(288 days)
CareTaker is intended to noninvasively and continuously measure a patient's blood pressure ("BP") and heart rate ("HR"), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis ("PDA") for use on adult patients at rest. CareTaker is calibrated using a manual sphygmomanometer. All parameters derived by CareTaker are reported to a remote display monitor via standard radio transmission. CareTaker does not provide any physiological alarm functions. The device is intended for use by clinicians or other properly trained medical personnel in a hospital or other appropriate clinical settings.
CareTaker is a cardiovascular monitoring device that noninvasively measures continuous blood pressure and heart rate via a finger cuff based on the scientific method of Pulse Decomposition Analysis ("PDA")
Here's a breakdown of the acceptance criteria and study information for the CareTaker Wireless Vital Signs Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Criteria | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Blood Pressure | AAMI SP-10 (AAMI/ANSI/ISO 81060) guidelines | Compliant with ISO 81060-2 standard |
| Safety | IEC 60601-1 (general medical electrical equipment safety) | Verified safe |
| Electromagnetic | IEC 60601-1-2 (electromagnetic compatibility of medical electrical equipment) | Verified electromagnetically compatible |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the document for the clinical study. It only mentions "a clinical study."
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. It is described as "a clinical study to compare with an arterial catheter."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not explicitly stated in the document. The ground truth was established by comparison to an "arterial catheter," which is a direct and invasive measurement of blood pressure, generally considered the gold standard.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was based on arterial catheter measurements, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this document. This device is a measurement tool, not an interpretive diagnostic system typically requiring MRMC studies for human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the device's performance was evaluated in a standalone manner. The clinical study compared the device's measurements directly against an arterial catheter, without human-in-the-loop interpretation impacting the primary performance metrics (blood pressure accuracy). The device does require trained personnel to operate it, but its core measurement algorithm's accuracy was tested independently.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established by direct comparison to an arterial catheter. This is considered a gold standard for blood pressure measurement, moving beyond expert consensus to direct physiological measurement.
8. The Sample Size for the Training Set
Not applicable/not stated. The document describes a post-market notification (510(k)) where the device's performance is being validated, not the development or training of its underlying algorithm. The "Pulse Decomposition Analysis ('PDA')" is a scientific method, implying it's a pre-established analytical approach, not necessarily a machine learning model that requires a distinct training set in the context of this regulatory document.
9. How the Ground Truth for the Training Set was Established
Not applicable/not stated, for the same reasons as #8. The PDA method itself would have been developed and validated through scientific research, but this document focuses on the device's compliance.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
Caretaker Medical, LLC Jeff Pompeo President & CEO 3042 Berkmar Drive Suite A Charlottesville, Virginia 22901-1455
Re: K151499
Trade/Device Name: Caretaker Wireless Vital Signs Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 16, 2016 Received: February 17, 2016
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. 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 801); medical device reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Arnold Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
CareTaker Wireless Vital Signs Monitor
Indications for Use (Describe)
CareTaker is intended to noninvasively and continuously measure a patient's blood pressure ("BP") and heart rate ("HR"), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis ("PDA") for use on adult patients at rest. CareTaker is calibrated using a manual sphygmomanometer. All parameters derived by CareTaker are reported to a remote display monitor via standard radio transmission. CareTaker does not provide any physiological alarm functions. The device is intended for use by clinicians or other properly trained medical personnel in a hospital or other appropriate clinical settings.
Type of Use (Select one or both, as applicable)
XPrescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
510(k) Summary of Safety and Effectiveness
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- Preparation Date: June 3, 2014
2) Submitted by:
CareTaker Medical, LLC 3042 Berkmar Drive, Suite A Charlottesville, Virginia 22901-1455 User Fee Organization Number 397095 Owner/Operator #: TBD
Contact Person/Prepared by: 3)
Jeff Pompeo President & CEO CareTaker Medical 3042 Berkmar Drive, Suite A Charlottesville, Virginia 22901-1455 Phone: 434-409-1945 Email: Jeff@caretakermedical.net
4) Device Identification:
Trade Name: CareTaker Wireless Vital Signs Monitor Common Name: CareTaker Continuous Non-Invasive Blood Pressure Monitor Classification: 21 CFR 870.1130, Product Code: DXN -System, Measurement, Blood-Pressure, Non-Invasive Device Class: II
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- Predicate Device: Nexfin HD (K072049)
- ର) Device Description: CareTaker is a cardiovascular monitoring device that noninvasively measures continuous blood pressure and heart rate via a finger cuff based on the scientific method of Pulse Decomposition Analysis ("PDA")
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- Intended Use: CareTaker is intended to noninvasively and continuously measure a patient's blood pressure ("BP") and heart rate ("HR"), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis ("PDA") for use on adult patients at rest. CareTaker is calibrated using a manual sphygmomanometer. All parameters derived by CareTaker are reported to a remote display monitor via standard radio transmission. CareTaker does not provide any physiological alarm functions. The
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K151499
device is intended for use by clinicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
8) Comparison to Predicate:
Both the CareTaker and the NextFin predicate device are continuous non-invasive blood pressure and heart rate monitors that derive these physiological parameters from the arterial pulse collected by a finger cuff.
The devices are characterized by the following common features and differences:
- . Both devices measure blood pressure within AAMI SP-10 (AAMI/ANSI/ISO 81060) guidelines.
- . Both devices require calibration and are intended for use on adult patients in clinical settings administered by trained medical staff.
- . Both devices obtain the required arterial pulse pressure signal from a digit. However, the Nexfin utilizes the Penaz principle, which requires that the arterial pressure be matched by the dynamic coupling pressure throughout the cardiac cycle, resulting in variable pressure and poor user comfort as well as occlusion of venous blood return. The CareTaker system, on the other hand, utilizes the Pulse Decomposition Algorithm pulse analysis approach to track blood pressure by monitoring the time evolution of temporal and amplitudinal pulse parameters. This approach requires only a low, constant coupling pressure well below diastole, without any occlusion.
- . Since the CareTaker system operates at a significantly lower coupling pressure with a lower risk of occluding blood flow to the monitored digit, the CareTaker technology is safer.
- . The Predicate's Penaz principle monitors the digit's blood volume using plethysmography, which requires electronic circuitry in the finger cuff for driving optical sources, such as light-emitting diodes, and for deriving electrical signals from the optical interrogation, using photo diodes. In contrast, the CareTaker system requires no electrical components to be part of the finger cuff.
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- Testing: The CareTaker has been tested in a clinical study to compare with an arterial catheter in recording blood pressure. The results are compliant with the ISO 81060-2 standard. Additionally, testing in accordance with the IEC 60601-1 and IEC 60601-1-2 standards has verified that the CareTaker is safe and electromagnetically compatible, similar to the predicate device.
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- Conclusion: The CareTaker device is substantially equivalent to the NexFin_HD in terms of capturing Blood Pressure and Heart Rate parameters from a finger cuff after manual calibration, although CareTaker uses a different methodology (PDA) to interpret and display the actual HR and BP parameters. CareTaker has clinically validated evidence attesting adherence to AAMI SP-10 (AAMI/ANSI/ISO 81060) standards and followed quality management system rigor to comply with IEC 60601 safety standards.
§ 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).