(130 days)
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 Oximeter is indicated for use on adults and transitional adolescents ≥ 40 kg.
The FORE-SIGHT Elite Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Oximeter consists of a monitor unit, preamplifier assembly, and sensor. The sensor uses multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four sensors with both numeric and real-time graphical display formats. The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB, RS-232 serial or wireless communications.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the FORE-SIGHT Elite™ Absolute Tissue Oximeter:
The provided text is a 510(k) summary for a medical device seeking substantial equivalence to existing devices. As such, it focuses on demonstrating that the new device performs similarly to predicate devices, rather than establishing novel absolute performance criteria with specific thresholds for accuracy, sensitivity, or specificity against a definitive ground truth.
Therefore, for many of your requested points, the answer will be "Not Applicable" or "Not Specified" because the nature of a 510(k) submission for this type of device does not typically require the same level of detailed performance metrics as, for example, an AI diagnostic algorithm. The primary "acceptance criterion" for a 510(k) is substantial equivalence to predicates.
Here's a breakdown based on your request:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for 510(k) of this device type) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Devices: | "The FORE-SIGHT Elite™ 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 predicate devices." |
| - Optical Operating Principle: | "The FORE-SIGHT Elite Absolute Tissue Oximeter compares substantially to the cited predicate devices in that they use fundamentally the same optical operating principle, called multidistance diffuse reflectance spectroscopy." |
| - Hemoglobin Measurement: | "All cited monitors use light to examine a cross-section tissue microvasculature... The spectroscopic analysis determines concentrations of hemoglobin in its oxygenated and deoxygenated states. All cited monitors calculate oxygen saturation which reflects the percentage of oxygenated hemoglobin in the sampled tissue." |
| - Technical Capabilities: | "The FORE-SIGHT Elite Absolute Tissue Oximeter compares substantially to the predicates. All have 4-channel capability, an LED light source, similar user interface features and the benefits of portability." |
| Safety: | "Clinical evaluation, safety testing and software validation demonstrate the FORE-SIGHT Elite Absolute Tissue Oximeter is substantially equivalent to the predicate devices." (Implied to meet safety standards comparable to predicates) |
| Clinical Performance: | "The FORE-SIGHT Elite Absolute Tissue Oximeter has successfully undergone extensive clinical validation for the indicated use. The premarket notification cites a validation report: Validation of the CAS Medical System's FORE-SIGHT Elite™ Absolute Tissue Oximeter for Somatic Tissue Oxygen Saturation (StO2%) in Adult and Transitional Adolescent Subjects." |
| Software Validation: | "CAS has conducted a full program of individual hardware, software, systems verification and validation studies of the FORE-SIGHT monitor and sensors." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The document mentions "extensive clinical validation" and refers to a "validation report," but doesn't provide the sample size within this summary.
- Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective/prospective). It just states "Clinical Testing to Show Substantial Equivalence."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable/Not specified. For a tissue oximeter, the ground truth would typically be established by comparing the device's readings against a reference method for oxygen saturation, not by expert consensus on images. The text does not describe this reference method or any "experts" involved in establishing ground truth for individual cases in a traditional sense.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation studies where there is subjective human assessment. This device measures a physiological parameter, and its validation would involve comparison to a direct (e.g., invasive blood gas analysis) or a highly accurate reference method, not an adjudication of human interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: No. This device is a measurement device (oximeter), not an AI-assisted diagnostic tool that helps human readers interpret images or data. Therefore, an MRMC study and effect size in terms of human reader improvement with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in a sense. The device itself performs the measurement and algorithm calculation to derive StO2 values. The validation would assess the accuracy of these measurements compared to a reference method, which is inherently a "standalone" performance assessment of the device's measurement capabilities. However, it's not "standalone AI algorithm" in the context of recent AI-powered diagnostic devices. The summary states: "The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics." This implies standalone algorithmic processing for the measurement itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not explicitly stated in the provided text, but for an oximeter, the ground truth would typically be established through:
- Direct, invasive measurements: Such as arterial or venous blood gas analysis to determine oxygen saturation.
- Highly validated reference oximeters or spectrophotometers: Used in controlled experimental settings.
- The text only mentions "extensive clinical validation" for somatic tissue oxygen saturation (StO2%), implying a comparison against an accepted reference standard for StO2.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. The concept of a "training set" is primarily relevant for machine learning or AI models that learn from data. While the device uses a "FORE-SIGHT algorithm," it's described more as a pre-programmed computation based on physical principles (spectroscopy) rather than a continuously learning AI. Therefore, it may not have a "training set" in the modern AI sense. If the algorithm was developed empirically, the data used for that development is not mentioned.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/Not specified (as per point 8).
{0}------------------------------------------------
6. 510(k) Summary
APR 2 9 2014
Image /page/0/Picture/3 description: The image shows the word "CASMED" in large, bold, black letters. The letters are slightly distressed, giving them a textured appearance. A small registered trademark symbol is located to the right of the letter "D".
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
| Submitter: | CAS Medical Systems, Inc. |
|---|---|
| Address: | 44 East Industrial Rd. Branford CT. 06405 USA |
| Contact: | Ron Jeffrey - Director, Regulatory AffairsPhone - (203) 488-6056Fax - (203) 488-9438Email - rjeffrey@casmed.com |
| Prepared: | December 16, 2013 |
| Trade Name: | FORE-SIGHT Elite™ Absolute Tissue Oximeter |
| Common Name: | FORE-SIGHT Oximeter |
| Classification Name: | Oximeter, Tissue Saturation (870.2700) (MUD) |
{1}------------------------------------------------
EQUIVALENCE (Predicate Device)
The FORE-SIGHT Elite™ Absolute Tissue Oximeter is equivalent to the following devices:
-
- Nonin Model 7600 Regional Oximeter Equanox (K102715)
- & FORE-SIGHT Absolute Tissue Oximeter Monitor (K112820)
DESCRIPTION
The FORE-SIGHT Elite Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2).
The Oximeter consists of a monitor unit, preamplifier assembly, and sensor. The sensor uses multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four sensors with both numeric and real-time graphical display formats.
The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB, RS-232 serial or wireless communications.
FORE-SIGHT Oximeter Monitor Intended 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 as follows:
When used with large sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on adults and transitional adolescents >40 kg.
FORE-SIGHT Monitor Technology Compared to Predicate Devices
The FORE-SIGHT Elite Absolute Tissue Oximeter compares substantially to the cited predicate devices in that they use fundamentally the same optical operating principle, called multidistance diffuse reflectance spectroscopy. All cited monitors use light to examine a crosssection tissue microvasculature (a mixed bed of arterioles, capillaries and venules). The FORE-SIGHT Elite Monitor and predicate devices analyze the light that is returned after having passed through tissues. The spectroscopic analysis determines concentrations of hemoglobin in its oxygenated and deoxygenated states. All cited monitors calculate oxygen saturation which reflects the percentage of oxygenated hemoglobin in the sampled tissue.
{2}------------------------------------------------
The FORE-SIGHT Elite Absolute Tissue Oximeter compares substantially to the predicates. All have 4-channel capability, an LED light source, similar user interface features and the benefits of portability.
Non-Clinical Performance Testing to Demonstrate Substantial Equivalence
The FORE-SIGHT Elite 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 predicate devices. In addition to the above laboratory tests, CAS has conducted a full program of individual hardware, software, systems verification and validation studies of the FORE-SIGHT monitor and sensors.
Clinical Testing to Show Substantial Equivalence
The FORE-SIGHT Elite Absolute Tissue Oximeter has successfully undergone extensive clinical validation for the indicated use. The premarket notification cites a validation report: Validation of the CAS Medical System's FORE-SIGHT Elite™ Absolute Tissue Oximeter for Somatic Tissue Oxygen Saturation (StO2%) in Adult and Transitional Adolescent Subjects.
Conclusions Drawn from Clinical and Non-Clinical Testing
Clinical evaluation, safety testing and software validation demonstrate the FORE-SIGHT Elite Absolute Tissue Oximeter is substantially equivalent to the predicate devices.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
April 29, 2014
Cas Medical Systems, Inc. Ron Jeffrey Director, Regulatory Affairs 44 East Industrial Rd. Branford, Connecticut 06405
Re: K133879
Trade/Device Name: Fore-Sight Elite Absolute Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Tissue Oximeter Regulatory Class: Class II Product Code: MUD Dated: March 28, 2014 Received: March 31, 2014
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 (sec 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
{4}------------------------------------------------
Page 2 - Ron Jeffrey
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 Small Manufacturers, International and Consumer Assistance at its toll-638-2041 or (301) 796-7100 or at its its Internet address free number (800) 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows the FDA logo. The logo is in black and white. The letters FDA are stylized and interconnected.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
K133879
Indications for Use
510(k) Number:
FORE-SIGHT Elite™ Absolute Tissue Oximeter. Device Name:
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 Oximeter is indicated for use on adults and transitional adolescents ≥ 40 kg.
Prescription Use J (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)
Image /page/5/Picture/11 description: The image shows a signature and a date stamp. The date stamp reads "Date: 2014.04.29 16:39:32 -04'00'". The signature is illegible but appears to be written in cursive. The image is black and white and has a grainy texture.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
§ 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).