(93 days)
Not Found
No
The description focuses on pre-set thresholds for alerts and a panic button, with no mention of AI/ML terms or learning capabilities.
No
The device is intended for monitoring and alerting caregivers about impacts or emergencies, not for providing treatment or therapy. The description explicitly states it is not intended to provide automated treatment decisions or substitute for professional healthcare judgment.
No
The device is described as a personal help device intended for monitoring residents and alerting caregivers about impacts or emergencies. It explicitly states it is not intended to provide automated treatment decisions or be used as a substitute for professional healthcare judgment, and "All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate healthcare professional." This indicates it does not diagnose medical conditions.
No
The device description explicitly mentions a "MyPHD™ personal help device" which is a physical monitor that can be worn on the wrist or clipped to the waist. This indicates the system includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The MobileCare™ Monitor 2100 system monitors the physical location and potential impacts experienced by individuals. It provides alerts based on these physical events.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the user. Its function is based on physical monitoring and alerting.
The device falls under the category of a personal emergency response system (PERS) or a fall detection system, which are not considered IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KMI
Device Description
The MobileCare Monitor™ is intended for monitoring residents in a long-term 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. It includes a MyPHD personal help device that can be worn on the wrist like a watch or clipped to the waist/attached with a bandage. The system provides alerts at pre-set thresholds for impacts and includes an emergency (panic) button. It is intended for 24-hour use. The device uses proprietary software for data collection and communicates wirelessly to a hub using Zigbee v3.2 (IEEE 802.15.4) protocol at 2.402 to 2.480 GHz (FHSS) ISM Band. It interfaces with accelerometers, impact detectors, door monitors, motion detectors, and a nurse call button. The hub is wall-powered (a/c), and sensor devices and the myPHDTM are battery-powered. The myPHDTM watch has a display for normal mode or flashing indicator if activated, and alerts can be silent (vibration) or audible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist, waist, torso, or other locations on the person.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Designated caregivers or professional staff; home and long-term care facilities including independent living, assisted living and rehabilitation settings.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Stanley Security Solutions, Inc., Senior Technologies Div. TABS Elite and Wireless TABs Bed and Chair Exit Monitor System, K925529
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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
1
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 CFR | ||
| 801 Subpart D)? | × | |
| Is the device intended for over-the-counter use (21 | ||
| CFR 807 Subpart C)? | × | |
| Does the device contain components derived from a | ||
| tissue 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 reprocessed | ||
| validation data? | N/A | |
| Does the device contain a drug? | × | |
| Does the device contain a biologic? | × |
2
| 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 Technical
Characteristics | Stanley Security
Solutions, Inc. Senior
Technologies Div.
TABS Professional
monitors w/Wireless
TABS System (Reg.
1929691) | Care
Electronics,
Inc.
WanderCare
(K925529) | Proposed device
(MobileCare™ Monitor
myPHD™) |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute
Indications for use | TABS System is
designed to notify staff
that a patient is leaving
a bed, chair, room or
wheelchair, by
identifying which
monitor is alarming so
staff can go directly to
the resident in need of
assistance. | WanderCare
provides
monitoring of a
wanderer in
the home. The
system alerts
the caregiver
when the
wanderer goes
beyond a set
range and
provides
location
tracking
capability up
to one mile so
that the
wanderer can
be located and
returned. | The MobileCare™
Monitor System is
designed to notify
healthcare providers
and caregivers to
know when a patient
requests assistance or
experiences an impact
that may be due to a
fall, and their
location, so staff can
go directly to the
resident in need of
assistance. |
| Prescription | No | No | No |
| Intended population | Long Term Care,
Assisted Living
Residential,
Rehabilitation and
Home Settings with
patients at risk for falls
and in need of other
assistance | Wanderers
(wandering
individuals) in
the home or in
facilities. | Long Term Care,
Assisted Living
Residential,
Rehabilitation and
Home Settings with
patients at risk for
falls and in need of
other assistance |
| Intended Environment
of Use | Home, Clinic | Home, Clinic | Home, Clinic |
| Design | | | |
| Method of data
collection | Proprietary Software | Proprietary
Software | Proprietary Software |
| Communication method
with Care Mgmt and
Nurse Call System | Wireless | Wireless | Wireless |
| Types of sensors which
can be interfaced to
receiver hub | Pressure sensors in bed
and chair pads, door
monitors, magnetic
locks, smoke detectors,
door/window
transmitters, motion
detectors, nurse call
transmitters | Transmitter | Accelerometers,
impact detectors,
door monitors, motion
detectors, and nurse
call button |
| Connectivity | Wireless to hub | Wireless
Transmitter to
Receiver
Antenna | Wireless mesh to hub |
| Communication method
of hub with devices | 900 Mhz Spread
Spectrum | RF approx
200-500 MHz | 2.4 Ghz Zigbee v3.2
(IEEE 802.15.4) |
| Communications
protocol | Proprietary | Proprietary | Zigbee v3.2
(IEEE 802.15.4) |
| Wireless frequency | 900 Mhz Spread
Spectrum | RF approx
200-500 MHz | 2.402 to 2.480 GHz
(FHSS) ISM Band |
| Power Source | Wall plug for hub (a/c)
and 9V battery for
510(k) approved sensor
devices. | 9V battery for
transmitter | Wall plug for hub
(a/c) and batteries for
510(k) approved
sensor devices and
myPHDTM |
| Form Factor | Pressure Pad under bed
or chair | "Fanny Pack"
worn at the
waist with
transmitter
and 9V battery
assembly
inside. | Wrist watch or as a
small case for
attachment to
clothing at torso or
under a bandage. |
| Display | Low battery indicator on
unit. Flashing light
indicating source of call. | No display on
Fanny Pack.
LCD display on
Care | On myPHDTM watch
display in normal
mode or flashing
indicator if activated |
| | to Remote Nurse Call
System annunciator. | management
system for
caregiver. | and also on remote
care management
system |
| Alerts | Audible alarm at
bedside when sensor
activated | Alerts
wirelessly to
care
management
system for
caregiver. | Alert silently
(vibration) or audibly
to caregiver or nurse
at bedside or
remotely when sensor
activated |
| Alert reset | Manual and Automatic
when pressure is re-
applied (e.g. patient
returns to bed) | Manual or
Automatic
when person
returns to
area. | Manual or Automatic
upon caregiver
acknowledgement of
activation. |
| Materials | Common plastic
materials for human use | Common
plastic case for
human use. | Common plastic
materials for human
use |
3
・
4
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.
5
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
6
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
7
Indications for Use
510(k) Number (if known): K090138
Device Name: _ MyPHD MobileCare Monitor TM Model 2100
Indications For Use:
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.
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 |