The MobileCare™ Monitor 2100 system includes a MyPHD™ personal help device that is intended to monitor residents in home and long-term care facilities including independent living, assisted living and rehabilitation settings. The monitor can be placed on the wrist using the Velcro strap and used like a watch by the resident. The other form of MyPHD offered has no wrist straps so it can be clipped to the waist or used in a bandage for attachment at other locations on the person as may be appropriate or preferred by the user or healthcare provider. The system provides an alert to designated caregivers or professional staff automatically at pre-set thresholds to indicate an impact has occurred. The system also includes an emergency (panic) button that can be pressed by the monitored individual to alert caregivers as needed. The users of the system include staff and residents. The product is intended to be used on a 24-hour basis. The system is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate healthcare professional.

Device Description

AI/ML Overview

The provided 510(k) summary for the KOGO 138 MobileCare Monitor™ does not contain information about specific acceptance criteria related to a clinical study or device performance metrics like sensitivity, specificity, or accuracy. It focuses on demonstrating substantial equivalence to predicate devices primarily through comparison of technical characteristics and intended use, and conformance to non-clinical safety (FCC regulations) and software validation standards.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are stated. The document indicates software validation was performed, but no results are provided.
Sample size used for the test set and the data provenance: Not applicable as no clinical test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a monitor with alerting capabilities; performance is not typically described in terms of "algorithm only" in this context. The document mentions an "impact sensor that may indicate a fall" and an "emergency (panic) button."
The type of ground truth used: Not applicable as no clinical performance study is detailed with ground truth.
The sample size for the training set: Not applicable as a machine learning training set is not mentioned for this device type.
How the ground truth for the training set was established: Not applicable.

Here's a summary of the available information regarding acceptance criteria and studies:

1. Acceptance Criteria and Reported Device Performance:

The document primarily relies on demonstrating substantial equivalence to predicate devices and adherence to non-clinical standards rather than clinical performance metrics.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	Conformance to FCC "Code of Federal Regulations" Title 47, Part 15, Subpart B, for receivers and Subpart C, Section 15.247 for Digital Modulation Intentional Radiators Operating within the band 2400-2483.5MHz.	Conforms to FCC Standards: A copy of the engineering test report demonstrating compliance is contained in Appendix B (not provided).
Performance	Validation of software.	Software Validated: A summary report of this software validation is included as Appendix D (not provided).
Substantial Equivalence	Similar intended use, design, and testing methods to predicate devices (Stanley Security Solutions, Inc., Senior Technologies Div. TABS Elite and Wireless TABs Bed and Chair Exit Monitor System and Care Electronics WanderCare T100).	Demonstrated Substantial Equivalence: "The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, design and testing methods." (Page 4)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified, as no clinical test set for performance evaluation is described in the provided text. The evaluation focuses on non-clinical aspects and substantial equivalence.
Data Provenance: Not applicable, as no clinical performance data are presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set requiring expert-established ground truth is described.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring adjudication is described.

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:

No, a multi-reader multi-case comparative effectiveness study was not done or reported. This type of study is more common for diagnostic imaging AI devices, whereas the MobileCare Monitor™ is a monitoring and alerting system.

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

The document does not describe a "standalone" algorithmic performance study in the context typically used for AI/ML devices (e.g., measuring accuracy of an image analysis algorithm). The device itself functions as a standalone monitoring system that provides alerts.

7. The type of ground truth used:

Not applicable, as no clinical performance study with defined ground truth is described. The "performance" aspect refers to software validation.

8. The sample size for the training set:

Not applicable, as no machine learning algorithm requiring a training set is explicitly mentioned or detailed in the provided information. The device functions based on sensors and pre-set thresholds, not a learned model.

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

Not applicable, as no machine learning algorithm or training set is described.

Summary

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KOGO 138

510(k) Summary

APR 2.4 2009

2000 Lee Highway
Second Floor
Falls Church Virginia 22042

Phone 703 580 0512
Fax 703 852 7902

www.aframedigital.com

Traditional 510(k) Notification Purpose:

MobileCare Monitor™ is intended for monitoring residents in a long-term Device Type: care facility. The product is intended to be a monitoring and alerting system similar to many commercially available panic button systems. This product adds location information and an impact sensor that may indicate a fall. Per FDA Request for Information # C070224 (See Appendix A), this is considered a Patient Bed Monitor, a Class I device, classification code KMI.

December 17, 2008 Date:

AFrame Digital, Inc. 510(k) Submitter: 8000 Lee Highway, 2nd Floor Falls Church, VA 22042 Owner/Operator#: 10028071 510(k) #: K090138
510(k) Contact: Sunil Saxena, MD Chief Medical Officer 8000 Lee Highway, 2nd Floor Falls Church, VA 22042 571-308-0147 (O) 703-852-7902 (F) ssaxena@aframedigital.com
Indications For Use: The MobileCareTM Monitor 2100 system includes a MyPHDTM personal help device that is intended to monitor residents in home and long-term care facilities including independent living, assisted living and rehabilitation settings. The monitor can be placed on the wrist using the Velcro strap and used like a watch by the resident. The other form of

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MyPHD offered has no wrist straps so it can be clipped to the waist or used in a bandage for attachment at other locations on the person as may be appropriate or preferred by the user or healthcare provider. The system provides an alert to designated caregivers or professional staff automatically at pre-set thresholds to indicate an impact has occurred. The system also includes an emergency (panic) button that can be pressed by the monitored individual to alert caregivers as needed. The users of the system include staff and residents. The product is intended to be used on a 24-hour basis. The system is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate healthcare professional.

Trade Name:	MobileCare™ Monitor
Common Name:	MobileCare™ Monitor
Classification:	Monitor, Bed Patient, (21 CFR 880.2400, Product Code KMI)
Product Code:	KMI (21 CFR 880.2400)
FDA Docs:	Request for Information # C070224 (Appendix A)
Basis:	New Submission

Design & Use of the Device: (Refer to Table 1 below)

Question	YES	NO
Is the device intended for prescription use (21 CFR801 Subpart D)?		×
Is the device intended for over-the-counter use (21CFR 807 Subpart C)?	×
Does the device contain components derived from atissue or other biologic source?		×
Is the device provided sterile?		×
Is the device intended for single use?		×
Is the device a reprocessed single use device?		×
If yes, does this device type require reprocessedvalidation data?		N/A
Does the device contain a drug?		×
Does the device contain a biologic?		×

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Does the device use software?	X
Does the submission include clinical information?	X
Is the device implanted?	X

Comparison to Predicate:

Substantially Equivalent Device

The AFrame Digital, Inc. MobileCare™ Monitor is substantially equivalent to the Stanley Security Solutions, Inc., Senior Technologies Div. TABS Elite and Wireless TABs Bed and Chair Exit Monitor System and the Care Electronics WanderCare T100.

Basis of Substantial Equivalence

Per FDA Request for Information # C070224 (See Appendix A), this is considered a Patient Bed Monitor, a Class I device, classification code KMI. The AFrame Digital MobileCare™ Monitor is similar to the primary predicate monitor device with respect to technical characteristics and performance in the following ways.

General TechnicalCharacteristics	Stanley SecuritySolutions, Inc. SeniorTechnologies Div.TABS Professionalmonitors w/WirelessTABS System (Reg.1929691)	CareElectronics,Inc.WanderCare(K925529)	Proposed device(MobileCare™ MonitormyPHD™)
AttributeIndications for use	TABS System isdesigned to notify staffthat a patient is leavinga bed, chair, room orwheelchair, byidentifying whichmonitor is alarming sostaff can go directly tothe resident in need ofassistance.	WanderCareprovidesmonitoring of awanderer inthe home. Thesystem alertsthe caregiverwhen thewanderer goesbeyond a setrange andprovideslocationtrackingcapability upto one mile sothat thewanderer canbe located andreturned.	The MobileCare™Monitor System isdesigned to notifyhealthcare providersand caregivers toknow when a patientrequests assistance orexperiences an impactthat may be due to afall, and theirlocation, so staff cango directly to theresident in need ofassistance.
Prescription	No	No	No
Intended population	Long Term Care,Assisted LivingResidential,Rehabilitation andHome Settings withpatients at risk for fallsand in need of otherassistance	Wanderers(wanderingindividuals) inthe home or infacilities.	Long Term Care,Assisted LivingResidential,Rehabilitation andHome Settings withpatients at risk forfalls and in need ofother assistance
Intended Environmentof Use	Home, Clinic	Home, Clinic	Home, Clinic
Design
Method of datacollection	Proprietary Software	ProprietarySoftware	Proprietary Software
Communication methodwith Care Mgmt andNurse Call System	Wireless	Wireless	Wireless
Types of sensors whichcan be interfaced toreceiver hub	Pressure sensors in bedand chair pads, doormonitors, magneticlocks, smoke detectors,door/windowtransmitters, motiondetectors, nurse calltransmitters	Transmitter	Accelerometers,impact detectors,door monitors, motiondetectors, and nursecall button
Connectivity	Wireless to hub	WirelessTransmitter toReceiverAntenna	Wireless mesh to hub
Communication methodof hub with devices	900 Mhz SpreadSpectrum	RF approx200-500 MHz	2.4 Ghz Zigbee v3.2(IEEE 802.15.4)
Communicationsprotocol	Proprietary	Proprietary	Zigbee v3.2(IEEE 802.15.4)
Wireless frequency	900 Mhz SpreadSpectrum	RF approx200-500 MHz	2.402 to 2.480 GHz(FHSS) ISM Band
Power Source	Wall plug for hub (a/c)and 9V battery for510(k) approved sensordevices.	9V battery fortransmitter	Wall plug for hub(a/c) and batteries for510(k) approvedsensor devices andmyPHDTM
Form Factor	Pressure Pad under bedor chair	"Fanny Pack"worn at thewaist withtransmitterand 9V batteryassemblyinside.	Wrist watch or as asmall case forattachment toclothing at torso orunder a bandage.
Display	Low battery indicator onunit. Flashing lightindicating source of call.	No display onFanny Pack.LCD display onCare	On myPHDTM watchdisplay in normalmode or flashingindicator if activated
	to Remote Nurse CallSystem annunciator.	managementsystem forcaregiver.	and also on remotecare managementsystem
Alerts	Audible alarm atbedside when sensoractivated	Alertswirelessly tocaremanagementsystem forcaregiver.	Alert silently(vibration) or audiblyto caregiver or nurseat bedside orremotely when sensoractivated
Alert reset	Manual and Automaticwhen pressure is re-applied (e.g. patientreturns to bed)	Manual orAutomaticwhen personreturns toarea.	Manual or Automaticupon caregiveracknowledgement ofactivation.
Materials	Common plasticmaterials for human use	Commonplastic case forhuman use.	Common plasticmaterials for humanuse

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・

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1. Non Clinical substantial equivalence

a. Safety The safety of the device is demonstrated conformance to the following standard:
FCC "Code of Federal Regulations" Title 47, Part 15, Subpart B, for receivers and Subpart C, Section 15.247 for Digital Modulation Intentional Radiators Operating within the band 2400-2483.5MHz
A copy of the engineering test report demonstrating compliance with the above is contained in Appendix B of this submission
b. Performance The performance of the device is demonstrated through the validation of the software. A summary report of this software validation is included as Appendix D of this submission.

2. Conclusion:

The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, design and testing methods.

Similarities/Differences of the proposed device when compared to the predicate: 3.

The data within this submission demonstrates that there are no significant differences between the application device and the predicate, indicating that the application device is safe, effective and substantially equivalent for marketing in the U.S.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure, composed of three curved lines. The symbol is positioned to the right of the text.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2009

Sunil Saxena, MD Chief Medical Officer AFrame Digital, Incorporated 8000 Lee Highway 2nd Floor Falls Church, Virginia 22042

Re: K090138

Trade/Device Name: MyPHD™ MobileCare™ Model 2100 Regulation Number: 21 CFR 880.2400 Regulation Name: Bed-Patient Monitor Regulatory Class: I Product Code: KMI Dated: March 26, 2009 Received: March 31, 2009

Dear Dr. Saxena:

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.

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

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Page 2- Dr. Saxena

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K090138

Device Name: _ MyPHD MobileCare Monitor TM Model 2100

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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 Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K090138

Regulation Number and Section

§ 880.2400 Bed-patient monitor.

(a)
Identification. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.