KINESIA

K063872 · Cleveland Medical Devices, Inc. · GYD · Apr 6, 2007 · Neurology

Device Facts

• Record ID: K063872
• Device Name: KINESIA
• Applicant: Cleveland Medical Devices, Inc.
• Product Code: GYD · Neurology
• Decision Date: Apr 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1950
• Device Class: Class 2

Intended Use

Kinesia is intended to monitor physical motions and muscle activity to quantify kinematics of movement disorder symptoms such as tremor and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired.

Device Story

Kinesia is a wearable monitoring system for movement disorders; captures 3D motion and electrical muscle activity. Patient module includes finger-worn unit (accelerometers, gyroscopes) and wrist-worn module (EMG inputs, battery, memory, wireless radio). System transmits data via 2.4-2.484 GHz telemetry to a computer unit for real-time monitoring or later analysis. Includes patient diary button for medication/symptom tracking. Used by clinicians to quantify tremor kinematics and assess activity; provides objective data to support clinical decision-making. Benefits patients through precise, longitudinal tracking of movement disorder symptoms.

Clinical Evidence

Bench testing only. The device was evaluated against voluntary standards including FCC Part 15.109 for radiated emissions and IEC 60601-1/1-2 for electrical safety, electromagnetic compatibility, and environmental conditions (operation, transport, storage). No clinical study data provided.

Technological Characteristics

Wearable system with finger-worn motion sensors (accelerometers, gyroscopes) and wrist-worn module. Connectivity via 2.4-2.484 GHz wireless telemetry. Inputs: 3-axis linear acceleration, 3-axis angular velocity, 2-channel EMG. Power: DC (rechargeable/replaceable batteries). Interface: PC-based software for data acquisition/analysis. Standards: FCC Part 15.109, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for monitoring physical motion and muscle activity to quantify kinematics of movement disorder symptoms, such as tremor, and to assess activity in patients where quantifiable analysis of motion and muscle activity is desired.

Regulatory Classification

Identification

A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.

Predicate Devices

• Family of Crystal 20 Monitors (K042039)
• Tremorometer (K010270)
• Actiwatch-Score (K991033)

Submission Summary (Full Text)

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K063872

## 510(k) SUMMARY

PR - 6 200

The Summary of Safety and Effectiveness information on Kipesia™ is being submitted in accordance with the requirements of 21 C.P.R. §807,92 and reflects data available and represented at the time the submission was propared, but caution should be exercised inlinterpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

| Applicant | Cleveland Medical Devices Inc.<br>4415 Euclid Avenue<br>Cleveland, Ohio 44103 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | [phone] |
| Facsimile | [phone] |
| Date | April 5, 2007 |
| Name | Hani Kayyali, President |
| Classification | 882.1400 |
| Predicate: | Family of Crystal 20 Monitors, K042039, Tremorometer, K010270, and<br>Actiwatch-Score, K991033. |
| Description: | Kinesia™ is designed to monitor and record motion and electrical activity<br>of muscle to quantify kinematics of movement disorders such as tremor for<br>research and diagnostic purposes. The patient unit consists of a wrist<br>module and ring sensor. Motion sensors including accelerometers and<br>gyroscopes are integrated into a finger worn unit to capture three<br>dimensional motions. The finger worn sensor unit is worn on a finger band<br>and is connected to a wrist worn module by a thin flexible wire. The wrist<br>module provides an input for two channels of electromyography, battery<br>power, on board memory, and an embedded radio for real-time wireless<br>transmission of the collected signals. The wrist module is worn on a<br>comfortable, adjustable wristband.<br><br>The signals are communicated between the patient module and the<br>computer unit using wireless technology based on 2.4-2.484 GHZ<br>frequencies. Kinesia will consist of four major components:<br><br>1. Patient Module(consists of ring and wrist module)<br>2. Computer Unit<br>3. Electromyography Leads<br>4. Interface Software<br><br>1. The Patient Module includes a user worn ring and wrist module<br>connected by a thin cable. The patient module monitors eight channels<br>of data including three channels of accelerometers (linear acceleration<br>sensors), three channels of gyroscopes (angular velocity sensors), and<br>two channels of electrical muscle activity (EMG). The data can be<br>transmitted in real-time over a wireless telemetry link to a computer or<br>be stored in onboard memory. The wireless link can either transmit<br>only (one-way) or transmit and receive (two-way). The basic<br>functional feature of the component is to acquire signals from the<br>subject, perform analog-to- |
| Description | digital conversion (when appropriate), encode, format, and transmit the<br>signals to the Computer Unit or store data in on board memory. The<br>Patient Module will operate on DC power from either rechargeable or<br>replaceable batteries. The Patient Module includes a push button<br>patient diary so the patient can indicate when they have taken their<br>medication and when their symptoms are severe.<br><br>2. The Computer Unit will have the ability to only receive (one-way) or<br>receive and transmit (two-way) data from the Patient Module. The<br>basic functional feature of this component is to receive data packets<br>from the patient unit, perform error detection and correction, and then<br>send the data to the PC Operator interface where the data can be<br>monitored in real time or stored and analyzed at a later time.<br><br>3: The Electromyography Leads provide an input for two channels of<br>EMG recordings. The leads provide five standard snap connector<br>inputs including two differential channels of EMG and a patient<br>ground. The leads are connected to a lemo connector. The lemo<br>connector attaches to the lemo input on the Patient Unit wrist module.<br><br>4. The Interface Software program consists of several software modules<br>that allow the user to acquire, store, and review data as acquired by the<br>hardware. |
| Intended Use | Kinesia is intended to monitor physical motion and muscle activity to<br>quantify kinematics of movement disorder symptoms such as tremor and<br>assess activity in any instance where quantifiable analysis of motion and<br>muscle activity is desired. |
| Contraindication: | Interference may occur in the vicinity of equipment marked with the<br>following symbol:<br><br><br>Such interference could be caused by the use of multiple units operating in<br>the same vicinity. |
| Warning | • Improper routing of leads may result in a choking hazard.<br>• Do not use in conjunction with a defibrillator.<br>• Do NOT expose the system to water. Water exposure may permanently<br>damage the unit. |
| Technological<br>Characteristics | Like the predicate devices, Kinesia is intended to monitor and record<br>motion and physiological signals from a patient's body, and save those<br>signals for analysis and review. |
| | 8 / 002 |
| Performance | Kinesia™ will be tested to the following voluntary standards: |
| Testing | FCC Part 15.109 Radiated emissions limits - Unintentional radiators.<br>Class B digital device.<br>• IEC60601-1, 10.1 Environmental Conditions, Transport and Storage<br>• IEC60601-1, 10.2 Environmental Conditions, Operation<br>• IEC60601-1, 19.3 Leakage currents, allowable values<br>• IEC60601-1-2, 36.202.3 Radiated RF electromagnetic fields<br>• IEC60601-1-2, 36.202.4 Electrical fast transient and bursts<br>• IEC60601-1-2, 36.202.7 Voltage dips, short interruptions, and voltage variations<br>• IEC60601-1-2, 36.202.6 Conducted Disturbances, Induced by RF fields<br>• IEC60601-1-2, 36.202.8 Magnetic Fields<br>• IEC60601-1-2, 36.202.2 Electrostatic Discharge<br>• IEC60601-1-2, 36.201 Emissions |
| Conclusion | It is the conclusion of Cleveland Medical Devices Inc. that Kinesia is<br>substantially equivalent to the predicate devices already on the market<br>(cleared by the 510(k) process) and presents no new concerns about safety<br>and effectiveness |

8 / 001

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## 510(k) SUMMARY, coutinued

The Summary of Safety and Effectiveness information on Kipesta™ is being submitted in accordance with the requirements of 21 C.F.R. §807.92 and reflects data valiable and represented at the tine the studies and or tests may require alterations of the conclusions or recommendations set forth.

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## 510(k) SUMMARY, continued

The Summary of Safety and Effectiveness information on Kinesia™ is being submitted in accordance with the requirements of 21 C.R.R. 8807.92 and reflects data wailable and represented at the time the submission was prepared, but cantion should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

8 / 003

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white.

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

Cleveland Medical Devices Inc. c/o Mr. Joseph Giuffrida Director, Division of Movement 4415 Euclid Ave. Cleveland, OH 44103

APR - 9 2012

Re: K063872

Trade/Device Name: Kinesia Regulation Number: 21 CFR 882.1950 Regulation Name: Tremor Transducer Regulatory Class: II Product Code: GYD Dated (Date on orig SE ltr): April 5, 2007 Received (Date on orig SE ltr): April 5, 2007

Dear Mr. Giuffrida:

This letter corrects our substantially equivalent letter of April 6, 2007.

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 (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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

n

Sincerely vours.

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 3 – Mr. Joseph Giuffrida

Indications for Use

510(k) Number (if known): K063872

Device Name: Kinesia

Indications For Use:

Kinesia is intended to monitor physical motions and muscle activity to quantify kinematics of movement disorder symptoms such as tremor and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired.

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

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

(PLEASE DO MOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices Page 1 of __
510(k) Number K063872