(120 days)
Not Found
No
The document describes a device that uses optical technology to measure tissue oxygen saturation. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an "adjunct monitor" to determine levels of blood oxygenation. It "measures a single parameter," and its data "should not be used as a sole basis for diagnosis or therapy," indicating it is a diagnostic/monitoring device, not a therapeutic one.
Yes
The device is intended to monitor absolute regional hemoglobin oxygen saturation of blood in individuals at risk for reduced flow or no-flow ischemic states, which provides information about the patient's physiological status, consistent with the function of a diagnostic device. However, it explicitly states that the data should not be used as the sole basis for diagnosis.
No
The device description explicitly mentions hardware components such as sensors, a monitor, LASER-SIGHT® Optical Technology, COOL-LIGHT™ sensor technology, and a rechargeable battery pack. The performance studies also mention hardware verification and validation.
Based on the provided information, 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.
- Device Function: The FORE-SIGHT Absolute Tissue Oximeter is a non-invasive device that measures oxygen saturation directly in the tissue using optical technology. It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring tissue oxygenation in individuals at risk of ischemic states, not diagnosing a condition based on laboratory analysis of a sample.
Therefore, the FORE-SIGHT Absolute Tissue Oximeter falls under the category of a non-invasive medical device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The noninvasive FORE-SIGHT® 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 Oximeter is indicated for use on the brain of adults and children over 40 Kg.
When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg.
When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg.
The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.
Product codes
MUD
Device Description
The FORE-SIGHT Absolute Tissue Oximeter measures a single parameter of oxygenated hemoglobin under the Sensor, allowing the clinican to continuously and accurately determine absolute levels of blood oxygenation in the tissue.
The Oximeter monitor features a LASER-SIGHT® Optical Technology generating 4 precise wavelenglis to optimize measurement of targeted hemoglobin states. COOL-LIGHT™ sensor technology ensures zero risk of patient burns. 3 sizes of sensors are available. The Oximeter is for continuous or spot checking use in a variety of hospital settings. A rechargeable battery pack permits the monitor to be used independently from an AC power source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain, skeletal muscle, abdomen
Indicated Patient Age Range
Adults, children, infants, neonates, adolescents
Intended User / Care Setting
Clinician, hospital settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The FORE-SIGHT® Absolute Tissue Oximeter has successfully undergone extensive performance, safety, electromagnetic, clinical, software and environmental testing to ensure it has been found to be substantially equivalent to the FORE-SIGHT predicate device. In addition to the above laboratory tests, CAS has conducted a full program of individual hardware, software and systems verification and validation studies of the FORE-SIGHT monitor and sensors.
The FORE-SIGHT Absolute Tissue Oximeter has successfully undergone extensive clinical study for the expanded indications for use especially for neonatal subjects. The premarket notification cites validation report "Validation of the CASMED FORE-SIGHT® Tissue Oximeter for Skeletal Muscle and Abdominal Tissue Oxygen Saturation (StO2%) in Pediatric and Neonatal Subjects".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
CASMED FORE-SIGHT ABSOLUTE TISSUE OXIMETER K112820 ADDITIONAL INFORMATION REQUEST Confidential
4 JAN 2012
Page 9 of 396
JAN 2 6 2012
Image /page/0/Picture/4 description: The image shows the word "CASMED" in a bold, sans-serif font. The letters are filled with a textured pattern, giving them a slightly rough appearance. A registered trademark symbol is present to the right of the letter "D".
510(k) SUMMARY
| Submitter: | CAS Medical Systems, Inc. |
|---|---|
| Address: | 44 East Industrial Rd. Branford CT. 06405 USA |
| Contact: | Ron Jeffrey - Director, Regulatory Affairs |
| Phone - (203) 315-6310 | |
| Fax - (203) 488-9438 | |
| Email – rjeffrey@casmed.com | |
| Prepared: | January 5, 2011 |
| Trade Name: | FORE-SIGHT® Absolute Tissue Oximeter |
| Common Name: | FORE-SIGHT Oximeter |
| Classification Name: | Oximeter, Tissue Saturation (870.2700) |
PREDICATE DEVICE
The FORE-SIGHT® Absolute Tissue Oximeter is equivalent to the following devices:
DESCRIPTION
The FORE-SIGHT Absolute Tissue Oximeter measures a single parameter of oxygenated hemoglobin under the Sensor, allowing the clinican to continuously and accurately determine absolute levels of blood oxygenation in the tissue.
The Oximeter monitor features a LASER-SIGHT® Optical Technology generating 4 precise wavelenglis to optimize measurement of targeted hemoglobin states. COOL-LIGHT™ sensor technology ensures zero risk of patient burns. 3 sizes of sensors are available. The Oximeter is for continuous or spot checking use in a variety of hospital settings. A rechargeable battery pack permits the monitor to be used independently from an AC power source.
INTENDED USE
The noninvasive FORE-SIGHT® 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 Oximeter is indicated for use on the brain of adults and children over 40 Kg.
1
4 JAN 2012
When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of suall adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg.
When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg,
The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.
FORE-SIGHT Monitor Technology Compared to Predicate Devices
The FORE-SIGHT Absolute Tissue Oximeter compares substantially to one or more of the cited predicate devices in that they use fundamentally the same optical operating principle, called 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 Monitor and predicate devices analyze the light that is returned after having passed through tissues. The analysis is for hemoglobin in is oxygenated and deoxygenated states. All cited monitors calculate oxygen saturation which reflects the percentage of oxygenated hemoglobin in the sampled tissue.
The FORE-SIGHT Absolute Tissue Oximeter is identical to the FORE-SIGHT predicate, except for the software and user interface modifications to support the expanded indications.
Non-Clinical Performance Testing to Demonstrate Substantial Equivalence
The FORE-SIGHT® Absolute Tissue Oximeter has successfully undergone extensive performance, safety, electromagnetic, clinical, software and environmental testing to ensure it has been found to be substantially equivalent to the FORE-SIGHT predicate device. In addition to the above laboratory tests, CAS has conducted a full program of individual hardware, software and systems verification and validation studies of the FORE-SIGHT monitor and sensors.
Clinical Testing to Show Substantial Equivalence
The FORE-SIGHT Absolute Tissue Oximeter has successfully undergone extensive clinical study for the expanded indications for use especially for neonatal subjects. The premarket notification cites validation report "Validation of the CASMED FORE-SIGHT® Tissue Oximeter for Skeletal Muscle and Abdominal Tissue Oxygen Saturation (StO2%) in Pediatric and Neonatal Subjects".
Conclusions Drawn from Clinical and Non-Clinical Testing
Clinical evaluation, safety testing and software validation demonstrate the FORE-SIGHT Absolute Tissue Oximeter is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal 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 its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 6 2012
CAS Medical Systems, Inc. c/o Mr. Ron Jeffrey Director, Regulatory Affairs 44 East Industrial Road Branford, CT 06405
Re: K112820
Trade/Device Name: FORE-SIGHT® Absolute Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: January 4, 2012 Received: January 9, 2012
Dear Mr. 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.
3
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 (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Debra Falls
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CASMED FORE-SIGHT ABSOLUTE TISSUE OXIMETER K112820 ADDITIONAL INFORMATION REQUEST Confidential
4 JAN 2012
Page 12 of 396
INDICATIONS FOR USE
510(k) Number K112820:
Device Name: FORE-SIGHT® Absolute Tissue Oximeter
Indications for Use:
The noninyasive FORE-SIGHT® 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 Oximeter is indicated for use on the brain of adults and children over 40 Kg.
When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg.
When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg.
The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.
Prescription Use AND/OR Over-The Counter Use
(PLEASE DO NOTR WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Dan I Kaufman MA
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K112820