ActTrust

K151784 · Condor Instruments Ltda. - Epp · LEL · May 25, 2016 · Neurology

Device Facts

• Record ID: K151784
• Device Name: ActTrust
• Applicant: Condor Instruments Ltda. - Epp
• Product Code: LEL · Neurology
• Decision Date: May 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2

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.

Device Story

ActTrust is a wrist-worn, battery-operated ambulatory monitor; measures physical activity, peripheral temperature, and ambient light. Inputs: 3-axis accelerometer (motion), thermistor (temperature), and RGB-IR light sensor. Data stored in non-volatile memory; downloaded via USB to PC for analysis by healthcare provider. Used in daily living and sleep environments; operated by patient (wearer) and healthcare provider (analysis). Provides objective data on movement and circadian rhythms; assists clinicians in assessing sleep parameters and physical activity levels. Benefits patient by enabling long-term, quantifiable monitoring of activity and sleep patterns outside clinical settings.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via simulated reference acceleration, frequency response testing (0.5-12.5 Hz), light sensor accuracy, and thermistor accuracy (+/- 0.5°C). Safety and electromagnetic compatibility verified per IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2 standards.

Technological Characteristics

Wrist-worn monitor; polycarbonate casing, hypoallergenic silicone band, AISI 430 stainless steel cover plate. Sensors: 3-axis solid-state accelerometer (0.01g-4g), thermistor, RGB-IR light sensor. 12-bit A/D conversion; 4MB non-volatile memory. Connectivity: USB for data download. Power: 3.7V rechargeable LIR2032H coin cell. IP67 water resistance. Non-sterile.

Indications for Use

Indicated for adults 22 years and older to monitor limb or body movements during daily living and sleep, analyze circadian rhythms, and assess physical activity.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Actiwatch (K983533)
• MotionWatch and PRO-Diary (K132764)
• SBV2 System (K111514)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone]

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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| Operating<br>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<br>Device) | Actiwatch<br>(Predicate device) | SBV2 System<br>(Predicate Device) | Motion Watch<br>(Predicate device) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PARAMETER | | | | |
| Indications<br>for use | The ActTrust is an<br>ultra-<br>compact,<br>lightweight,<br>wrist-worn<br>activity,<br>temperature and<br>ambient light<br>monitor that can<br>be used to<br>analyze circadian<br>rhythms,<br>automatically<br>collect and store<br>data for sleep<br>parameters, and | The Actiwatch® is<br>an ultra-compact,<br>lightweight,<br>wrist- worn<br>activity and<br>ambient light<br>monitor that can<br>be used to analyze<br>circadian rhythms,<br>automatically<br>collect and store<br>data for sleep<br>parameters, | The SBV2 System is<br>an activity monitor<br>designed and<br>intended for<br>documenting<br>physical<br>movements<br>associated with<br>applications in<br>physiological<br>monitoring. The<br>device's intended<br>use is to analyze<br>limb activity<br>associated with<br>movement during | The MotionWatch<br>and PRO-Diary are<br>compact,<br>lightweight, body-<br>worn activity<br>monitoring devices<br>that may be used to<br>document physical<br>movement<br>associated with<br>applications in<br>physiological<br>monitoring. The<br>devices are intended<br>to monitor limb or<br>body movements<br>during daily living |

| | | | | Table 2 - COMPARISON OF ACTTRUST TO PREDICATE DEVICES |
|--|--|--|--|-------------------------------------------------------|
|--|--|--|--|-------------------------------------------------------|

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| | limb or body<br>movements during<br>daily<br>living and sleep.<br>ActTrust is indicated<br>for adults of 22<br>years of age and<br>over. | and assess activity<br>in any instance<br>where<br>quantifiable<br>analysis of<br>physical motion<br>is desirable. | sleep and to<br>extract<br>information<br>about certain<br>sleep<br>parameters from<br>these<br>movements.<br>SBV2 can also be<br>used to assess<br>activity in any<br>instance where<br>quantifiable<br>analysis of<br>physical<br>motion is<br>desirable.<br>The use of the<br>SBV2 is<br>restricted to<br>adults 22 years<br>of age and<br>over. | and sleep. The<br>MotionWatch and<br>PRO-Diary can be<br>used to assess<br>activity in any<br>instance where<br>quantifiable<br>analysis of<br>physical motion is<br>desired.<br>Additionally, the<br>PRO-Diary has a<br>built-in score pad<br>that allows the<br>wearer to<br>subjectively assign<br>and enter<br>responses to pre-<br>programmed<br>questions. The<br>score pad can be<br>used as a<br>substitute or in<br>addition to the<br>traditional written<br>patient diary in<br>conjunction with<br>activity monitoring. |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>general<br>description | Compact, wearable,<br>battery-<br>operated<br>physical activity<br>data recorder | Compact,<br>wearable,<br>battery-<br>operated<br>physical activity<br>data recorder | Compact,<br>wearable,<br>battery-<br>operated<br>physical activity<br>data recorder | Compact,<br>wearable,<br>battery-operated<br>physical activity<br>data recorder |
| Activity<br>channels | 1, 2, or 3 | 1 | 1 | 1, 2, or 3 |
| Visual<br>appearance<br>and<br>physi<br>cal<br>descr<br>iptio | Plastic molded<br>wristwatch style<br>casing with<br>detachable band.<br>Size 47 x 31 x 12<br>(excluding band) | Plastic molded<br>wristwatch<br>style casing<br>with<br>detachable<br>band. Size 37<br>x 29 x 9 | Plastic molded<br>wristwatch<br>style casing<br>with<br>detachable<br>band. Size 38.1<br>x 38.1 x | Plastic molded<br>wristwatch style<br>casing with<br>detachable<br>band. Size 36 x<br>28.2 x 9.4<br>(excluding band) |
| Weight | 19 grams | 17 grams | 28.3 grams | 9.1 grams |
| Frame<br>Cover | Polycarbonate | Polycarbonate | Polycarbonate | ABS blend |
| Sampling<br>Intervals | Any between 1<br>and 86400 seconds | 15, 30, 60, 120,<br>300, 600 seconds | 60 seconds | 1, 2, 5, 10, 30, 60<br>seconds |
| Recording<br>time | 90 Days @ 60s<br>epoch | 45Days @ 60s<br>epoch | 30 Days @ 60s<br>epoch | 182 Days @ 60s<br>epoch |

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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 |
| Frequency<br>response | 0.5 to 12.5 Hz | 3 to 11Hz | 3 to 11Hz | 3 to 11 Hz |
| Moisture<br>Susceptibility | IPX7 | IPX7 | IP X6 | IPX7 |
| Sterility | None required | None required | None required | None required |
| Biocompatibility<br>(skin contact type) | Standard silicon<br>wrist band in<br>contact with intact<br>skin surface. | Standard nylon<br>wrist band in<br>contact with<br>intact | Santoprene wrist<br>band in contact<br>with intact skin<br>surface. | Standard nylon wrist<br>band in contact<br>with intact skin<br>surface. |
| Human factors | Worn in wrist like<br>a wristwatch; no<br>user interaction is<br>required. | Worn in wrist like<br>a wristwatch;no<br>user interaction<br>is required. | Worn in wrist like a<br>wristwatch; no<br>User interaction<br>is required. | Worn in wrist like<br>a wristwatch; no<br>User interaction is<br>required. |
| Electrical safety<br>(Recorder) | Battery operated | Battery operated | Battery operated | Battery operated |
| Power used<br>(Recorder) | 3.7 volt coin cell<br>type<br>LIR2032H (1 each,<br>rechargeable) | 3.0 volt coin cell<br>type CR2025 (1<br>each, user-<br>replaceable) | Rechargeable<br>3.7V Lithium<br>Coin Cell | 3.0 volt coin cell<br>type<br>CR2032 (1 each,<br>user-replaceable) |
| Battery Life<br>(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.

| Requirement<br>summary | Test/verification<br>Method | Pass/fail criteria | Test result |
|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| The device shall<br>measure linear<br>acceleration with an<br>accuracy of +/-5%<br>over the full range. | Apply a range of<br>simulated reference<br>acceleration and<br>record the results. | The recorded<br>acceleration over<br>the test range shall<br>meet the<br>requirement. | **PASS** |
| The device accuracy<br>shall be <= +/-5% at<br>the calibration point<br>(i.e. 1g). | Collate random<br>sample of<br>calibration records<br>and examine inter-<br>device variation. | The variation in<br>calibration values<br>shall meet or exceed<br>the requirement. | **PASS** |
| The device shall<br>have a frequency<br>response of 0.5 to<br>12.5 Hz. | Apply a fixed<br>acceleration over a<br>range of frequencies<br>and record the<br>results. | The frequency<br>response shall meet<br>the requirement to<br>within +/-10%. | **PASS** |
| The device shall<br>output zero counts<br>when no physical<br>stimulus is applied. | Set-up a sample<br>device and record<br>for a period with no<br>physical stimulus. | The device shall<br>record zero for the<br>period of no<br>physical stimulus. | **PASS** |
| The light sensor<br>shall have an<br>accuracy of +/-7.5%<br>over the stated<br>range. | Record a range of<br>light from darkness<br>to sunlight with a<br>sample device<br>simultaneously with<br>a calibrated light<br>meter. | The device shall<br>meet the<br>requirement,<br>however it is<br>acceptable that the<br>accuracy worsens as<br>light level increases.<br>The accuracy over<br>particular ranges<br>shall be specified in<br>the IFU. | **PASS** |
| The device shall<br>output zero lux<br>when the sensor is<br>in total darkness | Record data with<br>the light sensor<br>covered with fully<br>opaque tape. | The device shall<br>record zero lux for<br>the test-period. | **PASS** |

## TABLE 5.4: SUMMARY OF ACTTRUST NON-CLINICAL PERFORMANCE TESTING

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| The device shall<br>recover from<br>unexpected reset<br>events and/or total<br>loss of power with<br>no effect on the<br>stored data. | A sample device<br>shall be subjected to<br>multiple power on<br>reset events and the<br>stored data shall be<br>subsequently<br>downloaded and<br>examined. | No loss of<br>function/data shall<br>occur following the<br>multiple reset<br>events. | **PASS** |
|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------|
| The Thermistor shall<br>have an accuracy of<br>+/- 0.5°C over the<br>stated range. | Put the devices in a<br>climatic chamber<br>and a ramp curve on<br>the temperature<br>and examine inter-<br>device variation. | The temperature<br>must be between<br>the 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 | Contact<br>Classification | 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.