(15 days)
Not Found
No
The device description details standard signal processing and comparison to reference spectra, without mentioning AI or ML techniques.
No.
The M3 Monitor is explicitly stated as a device for "non-invasive continuous monitoring" of various blood parameters in an extracorporeal circuit, providing "monitoring information to trained clinicians." Its function is diagnostic and informational, not therapeutic.
Yes
The device is intended for non-invasive continuous monitoring of oxygen saturation, hematocrit/hemoglobin concentration, and blood flow in an extracorporeal circuit, providing "monitoring information to trained clinicians." This information is used for diagnostic purposes (e.g., assessing the patient's physiological state during treatment).
No
The device description clearly outlines multiple hardware components including a touch screen, measuring channels, sensor cables with LEDs and fiber optic cables, photodiodes, ultrasonic transducers, a memory card slot, RS232 link, AC mains power supply, battery back-up, and a pole mount clamp. While software is mentioned for data processing and display, it is integral to and dependent on these physical components.
Based on the provided information, 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 (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- M3 Monitor's Function: The M3 Monitor is described as a device for the non-invasive continuous monitoring of parameters within an extracorporeal circuit. This means it's monitoring blood as it flows through tubing outside of the patient's body, but it's still part of a system connected to the patient. It's not analyzing a collected sample in a laboratory setting.
- Method of Measurement: The device uses light transmission, reflection, and ultrasonic technology to measure parameters directly on the blood flowing through the tubing. This is a form of in vivo or ex vivo monitoring within a connected system, not in vitro analysis of a separate sample.
Therefore, while it monitors blood parameters, its method and location of measurement place it outside the typical definition of an In Vitro Diagnostic device. It's more accurately described as a monitoring device used in a clinical setting for patients undergoing procedures involving extracorporeal circulation.
N/A
Intended Use / Indications for Use
The M3 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation, hematocrit / haemoglobin concentration and the flow of the blood in an extracorporeal circuit.
The device provides monitoring information to trained clinicians and can be configured by them to alarm to set parameter specific alarms.
Product codes
DRY
Device Description
The Spectrum M3 Monitor consists of a 10.4 inch high definition touch screen and four 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 hematocrit 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.
The fourth active measuring channel is used to measure blood flow using Transonic proprietary technology. Flow measurement is accomplished by measuring the difference in transit time between a pair of upstream and down stream ultrasonic transducers.
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 haemoqlobin concentration. Session data can be stored to a memory card supplied with the system or via a RS232 link 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
Not Found
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 M3 Monitor can measure the oxygen saturation, hematocrit / haemoglobin concentration and flow of blood in extracorporeal blood tubing to an equivalent accuracy of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
As required by 21 CFR 807.92 (c) this 510(k) summary is prepared
Application Date:
11th May 2007
Applicant:
Spectrum Medical LLP Harrier 4. Meteor Business Park, Cheltenham Road East, Gloucester. GL2 9QL United Kingdom
Official Correspondent:
Mr. Steve Turner Managing Director Telephone: Fax: +44 (0) 8452 808127 Steve. Turner@spectrum-medical.com Email:
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:
Oxygen Saturation and Hematocrit / Haemoglobin Concentration:-
K071725 Spectrum Medical Ltd, M2 Monitor.
Flow:-
K872048 Transonic Inc. - Transonic Flowmeter (for flow measurement components).
Description of Proposed Device:
The Spectrum M3 Monitor consists of a 10.4 inch high definition touch screen and four 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
AUG 1 7 2007
1
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 hematocrit 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.
The fourth active measuring channel is used to measure blood flow using Transonic proprietary technology. Flow measurement is accomplished by measuring the difference in transit time between a pair of upstream and down stream ultrasonic transducers.
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 haemoqlobin concentration. Session data can be stored to a memory card supplied with the system or via a RS232 link 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 non-invasive continuous monitoring of oxygen saturation, hematocrit / haemoglobin concentration and flow of the blood in an 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 and Hematocrit / Haemoglobin Concentration:-
The proposed device has the same technological characteristics as the predicate M2 monitor cleared under 510(k) K0712725.
Flow:-
There are no differences between the proposed and Transonic Flowmeter device with respect to flow measurement. Both devices are manufactured, quality control tested, and calibrated under the same controls and procedures. Known flow rates using a "gold-standard" flow sensors, which are tested by timed fluid collection using NIST traceable stopwatch and volume standards, are utilized for 100% flow board and sensor calibration.
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 M3 Monitor can
2
measure the oxygen saturation, hematocrit / haemoglobin concentration and flow of blood in extracorporeal blood tubing to an equivalent accuracy of the predicate devices. The M3 Monitor is therefore considered substantially equivalent to its predicate devices.
3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 17 2007
Spectrum Medical Ltd. c/o Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories Inc. 12 Laboratory Drive Research Triangle, NC 27709
Re: K072131 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 Dated: July 30, 2007 Received: August 2, 2007
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 prìor 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 such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
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): _长07乙/3]
.
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The M3 Monitor is intended as a device for the non-invasive continuous monitoring I the MI- Montor is montover as and haemoglobin concentration and the flow of the blood in an extracorporeal circuit.
The device provides monitoring information to trained clinicians and can be configured by them to alarm to set parameter specific alarms.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K09263 |
|---|---|
| --------------- | -------- |