectiveness. This is assessed by having the same intended use/indications for use, clinical setting, target patient population, principle of operation for the pumps, and same pump speed and accuracy.	The Quantum Pump Console performs the same intended use/indications for use as the S5 System. It operates in the same clinical setting, targets the same patient population, utilizes the same principle of operation for the pumps, and exhibits the same pump speed and accuracy. The differences (centralized touchscreen vs. multiple screens, centralized control module vs. individual pump knobs) are stated not to raise new safety or effectiveness concerns.
Electrical Safety: Compliance with relevant standards for electrical safety.	"Electrical safety" testing was performed. (Specific standards or results are not detailed in this summary, but the general statement implies compliance).
Electromagnetic Compatibility (EMC): Compliance with relevant standards for EMC.	"Electromagnetic compatibility (EMC)" testing was performed. (Specific standards or results are not detailed).
Electrosurgery Interference: Demonstrates proper function and safety in the presence of electrosurgical equipment.	"Electrosurgery interference" testing was performed. (Specific standards or results are not detailed).
Hardware Functionality: Ensures proper operation of printed circuit boards.	"Hardware testing of printed circuit boards" was performed. (Specific tests or results are not detailed).
Software Verification and Validation: Ensures software functions as intended and meets specifications.	"Software verification and validation" was performed. (Specific tests, methodologies, or results are not detailed).

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

This document does not describe a "test set" in the context of clinical data for AI/ML performance. The testing performed is physical/electrical/software verification and validation of the device itself.

Sample Size for Test Set: Not applicable in the context of clinical/diagnostic performance testing using patient data. The testing involved verification and validation activities on the device hardware and software.
Data Provenance: Not applicable for patient data. The non-clinical tests were likely conducted in a laboratory or manufacturing setting.

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

Not applicable. The ground truth for the non-clinical tests is based on engineering specifications, regulatory standards, and expected device behavior, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. The non-clinical tests involve objective measurements against predefined specifications, not expert adjudication of ambiguous cases.

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

No MRMC comparative effectiveness study was performed or described. This is not an AI-assisted diagnostic device, but a medical device (heart-lung machine console) where the focus is on its physical and software functionality and safety compared to a predicate.

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

This question is not applicable. The Quantum Pump Console is not an algorithm-only device. It's a hardware system with integrated software, intended to be operated by a qualified medical professional. Its performance is always with a human-in-the-loop.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be:

Engineering specifications and design requirements: For hardware and software functionality.
Regulatory standards: For electrical safety, EMC, and other performance characteristics.
Predicate device's known performance characteristics: To establish equivalence in pump speed, accuracy, and overall operational principles.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning in a way that requires a "training set" of patient data.

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

Not applicable, as no training set (in the context of AI/ML) was used.

Summary

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May 25, 2018

Spectrum Medical Ltd Mark Drain Chief Financial Officer Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GL2 9QL GB

Re: K173834

Trade/Device Name: Quantum Pump Console Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II Product Code: DTQ Dated: April 24, 2018 Received: April 25, 2018

Dear Mark Drain:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173834

Device Name Quantum Pump Console

Indications for Use (Describe)

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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SpectrumMedical

K173834 page 1 of 3 Quantum Pump Console 510(k) Summary

I. SUBMITTER

Spectrum Medical Ltd Harrier 4, Meteor Business Park Cheltenham Road East Gloucester GL2 9QL United Kingdom

Phone: +44 (0) 1242 650 120 Fax: +44 (0) 8452 808 127

Contact Person: Mr. Mark Drain, Chief Financial Officer Date Summary Prepared: December 15, 2017

II. DEVICE

Proprietary Name:	Quantum Pump Console
Common Name:	Heart-Lung Machine
Classification Name:	Console, Heart-Lung Machine, Cardiopulmonary Bypass(21 CFR 870.4220)
Regulatory Class:	II
Product Code:	DTQ
Panel:	Office of Device Evaluation (ODE) /Division of Cardiovascular Devices (DCD)Circulatory Support Devices Branch (CSDB)

III. PREDICATE DEVICE

Stöckert S5 System (K060053) currently marketed by LivaNova

IV. DEVICE DESCRIPTION

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V. INTENDED USE / INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Spectrum Medical Ltd's Quantum Pump Console and LivaNova's S5 System have the same intended use/indications for use, clinical setting, target patient population, principle of operation for the pumps and same pump speed and accuracy.

Whereas the S5 System uses multiple screens for its interface and each pump has an individual screen, the Quantum Pump Console uses a single, centralized touchscreen interface. The S5 System can only control the pumps with a rotating knob on each pump while the Quantum Pump Console can control the pumps with its centralized user interface or with rotating knobs on a single integrated pump control module.

These differences in technological characteristics do not raise new issues of safety or effectiveness.

VII. PERFORMANCE DATA - NON-CLINICAL TESTING

No animal testing was submitted to support the substantial equivalence of the Quantum Pump Console to the S5 System. The following non-clinical testing was performed to support the substantial equivalence of the Quantum Pump Console to the S5 System:

. Electrical safety
. Electromagnetic compatibility (EMC)
. Electrosurgery interference
Hardware testing of printed circuit boards
Software verification and validation .

VIII. PERFORMANCE DATA - CLINICAL TESTING

No clinical data were submitted to support the substantial equivalence of the Quantum Pump Console to the S5 System.

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SpectrumMedical

Quantum Pump Console 510(k) Summary

IX. CONCLUSIONS

Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Pump Console has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 870.4220 Cardiopulmonary bypass heart-lung machine console.

(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).