ADULT CEREBRAL OXIMETER, MODEL 2040

K051257 · Cas Medical Systems, Inc. · DQA · Dec 22, 2005 · Cardiovascular

Device Facts

• Record ID: K051257
• Device Name: ADULT CEREBRAL OXIMETER, MODEL 2040
• Applicant: Cas Medical Systems, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

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 Story

The Model 2040 Cerebral Oximeter is a non-invasive monitor used in acute care settings (OR, ICU, ER) by healthcare professionals to assess brain oxygenation. It utilizes an optical transducer placed on the patient's forehead, containing a laser light source and photodiode detectors. The device employs diffuse reflectance spectroscopy to analyze light returning from the microvasculature, measuring oxygenated and deoxygenated hemoglobin. A patent-protected algorithm calculates absolute brain tissue oxygen saturation (StO2) and, when combined with pulse oximetry, provides absolute readings of brain venous oxygen saturation (SvO2). The system includes a laser interlock for safety. Clinicians use the displayed saturation values as an adjunct to other clinical information to monitor for potential neurological injury due to compromised brain oxygenation, aiding in clinical decision-making during surgical or acute care procedures.

Clinical Evidence

Clinical study conducted at Duke University Medical Center on healthy adult volunteers. Subjects underwent controlled hypoxic gas mixtures while monitored with the Model 2040 sensors on the forehead and reference internal jugular bulb/radial arterial catheters. Blood samples were analyzed via co-oximetry. Results showed strong correlation with reference values (StO2 bias 0.43 ± 3.78; SvO2 bias 0.63 ± 5.38) across SpO2 ranges of 70-100%.

Technological Characteristics

Optical transducer with laser light source and photodiode detectors; operates via diffuse reflectance spectroscopy. Class I laser product with laser interlock system. Graphic display monitor with user interface. Connectivity includes disposable probe attachment. Tested to UL60601-1, IEC60601-1, EN60601-1-2, and EN 865 standards.

Indications for Use

Indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation in the brain of adult patients. Not for use as the sole basis for diagnosis or therapy. Clinical utility in specific disease states has not been demonstrated.

Regulatory Classification

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.

Predicate Devices

• Somanetics Invos® 5100 / 3100A Cerebral Oximeter (K001842 / K960614)
• Spectros T-Stat™ 303 Microvascular Tissue Oximeter (K040684)
• Hitachi Medical ETG-4000 / 1000 Optical Topography System (K042501 / 011320)

Submission Summary (Full Text)

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K051257

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<br>Phone - [phone] Fax - [phone]<br>Email – [e-mail] |
| 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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#### 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
- * 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:

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- UL60601-1 (w/ CSA 22.2 No. 60601-1) Safety testing for use of the UL Classified mark;

- IEC60601-1 Safety of Medical Electrical Equipment; .
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- EN60601-1-2: 2001 Safety of Medical Electrical Equipment with regard to EMC Emissions . and EMC Immunity;
- EN 865 Pulse Oximeters (CAS VP/VR 050022) Particular Requirements (as applicable); .
- Testing specified in the Reviewer Guidance for Premarket Notification Submissions (CAS . 21-07-0076)
- VP/VR 050012 System Validation Plan .
- VP/VR 050013 System IPX1 Verification Plan
- 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 <70%.

## Conclusions Drawn from Clinical and Nonclinical Testing

The model 2040 St02 showed a strong correlation with the reference St02 over the spectrum of Sp02 values between 70 and 100%. The bias and precision (1 standard deviation) for the model 2040 St02 compared to reference St02 derived from co-oximetry of arterial (Sa02) and jugular bulb (Sjb02) blood samples was 0.43 ± 3.78, based on the following expression:

Reference St02% = Sa02 x 0.3 + Sjb02 x 0.7

The cerebral oximeter St02 value represents oxygen saturation in the brain tissue microvasculature containing venous and arterial blood volume at a ratio of 70:30. The model 2040 Sv02 showed a strong correlation with the reference SjbO2 over the spectrum of Sp02 values between 70 and 100%. The bias and precision for the model 2040 Sv02 compared to reference Sjb02, derived from cooximetry of the jugular bulb blood samples was 0.63 ± 5.38. Sv02 was determined from the following expression:

Sv02 = (St02 - Sp02 x 0.3) / 0.7

In the above expression, Sp02 is arterial oxygen saturation from a pulse oximeter and St02 is determined by the cerebral oximeter.

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Public Health Service

DEC 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ron Jeffrey Director, Regulatory Affairs CAS Medical Systems, Inc. 44 East Industrial Road Branford, Connecticut 06405

Re: K051257

Trade/Device Name: Adult Cerebral Oximeter Monitor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 2, 2005 Received: December 5, 2005

Dear Mr. Jeffrey:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(x) premaine is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manatise provide Americal Device American be of Development commerce prior to May 26, 1776, the enactinent with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the device, seeject to the of
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 acon controls. Existing major regulations affecting your device it may be subject to such additional vontrols. Title 21, Parts 800 to 898. In addition, FDA can be found in the Ood of Features concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that i Dri 3 issuates of a occession of the requirements of the Act that TDA has made a decemmation that your is a your is the Federal agencies. You must or any rederal statutes and regulations and adding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elcotronic forth in the quality byovens (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification: "The PDF in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice ion your as [phone]. Also, please note the regulation entitled, Collider the Office of Compulation (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Barbara Brehm

Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Adult Cerebral Oximeter, Model 2040

05/257

510(k) Number (if known):

Device Name:

Indications for Use:

The non-invasive Adult Cerebral Oximeter Model 2040 should The non-invasive Adult Sonitor of regional hemoglobin oxygen be used as an adjunts monin of an adult. The Cerebral Oximeter Monitor System should not be used as the sole Oximeler Monitor Oyoton is or the diagnosis or therapy. The value basis for decisions as to the critical oximeter Monitoring System has not been demonstrated in disease states.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use_ (21 CFR 807 Subpart C)

(Please do not write below this line – continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Xaubaro BneuuD

510(k) I

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Division of General, Restorative, and Neurological Devices

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