FORE-SIGHT ELITE Module Tissue Oximeter

K180003 · Cas Medical Systems, Inc. · MUD · May 10, 2018 · Cardiovascular

Device Facts

• Record ID: K180003
• Device Name: FORE-SIGHT ELITE Module Tissue Oximeter
• Applicant: Cas Medical Systems, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: May 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Device is a tissue oximeter module providing absolute regional hemoglobin oxygen saturation (StO2) measurements. Input: light absorption data from sensors using multiple wavelengths (660-900 nm) placed on tissue. Operation: module generates LED currents, processes detected light signals via multidistance diffuse reflectance spectroscopy, and applies FORE-SIGHT algorithm to calculate StO2. Output: numeric and real-time graphical StO2 values displayed on third-party host monitors via USB/serial interfaces. Used in clinical settings by healthcare providers to monitor patients at risk for ischemic states. Output assists clinicians in assessing tissue oxygenation, enabling timely clinical intervention to prevent ischemic injury.

Clinical Evidence

No new clinical trials conducted. Substantial equivalence supported by clinical validation data from predicate K143675 and earlier CASMED notifications. Clinical Equivalency Report (21-07-0542) documents that StO2 performance of the module is statistically equivalent to the predicate monitor.

Technological Characteristics

Multidistance diffuse reflectance spectroscopy; LED light source (660-900 nm); host-powered module; USB/serial connectivity; supports small, medium, and large sensors; provides simultaneous measurements for up to two sensors.

Indications for Use

Indicated for individuals at risk for reduced flow or no-flow ischemic states. Large sensors: adults and transitional adolescents ≥40 kg. Medium sensors: pediatric subjects ≥3 kg. Small sensors: cerebral use for pediatric subjects <8 kg; non-cerebral use for pediatric subjects <5 kg.

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

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

Reference Devices

• Multi-parameter Mobile Careguide 4100 Oximeter (K141496)
• Mobile Careguide 2100 Oximeter (K122645)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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 Affairs<br>Phone - [phone]<br>Fax - [phone]<br>Email - [e-mail] |
| 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 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.

#### 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.