(127 days)
No
The document describes a device that performs measurements from sensors and sends them to a workstation for display. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is described as a "Diagnostic Module" that provides "continuous non-invasive monitoring of critical clinical parameters." It measures various physiological parameters and sends them to a workstation for display, indicating a diagnostic rather than therapeutic function.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for the continuous monitoring of critical clinical parameters" and lists various measurements such as blood flow, gas bubbles, gas flow, PO2, PCO2, temperature, pressure, and reservoir level. These are all parameters that aid in diagnosing and monitoring a patient's condition during extracorporeal circulation procedures. The "Device Description" also emphasizes "continuous non-invasive monitoring of critical clinical parameters." These functions align with the definition of a diagnostic device that provides information about a patient's health status.
No
The device description explicitly states that the Quantum Diagnostic Module is connected via a cable and positioned between hardware devices (gas blender and oxygenator). It also mentions embedded and attached sensors, indicating physical hardware components are integral to its function.
Based on the provided information, the Quantum Diagnostic Module is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Quantum Diagnostic Module's Function: The Quantum Diagnostic Module monitors critical clinical parameters during procedures requiring extracorporeal circulation. It measures parameters like blood flow, gas flow, pressure, temperature, and reservoir level within the extracorporeal circuit. While these parameters are related to the patient's physiological state, the device is not directly analyzing a specimen derived from the patient's body in a laboratory setting.
- Parameters Measured: The parameters measured (blood flow, gas flow, pressure, temperature, level) are physical and physiological measurements within the extracorporeal circuit, not biochemical or cellular analysis of a bodily fluid specimen.
- Intended Use: The intended use is for continuous monitoring during a procedure, not for the diagnosis or monitoring of a disease or condition based on the analysis of a specimen.
The Quantum Diagnostic Module is a monitoring device used in conjunction with an extracorporeal circulation system. It provides real-time data about the performance of the circuit and the patient's physiological response within that circuit. This is distinct from the analysis of a bodily fluid specimen to gain diagnostic information.
N/A
Intended Use / Indications for Use
The Quantum Diagnostic Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Diagnostic Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Diagnostic Module include:
- · Measurement of up to three blood flow channels and arterial and venous flow differential
- · Indication of gas bubbles
- · Extracorporeal gas flow measurements (02, CO2, gas flow, and CO2 removal)
- · Predicted PO2 and PCO2
- · Temperature
- · Up to three circuit pressure channels
- · Reservoir level indication
The Quantum Diagnostic Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.
Product codes
DRY
Device Description
The Quantum Diagnostic Module is an accessory to the Quantum Workstation that provides continuous non-invasive monitoring of critical clinical parameters during procedures requiring extracorporeal circulation. The Quantum Diagnostic Module is connected to the Quantum Workstation via a cable and positioned between the gas blender and the oxygenator devices in the extracorporeal circuit. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Diagnostic Module is known as the Quantum Diagnostic System.
The Quantum Diagnostic Module performs three functions:
-
- Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator.
-
- Provides measurements from attached sensors for blood flow, bubble detection, pressure, level and temperature to monitor an extracorporeal blood loop.
-
- Sends these physiological measurements to the Quantum Workstation for display to the user.
The Quantum Diagnostic Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics. The Quantum Diagnostic Module only works with the Quantum Workstation.
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
Not Found
Intended User / Care Setting
The Quantum Diagnostic Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.
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)
No animal testing was submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor. The following non-clinical testing was performed to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor:
- Electrical safety .
- . Electromagnetic compatibility (EMC)
- Electrosurgery interference ●
- Hardware testing of printed circuit boards
- Software verification and validation ●
- In vitro evaluation testing (comparison testing)
- Usability validation ●
No clinical data were submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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March 28, 2018
Spectrum Medical Ltd Mark Drain Chief Financial Officer Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GL2 9OL Gb
Re: K173591
Trade/Device Name: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiopulmonary Bypass On-Line Blood Gas Monitor Regulatory Class: Class II Product Code: DRY Dated: February 23, 2018 Received: February 26, 2018
Dear Mark 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
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); good manufacturing practice requirements as set 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.
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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.
Nicole G. Ibrahim -S
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)
K173591
Device Name
Quantum Diagnostic Module
Indications for Use (Describe)
The Quantum Diagnostic Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Diagnostic Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Diagnostic Module include:
- · Measurement of up to three blood flow channels and arterial and venous flow differential
- · Indication of gas bubbles
- · Extracorporeal gas flow measurements (02, CO2, gas flow, and CO2 removal)
- · Predicted PO2 and PCO2
- · Temperature
- · Up to three circuit pressure channels
- · Reservoir level indication
The Quantum Diagnostic Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.
| 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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SpectrumMedical
I. SUBMITTER
Spectrum Medical Ltd Harrier 4, Meteor Business Park Cheltenham Road East Gloucester GL2 9QL United Kingdom
Phone: +44 (0) 1242 650 120 Fax: +44 (0) 8452 808 127
Contact Person: Mr. Mark Drain, Chief Financial Officer Date Summary Prepared: November 17, 2017
II. DEVICE
| Proprietary Name: | Quantum Diagnostic Module |
|---|---|
| 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 M4 Monitor (K110957)
This predicate has not been subject to a design-related recall.
Spectrum Medical Ltd's Quantum Workstation (K163657) was used as a reference device.
IV. DEVICE DESCRIPTION
The Quantum Diagnostic Module is an accessory to the Quantum Workstation that provides continuous non-invasive monitoring of critical clinical parameters during procedures requiring extracorporeal circulation. The Quantum Diagnostic Module is connected to the Quantum Workstation via a cable and positioned between the gas blender and the oxygenator devices in
4
SpectrumMedical
the extracorporeal circuit. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Diagnostic Module is known as the Quantum Diagnostic System.
The Quantum Diagnostic Module performs three functions:
-
- Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator.
-
- Provides measurements from attached sensors for blood flow, bubble detection, pressure, level and temperature to monitor an extracorporeal blood loop.
-
- Sends these physiological measurements to the Quantum Workstation for display to the user.
The Quantum Diagnostic Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics. The Quantum Diagnostic Module only works with the Quantum Workstation.
V. INTENDED USE / INDICATIONS FOR USE
The Quantum Diagnostic Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Diagnostic Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Diagnostic Module include:
- . Measurement of up to three blood flow channels and arterial and venous flow differential
- Indication of gas bubbles
- . Extracorporeal gas flow measurements (O2. CO2 gas flow, and CO2 removal)
- . Predicted PO2 and PCO2
- . Temperature
- . Up to three circuit pressure channels
- . Reservoir level indication
The Quantum Diagnostic Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Spectrum Medical Ltd's M4 Monitor and Quantum Diagnostic Module have the same manufacturer, clinical application, clinical setting, target patient population, and equivalent sensor performance. The Quantum Diagnostic Module has the same intended use
5
SpectrumMedical
when connected to the Quantum Workstation and the principles of operation of its sensors are identical or equivalent to those of the M4 Monitor.
Whereas the user interface is integrated into the M4 Monitor, the Quantum Diagnostic Module uses the Quantum Workstation to display the information and to power the module. The Quantum Diagnostic Module also has the capability to measure circuit pressures and blood reservoir levels.
These differences in technological characteristics 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 Diagnostic Module to the M4 Monitor. The following non-clinical testing was performed to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor:
- Electrical safety .
- . Electromagnetic compatibility (EMC)
- Electrosurgery interference ●
- Hardware testing of printed circuit boards
- Software verification and validation ●
- In vitro evaluation testing (comparison testing)
- Usability validation ●
VIII. PERFORMANCE DATA - CLINICAL TESTING
No clinical data were submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor.
IX. CONCLUSIONS
Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Diagnostic Module has been shown to be substantially equivalent to legally marketed predicate devices.