(139 days)
Not Found
No
The description focuses on accelerometer technology and data processing into "counts" for storage and off-line analysis by a healthcare provider. There is no mention of AI or ML algorithms being used for data analysis or interpretation within the device or its associated software.
No
The device is described as an activity monitoring device used for documenting physical movement and assessing activity in physiological monitoring, not for treating a condition or disease.
No
The device monitors physical movement and allows for subjective input but does not diagnose diseases or conditions. Its purpose is for "quantifiable analysis of physical motion".
No
The device description clearly states that the MotionWatch and PRO-Diary are "compact, lightweight, body-worn activity monitoring devices" with "physical characteristics similar to a small wristwatch" and utilize "state of the art miniature accelerometer technology" and an "ambient light sensor" or "display and score-pad". These are all hardware components. While software is required for configuration, data download, storage, and analysis, the core data acquisition is performed by the physical device.
Based on the provided text, the MotionWatch and PRO-Diary devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The MotionWatch and PRO-Diary devices are described as body-worn activity monitoring devices that measure physical movement (limb or torso) using accelerometers. The PRO-Diary also allows for subjective input from the wearer.
- Intended Use: The intended use is to document and quantify physical movement during daily living and sleep for physiological monitoring and activity assessment.
- No Specimen Analysis: There is no mention of these devices analyzing any biological specimens from the body. They are measuring external physical activity.
Therefore, the MotionWatch and PRO-Diary fall under the category of activity monitoring devices rather than In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LEL
Device Description
MotionWatch and PRO-Diary are compact, ambulatory, battery-operated activity recorders with physical characteristics similar to a small wristwatch.
The MotionWatch and PRO-Diary are intended for the acquisition and analysis of the physical activity of the body during daily living and sleep. The MotionWatch and PRO-Diary use state of the art miniature accelerometer technology to measure movements of the limb or torso and store these data within the devices differ in that the MotionWatch incorporates an ambient light sensor whereby the PRO-Diary incorporates a display and score-pad to allow subjective inputs.
The MotionWatch and PRO-Diary require operational software to allow configuration. data download, storage and off-line analysis of activity data by a health, care provider. The software can be run on an IBM-Compatible PC and the device is connected directly by means of a standard Universal Serial Bus connection for configuration and download.
The MotionWatch and PRO-Diary 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 into "counts" before being 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 torso
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health, care provider
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)
MotionWatch Non-Clinical Performance Testing:
- Requirement summary: The device shall measure linear acceleration with an accuracy of +/-5% over the full range.
- Test/verification Method: Apply a range of simulated reference acceleration and record the results.
- Pass/fail criteria: The recorded acceleration over the test range shall meet the requirement.
- Test result: PASS
- Requirement summary: The device accuracy shall be
§ 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
JAN 2 1 2014
5.0 510(K) SUMMARY
Summary information 5.1
- Submitter's name and address 5.1.1
Howard Smith, Engineering Director CamNtech, UK, Ltd. Upper Pendrill Court Ermine Street North -Papworth Everard Cambridge, United Kingdom CB233UY 011-44-1480-831223 Tel: 011-44-1480-831733 Fax:
16" January 2014 Date summary was prepared:
5.1.2 Name of device
Trade Names: Common Name: Classification Name: Product Regulation: Product Code:
MotionWatch and PRO-Diary Activity Recording Device Unclassified Unclassified LEL
Identification of predicate devices 5.1.3.
Actiwatch® (Mini-Mitter Co. Inc.), 510(k) Number : K983533 Actiwatch-Score® (Mini-Mitter Co. Inc.), 510(k) Number : K991033
5.2 Device description
5.2.1.1 Functions of the device
1
1
MotionWatch and PRO-Diary are compact, ambulatory, battery-operated activity recorders with physical characteristics similar to a small wristwatch.
The MotionWatch and PRO-Diary are intended for the acquisition and analysis of the physical activity of the body during daily living and sleep. The MotionWatch and PRO-Diary use state of the art miniature accelerometer technology to measure movements of the limb or torso and store these data within the devices differ in that the MotionWatch incorporates an ambient light sensor whereby the PRO-Diary incorporates a display and score-pad to allow subjective inputs.
The MotionWatch and PRO-Diary require operational software to allow configuration. data download, storage and off-line analysis of activity data by a health, care provider. The software can be run on an IBM-Compatible PC and the device is connected directly by means of a standard Universal Serial Bus connection for configuration and download.
Basic scientific concepts 5.2.1.2
The MotionWatch and PRO-Diary 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 into "counts" before being stored in the non-volatile memory of the device.
Physical characteristics of Device 5.2.1.3
2
Pertinent physical characteristics of the MotionWatch are shown in Table 5.1.
2
TABLE 5.1: PHYSICAL CHARACTERISTICS OF MOTIONWATCH AND
| Parameter | MotionWatch | PRO-Diary | Condition/Note |
|---|---|---|---|
| Size | 36mm x 28.2mm x | ||
| 9.4mm | 51.5mm x 34.6mm x | ||
| 9.4mm | Outer dimensions | ||
| (excluding strap) | |||
| Weight | 9.1 grams | 16 grams | excluding strap |
| Battery Type | CR2032, User | ||
| replacable | Fixed, rechargeable | ||
| Battery Life | 6 Months | 3 Weeks | Typical |
| Acceleration | |||
| Range | 0.01g to 8g | 0.01g to 8g | |
| Casing material | Polycarbonate/ABS | Polycarbonate/ABS | |
| Wrist band | Nylon with stainless | ||
| steel buckle | Nylon with stainless | ||
| steel buckle | |||
| Moisture | |||
| resistance | IPX71 | IP422 | 1) Water resistant to 1m |
| for 1 hour. |
- Drip resistant |
| Sampling
Intervals
(epochs) | 1 Second to 1 Minute | 1 Second to 1 Minute | User selectable |
| Recording time | 6 to 182 days | 6 to 21 days | Depending upon epoch |
| Memory | 512KB | 4MB | Non-Volatile |
| Indicators | Single LED Status | OLED Display for
subjective scoring | |
| Storage
Temperature | -25°C to 70°C | -25°C to 70°C | 0-93% RH |
| Operating
Temperature | 5°C to 40°C | 5°C to 40°C | 0-93% RH |
PRO-DIARY
Statement of the intended use 5.3
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 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
ﺩﺭﺍ
3
be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring.
5.4 Comparison of the Motion Watch with the predicate device
The MotionWatch is substantially equivalent to the predicate [ Actiwatch® FDA 510(k) Number: K983533 ]. The MotionWatch and the Actiwatch® are both 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 ability to store data until it is transferred to a personal computer. The MotionWatch and the Activatch® are of similar mechanical matcrials, construction, size, and human interface characteristics. The MotionWatch and the Activatch® are of similar electronic design and their operational characteristics and indications for use are equivalent. Table 5.2 compares the features of the MotionWatch with those of the Actiwatch®
TABLE 5.2. COMPARISON OF MOTIONWATCH TO ACTIWATCH
| COMPARISON
PARAMETER | MotionWatch
(Current Device) | Actiwatch
(Predicate Device) |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | 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 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. | 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, and assess activity in any
instance where quantifiable analysis of
physical motion is desirable. |
| Device general
description | Compact, wearable, battery-operated
physical activity data recorder | Compact, wearable, battery-operated
physical activity data recorder |
| Activity channels | 1, 2, or 3 | 1 |
| Visual
appearance and
physical
description of
Recorder | Plastic molded wristwatch style casing
with detachable band.
Size 36 x 28.2 x 9.4 (excluding band) | Plastic molded wristwatch style casing
with detachable band.
Size 37 x 29 x 9 (excluding band) |
| Weight | 9.1 grams | 17 grams |
| Materials | ABS blend | ABS Blend |
| Sampling
Intervals (epoch) | 1, 2, 5, 10, 15, 30, 60 seconds | 15, 30, 60, 120, 300, 600 seconds |
| Recording time | 182 Days @ 60s epoch | 45 Days @ 60s epoch |
| Memory | 512kBytes | 64kBytes |
| Raw Sampling
rate | 50 Hz | 32 Hz |
| A/D conversion | 12 bits | 8 bits |
| Frequency | 3 to 11 Hz | 3 to 11 Hz |
| Moisture
Susceptibility | IPX7 | IPX7 |
| Sterility | None required | None required |
| Biocompatibility
(skin contact
type) | Standard nylon 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. |
| Electrical safety
(Recorder) | Battery operated | Battery operated |
| Power used
(Recorder) | 3.0 volt coin cell type CR2032 (1 each,
user-replaceable) | 3.0 volt coin cell type CR2025 (1 each,
user-replaceable) |
| Battery Life
(typical) | 6 months | 6 months |
| | | |
4
.
:
5
5
Comparison of the PRO-Diary with the predicate device ર્સ્ડ
The PRO-Diary is substantially equivalent to the predicate [ Actiwatch-Score® FDA 510(k) Number: K991033 ]. The PRO-Diary and the Actiwatch-Score® are both 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 ability to store data until it is transferred to a personal computer. The PRO-Diary and the Actiwatch-Score® both incorporate a score-pad for the prompting and input of subjective patient data. The PRO-Diary and the Activatch-Score® are of similar mechanical materials, construction, size, and human interface characteristics. The PRO-Diary and the Activatch-Score® are of similar electronic design and their operational characteristics and indications for use are equivalent.
Table 5.3 compares the features of the PRO-Diary with those of the Actiwatch-Score®.
| COMPARISON
PARAMETER | PRO-Diary
(Current Device) | Actiwatch-Score
(Predicate Device) |
| ------------------------- | ------------------------------- | --------------------------------------- |
|---|
б
6
| Indications For | The MotionWatch and PRO-Diary are | The Actiwatch-Score® is a compact, |
|---|---|---|
| Use | compact, lightweight, body-worn activity | lightweight, wrist-worn activity monitor |
| monitoring devices that may be used to | that can be used to analyze circadian | |
| document physical movement associated | rhythms, automatically collect and | |
| with applications in physiological | analyze data for sleep parameters, and | |
| monitoring. The devices are intended to | assess activity in any instance where | |
| monitor limb or body movements during | quantifiable analysis of physical motion | |
| daily living and sleep. The MotionWatch | is desirable. In addition, the Actiwatch | |
| Score® has a built-in score pad that | ||
| and PRO-Diary can be used to assess | allows the subject to subjectively assign | |
| activity in any instance where quantifiable | and enter a score from 0 to 9. The score | |
| analysis of physical motion is desired. | pad can be used as a substitute or in | |
| Additionally, the PRO-Diary has a built-in | addition to the traditional patient diary | |
| score pad that allows the wearer to | used in conjunction with activity | |
| subjectively assign and enter responses to | monitoring. | |
| 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 | Compact, wearable, battery-operated | Compact, wearable, battery-operated |
| description | physical activity data recorder with | physical activity data recorder with |
| integrated score pad. | integrated score pad. | |
| Activity channels | 1, 2, or 3 | 1 |
| Visual | Plastic molded wristwatch style casing with | Plastic molded wristwatch style casing |
| appearance and | detachable band. | with detachable band. |
| physical | Size 51.5 x 34.6 x 9.4mm (excluding band) | Size 37 x 35 x 12mm (excluding band) |
| description of | ||
| Recorder | ||
| Weight | 16 grams | 25 grams |
| Materials | ABS blend | ABS Blend |
| Sampling | 1, 2, 5, 10, 15, 30, 60 seconds | 15, 30, 60, 120, 300, 600 seconds |
| Intervals (epoch) | ||
| Recording time | 21 Days @ 60s epoch | 45 Days @ 60s epoch |
| Memory | 4MBytes | 64kBytes |
| Raw Sampling | 50 Hz | 32 Hz |
| rate | ||
| A/D conversion | 12 bits | 8 bits |
| Frequency | 3 to 11 Hz | 3 to 11 Hz |
.
.
and the comments of the country
. .
and the comments of the comments of the comments of the comments of
7
| Moisture
| Susceptibility | IP32 | IP52 |
|---|---|---|
| Sterility | None required | None required |
| Biocompatibility | ||
| (skin contact | ||
| type) | Standard nylon wrist band in contact with | |
| intact skin surface. | Standard nylon wrist band in contact | |
| with intact skin surface. | ||
| Human factors | Worn on wrist like a wristwatch; display | |
| and score-pad for subjective input. | Worn on wrist like a wristwatch; disp | |
| and score-pad for subjective input. | ||
| Electrical safety | ||
| (Recorder) | Battery operated | Battery operated |
| Power used | ||
| (Recorder) | 3.7 volt rechargeable (1 each, not user- | |
| replaceable) | 3.0 volt coin cell type CR2025 (1 each, | |
| user-replaceable) | ||
| Battery Life | ||
| (typical) | 21 days between charging | 6 months between replacement |
. .
8
8
· Assessment of non-clinical performance data 5.6
There are no special controls or consensus standards applicable to the measurement of body movement. To verify the performance of the MotionWatch and PRO-Diary a sample of devices were subjected to a suite of bespoke tests to verify each performance parameter. Table 5.4 provides a summary of the MotionWatch non-clinical performance testing.
TABLE 5.4: SUMMARY OF MOTIONWATCH 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
11
Image /page/11/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2014
CamNtech Ltd. c/o Mr. Howard Smith Engineering Director Upper Pendrill Court Ermine Street North Papworth Everard. Cambridge, United Kingdom CB233UY
Re: K132764
Trade/Device Name: MotionWatch and PRO-Diary Regulation Number: Unclassified Common Name: Sleep Assessment Device (Activity Recorder) Regulatory Class: Class II Product Code: LEL Dated: December 16, 2013 Received: December 17, 2013
Dear Mr. Smith:
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.
12
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Carlos L. Pena -S
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological " and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
13
Indications for Use
510(k) Number: K132764
Device Name: MotionWatch and PRO-Diary
Indications for Use:
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 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.
AND/OR Prescription Use X ..... (part 21 CFR 801 Subpart D)
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center of Devices and Radiological Health (CDRH)
Carlos L. Pena -S
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