(30 days)
The intended use of the Quantum Workstation 12.1" is for the non-invasive continuous monitoring of oxygen saturation and haemotocrit / haemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12.1" is configured to measure and display the following measurements:
SaO2 Arterial Saturation (%)
SvO2 Venous Saturation (%)
Hb Haemogloblin (g/L and gm/dl and mmol/l)
Hct Calculated Haematocrit (%)
The Workstation 12.1" provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
The Workstation 12.1"'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 12.1".
The Quantum Workstation 12.1" 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 12.1" consists of a pole-mounted 12.1" landscape high definition touch screen. The touch screen displays individual and trend readings with alarm settings. The Quantum Workstation 12.1" has a Wi-Fi adapter and provides memory storage via an SD (Secure Digital) card. The Quantum Workstation 12.1" 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 12.1" 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 12.1" 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.
The Quantum Workstation 12.1" is a medical device for continuous non-invasive monitoring of oxygen saturation and hematocrit/hemoglobin concentration in an extracorporeal circuit during cardiopulmonary bypass. The document provided is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in a clinical setting.
Therefore, the information regarding acceptance criteria and performance is derived from a comparison to the predicate device and non-clinical bench testing, not a clinical study with human subjects demonstrating a specific effect size.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for the Quantum Workstation 12.1" are implicitly defined by its substantial equivalence to the predicate device, the Quantum Workstation (K163657), and adherence to relevant safety and performance standards. The reported device performance, therefore, matches that of the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate Device Performance) | Reported Device Performance (Quantum Workstation 12.1") |
|---|---|---|
| Blood Oxygen Saturation (SO2) | ||
| Range | 20-100% | Same |
| Range Temperature | 15-37°C | Same |
| Mean Offset | 0.48 | Same |
| Standard Deviation | ± 1.90 | Same |
| Hemoglobin (Hb) / Hematocrit (Hct) | ||
| Range (9/16" OD tube size) | 5-15 g/dL / 15-45% | Same |
| Range (other sensors) | 5–16.6 g/dL / 15-50% (for 5/16", 3/8", 7/16" OD tube size) | Same |
| Range Temperature | 15-37°C | Same |
| Mean Offset | 0.03 | Same |
| Standard Deviation | ± 0.60 | Same |
| Electrical Safety | Complies with: AAMI ANSI ES60601-1:2005/(R)2012 + A1:2012, IEC 60601-1-6:2010 + A1:2013, IEC 60601-1-8:2006 + A1:2012, IEC 60601-2-49:2011 | Complies with listed standards |
| EMC | Complies with: IEC 60601-1-2:2014 | Complies with listed standard |
| Mechanical Integrity | Withstands screen impact, resistant to cleaning products, functions after exposure to non-operational temperature and humidity extremes. | Passes all specified mechanical tests |
| Software Integrity | Class B software (non-serious injury possible) per IEC 62304:2006; verification and validation testing completed, with no risks of death or serious injury from faulty/incorrect data. Clinicians will rely on other devices. | Software confirmed as Class B, V&V testing completed |
Study Details
The substantial equivalence determination for the Quantum Workstation 12.1" was based on non-clinical testing (bench performance testing) and a comparison to a predicate device, not a clinical study involving human patients or a test set of clinical data with ground truth experts.
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used. The evaluation was based on bench testing of the physical device and its software.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert-established ground truth was used for a test set as this was not a clinical or AI performance evaluation.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This was a 510(k) submission for a physical medical device, not an AI/imaging diagnostic device requiring MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device provides quantitative measurements, not an algorithmic diagnosis or interpretation that would have standalone performance in the context of AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance characteristics (SO2, Hb/Hct), the "ground truth" was established by comparing the device's measurements to a reference blood gas analyzer for the predicate device. For the 510(k) of the Quantum Workstation 12.1", the ground truth for its performance was effectively the demonstrated performance of the predicate device and compliance with international standards for electrical safety, EMC, and software.
- The sample size for the training set: Not applicable. This device does not use machine learning that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the information provided is typical for a 510(k) submission for a continuous monitoring medical device, focusing on engineering validation, safety, and performance equivalence to a previously cleared predicate, rather than a clinical study evaluating diagnostic accuracy or AI performance in a clinical dataset.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 17, 2018
Spectrum Medical Ltd Colleen Powell Director of Regulatory Affairs Harrier 4. Meteor Business Park, Cheltenham Road East Gloucester, GL2 9OL Gb
Re: K181923
Trade/Device Name: Quantum Workstation 12.1" Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiopulmonary bypass on-line blood gas monitor Regulatory Class: Class II Product Code: DRY Dated: July 13, 2018 Received: July 18, 2018
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/cdrl/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 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) 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 -
Fernando Aguel
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)
Device Name Quantum Workstation 12.1"
Indications for Use (Describe)
The intended use of the Quantum Workstation 12.1" is for the non-invasive continuous monitoring of oxygen saturation and haemotocrit / haemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12.1" is configured to measure and display the following measurements:
SaO2 Arterial Saturation (%) SvO2 Venous Saturation (%) Hb Haemogloblin (g/L and gm/dl and mmol/l) Hct Calculated Haematocrit (%)
The Workstation 12.1" provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
The Workstation 12.1"'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 12.1".
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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510(k) Summary
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.
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: Mrs. Colleen Powell, Director of Regulatory Affairs
Date Summary Prepared:
II. DEVICE
| Proprietary Name: | Quantum Workstation 12.1" |
|---|---|
| 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 Quantum Workstation (K163657) 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 12.1" 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 12.1" consists of a pole-mounted 12.1" landscape high definition touch screen. The touch screen displays individual and trend readings with alarm settings. The Quantum Workstation 12.1" has a Wi-Fi adapter and provides memory storage via an SD (Secure Digital) card. The Quantum Workstation 12.1" 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 12.1" 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 12.1" 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.
V. INTENDED USE / INDICATIONS FOR USE
The intended use of the Quantum Workstation 12.1" is for the non-invasive continuous monitoring of oxygen saturation and haematocrit / haemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12.1" is configured to measure and display the following measurements:
| SaO2 | Arterial Saturation (%) |
|---|---|
| SVO2 | Venous Saturation (%) |
| Hb | Haemoglobin (g/L and gm/dl) |
| Hct | Calculated Haematocrit (%) |
The Workstation 12.1" provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
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The Workstation 12.1"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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
As shown in Table A, Spectrum Medical Ltd's Quantum Workstation (K163657) and Quantum Workstation 12.1" have the same manufacturer, intended use, clinical application, clinical setting / site of use, target 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 Quantum Workstation (K163657) and Quantum Workstation 12.1" differ in that the Quantum Workstation 12.1" has a smaller touch screen display, operates in a landscape orientation, and currently does not allow for pump control on the Spectrum Medical Ltd Quantum Pump Console (K173834)
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| Table A: Comparison Table, Quantum Workstation vs. Quantum Workstation | |||
|---|---|---|---|
| 12.1" |
| Device | Predicate Device | Proposed Device |
|---|---|---|
| Name | Quantum Workstation | Quantum Workstation 12.1" |
| 510(k) Number | K163657 | 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 | |
| Principal of Operation / Mechanism ofAction | Measures hemoglobinconcentration by transmittinginfrared light through the bloodtube and quantifying the level ofsignal attention with a photodiodeCalculates hematocrit fromhemoglobin measurement | Same |
| Haemoglobin (Hb) /Haematocrit (Hct) | ||
| Device | Predicate Device | Proposed Device |
| Performance | SO2Range = 20-100%Range Temperature = 15-37°CMean Offset = 0.48Standard Deviation = $\pm$ 1.90Hb / 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 = $\pm$ 0.60 | Same |
| Human Factors | Touch screen display showingindividual and trend readings withalarm settingsFlash memory storage forrecording case historyNo recalibration required due tonegligible driftAlso allows for display of 3rd-partydata without alarms | Same general human factorsfeatures, however does notcurrently allow 3rd party data todisplay |
| Touchscreen | 15" portrait | 12.1" landscape |
| Design | General design features (weight) | Same general design featuresSmall differences in weight |
| Compatibility withIntendedEnvironments | Used in surgical environmentsand conforms to 60601 electricalsafety and EMC requirements | Same |
| Battery Backup | Two-hour minimum life via twoLithium-Ion batteries | Same |
| Wireless Connectivity | Wi-Fi | Same |
| Wired Connectivity | 3 USB / 8 Spectrum AccessoryPorts (SAPs)(Allows connectivity to 3rd-partydevices for data display /graphing; alarms are notassociated with these data) | 3 USB / 8 Spectrum AccessoryPorts (SAPs)(Currently does not allowsconnectivity to 3rd-party devicesfor data display / graphing;alarms are not associated withthese data) |
| Disposable /Reusable | Not applicable(No patient-contacting parts) | Same |
| Device | Predicate Device | Proposed Device |
| FDA-RecognizedStandards Met | Electrical Safety:AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012including relevant clauses of IEC60601-2-49:2011 | Electrical Safety:AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012including relevant clauses ofIEC 60601-2-49:2011 |
| Electromagnetic Compatibility:IEC 60601-1-2:2014 | Electromagnetic Compatibility:IEC 60601-1-2:2014 | |
| 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 | 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 |
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VII. PERFORMANCE DATA - NON-CLINICAL TESTING
No animal testing was submitted to support the substantial equivalence of the Quantum Workstation 12.1" to the Quantum Workstation (K16357).
The following bench performance testing was performed to support the substantial equivalence of the Quantum Workstation 12.1" to the Quantum Workstation (K163657):
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing, including defibrillator protection and electrosurgery interference requirements, were conducted on the Quantum Workstation 12.1" and its accessories. The system complies with the following safety and emissions standards:
- o 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 12.1":
- 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 12.1" and its predicate, Quantum Workstation 12.1", were determined to be Class B software (non-serious injury is possible) per IEC 62304:2006 because, if the Quantum Workstation (K163657) or Quantum Workstation 12.1" 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.
VIII. PERFORMANCE DATA - CLINICAL TESTING
No clinical data were submitted to support the substantial equivalence of the Quantum Workstation 12.1" to the Quantum Workstation (K163657).
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IX. CONCLUSIONS
There are minor differences between the Quantum Workstation 12.1" and the predicate device (Quantum Workstation (K163657)) in technological characteristics with regards to, touch screen display size, operational orientation, HLM pump control. 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 12.1" is substantially equivalent to the Quantum Workstation (K163657).
§ 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).