(226 days)
Cerebral Adaptive Index (CAI) Algorithm
No
The description focuses on a derived parameter quantifying the dynamic relationship between two existing parameters (MAP and StO2) using a "coherence" metric, which is a standard signal processing technique, not explicitly AI/ML. The validation study uses traditional statistical methods (ROC analysis) and does not mention training or testing of an AI/ML model.
No
The device is described as an "informational index" and explicitly states it 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."
Yes
The device provides an "informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired," which helps in identifying a patient's physiological state regarding cerebral autoregulation. It is designed to discriminate between intact and impaired cerebral autoregulation, and performance metrics like sensitivity, specificity, and AUC are provided to demonstrate its diagnostic capability for this purpose.
No
The device description explicitly states that the CAI algorithm is a derived parameter that quantifies the relationship between MAP and StO2, which are acquired from the HemoSphere Pressure Cable and the ForeSight Oximeter Cable, respectively. These are hardware components necessary for the device's function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The description clearly states that the CAI algorithm uses real-time, continuous measurements of Mean Arterial Pressure (MAP) and cerebral tissue Oxygen Saturation (StO2) acquired directly from the patient via cables connected to external devices (HemoSphere Pressure Cable and ForeSight Oximeter Cable). These are physiological measurements taken in vivo, not analyses of specimens in vitro (outside the body).
- The intended use is to provide an informational index based on real-time physiological data. The algorithm processes live signals from the patient to derive an index representing the relationship between MAP and StO2. This is distinct from analyzing a blood sample, urine sample, or tissue biopsy in a laboratory setting, which is characteristic of IVDs.
The device is a software algorithm that processes physiological signals acquired from the patient to provide an index related to cerebral autoregulation. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MUD, QEM
Device Description
The Cerebral Adaptive Index (CAI) Algorithm is being renamed to Cerebral Autoregulation Index (CAI) Algorithm. The originally cleared Cerebral Adaptive Index is in effect an index of cerebral autoregulation, and the renaming results in a labeling change. The evidence to support the proposed labeling change for the Cerebral Autoregulation Index algorithm demonstrates the capability of CAI 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 (as a surrogate of cerebral perfusion pressure) and cerebral StO2 (as a surrogate of cerebral blood flow) of the patient.
The Cerebral Autoregulation Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI 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 between MAP and cerebral StO2. The output will be represented as an index value in a trend plot.
MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020).
CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will be represented as a number with a range between 0 to 100. A high CAI value (CAI >=45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation because cerebral autoregulation is likely impaired. Whereas a low CAI value (CAI
§ 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
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
2
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
3
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) | ||
| Submitter | Edwards Lifesciences LLC | |
| One Edwards Way, Irvine, CA 92614 | ||
| (949) 250-5466 | ||
| Contact | ||
| Person | Primary Contact | |
| Daphney Germain-Kolawole | ||
| Director, RA Program Management | ||
| Edwards Lifesciences LLC | ||
| One Edwards Way, | ||
| Irvine, CA USA, 92614 | ||
| Tel.: (949) 250-5466 | ||
| Email: | ||
| daphney_germainkolawole@edwards.com | Secondary Contact | |
| Karen Clement | ||
| Senior Director, Regulatory Affairs | ||
| Edwards Lifesciences LLC | ||
| One Edwards Way, | ||
| Irvine, CA USA, 92614 | ||
| Tel.: (949) 250-4746 | ||
| Email: karen_clement@edwards.com | ||
| Date | ||
| Prepared | September 13, 2024 | |
| Trade Name | Cerebral Autoregulation Index (CAI) Algorithm | |
| Regulation | ||
| Number / | ||
| Name | 21 CFR 870.2700 / Oximeter | |
| Product | ||
| Code | MUD (21 CFR 870.2700), QEM (21 CFR 870.2700) | |
| Regulation | ||
| Class | Class II | |
| Predicate | ||
| Device | Cerebral Adaptive Index (CAI) Algorithm | |
| Device | ||
| Description | The Cerebral Adaptive Index (CAI) Algorithm is being renamed to Cerebral | |
| Autoregulation Index (CAI) Algorithm. The originally cleared Cerebral Adaptive Index | ||
| is in effect an index of cerebral autoregulation, and the renaming results in a labeling | ||
| change. The evidence to support the proposed labeling change for the Cerebral | ||
| Autoregulation Index algorithm demonstrates the capability of CAI 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 (as a | ||
| surrogate of cerebral perfusion pressure) and cerebral StO2 (as a surrogate of cerebral | ||
| blood flow) of the patient. |
The Cerebral Autoregulation Index (CAI) Algorithm is a derived parameter that
quantifies the dynamic relationship between two existing hemodynamic parameters,
Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation
Saturation (StO2) in the cerebral tissue. CAI is intended to represent a surrogate
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
be represented as an index value in a trend plot.
MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881
on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight
Oximeter Cable (cleared in K201446 on October 1, 2020).
CAI will be continuously displayed at 20-second rate. The parameter will not have any
alarm ranges and will be represented as a number with a range between 0 to 100. A
high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and
informs the clinician that alterations in MAP may result in concomitant changes in
cerebral oxygen saturation because cerebral autoregulation is likely impaired. Whereas
a low CAI value (CAI