(107 days)
Not Found
No
The description mentions a "FORE-SIGHT algorithm" but provides no details suggesting it uses AI/ML techniques. The performance studies describe traditional statistical metrics (bias and precision) and calibration against a reference standard, not training or validation of an AI/ML model. There is no mention of AI, ML, DNN, or image processing.
No.
Explanation: The device is an adjunct monitor that measures absolute regional hemoglobin oxygen saturation. It provides information to clinicians but does not directly treat or prevent a medical condition.
Yes
Explanation: The device is described as an "absolute tissue oximeter" that measures "absolute regional hemoglobin oxygen saturation of blood." It is intended to be used by clinicians as an "adjunct monitor" for individuals at risk for "reduced flow or no-flow ischemic states" to help "continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2)." This monitoring provides information about a patient's physiological state to aid in medical diagnosis or treatment decisions.
No
The device description explicitly states that the Oximeter consists of a monitor unit, preamplifier assembly, and sensors, which are hardware components. While it includes a "FORE-SIGHT algorithm" (software), it is an integral part of a larger hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
- Device Function: The FORE-SIGHT ELITE Absolute Tissue Oximeter is a noninvasive device that measures hemoglobin oxygen saturation in the tissue using sensors placed on the skin. It does not analyze samples taken from the body.
Therefore, based on the provided information, the FORE-SIGHT ELITE Absolute Tissue Oximeter is a noninvasive medical device used for monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / 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 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
§ 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/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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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 | ||
| 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 |