MiPal allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. It is not intended for real-time, emergency, or critical care monitoring of patient vital signs. The MiPal is intended for use with adult and pediatric patients over twelve years of age.

SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.

Device Description

The MiPal is a communication hub intended to receive and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers.

The MiPal is designed to optionally collect NiBP, pulse, and SpO2. It may also collect other vitals through the vitals acquisition process via Bluetooth medical peripherals. Peripherals will include:

Scale
o Glucose meter

AI/ML Overview

The Watermark Medical MiPal is a communication hub intended to receive and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers. MiPal allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. The system allows retrospective review of certain physiological functions by qualified health care professionals. The MiPal is intended for use with adult and pediatric patients over twelve years of age. SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.

The provided text only briefly discusses performance data by stating: "The verification and validation results demonstrated that the MiPal was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements."

Therefore, I cannot provide detailed information for all requested sections due to the limited information in the provided text.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a table of acceptance criteria or specific reported device performance metrics. It only makes a general statement about compliance.

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

This information is not available in the provided 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 available in the provided text.

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

This information is not available in the provided 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:

This information is not available in the provided text. The device is described as a "communication hub" to collect and transmit data for retrospective review, not as an AI-assisted diagnostic tool for human readers.

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

The device is not described as having an algorithm that performs interpretations or diagnostics independently. Its function is to collect and transmit data for review by healthcare professionals. Therefore, a standalone performance study in the sense of an algorithm's diagnostic accuracy is not relevant to the described function of this device, and no such study is mentioned.

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

This information is not available in the provided text.

8. The sample size for the training set:

This information is not available in the provided text. The device is a data collection and transmission hub, not a machine learning model that would require a training set in the conventional sense for its primary function.

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

This information is not available in the provided text for the reasons stated in point 8.

Summary

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K120470/S001

Submitter:	Watermark Medical
Address:	1750 Clint Moore Road, Suite 101Boca Raton, FL 33487
Corporate Contact:	Frank Katarow, Chief Operating OfficerWaterMark Medical
Telephone:	877-710-6999
Establishment Registration #:	3008208119
Submission Contact:	Michael J. Leigh, consultant12715 Falcon DriveBrookfield, Wisconsin 53005Ph: (262) 957-6797
Trade Name:	MiPal
Predicate Device:	Honeywell HomMed Genesis OTC, K061087
Common Name:	Patient Vital Signs Monitor
Classification Name:	Regulation	Product	Classification Name	Device

Code

DRG

DXN

FRI

DQA

NBW

Transmitters And Receivers, Physiological

Noninvasive Blood Pressure Measurement

Signal, Radiofrequency Medical device product codes also supported by MiPal by means of separate medical devices

Patient Weight Scale

Glucose Test System

Class

Number

870.2910

870.1130

880.2700

870.2700

862.1345

510(k) Summary for Watermark Medical Mobile Application

Device Description:

System

Oximeter

The MiPal is designed to optionally collect NiBP, pulse, and SpO2. It may also collect other vitals through the vitals acquisition process via Bluetooth medical peripherals. Peripherals will include:

Scale
o Glucose meter

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Intended Use:

MiPal allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. The MiPal is intended for use with adult and pediatric patients over twelve years of age.

SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.

Performance Data:

The verification and validation results demonstrated that the MiPal was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of FDA.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird in flight, composed of three curved lines that suggest the shape of a bird's wing and head. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

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

JUL 1 1 2012

Watermark Medical, Inc c/o Michael J. Leigh Consultant 12715 Falcon Drive Brookfield, Wisconsin 53005

Re: K120470/S001

Trade Name: MiPal, Patient Vital Signs Monitor Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: II (two) Product Code: DRG Dated: May 22, 2012 Received: May 31, 2012

Dear Mr. Leigh:

This letter corrects our substantially equivalent letter of June 8, 2012.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosule) to regally manager of the Medical Device American be on to commence provision of May 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices that have occh recultion in assess approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) that do not require app to the general controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, boyer coursements for annual registration, listing of general controls provisions of the i 100 libeling, and prohibitions against misbranding and

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Page 2 - Mr. Michael J. Leigh

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 device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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): K120470/S001

Watermark Medical MiPal Device Name:

Indications For Use:

SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use x (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
---------------------

Division of Cardiovascular Devices

510(k) Number
---------------

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).