FORE-SIGHT, MC-2000 SERIES

K073036 · Cas Medical Systems, Inc. · DQA · Feb 25, 2008 · Cardiovascular

Device Facts

• Record ID: K073036
• Device Name: FORE-SIGHT, MC-2000 SERIES
• Applicant: Cas Medical Systems, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The non-invasive FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2040 should be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain. When used with FORE-SIGHT Large sensors, the Cerebral Oximeter Monitor is indicated for use with adults and children over 40 Kg. When used with FORE-SIGHT Small sensors, the Cerebral Oximeter Monitor is indicated for infants and neonates 2.5 Kg. and above. The Cerebral Oximeter Monitor should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the Cerebral Oximeter Monitor has not been demonstrated in disease states.

Device Story

FORE-SIGHT Cerebral Oximeter Monitor (Model MC-2000) provides non-invasive, real-time monitoring of cerebral tissue oxygen saturation (SctO2). System comprises optical transducer (laser light source, photodiode detectors) and graphic display monitor. Transducer placed on forehead; uses diffuse reflectance spectroscopy to measure oxygenated/deoxygenated hemoglobin in microvasculature. Patent-protected algorithm calculates absolute SctO2. Used in acute care settings (OR, ICU, ER) by clinicians to guard against neurological injury from compromised oxygenation. Provides quantitative data to assist clinical decision-making; not intended as sole diagnostic tool. Includes laser interlock safety feature.

Clinical Evidence

Adult validation: healthy volunteers, comparison of SctO2/SvO2 vs. jugular bulb catheter/radial arterial line co-oximetry during hypoxic gas challenges. RSME for SctO2 ±3.70% (45-95% range); RSME for SvO2 ±5.26% (35-90% range). Infant/Neonate validation: 2030 hours of data from neonates on VV-ECMO; comparison of SctO2 vs. internal jugular vein co-oximetry and pulse oximetry. RSME for SctO2 ±4.77% (50-95% range).

Technological Characteristics

Class I laser product; optical transducer with laser source and photodiode detectors. Uses diffuse reflectance spectroscopy. Connectivity: standalone monitor. Safety standards: IEC 60601-1, IEC 60825-1 (laser safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms). Software: programmable electrical medical system (IEC 60601-1-4).

Indications for Use

Indicated for adjunct monitoring of regional cerebral hemoglobin oxygen saturation. Large sensors: adults and children >40kg. Small sensors: infants and neonates ≥2.5kg. Not for use as sole basis for diagnosis or therapy; clinical value in disease states not demonstrated.

Regulatory Classification

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.

Predicate Devices

• CAS Adult Cerebral Oximeter Model 2040 (K051257)
• Somanetics INVOS® 5100 / 3100A Cerebral Oximeter (K001842 / K960614)
• Spectros T-Stat™ 303 Microvascular Tissue Oximeter (K040684)
• Nellcor N395/N595 Pulse Oximeter (K991823 / K012891)
• Masimo SET Radical Pulse Oximeter (K031330)

Submission Summary (Full Text)

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K073036

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Image /page/0/Picture/1 description: The image shows a logo with the word "CASIO" in a stylized font. The letters are filled with a pattern of small dots, giving them a textured appearance. To the right of the word, there is a circled "R" symbol, indicating that the logo is a registered trademark. The logo has a simple, yet recognizable design.

# 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 - [phone] Fax – [phone] Email - [e-mail] Prepared: February 1, 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 2040 (K051257)
- * Somanetics INVOS® 5100 / 3100A Cerebral Oximeter (K001842 / K960614);
- * Spectros T-Stat™ 303 Microvascular Tissue Oximeter (K040684);
- * Nellcor N395/N595 Pulse Oximeter (K991823 / K012891);
- * Masimo SET Radical Pulse Oximeter (K031330);

### 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..

### Cerebral Oximeter Monitor Intended Use

The non-invasive FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2040 should be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain. When used with FORE-SIGHT Large sensors, the Cerebral Oximeter Monitor is indicated for use with adults and children over 40 Kg. When used with FORE-SIGHT Small sensors, the Cerebral Oximeter Monitor is indicated for infants and neonates 2.5 Kg. and above. The Cerebral Oximeter Monitor should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the Cerebral Oximeter Monitor has not been demonstrated in disease states.

#### 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

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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;
- . 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 program of 22 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: 2030 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 cathererization. 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 (SaO2) data, were recorded from VV-ECMO neonates without alteration to patient care or blood oxygenation levels while being monitored by the FORE-SIGHT Cerebral Oximeter Monitor over a period of several days for each subject.

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### Conclusions Drawn from Clinical and Non-Clinical Testing

The data is presented as Root Mean Squared Error (RSME = $\sqrt{(bias^2 + precision^2)}$) for each measured parameter to determine the accuracy of the monitor. RSME accounts for errors relating to both the bias and precision (1 standard deviation) in calculating accuracy. Note that RSME values are approximately equal to the precision or one standard deviation when the bias is small.

Adult SetO2: 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 RSME for the Cerebral Oximeter Monitor SctO2 compared to reference SctO2 derived from cooximetry of arterial (SaO2) and jugular bulb (SjvO2) blood samples was ± 3.70 %, based on Equation 1 below.

Infant & Neonate SctO2: Using the FORE-SIGHT Small sensor, the Cerebral Oximeter SctO2 showed strong agreement with the reference SctO2 over the spectrum of values between 50 to 95%. The RSME (1 standard deviation) for the Cerebral Oximeter Monitor SctO2 compared to the reference SctO2 derived from pulse oximetry measured arterial oxygen saturation SaO2 and co-oximetry measured internal jugular vein venous oxygen saturation (Sjv() from blood samples was ± 4.77 %, based on Equation 1.

$$\text{Reference } \mathsf{SctO}_2\% = \mathsf{Sa}O_2 \ge 0.3 + \mathsf{Sy}\nu O_2 \ge 0.7 \tag{2}$$

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.

Adult SvO2: Using the FORE-SIGHT Large sensor, the Cerebral Oximeter SvO2 showed a strong correlation with the reference SjvO2 over the spectrum of values between 35 to 90%. The RSME for the Cerebral Oximeter Monitor SvO2 compared to reference SjvO2, derived from cooximetry of the jugular bulb blood samples was ± 5.26 %. SvO2 was determined from Equation 2 below.

$$\text{CaV}_2\text{=} \left(\text{Sct}\,O_2 - \text{Sa}O_2 \ge 0.3\right) / 0.7$$

#### Equation 2

In the above expression, SaO2 is arterial oxygen saturation from a pulse oximeter and SctO2 is determined by the FORE-SIGHT Cerebral Oximeter Monitor.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

FEB 2 5 2008

Re: K073036

Trade/Device Name: FORE-SIGHT® Cerebral Oximeter Monitor, Model MC 2000 Series Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: February 4, 2008 Received: February 6, 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 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.

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Page 2 – Mr. Ron Jeffrey

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M Wilkerson

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

Enclosure

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## Indications for Use

510(k) Number (if known): K073036

Device Name:

FORE-SIGHT® Cerebral Oximeter, Model MC-2000 Series

Indications for Use: The non-invasive FORE-SIGHT Cerebral Oximeter Model MC-2000 should be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain. When used with FORE-SIGHT large sensors, the Cerebral Oximeter Monitor is indicated for use with adults and children over 40Kg. When used with FORE-SIGHT small sensors, the Cerebral Oximeter Monitor is indicated for infants and neonates 2.5Kg and above. The Cerebral Oximeter Monitor System should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the oximeter has not been demonstrated in disease states.

V 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)

Mark A. Mellman

Page 1 of

Division of General, Res

alle Neurologica. Dornes

510(k) Number