(29 days)
No
The summary describes a standard physiological monitoring device with data display, storage, and alarm functions. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic calculations and trend display.
No.
The device is described as a monitoring system that provides information to clinicians, but it does not directly control patient care or provide treatment. Its function is to measure and display various blood parameters.
Yes
The device is intended for "continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood" which provides information to "trained clinicians" to make "clinical judgments regarding the treatment of the patient". Gathering information about a patient's condition for the purpose of making treatment decisions indicates a diagnostic function.
No
The device description explicitly states it consists of a physical workstation with a touch screen, ports, battery backup, and various sensors and accessories. It also mentions hardware testing and software verification and validation, indicating a hardware component is integral to the device.
Based on the provided information, the Quantum Workstation 12" Elite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donations, or to monitor therapeutic measures.
- Quantum Workstation's Function: The Quantum Workstation 12" Elite is described as a device for non-invasive continuous monitoring of blood parameters and for use in an extracorporeal circuit. While it measures blood parameters, it does so directly from the blood flowing through the extracorporeal circuit, not by examining a specimen in vitro (outside the body in a test tube or dish).
- Extracorporeal Circuit: The use in an extracorporeal circuit (like during cardiopulmonary bypass) means the blood is temporarily outside the body but is still part of the patient's circulatory system. The monitoring is happening in vivo (within the living organism) in this context, even though the blood is not physically inside the patient's body at that moment.
Therefore, the Quantum Workstation 12" Elite falls under the category of a monitoring device used in a clinical setting, rather than an IVD device that analyzes specimens in a laboratory setting.
N/A
Intended Use / Indications for Use
The intended use of the Quantum Workstation 12" Elite is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood and in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12" Elite is configured to measure and display the following measurements:
- · SaO2 Arterial Saturation (%)
- · SvO2 Venous Saturation (%)
- · Hb Hemoglobin (g/L and gm/dl)
- · Hct Calculated Hematocrit (%)
- · Blood Flow 2 channels with arterial and venous flow differentials
- · Pressure & Temperature 4 channels
The Quantum Workstation 12" Elite 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 iudgments regarding the treatment of the patient as a result of information displayed by the workstation.
Product codes (comma separated list FDA assigned to the subject device)
DRY
Device Description
The Quantum Workstation 12" Elite is an on-line, cardiopulmonary bypass, blood gas monitor that is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels. The device's enhanced functionality includes the ability to control centrifugal or roller pumps and make blood flow, blood pressure and blood temperature measurements.
The Quantum Workstation 12" Elite 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" Elite provides memory storage via an SD (Secure Digital) card. The Quantum Workstation 12" Elite is powered from the AC Mains supply and 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" Elite includes the following ports / connections:
- One (1) sensor port for the Hb / SO2 sensor
- Two (2) sensor ports for blood flow ●
- Two (2) sensor ports for blood pressure/temperature
- One (1) LAN / Ethernet port ●
- Two (2) USB 2.0 ports ●
- Three (3) Spectrum Medical ports
- One (1) User Serial Port
Accessories for the Quantum Workstation 12" Elite include the power supply, mounting arm (long or short), Hb / SQ2 sensor, flow sensors and pressure/temperature sensors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extracorporeal circuit
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinicians
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)
The following non-clinical testing was performed to support the substantial equivalence of the Quantum Workstation 12" Elite to the legally marketed predicate device:
- . Electrical safety
- Electromagnetic compatibility (EMC) ●
- Hardware testing
- Software verification and validation ●
No animal testing was submitted to support the substantial equivalence of the Quantum Workstation 12" Elite to the Quantum Workstation 12.1".
No clinical data were submitted to support the substantial equivalence of the Quantum Workstation 12" Elite to the Quantum Workstation 12.1".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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October 2, 2020
Spectrum Medical Ltd Colleen Powell Director of Regulatory Affairs Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, Gloucetershire GL2 9QL United Kingdom
Re: K202557
Trade/Device Name: Quantum Workstation 12" Elite Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiopulmonary Bypass On-Line Blood Gas Monitor Regulatory Class: Class II Product Code: DRY Dated: September 1, 2020 Received: September 3, 2020
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
1
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,
for Fernando Aguel Assistant Director 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
2
Indications for Use
510(k) Number (if known) K202557
Device Name Quantum Workstation 12" Elite
Indications for Use (Describe)
The intended use of the Quantum Workstation 12" Elite is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood and in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12" Elite is configured to measure and display the following measurements:
- · SaO2 Arterial Saturation (%)
- · SvO2 Venous Saturation (%)
- · Hb Hemoglobin (g/L and gm/dl)
- · Hct Calculated Hematocrit (%)
- · Blood Flow 2 channels with arterial and venous flow differentials
- · Pressure & Temperature 4 channels
The Quantum Workstation 12" Elite 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 iudgments regarding the treatment of the patient as a result of information displayed by the workstation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Quantum Workstation 12" Elite 510(k) Summary K202557 Page 1 of 3
510(k) Summary
I. SUBMITTER
| Name: | Spectrum Medical Ltd |
|---|---|
| Address: | Harrier 4, Meteor Business Park |
| Cheltenham Road East Gloucester | |
| GL2 9QL | |
| United Kingdom | |
| Contact Person: | Colleen Powell, Director of Regulatory Affairs |
| Phone: | +44 (0) 1242 650 120 |
| Fax: | +44 (0) 8452 808 127 |
| Date Summary Prepared: | September 1, 2020 |
| II. DEVICE | |
| Proprietary Name: | Quantum Workstation 12" Elite |
| 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 Health Technology 2 (OHT2 Cardiovascular Devices) / |
| Division of Health Technology 2B (Circulatory Support, Structural and | |
| Vascular Devices) |
III. PREDICATE DEVICE
The predicate device for this submission is Spectrum Medical Ltd.'s Quantum Workstation 12.1" (K181923). This predicate has not been subject to a design-related recall. Three reference devices manufactured by Spectrum Medical Ltd. were used, and these included the Quantum Diagnostic Module (K173591), Quantum Smart Occluders (K190282) and Quantum Pump Console (K173834).
IV. DEVICE DESCRIPTION
The Quantum Workstation 12" Elite is an on-line, cardiopulmonary bypass, blood gas monitor that is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels. The device's enhanced functionality includes the ability to control centrifugal or roller pumps and make blood flow, blood pressure and blood temperature measurements.
The Quantum Workstation 12" Elite 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" Elite provides memory storage via an SD (Secure Digital) card. The Quantum Workstation 12" Elite is powered from the AC Mains supply and incorporates a battery
4
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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" Elite includes the following ports / connections:
- One (1) sensor port for the Hb / SO2 sensor
- Two (2) sensor ports for blood flow ●
- Two (2) sensor ports for blood pressure/temperature
- One (1) LAN / Ethernet port ●
- Two (2) USB 2.0 ports ●
- Three (3) Spectrum Medical ports
- One (1) User Serial Port
Accessories for the Quantum Workstation 12" Elite include the power supply, mounting arm (long or short), Hb / SQ2 sensor, flow sensors and pressure/temperature sensors.
V. INTENDED USE / INDICATIONS FOR USE
The intended use of the Quantum Workstation 12" Elite 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 12" Elite is configured to measure and display the following measurements:
| SaO2 | Arterial Saturation (%) |
|---|---|
| SvO2 | Venous Saturation (%) |
| Hb | Hemoglobin (g/L, gm/dl and mmol/L) |
| Hct | Calculated Hematocrit (%) |
| Blood Flow | 2 channels with arterial and venous flow differentials |
| Pressure and temperature | 4 channels |
The Quantum Workstation 12" Elite 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Spectrum Medical Ltd's Quantum Workstation 12.1" (K181923) and Quantum Workstation 12" Elite 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 have an Ethernet port and SD card memory storage. They both are also compatible with the intended environment and with other devices.
Spectrum Medical Ltd's Quantum Workstation 12" Elite and Quantum Workstation 12.1" differ in
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SpectrumMedical
that the Quantum Workstation 12" Elite provides additional measurements for blood flow, pressure and bubble detection. The Quantum Workstation 12" Elite can also control centrifugal or roller pumps.
These differences 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 Workstation 12" Elite to the Quantum Workstation 12.1".
The following non-clinical testing was performed to support the substantial equivalence of the Quantum Workstation 12" Elite to the legally marketed predicate device:
- . Electrical safety
- Electromagnetic compatibility (EMC) ●
- Hardware testing
- Software verification and validation ●
VIII. PERFORMANCE DATA - CLINICAL TESTING
No clinical data were submitted to support the substantial equivalence of the Quantum Workstation 12" Elite to the Quantum Workstation 12.1".
IX. CONCLUSIONS
Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Workstation 12" Elite has been shown to be substantially equivalent to a legally marketed predicate device.