(171 days)
No
The description refers to an "Algorithm" that quantifies a relationship between two parameters using a calculated index and correlation, but there is no mention of AI, ML, training sets, or complex learning processes typically associated with AI/ML. The validation uses standard statistical methods like Pearson's Correlation Coefficient and AUC.
No.
The "Intended Use / Indications for Use" states that "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 Adaptive Index (CAI) Algorithm."
Yes
The device provides an "informational index" (CAI) that helps "assess the level of coherence" between two physiological parameters, and it quantifies the "dynamic relationship" between them. The description also states it helps clinicians "recognize/identify possible causes" of certain events, which are all hallmarks of a diagnostic aid or device used in diagnosis.
Yes
The device is described as an "Algorithm" that processes data acquired from existing, cleared hardware devices (HemoSphere Pressure Cable and ForeSight Oximeter Cable). It generates a derived parameter (CAI) and a trended graph, which are software outputs. The description focuses solely on the algorithm's function and performance, without mentioning any new or modified hardware components.
Based on the provided information, the Cerebral Adaptive Index (CAI) Algorithm is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- CAI's Function: The CAI Algorithm processes data from existing, cleared devices (HemoSphere Pressure Cable and ForeSight Oximeter Cable) that measure physiological parameters in vivo (within the living body) – specifically, Mean Arterial Pressure (MAP) and cerebral tissue oxygenation (StO2). It does not analyze specimens taken from the body.
- Intended Use: The intended use describes CAI as an "informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation (StO2) in patient's cerebral tissue." This is based on real-time physiological measurements, not laboratory analysis of specimens.
Therefore, the CAI Algorithm falls under the category of a medical device that processes physiological data acquired in vivo, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cerebral Adaptive Index (CAI) Algorithm is an informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation (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 Adaptive Index (CAI) Algorithm.
Product codes (comma separated list FDA assigned to the subject device)
MUD, QEM
Device Description
Cerebral Adaptive 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 show the level of coherence between MAP and cerebral StO2. The output will be represented as an index value and a trended graph.
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).
The CAI parameter can enhance clinician's understanding of the underlying hemodynamic changes behind cerebral desaturation events. It helps the clinician recognize/ identify possible causes of, for example, decrease in StO2 and clinical events related to StO2 decrease (e.g., hypotension as opposed to inadequate oxygen content).
CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will only be represented as a number with a range between 0 to 100. A high CAI value (CAI greater than or equal to 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 Whereas a low CAI value (CAI lower than 45) means there is lesser coherence between the two parameters, and therefore alterations in MAP may not result in concomitant changes in cerebral oxygen saturation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cerebral tissue
Indicated Patient Age Range
patients over 18 years of age
Intended User / Care Setting
Cerebral Adaptive Index (CAI) Algorithm is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found. Information refers to "validation" instead of "training". See test set.
Description of the test set, sample size, data source, and annotation protocol
The validation dataset was retrospectively obtained from 4 different clinical sites within US (Northwestern University, Chicago; UC Davis, Sacramento; University of Minnesota, Minneapolis; Stanford University, Stanford). A total of 145 subjects aged 18 or older were randomly selected for inclusion in the CAI Algorithm validation study.
MAP and StO2 time-series data obtained from adult (18 years and older) patients were used for the validation testing. To validate and assess the performance of CAI, a Receiver Operating Characteristic (ROC) analysis was performed based on weak/moderate and strong MAP-StO2 association. Labeling of weak/moderate versus strong MAP-StO2 association states is conducted based on the computed values of the Pearson's Correlation Coefficient (Corr) between MAP and StO2 in the utilized time-series clinical data. Specifically, 0
§ 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
May 26, 2023
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, LLC Sara Pesian Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614
Re: K223651
Trade/Device Name: Cerebral Adaptive Index (CAI) Algorithm Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD, QEM Dated: April 28, 2023 Received: April 28, 2023
Dear Sara Pesian:
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.
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
1
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 (QS) 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 mediation-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,
Patrick Antkowiak -S
Patrick Antkowiak Acting 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) K223651
Device Name Cerebral Adaptive Index (CAI) Algorithm
Indications for Use (Describe)
Cerebral Adaptive Index (CAI) Algorithm is an informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation (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 Adaptive 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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K223651
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number: | 2015691 |
| Contact
Person: | Sara Pesian
Manager, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
sara_pesian@edwards.com
Telephone: (949) 250-2232 |
| Date: | May 26, 2023 |
| Trade Name: | Cerebral Adaptive Index (CAI) Algorithm |
| Common
Name: | Oximetry |
| Classification
Name: | Oximeter 21 CFR 870.2700 |
| Product
Code: | MUD, Class II
QEM, Class II |
| Primary
Predicate
Device: | HemoSphere ForeSight Oximeter Cable on HemoSphere Advanced Monitoring
Platform, manufactured by Edwards Lifesciences, K213682 cleared June 22, 2022.
is being utilized for substantial equivalence since it contains the same StO2
algorithm as the subject device, and similar indications for use/intended use and
principle of operation and technology as the subject CAI Algorithm. |
| Reference
Predicate
Device (s) | FORE-SIGHT ELITE Absolute Tissue Oximeter, manufactured by Edwards
Lifesciences, K190205 cleared August 29, 2019 and HemoSphere Pressure
Cable, manufactured by Edwards Lifesciences, K180881 cleared November 16,
2018 are being utilized as reference devices |
510(k) Summary – Cerebral Adaptive Index (CAI) Algorithm
4
| Device
Description: | Cerebral Adaptive 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 show the level of
coherence between MAP and cerebral StO2. The output will be represented as an
index value and a trended graph.
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).
The CAI parameter can enhance clinician's understanding of the underlying
hemodynamic changes behind cerebral desaturation events. It helps the clinician
recognize/ identify possible causes of, for example, decrease in StO2 and clinical
events related to StO2 decrease (e.g., hypotension as opposed to inadequate
oxygen content).
CAI will be continuously displayed at 20-second rate. The parameter will not
have any alarm ranges and will only 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 Whereas a low CAI value
(CAI 0.89 [0.85, 0.92] | 0.65 [0.53, 0.76] | 0.93 [0.92, 0.95] | 45 |
Table 1-7 ROC analysis results for Stanford University Clinical Data
| ROC Analysis - SU Clinical Data | |||
|---|---|---|---|
| AUC | Sens | Spec | Threshold (%) |
| 0.87 [0.70, 0.98] | 0.96 [0.90, 0.99] | 0.75 [0.52, 0.92] | 45 |
Benefit-Risk There was no exclusion of data across the spectrum of weak, moderate, and Analysis strong MAP-StO2 association states in the post-hoc statistical analysis. All patient conditions were included in the analysis.
CAI quantifies the dynamic relationship between two existing hemodynamic parameters, MAP and StO2 in the cerebral tissue, to show the level of coherence between the two parameters. The ROC analysis against Corr demonstrates that
9
CAI can accurately differentiate weak/moderately MAP-StO2 association from strong MAP-StO2 association states at the chosen threshold of 45. Although the agreement between CAI and Corr is strong but not perfect, the benefits outweigh the risks, as CAI can enhance clinician's understanding of the underlying hemodynamic changes behind cerebral desaturation events that may not be easily identifiable if just visually looking at MAP and StO2 values individually (which is the current clinical practice). Additionally, CAI is continuously calculated and displayed, enabling clinicians to continuously assess the underlying hemodynamic changes instead of visually/mentally calculating the relationship which is more susceptible to error and subjective judgement.
While CAI will be shown on the monitor as an index value and a trended graph, both StO2 and MAP trends will still be individually displayed on the monitor for review by the clinician and to aid them make treatment decisions based on these individual values.
Conclusions Overall Conclusion:
The Cerebral Adaptive Index (CAI) Algorithm has successfully passed functional and performance testing, including software verification and validation, bench, and clinical analysis. Completion of all performance verification and validation activities demonstrated that the subject device meets its predetermined design and performance specifications. Verification activities performed confirmed that the differences in the features and design did not adversely affect the safety and effectiveness of the subject device. Note that the lower bound CI performance goal was not pre-specified, but the observed results demonstrate safety and effectiveness. The testing performed demonstrates that the Cerebral Adaptive Index (CAI) Algorithm is substantially equivalent to its legally marketed predicate.