(30 days)
No reference devices were used in this submission.
No
The document describes a standard blood gas monitor with data display, storage, and alarm functions. There is no mention of AI, ML, or any advanced analytical techniques beyond basic parameter monitoring and trending.
No
The device is described as a "blood gas monitor" primarily used for "non-invasive continuous monitoring" of oxygen saturation, hematocrit, and hemoglobin concentration. It provides "monitoring information" and "does not directly control patient care," indicating a diagnostic rather than therapeutic function.
Yes
The device is intended for "non-invasive continuous monitoring of oxygen saturation and haemotocrit / haemoglobin concentration of the blood in an extracorporeal circuit," which are measurements used to inform clinical judgments and aid in diagnosis or patient management.
No
The device description explicitly details hardware components such as a touch screen, Wi-Fi adapter, SD card, AC power supply, battery backup, and various physical ports for sensors and accessories. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Quantum Workstation 12.1" is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is intended for the "non-invasive continuous monitoring of oxygen saturation and haemotocrit / haemoglobin concentration of the blood in an extracorporeal circuit." This involves analyzing blood components (oxygen saturation, haemoglobin, haematocrit) to provide diagnostic information about the patient's physiological state during extracorporeal circulation.
- Device Description: It is described as an "online, cardiopulmonary bypass, blood gas monitor." Blood gas analysis is a common type of in vitro diagnostic testing.
- Measurements: The device measures and displays specific blood parameters (SaO2, SvO2, Hb, Hct). These are measurements taken from the blood itself, even though the monitoring is non-invasive in the sense that it's done on the extracorporeal circuit rather than directly on the patient's body.
- Extracorporeal Circuit: While the blood is still technically within the patient's circulatory system via the extracorporeal circuit, the analysis is happening outside of the patient's body in a controlled environment. This aligns with the concept of "in vitro" (in glass or outside the body).
The fact that the device provides monitoring information to trained clinicians who make clinical judgments based on the data, rather than directly controlling patient care, is consistent with the role of many IVD devices. They provide diagnostic information that informs clinical decision-making.
Therefore, the Quantum Workstation 12.1" fits the definition of an In Vitro Diagnostic device as it performs tests on blood (even in an extracorporeal circuit) to provide diagnostic information about a patient's condition.
N/A
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 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".
Product codes
DRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Patients (all ages, both genders) undergoing extracorporeal circulation
Intended User / Care Setting
Trained clinicians, Perfusionist / Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench performance testing:
- Electrical safety and electromagnetic compatibility (EMC): Testing included defibrillator protection and electrosurgery interference requirements. The system complies with specified safety and emissions standards.
- Mechanical testing: Performed 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 environmental extremes of temperature and humidity.
- Software verification and validation testing: System-level and subcomponent-level software verification and validation testing were conducted. The software was determined to be Class B per IEC 62304:2006, meaning non-serious injury is possible, as clinicians will rely on other medical devices to confirm diagnostic values if the device displays faulty data, thus no risk of death or serious injury from the software.
Clinical testing: No clinical data were submitted.
Key Results: The bench performance tests confirm that the Quantum Workstation 12.1" is substantially equivalent to the Quantum Workstation (K163657).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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
See PRA Statement below.
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.gov
"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."
3
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.
4
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.
5
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)
6
| 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 Ltd | |
| Gloucester, England | Same | |
| Intended Use | Extracorporeal monitoring of | |
| blood oxygen saturation, | ||
| haematocrit and haemoglobin | ||
| levels | Same | |
| Clinical Application | Online monitoring of | |
| extracorporeal arterial and | ||
| venous blood lines, and | ||
| hematocrit and hemoglobin levels | ||
| using sensor probes attached to | ||
| the external surface of blood | ||
| tubing | Same | |
| Clinical Setting / | ||
| Sites of Use | Hospital | Same |
| Target user | Perfusionist | Same |
| Target patient | ||
| population | Patients (all ages, both genders) | |
| undergoing extracorporeal | ||
| circulation | Same | |
| Principal of Operation / Mechanism of | ||
| Action | Comparison of the different | |
| patterns of absorbance of visible | ||
| light reflected from oxy and deoxy | ||
| forms of hemoglobin | Same | |
| Blood oxygen | ||
| saturation | ||
| (SO2 %) | Single synchronization with | |
| reference blood gas analyzer; | ||
| independent of blood flow, blood | ||
| temperature, and hemodilution | ||
| Principal of Operation / Mechanism of | ||
| Action | Measures hemoglobin | |
| concentration by transmitting | ||
| infrared light through the blood | ||
| tube and quantifying the level of | ||
| signal attention with a photodiode | ||
| Calculates hematocrit from | ||
| hemoglobin measurement | Same | |
| Haemoglobin (Hb) / | ||
| Haematocrit (Hct) | ||
| Device | Predicate Device | Proposed Device |
| Performance | SO2 | |
| Range = 20-100% | ||
| Range Temperature = 15-37°C | ||
| Mean Offset = 0.48 | ||
| Standard Deviation = $\pm$ 1.90 |
Hb / Hct
Range:
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°C
Mean Offset = 0.03
Standard Deviation = $\pm$ 0.60 | Same |
| Human Factors | Touch screen display showing
individual and trend readings with
alarm settings
Flash memory storage for
recording case history
No recalibration required due to
negligible drift
Also allows for display of 3rd-party
data without alarms | Same general human factors
features, however does not
currently allow 3rd party data to
display |
| Touchscreen | 15" portrait | 12.1" landscape |
| Design | General design features (weight) | Same general design features
Small differences in weight |
| Compatibility with
Intended
Environments | Used in surgical environments
and conforms to 60601 electrical
safety and EMC requirements | Same |
| Battery Backup | Two-hour minimum life via two
Lithium-Ion batteries | Same |
| Wireless Connectivity | Wi-Fi | Same |
| Wired Connectivity | 3 USB / 8 Spectrum Accessory
Ports (SAPs)
(Allows connectivity to 3rd-party
devices for data display /
graphing; alarms are not
associated with these data) | 3 USB / 8 Spectrum Accessory
Ports (SAPs)
(Currently does not allows
connectivity to 3rd-party devices
for data display / graphing;
alarms are not associated with
these data) |
| Disposable /
Reusable | Not applicable
(No patient-contacting parts) | Same |
| Device | Predicate Device | Proposed Device |
| FDA-Recognized
Standards Met | Electrical Safety:
AAMI ANSI ES60601-
1:2005/(R)2012 and A1:2012
including relevant clauses of IEC
60601-2-49:2011 | Electrical Safety:
AAMI ANSI ES60601-
1:2005/(R)2012 and A1:2012
including relevant clauses of
IEC 60601-2-49:2011 |
| | Electromagnetic Compatibility:
IEC 60601-1-2:2014 | Electromagnetic Compatibility:
IEC 60601-1-2:2014 |
| | Other:
IEC 60601-1-6:2010 + A1:2013
IEC 60601-1-8:2006 + A1:2012
IEC 62133:2012
AAMI ANSI IEC 62304:2006
IEC 62366:2007+A1:2014
ISO 14971:2007 | Other:
IEC 60601-1-6:2010 + A1:2013
IEC 60601-1-8:2006 + A1:2012
IEC 62133:2012
AAMI ANSI IEC 62304:2006
IEC 62366:2007+A1:2014
ISO 14971:2007 |
7
8
9
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).
10
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).