(255 days)
No
The description mentions a "FORE-SIGHT algorithm" but provides no details suggesting it uses AI/ML techniques. The focus is on light absorption measurements and signal processing.
No.
The device is described as an "adjunct monitor" of oxygen saturation and hemoglobin levels, providing diagnostic information for clinicians to assess a patient's condition. It does not actively treat or intervene in a disease process.
Yes
This device is intended to monitor absolute regional hemoglobin oxygen saturation and relative changes in oxygenated, deoxygenated, and total hemoglobin, to assess individuals at risk for reduced flow or no-flow ischemic states. This information is used by clinicians to aid in diagnosis and monitoring of patient conditions.
No
The device description explicitly lists hardware components such as a signal acquisition and processing unit, power isolation box, cables, and sensors. It also describes the sensors using multiple wavelengths and the Module controlling measurement sequences and processing detected light signals.
Based on the provided information, the FORE-SIGHT ELITE Tissue Oximeter Module is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- Device Function: The FORE-SIGHT ELITE Tissue Oximeter Module is a noninvasive device that measures hemoglobin oxygen saturation and changes in hemoglobin concentrations under the sensor placed on the patient's tissue. It does not involve the collection or analysis of specimens taken from the body.
- Intended Use: The intended use describes it as an "adjunct monitor" of absolute and relative changes in blood oxygenation and hemoglobin in tissue. This is a noninvasive monitoring function, not an in vitro diagnostic test.
Therefore, the FORE-SIGHT ELITE Tissue Oximeter Module falls under the category of a noninvasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The noninvasive FORE-SIGHT ELITE Tissue Oximeter "Module" 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 Module is also intended for use as an adjunct monitor of relative changes of oxygenated hemoglobin, deoxygenated hemoglobin, and their summation, total hemoglobin, of blood under the sensors. The Module is intended to allow for the display of StO2 and regional hemoglobin on a third party display/patient monitor and is indicated for use as follows:
When used with large sensors, the Module is indicated for use on adults and transitional adolescents ≥40 kg. When used with medium sensors, the Module is indicated for use on pediatric subjects ≥3 kg. When used with small sensors, the Module 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).
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October 21, 2019
CAS Medical Systems, Inc. Ron Jeffrey Director, Regulatory Affairs 44 East Industrial Road Branford, Connecticut 06405
Re: K190270
Trade/Device Name: FORE-SIGHT ELITE Tissue Oximeter Module Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: February 6, 2019 Received: February 8, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190270
Device Name
FORE-SIGHT ELITE Tissue Oximeter Module
Indications for Use (Describe)
The noninvasive FORE-SIGHT ELITE Tissue Oximeter "Module" 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 Module is also intended for use as an adjunct monitor of relative changes of oxygenated hemoglobin, deoxygenated hemoglobin, and their summation, total hemoglobin, of blood under the sensors. The Module is intended to allow for the display of StO2 and regional hemoglobin on a third party display/patient monitor and is indicated for use as follows:
When used with large sensors, the Module is indicated for use on adults and transitional adolescents ≥40 kg. When used with medium sensors, the Module is indicated for use on pediatric subjects ≥3 kg. When used with small sensors, the Module is indicated for cerebral use on pediatric subjects Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K190270
510(k) Summary
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: | February 6, 2019 |
| Trade Name: | FORE-SIGHT ELITE® Tissue Oximeter Module |
| 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® Tissue Oximeter Module is equivalent to the following device:
FORE-SIGHT ELITE Tissue Oximeter Module (K180003);
REFERENCE DEVICE
- Hamamatsu Photonics Niro-200NX (K143219); ●
DESCRIPTION
The FORE-SIGHT ELITE Tissue Oximeter Module measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Module additionally measures relative changes in oxygenated and deoxygenated hemoglobin concentrations for assessment of oxygenation changes as well as their sum, total hemoglobin concentration, under the sensor.
The Oximeter Module consists of a signal acquisition and processing unit, power isolation box, host 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 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 provides simultaneous measurements on up to two Sensors.
The Module is a host-powered device. The host configures the Oximeter and provides applicable audible, on-screen, and dedicated visual alarm indicators. The host monitor also provides numeric and/or realtime graphical display for tissue blood oxygenation saturation and changes in hemoglobin concentrations. 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 Tissue Oximeter Module 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 Module is also intended for use as an adjunct monitor of relative changes of oxygenated hemoglobin, deoxygenated hemoglobin, and their summation, total hemoglobin, of blood under the sensors. The Module is intended to allow for the display of StO2 and regional hemoglobin on a third party display/patient monitor and is indicated for use as follows: When used with large sensors, the Module is indicated for use on adults and transitional adolescents ≥40 kg. When used with medium sensors, the Module is indicated for use on pediatric subjects ≥3 kg. When used with small sensors, the Module is indicated for cerebral use on pediatric subjects 1 Validations performed on healthy adult volunteers (Age: 19 to 40 years, BMI: 18 to 30.5, Gender: 12 Male and 13 Fementation: 15 Light, 5 Moderate, 5 Dark)
2 Validations performed on healthy volunteer subjects (Age: 19 to 40 years, BMI: 18 to 31.6, Gender: 22 Male and 21 Female, Skin Pigmentation: 21 Light, 14 Moderate, and 8 Dark). Convenience sample measurements evaluated on cardiac surgical patients undergoing cardiopulmonary bypass procedures (Age: 47 to 89 years, BMI: 23.8 to 29.6, Gender: 3 Male and 2 Female, Skin Pight, 1 Moderate).
3 Performance on cardiac surgical patients evaluated using convenients on pediatric patients undergoing interventional catheterization procedures (Age: 0.4 to 9.2 years, BMI: 14.1 to 18.2, Gender: 4 Male and 1 Female, Skin Pigmentation: 2 Light, 1 Moderate, 2 Dark).
Unlike the other FORE-SIGHT ELITE validation studies, this cerebral validation study did not include invasive measurements because of the challenge for medical centers to obtain consent to internal jugular venous catheter in very small subjects.
StO2 data was averaged in two-minute windows for term, premature low birth weight (LBW), and very low birth weight (VLBW) neonates for the following reasons: 1) to reduce the influence of acute changes in body position or touch as the hemodynamics BW and VLBW neonates are not as stable compared to normal birth weight neonates, and 2) to enable measurements for both 3010 and FORE-SIGHT ELITE Sensors or across multiple abdominal locations at nominally the same time for the tes for which only one Sensor can be fitted on the head or specific abdominal location