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.

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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lacks a specific, quantitative "acceptance criteria" table with corresponding numerical performance targets. Instead, the justification for substantial equivalence relies on the device having "equivalent accuracy" to predicate devices.

Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
Oxygen Saturation	Equivalent accuracy to predicate M2 monitor	"can measure... to an equivalent accuracy of the predicate devices." (No specific numerical accuracy provided)
Hematocrit / Hemoglobin Concentration	Equivalent accuracy to predicate M2 monitor	"can measure... to an equivalent accuracy of the predicate devices." (No specific numerical accuracy provided)
Flow Measurement	Equivalent accuracy to predicate Transonic Flowmeter	"can measure... to an an equivalent accuracy of the predicate devices." (No specific numerical accuracy provided)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide any specific information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). The statement "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" is the extent of the information.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not mention the use of human experts to establish ground truth for a test set. The focus is on technical equivalence to existing devices and "gold-standard" flow sensors.

4. Adjudication Method:

Given that there's no mention of human experts or a test set requiring adjudication, there is no information about an adjudication method (e.g., 2+1, 3+1, none) in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a "Blood Gas Monitor" and not an imaging or diagnostic device that would typically involve human readers for interpretation. The evaluation focuses on the device's measurement accuracy compared to predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The provided text implicitly describes a "standalone" evaluation of the device's technical performance. The "performance data" mentioned is focused on the device's ability to measure parameters accurately, independent of human interaction beyond initial setup and configuration. This is not explicitly called a "standalone study" in the modern sense of AI algorithms, but the nature of the device's function implies its core measurement capabilities were assessed independently.

7. Type of Ground Truth Used:

Oxygen Saturation and Hematocrit/Hemoglobin Concentration: The document does not explicitly state how "ground truth" was established for these parameters during the "performance data" collection. It only states that the proposed device has the "same technological characteristics" as its predicate and aims for "equivalent accuracy." This often implies comparison against more established laboratory methods or reference instruments, but this is not detailed.
Flow Measurement: For flow, the ground truth is established using a "gold-standard" flow sensors, which are tested by timed fluid collection using NIST traceable stopwatch and volume standards.

8. Sample Size for the Training Set:

The provided text does not mention a "training set" or "sample size for the training set." This device, a Blood Gas Monitor, operates on established biophysical principles and algorithms, likely calibrated during its manufacturing process. It does not appear to employ machine learning that would necessitate a distinct "training set" in the context of typical AI/ML medical devices.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a "training set" (see point 8), there is no information on how its ground truth would have been established. The device relies on physical principles and calibration, not a machine learning model trained on a dataset with established ground truth.

Summary

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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:

AUG 1 7 2007

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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

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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.

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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.

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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 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

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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
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Regulation Number and Section

§ 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).