(128 days)
No
The description mentions a "FORE-SIGHT algorithm" but provides no details suggesting it uses AI or ML. The focus is on light absorption measurements and standard signal processing.
No.
The device is described as a noninvasive tissue oximeter intended for monitoring absolute regional hemoglobin oxygen saturation, which is a diagnostic function, not a therapeutic one. It provides data to the clinician, allowing them to assess a patient's condition, but it does not directly treat or alleviate a medical condition.
Yes
Explanation: The device is described as an "adjunct monitor of absolute regional hemoglobin oxygen saturation of blood" and is intended to help clinicians determine "absolute levels of blood oxygenation in the tissue (StO2)." This function directly supports the diagnosis of conditions related to reduced blood flow or ischemic states by providing critical physiological data.
No
The device description explicitly states that the Oximeter consists of a module/monitoring unit, power and communication cables, and sensor cables, in addition to the software/algorithm. This indicates the presence of hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The description clearly states that the FORE-SIGHT ELITE Module Tissue Oximeter is a noninvasive device that measures hemoglobin oxygen saturation under the sensors placed on the skin. It does not involve the collection or analysis of biological samples like blood, urine, or tissue.
- The intended use is for in vivo monitoring. The device is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood in individuals. This indicates direct measurement on a living person, which is characteristic of in vivo diagnostics, not in vitro diagnostics.
Therefore, the FORE-SIGHT ELITE Module Tissue Oximeter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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 |
| Phone - (203) 488-6056 | |
| Fax - (203) 488-9438 | |
| Email - rjeffrey@casmed.com | |
| 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