The noninvasive FORE-SIGHT ELITE Absolute 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 and is indicated for use as follows:

When used with Large Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on adults and transitional adolescents ≥40 kg.
When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥3 kg.
When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5 kg.

Device Description

The FORE-SIGHT ELITE Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2).

The Oximeter consists of a monitor unit, preamplifier assembly, and 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 monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four Sensors with both numeric and real-time graphical display formats.

The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB and RS-232.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy (Bias & Precision)	Ranging from 0.05 ± 5.06% to 0.03 ± 5.69% compared to weighted co-oximetry reference.
Safety	No safety issues or adverse events related to the FORE-SIGHT ELITE Absolute Tissue Oximeter were encountered.
Compliance with Predetermined Specification	Test results demonstrated that the oximeter complies with its predetermined specification (System Functional and Performance Testing).
Electrical Safety	Met ANSI/AAMI ES60601-1: (2005), IEC 60601-1-8: (2006), IEC 60601-1-6: (2010), IEC 62366: (2007).
Electromagnetic Compatibility	Met IEC 60601-1-2: (2007).
Biological Safety (Materials)	Assured by biological testing under the standard ISO10993-1.

Study Information

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

Sample Size (Test Set): 136 subjects.
Data Provenance: Not explicitly stated, but the study was conducted at "multiple institutions." Given the context of a 510(k) submission to the FDA in the US, it's highly probable the data is from the United States. The study involved a "demographically diverse population."
Retrospective or Prospective: Not explicitly stated. However, the nature of "clinically validated" and "measurements... calibrated against a weighted co-oximetry reference of arterial and venous blood samples drawn simultaneously" suggests a prospective clinical study where measurements were taken for the purpose of validation.

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 in the document. The ground truth was established using a weighted co-oximetry reference of arterial and venous blood samples, not expert opinion.

4. Adjudication method for the test set:

This information is not applicable/provided. The ground truth was based on objective blood sample analysis (co-oximetry), not expert consensus that would require adjudication.

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, an MRMC comparative effectiveness study was not done. This device is an oximeter, which provides a direct physiological measurement, rather than an AI-driven image analysis tool that typically involves human interpretation.

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

Yes, the clinical validation was for the standalone performance of the FORE-SIGHT ELITE Absolute Tissue Oximeter. The accuracy values provided (0.05 ± 5.06% to 0.03 ± 5.69%) reflect the device's performance against the gold standard without human interpretation as part of the measurement. It's intended as an "adjunct monitor," meaning it provides data for clinicians but its core function is autonomous measurement.

7. The type of ground truth used:

Weighted co-oximetry reference of arterial and venous blood samples. These samples were drawn simultaneously from vascular locations appropriate to the tissue of interest (jugular bulb, central venous, umbilical venous) and weighted with a 30% arterial and 70% venous contribution.

8. The sample size for the training set:

The document does not explicitly state a separate training set size. The device was "designed and developed in accordance with CASMED development processes" and "verified and validated," which would include internal development and testing. The 136 subjects mentioned are for the clinical validation (test set) for substantial equivalence, not necessarily the internal training data for algorithm development.

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

This information is not explicitly provided for a training set. For the clinical validation (test set), as stated in point 7, the ground truth was established using weighted co-oximetry reference of arterial and venous blood samples. It's reasonable to infer that similar methods (or other physiological gold standards) would have been used during the device's internal development and refinement.

Summary

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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 10, 2015

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

Re: K143675

Trade/Device Name: Fore-Sight Elite Absolute Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: March 18, 2015 Received: March 19, 2015

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

\http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mitchell Stein

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number:	K143675
Device Name:	FORE-SIGHT ELITE® Absolute Tissue Oximeter.
Indications for Use:	The noninvasive FORE-SIGHT ELITE Absolute Tissue Oximeter isintended for use as an adjunct monitor of absolute regional hemoglobin oxygensaturation of blood under the sensors in individuals at risk for reduced flow orno-flow ischemic states and is indicated for use as follows:
	When used with Large Sensors, the FORE-SIGHT ELITE Oximeter is●indicated for use on adults and transitional adolescents ≥40 kg.When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is●indicated for use on pediatric subjects ≥3 kg.When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is●indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use onpediatric subjects <5 kg.
Prescription Use ✔(Part 21 CFR 801 Subpart D)	Over-the-Counter UseAND/OR(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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6. 510(k) Summary

Image /page/3/Picture/1 description: The image shows the word "CASMED" in a bold, red font. The letters are all capitalized and connected to each other. There is a registered trademark symbol to the right of the letter D.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K143675

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 22, 2014
Trade Name:	FORE-SIGHT ELITE® Absolute Tissue Oximeter
Common Name:	FORE-SIGHT Oximeter
Classification Name:	Oximeter, Tissue Saturation (870.2700) (MUD)
Predicate Device(s):

� FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor (K133879)
� FORE-SIGHT Absolute Tissue Oximeter Monitor (K112820)
❖ Nonin Model 7600 Regional Oximeter Equanox (K113215)

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DESCRIPTION

FORE-SIGHT Oximeter Monitor Intended Use

When used with large sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on adults and transitional adolescents ≥40 kg. When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥3 kg. When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.

FORE-SIGHT Monitor Technology Compared to Predicate Devices

The FORE-SIGHT ELITE Absolute Tissue Oximeter compares substantially to the cited predicate devices in that they use fundamentally the same optical operating principle, called multi-distance 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 Monitor 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.

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The following table compares design, materials, energy and others characteristics.

Characteristic	K143675 (thisSubmission)	CASMEDELITE	CASMEDK112820	NONINK113215	How TheyCompare
		K133879
FDA	Class II,	Class II,	Class II,	Class II,	Same
Classification	870.2700,	870.2700,	870.2700,	870.2700.
	MUD	MUD	MUD	MUD
Purpose	Detect	Detect	Detect	Detect	Same
	changing levels	changing levels	changing levels	changing levels
	in cerebral or	in cerebral or	in cerebral or	in cerebral or
	somatic	somatic	somatic	somatic
	oxygenated	oxygenated	oxygenated	oxygenated
	hemoglobin in	hemoglobin in	hemoglobin in	hemoglobin in
	sampled tissue	sampled tissue	sampled tissue	sampled tissue
Indicated For	Adults and	Adult and	Adults and	Adults and	Same as
	Pediatric	Transitional	Pediatric	Pediatric	CASMED
	subjectsdepending on	adolescents	subjects	subjects	predicate
	sensor size		depending onsensor size
Parameters	Single	Single	Single	Single	Same
Monitored
	Near-infrared	Near-infrared	Near-infrared	Near-infrared	Same
Technology	Spectroscopy	Spectroscopy	Spectroscopy	Spectroscopy
	(NIRS)	(NIRS)	(NIRS)	(NIRS)
Monitoring	4 - Channels	4 - Channels	2 - Channels	4 - Channels	Same as
Channels					CASMED
					predicate
System	Monitor,	Monitor,	Monitor,	Monitor,	Same
Components	Preamp,	Preamp,	Preamp,	Preamp,
	Sensor	Sensor	Sensor	Sensor
Power	100 to 240	100 to 240	110 to 240	100 to 240	Same as
Requirements	VAC 50/60 Hz	VAC 50/60 Hz	VAC 50/60 Hzand Lead Acid	VAC 50/60 Hz	CASMEDpredicate
	and Lead AcidBattery	and Lead AcidBattery	Battery	and Li-ionBattery
Sensor Size(s)	(4) Large,	(1) Large	(4) Large,	(2) sizes, one	Same as
	Medium, Small		Medium, Small	with adhesive,	CASMED
	and Small		and Small	one without	predicate
	Non-adhesive		Non-adhesive
Sensor Light	LED	LED	Laser Photo	LED	Same as most
Source			Diode		predicates
Operating	Continuous	Continuous	Continuous	Continuous	Same
Modes
Patient Contact	Medical	Medical	Medical	Unknown	Similar to
Material	Adhesive and	Adhesive	Adhesive and		CASMED
	Orthopedic		biocompatible		predicate
	foam/fabric		fabric (small
	composition		non-adhesive)
	(small non-
	adhesive)

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Non-Clinical Performance Testing to Demonstrate Substantial Equivalence

The FORE-SIGHT ELITE Absolute tissue Oximeter has successfully undergone extensive performance, (safety, electromagnetic, and system testing) to ensure it has been found to be substantially equivalent to the predicate devices. Evaluation for the safety of materials is assured by biological testing under the standard ISO10993-1. All testing is a product of the risk management process.

Test standards met:

Category	Testing Summary
Electrical Safety andUsability	ANSI/AAMI ES60601-1: (2005) IEC 60601-1-8: (2006) IEC 60601-1-6: (2010) IEC 62366: (2007)
Electromagnetic Testing	IEC 60601-1-2: (2007)
System Functional andPerformance Testing	The FORE-SIGHT ELITE Oximeter was designed and developed inaccordance with CASMED development processes and was verified andvalidated. Test results demonstrated that the oximeter complies with itspredetermined specification.

Clinical Testing to Show Substantial Equivalence

The FORE-SIGHT ELITE Absolute Tissue Oximeter was clinically validated for cerebral and noncerebral body locations on a demographically diverse population of 136 subjects at multiple institutions with ages ranging from 1 day to 17 years old including very low birth weight and premature neonates. Measurements of the tissue oxygenation were calibrated against a weighted co-oximetry reference of arterial and venous blood samples drawn simultaneously from vascular locations appropriate to the tissue of interest (jugular bulb, central venous, umbilical venous) with a 30% arterial and 70% venous contribution. Tissue saturations were obtained in the range of 48-96%. Accuracy was determined as a bias and precision to the weighted co-oximetry reference with values from 0.05 ± 5.06% to 0.03 ± 5.69% depending upon body location. No safety issues or adverse events related to the FORE-SIGHT ELITE Absolute Tissue Oximeter were encountered.

Conclusions Drawn from Clinical and Non-Clinical Testing

Clinical evaluation, safety testing and software validation demonstrate the FORE-SIGHT ELITE Absolute 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).