(220 days)
Not Found
No
The summary mentions a "patent-protected algorithm" but does not provide any details suggesting it utilizes AI or ML techniques. The focus is on optical measurement and signal processing.
No.
The device is described as an "adjunct monitor" that provides "information to guard against neurological injuries" by measuring brain oxygenation, and is explicitly stated "should not be used as the sole basis for decisions as to the diagnosis or therapy." This indicates it is a diagnostic or monitoring tool, not one that directly treats or prevents a condition.
No
The device is described as an "adjunct monitor of regional hemoglobin oxygen saturation" and states it "should not be used as the sole basis for decisions as to the diagnosis or therapy." This indicates it provides information to aid clinical decision-making, rather than directly making a diagnosis.
No
The device description explicitly states that the device consists of both hardware components (optical transducer, graphic display monitor) and software (patent-protected algorithm).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 Adult Cerebral Oximeter Model 2040 is a non-invasive device that measures regional hemoglobin oxygen saturation of blood in the brain directly on the patient's forehead using optical methods. 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 regional hemoglobin oxygen saturation in the brain. This is a monitoring function performed on the living subject, not a diagnostic test performed on a sample.
- Device Description: The description emphasizes the non-invasive nature and the use of an optical transducer placed on the forehead.
- Performance Studies: The performance studies compare the device's readings to measurements obtained from invasive methods (jugular bulb catheter and arterial line) and co-oximetry of blood samples, but the device itself is not performing the analysis on these samples.
Therefore, because the device operates non-invasively on the patient and does not analyze specimens taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The non-invasive Adult Cerebral Oximeter Model 2040 should be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. The Cerebral Oximeter Monitor System should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the Cerebral Oximeter Monitoring System has not been demonstrated in disease states.
Product codes
DQA
Device Description
The Adult Cerebral Oximeter, model 2040 measures brain oxygenation allowing the clinician to accurately determine absolute levels of tissue and venous oxygenation in the brain. This measurement can be of significant value in numerous acute care (OR, ICU, ER) situations, providing health care professionals with information to guard against neurological injuries due to compromised brain oxygenation, which can occur during many surgical and clinical situations.
The 2040 Cerebral Oximeter consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display monitor with user interface. The non-invasive, reflection mode, optical transducer is placed on the forehead of the subject via a disposable probe attachment to determine cerebral oxygenation. The 2040 Cerebral Oximeter will be safe to use, since it is designed to operate as a Class I laser product, the safest FDA laser classification. Additional safety features include a laser interlock system designed to prevent laser operation in case the optical transducer is not securely attached to the subject. A patent-protected algorithm optimizes accuracy of the device in measurements of absolute brain tissue oxygen saturation and, in conjunction with pulse oximetry, in providing absolute readings of brain venous oxygen saturation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical transducer
Anatomical Site
brain
Indicated Patient Age Range
adult
Intended User / Care Setting
clinician, health care professionals in acute care (OR, ICU, ER) situations
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
Clinical data on adult subjects was collected at the Duke University Medical Center in Durham, North Carolina. In this study, healthy adult volunteers were subjects for comparison using an internal jugular bulb catheter on the subject's right side and a radial arterial line on the left. Two sensors from the cerebral oximeter model 2040 were placed on the patient's forehead, on the right and left sides respectively. Hypoxic mixtures of gas were delivered and data was collected a different periods of ascending and descending concentrations in 5 minute intervals. At set points, blood samples were drawn simultaneously from the jugular bulb and the radial arterial catheters and analysis for oxygen tension was performed using a co-oximeter. The patient was monitored and protocol stopped if Sp02 values from a pulse oximeter reached
§ 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/1 description: The image shows the logo for CAS Medical Systems, Inc. The logo includes the company name in bold, uppercase letters, with the tagline "TECHNOLOGY APPLIED TO MEDICINE" underneath. The address "44 EAST INDUSTRIAL ROAD, BRANFORD, CONNECTICUT 06405" is printed below the tagline.
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203-488-6056 (FAX) 203-488-9438
DEC 2 2 2005
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: | May 9, 2005 |
| Trade Name: | Adult Cerebral Oximeter Monitor |
| Common Name: | Model 2040 Monitor |
| Classification Name: | Cerebral Oximeter (870.2700) |
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Kosis2
EQUIVALENCE (Predicate Device)
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The Adult Cerebral Oximeter Monitor, Model 2040 is equivalent to the following devices:
- Somanetics Invos® 5100 / 3100A Cerebral Oximeter (K001842 / K960614);
- Spectros T-Stat™ 303 Microvascular Tissue Oximeter (K040684); な
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- Hitachi Medical ETG-4000 / 1000 Optical Topography System (K042501 / 011320).
DESCRIPTION
The Adult Cerebral Oximeter, model 2040 measures brain oxygenation allowing the clinician to accurately determine absolute levels of tissue and venous oxygenation in the brain. This measurement can be of significant value in numerous acute care (OR, ICU, ER) situations, providing health care professionals with information to guard against neurological injuries due to compromised brain oxygenation, which can occur during many surgical and clinical situations.
The 2040 Cerebral Oximeter consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display monitor with user interface. The non-invasive, reflection mode, optical transducer is placed on the forehead of the subject via a disposable probe attachment to determine cerebral oxygenation. The 2040 Cerebral Oximeter will be safe to use, since it is designed to operate as a Class I laser product, the safest FDA laser classification. Additional safety features include a laser interlock system designed to prevent laser operation in case the optical transducer is not securely attached to the subject. A patent-protected algorithm optimizes accuracy of the device in measurements of absolute brain tissue oxygen saturation and, in conjunction with pulse oximetry, in providing absolute readings of brain venous oxygen saturation ..
Adult Cerebral Oximeter Intended Use
The non-invasive Adult Cerebral Oximeter Model 2040 should be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. The Cerebral Oximeter Monitor System should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the Cerebral Oximeter Monitoring System has not been demonstrated in disease states.
Device Technological Characteristics Comparing Device to Predicates
The Adult Cerebral Oximeter, Model 2040 compares substantially to one or more of the predicates cited in that they use fundamentally the same optical operating principle, called diffuse reflectance spectroscopy. All monitors use light to probe a cross-section of the microvasculature of tissue (mixed bed of arterioles, capillaries and venuoles). The 2040 and predicates analyze light returning from tissue, after having passed through tissues, for hemoglobin in its oxygenated and dcoxygenated forms in the optically sampled region. All calculate tissue oxygen saturation (%St02), a value reflecting percentage of oxygenated hemoglobin in the sampled mircovasculature of tissue.
Nonclinical Performance Testing to Show Substantial Equivalence
The Adult Cerebral Oximeter, Model 2040 will be tested in accordance with the following standards as per CAS Product Performance Specifications prior to release to market. The following non-clinical tests will be performed:
Image /page/1/Picture/16 description: The image is a black and white photograph. The left side of the image is mostly black, while the right side of the image is a mix of black and white. The black and white mix on the right side of the image appears to be some kind of texture. The image is mostly dark, with some light areas on the right side.
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UL60601-1 (w/ CSA 22.2 No. 60601-1) Safety testing for use of the UL Classified mark;
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IEC60601-1 Safety of Medical Electrical Equipment; .
05125 -
EN60601-1-2: 2001 Safety of Medical Electrical Equipment with regard to EMC Emissions . and EMC Immunity;
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EN 865 Pulse Oximeters (CAS VP/VR 050022) Particular Requirements (as applicable); .
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Testing specified in the Reviewer Guidance for Premarket Notification Submissions (CAS . 21-07-0076)
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VP/VR 050012 System Validation Plan .
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VP/VR 050013 System IPX1 Verification Plan
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VP/VR 050014 Hardware Verification Plan .
Clinical Testing to Show Substantial Equivalence
Clinical data on adult subjects was collected at the Duke University Medical Center in Durham, North Carolina. In this study, healthy adult volunteers were subjects for comparison using an internal jugular bulb catheter on the subject's right side and a radial arterial line on the left. Two sensors from the cerebral oximeter model 2040 were placed on the patient's forehead, on the right and left sides respectively. Hypoxic mixtures of gas were delivered and data was collected a different periods of ascending and descending concentrations in 5 minute intervals. At set points, blood samples were drawn simultaneously from the jugular bulb and the radial arterial catheters and analysis for oxygen tension was performed using a co-oximeter. The patient was monitored and protocol stopped if Sp02 values from a pulse oximeter reached