(75 days)
Not Found
No
The document describes a "Fore-Sight algorithm" for determining StO2 values, but there is no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies. The algorithm appears to be a standard signal processing or calculation method based on light absorption values and patient characteristics, not an AI/ML model.
No.
The device is described as an "adjunct monitor" to measure blood oxygen saturation, indicating it is for diagnostic or monitoring purposes, not for treating a condition.
Yes
This device is a diagnostic device because its intended use is to monitor absolute regional hemoglobin oxygen saturation of blood, which provides information about the patient's physiological state for clinical assessment and decision-making.
No
The device description explicitly states it includes a monitor unit, preamplifier assembly, and sensors, which are hardware components. While it contains software (the Fore-Sight algorithm), it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The description states the Fore-Sight Elite Absolute Tissue Oximeter is a "non-invasive" device that measures hemoglobin oxygen saturation "under the sensor" in the tissue. This indicates it's measuring directly on the body, not analyzing a sample taken from the body (like blood, urine, or tissue).
- The intended use is for monitoring physiological parameters in vivo. The device is used as an "adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensor" in individuals at risk of ischemic states. This is a direct measurement of a physiological state within the living body.
Therefore, the Fore-Sight Elite Absolute Tissue Oximeter is a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The non-invasive Fore-Sight Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensor 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 ELITE Oximeter is indicated for use on adults and transitional adolescents ≥40 Kg.
-
When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥ 3 Kg.
-
When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects
§ 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
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February 10, 2021
Edwards Lifesciences, LLC Michelle Ducca Sr. Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K203490
Trade/Device Name: FORE-SIGHT ELITE Absolute Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: November 25, 2020 Received: November 27, 2020
Dear Michelle Ducca:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203490
Device Name FORE-SIGHT ELITE Absolute Tissue Oximeter
Indications for Use (Describe)
The non-invasive Fore-Sight Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensor 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 ELITE Oximeter is indicated for use on adults and transitional adolescents ≥40 Kg.
-
When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥ 3 Kg.
-
When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects |
| | |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary – FORE-SIGHT ELITE Absolute Tissue Oximeter
I. Submitter:
Predicate
Devices:
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number: | 2015691 |
| Contact Person: | Michelle Ducca
Sr. Specialist, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
Telephone: (949) 250-1580
Fax: (949) 809-2972 |
| Date Prepared: | November 25, 2020 |
| II.
Device Information | |
| Platform Name
(Name of the
Device) | Fore-Sight Elite Absolute Tissue Oximeter |
| Trade Name: | Fore-Sight Elite Absolute Tissue Oximeter |
| Common Name: | Fore-Sight Elite Monitor |
| Classification
Name: | Oximeter
21 CFR 870.2700 |
| Product Code
and Regulatory
Class: | MUD, Class II |
| III.
Predicate Device | |
| Primary
Predicate Device: | Fore-Sight Elite Absolute Tissue Oximeter manufactured by CAS Medica
Inc. (Now Edwards Lifesciences, K143675, cleared on April 10, 2015). |
| Additional | HemoSphere Advanced Monitoring Platform (K201446, cleared on |
October 1, 2020).
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IV. Device Description
The FORE-SIGHT ELITE Absolute Tissue Oximeter measures Device Description: hemoglobin under the sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2).
The Fore-Sight Elite Monitor is used together with the preamplifier assembly (cable), and Small, Medium and Large Sensors.
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 pack. 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 and RS-232.
V. Indications for Use:
Note: the indication for Use statements are identical for the previously cleared technology (K143675, cleared on April 10, 2015).
FORE-SIGHT ELITE Absolute Tissue Oximeter
The non-invasive Fore-Sight Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensor 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 ELITE Oximeter is indicated for use on adults and transitional adolescents >40 Kg.
- When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥ 3 Kg.
5
- When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects