ActiGraph CentrePoint Insight Watch

K181077 · Actigraph · LEL · May 24, 2018 · Neurology

Device Facts

• Record ID: K181077
• Device Name: ActiGraph CentrePoint Insight Watch
• Applicant: Actigraph
• Product Code: LEL · Neurology
• Decision Date: May 24, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5050
• Device Class: Class 2

Indications for Use

The CentrePoint Insight Watch is a small wrist-worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The CentrePoint Insight Watch can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

Device Story

Compact, wrist-worn activity monitor; utilizes 3-axis MEMS accelerometer to capture physical motion data; data timestamped and stored in non-volatile memory; device charged via separate dock connected to USB power source; data offloaded to PC for post-processing; used in clinical or home settings; operated by patients or clinicians; output provides quantifiable physical motion metrics; assists clinicians in assessing activity levels and circadian rhythms; benefits include objective, long-term monitoring of patient movement and sleep patterns.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including performance/reliability testing, comparative data analysis, biocompatibility, and electrical safety/EMC testing.

Technological Characteristics

Wrist-worn device; 3-axis MEMS accelerometer; sampling rate 32-256 Hz; +/- 8g dynamic range; 512 MB memory; rechargeable lithium battery; Bluetooth Low Energy; housing: medical-grade copolyester; wrist band: silicon (ISO 10993-1 compliant); IP57 water resistance; firmware: Embedded C.

Indications for Use

Indicated for patients requiring physiological monitoring of physical movement and activity, including movement during sleep, circadian rhythm analysis, and general quantifiable analysis of physical motion.

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

• ActiTrainer (K080545)

Submission Summary (Full Text)

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May 24, 2018

ActiGraph, Inc. Brian Bell Vice President of Quality Affairs and Regulatory Affairs 49 E Chase Street Pensacola, Florida 32502

Re: K181077

Trade/Device Name: ActiGraph CentrePoint Insight Watch Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: LEL Dated: April 20, 2018 Received: April 24, 2018

Dear Brian Bell:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Hoffmann -S

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) K181077

Device Name ActiGraph CentrePoint Insight Watch

#### Indications for Use (Describe)

The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for document associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The Insight watch can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <span style="font-size:20px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# K181077

#### 510(k) Summary

#### Submitter Information

Company Name: Contact Person: Address: Telephone Number: Date Prepared:

ActiGraph, Inc. Brian A. Bell [e-mail] 49 E Chase St. Pensacola, FL 32502 850-332-7900 x5115 May 24, 2018

# Subject Device

Trade Name: Common or Usual Name: Classification:

ActiGraph CentrePoint Insight Watch Sleep assessment device (actigraphy) Class II, Biofeedback Device 21 CFR 882.5050 LEL

Product Code:

# Predicate Device

Predicate:

ActiTrainer K080545 21 CFR 890.5360, ISD (measuring exercising equipment)

# Device Description

The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is intended to acquire and store data from an onboard accelerometer while being worn during normal activities and/or during sleep. The data record is timestamped and stored in non-volatile memory for later retrieval. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis.

The housing is constructed of a combination of opaque and clear copolyesters formulated specifically for medical devices (i.e., tested and determined biocompatible), and the core data collection sensor is a 3-axis microelectromechanical system (MEMS) accelerometer. A charging dock connected to a USB power source is used to charge the device battery and communicate with a PC or peripheral.

# Intended Use

The CentrePoint Insight Watch is a small wrist-worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The CentrePoint Insight Watch can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

# Comparison of Technological Characteristics with Predicate

The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is intended to acquire and store data from an onboard accelerometer while being worn by the end user during normal activities and/or during sleep. The subject device includes a dock accessory which is required to charge the watch. Table 1, below, includes a comparison of the predicate and subject devices.

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# Table 1

| Characteristic | Predicate Device K080545 | Subject Device K181077 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use<br>(Identical) | Rx Only<br>A small worn activity monitor<br>designed for documenting physical<br>movement associated with<br>applications in physiological<br>monitoring. The device is intended to<br>monitor the activity associated with<br>movement during sleep. Can be used<br>to analyze circadian rhythms and<br>assess activity in any instance where<br>quantifiable analysis of physical<br>motion is desirable. | Same |
| Materials of<br>Construction | Polycarbonate (housing)<br>Nylon & Velcro® (wrist band) | Different; Combination Copolymer<br>(housing)<br>Silicon (wrist band), conforms to<br>10993-1 Fourth edition 2009-10-15 |
| Power Source | Lithium Ion Battery Rechargeable via<br>USB | Same |
| Accelerometer<br>Type | Microelectromechanical system<br>(MEMS)-based integrated circuit | Same |
| Accelerometer<br>Sampling Rate | 30 Hz, Analog method | Different: Digital method, 32 Hz –<br>256 Hz |
| Accelerometer<br>Dynamic Range | +/- 5 g | +/- 8 g |
| Firmware | Embedded C | Embedded C (updated version) |
| Wireless<br>Communications<br>Interface | Polar® module | Different: Bluetooth® Low Energy;<br>conforms to AAMI / ANSI / IEC<br>60601-1-2, Medical Electrical<br>Equipment - Part 1-2: General<br>Requirements for Safety - Collateral<br>Standard: Electromagnetic<br>Compatibility - Requirements and<br>Tests and IEC 60601-1-2, Medical<br>Electrical Equipment - Part 1-2:<br>General Requirements For Basic<br>Safety And Essential Performance -<br>Collateral Standard: Electromagnetic |
| | | Disturbances – Requirements And Tests. |
| Memory | 1024kB | 512 MB |
| Heart Rate | BPM | Same |
| Accelerometer Sensitivity | 4 milli-g per Least Significant Bit | Different; 2.4 milli-g per Least Significant Bit |
| Storage Temperature | -10 °C to 50 °C | Same |
| Operating Temperature | 0 °C to 40 °C | Different; -10°C to 55°C (discharging)<br>0°C to 45°C while charging |
| Water Resistance | IP21 (condensation) | Minimum IP57 (1m for 30 minutes) |
| Weight | 51 grams | 33 grams |
| Size | Width: 3.37 in (85.6 mm)<br>Height: 1.5 in (38.1 mm)<br>Thickness: 0.6 in (15.2 mm) | Width: 1.41 in (35.8 mm)<br>Height: 1.97 in (50.1 mm)<br>Thickness: 0.41 in (10.5 mm) |
| Recording Time @ 1 min. Epoch | 14 days | 30 days |

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# Technological and Performance Characteristics

The subject device, Insight Watch, includes the same fundamental technology and functionality of the predicate device, ActiTrainer, by monitoring activity using a three-axis accelerometer.

In this Special 510(k) Submission, the objective of the modification is to reduce the overall dimension to those of a wrist watch. To achieve this size reduction, the USB A-Type male connector was replaced with pins that contact a separate charging dock.

The CentrePoint Insight Watch incorporates several sub-component upgrades resulting from electronic component obsolescence, as the predicate was designed 10 years. However, this does not change how the product is intended to be used or its fundamental design and principle of operation.

The similarities to the predicate ActiTrainer device are:

- Same intended use and indications for use by way of accelerometry and heart rate . monitoring (i.e., monitor for non-specific activity and motion)
- · Same fundamental scientific technology characteristics
- · Utilize a microelectromechanical system (MEMS) accelerometer to measure movement
- · Leverage a microcontroller to sample and store data from the MEMS accelerometer

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- Contain digital memory to store the sampled data o
- Utilize USB technology to offload stored data and recharge the lithium battery о
- Same power source, a rechargeable lithium battery o
- Same operating principle 0
- Incorporate the same basic design (small wearable) ●

#### Non-Clinical Testing in Support of Substantial Equivalence and Device Performance

The following bench testing was conducted to support a determination of substantial equivalence to the predicate and to demonstrate performance. The non-clinical bench tests included:

- Performance and reliability testing
- Comparative data analysis
- Basic safety and essential performance in accordance with AAMI ES60601 .
- Electromagnetic compatibility (EMC) in accordance with IEC 60601
- Biocompatibility and material standards confirms there is no harm to the patient wearing the device.
- . System compatibility with ActiGraph software for data download and collection

#### Conformance to Recognized Voluntary Consensus Standards

Standards to which the subject device conforms are outlined below:

| Body | Standard ID | Standard Title |
|---------------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC | 60601-1-2 | Medical Electrical Equipment - Part 1-2: General<br>Requirements For Basic Safety And Essential<br>Performance - Collateral Standard: Electromagnetic<br>Disturbances - Requirements And Tests. |
| ANSI<br>AAMI<br>ISO | 14971:2007/(R)2010<br>(Corrected 4<br>October 2007) | Medical devices - Applications of risk management to<br>medical devices |
| AAMI<br>ANSI<br>ISO | 60601-1-2 | Medical Electrical Equipment - Part 1-2: General<br>Requirements for Safety - Collateral Standard:<br>Electromagnetic Compatibility - Requirements and<br>Tests |
| ISO | 10993-1<br>Fourth Edition 2009-<br>10-15 | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk<br>management process [Including: Technical<br>Corrigendum 1 (2010)] |
| IEC | 62133<br>Edition 2.0 2012-12 | Secondary cells and batteries containing alkaline or<br>other non-acid electrolytes - Safety requirements for<br>portable sealed secondary cells, and for batteries<br>made from them, for use in portable applications<br>[Including: Corrigendum 1 (2013)] |
| ISO | 15223-1<br>Edition: 3, Corrected<br>version: 2017-03 | Medical devices - Symbols to be used with medical<br>device labels, labelling and information to be<br>supplied -- Part 1: General requirements |

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| Body | Standard ID | Standard Title |
|------|---------------------------------------------------------------------|----------------------------------------------|
| IEC | 60529; Edition: 2:<br>1989 consolidated<br>with amendment<br>1:1999 | Degrees of protection provided by enclosures |

# Clinical Testing

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

#### Conclusion

Through the comparison of technological and performance characteristics, the proposed device found to be substantially equivalent to the predicate device.