The FORE-SIGHT® Cerebral Oximeter, Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain (SctO2). It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the FORE-SIGHT has not been demonstrated in disease states.

Device Description

The Cerebral Oximeter Monitor measures cerebral tissue oxygen saturation allowing the clinician to accurately determine absolute levels of brain tissue blood oxygen saturation and brain venous oxygen saturation in the brain. This measurement can be of significant value in numerous acute care (OR ICU. ER) situations, providing health care professionals with information to guard against neurological injuries due to compromised brain oxygenation, which can occur during many surgical and clinical procedures.

The Cerebral Oximeter Monitor consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display monitor with user interface. The non-invasive, reflection mode, optical transducer is placed on the forehead of the subject via a disposable sensor attachment to determine cerebral oxygenation. The Cerebral Oximeter Monitor is safe to use, because it is designed to operate as a Class I laser product, the safest FDA laser classification. Additional safety features include a laser interlock system designed to prevent laser operation in case the optical transducer is not securely attached to the subject. A patent-protected algorithm optimizes accuracy of the device for measurements of absolute cerebral tissue oxygen saturation ..

AI/ML Overview

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

Device: FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2000 Series

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as target values or thresholds in the provided document. Instead, the document presents the measured "Precision" (1 Standard deviation) of the device's SctO2 readings compared to a reference method, and implies that these precision values are considered acceptable for demonstrating substantial equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance
Precision (1 standard deviation) for SctO2 compared to reference method for Adult subjects over a spectrum of 45-95% SctO2	± 3.7 % (Adult SctO2: "The Precision (1 Standard deviation) for the Cerebral Oximeter Monitor SctO2 compared to reference SctO2 derived from co-oximetry of arterial (SaO2) and jugular bulb (SjvO2) blood samples was ± 3.7 %, based on Equation 1 below.")
Precision (1 standard deviation) for SctO2 compared to reference method for Pediatric subjects over a spectrum of 50-99% SctO2	± 4.86 % (Pediatric SctO2: "The Precision (1 Standard deviation) for the Cerebral Oximeter Monitor SctO2 compared to reference SctO, derived from co-oximetry of arterial (SaO) and jugular bulb (SivO2) blood samples was ± 4.86 %, based on Equation 1 below.")
Precision (1 standard deviation) for SctO2 compared to reference method for Infant & Neonate subjects over a spectrum of 50-99% SctO2	± 5.0 % (Infant & Neonate SctO2: "The Precision (1 Standard deviation) for the Cerebral Oximeter Monitor SctO2 compared to the reference SctO2 derived from pulse oximetry measured arterial oxygen saturation SaO2 and cooximetry measured internal jugular vein venous oxygen saturation (SjvO2) from blood samples was ± 5.0 %, based on Equation 1.")

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

The document provides information about the patient cohorts used for clinical validation, which serve as the test sets for demonstrating performance.

Adult Subjects:
- Sample Size: Not explicitly stated as a number of subjects. The text mentions "healthy adult volunteers."
- Data Provenance: Prospective. Data was collected at Duke University Medical Center in Durham, North Carolina, on currently enrolled subjects.
Infant & Neonate Subjects:
- Sample Size: "2044 hours of clinical data" were collected. The number of individual subjects is not specified.
- Data Provenance: Prospective. Data was collected at the Children's National Medical Center in Washington, DC, and the Children's Hospital of Atlanta (CHOA), Emory University, Atlanta, GA. Subjects were undergoing veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO).
Pediatric Subjects:
- Sample Size: Not explicitly stated as a number of subjects.
- Data Provenance: Prospective. Data was collected at Boston Children's Hospital in Boston, MA. Subjects were undergoing cardiac catheterization.

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

The ground truth was established through direct physiological measurements, not by expert interpretation. Experts (medical staff) were involved in the collection of these physiological samples and managing the patient protocols, but not in establishing an "expert consensus" ground truth.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct physiological measurements (blood samples analyzed by co-oximetry) which are considered objective. There was no need for expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

No, an MRMC comparative effectiveness study was not done. This device is a direct measurement device (oximeter), not an AI-assisted diagnostic tool that requires human interpretation. The clinical studies focused on validating the device's accuracy against direct physiological measurements.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance reported is inherently standalone. The FORE-SIGHT® Cerebral Oximeter Monitor provides a direct SctO2 reading. The clinical studies evaluated the accuracy of this reading by comparing it to reference physiological measurements, without human interpretation of the device's output influencing the reported performance metrics (precision).

7. The Type of Ground Truth Used

The ground truth used was physiological measurements (blood samples) analyzed by co-oximetry.

Adult and Pediatric: Reference SctO2 was derived from simultaneously drawn arterial (SaO2) and jugular bulb (SjvO2) blood samples, analyzed by a co-oximeter, and calculated using the formula: Reference SctO2% = SaO2 x 0.3 + SjvO2 x 0.7.
Infant & Neonate: Reference SctO2 was derived from pulse oximetry measured arterial oxygen saturation (SaO2) and co-oximetry measured internal jugular vein venous oxygen saturation (SjvO2) from blood samples, using the same formula mentioned above.

8. The Sample Size for the Training Set

The provided document describes clinical validation studies, which are typically for testing and not for training. It does not explicitly mention a "training set" or its sample size in the context of device development. The "patent-protected algorithm" for optimizing accuracy implies an internal development and calibration process, but details of the data used for that are not provided in this regulatory submission.

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

As no specific "training set" is described for algorithm development in this document, the method for establishing ground truth for it is also not detailed. Based on the validation methods, it's highly probable that similar physiological measurement techniques would have been used during the device's development and calibration phases.

Summary

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MAR 1 9 2009

and the county of

K 083892

and the country of the states and the commend of

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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 Affairs Phone - (203) 488-6056Fax – (203) 488-9438Email – rjeffrey@casmed.com
Prepared:	December 23, 2008
Trade Name:	FORE-SIGHT® Cerebral Oximeter Monitor
Common Name:	Model MC-2000 Series
Classification Name:	Cerebral Oximeter (870.2700)

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EQUIVALENCE (Predicate Device)

The FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2000 is equivalent to the following devices:

CAS Adult Cerebral Oximeter Model 2000 (K061960 / K073036)
- Somanetics INVOS® 5100C / 3100A Cerebral Oximeter (K001842 / K960614 / K051274 / K080769):
Spectros T-Stat™ 303 Microvascular Tissue Oximeter (K040684);
- Nellcor N395/N595 Pulse Oximeter (K991823 / K012891);
- Masimo SET Radical Pulse Oximeter (K031330);

DESCRIPTION

Cerebral Oximeter Monitor Intended Use

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Cerebral Oximeter Monitor Technology Compared to Predicate Devices

The FORE-SIGHT Cerebral Oximeter Monitor compares substantially to one or more of the cited predicate devices in that they use fundamentally the same optical operating principle, called diffuse reflectance spectroscopy. All cited monitors use light to probe a cross-section tissue microvasculature. (mixed bed of arterioles, capillaries and venules). The Cerebral Oximeter Monitor and predicate devices analyze light returning from tissue, after having passed through tissues, for hemoglobin in its oxygenated and deoxygenated forms in the optically sampled region. All cited monitors calculate oxygen saturation. This value reflects the percentage of oxygenated hemoglobin in the sampled tissue.

Non-Clinical Performance Testing to Demonstrate Substantial Equivalence

The Cerebral Oximeter Monitor has been tested to the following standards in accordance with CAS Medical Systems Product Performance Specifications. The following non-clinical tests have been performed:

UL 60601-1 Safety testing for use of the UL Classified mark: �
CAN/CSA C22.2 No. 601.1-M90 .
. IEC 60601-1 Safety of Medical Electrical Equipment;
EN 60601-1 Safety of Medical Electrical Equipment; �
IEC 60601-1-1 Safety of Medical Electrical Systems; .
IEC 60601-1-2: 2001 Safety of Medical Electrical Equipment with regard to EMC Emissions . and EMC Immunity;
0 IEC 60601-1-4 Safety of Programmable Electrical Medical Systems;
� IEC 60601-1-8 Safety of Alarm Systems for Medical Equipment/Systems;
IEC 60825-1: Safety of Laser Products (with amendments A1 and A2); .

In addition to the above laboratory tests, CAS has conducted a full compliment of individual hardware, software and systems monitor and sensor verification and validation studies.

Clinical Testing to Show Substantial Equivalence

Adult Subject Validation: Clinical data on adult subjects was collected at the Duke University Medical Center in Durham, North Carolina. In this study, healthy adult volunteers were subjects for comparison using an internal jugular bulb catheter on the subject's right side and a radial arterial line on the left. Two sensors from the FORE-SIGHT Cerebral Oximeter Monitor were placed bilaterally on the patient's forehead. Hypoxic mixtures of gas were delivered and data was collected in 5 minute intervals during periods of ascending and descending concentrations. At each data collection point, blood samples were drawn simultaneously from the jugular bulb and the radial arterial catheters and analyzed for hemoglobin oxygen saturation using a co-oximeter. The patient was monitored and the protocol stopped if SpO2 values from a pulse oximeter reached 70%.

Infant & Neonate Subject Validation: 2044 hours of clinical data was collected at the Children's National Medical Center in Washington, DC, and the Children's Hospital of Atlanta (CHOA), Emory University, Atlanta, GA, from subjects undergoing veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO) with cephalad catheterization. In this study, cerebral venous oxygen saturation (SjvO2) measured from blood samples obtained from the internal jugular vein via the cephalad catheter, along with pulse oximetry arterial oxygen saturation (SaQ2) data, were recorded from VV-ECMO neonates without alteration to patient care or blood oxygenation levels while being

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monitored by the FORE-SIGHT Cerebral Oximeter Monitor over a period of several days for each subject.

Pediatric Subject Validation: Clinical data on pediatric subjects were collected at Boston Children's Hospital in Boston. MA from subjects undergoing cardiac catheterization. In this study, cerebral venous oxygen saturation (SivO-) measured from blood samples obtained from the internal jugular vein, along with arterial oxygen saturation (SaOz) data, were recorded from cardiac catheterization subjects without alteration to patient care while being monitored by the FORE-SIGHT Cerebral Oximeter Monitor

Conclusions Drawn from Clinical and Non-Clinical Testing

The data is presented as Precision measured as one standard deviation for the cerebral tissue oxygen saturation (SctO2) parameter to determine the accuracy of the monitor.

Adult SctO .; Using the FORE-SIGHT Large sensor, the Cerebral Oximeter SctO2 showed a strong correlation with the reference SctO2 over the spectrum of values between 45 to 95%. The Precision (1 Standard deviation) for the Cerebral Oximeter Monitor SctO2 compared to reference SctO2 derived from co-oximetry of arterial (SaO2) and jugular bulb (SjvO2) blood samples was ± 3.7 %, based on Equation 1 below.

Pediatric SctO2: Using the FORE-SIGHT Medium sensor, the Cerebral Oximeter SctO2 showed a strong correlation with the reference SctO2 over the spectrum of values between 50 to 99%. The Precision (1 Standard deviation) for the Cerebral Oximeter Monitor SctO2 compared to reference SctO, derived from co-oximetry of arterial (SaO) and jugular bulb (SivO2) blood samples was ± 4.86 %, based on Equation 1 below.

Infant & Neonate SctO2: Using the FORE-SIGHT Small sensor, the Cerebral Oximeter SctO2 showed strong agreement with the reference Sct.O2 over the spectrum of values between 50 to 99%. The Precision (1 Standard deviation) for the Cerebral Oximeter Monitor SctO2 compared to the reference SctO2 derived from pulse oximetry measured arterial oxygen saturation SaO2 and cooximetry measured internal jugular vein venous oxygen saturation (SjvO2) from blood samples was ± 5.0 %, based on Equation 1.

Reference SctO2% = SaO2x 0.3 + SjvO2x 0.7

Equation I

The Cerebral Oximeter Monitor SctO2 value represents oxygen saturation in the brain tissue microvasculature containing venous and arterial blood volume at a ratio of 70:30.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, depicted with bold, black lines.

MAR 1 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K083892

Trade/Device Name: FORE-SIGHT™ Cerebral Oximeter Monitor, Model 2000 Series Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 23, 2008 Received: December 29, 2008

Dear Mr. 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.

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.

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

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Page 2 - Mr. Ron Jeffrey

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) 276-0115. 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 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,
Mark N. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K083892

Device Name:

FORE-SIGHT™ Cerebral Oximeter Monitor, Model 2000 Series.

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (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)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

Page 1 of 1

510(k) Number K083892

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).