Cerebral Autoregulation Index (CAI) Algorithm

K240596 · Edwards Lifesciences · MUD · Oct 16, 2024 · Cardiovascular

Device Facts

• Record ID: K240596
• Device Name: Cerebral Autoregulation Index (CAI) Algorithm
• Applicant: Edwards Lifesciences
• Product Code: MUD · Cardiovascular
• Decision Date: Oct 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Cerebral Autoregulation Index (CAI) Algorithm is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The algorithm is intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence or lack thereof between MAP and cerebral StO2.

Device Story

CAI Algorithm is a derived parameter quantifying the dynamic relationship between Mean Arterial Pressure (MAP) and cerebral tissue oxygen saturation (StO2). Inputs: MAP (via HemoSphere pressure cable) and StO2 (via ForeSight oximeter cable). Operation: Algorithm calculates coherence between MAP and StO2; outputs a continuous index value (0-100) displayed at 20-second intervals. High values (≥45) suggest impaired autoregulation (MAP alterations may affect cerebral oxygenation); low values (<45) suggest intact autoregulation. Used in hospital critical care environments by clinicians. Output serves as an informational surrogate to assist in hemodynamic monitoring; does not replace clinical judgment or dictate therapeutic decisions.

Clinical Evidence

Retrospective analysis of 50 adult patients (cardiac and general surgery) across 3 clinical sites. Ground truth for autoregulation status (intact vs. impaired) established via polynomial fit of CBFV-MAP data. Performance at threshold 45: AUC 0.92 (95% CI: 0.89, 0.94), Sensitivity 82% (95% CI: 75, 88), Specificity 94% (95% CI: 91, 96). Results consistent across sites.

Technological Characteristics

Software-based algorithm calculating coherence between MAP and StO2. Inputs: HemoSphere pressure cable (K180881) and ForeSight oximeter cable (K201446). Output: 0-100 index value displayed at 20-second intervals. Complies with IEC 62304:2006/A1:2016 for software life cycle processes.

Indications for Use

Indicated for patients over 18 years of age receiving advanced hemodynamic monitoring. Provides an informational index representing a surrogate measurement of cerebral autoregulation status (intact vs. impaired) based on coherence between Mean Arterial Pressure (MAP) and cerebral tissue oxygen saturation (StO2). Not indicated for treatment of any disease or condition; no therapeutic decisions should be made based solely on the CAI.

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

• Cerebral Adaptive Index (CAI) Algorithm (K223651)

Submission Summary (Full Text)

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October 16, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Edwards Lifesciences Daphney Germain-Kolawole Director, Regulatory Affairs Program Management One Edwards Way Irvine, California 92614

Re: K240596

Trade/Device Name: Cerebral Autoregulation Index (CAI) Algorithm Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD, QEM Dated: September 13, 2024 Received: September 16, 2024

Dear Daphney Germain-Kolawole:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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# FDA Patrick Antkowiak -S

for

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K240596

#### Device Name

Cerebral Autoregulation Index (CAI) Algorithm

#### Indications for Use (Describe)

Cerebral Autoregulation Index (CAI) Algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere pressure cable and StO2 is acquired by the ForeSight oximeter cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Autoregulation Index (CAI) Algorithm.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

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

| | Cerebral Autoregulation Index (CAI) Algorithm | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Submitter | Edwards Lifesciences LLC<br>One Edwards Way, Irvine, CA 92614<br>[phone] | |
| Contact<br>Person | Primary Contact<br>Daphney Germain-Kolawole<br>Director, RA Program Management<br>Edwards Lifesciences LLC<br>One Edwards Way,<br>Irvine, CA USA, 92614<br>Tel.: [phone]<br>Email:<br>[e-mail] | Secondary Contact<br>Karen Clement<br>Senior Director, Regulatory Affairs<br>Edwards Lifesciences LLC<br>One Edwards Way,<br>Irvine, CA USA, 92614<br>Tel.: [phone]<br>Email: [e-mail] |
| Date<br>Prepared | September 13, 2024 | |
| Trade Name | Cerebral Autoregulation Index (CAI) Algorithm | |
| Regulation<br>Number /<br>Name | 21 CFR 870.2700 / Oximeter | |
| Product<br>Code | MUD (21 CFR 870.2700), QEM (21 CFR 870.2700) | |
| Regulation<br>Class | Class II | |
| Predicate<br>Device | Cerebral Adaptive Index (CAI) Algorithm | |
| Device<br>Description | The Cerebral Adaptive Index (CAI) Algorithm is being renamed to Cerebral<br>Autoregulation Index (CAI) Algorithm. The originally cleared Cerebral Adaptive Index<br>is in effect an index of cerebral autoregulation, and the renaming results in a labeling<br>change. The evidence to support the proposed labeling change for the Cerebral<br>Autoregulation Index algorithm demonstrates the capability of CAI to represent a<br>surrogate measurement of whether cerebral autoregulation is likely intact or is likely<br>impaired, as expressed by the level of coherence or lack thereof between MAP (as a<br>surrogate of cerebral perfusion pressure) and cerebral StO2 (as a surrogate of cerebral<br>blood flow) of the patient.<br><br>The Cerebral Autoregulation Index (CAI) Algorithm is a derived parameter that<br>quantifies the dynamic relationship between two existing hemodynamic parameters,<br>Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation<br>Saturation (StO2) in the cerebral tissue. CAI is intended to represent a surrogate<br>measurement of whether cerebral autoregulation is likely intact or is likely impaired as | |
| Cerebral Autoregulation Index (CAI) Algorithm | | |
| expressed by the level of coherence between MAP and cerebral StO2. The output will<br>be represented as an index value in a trend plot.<br><br>MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881<br>on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight<br>Oximeter Cable (cleared in K201446 on October 1, 2020).<br><br>CAI will be continuously displayed at 20-second rate. The parameter will not have any<br>alarm ranges and will be represented as a number with a range between 0 to 100. A<br>high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and<br>informs the clinician that alterations in MAP may result in concomitant changes in<br>cerebral oxygen saturation because cerebral autoregulation is likely impaired. Whereas<br>a low CAI value (CAI < 45) means there is lesser coherence between the two<br>parameters, and therefore alterations in MAP may not result in concomitant changes in<br>cerebral oxygen saturation because cerebral autoregulation is likely intact. | | |
| Indications<br>for Use | Cerebral Autoregulation Index (CAI) Algorithm is an informational index intended to<br>represent a surrogate measurement of whether cerebral autoregulation is likely intact<br>or is likely impaired as expressed by the level of coherence or lack thereof between<br>Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation<br>Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere<br>pressure cable and StO2 is acquired by the ForeSight oximeter cable. CAI is intended for<br>use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI<br>is not indicated to be used for treatment of any disease or condition and no therapeutic<br>decisions should be made based solely on the Cerebral Autoregulation Index (CAI)<br>Algorithm. | |
| Intended Use | Cerebral Autoregulation Index (CAI) Algorithm is intended to be used by qualified<br>personnel or trained clinicians in a critical care environment in a hospital setting. The<br>algorithm is intended to represent a surrogate measurement of whether cerebral<br>autoregulation is likely intact or is likely impaired as expressed by the level of<br>coherence or lack thereof between MAP and cerebral StO2. | |
| Comparative<br>Analysis | The subject Cerebral Autoregulation Index (CAI) Algorithm is similar to the predicate<br>Cerebral Adaptive Index (CAI) Algorithm in terms of the intended use and indications<br>for use. The technological characteristics are identical (including design and principle<br>of operation). Both the subject and predicate devices use the measurement of absolute<br>regional hemoglobin oxygen saturation of blood under the sensor in their calculations.<br>When sensors are applied to patient's cerebral region, CAI uses the StO2 signals in<br>conjunction with MAP signals and calculates the coherence between the measured<br>cerebral StO2 and MAP. Hence, the predicate Cerebral Adaptive Index (CAI)<br>Algorithm is being used to establish substantial equivalence for the subject Cerebral<br>Autoregulation Index (CAI) Algorithm.<br>The following table details the comparisons and differences between the subject and<br>predicate devices. | |

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| | Parameter | Subject Device<br>Cerebral<br>Autoregulation<br>Index (CAI)<br>Algorithm | Predicate<br>Device<br>Cerebral<br>Adaptive Index<br>(CAI) Algorithm | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Trade Name | Cerebral<br>Autoregulation<br>Index (CAI)<br>Algorithm | Cerebral<br>Adaptive Index<br>(CAI) Algorithm | Same +<br>Autoregulation<br><br>Device name has<br>been modified to<br>reference<br>"Autoregulation"<br>to distinguish this<br>model from the<br>predicate version. |
| | 510(k)<br>number | K240596 | K223651 | Not applicable |
| | Manufacturer | Edwards<br>Lifesciences | Edwards<br>Lifesciences | Same |
| | Device<br>Classification | Class II | Class II | Same |
| | Regulation<br>Number | 21 CFR<br>870.2700 | 21 CFR<br>870.2700 | Same |
| | Product Code<br>– Device<br>Classification<br>Name | MUD –<br>Oximeter,<br>Tissue<br>Saturation<br>QEM -<br>Cerebral<br>Oximeter | MUD –<br>Oximeter, Tissue<br>Saturation<br>QEM – Cerebral<br>Oximeter | Same |
| | Intended Use | Cerebral<br>Autoregulation<br>Index (CAI)<br>Algorithm is<br>intended to be<br>used by<br>qualified<br>personnel or<br>trained<br>clinicians in a<br>critical care<br>environment in<br>a hospital | Cerebral<br>Adaptive Index<br>(CAI) Algorithm<br>is intended to be<br>used by qualified<br>personnel or<br>trained clinicians<br>in a critical care<br>environment in a<br>hospital setting.<br>The algorithm is<br>intended to show<br>the level of | Same +<br>Autoregulation<br><br>Device name has<br>been modified to<br>reference<br>“Autoregulation”.<br><br>The Cerebral<br>Adaptive Index is<br>in effect an index<br>of cerebral |
| Cerebral Autoregulation Index (CAI) Algorithm | | | | |
| | setting. CAI is<br>intended to<br>represent a<br>surrogate<br>measurement of<br>whether<br>cerebral<br>autoregulation<br>is likely intact<br>or is likely<br>impaired as<br>expressed by<br>the level of<br>coherence or<br>lack thereof<br>between MAP<br>and cerebral<br>StO2. | coherence<br>between MAP<br>and cerebral<br>StO2. | autoregulation.<br>The evidence to<br>support the<br>proposed labeling<br>change for the<br>Cerebral<br>Autoregulation<br>Index algorithm<br>demonstrates the<br>capability of CAI<br>to represent a<br>surrogate<br>measurement of<br>whether cerebral<br>autoregulation is<br>likely intact or is<br>likely impaired as<br>expressed by the<br>level of<br>coherence or lack<br>thereof between<br>MAP and<br>Cerebral StO2 of<br>the patient. | |
| Indications<br>for Use | Cerebral<br>Autoregulation<br>Index (CAI)<br>Algorithm is an<br>informational<br>index intended<br>to represent a<br>surrogate<br>measurement of<br>whether<br>cerebral<br>autoregulation<br>is likely intact<br>or is likely<br>impaired as<br>expressed by<br>the level of<br>coherence or<br>lack | Cerebral<br>Adaptive Index<br>(CAI) Algorithm<br>is an<br>informational<br>index to help<br>assess the level<br>of coherence or<br>lack thereof<br>between Mean<br>Arterial Pressure<br>(MAP) and the<br>Absolute Levels<br>of Blood<br>Oxygenation<br>Saturation (StO2)<br>in patient's<br>cerebral tissue.<br>MAP is acquired<br>by the | Similar<br>indications.<br><br>Device name has<br>been modified to<br>reference<br>"Autoregulation".<br><br>The Cerebral<br>Adaptive Index is<br>in effect an index<br>of cerebral<br>autoregulation,<br>which results in a<br>labeling change.<br>The evidence to<br>support the<br>proposed labeling<br>change for the<br>Cerebral | |
| Cerebral Autoregulation Index (CAI) Algorithm |…