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.

AI/ML Overview

The document provides details of the Actiheart device, an ambulatory Heart Rate and Activity Recorder. It includes information on its substantial equivalence to a predicate device, indications for use, device description, and performance testing results against acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size of unique patients or recordings for the test sets. Instead, it refers to "libraries of ECG waveforms" such as the MIT-BIH Normal Sinus Rhythm waveform library, European ST-T waveform library, and AAMI Normal Sinus Rhythm waveform library. These are standardized, publicly available databases of ECG recordings, often used for testing algorithms and devices. The provenance of these publicly available libraries is generally known, but not detailed in this document. The testing described is a "bench test comparison report" and relies on "library recordings of known Heart Rate." This suggests a retrospective analysis using pre-recorded data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Ground truth for these waveform libraries is typically established through a combination of expert cardiological review and often includes reference annotations that have been meticulously validated.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set. Given that it relies on established ECG waveform libraries, the ground truth (e.g., true heart rate, QRS complex locations) from these libraries would serve as the reference, precluding the need for real-time expert adjudication of the device's output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The study focuses purely on the standalone performance of the Actiheart device against established benchmarks and in comparison to a predicate device in a bench test setting. It does not evaluate human readers' improvement with or without AI assistance.

6. Standalone Performance

Yes, a standalone performance study was conducted. The "Actiheart to Mini Logger Series 2000 bench test comparison report" directly assesses "the Heart Rate detection performance characteristics of both devices side-by-side against a set of library recordings of known Heart Rate." This is further supported by "Additional testing with the use of simulated recordings per ASTM EC13:2002," and the detailed "Assessment of non-clinical performance data" which lists various tests applied to the "submitted Recorder" (Actiheart) against specific performance requirements. These tests evaluate the device's ability to detect and measure heart rate independently.

7. Type of Ground Truth Used

The ground truth used for the performance testing cited in Table 10D is based on "known Heart Rate" from "libraries of ECG waveforms" such as MIT-BIH, European ST-T, and AAMI Normal Sinus Rhythm waveform libraries. These libraries contain reference annotations (e.g., R-peak locations, true heart rates) typically established through expert consensus and automated validation. The document also mentions testing with "simulated recordings per ASTM EC13:2002," implying a ground truth derived from controlled, simulated ECG signals.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for any algorithms within the Actiheart device. It mentions "proprietary code transforms digitized signal and detects location of features in ECG complex" and "proprietary algorithms to detect motion" and "proprietary algorithm" for caloric expenditure, but does not detail the development or training of these algorithms.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set (if any was used for the proprietary algorithms) was established.

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: 724-387-4120 Fax: 724-387-4216 Zita.yurko@respironics.com

Heart Rate Monitor

Proprietary Name		Actiheart
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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

Device Description

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

PhysiologicalParameter	Where Obtained	Technology	Value Obtained
Heart Rate	Actiheart	Differential amplifiersenses andamplifies ECGsignal. Proprietarycode transformsdigitized signal anddetects location offeatures in ECGcomplex.	Digital valuecorresponding toheart Beats PerMinute (BPM).
Activity	Actiheart	Signal fromaccelerometeramplifier is digitizedand analyzed usingproprietaryalgorithms to detectmotion.	Digital valuecorresponding toActivity Counts
Caloric Expenditure(derived)	Software	Conversion ofActivity Counts andHR tocorresponding valueof CaloriesExpended(proprietaryalgorithm)	Valuecorresponding toCalories 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, overall38mm diameter12.5mm 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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COMPARISONPARAMETER	Actiheart	Mini-Logger® Series 2000 withHeart Rate Probe(K991045)
Device description	Compact, wearable, battery-operated physiological datarecorder	Compact, wearable, battery-operated physiological datarecorder
Where used	Actiheart may be used wherequantifiable measurement ofhuman Heart Rate and/or Activity isneeded. It may be used in thehome or hospital environments	The Mini-Logger® may be used inany instance where quantifiableanalysis of physiological data isdesirable. It may be used in thehome or hospital environments
Visual appearance andphysical description ofRecorder/probe	195mm length38mm diameter12.5mm tail clip	145 mm length31 mm wide
HR channels	1	1
Materials(Recorder)	Polycarbonate/ABS plastic case	ABS plastic case
Mode of operation(Recorder)	Recorder input	Wireless Recorder input andDirect-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 5BPM(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 ECGelectrodes
Human factors(Recorder)	Attaches to ECG electrodes	Waist pack carrying case, direct-wire attachment to ECGelectrodes, 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	ActiheartPerformance
Tall T-wave RejectionCapability	Reject Tall T-Waves up to 1.2mV with ±10% accuracy or ±5BPM (greater of two)	Sensitivity is better than 98 %Specificity is 100%
MIT-BIH Normal Sinus Rhythmwaveform library	Detect HR with accuracy of±10% or ±5 BPM (greater oftwo)	Sensitivity is better than 99%Specificity is better than 98%
European ST-T waveformlibrary	Detect HR with accuracy of±10% or ±5 BPM (greater oftwo)	Sensitivity is better than 99%Specificity is better than 97%
AAMI Normal Sinus Rhythmwaveform library	Detect HR with accuracy of±10% or ±5 BPM (greater oftwo)	Sensitivity is better than 99%Specificity is better than 99%
Line frequency tolerance anddrift tolerance	Detect HR with accuracy of±10% or ±5 BPM (greater oftwo) when drift or line noisepresent	No difference between HRmeasurement for waveformswith and without superimposednoise
Range and accuracy of HRmeter	Detect HR with accuracy of±10% or ±5 BPM (greater oftwo) over specified range of 32to 255 BPM	Within limits for all values of HR
Amplitude of QRS waveform	Detect HR with accuracy of±10% or ±5 BPM (greater oftwo) for amplitudes 0.5 mV to5 mV	Within limits for all values ofamplitude between 0.45 mV and9 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.

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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 (800) 638-2041 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

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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

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).