FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER

K133879 · Cas Medical Systems, Inc. · MUD · Apr 29, 2014 · Cardiovascular

Device Facts

• Record ID: K133879
• Device Name: FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
• Applicant: Cas Medical Systems, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Apr 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

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 Oximeter is indicated for use on adults and transitional adolescents ≥ 40 kg.

Device Story

Noninvasive tissue oximeter; monitors absolute regional hemoglobin oxygen saturation (StO2) in tissue microvasculature. Inputs: light absorption signals (660-900 nm) from sensors placed on patient. Operation: monitor unit generates LED currents; dual-channel preamplifier amplifies detected light; algorithm processes absorption values and patient characteristics to calculate StO2. Output: numeric and real-time graphical display of StO2 for up to four sensors. Used in clinical settings by healthcare providers; supports remote viewing via VGA output. Data export via USB, RS-232, or wireless. Assists clinicians in identifying ischemic states; enables timely intervention to improve patient outcomes.

Clinical Evidence

Clinical validation performed for somatic tissue oxygen saturation (StO2%) in adult and transitional adolescent subjects. Validation report cited in premarket notification. Device underwent extensive clinical, hardware, software, and systems verification and validation studies.

Technological Characteristics

Multidistance diffuse reflectance spectroscopy; 660-900 nm wavelength range. Mains-powered with battery backup. Touchscreen interface; VGA output; USB, RS-232, and wireless connectivity. 4-channel sensor capability. Software-based algorithm for StO2 calculation.

Indications for Use

Indicated for adults and transitional adolescents ≥ 40 kg at risk for reduced flow or no-flow ischemic states.

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

• Nonin Model 7600 Regional Oximeter Equanox (K102715)
• FORE-SIGHT Absolute Tissue Oximeter Monitor (K112820)

Submission Summary (Full Text)

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## 6. 510(k) Summary

# APR 2 9 2014

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### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

| Submitter: | CAS Medical Systems, Inc. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Address: | 44 East Industrial Rd. Branford CT. 06405 USA |
| Contact: | Ron Jeffrey - Director, Regulatory Affairs<br>Phone - [phone]<br>Fax - [phone]<br>Email - [e-mail] |
| Prepared: | December 16, 2013 |
| Trade Name: | FORE-SIGHT Elite™ Absolute Tissue Oximeter |
| Common Name: | FORE-SIGHT Oximeter |
| Classification Name: | Oximeter, Tissue Saturation (870.2700) (MUD) |

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#### EQUIVALENCE (Predicate Device)

The FORE-SIGHT Elite™ Absolute Tissue Oximeter is equivalent to the following devices:

- * Nonin Model 7600 Regional Oximeter Equanox (K102715)
- & FORE-SIGHT Absolute Tissue Oximeter Monitor (K112820)

#### 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 sensor. The sensor uses 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, RS-232 serial or wireless communications.

#### FORE-SIGHT Oximeter Monitor Intended Use

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 as follows:

When used with large sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on adults and transitional adolescents >40 kg.

#### 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 multidistance diffuse reflectance spectroscopy. All cited monitors use light to examine a crosssection 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 FORE-SIGHT Elite Absolute Tissue Oximeter compares substantially to the predicates. All have 4-channel capability, an LED light source, similar user interface features and the benefits of portability.

#### Non-Clinical Performance Testing to Demonstrate Substantial Equivalence

The FORE-SIGHT Elite Absolute tissue Oximeter has successfully undergone extensive performance, safety, electromagnetic, clinical, software and environmental testing to ensure it has been found to be substantially equivalent to the predicate devices. In addition to the above laboratory tests, CAS has conducted a full program of individual hardware, software, systems verification and validation studies of the FORE-SIGHT monitor and sensors.

#### Clinical Testing to Show Substantial Equivalence

The FORE-SIGHT Elite Absolute Tissue Oximeter has successfully undergone extensive clinical validation for the indicated use. The premarket notification cites a validation report: Validation of the CAS Medical System's FORE-SIGHT Elite™ Absolute Tissue Oximeter for Somatic Tissue Oxygen Saturation (StO2%) in Adult and Transitional Adolescent Subjects.

#### 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.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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#### April 29, 2014

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

Re: K133879

> Trade/Device Name: Fore-Sight Elite Absolute Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Tissue Oximeter Regulatory Class: Class II Product Code: MUD Dated: March 28, 2014 Received: March 31, 2014

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 (sec 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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Page 2 - Ron Jeffrey

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 Small Manufacturers, International and Consumer Assistance at its toll-638-2041 or [phone] or at its its Internet address free number (800) 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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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#### K133879

## Indications for Use

510(k) Number:

FORE-SIGHT Elite™ Absolute Tissue Oximeter. Device Name:

Indications for Use:

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 Oximeter is indicated for use on adults and transitional adolescents ≥ 40 kg.

Prescription Use J (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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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