(16 days)
No
The description details standard optical measurement techniques and software for comparing spectra and calculating values, without mentioning AI or ML algorithms.
No
The device is for monitoring purposes, providing data on blood parameters in an extracorporeal circuit. It does not actively treat or diagnose a disease, but rather provides information to clinicians.
Yes
The device is intended for the non-invasive continuous monitoring of oxygen saturation, hematocrit, and hemoglobin concentration, which are diagnostic measurements of blood parameters in an extracorporeal circuit.
No
The device description clearly outlines hardware components including a touch screen, measuring channels, sensor cables with LEDs and fiber optics, a spectrometer, a photo diode, a memory card, and a power supply with battery backup. While software is mentioned for data processing and display, it is integral to a physical hardware system.
Based on the provided information, the M2 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.
- M2 Monitor's Function: The M2 Monitor measures parameters (oxygen saturation, hematocrit, haemoglobin) directly within an extracorporeal circuit. This means the blood is still within a system connected to the patient, not a collected specimen being analyzed in a lab. The measurements are taken in vivo (within a living organism or system connected to one), even though it's outside the main body.
Therefore, the M2 Monitor falls under the category of a non-invasive continuous monitoring device used in an extracorporeal circuit, not an IVD.
N/A
Intended Use / Indications for Use
The M2 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration 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.
Product codes
DRY
Device Description
The Spectrum M2 Monitor consists of a 10.4 inch high definition touch screen and three 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 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
Parameter values are displayed in both a digital and trended format. The M2 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 or via a RS232 link to a remote computer.
The M2 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 M2 Monitor can measure the oxygen saturation and hematocrit / haemoglobin concentration of blood and in extracorporeal circuit to an equivalent accuracy to its predicate device.
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).
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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K07/725". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with the "K" having a distinct shape and the numbers being slightly slanted.
As required by 21 CFR 807.92 (c) this 510(k) summary is prepared
Application Date:
11th May 2007
Applicant:
JUL 1 1 2007
Spectrum Medical Ltd. Harrier 4, Meteor Business Park, Cheltenham Road East, Gloucester. GL2 9QL United Kingdom
Official Correspondent:
Mr. Steve Turner Managing Director Telephone: +44 (0) 8452 808127 Fax: Steve. Turner@spectrum-medical.com Email:
Proposed Device:
Blood Gas Monitor Trade Name: M2 Monitor Classification Name: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 21 CFR 870.4330, Product code: DRY
Predicate Devices:
K931968 3M Health Care Ltd, CDI 100 Extracorporeal Hematocrit / Oxygen Monitoring Device and K062468 Spectrum Medical Ltd, M2 Oxygen Saturation Monitor.
Description of Proposed Device:
The Spectrum M2 Monitor consists of a 10.4 inch high definition touch screen and three 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 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
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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
Parameter values are displayed in both a digital and trended format. The M2 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 or via a RS232 link to a remote computer.
The M2 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 M2 Monitor is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / haemoglobin concentration 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 alarms.
Summary of Technological Characteristics
The proposed device has the same technological characteristics as the predicate M2 monitor cleared under 510(k) K062468 with the exception of the measurement of hematocrit / haemoglobin concentration.
For the measurement of hematocrit / haemoglobin concentration the proposed device has the same technological characteristics as the CDI monitor cleared under 510(k) K931968. The major difference in the technological characteristics of the proposed device and the predicate CDI 100 device is that the proposed device provides a completely non-invasive measurement of the blood in the extracorporeal blood tubing while the predicate involves the use of a cuvette inserted into the blood tubing.
Substantial Equivalence Determination
The M2 Monitor has an intended use that is also featured in the predicate device. Performance data has been provided to show that the M2 Monitor can measure the oxygen saturation and hematocrit / haemoglobin concentration of blood and in extracorporeal circuit to an equivalent accuracy to its predicate device. The M2 Monitor is therefore considered substantially equivalent to its predicate device for the monitoring of oxygen saturation in extracorporeal blood line tubing.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2007
Spectrum Medical Ltd. c/o Mr. Jeff D. Rongero Senior Project Engineer 12 Laboratory Dr. Research Triangle, NC 27709
Re: K071725
M2 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: June 25, 2007 Received: June 25, 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 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 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.
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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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________ M2 Monitor
Indications for Use:
The M2 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration 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.
X Prescription Use (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
510(k) Number K071725