(15 days)
Not Found
No
The description details standard signal processing and comparison to reference spectra, without mentioning AI or ML techniques.
No.
The device is for monitoring physiological parameters in an extracorporeal circuit, not for treatment or therapy.
Yes
The device is intended for "non-invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration, blood flow and gaseous emboli in an extracorporeal circuit," and "provides monitoring information to trained clinicians," which aligns with the definition of a diagnostic device that detects, monitors, or identifies diseases or conditions.
No
The device description clearly outlines hardware components including a touch screen, measuring channels, sensor cables, LEDs, fiber optic cables, photo detectors, spectrometers, photo diodes, ultrasonic transducers, a memory card, and a battery back-up. While software is mentioned for data processing and display, it is integral to and dependent on these physical components.
Based on the provided text, the M3 Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- M3 Monitor's Function: The M3 Monitor measures parameters directly within an extracorporeal circuit. This means it's monitoring blood as it flows outside the body during a medical procedure, not analyzing a collected sample in a laboratory setting.
- Parameters Measured: The parameters measured (oxygen saturation, hematocrit, haemoglobin concentration, blood flow, gaseous emboli) are being monitored in real-time within the circuit, not determined from a processed sample.
Therefore, the M3 Monitor falls under the category of a medical device used for monitoring during extracorporeal procedures, rather than an IVD.
N/A
Intended Use / Indications for Use
The intended use of the M3 Monitor is for the non- invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration, blood flow and gaseous emboli in an extracorporeal circuit.
The device provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
Product codes (comma separated list FDA assigned to the subject device)
DRY, KRL
Device Description
The Spectrum M3 Monitor consists of a 10.4 inch high definition touch screen and five active measuring channels mounted into a flat panel unit. Sensor cables are used to connect the active measuring channels to the external surface of extracorporeal blood line tubing. Two active measuring channels are used to measure venous and arterial oxygen saturation. The sensor cable head contains a light emitting diode that sends light through the extracorporeal tube, which illuminates the blood. The reflected spectra is collected by a fibre optic cable and quantified by a photo detector contained within a spectrometer. These spectra are compared to reference spectra by the monitor's software to determine the oxygen saturation of the blood. The third active measuring channel is used to measure bematocrit or haemoglobin concentration. The sensor cable head contains a light emitting diode that transmits near-infra-red light through the extracorporeal tube. A photo diode measures a received light level. The level of signal attenuation is used to calculate hematocrit or haemoglobin concentration.
Three further active and optional measuring channels (i.e. the fourth, fifth and sixth channels) are used to measure simultaneously blood flow and the presence of emboli. Flow measurement is accomplished by measuring the difference in transit time between a pair of upstream and down stream ultrasonic transducers. Emboli is measured by detecting reductions in the amplitude of the ultrasonic signal.
Parameter values are displayed in both a digital and trended format. The M3 Monitor has been designed to self-detect the selected sensor and to automatically configure the required parameter display screens. The device can be configured by the trained clinician to set parameter specific alarms and to select either the display of hematocrit or haemoglobin concentration. Session data can be stored to a memory card supplied with the system, via a RS232 link or wirelessly to a remote computer.
The M3 Monitor is powered from the AC Mains supply and also incorporates a battery back-up that automatically switches on in the event of an interruption to the mains power supply. The system weighs 4.5 kg and is supplied with a pole mount clamp.
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)
Performance data has been provided to show that the revised M3 Monitor can measure the oxygen saturation, hematocrit / haemoglobin concentration, the flow of blood and gaseous emboli in an extracorporeal circuit to an equivalent or improved accuracy when compared to the predicate devices.
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.
Not Found
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).
0
K091 908
JUL 10 2009
As required by 21 CFR 807.92 (c) this 510(k) summary is prepared
Application Date:
8" May 2009
Applicant:
Spectrum Medical LLP Harrier 4, Meteor Business Park, Cheltenham Road East, Gloucester. GL2 9QL United Kingdom
Official Correspondent:
Mr. Steve Turner Chief Executive Officer +44 (0) 1242 650121 Telephone: +44 (0) 8452 808127 Fax: Email: Steve. Turner@spectrum-medical.com
Proposed Device:
Blood Gas Monitor Trade Name: M3 Monitor Classification Name: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 21 CFR 870.4330, Product code: DRY
Predicate Devices:
K072131 Spectrum Medical - M3 Monitor.
K940651 Sarns - Ultrasonic Air Sensor
Description of Proposed Device:
The Spectrum M3 Monitor consists of a 10.4 inch high definition touch screen and five active measuring channels mounted into a flat panel unit. Sensor cables are used to connect the active measuring channels to the external surface of extracorporeal blood line tubing. Two active measuring channels are used to measure venous and arterial oxygen saturation. The sensor cable head contains a light emitting diode that sends light through the extracorporeal tube, which illuminates the blood. The reflected spectra is collected by a fibre optic cable and quantified by a photo detector contained within a spectrometer. These spectra are compared to reference spectra by the monitor's software to determine the oxygen saturation of the blood. The third active measuring channel is used to measure bematocrit or haemoglobin concentration. The sensor cable head contains a light emitting diode that transmits near-infra-red light through the extracorporeal tube. A
1
photo diode measures a received light level. The level of signal attenuation is used to calculate hematocrit or haemoglobin concentration.
Three further active and optional measuring channels (i.e. the fourth, fifth and sixth channels) are used to measure simultaneously blood flow and the presence of emboli. Flow measurement is accomplished by measuring the difference in transit time between a pair of upstream and down stream ultrasonic transducers. Emboli is measured by detecting reductions in the amplitude of the ultrasonic signal.
Parameter values are displayed in both a digital and trended format. The M3 Monitor has been designed to self-detect the selected sensor and to automatically configure the required parameter display screens. The device can be configured by the trained clinician to set parameter specific alarms and to select either the display of hematocrit or haemoglobin concentration. Session data can be stored to a memory card supplied with the system, via a RS232 link or wirelessly to a remote computer.
The M3 Monitor is powered from the AC Mains supply and also incorporates a battery back-up that automatically switches on in the event of an interruption to the mains power supply. The system weighs 4.5 kg and is supplied with a pole mount clamp.
Intended Use of Proposed Device
The intended use of the M3 Monitor is for the nor-invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration, blood flow and gaseous emboli in the extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarm levels.
Summary of Technological Characteristics
Oxygen Saturation. Hematocrit / Haemoglobin Concentration and Flow :-
The proposed device has the same technological characteristics as the predicate M3 monitor cleared under 510(k) K072131. Although the proposed device can now be confiqured to offer up to three flow channels compared with the predicates single channel capability.
Emboli:-
There is no difference between the proposed device and predicate device in that both devices use the same ultrasonic technology. However with the proposed device the ultrasonic signal disruption software has been significantly developed to better quantify gaseous emboli with greater levels of precision.
Substantial Equivalence Determination
The M3 Monitor has an intended use that is also featured in its two predicate devices. Performance data has been provided to show that the revised M3 Monitor can measure the oxygen saturation, hematocrit / haemoglobin concentration, the flow of blood and gaseous emboli in an extracorporeal circuit to an equivalent or
2
improved accuracy when compared to the predicate devices. The M3 Monitor is therefore considered substantially equivalent to its predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned or reproduced image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2009
Spectrum Medical Ltd. c/o Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories Inc. 12 Laboratory Drive Research Triangle, NC 27709
Re: K091908
M3 Monitor Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiopulmonary bypass on-line blood gas monitor Regulatory Class: Class II (two) Product Code: DRY, KRL Dated: June 23, 2009 Received: June 25, 2009
Dear Mr. Rongero:
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.
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.
4
Page 2 - Mr. Jeff D. Rongero
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Dumen R. bohner
A Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _K091908
Device Name: M3 Monitor
Indications For Use:
The intended use of the M3 Monitor is for the non- invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration, blood flow and gaseous emboli in an extracorporeal circuit.
The device provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nama P. Rohliner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k o91908
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