(98 days)
Kinesia is intended to monitor physical motion 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.
Kinesia™ is designed to monitor and record motion and electrical activity of muscle to quantify kinematics of movement disorders such as tremor for research and diagnostic purposes. The patient unit consists of a wrist module and ring sensor. Motion sensors including accelerometers and gyroscopes are integrated into a finger worn unit to capture three dimensional motions. The finger worn sensor unit is worn on a finger band and is connected to a wrist worn module by a thin flexible wire. The wrist module provides an input for two channels of electromyography, battery power, on board memory, and an embedded radio for real-time wireless transmission of the collected signals. The wrist module is worn on a comfortable, adjustable wristband.
The signals are communicated between the patient module and the computer unit using wireless technology based on 2.4-2.484 GHZ frequencies. Kinesia will consist of four major components:
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Patient Module(consists of ring and wrist module)
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Computer Unit
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Electromyography Leads
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Interface Software
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The Patient Module includes a user worn ring and wrist module connected by a thin cable. The patient module monitors eight channels of data including three channels of accelerometers (linear acceleration sensors), three channels of gyroscopes (angular velocity sensors), and two channels of electrical muscle activity (EMG). The data can be transmitted in real-time over a wireless telemetry link to a computer or be stored in onboard memory. The wireless link can either transmit only (one-way) or transmit and receive (two-way). The basic functional feature of the component is to acquire signals from the subject, perform analog-to-digital conversion (when appropriate), encode, format, and transmit the signals to the Computer Unit or store data in on board memory. The Patient Module will operate on DC power from either rechargeable or replaceable batteries. The Patient Module includes a push button patient diary so the patient can indicate when they have taken their medication and when their symptoms are severe.
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The Computer Unit will have the ability to only receive (one-way) or receive and transmit (two-way) data from the Patient Module. The basic functional feature of this component is to receive data packets from the patient unit, perform error detection and correction, and then send the data to the PC Operator interface where the data can be monitored in real time or stored and analyzed at a later time.
3: The Electromyography Leads provide an input for two channels of EMG recordings. The leads provide five standard snap connector inputs including two differential channels of EMG and a patient ground. The leads are connected to a lemo connector. The lemo connector attaches to the lemo input on the Patient Unit wrist module.
- The Interface Software program consists of several software modules that allow the user to acquire, store, and review data as acquired by the hardware.
The provided text describes the Kinesia™ device, its intended use, and its performance testing against various voluntary standards. However, it does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, or information on sample size, data provenance, ground truth establishment, or expert involvement as requested.
The "Performance Testing" section states that Kinesia™ will be tested to certain voluntary standards (e.g., FCC Part 15.109, IEC60601-1 series). This indicates that the device intended to comply with these standards, but the document does not provide the results of these tests or specific acceptance criteria met.
Therefore, based solely on the provided text, a table of acceptance criteria and reported device performance, and details of a study meeting these criteria, cannot be fully generated.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Anticipated based on standards listed) | Reported Device Performance (Not provided in text) |
|---|---|
| Compliance with FCC Part 15.109 Radiated emissions limits - Unintentional radiators. Class B digital device. | Results are not detailed. |
| Compliance with IEC60601-1, 10.1 Environmental Conditions, Transport and Storage | Results are not detailed. |
| Compliance with IEC60601-1, 10.2 Environmental Conditions, Operation | Results are not detailed. |
| Compliance with IEC60601-1, 19.3 Leakage currents, allowable values | Results are not detailed. |
| Compliance with IEC60601-1-2, 36.202.3 Radiated RF electromagnetic fields | Results are not detailed. |
| Compliance with IEC60601-1-2, 36.202.4 Electrical fast transient and bursts | Results are not detailed. |
| Compliance with IEC60601-1-2, 36.202.7 Voltage dips, short interruptions, and voltage variations | Results are not detailed. |
| Compliance with IEC60601-1-2, 36.202.6 Conducted Disturbances, Induced by RF fields | Results are not detailed. |
| Compliance with IEC60601-1-2, 36.202.8 Magnetic Fields | Results are not detailed. |
| Compliance with IEC60601-1-2, 36.202.2 Electrostatic Discharge | Results are not detailed. |
| Compliance with IEC60601-1-2, 36.201 Emissions | Results are not detailed. |
Missing Information (Not found in the provided text):
- Specific quantitative acceptance criteria: The document lists standards but does not specify the pass/fail thresholds or performance metrics (e.g., accuracy, precision, sensitivity, specificity) for quantifying movement disorder symptoms or activity.
- Actual test results: The document states the device will be tested to these standards but does not provide any reported device performance data against these or any other criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not provided.
- Data provenance: Not provided. The document outlines regulatory compliance testing (e.g., electrical safety, EMC), but not a clinical or performance study with a "test set" in the context of, for example, classifying tremor.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. The listed "Performance Testing" refers to compliance with voluntary engineering and safety standards, not a study involving expert-adjudicated ground truth for clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. The Kinesia™ device is described as a monitor and recorder of motion and electrical activity, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided in the context of clinical performance algorithms. The device itself is a standalone measurement instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the clinical sense. The "ground truth" for the listed performance testing would be the specifications and requirements of the voluntary standards themselves (e.g., measured leakage current must be below X mA).
8. The sample size for the training set
- Not applicable/Not provided. This document does not describe the development of a machine learning algorithm; it describes a medical device with sensors and a software interface.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Conclusion based on provided text:
The document focuses on the technical description, intended use, and intent to comply with general safety and electromagnetic compatibility (EMC) standards. It does not provide details of a clinical performance study with specific acceptance criteria related to its quantitative analysis capabilities, nor does it include information about data sets (training or test), ground truth establishment, or expert involvement in such a study. The information provided is consistent with a 510(k) summary for a monitoring device primarily demonstrating substantial equivalence through technological characteristics and compliance with recognized safety standards.
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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.4415 Euclid AvenueCleveland, Ohio 44103 |
|---|---|
| Telephone | (216) 791-6720 |
| Facsimile | (216) 791-6739 |
| Date | April 5, 2007 |
| Name | Hani Kayyali, President |
| Classification | 882.1400 |
| Predicate: | Family of Crystal 20 Monitors, K042039, Tremorometer, K010270, andActiwatch-Score, K991033. |
| Description: | Kinesia™ is designed to monitor and record motion and electrical activityof muscle to quantify kinematics of movement disorders such as tremor forresearch and diagnostic purposes. The patient unit consists of a wristmodule and ring sensor. Motion sensors including accelerometers andgyroscopes are integrated into a finger worn unit to capture threedimensional motions. The finger worn sensor unit is worn on a finger bandand is connected to a wrist worn module by a thin flexible wire. The wristmodule provides an input for two channels of electromyography, batterypower, on board memory, and an embedded radio for real-time wirelesstransmission of the collected signals. The wrist module is worn on acomfortable, adjustable wristband.The signals are communicated between the patient module and thecomputer unit using wireless technology based on 2.4-2.484 GHZfrequencies. Kinesia will consist of four major components:1. Patient Module(consists of ring and wrist module)2. Computer Unit3. Electromyography Leads4. Interface Software1. The Patient Module includes a user worn ring and wrist moduleconnected by a thin cable. The patient module monitors eight channelsof data including three channels of accelerometers (linear accelerationsensors), three channels of gyroscopes (angular velocity sensors), andtwo channels of electrical muscle activity (EMG). The data can betransmitted in real-time over a wireless telemetry link to a computer orbe stored in onboard memory. The wireless link can either transmitonly (one-way) or transmit and receive (two-way). The basicfunctional feature of the component is to acquire signals from thesubject, perform analog-to- |
| Description | digital conversion (when appropriate), encode, format, and transmit thesignals to the Computer Unit or store data in on board memory. ThePatient Module will operate on DC power from either rechargeable orreplaceable batteries. The Patient Module includes a push buttonpatient diary so the patient can indicate when they have taken theirmedication and when their symptoms are severe.2. The Computer Unit will have the ability to only receive (one-way) orreceive and transmit (two-way) data from the Patient Module. Thebasic functional feature of this component is to receive data packetsfrom the patient unit, perform error detection and correction, and thensend the data to the PC Operator interface where the data can bemonitored in real time or stored and analyzed at a later time.3: The Electromyography Leads provide an input for two channels ofEMG recordings. The leads provide five standard snap connectorinputs including two differential channels of EMG and a patientground. The leads are connected to a lemo connector. The lemoconnector attaches to the lemo input on the Patient Unit wrist module.4. The Interface Software program consists of several software modulesthat allow the user to acquire, store, and review data as acquired by thehardware. |
| Intended Use | Kinesia is intended to monitor physical motion and muscle activity toquantify kinematics of movement disorder symptoms such as tremor andassess activity in any instance where quantifiable analysis of motion andmuscle activity is desired. |
| Contraindication: | Interference may occur in the vicinity of equipment marked with thefollowing symbol:Such interference could be caused by the use of multiple units operating inthe same vicinity. |
| Warning | • Improper routing of leads may result in a choking hazard.• Do not use in conjunction with a defibrillator.• Do NOT expose the system to water. Water exposure may permanentlydamage the unit. |
| TechnologicalCharacteristics | Like the predicate devices, Kinesia is intended to monitor and recordmotion and physiological signals from a patient's body, and save thosesignals 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.Class B digital device.• IEC60601-1, 10.1 Environmental Conditions, Transport and Storage• IEC60601-1, 10.2 Environmental Conditions, Operation• IEC60601-1, 19.3 Leakage currents, allowable values• IEC60601-1-2, 36.202.3 Radiated RF electromagnetic fields• IEC60601-1-2, 36.202.4 Electrical fast transient and bursts• IEC60601-1-2, 36.202.7 Voltage dips, short interruptions, and voltage variations• IEC60601-1-2, 36.202.6 Conducted Disturbances, Induced by RF fields• IEC60601-1-2, 36.202.8 Magnetic Fields• IEC60601-1-2, 36.202.2 Electrostatic Discharge• IEC60601-1-2, 36.201 Emissions |
| Conclusion | It is the conclusion of Cleveland Medical Devices Inc. that Kinesia issubstantially equivalent to the predicate devices already on the market(cleared by the 510(k) process) and presents no new concerns about safetyand 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 (800) 638-2041 or (301) 796-7100 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
§ 882.1950 Tremor transducer.
(a)
Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.(b)
Classification. Class II (performance standards).