The noninvasive FORE-SIGHT ELITE Module Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The FORE-SIGHT ELITE Module Tissue Oximeter is intended to allow for the display of StO2 on a third party display/patient monitor. The FORE-SIGHT ELITE Module Tissue Oximeter when used with large sensors, is indicated for use on adults and transitional adolescents ≥40 kg. When used with Medium Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for use on pediatric subjects ≥3 kg. When used with Small Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.

Device Description

The FORE-SIGHT ELITE Module Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation in the tissue (StO2). The Oximeter consists of a module / monitoring unit, power and communication cables and sensor cables to connect with FDA cleared FORE-SIGHT ELITE small, medium and large sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The module unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The module unit provides simultaneous measurements on up to two Sensors with both numeric and real-time graphical display formats appearing on a host monitor. The Module unit is a host-powered device. The host configures the Oximeter and provides applicable audible, on-screen, and dedicated visual alarm indicators. Measurement data is delivered to the host through various interfaces including USB and serial connections.

AI/ML Overview

The provided document describes the FORE-SIGHT ELITE Module Tissue Oximeter, but it does not contain a typical acceptance criteria table with reported device performance metrics like sensitivity, specificity, or accuracy, which are common for AI/ML device descriptions. This device is a tissue oximeter, and its performance would typically be evaluated against established physiological measurement standards, not necessarily against ground truth established by experts in a diagnostic context.

However, I can extract information related to clinical testing and equivalence demonstration:

Clinical Testing Approach and Equivalence:

The document states:
"The FORE-SIGHT ELITE Module Tissue Oximeter technology has successfully undergone extensive clinical validation for the indicated use, as demonstrated in the clearance of K143675 and earlier CASMED Premarket Notifications. As documented in the FORE-SIGHT ELITE Clinical Equivalency Report (21-07-0542), there is no difference between the clinical functionality of this Module and the Monitor cited in K143675 making the St02 performance of FORE-SIGHT ELITE Module and FORE-SIGHT ELITE monitor statistically the same."

This indicates that the device's performance is established by demonstrating its equivalence to a previously cleared predicate device (FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor, K143675). The key claim is that the StO2 performance of the new module is statistically the same as the predicate monitor.

Given the information, a table of acceptance criteria and reported device performance as typically expected for diagnostic AI/ML algorithms cannot be fully constructed. However, based on the provided text, the core "acceptance criteria" and "performance" for this device revolve around demonstrating statistical equivalence to the predicate.

Here's how we can frame the response based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Primary Criteria: Statistical equivalence of StO2 performance to the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor (K143675).	"There is no difference between the clinical functionality of this Module and the Monitor cited in K143675 making the St02 performance of FORE-SIGHT ELITE Module and FORE-SIGHT ELITE monitor statistically the same."
Clinical Validation: Successful extensive clinical validation for the indicated use.	Achieved through demonstration of equivalence to K143675 and earlier CASMED Premarket Notifications.
Non-Clinical Performance: Successful performance, safety, electromagnetic, software, and environmental testing.	Successfully undergone and passed these tests to ensure substantial equivalence.
Hardware & Software Validation: Full program of individual hardware, software, and systems verification and validation studies.	Successfully completed these studies.

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of a dataset reviewed for metrics like sensitivity or specificity. Instead, it refers to "extensive clinical validation" and an "equivalence report" (21-07-0542) comparing the new module to the predicate device (K143675). The sample size and data provenance for these underlying clinical validations are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. For a tissue oximeter, the "ground truth" would typically be established by validated physiological measurements rather than expert consensus on diagnostic images.

4. Adjudication method for the test set

This information is not provided for a "test set" in the context of expert review.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such MRMC study is mentioned. This device is a physiological monitoring device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output for diagnostic purposes.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a standalone physiological monitor. Its performance is inherent in its measurement of StO2. The clinical testing mentioned ("clinical validation for the indicated use") implicitly refers to the standalone performance of the technology, evaluated against clinical outcomes or comparison to a reference standard, and then its equivalence to the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth for the underlying clinical validations of the oximetry technology. For tissue oximeters, ground truth typically involves reference oximetry methods, in-vitro experiments, or correlation with clinical outcomes related to tissue oxygenation. The primary evidence presented for this specific submission is the equivalence to a predicate device that has already established its performance via prior clinical validation.

8. The sample size for the training set

This information is not provided. The FORE-SIGHT ELITE Module uses an algorithm ("FORE-SIGHT algorithm") to determine StO2 values, but the details of its development and any "training set" are not disclosed in this summary.

9. How the ground truth for the training set was established

This information is not provided.

Summary

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May 10, 2018

CAS Medical Systems, Inc. Ron Jeffrey Director, Regulatory Affairs 44 East Industrial Road Branford, Connecticut 06405

Re: K180003

Trade/Device Name: FORE-SIGHT ELITE Module Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: April 6, 2018 Received: April 9, 2018

Dear Ron Jeffrey:

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 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);

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Page 2 - Ron Jeffrey

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,

M.A. Wilhelm

for 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) K180003

Device Name

FORE-SIGHT ELITE Module Tissue Oximeter

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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006_510(k) Summary

Image /page/3/Picture/2 description: The image shows the word "CASMED" in a bold, red font. The letters are all capitalized and slightly slanted to the right. A small, circled "R" symbol is located to the right of the word, indicating that it is a registered trademark.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter:	CAS Medical Systems, Inc.
Address:	44 East Industrial Rd. Branford CT. 06405 USA
Contact:	Ron Jeffrey - Director, Regulatory AffairsPhone - (203) 488-6056Fax - (203) 488-9438Email - rjeffrey@casmed.com
Prepared:	December 29, 2017
Trade Name:	FORE-SIGHT ELITE® Module Tissue Oximeter
Common Name:	FORE-SIGHT ELITE Module
Classification Name:	Oximeter, Tissue Saturation (870.2700) (MUD)

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EQUIVALENCE (Predicate Device)

The FORE-SIGHT ELITE® Module Tissue Oximeter is equivalent to the following device:

FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor (K143675):

REFERENCE DEVICES

0 Multi-parameter Mobile Careguide 4100 Oximeter (K141496):
Mobile Careguide 2100 Oximeter (K122645) o

DESCRIPTION

The Oximeter consists of a module / monitoring unit, power and communication cables and sensor cables to connect with FDA cleared FORE-SIGHT ELITE small, medium and large sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The module unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The module unit provides simultaneous measurements on up to two Sensors with both numeric and real-time graphical display formats appearing on a host monitor.

The Module unit is a host-powered device. The host configures the Oximeter and provides applicable audible, on-screen, and dedicated visual alarm indicators. Measurement data is delivered to the host through various interfaces including USB and serial connections.

FORE-SIGHT Oximeter Monitor Intended Use

The noninvasive FORE-SIGHT ELITE Module Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The FORE-SIGHT ELITE Module Tissue Oximeter is intended to allow for the display of StO2 on a third party display/patient monitor. The FORE-SIGHT ELITE Module Tissue Oximeter when used with large sensors, is indicated for use on adults and transitional adolescents ≥40 kg. When used with Medium Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for use on pediatric subjects ≥3 kg. When used with Small Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for cerebral use on pediatric subjects < 8 kg and non-cerebral use on pediatric subjects <5kg.

FORE-SIGHT Module Technology Compared to Predicate Devices

The FORE-SIGHT ELITE Module Tissue Oximeter compares substantially to the predicate devices and repackages the technology used in the ELITE (K143675) to allow integration into CASMED and third party monitoring systems. Both the FORE-SIGHT ELITE Module and Monitor use the same Sensors. The FORE-

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SIGHT ELITE Module Tissue Oximeter use fundamentally the same optical operating principle, called multidistance diffuse reflectance spectroscopy. All cited monitors use light to examine a cross-section tissue microvasculature (a mixed bed of arterioles, capillaries and venules). The FORE-SIGHT ELITE Module and predicate devices analyze the light that is returned after having passed through tissues. The spectroscopic analysis determines concentrations of hemoglobin in its oxygenated and deoxygenated states. All cited monitors calculate oxygen saturation which reflects the percentage of oxygenated hemoglobin in the sampled tissue.

The FORE-SIGHT ELITE Module Tissue Oximeter compares substantially to the predicates. All have multichannel capability, an LED light source, similar user interface features on the monitor or host device and the benefits of portability.

Non-Clinical Performance Testing to Demonstrate Substantial Equivalence

The FORE-SIGHT ELITE Module Tissue Oximeter has successfully undergone extensive performance, safety, electromagnetic, software and environmental testing to ensure substantial equivalence to the predicate devices. In addition to the above laboratory tests, CAS has conducted a full program of individual hardware, software, and systems verification and validation studies.

Clinical Testing to Show Substantial Equivalence

The FORE-SIGHT ELITE Module Tissue Oximeter technology has successfully undergone extensive clinical validation for the indicated use, as demonstrated in the clearance of K143675 and earlier CASMED Premarket Notifications. As documented in the FORE-SIGHT ELITE Clinical Equivalency Report (21-07-0542), there is no difference between the clinical functionality of this Module and the Monitor cited in K143675 making the St02 performance of FORE-SIGHT ELITE Module and FORE-SIGHT ELITE monitor statistically the same.

Conclusions Drawn from Clinical and Non-Clinical Testing

Clinical evaluation, safety / EMC testing, and software validation demonstrate the FORE-SIGHT ELITE Module Tissue Oximeter is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).