ACTIHEART

• K Number: K052489
• Device Name: ACTIHEART
• Manufacturer: RESPIRONICS, INC.
• Date Cleared: 2005-09-27 ( 15 days)
• Product Code: GWK
• Regulation Number: 882.1845

Intended Use

The Actiheart is an ambulatory Heart Rate and Activity Recorder. Actiheart may be used to quantifiably measure Heart Rate, Activity, and estimates of Caloric Expenditure. This device is not intended for use as an ECG monitor.

Device Description

Actiheart is a compact, ambulatory, physiological Heart Rate and Activity data recorder. Actiheart may be attached to the chest surface through the use of standard ECG electrodes. Recorded data may be transferred later to a PC for display and conversion for export to other programs.

Predicate Devices

K991045

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a data recorder and analysis software that performs standard physiological measurements and comparisons to a predicate device using established testing protocols. There is no mention of AI, ML, or related concepts.

Therapeutic

No.
The "Intended Use / Indications for Use" states that Actiheart "may be used to quantifiably measure Heart Rate, Activity, and estimates of Caloric Expenditure" and "This device is not intended for use as an ECG monitor." It is a measurement device, not one that treats or prevents a condition.

Diagnostic

No
The device is described as a recorder for quantifiable measurement of heart rate, activity, and caloric expenditure, and explicitly states it is "not intended for use as an ECG monitor." It functions to record data for later analysis, not to provide immediate diagnostic information or interpret clinical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "compact, ambulatory, physiological Heart Rate and Activity data recorder" and is attached to the chest surface using "standard ECG electrodes," indicating it is a hardware device that records data. While it mentions data transfer to a PC for display and conversion (software components), the core device is hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the Actiheart device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
• Actiheart's Function: The Actiheart is described as an ambulatory Heart Rate and Activity Recorder that measures Heart Rate, Activity, and estimates Caloric Expenditure. It attaches to the chest surface using ECG electrodes to record physiological data from the body.
• Lack of Specimen Examination: The description does not mention the examination of any specimens (blood, tissue, urine, etc.) derived from the human body. The data is collected directly from the body's electrical signals and movement.

Therefore, the Actiheart falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Actiheart is an ambulatory Heart Rate and Activity Recorder. Actiheart may be used to quantifiably measure Heart Rate, Activity, and estimates of Caloric Expenditure. This device is not intended for use as an ECG monitor.

Product codes

GWK

Device Description

Actiheart is a compact, ambulatory, physiological Heart Rate and Activity data recorder. Actiheart may be attached to the chest surface through the use of standard ECG electrodes. Recorded data may be transferred later to a PC for display and conversion for export to other programs.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Chest surface

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home or hospital environments.

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

Actiheart to Mini Logger Series 2000 bench test comparison report; assesses the Heart Rate detection performance characteristics of both devices side-by-side against a set of library recordings of known Heart Rate. Additional testing with the use of simulated recordings per ASTM EC13:2002.
The performance of the Actiheart Recorder has been tested in accordance with applicable clauses of ANSI/AAMI EC13:2002, American National Standard for Heart Rate (HR) Meters. The categories of tests applied to the submitted Recorder are listed as follows:

• Tall T-wave rejection capability
• Measurement of HR sensitivity and specificity for several libraries of ECG waveforms
• Measurement of HR in the presence of line frequency and drift noise
• Measurement of range and accuracy of ECG detection
• Measurement of HR detection over a range of QRS amplitudes
• Accuracy and response to irregular rhythms

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing included: safety, performance and comparative tests.

• Actiheart to Mini Logger Series 2000 bench test comparison report; assesses the Heart Rate detection performance characteristics of both devices side-by-side against a set of library recordings of known Heart Rate. Additional testing with the use of simulated recordings per ASTM EC13:2002.
• Actiheart Software Functional Requirements Test Procedure/Report; assesses the features of the Actiheart to ensure compliance with the Software requirements.
• Actiheart Shock & Vibration Test
• Actiheart Temperature & Humidity Test

The performance of the Actiheart Recorder has been tested in accordance with applicable clauses of ANSI/AAMI EC13:2002, American National Standard for Heart Rate (HR) Meters. The categories of tests applied to the submitted Recorder are listed as follows:

• Tall T-wave rejection capability
• Measurement of HR sensitivity and specificity for several libraries of ECG waveforms
• Measurement of HR in the presence of line frequency and drift noise
• Measurement of range and accuracy of ECG detection
• Measurement of HR detection over a range of QRS amplitudes
• Accuracy and response to irregular rhythms

For all the categories, we have determined that Actiheart performance meets that of the currently-marketed predicate device, Mini-Logger® Series 2000 Heart Rate Probe. Neither the submitted device (Actiheart) nor the predicate device (Mini-Logger® Series 2000 Heart Rate Probe) is capable of detecting all types of irregular rhythms as specified in ANSI/AAMI EC13, Clause 4.1.2.1(e).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Tall T-wave Rejection Capability: Sensitivity is better than 98 %, Specificity is 100%
MIT-BIH Normal Sinus Rhythm waveform library: Sensitivity is better than 99%, Specificity is better than 98%
European ST-T waveform library: Sensitivity is better than 99%, Specificity is better than 97%
AAMI Normal Sinus Rhythm waveform library: Sensitivity is better than 99%, Specificity is better than 99%
Line frequency tolerance and drift tolerance: No difference between HR measurement for waveforms with and without superimposed noise
Range and accuracy of HR meter: Within limits for all values of HR
Amplitude of QRS waveform: Within limits for all values of amplitude between 0.45 mV and 9 mV.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K991045

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.1845 Physiological signal conditioner.

(a)
Identification. A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.(b)
Classification. Class II (performance standards).

Summary

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June 15, 2005

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SEP 27 2005

510(K) SUMM/

Date of Submission

Dollars

Official Contact / Address of Manufacturing facility

Zita A. Yurko Manager, Regulatory Affairs Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15668

Phone: [phone] Fax: [phone] [e-mail]

Heart Rate Monitor

Proprietary Name		Actiheart
------------------	--	-----------

Common/Usual Name

Classification

Predicate Devices

Physiological Signal Recorder Device Classification Name

Neurology

21 CFR 882.1845 Classification Reference

Class II

Appropriate Classification Panel

GWK Product Code

Mini Logger Series 2000 (Mini Mitter Co., Inc.)

New device Reason for submission

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Substantial Equivalence

This premarket notification submission demonstrates that the Actiheart system is substantially equivalent to the Mini Logger Series 2000 (K991045).

The design of the Actiheart was verified through the use of design verification and validation testing. The Hazards Control Measures Traceability Matrix provided in the Risk Analysis assured that all hazards identified by the risk analysis were successfully mitigated.

This submission is seeking to obtain clearance to market a new product that is substantially equivalent to the Mini Logger Series 2000. The new product (Actiheart) performs substantially equivalent measurements of Heart Rate and Activity as the Mini Logger Series 2000.

Indications for Use

The Actiheart is an ambulatory Heart Rate and Activity Recorder. Actiheart may be used to quantifiably measure Heart Rate, Activity, and estimates of Caloric Expenditure. This device is not intended for use as an ECG monitor.

Device Description

Actiheart is a compact, ambulatory, physiological Heart Rate and Activity data recorder. Actiheart may be attached to the chest surface through the use of standard ECG electrodes. Recorded data may be transferred later to a PC for display and conversion for export to other programs.

Basic scientific concepts

The device acquires and logs digital data whose values represent the rate of Heart Beat (BPM), based on a proprietary analysis of ECG complexes. (Actiheart is not an ECG monitor.) The scientific concepts and technologies that are used to sense the signals are summarized in Table 10A.

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TABLE 10A. BASIC TECHNOLOGIES USED FOR PHYSIOLOGICAL SIGNAL RECORDING IN

ACTIHEART RECORDERS

| Physiological

Parameter	Where Obtained	Technology	Value Obtained
Heart Rate	Actiheart	Differential amplifier
senses and
amplifies ECG
signal. Proprietary
code transforms
digitized signal and
detects location of
features in ECG
complex.	Digital value
corresponding to
heart Beats Per
Minute (BPM).
Activity	Actiheart	Signal from
accelerometer
amplifier is digitized
and analyzed using
proprietary
algorithms to detect
motion.	Digital value
corresponding to
Activity Counts
Caloric Expenditure
(derived)	Software	Conversion of
Activity Counts and
HR to
corresponding value
of Calories
Expended
(proprietary
algorithm)	Value
corresponding to
Calories Expended

Physical characteristics of Actiheart

Pertinent physical characteristics of the Actiheart are shown in Table 10B.

TABLE 10B. PHYSICAL CHARACTERISTICS OF ACTIHEART RECORDER

Parameter	Value	Condition/Note
Size	195mm length, overall
38mm diameter
12.5mm tail clip	Outer dimensions
Weight	12 grams	With no ECG electrodes attached
Case material	Polycarbonate/ABS	Flammability rating UL94 V-0
Attachment clip material	Stainless steel
Attachment type	Adult ECG snap
Battery type	3.0 volt lithium rechargeable	Not user replaceable
Indicators	Green LED	Coincident with heart beat

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Functional Description

Actiheart is intended for the measurement, storage, and display of physiological data (Heart Rate (HR) and Activity (ACT)). In addition, Actiheart derives an approximate value of Energy Expenditure from the values of HR and ACT. Actiheart can be attached to the subject's chest using standard ECG electrodes. Through the use of various types of standard ECG electrodes, the Recorder may be worn for varying lengths of time, dependent on the amount of data logging desired and the recommendations of the ECG electrode manufacturer. Parameter data are logged on board the Recorder and later transferred through a cable to a personal computer via the Reader. The PC Software can be used to display the physiological data and store the data for future comparison. The Multicharger is used to re-charge the Recorder's onboard rechargeable lithium battery.

Technological characteristics, comparison to predicate device

Actiheart and the Mini-Logger Series 2000 Heart Rate Probe (K991045) are each diagnostic test systems based upon the concept of an ambulatory, unattended physiological recorder that logs physiological data to the logging device. Each of these devices is a solid-state Recorder with differential amplifiers, data collection and analysis algorithms, and with the ability to store data until it is transfered into the PC. Actiheart and the Mini-Logger Series 2000 Heart Rate Probe are of similar size and weight. Both devices measure and record Heart Rate and Activity.

The physiological data logging device presented in this 510(k) submission (Actiheart) is substantially equivalent to the Heart Rate Probe currently marketed as part of the Mini-Logger® Series 2000 Physiological Data Logging Device (K991045).

The Actiheart and the Mini-Logger® Series 2000 Heart Rate Probe are of similar size and weight. Both devices have the ability to measure Heart Rate. Both devices are surface-mounting, chest-worn, and ambulatory.

The performance characteristics are illustrative of comparable devices. Similarities and differences between Actiheart and the predicate device are presented below in Table 10C. Where differences exist, they reflect reduced indications for use and improvements in convenience of use.

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| COMPARISON
PARAMETER | Actiheart | Mini-Logger® Series 2000 with
Heart Rate Probe
(K991045) |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | Compact, wearable, battery-
operated physiological data
recorder | Compact, wearable, battery-
operated physiological data
recorder |
| Where used | Actiheart may be used where
quantifiable measurement of
human Heart Rate and/or Activity is
needed. It may be used in the
home or hospital environments | The Mini-Logger® may be used in
any instance where quantifiable
analysis of physiological data is
desirable. It may be used in the
home or hospital environments |
| Visual appearance and
physical description of
Recorder/probe | 195mm length
38mm diameter
12.5mm tail clip | 145 mm length
31 mm wide |
| HR channels | 1 | 1 |
| Materials
(Recorder) | Polycarbonate/ABS plastic case | ABS plastic case |
| Mode of operation
(Recorder) | Recorder input | Wireless Recorder input and
Direct-wired Recorder input |
| Design features
(System) | Maximum recording time 14 days | Maximum recording time 88 days |
| Memory
(system) | 1 Megabit | 128 Kilobyte or 1 Megabyte |
| Performance | Comparable (see included) | Comparable (see included) |
| Heart Rate range | 35 to 255 BPM | Up to 250 BPM |
| Heart Rate resolution | 1 BPM | 1 BPM |
| Heart Rate accuracy* | ±10% of value, not to exceed 5
BPM
(Meets EC-13-4.2.7) | Unpublished |
| R-wave detection | dv/dt with variable threshold,
sampling at 128 Hz | Performed by the heart rate probe.
Method is unpublished. |
| Sterility
(Recorder) | None required | None required |
| Biocompatibility
(Recorder) | Through the use of ECG electrodes | Through the use of ECG
electrodes |
| Human factors
(Recorder) | Attaches to ECG electrodes | Waist pack carrying case, direct-
wire attachment to ECG
electrodes, or telemetric link |
| Electrical safety
(Recorder) | Battery operated | Battery operated |
| Power used
(Recorder) | 3.0 volt rechargeable lithium battery
(1 each) | 3.6 volt disposal lithium battery
(2 each) |

TABLE 10C. SUBSTANTIAL EQUIVALENCE COMPARISON

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Performance testing

An extensive collection of tests has been conducted and successfully completed, including safety, performance and comparative tests. Declarations of conformance to the FDA Recognized list of consensus standards, as well as FDA reviewers guidance and Applicable voluntary standards have been provided in support of the safety and effectiveness of the Actiheart System. This list of performance testing included/will include:

• IEC 60601-1: 1988 + A1: 1991 + A2: 1995, Medical Electrical Equipment Part 1: General . Requirements for Safety - Tab 11A
• IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic . Compatibility - Requirements and tests - Tab 11B
• ISO-10993-1: Biological Evaluation of Medical Devices Evaluation and Testing Tab 9 .
• FDA Reviewer's Guidance (#G95-1, 5/1/95) Biological Evaluation of Medical Devices; Use of ISOt 10993 – Tab 9
• Actiheart to Mini Logger Series 2000 bench test comparison report; assesses the Heart Rate . detection performance characteristics of both devices side-by-side against a set of library recordings of known Heart Rate. Additional testing with the use of simulated recordings per ASTM EC13:2002.
• Actiheart Software Functional Requirements Test Procedure/Report; assesses the features of the . Actiheart to ensure compliance with the Software requirements.
• Actiheart Shock & Vibration Test .
• Actiheart Temperature & Humidity Test .

Additional testing has been performed in to ensure safety & effectiveness of the Actiheart System. The following set of standards and guidance documents have been used in the Actiheart System. These include:

Required Standards – A Declaration of Conformity for each of these standards is provided in the submittal:

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• IEC 60601-1: 1988 + A1: 1991 + A2: 1995, Medical Electrical Equipment Part 1: General . Requirements for Safety
• IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic . Compatibility - Requirements and tests
• ISO-10993-1: Biological Evaluation of Medical Devices Evaluation and Testing {Biocompatibility has . been established by the device clearances associated with the patient applied parts – no separate DOC is provided to demonstrate compliance with this standard}

Voluntary Standards - Guidance, when applicable, has been adopted from the following standards.

• ANSI/ASTM EC13:2002 Cardiac monitors, heart rate meters, and alarms [applicable clauses] .
  Reviewers Guidance - Guidance, when applicable, has been adopted from each of the FDA Reviewers Guidance documents

• FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, t May 2005

• FDA Reviewer's Guidance (#G95-1, 5/1/95) Biological Evaluation of Medical Devices; Use of ISOt 10993

• FDA Reviewer's Guidance for Premarket Notification Submissions, Appendix A, November 1993 .

• FDA Reviewer's Guidance General Principles of Software Validation; Final Guidance for Industry and ● FDA Staff. January 2002

Assessment of non-clinical performance data

The performance of the Actifieart Recorder has been tested in accordance with applicable clauses of ANSI/AAMI EC13:2002, American National Standard for Heart Rate (HR) Meters. The categories of tests applied to the submitted Recorder are listed as follows:

• . Tall T-wave rejection capability
• Measurement of HR sensitivity and specificity for several libraries of ECG waveforms .
• Measurement of HR in the presence of line frequency and drift noise .
• Measurement of range and accuracy of ECG detection .
• Measurement of HR detection over a range of QRS amplitudes .
• Accuracy and response to irregular rhythms .

A detailed disclosure of the test results has been provided in Tab 5 of this Application. For all the categories, we have determined that Actiheart performance meets that of the currently-marketed predicate device, Mini-Logger® Series 2000 Heart Rate Probe. Neither the submitted device (Actiheart) nor the predicate device (Mini-Logger® Series 2000 Heart Rate Probe) is capable of detecting all types of irregular rhythms as specified in ANSI/AAMI EC13, Clause 4.1.2.1(e). However, per ANSI/AAMI EC13, a note has been placed in the Actiheart Instruction Manual indicating such. A summary of our results appears in Table 10D.

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| Figure of Merit | Requirement | Actiheart
Performance |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Tall T-wave Rejection
Capability | Reject Tall T-Waves up to 1.2
mV with ±10% accuracy or ±5
BPM (greater of two) | Sensitivity is better than 98 %
Specificity is 100% |
| MIT-BIH Normal Sinus Rhythm
waveform library | Detect HR with accuracy of
±10% or ±5 BPM (greater of
two) | Sensitivity is better than 99%
Specificity is better than 98% |
| European ST-T waveform
library | Detect HR with accuracy of
±10% or ±5 BPM (greater of
two) | Sensitivity is better than 99%
Specificity is better than 97% |
| AAMI Normal Sinus Rhythm
waveform library | Detect HR with accuracy of
±10% or ±5 BPM (greater of
two) | Sensitivity is better than 99%
Specificity is better than 99% |
| Line frequency tolerance and
drift tolerance | Detect HR with accuracy of
±10% or ±5 BPM (greater of
two) when drift or line noise
present | No difference between HR
measurement for waveforms
with and without superimposed
noise |
| Range and accuracy of HR
meter | Detect HR with accuracy of
±10% or ±5 BPM (greater of
two) over specified range of 32
to 255 BPM | Within limits for all values of HR |
| Amplitude of QRS waveform | Detect HR with accuracy of
±10% or ±5 BPM (greater of
two) for amplitudes 0.5 mV to
5 mV | Within limits for all values of
amplitude between 0.45 mV and
9 mV. |

TABLE 10D. ACTIHEART HEART RATE MEASUREMENT CHARACTERISTICS

Conclusion

It is the conclusion of Respironics that the Actiheart system is substantially equivalent to Mini Logger Series 2000 (K991045) and presents no new concerns about safety and effectiveness.

(End of Tab.)

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SEP 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Respironics, Inc. c/o Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K052489 Trade/Device Name: Actiheart Regulation Number: 21 CFR 882.1845 Regulation Name: Physiological signal conditioner Regulatory Class: II Product Code: GWK Dated: September 8, 2005 Received: September 12, 2005

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorobate) is registy
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1977, the accordance with the provisions of the Federal Food, Drug, devices mat nave occh rechasined in asseroval of a premarket approval application (PMA). allo Cosment Act (71ct) that do not requently of the general controls provisions of the Act. The I ou may, merelore, manel act include requirements for annual registration, listing of general controls provisions of mactice, 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 If your device is elassined (600 as controls. Existing major regulations affecting your device can may be subject to such additional controlio "Entraligning to the 898. In addition, FDA may be round interents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease oe advised that I Dri Visuan to syour device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cachi statutes and regalancents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It I art 607), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

9

Page 2- Mr. Neil E. Devine, Jr.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing of substantial equivalence of your device to a legally premarket notification: "The FDA miding of basically 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
r the results of the may on 1011 at the subscription on to the receiled If you desire specific advice for your ac not our sales. Also, please note the regulation entitled, conlact the Office of Comphance at (216) 276 - 310 - 410 Part 807.97). You may obtain Misorallumg by reference to premainer to premainterial in Act from the Division of Small other general International and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millken

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

Enclosure

10

Indications for Use

510(k) Number (if known): _KOS 2489

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Actiheart is an ambulatory Heart Rate and Activity Recorder. Actifieart may be used to quantifiably measure Heart Rate, Activity, and estimates of Caloric Expenditure. This device is not intended for use as an ECG monitor.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milliken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K052484