(127 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any AI/ML-specific components or processes.
No.
The device measures hemodynamic parameters and is explicitly stated not to be intended to predict or detect cardiovascular mortality or any other condition, disease, and/or patient outcome, which indicates it is for diagnostic or monitoring purposes, not therapeutic intervention.
Yes
Explanation: The device provides "calibrated cardiac output/stroke volume (CO/SV), left ventricular ejection time (LVET), and heart rate variability (HRV) in adult patients," which are measurements used to assess physiological conditions and aid in diagnosis.
No
The device is described as a "firmware upgrade that runs on the Caretaker platform" and provides additional measures to existing predicate devices which include a "Physiological Monitor" (K211588, K163255, K151499). This indicates it is software that operates on a hardware platform, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The Caretaker Advanced Hemodynamic Parameters is a firmware upgrade that provides physiological measurements (cardiac output, stroke volume, LVET, HRV) directly from the patient using a finger cuff. It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring physiological parameters in adult patients, not analyzing biological samples for diagnostic purposes.
- Device Description: The description reinforces that it's a firmware upgrade for a physiological monitor, not a system for analyzing samples.
Therefore, the device falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
Product codes
DXN, DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Nexfin_HD (for cardiac output/stroke volume, K072049), Portapres model 2 (for left ventricular ejection time, K023338), ANSWatch (for heart rate variability measures, K123130).
Reference Device(s)
K181196, K211588, K163255, K151499
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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. 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
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). 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,
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
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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.
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510(k) Summary
510(k) Summary of Safety and Effectiveness
-
- 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
- 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).
-
- 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.
-
- 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