CareTaker is intended to noninvasively and continuously measure a patient's blood pressure ("BP"), heart rate ("HR"), ould respiration rate ("RSP"), 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 method or any A MI 81060 compliant BP device, or is automatically calibration mode. All parameters derived by Care Taker are reported to an integrated LCD screen and optionally to a remote display monitor (RDDS) via standard radio transmission protocols. The device is intended for use by clinicians or other properly trained medical personnel and does not provide any physiological alarm functions.

Device Description

CareTaker is a cardiovascular monitoring device that non-invasively measures continuous blood pressure, heart rate and respiration rate via a finger cuff based on the scientific method of Pulse Decomposition Analysis ("PDA"). CareTaker is calibrated using any manual or AAMI 81060 compliant blood pressure device or is automatically calibrated using its self-calibration mode.

AI/ML Overview

The provided text describes the CareTaker4 Physiological Monitor (K163255), a device intended for noninvasive and continuous measurement of blood pressure, heart rate, and respiration rate in adult patients at rest. The information regarding acceptance criteria and the study proving device performance is extracted below:

1. A table of acceptance criteria and the reported device performance

The document references adherence to AAMI SP-10 guidelines for blood pressure measurement but does not explicitly state the numerical acceptance criteria from these guidelines. It states that both the predicate CareTaker and the CareTaker4 measure blood pressure "within AAMI SP-10 guidelines," and similarly for the comparison with the Nexfin HD.

Parameter	Acceptance Criteria (Reference)	Reported Device Performance
Blood Pressure	AAMI SP-10 guidelines	Measures within AAMI SP-10 guidelines
Heart Rate	Not explicitly stated	Provides continuous heart rate readings
Respiration Rate	Not explicitly stated	Provides respiration rate readings (performance equivalent to or better than predicate)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes the device for direct measurement and does not mention human-in-the-loop performance or MRMC studies. Therefore, this information is not applicable/not provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device's performance, particularly for blood pressure measurement, is described in a standalone context relative to AAMI SP-10 guidelines. The clinical validation attesting to adherence to SP10 standards implies a standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For blood pressure, the ground truth appears to be based on the AAMI SP-10 guidelines, which typically involve comparisons against a reference standard known to be accurate (e.g., intra-arterial measurement or a highly accurate non-invasive oscillometric device). The device itself can be calibrated using a "manual method or any AAMI 81060 compliant BP device." The text states "clinically validated evidence attesting adherence to SP10 standards," suggesting a comparison against established clinical reference methods for blood pressure.

For heart rate and respiration rate, the ground truth methods are not explicitly stated, but the comparison to predicate devices (which analyze pulsatile signals for respiration rate) suggests a comparison against established methods for measuring these parameters.

8. The sample size for the training set

This information is not provided in the given text.

9. How the ground truth for the training set was established

This information is not provided in the given text. The text does not distinguish between training and test sets or detail the ground truth establishment for a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

April 21, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

CareTaker Medical, LLC Jeff Pompeo President & CEO 3042 Berkmar Drive, Suite A Charlottesville, Virginia 22901

Re: K163255

Trade/Device Name: CareTaker4 Physiological Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 15, 2017 Received: March 16, 2017

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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.

Mada Jellm
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K163255

Device Name

CareTaker4 Physiological Monitor

Indications for Use (Describe)

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 The 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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

510(k) Summary

510(k) Summary of Safety and Effectiveness

Preparation Date: November 9, 2016 1)

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: CareTaker4 Physiological Monitor Classification: 21 CFR 870.1130, Product Code: DXN -System, Measurement, Blood-Pressure, Non-Invasive Device Class: II

Predicate Devices: CareTaker (K151499), Nexfin HD (K072049), HealthPatch MD 5) (K152139)
Device Description: CareTaker is a cardiovascular monitoring device that non-6) invasively measures continuous blood pressure, heart rate and respiration rate via a finger cuff based on the scientific method of Pulse Decomposition Analysis ("PDA"). CareTaker is calibrated using any manual or AAMI 81060 compliant blood pressure device or is automatically calibrated using its self-calibration mode.

Intended Use: CareTaker is intended to noninvasively and continuously measure a 7) patient's blood pressure ("BP"), heart rate ("HR") and respiration rate ("RSP"), 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

{4}------------------------------------------------

using a manual method or any AAMI 81060 compliant BP device, or is automatically calibrated using its self-calibration mode. All parameters derived by CareTaker are reported to an integrated LCD screen and optionally to a remote display monitor ("RDDS") via standard radio transmission protocols. The device is intended for use by clinicians or other properly trained medical personnel and does not provide any physiological alarm functions.

8) Comparison to Predicates:

Provision of continuous non-invasive blood pressure and heart rate

Both the predicate CareTaker and the present CareTaker system use the Pulse Decomposition Analysis method for the tracking of blood pressure. Both devices measure blood pressure within AAMI SP-10 guidelines. Both devices require calibration and are intended for use on adult patients in clinical settings administered by trained medical staff. Both systems are identical with regard to electronic circuitry, pneumatic layout and components and algorithmic pulse analysis. While the CareTaker4 has an onboard display, the predicate CareTaker does not. While the CareTaker4 is capable of self-calibration, the predicate CareTaker is not. While the CareTaker4 is capable of determining respiration rates, the predicate CareTaker is not. Both systems operate at a coupling pressure significantly lower than normal diastole with a lower risk of occluding blood flow to the monitored digit, making the technology is safer.

Provision of calibrated blood pressure readings

The CareTaker system and the predicate Nexfin_HD device provide calibrated blood pressure readings. While the Nexfin HD uses the Penaz/Physiocal method to obtain blood pressure calibration, the CareTaker uses the principle of oscillometry. Both devices measure blood pressure within AAMI SP-10 guidelines. Both devices obtain the required arterial pulse pressure signal from a digit. However, because they use different technologies for the determination of blood pressure, their coupling to the monitored digit is very different. Since the CareTaker system operates at a significantly lower coupling pressure with a lower risk of occluding blood flow to the monitored digit, the technology is safer. The ability of the CareTaker system to operate with lower, constant coupling pressure also has significant consequences regarding portability and versatility of the technology compared to that of the predicate Nexfin device.

Provision of respiration rate readings

With regard to respiration rate detection, both the CareTaker4 and the predicate HealthPatch MD analyze a pulsatile, heartbeat-related signal. In the case of the CareTaker4 it is the derivative arterial pressure pulse, in the case of the respiration detection predicate device it is an EKG signal. In both systems signal amplitude and inter-beat interval-related changes are used to detect and determine the respiration rate.

{5}------------------------------------------------

9) Conclusions:

Provision of continuous non-invasive blood pressure and heart rate

The CareTaker4 device is substantially equivalent to the predicate CareTaker device in regard to providing continuous blood pressure and heartrate readings.

Provision of calibrated blood pressure readings

The CareTaker4 device is substantially equivalent to the NexFin HD in terms of providing calibrated blood pressure readings from a finger cuff, although CareTaker4 uses a different methodology (PDA). Like the Nexfin HD, CareTaker4 has clinically validated evidence attesting adherence to SP10 standards and followed quality management system rigor to comply with IEC 60601 safety standards.

Provision of respiration rate readings

The CareTaker4 device is substantially equivalent to the HealthPatch MD in terms of providing a respiration rate derived from a pulse sensor, although CareTaker4 uses a differentiated arterial pulse signal while the predicate device uses an EKG signal. The CareTaker4 has clinically validated evidence attesting performance equivalent to or better than the predicate device.

Regulation Number and Section

§ 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).