The Quantum Mini Ventilation Module is intended to provide independently regulated O2 outputs for a controlled flow of O2 into the ECC circuit. The Quantum Mini Ventilation Module is an accessory that works with the Quantum workstation.

The following parameters are provided by the Quantum Mini Ventilation Module:

· Control of gas flow (02)

· Extracorporeal gas flow measurements for O2

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

Device Description

The Quantum Mini Ventilation Module is a gas control unit that is intended to provide independently regulated oxygen outputs for a controlled flow for procedures involving an extracorporeal circuit.

The Quantum Mini Ventilation Module provides a simplified patient ventilation capability. The device consists of a single O2 input port that receives oxygen from the hospital infrastructure and two (2) oxygen outputs that are designed to provide O2 sweep and pO2 Reg.

The device interfaces with and is powered by any model of the Quantum workstation. The Quantum Mini Ventilation Module does not contain any user interface; instead, all measurements are displayed on the Quantum workstation.

AI/ML Overview

This is a summary of the acceptance criteria and study information for the Quantum Mini Ventilation Module, based on the provided FDA 510(k) summary.

Note: This device is a cardiopulmonary bypass gas control unit, which typically involves engineering performance testing rather than studies involving AI algorithms or human reader performance with medical images. Therefore, many of the requested fields related to AI, medical image analysis, and expert consensus for ground truth are not applicable to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (if quantifiable)	Reported Device Performance (Summary from Non-Clinical Testing)
Electrical Safety	Not explicitly detailed in the document.	Testing performed; results support substantial equivalence.
Electromagnetic Compatibility (EMC)	Not explicitly detailed in the document.	Testing performed; results support substantial equivalence.
Hardware Testing	Not explicitly detailed in the document.	Testing performed; results support substantial equivalence.
Software Verification and Validation	Not explicitly detailed in the document.	Testing performed; results support substantial equivalence.
Functional Performance	Independently regulated O2 outputs; controlled flow of O2; extracorporeal gas flow measurements for O2.	Achieves intended outputs and measurements. Differences from predicate (e.g., fewer gas supplies, no vacuum management) do not raise new safety/effectiveness issues.
Intended Use	To provide independently regulated O2 outputs for a controlled flow of O2 into the ECC circuit. Works with Quantum workstation.	Meets the stated indications for use.

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

Sample Size: Not applicable in the context of a "test set" for an AI algorithm or medical image data. The testing described is engineering performance testing of hardware and software.
Data Provenance: Not applicable. The testing is internal engineering and software validation.

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

Not applicable. This is not an AI/image-based device where expert consensus on "ground truth" for a test set is typically established.

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

Not applicable. This is not an AI/image-based device requiring an adjudication method for a test set.

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 medical device for controlling gas flow in cardiopulmonary bypass, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a hardware module with embedded software for control and measurement, not a standalone AI algorithm. It operates under the control of an experienced and trained clinician via the Quantum workstation.

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

Ground Truth Type: For engineering performance testing, the "ground truth" refers to established engineering standards, specifications, and validated measurement techniques ensuring the device functions as designed and meets regulatory requirements for safety and performance (e.g., accurate flow measurements against calibrated instruments, electrical safety compliance, EMC compliance).

8. The sample size for the training set:

Not applicable. This device does not use a "training set" in the machine learning sense. Software development involves verification and validation against requirements and design specifications.

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

Not applicable. This device does not have a "training set" in the machine learning sense.

Summary

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May 4, 2021

Spectrum Medical Ltd. Colleen Powell Director, Regulatory Affairs Harrier 4, Meteor Business Park, Cheltenham Road East Gloucestershire, Gloucester GL29QL United Kingdom

Re: K210669

Trade/Device Name: Quantum Mini Ventilation Module Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiopulmonary Bypass Gas Control Unit Regulatory Class: Class II Product Code: DTX Dated: March 4, 2021 Received: March 5, 2021

Dear Colleen Powell:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Assistant Director (Acting) 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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March 4.

2021

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K210669

Device Name Quantum Mini Ventilation Module

Indications for Use (Describe)

The following parameters are provided by the Quantum Mini Ventilation Module:

· Control of gas flow (02)

· Extracorporeal gas flow measurements for O2

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

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

510(k) Summary

I. SUBMITTER

Name:	Spectrum Medical Ltd
Address:	Harrier 4, Meteor Business ParkCheltenham Road EastGloucester GL2 9QLUnited Kingdom
Contact Person:	Colleen Powell, Director of Regulatory Affairs
Phone:	+44 (0) 1242 387082
Fax:	+44 (0) 8452 808 127
Date Summary Prepared:	March 4, 2021
II. DEVICE
Proprietary Name:	Quantum Mini Ventilation Module
Common Name:	Gas control unit for heart lung machine
Classification Name:	Gas Control Unit, Cardiopulmonary Bypass (21 CFR 870.4330)
Regulatory Class:	II
Product Code:	DTX
Panel:	Office of Health Technology 2 (OHT2 Cardiovascular Devices) /Division of Health Technology 2B (Circulatory Support, Structuraland Vascular Devices)

III. PREDICATE DEVICE

The predicate device for this submission is Spectrum Medical Ltd.'s Quantum Ventilation Module (K202733).

This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

The Quantum Mini Ventilation Module is a gas control unit that is intended to provide independently regulated oxygen outputs for a controlled flow for procedures involving an extracorporeal circuit.

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SpectrumMedical

V. INTENDED USE / INDICATIONS FOR USE

The following parameters are provided by the Quantum Mini Ventilation Module:

. Control of gas flow (O2)
Extracorporeal gas flow measurements for O2 .

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

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed Quantum Mini Ventilation Module and cleared Quantum Ventilation Module have the same intended use as both are designed to monitor parameters in extracorporeal circuits and provide gas delivery to the oxygenator. Both devices have the same manufacturer, clinical application, clinical setting, target user and target patient population. Both devices are powered by and display measurements on the Quantum workstation. Both devices are part of the gas line to the oxygenator in an extracorporeal circuit and can measure oxygen flow.

However, the proposed Quantum Mini Ventilation Module only has one gas supply (oxygen) compared to three gas supplies with the cleared device. The proposed device does not have vacuum management functionality and cannot provide any physiological measurements like the cleared Quantum Ventilation Module. Furthermore, the proposed device does not have a display and can only be controlled by the Quantum workstation, while the predicate device has rotary knobs and touchscreen display which can be used for control.

The proposed Quantum Mini Ventilation Module is substantially equivalent with regards to intended use, technology, and performance specifications to the currently cleared Quantum Ventilation Module. The differences between the devices 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 Mini Ventilation Module to the Quantum Ventilation Module (QVM2).

The following non-clinical testing was performed to support the substantial equivalence of the Quantum Mini Ventilation Module to the legally marketed predicate device:

. Electrical safety
Electromagnetic compatibility (EMC) ●
Hardware testing
Software verification and validation ●

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SpectrumMedical

VIII. PERFORMANCE DATA – CLINICAL TESTING

No clinical data were submitted to support the substantial equivalence of the Quantum Mini Ventilation Module to the Quantum Ventilation Module.

IX. CONCLUSIONS

Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to the predicate device, the Quantum Mini Ventilation Module has been shown to be substantially equivalent to a legally marketed predicate device.

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).