(329 days)
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.
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 device is an activity, temperature, and ambient light monitor designed to analyze circadian rhythms, collect sleep parameters, and assess physical movement.
Here's an analysis of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Requirement Summary | Pass/Fail Criteria | Test Result |
|---|---|---|
| The device shall measure linear acceleration with an accuracy of +/-5% over the full range. | The recorded acceleration over the test range shall meet the requirement. | PASS |
| The device accuracy shall be <= +/-5% at the calibration point (i.e. 1g). | The variation in calibration values shall meet or exceed the requirement. | PASS |
| The device shall have a frequency response of 0.5 to 12.5 Hz. | The frequency response shall meet the requirement to within +/-10%. | PASS |
| The device shall output zero counts when no physical stimulus is applied. | The device shall record zero for the period of no physical stimulus. | PASS |
| The light sensor shall have an accuracy of +/-7.5% over the stated range. | The device shall meet the requirement, however it is acceptable that the accuracy worsens as light level increases. The accuracy over particular ranges shall be specified in the IFU. | PASS |
| The device shall output zero lux when the sensor is in total darkness | The device shall record zero lux for the test-period. | PASS |
| The device shall recover from unexpected reset events and/or total loss of power with no effect on the stored data. | No loss of function/data shall occur following the multiple reset events. | PASS |
| The Thermistor shall have an accuracy of +/- 0.5°C over the stated range. | The temperature must be between the specified range | PASS |
These acceptance criteria were established to verify the performance parameters of the device's main sensors (accelerometer, light sensor, and thermistor) and its data integrity under various conditions.
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "To verify the performance of the ActTrust a sample of devices were subjected to a suite of bespoke tests to verify each performance parameter." However, the specific sample size (number of devices) used for this test set is not explicitly stated.
The data provenance is not mentioned (e.g., country of origin, retrospective or prospective). The tests were conducted internally by the manufacturer ("bespoke tests").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. The document describes a series of technical performance tests comparing the device's output against known inputs or established reference points, rather than a study requiring expert interpretation of results to establish ground truth.
4. Adjudication Method for the Test Set:
An adjudication method is not applicable and not mentioned. The tests are objective measurements against defined criteria (e.g., "The recorded acceleration over the test range shall meet the requirement").
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC comparative effectiveness study was mentioned or performed. This device is a sensor for collecting activity data, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance assessment was done. The performance testing described in Table 5.4 focuses on the device's sensors and data recording capabilities independent of human interpretation. For example, testing the accuracy of the accelerometer, light sensor, and thermistor involves comparing the device's output to known reference values, without any human-in-the-loop component for the measurement itself. The device's operational software is mentioned for "off-line analysis of activity data by a health care provider," but the performance criteria listed are for the raw data acquisition.
7. The Type of Ground Truth Used:
The ground truth used for these tests was based on known physical inputs and calibrated reference measurements.
- Linear Acceleration: Simulated reference acceleration.
- Calibration Point (1g): Comparison to random samples of calibration records to examine inter-device variation, implying a known 1g reference.
- Frequency Response: Fixed acceleration over a range of frequencies.
- Zero Counts: No physical stimulus applied (known zero motion).
- Light Sensor Accuracy: Simultaneously using a calibrated light meter.
- Zero Lux: Sensor covered with fully opaque tape (known total darkness).
- Thermistor Accuracy: Devices placed in a climatic chamber with a ramp curve on the temperature (known temperature changes).
8. The Sample Size for the Training Set:
This information is not applicable and not provided. The ActTrust is described as a data collection device with embedded sensors; the provided documentation focuses on its hardware performance and does not describe it as an AI/machine learning device that would typically have a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided, as no training set for an AI/ML algorithm is described.
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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.
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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
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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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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.
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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 |
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| OperatingTemperature | 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 (CurrentDevice) | Actiwatch(Predicate device) | SBV2 System(Predicate Device) | Motion Watch(Predicate device) |
|---|---|---|---|---|
| PARAMETER | ||||
| Indicationsfor use | The ActTrust is anultra-compact,lightweight,wrist-wornactivity,temperature andambient lightmonitor that canbe used toanalyze circadianrhythms,automaticallycollect and storedata for sleepparameters, and | The Actiwatch® isan ultra-compact,lightweight,wrist- wornactivity andambient lightmonitor that canbe used to analyzecircadian rhythms,automaticallycollect and storedata for sleepparameters, | The SBV2 System isan activity monitordesigned andintended fordocumentingphysicalmovementsassociated withapplications inphysiologicalmonitoring. Thedevice's intendeduse is to analyzelimb activityassociated withmovement during | The MotionWatchand PRO-Diary arecompact,lightweight, body-worn activitymonitoring devicesthat may be used todocument physicalmovementassociated withapplications inphysiologicalmonitoring. Thedevices are intendedto monitor limb orbody movementsduring daily living |
| Table 2 - COMPARISON OF ACTTRUST TO PREDICATE DEVICES | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------- |
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| limb or bodymovements duringdailyliving and sleep.ActTrust is indicatedfor adults of 22years of age andover. | and assess activityin any instancewherequantifiableanalysis ofphysical motionis desirable. | sleep and toextractinformationabout certainsleepparameters fromthesemovements.SBV2 can also beused to assessactivity in anyinstance wherequantifiableanalysis ofphysicalmotion isdesirable.The use of theSBV2 isrestricted toadults 22 yearsof age andover. | and sleep. TheMotionWatch andPRO-Diary can beused to assessactivity in anyinstance wherequantifiableanalysis ofphysical motion isdesired.Additionally, thePRO-Diary has abuilt-in score padthat allows thewearer tosubjectively assignand enterresponses to pre-programmedquestions. Thescore pad can beused as asubstitute or inaddition to thetraditional writtenpatient diary inconjunction withactivity monitoring. | |
|---|---|---|---|---|
| Devicegeneraldescription | Compact, wearable,battery-operatedphysical activitydata recorder | Compact,wearable,battery-operatedphysical activitydata recorder | Compact,wearable,battery-operatedphysical activitydata recorder | Compact,wearable,battery-operatedphysical activitydata recorder |
| Activitychannels | 1, 2, or 3 | 1 | 1 | 1, 2, or 3 |
| Visualappearanceandphysicaldescriptio | Plastic moldedwristwatch stylecasing withdetachable band.Size 47 x 31 x 12(excluding band) | Plastic moldedwristwatchstyle casingwithdetachableband. Size 37x 29 x 9 | Plastic moldedwristwatchstyle casingwithdetachableband. Size 38.1x 38.1 x | Plastic moldedwristwatch stylecasing withdetachableband. Size 36 x28.2 x 9.4(excluding band) |
| Weight | 19 grams | 17 grams | 28.3 grams | 9.1 grams |
| FrameCover | Polycarbonate | Polycarbonate | Polycarbonate | ABS blend |
| SamplingIntervals | Any between 1and 86400 seconds | 15, 30, 60, 120,300, 600 seconds | 60 seconds | 1, 2, 5, 10, 30, 60seconds |
| Recordingtime | 90 Days @ 60sepoch | 45Days @ 60sepoch | 30 Days @ 60sepoch | 182 Days @ 60sepoch |
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| 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 |
| Frequencyresponse | 0.5 to 12.5 Hz | 3 to 11Hz | 3 to 11Hz | 3 to 11 Hz |
| MoistureSusceptibility | IPX7 | IPX7 | IP X6 | IPX7 |
| Sterility | None required | None required | None required | None required |
| Biocompatibility(skin contact type) | Standard siliconwrist band incontact with intactskin surface. | Standard nylonwrist band incontact withintact | Santoprene wristband in contactwith intact skinsurface. | Standard nylon wristband in contactwith intact skinsurface. |
| Human factors | Worn in wrist likea wristwatch; nouser interaction isrequired. | Worn in wrist likea wristwatch;nouser interactionis required. | Worn in wrist like awristwatch; noUser interactionis required. | Worn in wrist likea wristwatch; noUser interaction isrequired. |
| Electrical safety(Recorder) | Battery operated | Battery operated | Battery operated | Battery operated |
| Power used(Recorder) | 3.7 volt coin celltypeLIR2032H (1 each,rechargeable) | 3.0 volt coin celltype CR2025 (1each, user-replaceable) | Rechargeable3.7V LithiumCoin Cell | 3.0 volt coin celltypeCR2032 (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
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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.
| Requirementsummary | Test/verificationMethod | Pass/fail criteria | Test result |
|---|---|---|---|
| The device shallmeasure linearacceleration with anaccuracy of +/-5%over the full range. | Apply a range ofsimulated referenceacceleration andrecord the results. | The recordedacceleration overthe test range shallmeet therequirement. | PASS |
| The device accuracyshall be <= +/-5% atthe calibration point(i.e. 1g). | Collate randomsample ofcalibration recordsand examine inter-device variation. | The variation incalibration valuesshall meet or exceedthe requirement. | PASS |
| The device shallhave a frequencyresponse of 0.5 to12.5 Hz. | Apply a fixedacceleration over arange of frequenciesand record theresults. | The frequencyresponse shall meetthe requirement towithin +/-10%. | PASS |
| The device shalloutput zero countswhen no physicalstimulus is applied. | Set-up a sampledevice and recordfor a period with nophysical stimulus. | The device shallrecord zero for theperiod of nophysical stimulus. | PASS |
| The light sensorshall have anaccuracy of +/-7.5%over the statedrange. | Record a range oflight from darknessto sunlight with asample devicesimultaneously witha calibrated lightmeter. | The device shallmeet therequirement,however it isacceptable that theaccuracy worsens aslight level increases.The accuracy overparticular rangesshall be specified inthe IFU. | PASS |
| The device shalloutput zero luxwhen the sensor isin total darkness | Record data withthe light sensorcovered with fullyopaque tape. | The device shallrecord zero lux forthe test-period. | PASS |
TABLE 5.4: SUMMARY OF ACTTRUST NON-CLINICAL PERFORMANCE TESTING
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| The device shallrecover fromunexpected resetevents and/or totalloss of power withno effect on thestored data. | A sample deviceshall be subjected tomultiple power onreset events and thestored data shall besubsequentlydownloaded andexamined. | No loss offunction/data shalloccur following themultiple resetevents. | PASS |
|---|---|---|---|
| The Thermistor shallhave an accuracy of+/- 0.5°C over thestated range. | Put the devices in aclimatic chamberand a ramp curve onthe temperatureand examine inter-device variation. | The temperaturemust be betweenthe specified range | PASS |
In addition to performance testing, the devices have been evaluated and tested for safety and electromagnetic interference according to the following internationally recognized standards:
IEC60601 - 1: 2005 Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance.
IEC60601-1 -11:2010 Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance. Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC60601-1-2: 2007, Medical Electrical Equipment - PART 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
UL1642:2012, Lithium Battery – Standard for safety.
The testing according to these standards has raised no issues as to the safety and effectiveness of the present devices or the present devices compared to the predicate devices.
Furthermore, an analysis and rationale about the devices biocompatibility and sterile process was made and the summaries are shown in Tables 5.5 and 5.6.
TABLE 5.5: SUMMARY OF ACTTRUST BIOCOMPATIBILITY ANALYSIS
| Item | Material | ContactClassification | Rationale |
|---|---|---|---|
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| Frame cover | Polycarbonate | Surface-contacting, up to 3 months | Same material as the one used in other devices previously approved |
|---|---|---|---|
| Wristband | Hypoallergenic silicone | Surface-contacting, up to 3 months | Made of hypoallergenic silicone and designed and used in commercial watches. |
| Cover Plate | Stainless steel AISI 430 | Surface-contacting, up to 3 months | The AISI 430 is graded as surgical and has historically been used in many biocompatible devices. |
TABLE 5.6: SUMMARY OF ACTTRUST STERILIZATION ANALYSIS
| Item | Material | STERILIZATION |
|---|---|---|
| Frame cover | Polycarbonate | non-sterile when used |
| Wristband | Hypoallergenic silicone | non-sterile when used |
| Cover Plate | Stainless steel AISI 430 | non-sterile when used |
5.7 Conclusion
The results of the performance testing and safety and environmental testing show that the ActTrust is as safe, as effective, and perform as well as the predicate device.
§ 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.