The intended use of the Quantum Workstation is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation is configured to measure and display the following measurements:

SaO2 Arterial Saturation (%)
Venous Saturation (%) Sv02
Hb Hemoglobin (g/L and gm/dl)
Calculated Hematocrit (%) Hct

The Workstation provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.

The Workstation's monitoring and alarm functionality does not directly control patient care. The User makes clinical judgments regarding the treatment of the patient as a result of information displayed by the Workstation.

Device Description

The Quantum Workstation is an online, cardiopulmonary bypass, blood gas monitor. It is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels.

The Quantum Workstation consists of a pole-mounted 14 ¾" portrait high definition touch screen. The touch screen displays individual and trend readings with alarm settings. Third party data may also be displayed (without alarms). The Quantum Workstation has a Wi-Fi adapter and provides memory storage via an SD (Secure Digital) card. The Quantum Workstation is powered from the AC Mains supply and also incorporates a battery backup that automatically switches on in the event of an interruption to the mains power supply. The battery backup is provided via two (2) lithium-ion batteries with a two-hour minimum life.

The Quantum Workstation includes the following ports / connections:

. One (1) sensor port for the Hb / SO2 sensor
One (1) LAN / Ethernet port
. Three (3) USB 2.0 ports
Eight (8) additional LAN ports described as SAP (Spectrum Accessory Ports) to . support a range of Spectrum Medical manufactured modules - these are for future use

Accessories for the Quantum Workstation include the power supply, mounting arm (long or short), and Hb / SO2 sensor. Different Hb / SO2 sensors are available based on the diameter and thickness of the extracorporeal tubing.

AI/ML Overview

The provided text does not contain a detailed description of acceptance criteria for a specific device performance and a study proving it meets these criteria. Instead, it is an FDA 510(k) summary for the "Quantum Workstation," a blood gas monitor. The summary focuses on demonstrating substantial equivalence to a predicate device (M2 Monitor) rather than presenting a performance study against predefined acceptance criteria.

Specifically, the document states:
"In vitro testing was performed to confirm, as shown in Table A, that the SO2 and Hb (with calculated Hct) functional performance for the Quantum Workstation was unchanged from the M2 Monitor."
And further:
"No clinical data were submitted to support the substantial equivalence of the Quantum Workstation to the M2 Monitor."

This indicates that the "performance data" provided refers to the comparison of the Quantum Workstation's functional performance to its predicate device, the M2 Monitor, and not to a study against explicit acceptance criteria with detailed statistical analysis.

However, Table A (on Pages 6 and 7) does provide some performance specifications for the predicate device, which the new device is stated to have "Same" performance as. These can be inferred to be the de-facto performance metrics considered in the comparison:

1. Table of Acceptance Criteria (Inferred from Predicate Performance) and the Reported Device Performance:

Parameter	Acceptance Criteria (Predicate Performance)	Reported Device Performance (Quantum Workstation)
SO2	Range = 20-100%	Same
	Range Temperature = 15-37°C	Same
	Mean Offset = 0.48	Same
	Standard Deviation = ±1.90	Same
Hb / Hct	Range: 5-15 g/dL / 15-45% (for 9/16" OD tube size)	Same
	Range: 5-16.6 g/dL / 15-50% (for other sensors)	Same
	Range Temperature = 15-37°C	Same
	Mean Offset = 0.03	Same
	Standard Deviation = ±0.60	Same

Additional context: The document states that the new device uses an "equivalent Hb / SO2 sensor to M2 Monitor" with "improved electrical isolation and different colored cable boot," which likely contributes to the "Same" performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "In vitro testing was performed" for SO2 and Hb performance. However, it does not specify the sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The performance comparison is stated to be against the M2 Monitor's established performance, implying the predicate device itself serves as the reference, rather than independent expert-established ground truth.

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

This information is not provided in the document.

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

The document describes a medical monitoring device, not an AI-assisted diagnostic tool for human readers. Therefore, no MRMC comparative effectiveness study was performed or is relevant in this context. The device provides "monitoring information to trained clinicians" and "The User makes clinical judgments regarding the treatment of the patient as a result of information displayed by the Workstation," indicating it's a data display tool for clinicians, not an AI to improve human reader performance.

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

The entire performance evaluation, as described, is essentially a standalone (algorithm only) performance comparison against the predicate device's established specifications. The device continuously monitors and displays measurements without requiring human input for its core measurement function.

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

The "ground truth" for the new device's performance comparison was the established functional performance of the predicate device (M2 Monitor), as detailed in Table A. For blood gas monitors, this typically involves laboratory reference methods for SO2, Hb, and Hct, but the document does not elaborate on how the M2 Monitor's original performance metrics were established. It simply states the new device's performance was "unchanged from the M2 Monitor."

8. The sample size for the training set

The document does not describe the Quantum Workstation as an AI/ML device that requires a "training set." Its function is based on optical measurement principles. Therefore, no training set is mentioned or applicable in the context of this device's stated technology.

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

As there is no training set, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 18, 2017

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

Re: K163657

Trade/Device Name: Quantum Workstation Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiopulmonary bypass on-line blood gas monitor Regulatory Class: Class II Product Code: DRY Dated: December 16, 2016 Received: December 23, 2016

Dear Mr. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Willemsen
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)

K163657

Device Name Quantum Workstation

Indications for Use (Describe)

SaO2 Arterial Saturation (%)
Venous Saturation (%) Sv02
Hb Hemoglobin (g/L and gm/dl)
Calculated Hematocrit (%) Hct

The Workstation provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.

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)

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510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.

510(k) Number: K163657

I. SUBMITTER

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

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

Contact Person: Mr. Mark Drain, Chief Financial Officer

Date Summary Prepared: January 17, 2017

II. DEVICE

Proprietary Name:	Quantum Workstation
Common Name:	Blood Gas Monitor
Classification Name:	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass(21 CFR 870.4330)
Regulatory Class:	II
Product Code:	DRY
Panel:	Office of Device Evaluation (ODE) /Division of Cardiovascular Devices (DCD)Circulatory Support Devices Branch (CSDB)

III. PREDICATE DEVICE

Spectrum Medical Ltd's M2 Monitor (K071725)

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

No reference devices were used in this submission.

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IV. DEVICE DESCRIPTION

The Quantum Workstation includes the following ports / connections:

. One (1) sensor port for the Hb / SO2 sensor
One (1) LAN / Ethernet port
. Three (3) USB 2.0 ports
Eight (8) additional LAN ports described as SAP (Spectrum Accessory Ports) to . support a range of Spectrum Medical manufactured modules - these are for future use

V. INTENDED USE / INDICATIONS FOR USE

SaO2	Arterial Saturation (%)
SvO2	Venous Saturation (%)
Hb	Hemoglobin (g/L and gm/dl)
Hct	Calculated Hematocrit (%)

The Workstation provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

As shown in Table A, Spectrum Medical Ltd's M2 Monitor and Quantum Workstation have the same manufacturer, intended use, clinical application, clinical setting / site of user, target patient population, and principle of operation / mechanism of operation / fundamental scientific technology. They also have the same performance for SO2, Hb, and Hct. They both display individual and trend readings with alarm settings and don't require recalibration due to negligible drift. They both have a Wi-Fi adapter, Ethernet port, and SD card memory storage. They both run on line power with battery backup available. They both are also compatible with the intended environment and with other devices.

Spectrum Medical Ltd's M2 Monitor and Quantum Workstation differ in that the Quantum Workstation has a larger touch screen display, has additional USB and LAN ports, allows for display of 3%-party data without alarms, and provides additional graphs with a pinch action feature for graph resizing. The M2 Monitor uses three nickel hydride batteries to provide an ~1hour battery life whereas the Quantum Workstation uses two lithium-ion batteries to provide a 2hour minimum battery life.

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Device	Predicate Device	Proposed Device
Name	M2 Monitor	Quantum Workstation
510(k) Number	K071725	To be assigned
Manufacturer	Spectrum Medical LtdGloucester, England	Same
Intended Use	Extracorporeal monitoring ofblood oxygen saturation,haematocrit and haemoglobinlevels	Same
Clinical Application	Online monitoring ofextracorporeal arterial andvenous blood lines, andhematocrit and hemoglobin levelsusing sensor probes attached tothe external surface of bloodtubing	Same
Clinical Setting /Sites of Use	Hospital	Same
Target user	Perfusionist	Same
Target patientpopulation	Patients (all ages, both genders)undergoing extracorporealcirculation	Same
Principal of Operation/ Mechanism ofAction	Comparison of the differentpatterns of absorbance of visiblelight reflected from oxy and deoxyforms of hemoglobin	Same
Blood oxygensaturation(SO2 %)	Single synchronization withreference blood gas analyzer;independent of blood flow, bloodtemperature, and hemodilution	Device uses equivalent Hb /SO2 sensor to M2 Monitor (hasimproved electrical isolation anddifferent colored cable boot)
Principal of Operation/ Mechanism ofActionHemoglobin (Hb) /Hematocrit (Hct)	Measures hemoglobinconcentration by transmittinginfrared light through the bloodtube and quantifying the level ofsignal attention with a photodiodeCalculates hematocrit fromhemoglobin measurement	Device uses equivalent Hb /SO2 sensor to M2 Monitor (hasimproved electrical isolation anddifferent colored cable boot)
Device	Predicate Device	Proposed Device
Performance	SO2Range = 20-100%Range Temperature = 15-37°CMean Offset = 0.48Standard Deviation = ±1.90	Same
	Hb / HctRange:5-15 g/dL / 15-45%(for 9/16" OD tube size)5-16.6 g/dL / 15-50%(for all other sensors: 5/16",3/8", 7/16" OD tube size)Range Temperature = 15-37°CMean Offset = 0.03Standard Deviation = ±0.60
Human Factors	Touch screen display showingindividual and trend readings withalarm settingsFlash memory storage forrecording case historyNo recalibration required due tonegligible drift	Same general human factorsfeaturesAlso allows for display of 3rd-party data without alarms
Touchscreen	10.4" landscape	15" portrait
Design	Compact, lightweight, polemounted on clamp	Same general design featuresSmall differences in weight andpole clamp design
Compatibility withIntendedEnvironments	Used in surgical environmentsand conforms to 60601 electricalsafety and EMC requirementsCompliant with 2nd edition IEC60601 (and 3rd edition in a laterupdate)	Same general electricalcompatibility featuresCompliant with 3rd edition IEC60601
Battery Backup	One-hour life via three NickelHydride batteries	Two-hour minimum life via twoLithium-Ion batteries
Wireless Connectivity	Wi-Fi and Bluetooth	Wi-Fi
Wired Connectivity	2 USB / 3 Accessory Ports	3 USB / 8 Spectrum AccessoryPorts (SAPs)(Allows connectivity to 3rd-partydevices for data display /graphing; alarms are notassociated with these data)SAPs are for future use
Disposable /Reusable	Not applicable(No patient-contacting parts)	Same
Device	Predicate Device	Proposed Device
FDA-RecognizedStandards Met	Electrical Safety:With 510(k) submission:IEC 60601-1 2nd Edition 1988 withA1:1991 and A2:1995 includingrelevant clauses of IEC 60601-2-49:2001 clauses 5, 6, 14, 17, 19,20, 44, 49 & 56	Electrical Safety:AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012including relevant clauses ofIEC 60601-2-49:2011
	Updated in 2013:IEC 60601-1 3rd Edition;UL 60601-1/CAN/CSA C22.2 No.601.1
	Electromagnetic Compatibility:With 510(k) submission:IEC 60601-1-2:2001 Clause 36only (EMC)	Electromagnetic Compatibility:IEC 60601-1-2:2014
	Updated in 2013:IEC 60601-1-2:2007
	Other:IEC 60601-1-8:2006IEC 62133:2002AAMI ANSI IEC 62304:2006ISO 14971:2000 + A1:2003Updated in 2013:ISO 14971:2007	Other:IEC 60601-1-6:2010 + A1:2013IEC 60601-1-8:2006 + A1:2012IEC 62133:2012AAMI ANSI IEC 62304:2006IEC 62366:2007+A1:2014ISO 14971:2007

Table A: Comparison Table, M2 Monitor vs. Quantum Workstation

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VII. PERFORMANCE DATA - NON-CLINICAL TESTING

No animal testing was submitted to support the substantial equivalence of the Quantum Workstation to the M2 Monitor.

The following bench performance testing was performed to support the substantial equivalence of the Quantum Workstation to the M2 Monitor:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing, including defibrillator protection and electrosurgery interference requirements, were conducted on the Quantum Workstation and its accessories. The system complies with the following safety and emissions standards:

. AAMI ANSI ES60601-1:2005/(R)2012 + A1:2012
IEC 60601-1-2:2014 .
IEC 60601-1-6:2010 + A1:2013 .
IEC 60601-1-8:2006 + A1:2012 .
. IEC 60601-2-49:2011

Mechanical testing

In addition to the mechanical tests included in the 60601 tests, the following mechanical tests were performed on the Quantum Workstation:

. screen impact test for the touch screen,
. effects of cleaning products on the enclosure material and labels / markings, and
. product function after exposure to non-operational (storage and transport) environmental requirement extremes of temperature and humidity.

Software verification and validation testing

The software for the Quantum Workstation and its predicate, M2 Monitor, were determined to be Class B software (non-serious injury is possible) per IEC 62304:2006 because, if the M2 Monitor or Quantum Workstation display faulty or incorrect data, clinicians will rely on other medical devices in the operating room to confirm the diagnostic values. Therefore, there are no risks of death or serious injury possible from the device's software.

System-level and subcomponent-level software verification and validation testing were conducted for the Quantum Workstation.

A usability validation test was also performed for the Quantum Workstation user interface.

SO2 and Hb performance testing

In vitro testing was performed to confirm, as shown in Table A, that the SO2 and Hb (with calculated Hct) functional performance for the Quantum Workstation was unchanged from the M2 Monitor.

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VIII. PERFORMANCE DATA - CLINICAL TESTING

No clinical data were submitted to support the substantial equivalence of the Quantum Workstation to the M2 Monitor.

IX. CONCLUSIONS

There are minor differences between the Quantum Workstation and the predicate device (M2 Monitor) in technological characteristics with regards to battery type and life, touch screen display size, number of USB and LAN ports, pinch action for graph resizing, and display of 3°party data without alarms. However, these differences do not raise new questions of safety or effectiveness. Thus, the device characteristics compared in Table A and the results of the bench performance tests confirm that the Quantum Workstation is substantially equivalent to the M2 Monitor.

Regulation Number and Section

§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.

(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).