(329 days)
Not Found
No
The summary describes a device that collects and stores data for off-line analysis by a healthcare provider. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis is performed "off-line" by a healthcare provider, suggesting traditional data processing rather than automated AI/ML interpretation.
No
The device is described as a monitor for activity, temperature, and ambient light, used to analyze circadian rhythms, collect sleep parameters, and assess physical motion. It is not indicated for treating any condition or providing therapy.
No
The device description indicates its use for "acquisition and analysis of the physical activity of the body, peripheral temperature and light exposure," and monitoring "limb or body movements." It's primarily a data logger and monitor for these physical parameters, not stated to diagnose any specific medical condition or disease.
No
The device description explicitly states it is a "compact, ambulatory, battery-operated data recorder" with physical characteristics similar to a wristwatch, indicating it is a hardware device that collects data. While it requires software for configuration and analysis, the core device is hardware.
Based on the provided information, the ActTrust device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ActTrust Function: The ActTrust device monitors physical activity, temperature, and ambient light by being worn on the wrist or body. It collects data related to movement and environmental factors.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples from the patient. Its function is based on external measurements and physical motion.
Therefore, the ActTrust falls under the category of a wearable medical device for monitoring physiological and environmental parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ActTrust is an ultra-compact, lightweight, wrist-worn activity, temperature and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and store data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. The device is intended to monitor limb or body movements during daily living and sleep. ActTrust is indicated for adults of 22 years of age and over.
Product codes
LEL
Device Description
ActTrust is a compact, ambulatory, battery-operated data recorder with physical characteristics similar to a small wristwatch. The ActTrust is intended for the acquisition and analysis of the physical activity of the body, peripheral temperature and light exposure during daily living and sleep. The ActTrust uses state of the art miniature electronic technology to measure the data and store these data within the device. The ActTrust require operational software to allow configuration, data download, storage and off-line analysis of activity data by a health care provider. The device is connected directly by means of a standard Universal Serial Bus connection for configuration and download. The ActTrust utilize a motion sensor known as an "accelerometer" to measure the occurrence and degree of motion. The sensor is a solid-state device with a digital output directly proportional to physical acceleration in 1, 2 or 3 axes of orientation. The acceleration data are processed before being stored in the non-volatile memory of the device. The temperature sensor is a thermistor. These sensors electrical resistance changes according to the temperature. These chances are read by a micro-controller and the values are then stored in the non-volatile memory of the device. The light sensor measures the total light and its components in RGB-IR spectrum and then these data are stored in the non-volatile memory of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb or body
Indicated Patient Age Range
adults of 22 years of age and over
Intended User / Care Setting
Not Found
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)
Device performance was verified with a suite of bespoke non-clinical tests. Key tests included:
- Linear acceleration accuracy: Tested by applying a range of simulated reference acceleration and recording results. Passed with +/-5% accuracy over the full range.
- Device accuracy at calibration point (1g): Tested by collating a random sample of calibration records and examining inter-device variation. Passed, meeting or exceeding the requirement.
- Frequency response: Tested by applying a fixed acceleration over a range of frequencies. Passed with 0.5 to 12.5 Hz frequency response within +/-10%.
- Zero counts when no physical stimulus: Tested by setting up a sample device and recording for a period with no physical stimulus. Passed, recording zero for the period.
- Light sensor accuracy: Tested by recording a range of light from darkness to sunlight with a sample device simultaneously with a calibrated light meter. Passed with +/-7.5% accuracy over the stated range, with acceptable worsening as light level increases.
- Zero lux in total darkness: Tested by recording data with the light sensor covered with fully opaque tape. Passed, recording zero lux.
- Recovery from unexpected resets/power loss: Tested by subjecting a sample device to multiple power on reset events and downloading stored data. Passed, with no loss of function/data.
- Thermistor accuracy: Tested by placing devices in a climatic chamber with a ramp curve on temperature and examining inter-device variation. Passed with accuracy of +/- 0.5°C over the stated range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2016
Condor Instruments Ltda. - EPP Rodrigo Trevisan Okamoto, Managing Director Rua Brigadeiro Luis Antonio, 551, Cj 124 Sao Paulo, SP Brazil 01318-000
Re: K151784
Trade/Device Name: ActTrust Regulation Number: 21 CFR Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LEL Dated: April 18, 2016 Received: April 22, 2016
Dear Rodrigo Okamoto:
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 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.
1
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,
William J. Heetderks -A
Digitally signed by William J. Heetderks -A
DN: c=US, o=U.S. Government, ou=HHS, ou=NIH,
ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -A
Date: 2016.05.25 15:41:54 -04'00'
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151784
Device Name
ActTrust
Indications for Use (Describe)
The ActTrust is an ultra-compact, lightweight, wrist-worn activity, temperature and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and store data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. The device is intended to monitor limb or body movements during daily living and sleep. ActTrust is indicated for adults of 22 years of age and over.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 801 CFR Subpart D) | Over-The-Counter Use (81 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------- | --------------------------------------------- |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
06/02/2015
- ട 510(K) SUMMARY
- Summary information 5.1
- 5.1.1 Submitter's name and address
Rodrigo Trevisan Okamoto, Managing Director
Condor Instruments LTDA - EPP
Av. Brigadeiro Luís Antônio, 551, cj 124
São Paulo , SP, Brazil
01318-000
Tel: +55 11 2129-6662
Date summary was prepared: 2th June 2015
Name of device 5.1.2
Trade Names: ActTrust
Common Name: Activity Recording Device, Actimeter
Classification Name: Unclassified
Product Regulation: Unclassified
Product Code: LEL
Device non-sterile when used
5.1.3 Identification of predicate devices
Number K983533 - "Actiwatch" - Mini-Mitter Number K132764 - "MotionWatch and PRO-Diary" - CamNtech Number K111514 - "SBV2 System" - SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE
5.2 Device description
5.2.1 Functions of the device
ActTrust is a compact, ambulatory, battery-operated data recorder with physical characteristics similar to a small wristwatch.
4
The ActTrust is intended for the acquisition and analysis of the physical activity of the body, peripheral temperature and light exposure during daily living and sleep. The ActTrust uses state of the art miniature electronic technology to measure the data and store these data within the device.
The ActTrust require operational software to allow configuration, data download, storage and off-line analysis of activity data by a health care provider. The device is connected directly by means of a standard Universal Serial Bus connection for configuration and download.
5.2.2 Basic scientific concepts
The ActTrust utilize a motion sensor known as an "accelerometer" to measure the Occurrence and degree of motion. The sensor is a solid-state device with a digital output directly proportional to physical acceleration in 1, 2 or 3 axes of orientation. The acceleration data are processed before being stored in the non-volatile memory of the device.
The temperature sensor is a thermistor. These sensors electrical resistance changes according to the temperature. These chances are read by a micro-controller and the values are then stored in the non-volatile memory of the device.
The light sensor measures the total light and its components in RGB-IR spectrum and then these data are stored in the non-volatile memory of the device.
5.2.3 Physical characteristics of Device
Pertinent physical characteristics of the ActTrust are shown in Table 5. 1.
| Parameter | ActTrust | Condition/Note |
|---|---|---|
| Size | 47mm x 31mm x 12 mm | Outer dimensions (excluding strap) |
| Weight | 19 grams | excluding strap |
| Battery Type | Fixed, rechargeable | |
| Battery Life | 3 Months | Typical |
| Acceleration Range | 0.01g to 4g | |
| Casing material | Polycarbonate | |
| Wrist band | silicone with stainless steel buckle | |
| Moisture Resistance | IP67 | Water resistant to 1m for 1 hour. |
| Sampling Intervals (epochs) | 1s to 86400s | User selectable |
| Recording time | typical 90 days | Depending upon epoch |
| Memory | 4 MB | Non-Volatile |
| Storage Temperature | -20 °C a 60 °C |
5
| Operating
| Temperature | 0 °C a 60 °C | |
|---|---|---|
| -------------------------- | -------------- | -- |
5.3 Statement of the intended use
The ActTrust is an ultra-compact, lightweight, wrist-worn activity, temperature and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and store data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. The device is intended to monitor limb or body movements during daily living and sleep. ActTrust is indicated for adults of 22 years of age and over.
5.4 Comparison of the ActTrust with the predicate device
The ActTrust is Substantially equivalent to the predicates [Actiwatch® FDA 510(k) Number: K983533, SBV2 System FDA 510(k) Number: K111514, and Motion Watch FDA 510(k) Number: K132764] . The ActTrust and the Predicate Devices are all physical activity recording systems based upon the concept of an ambulatory, unattended recorder that logs data to the device. Each of these devices is a solid-state recorder with accelerometer sensor, data collection means, and with the capability to store data until it is transferred to a personal Computer. The ActTrust and the Predicate Devices are of similar mechanical designs, construction, size, and human interface characteristics. The ActTrust and the Predicate Devices are of similar electronic design and their operational characteristics and indications for use are equivalent. Table 5.2 compares the features of the ActTrust with those of the Predicate Devices.
| COMPARISON | ActTrust (Current
Device) | Actiwatch
(Predicate device) | SBV2 System
(Predicate Device) | Motion Watch
(Predicate device) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PARAMETER | | | | |
| Indications
for use | The ActTrust is an
ultra-
compact,
lightweight,
wrist-worn
activity,
temperature and
ambient light
monitor that can
be used to
analyze circadian
rhythms,
automatically
collect and store
data for sleep
parameters, and | The Actiwatch® is
an ultra-compact,
lightweight,
wrist- worn
activity and
ambient light
monitor that can
be used to analyze
circadian rhythms,
automatically
collect and store
data for sleep
parameters, | The SBV2 System is
an activity monitor
designed and
intended for
documenting
physical
movements
associated with
applications in
physiological
monitoring. The
device's intended
use is to analyze
limb activity
associated with
movement during | The MotionWatch
and PRO-Diary are
compact,
lightweight, body-
worn activity
monitoring devices
that may be used to
document physical
movement
associated with
applications in
physiological
monitoring. The
devices are intended
to monitor limb or
body movements
during daily living |
| Table 2 - COMPARISON OF ACTTRUST TO PREDICATE DEVICES | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------- |
6
| | limb or body
movements during
daily
living and sleep.
ActTrust is indicated
for adults of 22
years of age and
over. | and assess activity
in any instance
where
quantifiable
analysis of
physical motion
is desirable. | sleep and to
extract
information
about certain
sleep
parameters from
these
movements.
SBV2 can also be
used to assess
activity in any
instance where
quantifiable
analysis of
physical
motion is
desirable.
The use of the
SBV2 is
restricted to
adults 22 years
of age and
over. | and sleep. The
MotionWatch and
PRO-Diary can be
used to assess
activity in any
instance where
quantifiable
analysis of
physical motion is
desired.
Additionally, the
PRO-Diary has a
built-in score pad
that allows the
wearer to
subjectively assign
and enter
responses to pre-
programmed
questions. The
score pad can be
used as a
substitute or in
addition to the
traditional written
patient diary in
conjunction with
activity monitoring. |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
general
description | Compact, wearable,
battery-
operated
physical activity
data recorder | Compact,
wearable,
battery-
operated
physical activity
data recorder | Compact,
wearable,
battery-
operated
physical activity
data recorder | Compact,
wearable,
battery-operated
physical activity
data recorder |
| Activity
channels | 1, 2, or 3 | 1 | 1 | 1, 2, or 3 |
| Visual
appearance
and
physi
cal
descr
iptio | Plastic molded
wristwatch style
casing with
detachable band.
Size 47 x 31 x 12
(excluding band) | Plastic molded
wristwatch
style casing
with
detachable
band. Size 37
x 29 x 9 | Plastic molded
wristwatch
style casing
with
detachable
band. Size 38.1
x 38.1 x | Plastic molded
wristwatch style
casing with
detachable
band. Size 36 x
28.2 x 9.4
(excluding band) |
| Weight | 19 grams | 17 grams | 28.3 grams | 9.1 grams |
| Frame
Cover | Polycarbonate | Polycarbonate | Polycarbonate | ABS blend |
| Sampling
Intervals | Any between 1
and 86400 seconds | 15, 30, 60, 120,
300, 600 seconds | 60 seconds | 1, 2, 5, 10, 30, 60
seconds |
| Recording
time | 90 Days @ 60s
epoch | 45Days @ 60s
epoch | 30 Days @ 60s
epoch | 182 Days @ 60s
epoch |
7
| Memory | 4 MB | 64 kB | 64 kB | 512 kB |
|---|---|---|---|---|
| Raw Sampling rate | 25 Hz | 32Hz | 16Hz | 50 Hz |
| A/D conversion | 12 bits | 8 bits | 8 bits | 12 bits |
| Frequency | ||||
| response | 0.5 to 12.5 Hz | 3 to 11Hz | 3 to 11Hz | 3 to 11 Hz |
| Moisture | ||||
| Susceptibility | IPX7 | IPX7 | IP X6 | IPX7 |
| Sterility | None required | None required | None required | None required |
| Biocompatibility | ||||
| (skin contact type) | Standard silicon | |||
| wrist band in | ||||
| contact with intact | ||||
| skin surface. | Standard nylon | |||
| wrist band in | ||||
| contact with | ||||
| intact | Santoprene wrist | |||
| band in contact | ||||
| with intact skin | ||||
| surface. | Standard nylon wrist | |||
| band in contact | ||||
| with intact skin | ||||
| surface. | ||||
| Human factors | Worn in wrist like | |||
| a wristwatch; no | ||||
| user interaction is | ||||
| required. | Worn in wrist like | |||
| a wristwatch;no | ||||
| user interaction | ||||
| is required. | Worn in wrist like a | |||
| wristwatch; no | ||||
| User interaction | ||||
| is required. | Worn in wrist like | |||
| a wristwatch; no | ||||
| User interaction is | ||||
| required. | ||||
| Electrical safety | ||||
| (Recorder) | Battery operated | Battery operated | Battery operated | Battery operated |
| Power used | ||||
| (Recorder) | 3.7 volt coin cell | |||
| type | ||||
| LIR2032H (1 each, | ||||
| rechargeable) | 3.0 volt coin cell | |||
| type CR2025 (1 | ||||
| each, user- | ||||
| replaceable) | Rechargeable | |||
| 3.7V Lithium | ||||
| Coin Cell | 3.0 volt coin cell | |||
| type | ||||
| CR2032 (1 each, | ||||
| user-replaceable) | ||||
| Battery Life | ||||
| (typical) | 3 months | 6 months | 30 days | 6 months |
5.5 Differences between ActTrust and Predicate Devices
5.5.1 Differences between ActTrust and SBV2 system (Predicate Device)
All the differences between the ActTrust and the SBV2 system have no effect on the safety of the device and implies in minor functionalities changes.
5.5.2 Differences between ActTrust and Actiwatch (Predicate Device)
The meaningful difference between differences between ActTrust and Actiwatch predicate device is the means of commercial distribution. The ActTrust is intended for Over-The-Counter commercial distribution. Actiwatch is indicated for Prescription Use.
5.5.3 Differences between ActTrust and Motion Watch (Predicate Device)
All the differences between the ActTrust and the SBV2 system have no effect on the safety of the device and implies in minor functionalities changes.
5.6 Assessment of non-clinical performance data
There are no special controls or consensus standards applicable to the measurement of body movement. To verify the performance of the ActTrust a sample of devices were
8
subjected to a suite of bespoke tests to verify each performance parameter. Table 5.4 provides a summary of the ActTrust non-clinical performance testing.
| Requirement
summary | Test/verification
Method | Pass/fail criteria | Test result |
|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| The device shall
measure linear
acceleration with an
accuracy of +/-5%
over the full range. | Apply a range of
simulated reference
acceleration and
record the results. | The recorded
acceleration over
the test range shall
meet the
requirement. | PASS |
| The device accuracy
shall be