FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
Device Facts
| Record ID | K094030 |
|---|---|
| Device Name | FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 |
| Applicant | Cas Medical Systems, Inc. |
| Product Code | MUD · Cardiovascular |
| Decision Date | Dec 23, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The FORE-SIGHT® Oximeter. Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain and skeletal muscle. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. 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. When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates ≤ 8 kg. When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on skeletal muscle of infants, children and adolescents between 5 and 50 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.
Device Story
FORE-SIGHT Oximeter (MC-2000 Series) performs continuous noninvasive monitoring of regional hemoglobin oxygen saturation in brain and skeletal muscle. Device utilizes optical transducer with laser light source and photodiode detectors; operates via diffuse reflectance spectroscopy to probe tissue microvasculature. System calculates oxygenated/deoxygenated hemoglobin percentages. Hardware includes graphic display/user interface; laser interlock system ensures safety. Used in clinical settings; operated by healthcare professionals. Output provides real-time oxygen saturation values to assist clinicians in monitoring patients at risk for ischemic states. Data not intended as sole basis for diagnosis or therapy.
Clinical Evidence
Clinical validation involved comparing FORE-SIGHT Oximeter values to CO-oximetry data from invasive arterial and venous blood samples in skeletal muscle. Study population included infants, children, and adolescents in a catheterization laboratory. Results demonstrated precision (1 SD) of ± 4.9% for skeletal muscle, comparable or superior to predicate devices.
Technological Characteristics
Optical transducer with laser light source and photodiode detectors. Uses diffuse reflectance spectroscopy at four wavelengths. Class 1 laser product with laser interlock safety feature. Disposable sensors (Small, Medium, Large). System includes graphic display and user interface. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-8, and IEC 60825-1 standards.
Indications for Use
Indicated for continuous noninvasive monitoring of regional hemoglobin oxygen saturation in brain and skeletal muscle for individuals at risk of ischemic states. Brain monitoring: Large sensors (>40 kg), Medium sensors (4-80 kg), Small sensors (≤8 kg). Skeletal muscle monitoring: Medium sensors (5-50 kg).
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
- CAS Medical Systems Cerebral Oximeter (K091452)
- Somanetics Corporation INVOS® 5100C Cerebral/Somatic Oximeter (K082327)
- Hutchinson Technology InSpectra™ StO2 Tissue Oxygenation Monitor, Model 650 (K100915)
- Spectros Corporation T-Stat™ 303 Microvascular Tissue Oximeter (K081233)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "CASMED" in a bold, sans-serif font. The letters are all capitalized and black. There is a registered trademark symbol to the right of the letter "D".
DEC 2 3 2010
5101k):
k194030
# 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<br>Fax - (203) 488-9438<br>Email - rjeffrey@casmed.com |
| Prepared: | December 23, 2010 |
| Trade Name: | FORE-SIGHT® Absolute Tissue Oximeter |
| Common Name: | Tissue Oximeter |
| Classification Name: | Oximeter, Tissue Saturation |
| Classification #: | 21 CFR (870.2700) |
| Product Code: | MUD |
| 510k | K094030 |
{1}------------------------------------------------
#### DESCRIPTION
The FORE-SIGHT Oximeter, MC-2000 Series, measures brain and skeletal muscle tissue oxygen saturation.
The FORE-SIGHT Oximeter consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display with user interface. The noninvasive, reflection mode, optical transducer is placed on the forehead (brain) or skeletal muscle, via a disposable sensor to determine tissue oxygenation. The FORE-SIGHT Oximeter is safe to use because it is designed to operate as a class 1 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.
#### FORE-SIGHT Oximeter Indications for Use
The FORE-SIGHT® Oximeter, Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain and skeletal muscle. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states.
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. When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates ≤ 8 kg.
When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on skeletal muscle of infants, children and adolescents between 5 and 50 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 Oximeter Technology Compared to Predicate Devices
The FORE-SIGHT 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 probe a cross-section of tissue microvasculature (i.e., a mixed bed of arterioles, capillaries and venules). The FORE-SIGHT Oximeter and predicate devices analyze light returning from the sampled tissue, after having passed through tissues, for hemoglobin in its oxygenated and deoxygenated forms. All cited monitors calculate oxygen saturation. This value reflects the percentage of oxygenated hemoglobin in the sampled tissue.
{2}------------------------------------------------
## EQUIVALENCE (Predicate Device)
The FORE-SIGHT® Oximeter, MC-2000 Series, is equivalent to the following devices:
- * CAS Medical Systems Cerebral Oximeter (K091452)
- * Somanetics Corporation INVOS® 5100C Cerebral/Somatic Oximeter (K082327)
- ** Hutchinson Technology InSpectra™ StO2 Tissue Oxygenation Monitor, Model 650 (K100915)
- * Spectros Corporation T-Stat™ 303 Microvascular Tissue Oximeter (K081233)
| Comparison '<br>lable | | | | |
|-----------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | ------------------------------------ | annon de film and contraction of the comments of consisted on the first and the forme to the first and | But the contract and the contribution to call be claim and the closes of the closes of the closes of the closes of the closes of the closes of the closes of the closes of the | NO. OF ALL OLL BLACK OF CLASS OF CHARGES.<br>--------------------------------------------------------------------------------- |
| Predicate Device | Similarities to FORE-SIGHT<br>K 094030 | Differences from FORE-SIGHT<br>K 094030 |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CAS Medical<br>Systems<br>FORE-SIGHT<br>Oximeter<br>(K091452) | Same laser light source/energy; Same four wavelengths; Same sensor / monitor design; Same physiological purpose; Cerebral tissue oxygen saturation<br>measurement; Same "cerebral" IFU; Same small, medium and large<br>sensor sizes for cerebral; Same cerebral performance. | Slight modifications of algorithm; Slight user interface changes; Added skeletal muscle monitoring<br>with medium sensors for specific<br>patient groups/weights |
| Somanetics<br>Corporation<br>INVOS 5100C<br>Oximeter<br>(K082327) | Tissue oximeter; Cerebral and somatic monitoring; Same hospital area of use; Same patient population groups for<br>cerebral monitoring; Same parameter measured; Adhesive sensor. | IFU includes cerebral for all<br>individuals sensor size dependant; Infants, children and adolescent<br>population for skeletal muscles; LED light source, two wavelengths,<br>LEDs in sensor; Trend monitor <2.5 kg. |
| Hutchinson<br>Technology<br>InSpectra StO2<br>Tissue<br>Oxygenation<br>Monitor<br>(K100915) | Tissue oximeter; Four wavelengths; Fiber optics used; IFU includes skeletal muscle; Adhesive sensor. | LED light source; Specific patient population not<br>identified. |
| Spectros<br>Corporation T-<br>Stat<br>Microvascular<br>Tissue Oximeter<br>(K081233) | Tissue oximeter, Broad bandwidth white light; Fiber optics used; IFU states microvascular tissue<br>spaces; Various needle or probe- like<br>sensors. | Visible white light source; Specific monitoring sites not<br>identified. |
{3}------------------------------------------------
#### Non-Clinical Performance Testing to Demonstrate Substantial Equivalence
The FORE-SIGHT Oximeter. MC-2000 Series has been tested to the following standards in accordance with CAS Medical Svstems Product Performance Specifications:
- UL 60601-1 Safety testing for use of the UL Classified mark; .
- CAN/CSA C22.2 No. 601.1-M90; .
- IEC 60601-1 Safety of Medical Electrical Equipment: .
- EN 60601-1 Safety of Medical Electrical Equipment: .
- IEC 60601-1-1 Safety of Medical Electrical Systems: .
- . IEC 60601-1-2: 2001 Safety of Medical Electrical Equipment with regard to EMC Emissions and EMC Immunity:
- . IEC 60601-1-4 Safety of Programmable Electrical Medical Systems;
- IEC 60601-1-8 Safety of Alarm Systems for Medical Equipment/Systems; .
- IEC 60825-1: Safety of Laser Products (with amendments A1 and A2) .
In addition to the above laboratory tests, CAS has conducted a full program of individual hardware, software and systems monitor and sensor verification and validation studies.
### Clinical Testing to Demonstrate Substantial Equivalence
Pediatric Subject Skeletal Muscle Validation: CO-oximetry data from invasive arterial and venous blood samples from sites representative of skeletal muscle were respectively compared to FORE-SIGHT Oximeter values. FORE-SIGHT sensors were placed over skeletal muscle of adolescents, children, and infants undergoing examination in a catheterization laboratory.
### Conclusions Drawn from Clinical and Non-Clinical Testing
When compared to CO-oximetry measurements, the precision (1 Standard deviation) of FORE-SIGHT Oximeter values (StO>) were ± 4.9 % for skeletal muscle in human subjects. The precision of FORE-SIGHT Oximeter values were comparable or better than the predicate devices. when compared to CO-oximetry measurements.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
CAS Medical Systems, Inc. % Mr. Ron Jeffrey Director, Regulatory Affairs 44 East Industrial Road Branford, CT 06405
DEC 2 3 2010
Re: K094030
Trade/Device Name: Fore-Sight Absolute Cerebral and Somatic Oximeter, MC-2000 Series Regulation Number: CFR 21 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: MUD Dated: November 8, 2010 Received: November 9, 2010
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.
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 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
{5}------------------------------------------------
forth in the quality systems (OS) 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.
Dubmal Falls
Malvina B. Evdelman. M. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
# Indications for Use
DEC 2 3 2010
510(k) Number:
K 094030
Device Name:
FORE-SIGHT® Absolute Tissue Oximeter Model MC-2000 Series.
## Indications for Use:
The FORE-SIGHT® Oximeter. Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain and skeletal muscle. It is intended for use in any individual at risk for reducedflow or no-flow ischemic states.
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. When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates ≤ 8 kg.
When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on skeletal muscle of infants, children and adolescents between 5 and 50 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 _ v _ _ (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)
(Division Sign-Off) (Division Sign Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
K094030 510(k) Number -
