CareTaker Monitor App

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March 30, 2022 Caretaker Medical, LLC Jeff Pompeo President & CEO 941 Glenwood Station Ln, Suite 301 Charlottesville, Virginia 22901 Re: K213699 Trade/Device Name: Caretaker Advanced Hemodynamic Parameters Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, DRG Dated: March 1, 2022 Received: March 2, 2022 Dear Jeff Pompeo: 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. 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You must comply with all the Act's {1}------------------------------------------------ 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). 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Sincerely, LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K213699 Device Name # Caretaker Advanced Hemodynamic Parameters Indications for Use (Describe) The Caretaker Advanced Hemodynamic Parameters provides calibrated cardiac output/stroke volume (CO/SV), left ventricular ejection time (LVET), and heart rate variability (HRV) in adult patients to the existing Caretaker Remote Display App And Caretaker Software Library (K181196) via Pulse Decomposition Analysis ("PDA")(K211588, K163255, K151499). To provide CO/SV measurements. the Caretaker platform is to be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # 510(k) Summary of Safety and Effectiveness - 1) Preparation Date: 29 Mar 2022 ## 2) Submitted by: Caretaker Medical, LLC 941 Glenwood Station Ln, Suite 301 Charlottesville, Virginia 2290 User Fee Organization Number 397095 Owner/Operator #: 10054848 3) Contact Person/Prepared by: Jeff Pompeo President & CEO CareTaker Medical 941 Glenwood Station Ln, Suite 301 Charlottesville, Virginia 22901-1455 Phone: 434-409-1945 Email: Jeff@caretakermedical.net #### 4) Device Identification: | Trade Name: | Caretaker Advanced Hemodynamic Parameters | |-----------------------|------------------------------------------------------------------------| | Common Name: | Caretaker Advanced Hemodynamic Parameters | | Product Code(s): | DXN -System, Measurement, Blood-Pressure, Non-Invasive | | | DRG - Transmitters and Receivers, Physiological signal, Radiofrequency | | Regulation Number(s): | 21 CFR 870.1130 | | | 21 CFR 870.2910 | | Device Class: | II | Device Class: Il - ર) Nexfin_HD (for cardiac output/stroke volume, K072049), Finapres Predicate Devices: Portapres model 2 (for left ventricular ejection time, K023338), and ANSWatch (for heart rate variability measures, K123130). - 6) Device Description: The Caretaker Advanced Hemodynamic Parameters is a firmware upgrade that runs on the Caretaker platform to provide additional hemodynamic measures to the Caretaker Remote Display App And Caretaker Software Library, K181196, and CareTaker Physiological Monitor, (K211588, K163255, K151499). These parameters are not intended to predict or detect cardiovascular mortality or any other condition, disease, and/or patient outcome. - 7) Intended Use: The Caretaker Advanced Hemodynamic Parameters provides calibrated cardiac output/stroke volume (CO/SV), left ventricular ejection time (LVET), and heart rate variability (HRV) in adult patients to the existing Caretaker Remote Display App And Caretaker Software Library (K181196) via Pulse Decomposition Analysis ("PDA")(K211588, K163255, K151499). To provide CO/SV measurements, the Caretaker platform is to be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure {4}------------------------------------------------ accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting. Page 2 of 3 ### 8) Comparison to Predicates: ### ● Cardiac Output / Stroke Volume The patient groups represent challenged cardiac physiologies that necessitated the monitoring of cardiac output among other vital signs. Common to all groups is a high incidence of hypertension, 76%, as well as diabetes, 26%. Less than 16%, across all cohorts, have a normal BMI<25. The CTM PDA model currently does not use patient demographic data because internally obtained correlations between such data and hemodynamic parameters such as blood pressure, CO etc. are weak. CTM's approach to calculating CO incorporates refined approaches to modeling efforts that others have pursued. The Windkessel, Area-Under-the-Curve, approach that was originally proposed by Warner 1 is based on two concepts: A) mass is conserved, meaning the volume of blood entering a vessel is equal to the volume leaving, B) compliance is part of the model since during systole, as pressure inside the vessel is increasing, the vessel expands and absorbs some of the blood that would otherwise pass through it. During diastole, as the pressure inside the vessel drops, the vessel contracts and the additional blood that was stored during systole is expelled. After dividing the pulse contour into systolic and diastolic regions, flow equations for both regions can be established that relate stroke volume to the ratio of systolic to diastolic pulse areas and the end-systolic pressure while aortic resistance is incorporated via a proportionality constant. The Caretaker Physiological Monitor System is substantially equivalent to the NexFin HD in terms of providing the hemodynamic parameters cardiac output and stroke volume based on arterial pulse signals obtained from a finger cuff, preferably with calibration via thermodilution, although Caretaker uses a slightly different methodology (PDA/modified Wesseling) to obtain these hemodynamic parameters. Caretaker has clinically validated evidence attesting equivalent performance to that of the predicate device and followed quality management system rigor to comply with IEC 60601 safety standards. ## Left Ventricular Ejection Time (LVET) ● Baseline demographic information is presented below | Characteristic | Mean (SD) or N (%) | |-----------------------------------------------------------|--------------------| | Age - mean (std. dev.) – yr. | 66.8 (9.8) | | Body Mass Index - mean (std. dev.) – kg/m² | 31.4 (7.3) | | Male Sex - no. (%) | 27 (57.5) | | Tobacco Use - no. (%) | 31 (66.0) | | Hypertension – no. (%) | 40 (85.1) | | Diabetes Mellitus - no. (%) | 22 (46.8) | | Indication for Cardiac Catheterization - no. (%) | | | Acute Coronary Syndrome, Stable Angina, or known Coronary | 28 (59.6) | {5}------------------------------------------------ K213699 | Artery Disease | | |--------------------------------|-----------| | Valvular Disease | 12 (25.5) | | Other Indications | 7 (14.9) | | Vascular Access Site - no. (%) | | | Radial Artery | 26 (55.3) | | Femoral Artery | 21 (44.7) | Primary indications for cardiac catheterization procedures mostly consisted of coronary evaluation (37/47, 78%). Other primary indications included hemodynamic assessment for a suspected severe aortic stenosis. The radial artery was more commonly used for a vascular access (27/47, 57%) compared to the femoral artery. Of the study participants, 21% underwent percutaneous coronary intervention. LVET was obtained from central aortic BP tracings by measuring the time interval between the initiating point of upstroke of the aortic pressure wave form and the dichrotic notch according to established guidelines. The Caretaker Physiological Monitor System is substantially equivalent to the Portapres model 2 in terms of providing the LVET hemodynamic parameter based on arterial pulse signals obtained from a finger cuff. Both the predicate device and the Caretaker use pulse analysis of the arterial pressure pulse to determine LVET. Caretaker has clinically validated evidence attesting equivalent performance to that of the predicate device and followed quality management system rigor to comply with IEC 60601 safety standards. ## ● Heart Rate Variabilitv Overall subject demographics were as follows: age (mean: 50.9 y (standard deviation: 16.8)), sex (34 m/26 f), height (67.1 inch (4.43)), weight (179 lbs. (36.5 BMI (28.2 (5.41)). The protocol of the interventions utilized hand in ice-bath immersions, ice bag on forehead, light valsalva maneuvers, ball gripping and leg raises. In addition there were extended period of supine relaxation. The Caretaker Physiological Monitor System is substantially equivalent to the ANSWatch in terms of providing heart rate variability measures derived from a peripheral mechanical arterial pulse sensor. The Caretaker has clinically validated evidence attesting performance equivalent to or better than the predicate device. ## Conclusions: 9) - . Cardiac Output / Stroke Volume The CareTaker Monitor is substantially equivalent to the NexFin HD. - Left Ventricular Ejection Time (LVET) The CareTaker Monitor is substantially equivalent to the ● Portapres model 2. - Heart Rate Variability The CareTaker Monitor is substantially equivalent to the ANSWatch.