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.

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.

AI/ML Overview

The ActiGraph CentrePoint Insight Watch is a wrist-worn activity monitor designed for physiological monitoring, particularly for tracking movement during sleep to analyze circadian rhythms and assess physical motion.

Here's a breakdown of the acceptance criteria and supporting studies:

Table of acceptance criteria and the reported device performance:

Characteristic	Acceptance Criteria (Predicate Device K080545)	Reported Device Performance (Subject Device K181077)
Indications for Use	Rx Only; A small 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. Can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.	Same
Materials of Construction	Polycarbonate (housing); Nylon & Velcro® (wrist band)	Different: Combination Copolymer (housing); Silicon (wrist band), conforms to 10993-1 Fourth edition 2009-10-15
Power Source	Lithium Ion Battery Rechargeable via USB	Same
Accelerometer Type	Microelectromechanical system (MEMS)-based integrated circuit	Same
Accelerometer Sampling Rate	30 Hz, Analog method	Different: Digital method, 32 Hz – 256 Hz
Accelerometer Dynamic Range	+/- 5 g	+/- 8 g
Firmware	Embedded C	Embedded C (updated version)
Wireless Communications Interface	Polar® module	Different: Bluetooth® Low Energy; conforms to AAMI / ANSI / IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests and IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - 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); 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); Height: 1.5 in (38.1 mm); Thickness: 0.6 in (15.2 mm)	Width: 1.41 in (35.8 mm); Height: 1.97 in (50.1 mm); Thickness: 0.41 in (10.5 mm)
Recording Time @ 1 min. Epoch	14 days	30 days

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document states that "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." Therefore, there is no clinical test set described in this submission. The "test set" in this context refers to devices used for non-clinical bench testing. The sample size for these non-clinical tests is not explicitly mentioned, nor is the provenance of data for these tests beyond being "bench testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set for ground truth establishment is described. The acceptance is based on substantial equivalence to a predicate device through non-clinical bench testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an activity monitor, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: The document describes the device as a standalone activity monitor that records and stores data from an accelerometer. Non-clinical bench testing was performed to demonstrate its performance and reliability in this standalone function. The "study" mentioned is the series of non-clinical bench tests performed to support substantial equivalence.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be established engineering specifications and recognized voluntary consensus standards. For example, accelerometer dynamic range, sampling rate, memory capacity, water resistance, weight, size, and recording time were compared against the predicate device's capabilities and against the device's own internal specifications validated through bench testing. 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
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set for model development.
How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model for this device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K181077

510(k) Summary

Submitter Information

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

ActiGraph, Inc. Brian A. Bell brian.bell@actigraphcorp.com 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

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(Identical)	Rx OnlyA small worn activity monitordesigned for documenting physicalmovement associated withapplications in physiologicalmonitoring. The device is intended tomonitor the activity associated withmovement during sleep. Can be usedto analyze circadian rhythms andassess activity in any instance wherequantifiable analysis of physicalmotion is desirable.	Same
Materials ofConstruction	Polycarbonate (housing)Nylon & Velcro® (wrist band)	Different; Combination Copolymer(housing)Silicon (wrist band), conforms to10993-1 Fourth edition 2009-10-15
Power Source	Lithium Ion Battery Rechargeable viaUSB	Same
AccelerometerType	Microelectromechanical system(MEMS)-based integrated circuit	Same
AccelerometerSampling Rate	30 Hz, Analog method	Different: Digital method, 32 Hz –256 Hz
AccelerometerDynamic Range	+/- 5 g	+/- 8 g
Firmware	Embedded C	Embedded C (updated version)
WirelessCommunicationsInterface	Polar® module	Different: Bluetooth® Low Energy;conforms to AAMI / ANSI / IEC60601-1-2, Medical ElectricalEquipment - Part 1-2: GeneralRequirements for Safety - CollateralStandard: ElectromagneticCompatibility - Requirements andTests and IEC 60601-1-2, MedicalElectrical Equipment - Part 1-2:General Requirements For BasicSafety And Essential Performance -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)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)Height: 1.5 in (38.1 mm)Thickness: 0.6 in (15.2 mm)	Width: 1.41 in (35.8 mm)Height: 1.97 in (50.1 mm)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: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: ElectromagneticDisturbances - Requirements And Tests.
ANSIAAMIISO	14971:2007/(R)2010(Corrected 4October 2007)	Medical devices - Applications of risk management tomedical devices
AAMIANSIISO	60601-1-2	Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral Standard:Electromagnetic Compatibility - Requirements andTests
ISO	10993-1Fourth Edition 2009-10-15	Biological evaluation of medical devices - Part 1:Evaluation and testing within a riskmanagement process [Including: TechnicalCorrigendum 1 (2010)]
IEC	62133Edition 2.0 2012-12	Secondary cells and batteries containing alkaline orother non-acid electrolytes - Safety requirements forportable sealed secondary cells, and for batteriesmade from them, for use in portable applications[Including: Corrigendum 1 (2013)]
ISO	15223-1Edition: 3, Correctedversion: 2017-03	Medical devices - Symbols to be used with medicaldevice labels, labelling and information to besupplied -- Part 1: General requirements

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Body	Standard ID	Standard Title
IEC	60529; Edition: 2:1989 consolidatedwith amendment1:1999	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.

Regulation Number and Section

§ 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.