FORE-SIGHT Elite Absolute Tissue Oximeter

K143675 · Cas Medical Systems, Inc. · MUD · Apr 10, 2015 · Cardiovascular

Device Facts

• Record ID: K143675
• Device Name: FORE-SIGHT Elite Absolute Tissue Oximeter
• Applicant: Cas Medical Systems, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Apr 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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 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 Story

Noninvasive monitor of absolute regional hemoglobin oxygen saturation (StO2) in tissue microvasculature; uses multi-distance diffuse reflectance spectroscopy. Input: light absorption signals from tissue via sensors (660-900 nm). Processing: monitor unit controls LED currents, amplifies signals, and applies algorithm to determine StO2. Output: continuous numeric and real-time graphical display of StO2 values for up to four sensors. Used in clinical settings by healthcare providers; provides adjunct data for monitoring ischemic risk. Features touchscreen interface, audible/visual alarms, and data export (USB/RS-232). Benefits: provides clinicians with absolute oxygenation levels to inform decision-making regarding patient perfusion status.

Clinical Evidence

Clinical validation study on 136 subjects (ages 1 day to 17 years, including premature neonates). Measurements calibrated against weighted co-oximetry reference (30% arterial/70% venous blood samples). Tissue saturations ranged 48-96%. Accuracy (bias and precision) reported between 0.05 ± 5.06% and 0.03 ± 5.69% depending on body location. No adverse events reported.

Technological Characteristics

Multi-distance diffuse reflectance spectroscopy; 660-900 nm LED light source. Components: monitor unit, preamplifier, and sensors (Small, Medium, Large). Materials: medical adhesive and orthopedic foam/fabric (ISO 10993-1 compliant). Power: 100-240 VAC, 50/60 Hz with lead-acid battery backup. Connectivity: USB, RS-232, VGA video output. Software-based signal processing.

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 on pediatric subjects <8 kg; non-cerebral use on 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 (K133879)
• FORE-SIGHT Absolute Tissue Oximeter Monitor (K112820)
• Nonin Model 7600 Regional Oximeter Equanox (K113215)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 is<br>intended for use as an adjunct monitor of absolute regional hemoglobin oxygen<br>saturation of blood under the sensors in individuals at risk for reduced flow or<br>no-flow ischemic states and is indicated for use as follows: | | |
| | When used with Large Sensors, the FORE-SIGHT ELITE Oximeter is<br>●<br>indicated for use on adults and transitional adolescents ≥40 kg.<br>When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is<br>●<br>indicated for use on pediatric subjects ≥3 kg.<br>When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is<br>●<br>indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on<br>pediatric subjects <5 kg. | | |
| Prescription Use ✔<br>(Part 21 CFR 801 Subpart D) | Over-the-Counter Use<br>AND/OR<br>(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)

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

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.

#### 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. 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 (this<br>Submission) | CASMED<br>ELITE | CASMED<br>K112820 | NONIN<br>K113215 | How They<br>Compare |
|-----------------|------------------------------|--------------------------|-------------------------------|-----------------------|---------------------|
| | | 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 |
| | subjects<br>depending on | adolescents | subjects | subjects | predicate |
| | sensor size | | depending on<br>sensor 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 Hz<br>and Lead Acid | VAC 50/60 Hz | CASMED<br>predicate |
| | and Lead Acid<br>Battery | and Lead Acid<br>Battery | Battery | and Li-ion<br>Battery | |
| 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 and<br>Usability | 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 and<br>Performance Testing | The FORE-SIGHT ELITE Oximeter was designed and developed in<br>accordance with CASMED development processes and was verified and<br>validated. Test results demonstrated that the oximeter complies with its<br>predetermined 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.