(28 days)
Not Found
No
The summary describes a device that collects accelerometer data for analysis by healthcare professionals or researchers. It mentions firmware for device operations and communication but does not indicate any on-device or associated software that uses AI/ML for data processing or interpretation. The analysis of the collected data is left to the user.
No.
The device is intended for documenting physical movement, analyzing circadian rhythms, and assessing activity for quantifiable analysis of physical motion, not for therapeutic intervention or treatment.
No
The device is an activity monitor that collects physical movement data for analysis by healthcare professionals or researchers. It states it can "assess activity" and for "quantifiable analysis of physical motion," but not that it provides a diagnosis.
No
The device description clearly states it is a "wrist-worn wearable device" that "continuously record[s] high resolution digital acceleration data" using a "high-resolution digital accelerometer." It also mentions a display, button, and accessories for charging and data transfer, all of which are hardware components.
Based on the provided information, the ActiGraph LEAP™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This includes things like blood tests, urine tests, and tissue analysis.
- ActiGraph LEAP™ Function: The ActiGraph LEAP™ is a wearable device that measures physical movement on the body. It collects data from the patient directly, not from a specimen taken from the patient.
- Intended Use: The intended use is to document physical movement associated with physiological monitoring, analyze circadian rhythms, and assess activity. While this data can be used by healthcare professionals for analysis, the device itself is not performing a diagnostic test on a biological sample.
Therefore, the ActiGraph LEAP™ falls under the category of a wearable medical device for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ActiGraph LEAP™ 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 ActiGraph LEAP™ can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
Product codes
LEL
Device Description
The ActiGraph LEAP™ is a wrist-worn wearable device intended to continuously record high resolution digital acceleration data associated with a patient's physical movement. In practice, a healthcare professional or researcher can prescribe the device to collect physiological data from patients in applications where quantifiable analysis of physical motion is desirable. Having physical characteristics like those of an electronic wristwatch, the device is set to collect data by the healthcare professional then placed on the subject's wrist. The device is designed to be worn during normal activities and/or during sleep over a period of days to weeks. The patient does not need to interact with the device to control the operation or data collection. The data stored on the device can be downloaded via USB or Bluetooth Low Energy and made accessible to healthcare professionals or researchers for further analysis.
The ActiGraph LEAP™ device will be supported by accessories for recharging the battery and transferring data from the device. A USB Charging Dock with a three-foot USB A cable for both charging and data transfer to a PC using the supplied communication software. The USB Charging Dock connects to the recessed electrical contacts on the back of the device. An off-the-shelf international Wall Mount AC Adapter is also supplied for optional wall charging. The USB Charging Dock can be plugged into the Wall Mount AC Adapter's USB A port for charging the device.
The device uses a high-resolution digital accelerometer to accurately measure linear accelerations in 3axes associated with the patient's physical movement. The accelerometer technology is a microelectromechanical system (MEMS) implemented as an integrated circuit. The accelerometer data is converted to a digital representation on the MEMS accelerometer and then recorded, with timestamp, to the device's on-board memory. The memory is an 8 Gb serial NAND flash capable of storing 30 days of accelerometer data under the default operating mode. The sample rate of the accelerometer is configurable at the following rates: 32Hz, 64Hz, 128 Hz and 256Hz.
The LCD display indicates the battery level, current functional state of the device, and date and time. The device has a 30-day battery life under the default operating mode and can be charged using the USB Charging Dock accessory. The display does not provide feedback to the wearer/patient regarding data measures. There is a simple button on the side used to turn on the display so the wearer can read the date/time and button presses are recorded in the log.
The device firmware executes on internal processors to control the device operations, display, and external communication protocols. The accelerometer sensor data can be downloaded from the device either via USB (using the dock) or via Bluetooth Low Energy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional or researcher
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary & Conclusions:
The device enclosure, dimensions, and materials have been updated to modern compositions used in similar wearable devices. The materials are intended to have contact with intact skin for durations which may exceed 24 hours; therefore, they have been evaluated for cytotoxicity, sensitization, and irritation per the FDA guidance on biocompatibility and the use of the ISO 10993-1 standard. Clinical testing is not applicable to this submission.
The following technological characteristics of the device are the predicate (cleared with the predicate device):
- . The principle of operation is the same. A microelectromechanical system (MEMS) accelerometer is used to measure movement.
- . The accelerometer data is converted to a digital representation on the MEMS accelerometer and then recorded, with timestamp, to the device's non-volatile memory.
- . The LCD display on the subject device indicates the battery level, the current functional state of the device, and date and time. This is the same as predicate device.
- . The LCD display on the subject device does not provide feedback to the wearer/patient regarding data measures. This is the same as predicate device.
- The power source is the same as the predicate device, a rechargeable lithium battery.
- The physical characteristics are the same, a wrist-worn device, like an electronic watch.
- . Data stored on the device can be downloaded via USB or Bluetooth Low Energy.
- . The software has not changed
The methods and results demonstrate substantial equivalence to the predicate (K181077), as this difference in material does not raise different or new questions of safety and effectiveness. The tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate (K181077). Therefore, the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
0
June 23, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
ActiGraph, LLC Brian Bell VP of Regulatory 70 North Baylen Street, Suite 400 Pensacola, Florida 32504
Re: K231532
Trade/Device Name: ActiGraph LEAP activity monitor (ActiGraph LEAP) Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: LEL Dated: May 25, 2023 Received: May 26, 2023
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Patrick Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231532
Device Name
ActiGraph LEAP activity monitor (ActiGraph LEAP)
Indications for Use (Describe)
The ActiGraph LEAP™ is a small worn activity monitor designed for document associated with applications in physiological monitoring. The device is intended to montor the activity associated with movement during sleep. The ActiGraph LEAP™ 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Special 510(k) Summary K231532
Contact Details
| Applicant Name | ActiGraph, LLC |
|---|---|
| Applicant Address | 70 North Baylen Street, Suite 400 Pensacola FL 32504 United States |
| Applicant Contact Telephone | 8503327900 |
| Applicant Contact | Mr. Brian Bell |
| Applicant Contact Email | brian.bell@theactigraph.com |
Device Name
| Device Trade Name | ActiGraph LEAP activity monitor (ActiGraph LEAP) |
|---|---|
| Common Name | Biofeedback device |
| Classification Name | Device, Sleep Assessment |
| Regulation Number | 882.5050 |
| Product Code | LEL |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary
Predicate is listed first) | Product Code |
|-------------|-------------------------------------------------------------|--------------|
| K181077 | CentrePoint Insight Watch | LEL |
Device Description Summary
The ActiGraph LEAP™ is a wrist-worn wearable device intended to continuously record high resolution digital acceleration data associated with a patient's physical movement. In practice, a healthcare professional or researcher can prescribe the device to collect physiological data from patients in applications where quantifiable analysis of physical motion is desirable. Having physical characteristics like those of an electronic wristwatch, the device is set to collect data by the healthcare professional then placed on the subject's wrist. The device is designed to be worn during normal activities and/or during sleep over a period of days to weeks. The patient does not need to interact with the device to control the operation or data collection. The data stored on the device can be downloaded via USB or Bluetooth Low Energy and made accessible to healthcare professionals or researchers for further analysis.
The ActiGraph LEAP™ device will be supported by accessories for recharging the battery and transferring data from the device. A USB Charging Dock with a three-foot USB A cable for both charging and data transfer to a PC using the supplied communication software. The USB Charging Dock connects to the recessed electrical contacts on the back of the device. An off-the-shelf international Wall Mount AC Adapter is also supplied for optional wall charging. The USB Charging Dock can be plugged into the Wall Mount AC Adapter's USB A port for charging the device.
The device uses a high-resolution digital accelerometer to accurately measure linear accelerations in 3axes associated with the patient's physical movement. The accelerometer technology is a microelectromechanical system (MEMS) implemented as an integrated circuit. The accelerometer data is converted to a digital representation on the MEMS accelerometer and then recorded, with timestamp, to the device's on-board memory. The memory is an 8 Gb serial NAND flash capable of storing 30 days of
4
Special 510(k) Summary K231532
accelerometer data under the default operating mode. The sample rate of the accelerometer is configurable at the following rates: 32Hz, 64Hz, 128 Hz and 256Hz.
The LCD display indicates the battery level, current functional state of the device, and date and time. The device has a 30-day battery life under the default operating mode and can be charged using the USB Charging Dock accessory. The display does not provide feedback to the wearer/patient regarding data measures. There is a simple button on the side used to turn on the display so the wearer can read the date/time and button presses are recorded in the log.
The device firmware executes on internal processors to control the device operations, display, and external communication protocols. The accelerometer sensor data can be downloaded from the device either via USB (using the dock) or via Bluetooth Low Energy.
Intended Use / Indications for Use
The ActiGraph LEAP™ 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 ActiGraph LEAP™ can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
Indications for Use Comparison with the Predicate(s)
The subject device has the same intended use and indications for use as the predicate device CentrePoint Insight Watch (K181077).
Technological Comparison with the Predicate(s)
The following physical and technological characteristics are changes from the predicate device:
- . The geometric outline dimensions of the device have changed for aesthetic purposes. The device body has a smaller area, mostly due to the height change from 50.1 mm to 39 mm and the device is thicker by 1.8 mm. These changes do not raise different questions of safety and effectiveness.
- . The device enclosure materials have been updated to modern compositions used in similar wearable devices. The materials will have contact with intact skin for durations which may exceed 24 hours; therefore, they have been evaluated for cytotoxicity, sensitization, and irritation as applicable per the FDA Guidance Document on biocompatibility and the use of the ISO 10993-1 standard. This difference does not raise different questions of safety and effectiveness. The methods and results of the biocompatibility testing demonstrate substantial equivalence to the predicate.
A subject-predicate comparison is provided as Table 1 to demonstrate substantial equivalence in a tabular format.
5
ActiGraph.
Special 510(k) Summary K231532
Table 1. Comparison to the predicate device K181077.
| Characteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| ActiGraph CentrePoint Insight | |||
| Watch (K181077) | ActiGraph LEAP™ | ||
| Indications for | |||
| Use Statement | The ActiGraph CentrePoint Insight | ||
| Watch is 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. The | |||
| Insight watch can be used to | |||
| analyze circadian rhythms and | |||
| assess activity in any instance | |||
| where quantifiable analysis of | |||
| physical motion is desirable. | The ActiGraph LEAP™ device is | ||
| 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. The device can be used to | |||
| analyze circadian rhythms and | |||
| assess activity in any instance | |||
| where quantifiable analysis of | |||
| physical motion is desirable. | Same; Device name has | ||
| changed | |||
| Anatomical Site | Wrist | Wrist | Same |
| Prescription Use | |||
| Only or OTC | Prescription Use Only | Prescription Use Only | Similar |
| User Interface | Device display indicates battery | ||
| level, functional status, and time of | |||
| day. No data measures or feedback | |||
| to patient. | Device screen shows battery | ||
| level, functional status, and time | |||
| of day. No data measures or | |||
| feedback to patient. | Same | ||
| Outlines | |||
| Dimensions | Width: 35.8 mm (1.41 in) | ||
| Height: 50.1 mm (1.97 in) | |||
| Thickness: 10.5 mm (0.41 in) | Width: 38.5 mm (1.52 in) | ||
| Height: 39 mm (1.54 in) | |||
| Thickness: 12.3 mm (0.48 in) | Different | ||
| Display Type | LCD Display | LCD Display | Same |
| Energy Source | Battery | Battery | Same |
| Battery Type | Rechargeable Lithium-Ion | Rechargeable Lithium-Ion | Same |
| Battery Charger | USB Charging Dock | USB Charging Dock | Same |
| Principle of | |||
| Operation - | |||
| Technology | A microelectromechanical system | ||
| (MEMS) accelerometer to measure | |||
| linear accelerations associated with | |||
| human body movement and record | |||
| data into non-volatile memory. | |||
| Specs: 3-axis, 32-256Hz, +/- 8g | A microelectromechanical system | ||
| (MEMS) accelerometer to | |||
| measure linear accelerations | |||
| associated with human body | |||
| movement and record data into | |||
| non-volatile memory. | |||
| Specs: 3-axis, 32-256Hz, +/- 8g | Same | ||
| Patient Skin | |||
| Contacting | |||
| Material | Housing: Plastic polymer | ||
| Lens: Hardened glass | |||
| Band and buckle: Silicon and plastic | |||
| polymer | Housing: Plastic polyamide | ||
| (Chendong PA+50%GF CP9021 | |||
| F60LW BK3027F) | |||
| Lens: Hardened glass (Caihong | |||
| CG01pro+ high aluminosilicate | |||
| glass) | |||
| Strap (band) and buckle: Silicon | |||
| (Midgold GF2041E) and Plastic | |||
| polyamide (Chendong PA+50%GF | |||
| CP9021 F60LW BK3027F) | |||
| Bottom case lens: Nylon | Different; Biocompatibility | ||
| testing has been submitted | |||
| to account for this change. | |||
| Software / | |||
| Firmware | Embedded firmware for | ||
| microcontroller which does not | |||
| connect to the internet. | |||
| Communication software for data | |||
| transfer. | Embedded firmware for | ||
| microcontroller which does not | |||
| connect to the internet. | |||
| Communication software for data | |||
| transfer. | Same | ||
| Characteristic | Predicate Device | Subject Device | Comparison |
| ActiGraph CentrePoint Insight | |||
| Watch (K181077) | ActiGraph LEAP™ | ||
| Sterility | Supplied and used non-sterile | Supplied and used non-sterile | Same |
| Storage and | |||
| Transport | |||
| Environment | Temperature: -20C to +55C | ||
| Relative Humidity: 15% to 90% | Temperature: -20C to +55C | ||
| Relative Humidity: 15% to 90% | Same | ||
| Operating | |||
| Environment | Temperature: -10C to +55C | ||
| Relative Humidity: 15% to 90% | Temperature: 0C to +55C | ||
| Relative Humidity: 15% to 90% | Same |
6
Special 510(k) Summary K231532
Non-Clinical Test Summary & Conclusions
The device enclosure, dimensions, and materials have been updated to modern compositions used in similar wearable devices. The materials are intended to have contact with intact skin for durations which may exceed 24 hours; therefore, they have been evaluated for cytotoxicity, sensitization, and irritation per the FDA guidance on biocompatibility and the use of the ISO 10993-1 standard. Clinical testing is not applicable to this submission.
The following technological characteristics of the device are the predicate (cleared with the predicate device):
- . The principle of operation is the same. A microelectromechanical system (MEMS) accelerometer is used to measure movement.
- . The accelerometer data is converted to a digital representation on the MEMS accelerometer and then recorded, with timestamp, to the device's non-volatile memory.
- . The LCD display on the subject device indicates the battery level, the current functional state of the device, and date and time. This is the same as predicate device.
- . The LCD display on the subject device does not provide feedback to the wearer/patient regarding data measures. This is the same as predicate device.
- The power source is the same as the predicate device, a rechargeable lithium battery.
- The physical characteristics are the same, a wrist-worn device, like an electronic watch.
- . Data stored on the device can be downloaded via USB or Bluetooth Low Energy.
- . The software has not changed
The methods and results demonstrate substantial equivalence to the predicate (K181077), as this difference in material does not raise different or new questions of safety and effectiveness. The tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate (K181077). Therefore, the subject device is substantially equivalent to the predicate device.