The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired.

Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring.

Device Description

MotionWatch and PRO-Diary are compact, ambulatory, battery-operated activity recorders with physical characteristics similar to a small wristwatch.

The MotionWatch and PRO-Diary are intended for the acquisition and analysis of the physical activity of the body during daily living and sleep. The MotionWatch and PRO-Diary use state of the art miniature accelerometer technology to measure movements of the limb or torso and store these data within the devices differ in that the MotionWatch incorporates an ambient light sensor whereby the PRO-Diary incorporates a display and score-pad to allow subjective inputs.

The MotionWatch and PRO-Diary require operational software to allow configuration. data download, storage and off-line analysis of activity data by a health, care provider. The software can be run on an IBM-Compatible PC and the device is connected directly by means of a standard Universal Serial Bus connection for configuration and download.

The MotionWatch and PRO-Diary utilize a motion sensor known as an "accelerometer" to measure the occurrence and degree of motion. The sensor is a solid state device with a digital output directly proportional to physical acceleration in 1, 2 or 3 axes of orientation. The acceleration data are processed into "counts" before being stored in the non-volatile memory of the device.

AI/ML Overview

Here's the breakdown of the acceptance criteria and the study details for the MotionWatch and PRO-Diary devices, based on the provided text:

Acceptance Criteria and Device Performance

The provided document details non-clinical performance testing for both the MotionWatch and PRO-Diary. The acceptance criteria and reported device performance are presented below. It's important to note that these are engineering performance specifications rather than clinical study endpoints.

MotionWatch Non-Clinical Performance Testing:

Requirement Summary	Test/Verification Method	Pass/Fail Criteria	Test Result
Measure linear acceleration with an accuracy of +/-5% over the full range	Apply a range of simulated reference acceleration and record the results.	The recorded acceleration over the test range shall meet the requirement.	PASS
Accuracy shall be <= +/-5% at the calibration point (i.e. 1g).	Collate random sample of calibration records and examine inter-device variation.	The variation in calibration values shall meet or exceed the requirement.	PASS
Frequency response of 3 to 11 Hz	Apply a fixed acceleration over a range of frequencies and record the results	The frequency response shall meet the requirement to within +/- 10%	PASS
Output zero counts when no physical stimulus is applied	Set-up a sample device and record for a period with no physical stimulus.	The device shall record zero for the period of no physical stimulus.	PASS
Light sensor accuracy of +/- 7.5% over the stated range.	Record a range of light from darkness to sunlight with a sample device simultaneously with a calibrated light meter. Compare the results.	The device shall meet the requirement, however it is acceptable that the accuracy worsens as light level increases. The accuracy over particular ranges shall be specified in the IFU.	PASS
Output zero lux when the sensor is in total darkness	Record data with the light sensor covered with fully opaque tape.	The device shall record zero lux for the test period.	PASS
Recover from unexpected reset events and/or total loss of power with no effect on the stored data.	A sample device shall be subjected to multiple power on reset events and the stored data shall be subsequently downloaded and examined.	No loss of function/data shall occur following the multiple reset events.	PASS

PRO-Diary Non-Clinical Performance Testing:

Requirement Summary	Test/Verification Method	Pass/Fail Criteria	Test Result
Measure linear acceleration with an accuracy of +/-5% over the full range	Apply a range of simulated reference acceleration and record the results.	The recorded acceleration over the test range shall meet the requirement.	PASS
Accuracy shall be <= +/-5% at the calibration point (i.e. 1g).	Collate random sample of calibration records and examine inter-device variation.	The variation in calibration values shall meet or exceed the requirement.	PASS
Frequency response of 3 to 11 Hz	Apply a fixed acceleration over a range of frequencies and record the results	The frequency response shall meet the requirement to within +/- 10%	PASS
Output zero counts when no physical stimulus is applied	Set-up a sample device and record for a period with no physical stimulus.	The device shall record zero for the period of no physical stimulus.	PASS
Display legible in low-light conditions (<100 lux) with normal corrected vision.	A sample device is observed under the stated light conditions.	The display shall be legible in accordance with the requirements.	PASS
Display legible in bright-light conditions (<20000 lux) with normal corrected vision.	A sample device is observed under the stated light conditions.	The display shall be legible in accordance with the requirements.	PASS
Responses to questions accurately recorded and displayed in the results viewer.	A sample device is used to record entries pre-defined in a written log. The downloaded and displayed data are compared to the written log.	There shall be no differences between the electronically reported data and the written log.	PASS

Study Details:

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

Sample Size: The document repeatedly refers to "a sample of devices" or "a sample device" for testing. However, no specific number for the sample size (i.e., how many individual devices were tested) is provided for any of the performance tests.
Data Provenance: Not explicitly stated. Given the submitter's address (CamNtech, UK, Ltd. ... Cambridge, United Kingdom), the testing was likely conducted in the United Kingdom. The study appears to be a prospective series of engineering validation tests rather than a retrospective analysis of existing data.

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

Not applicable. The "ground truth" in this context refers to the verifiable physical conditions (e.g., applied acceleration, light levels) used to test the device's accuracy. These are objective measurements rather than subjective expert interpretations. In the case of the PRO-Diary's subjective input test, the written log serves as the ground truth, which is a direct record.
No human experts were used to establish the "ground truth" for the device's physical performance characteristics.

4. Adjudication Method for the Test Set:

Not applicable. This was not a clinical study involving subjective measures or ambiguous data interpretation requiring adjudication. The pass/fail criteria are objective and directly measured against known physical inputs or comparisons to a reference (e.g., calibrated light meter, written log).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

No such study was conducted or reported. The devices (MotionWatch and PRO-Diary) are activity recorders. They collect raw physical movement data and, in the case of the PRO-Diary, subjective inputs. They do not employ AI or machine learning for interpretation, nor do they involve "human readers" interpreting data in a diagnostic or assessment capacity where AI assistance would be relevant for improvement. The document describes basic device performance validation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Yes, in essence. The entire performance testing described is "standalone" in the sense that it evaluates the device's inherent ability to measure and record physical parameters and, for the PRO-Diary, to record subjective input accurately. There is no "human-in-the-loop" performance being measured in these engineering validation tests, other than a human observing a display's legibility or comparing a written log (for the PRO-Diary's subjective input feature).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for these performance tests includes:

Simulated reference acceleration: For accuracy and frequency response of acceleration measurements.
Absence of physical stimulus: For zero count output.
Calibrated light meter: For light sensor accuracy.
Total darkness (covered sensor): For zero lux output.
Controlled power on/off events: For recovery after reset.
Written log: For the accuracy of subjective input recording and display on the PRO-Diary.

8. The Sample Size for the Training Set:

Not applicable. These devices are not AI/ML-based systems that require a training set. They are hardware devices with embedded software for data acquisition and storage, validated through direct physical performance testing against known inputs.

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established for one.

Summary

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K132764

JAN 2 1 2014

5.0 510(K) SUMMARY

Summary information 5.1

Submitter's name and address 5.1.1
Howard Smith, Engineering Director CamNtech, UK, Ltd. Upper Pendrill Court Ermine Street North -Papworth Everard Cambridge, United Kingdom CB233UY 011-44-1480-831223 Tel: 011-44-1480-831733 Fax:

16" January 2014 Date summary was prepared:

5.1.2 Name of device

Trade Names: Common Name: Classification Name: Product Regulation: Product Code:

MotionWatch and PRO-Diary Activity Recording Device Unclassified Unclassified LEL

Identification of predicate devices 5.1.3.

Actiwatch® (Mini-Mitter Co. Inc.), 510(k) Number : K983533 Actiwatch-Score® (Mini-Mitter Co. Inc.), 510(k) Number : K991033

5.2 Device description

5.2.1.1 Functions of the device

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MotionWatch and PRO-Diary are compact, ambulatory, battery-operated activity recorders with physical characteristics similar to a small wristwatch.

Basic scientific concepts 5.2.1.2

Physical characteristics of Device 5.2.1.3

Pertinent physical characteristics of the MotionWatch are shown in Table 5.1.

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TABLE 5.1: PHYSICAL CHARACTERISTICS OF MOTIONWATCH AND

Parameter	MotionWatch	PRO-Diary	Condition/Note
Size	36mm x 28.2mm x9.4mm	51.5mm x 34.6mm x9.4mm	Outer dimensions(excluding strap)
Weight	9.1 grams	16 grams	excluding strap
Battery Type	CR2032, Userreplacable	Fixed, rechargeable
Battery Life	6 Months	3 Weeks	Typical
AccelerationRange	0.01g to 8g	0.01g to 8g
Casing material	Polycarbonate/ABS	Polycarbonate/ABS
Wrist band	Nylon with stainlesssteel buckle	Nylon with stainlesssteel buckle
Moistureresistance	IPX71	IP422	1) Water resistant to 1mfor 1 hour.2) Drip resistant
SamplingIntervals(epochs)	1 Second to 1 Minute	1 Second to 1 Minute	User selectable
Recording time	6 to 182 days	6 to 21 days	Depending upon epoch
Memory	512KB	4MB	Non-Volatile
Indicators	Single LED Status	OLED Display forsubjective scoring
StorageTemperature	-25°C to 70°C	-25°C to 70°C	0-93% RH
OperatingTemperature	5°C to 40°C	5°C to 40°C	0-93% RH

PRO-DIARY

Statement of the intended use 5.3

Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can

ﺩﺭﺍ

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be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring.

5.4 Comparison of the Motion Watch with the predicate device

The MotionWatch is substantially equivalent to the predicate [ Actiwatch® FDA 510(k) Number: K983533 ]. The MotionWatch and the Actiwatch® are both physical activity recording systems based upon the concept of an ambulatory, unattended recorder that logs data to the device. Each of these devices is a solid-state recorder with accelerometer sensor, data collection means, and with the ability to store data until it is transferred to a personal computer. The MotionWatch and the Activatch® are of similar mechanical matcrials, construction, size, and human interface characteristics. The MotionWatch and the Activatch® are of similar electronic design and their operational characteristics and indications for use are equivalent. Table 5.2 compares the features of the MotionWatch with those of the Actiwatch®

TABLE 5.2. COMPARISON OF MOTIONWATCH TO ACTIWATCH

COMPARISONPARAMETER	MotionWatch(Current Device)	Actiwatch(Predicate Device)
Indications foruse	The MotionWatch and PRO-Diary arecompact, lightweight, body-worn activitymonitoring devices that may be used todocument physical movement associatedwith applications in physiologicalmonitoring. The devices are intended tomonitor limb or body movements duringdaily living and sleep. The MotionWatchand PRO-Diary can be used to assessactivity in any instance wherequantifiable analysis of physical motion isdesired.Additionally, the PRO-Diary has a built-inscore pad that allows the wearer tosubjectively assign and enter responsesto pre-programmed questions. The scorepad can be used as a substitute or inaddition to the traditional written patientdiary in conjunction with activitymonitoring.	The Actiwatch® is an ultra-compact,lightweight, wrist-worn activity andambient light monitor that can be used toanalyze circadian rhythms, automaticallycollect and store data for sleepparameters, and assess activity in anyinstance where quantifiable analysis ofphysical motion is desirable.
Device generaldescription	Compact, wearable, battery-operatedphysical activity data recorder	Compact, wearable, battery-operatedphysical activity data recorder
Activity channels	1, 2, or 3	1
Visualappearance andphysicaldescription ofRecorder	Plastic molded wristwatch style casingwith detachable band.Size 36 x 28.2 x 9.4 (excluding band)	Plastic molded wristwatch style casingwith detachable band.Size 37 x 29 x 9 (excluding band)
Weight	9.1 grams	17 grams
Materials	ABS blend	ABS Blend
SamplingIntervals (epoch)	1, 2, 5, 10, 15, 30, 60 seconds	15, 30, 60, 120, 300, 600 seconds
Recording time	182 Days @ 60s epoch	45 Days @ 60s epoch
Memory	512kBytes	64kBytes
Raw Samplingrate	50 Hz	32 Hz
A/D conversion	12 bits	8 bits
Frequency	3 to 11 Hz	3 to 11 Hz
MoistureSusceptibility	IPX7	IPX7
Sterility	None required	None required
Biocompatibility(skin contacttype)	Standard nylon wrist band in contactwith intact skin surface.	Standard nylon wrist band in contact withintact skin surface.
Human factors	Worn in wrist like a wristwatch; no userinteraction is required.	Worn in wrist like a wristwatch; no userinteraction is required.
Electrical safety(Recorder)	Battery operated	Battery operated
Power used(Recorder)	3.0 volt coin cell type CR2032 (1 each,user-replaceable)	3.0 volt coin cell type CR2025 (1 each,user-replaceable)
Battery Life(typical)	6 months	6 months

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Comparison of the PRO-Diary with the predicate device ર્સ્ડ

The PRO-Diary is substantially equivalent to the predicate [ Actiwatch-Score® FDA 510(k) Number: K991033 ]. The PRO-Diary and the Actiwatch-Score® are both physical activity recording systems based upon the concept of an ambulatory, unattended recorder that logs data to the device. Each of these devices is a solid-state recorder with accelerometer sensor, data collection means, and with the ability to store data until it is transferred to a personal computer. The PRO-Diary and the Actiwatch-Score® both incorporate a score-pad for the prompting and input of subjective patient data. The PRO-Diary and the Activatch-Score® are of similar mechanical materials, construction, size, and human interface characteristics. The PRO-Diary and the Activatch-Score® are of similar electronic design and their operational characteristics and indications for use are equivalent.

Table 5.3 compares the features of the PRO-Diary with those of the Actiwatch-Score®.

COMPARISONPARAMETER	PRO-Diary(Current Device)	Actiwatch-Score(Predicate Device)
-------------------------	-------------------------------	---------------------------------------

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Indications For	The MotionWatch and PRO-Diary are	The Actiwatch-Score® is a compact,
Use	compact, lightweight, body-worn activity	lightweight, wrist-worn activity monitor
	monitoring devices that may be used to	that can be used to analyze circadian
	document physical movement associated	rhythms, automatically collect and
	with applications in physiological	analyze data for sleep parameters, and
	monitoring. The devices are intended to	assess activity in any instance where
	monitor limb or body movements during	quantifiable analysis of physical motion
	daily living and sleep. The MotionWatch	is desirable. In addition, the ActiwatchScore® has a built-in score pad that
	and PRO-Diary can be used to assess	allows the subject to subjectively assign
	activity in any instance where quantifiable	and enter a score from 0 to 9. The score
	analysis of physical motion is desired.	pad can be used as a substitute or in
	Additionally, the PRO-Diary has a built-in	addition to the traditional patient diary
	score pad that allows the wearer to	used in conjunction with activity
	subjectively assign and enter responses to	monitoring.
	pre-programmed questions. The score pad
	can be used as a substitute or in addition
	to the traditional written patient diary in
	conjunction with activity monitoring.
Device general	Compact, wearable, battery-operated	Compact, wearable, battery-operated
description	physical activity data recorder with	physical activity data recorder with
	integrated score pad.	integrated score pad.
Activity channels	1, 2, or 3	1
Visual	Plastic molded wristwatch style casing with	Plastic molded wristwatch style casing
appearance and	detachable band.	with detachable band.
physical	Size 51.5 x 34.6 x 9.4mm (excluding band)	Size 37 x 35 x 12mm (excluding band)
description of
Recorder
Weight	16 grams	25 grams
Materials	ABS blend	ABS Blend
Sampling	1, 2, 5, 10, 15, 30, 60 seconds	15, 30, 60, 120, 300, 600 seconds
Intervals (epoch)
Recording time	21 Days @ 60s epoch	45 Days @ 60s epoch
Memory	4MBytes	64kBytes
Raw Sampling	50 Hz	32 Hz
rate
A/D conversion	12 bits	8 bits
Frequency	3 to 11 Hz	3 to 11 Hz

and the comments of the country

. .

and the comments of the comments of the comments of the comments of

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MoistureSusceptibility	IP32	IP52
Sterility	None required	None required
Biocompatibility(skin contacttype)	Standard nylon wrist band in contact withintact skin surface.	Standard nylon wrist band in contactwith intact skin surface.
Human factors	Worn on wrist like a wristwatch; displayand score-pad for subjective input.	Worn on wrist like a wristwatch; dispand score-pad for subjective input.
Electrical safety(Recorder)	Battery operated	Battery operated
Power used(Recorder)	3.7 volt rechargeable (1 each, not user-replaceable)	3.0 volt coin cell type CR2025 (1 each,user-replaceable)
Battery Life(typical)	21 days between charging	6 months between replacement

. .

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· Assessment of non-clinical performance data 5.6

There are no special controls or consensus standards applicable to the measurement of body movement. To verify the performance of the MotionWatch and PRO-Diary a sample of devices were subjected to a suite of bespoke tests to verify each performance parameter. Table 5.4 provides a summary of the MotionWatch non-clinical performance testing.

TABLE 5.4: SUMMARY OF MOTIONWATCH NON-CLINICAL PERFORMANCE TESTING

Requirement summary	Test/verificationMethod	Pass/fail criteria	Test result
The device shall measurelinear acceleration withan accuracy of +/-5%over the full range	Apply a range ofsimulated referenceacceleration andrecord the results.	The recordedacceleration over the testrange shall meet therequirement.	PASS
The device accuracy shallbe <= +/-5% at thecalibration point (i.e. 1g).	Collate randomsample of calibrationrecords and examineinter-device variation.	The variation incalibration values shallmeet or exceed therequirement.	PASS
The device shall have afrequency response of 3to 11 Hz	Apply a fixedacceleration over arange of frequenciesand record the results	The frequency responseshall meet therequirement to within +/-10%	PASS
The device shall outputzero counts when nophysical stimulus isapplied	Set-up a sampledevice and record fora period with nophysical stimulus.	The device shall recordzero for the period of nophysical stimulus.	PASS.
The light sensor shallhave an accuracy of +/- 7.5% over the statedrange.	Record a range oflight from darkness tosunlight with asample devicesimultaneously with acalibrated lightmeter. Compare theresults	The device shall meet therequirement, however itis acceptable that theaccuracy worsens as lightlevel increases. Theaccuracy over particularranges shall be specifiedin the IFU.	PASS.
The device shall outputzero lux when the sensoris in total darkness	Record data with thelight sensor coveredwith fully opaquetape.	The device shall recordzero lux for the testperiod.	PASS
The device shall recoverfrom unexpected resetevents and/or total lossof power with no effecton the stored data.	A sample device shallbe subjected tomultiple power onreset events and thestored data shall besubsequentlydownloaded andexamined	No loss of function/datashall occur following themultiple reset events.	PASS

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Table 5.5 provides a summary of the PRO-Diary non-clinical performance testing.

TABLE 5.5: SUMMARY OF PRO-DIARY NON-CLINICAL PERFORMANCE TESTING

Requirement summary	Test/verificationMethod	Pass/fail criteria	Test result
The device shall measurelinear acceleration withan accuracy of +/-5%over the full range	Apply a range ofsimulated referenceacceleration andrecord the results.	The recordedacceleration over the testrange shall meet therequirement.	PASS
The device accuracy shallbe <= +/-5% at thecalibration point (i.e. 1g).	Collate randomsample of calibrationrecords and examineinter-device variation.	The variation incalibration values shallmeet or exceed therequirement.	PASS
The device shall have afrequency response of 3to 11 Hz	Apply a fixedacceleration over arange of frequenciesand record the results	The frequency responseshall meet therequirement to within +/-10%	PASS
The device shall outputzero counts when nophysical stimulus isapplied	Set-up a sampledevice and record fora period with nophysical stimulus.	The device shall recordzero for the period of nophysical stimulus.	PASS
The display shall belegible in low-lightconditions (<100 lux)with normal correctedvision.	A sample device isobserved under thestated lightconditions	The display shall belegible in accordance withthe requirements	PASS
The display shall belegible in bright-lightconditions (<20000 lux)with normal correctedvision.	A sample device isobserved under thestated lightconditions	The display shall belegible in accordance withthe requirements	PASS
The responses toquestions shall beaccurately recorded anddisplayed in the resultsviewer.	A sample device isused to record entriespre-defined in awritten log. Thedownloaded anddisplayed data arecompared to thewritten log.	There shall be nodifferences between theelectronically reporteddata and the written log	PASS

In addition to performance testing, the devices have been evaluated and tested for safety and electromagnetic interference according to the following internationally recognized standards:

IEC60601-1: 2005 Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance.

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IEC60601-1-11:2010 Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance. Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

IEC60601-1-2: 2007, Medical Electrical Equipment - PART 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

The testing according to these standards has raised no issues as to the safety and effectiveness of the present devices or the present devices compared to the predicate devices.

5.7 Conclusion

| |

The results of the performance testing and safety and environmental testing show that the MotionWatch and PRO-Diary are as safe, as effective, and perform as well as the predicate device.

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Image /page/11/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 21, 2014

CamNtech Ltd. c/o Mr. Howard Smith Engineering Director Upper Pendrill Court Ermine Street North Papworth Everard. Cambridge, United Kingdom CB233UY

Re: K132764

Trade/Device Name: MotionWatch and PRO-Diary Regulation Number: Unclassified Common Name: Sleep Assessment Device (Activity Recorder) Regulatory Class: Class II Product Code: LEL Dated: December 16, 2013 Received: December 17, 2013

Dear Mr. Smith:

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.

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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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Carlos L. Pena -S

Carlos L. Peña, Ph.D., M.S. 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: K132764

Device Name: MotionWatch and PRO-Diary

Indications for Use:

AND/OR Prescription Use X ..... (part 21 CFR 801 Subpart D)

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

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

Concurrence of Center of Devices and Radiological Health (CDRH)

Carlos L. Pena -S

page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.