ACTITRAINER

K080545 · Actigraph, LLC · ISD · Jul 24, 2008 · Physical Medicine

Device Facts

• Record ID: K080545
• Device Name: ACTITRAINER
• Applicant: Actigraph, LLC
• Product Code: ISD · Physical Medicine
• Decision Date: Jul 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2

Intended Use

The ActiTrainer 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 ActiTrainer can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

Device Story

ActiTrainer is a wearable activity monitor housed in a polycarbonate enclosure. It utilizes an internal accelerometer to record physical movement data and an optional Polar heart rate strap for heart rate monitoring. The device captures movement signals, stores them in internal RAM, and allows data download to a PC via USB. Data is processed and displayed using ActiLife software. Used in clinical or research settings to document movement, analyze circadian rhythms, and assess physical activity. Healthcare providers review the output to quantify motion, aiding in physiological monitoring and clinical decision-making regarding patient activity levels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polycarbonate housing; accelerometer-based sensing; Lithium Ion battery; 1024kB memory; USB connectivity for data transfer; microprocessor-controlled data acquisition; optional heart rate channel (BPM).

Indications for Use

Indicated for monitoring physical movement and activity during sleep, analyzing circadian rhythms, and assessing physical motion in patients requiring physiological monitoring.

Regulatory Classification

Identification

Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.

Special Controls

*Classification.* Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Actigraph (K040554)

Submission Summary (Full Text)

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Koro545

VII 510(k) Summary

JUL 2 4 2008

Applicant: ActiGraph, LLC 15 W. Main St. Pensacola, FL 32502 Phone: [phone] Fax: [phone]

Point of Contact: John G. Schneider, VP of R&D

Trade Name: ActiTrainer

Common Names: Activity Recording Device

Classification Name: ISD

Equivalent Legally Marketed device: The ActiTrainer is similar in function to the ActiGraph LLC's legally marketed activity monitor, the Actigraph, K040554.

Description of Device: The ActiTrainer is housed in a polycarbonate plastic housing. It is 8.5 cm long by 3.4 cm wide by 1.6 cm thick and it weights 51 grams. It also has an optional Polar heart strap. Data is downloaded into a PC via a USB plug and the data is displayed with ActiGraph LLC's ActiLife software.

Intended Use. The ActiTrainer 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 ActiTrainer can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

Technological Characteristics: The ActiTrainer is substantially equivalent to the Actigraph, they both record and same movement with accelerometer and save the data internally on RAM. They both use an on board microprocessor for controlling the data which can be displayed with ActiGraph LLC's ActiLife data. ActiTrainer has an optional heart rate channel and expanded memory capability to handle the extra data.

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Image /page/1/Picture/0 description: The image shows the logo for ActiGraph. The logo features a stick figure standing in the middle of a heartbeat line. Above the word ActiGraph is the phrase "...the technology of health". Below the heartbeat line is the website address www.theactigraph.com.

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| Comparison Table | | |
|------------------------------|---------------------------|-----------------------|
| Parameter | Actigraph (Predicate) | ActiTrainer |
| Size | 5.1 x 5.1 x 1.1 | 8.5 x 3.4 x 1.6 |
| Weight | 42.5 grams | 51 grams |
| Battery Type | Lithium/Manganese Dioxide | Lithium Ion |
| Accelerometer Sensivity | 16 milliGs | 4 milliGs |
| Enclosure | Polycarbonate | Polycarbonate |
| Sampling Intervals | 1 second and 4 minutes | 1 second to 4 minutes |
| Recording Time @ 1min. Epoch | 11 days | 14 days |
| Memory | 256kB | 1024kB |
| Storage Temperature | -10°C to 50°C | -10°C to 50°C |
| Operating Temperature | 0°C to 40°C | 0°C to 40°C |
| Heart Rate | n.a. | BPM |

Table 1. Comparing the ActiTrainer to the Actigraph

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Actigraph, LLC. % Mr. John Schneider Vice President of R & D 15 West Main Street Pensacola, Florida 32502

JUL 2 4 2008

Re: K080545

> Trade Name: ActiTrainer Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring Exercise Equipment Regulatory Class: Class II Product Code: ISD Dated: June 6, 2008 Received: June 11, 2008

Dear Mr. Schneider:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Mr. John Schneider

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Mark M. Mullican

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/0 description: The image shows the logo for ActiGraph. The logo features a stylized human figure with outstretched arms, forming the letter 'A' in 'ActiGraph'. Above the text, it reads '...the technology of health'. Below the text is the website address 'www.theActigraph.com'.

## Indications for Use

510(k) Number (if known):

Device Name: ActiTrainer ActiTrainer

Indications for Use:

The ActiTrainer 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 ActiTrainer can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative, and Neurological Devices |
| | 510(k) Number k080548 |
| | Page 1 of 1 |

Fax: [phone] Pensacola, FL USA Ph: 850-332-7900 15 West Main Street Website: www.TheActiGraph.com