The Quantum Ventilation Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Ventilation Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Ventilation Module include:

· Measurement of up to three blood flow channels and arterial and venous flow differential
Indication of gas bubbles
· Extracorporeal gas flow measurements (02, CO2, gas flow, and CO2 removal)
· Predicted PO2 and PCO2
· Temperature
· Up to three circuit pressure channels
· Reservoir level indication
Two channels of vacuum
· Blend and control gas flow (air/O2/CO2)

The Quantum Ventilation Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

Device Description

The Quantum Ventilation Module provides gas blending and continuous non-invasive monitoring of critical clinical parameters in extracorporeal circuits used in cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) procedures. The Quantum Ventilation Module is an accessory to the Quantum Workstation or can be used in place of the Quantum Diagnostic Module as part of the Quantum Pump Console. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Ventilation Module is known as the Quantum Ventilation System.

The Quantum Ventilation Module performs five functions:

1. Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator.
1. Provides measurements from attached sensors for blood flow, bubble detection, pressure, level and temperature to monitor an extracorporeal blood loop.
1. Provides gas blending to ensure the precision delivery of FiO₂ (21 to 100%), CO₂ and sweep flow rates.
1. Provides regulation of vacuum supply to provide two channels of vacuum. One is flow-regulated to remove waste anesthesia gas, the other pressure-regulated for applications including Vacuum-Assisted Venous Drainage (VAVD) and hemoconcentration.
1. Sends these physiological measurements to the Quantum Workstation for display to the user.

The Quantum Ventilation Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics, in addition to performing electronic gas blending of up to three gases and built-in vacuum management for the removal of waste anesthetic gas. The primary interface for controlling and displaying measurements is the Quantum Workstation: however, the Quantum Ventilation Module also contains a display with control knobs. The Quantum Ventilation Module only works with the Quantum Workstation.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called the Quantum Ventilation Module. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA) application.

Therefore, the document does not describe a study involving an AI algorithm or meeting the typical acceptance criteria for AI/ML device performance. Instead, it focuses on non-clinical performance data to demonstrate the device's functionality and safety as a medical instrument.

Given this context, I will address the questions to the best of what can be inferred from the provided text, noting where the information is absent due to the nature of a 510(k) submission for a non-AI hardware device.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for a Hardware Device)

The document primarily discusses non-clinical performance data, which are typically tests to ensure the device performs as intended and is safe. The "acceptance criteria" here are implied by the successful completion of these tests.

1. A table of acceptance criteria and the reported device performance

Since this is a hardware device (Ventilation Module) and not an AI algorithm, the acceptance criteria are not in terms of common AI metrics like sensitivity, specificity, or AUC, nor is there comparative effectiveness data against human readers. The criteria are related to the device's physical and electronic performance, along with its software validation. The document states:

Acceptance Criteria Category (Implied)	Reported Device Performance Summary (as per document)
Electrical Safety	Non-clinical testing performed to support substantial equivalence. (Implies successful completion.)
Electromagnetic Compatibility (EMC)	Non-clinical testing performed to support substantial equivalence. (Implies successful completion.)
Electrosurgery Interference	Non-clinical testing performed to support substantial equivalence. (Implies successful completion.)
Hardware Testing (Printed Circuit Boards)	Non-clinical testing performed to support substantial equivalence. (Implies successful completion.)
Software Verification and Validation	Non-clinical testing performed to support substantial equivalence. (Implies successful completion.)
Usability Validation	Non-clinical testing performed to support substantial equivalence. (Implies successful completion.)
Diagnostic Measurements Accuracy (e.g., flow, pressure, temperature, gas)	"Equivalent sensor performance" to the predicate device (Quantum Diagnostic Module K173591) is claimed, implying accuracy meets established standards for these parameters.
Gas Blending Precision (FiO₂, CO₂, sweep flow rates)	Claimed to "ensure the precision delivery" of these parameters.
Vacuum Regulation	Provides "regulation of vacuum supply."

2. Sample size used for the test set and the data provenance

This information is not applicable in the context of an "AI test set" here. The "test set" would refer to the physical units of the device subjected to non-clinical tests. The tests performed ("Electrical safety", "Electromagnetic compatibility", "Electrosurgery interference", "Hardware testing of printed circuit boards", "Software verification and validation", "Usability validation") are typically laboratory-based engineering and software validation tests. The document does not specify the number of units tested, the conditions, or the specific "data provenance" (e.g., country of origin) beyond the manufacturer being in the UK. These are not data-driven performance studies on patient cohorts.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as this is a hardware device. Ground truth, in the context of AI, refers to annotated data. For a hardware device, "ground truth" might refer to established measurement standards or known physical properties used for calibration and validation of sensors. The document does not specify the number or qualifications of experts involved in these engineering validation processes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among human readers for image labeling or clinical decision-making ground truth in AI studies. For hardware testing, performance is measured against engineering specifications and industry standards, not through expert adjudication in this manner.

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. This is a hardware medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant, and the concept of human readers improving with AI assistance does not apply.

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

This refers to an AI algorithm's performance. The Quantum Ventilation Module is a hardware device with embedded software, but it's not an AI algorithm that makes diagnostic decisions or interpretations in the way this question implies. Its performance is the measurement and control capabilities of the instrument itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a hardware device, the "ground truth" for non-clinical performance validation would be derived from:

Engineering specifications and design documents.
International and national standards for electrical safety, EMC, and medical device performance (e.g., IEC standards).
Calibration standards for sensors (e.g., precision gas mixes, flow simulators, temperature baths, pressure gauges).
Bench testing and physical measurements.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model trained on a dataset. It's a hardware device with firmware.

9. How the ground truth for the training set was established

Not applicable. As there is no "training set" in the AI sense, this question is not relevant. The "ground truth" for developing the device's functionality would stem from engineering principles, clinical requirements for extracorporeal circulation, and established medical device design practices.

Summary

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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.

October 18, 2018

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

Re: K181942

Trade/Device Name: Quantum Ventilation Module Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiopulmonary Bypass Gas Control Unit Regulatory Class: Class II Product Code: DTX Dated: July 19, 2018 Received: July 20, 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. 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

Fernando Aguel
-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181942

Device Name Quantum Ventilation Module Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Indications for Use (Describe)

· Measurement of up to three blood flow channels and arterial and venous flow differential
Indication of gas bubbles
· Extracorporeal gas flow measurements (02, CO2, gas flow, and CO2 removal)
· Predicted PO2 and PCO2
· Temperature
· Up to three circuit pressure channels
· Reservoir level indication
Two channels of vacuum
· Blend and control gas flow (air/O2/CO2)

The Quantum Ventilation Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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SpectrumMedical

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: July 19, 2018

II. DEVICE

Proprietary Name:	Quantum Ventilation Module
Common Name:	Gas blender for heart lung machine
Classification Name:	Gas Control Unit, Cardiopulmonary Bypass(21 CFR 870.4300)
Regulatory Class:	II
Product Code:	DTX
Panel:	Office of Device Evaluation (ODE) /Division of Cardiovascular Devices (DCD)Circulatory Support Devices Branch (CSDB)

III. PREDICATE DEVICES

The primary predicate device is Spectrum Medical's Quantum Diagnostic Module (K173591) and an additional predicate device is LivaNova's Stöckert Gas Blender (K101046).

These predicates have not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

Traditional 510(k) Application July 19, 2018 Quantum Ventilation Module 510(k) Summary

K181942 Page 1 of 4

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Spectrum Medical

Traditional 510(k) Application July 19, 2018 Quantum Ventilation Module 510(k) Summary

combination of the Quantum Workstation and Quantum Ventilation Module is known as the Quantum Ventilation System.

The Quantum Ventilation Module performs five functions:

1. Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator.
1. Provides measurements from attached sensors for blood flow, bubble detection, pressure, level and temperature to monitor an extracorporeal blood loop.
1. Provides gas blending to ensure the precision delivery of FiO₂ (21 to 100%), CO₂ and sweep flow rates.
1. Provides regulation of vacuum supply to provide two channels of vacuum. One is flow-regulated to remove waste anesthesia gas, the other pressure-regulated for applications including Vacuum-Assisted Venous Drainage (VAVD) and hemoconcentration.
1. Sends these physiological measurements to the Quantum Workstation for display to the user.

V. INTENDED USE / INDICATIONS FOR USE

. Measurement of up to three blood flow channels and arterial and venous flow differential
. Indication of gas bubbles
. Extracorporeal gas flow measurements (O2, CO2, gas flow, and CO2 removal)
o Predicted PO2 and PCO2
o Temperature
. Up to three circuit pressure channels
. Reservoir level indication
. Two channels of vacuum
. Blend and control gas flow (air/O2/CO2)

The Quantum Ventilation Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

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SpectrumMedical

Traditional 510(k) Application July 19, 2018 Quantum Ventilation Module 510(k) Summary

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The Quantum Ventilation Module, the Quantum Diagnostic Module and the Stöckert Gas Blender have the same intended use as all are designed to monitor critical parameters in extracorporeal circuits. All three devices have the same clinical application, clinical setting, target user and target patient population and are powered from another device via cable.

Spectrum Medical Ltd's Quantum Diagnostic Module and Quantum Ventilation Module also have the same manufacturer, same diagnostic measurements, equivalent sensor performance and same principal of operation of its sensors. The Quantum Diagnostic Module does not have a display nor can it blend gas or perform vacuum management.

The Quantum Ventilation Module and the Stockert Gas Blender both blend gas electronically and can blend air, oxygen and carbon dioxide. Both devices are part of the gas line to the oxygenator in an extracorporeal circuit and can display information on the module or a separate display. The Quantum Ventilation Module can make diagnostic measurements of blood flow, bubble detection, circuit pressure, blood reservoir level, and temperature while the Stöckert Gas Blender cannot. The Quantum Ventilation Module also has two vacuum channels while the Stöckert Gas Blender has none.

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 Ventilation Module to the Quantum Diagnostic Module and Stöckert Gas Blender. The following non-clinical testing was performed to support the substantial equivalence of the Quantum Ventilation Module to the predicate devices:

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

VIII. PERFORMANCE DATA - CLINICAL TESTING

No clinical data were submitted to support the substantial equivalence of the Quantum Ventilation Module to the Quantum Diagnostic Module and Stöckert Gas Blender.

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SpectrumMedical

Traditional 510(k) Application July 19, 2018 Quantum Ventilation Module 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 Ventilation Module has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 870.4300 Cardiopulmonary bypass gas control unit.

(a)
Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.(b)
Classification. Class II (performance standards).