SONOSENS

K033193 · Friendly Sensors AG · NKI · Jan 23, 2004 · Orthopedic

Device Facts

• Record ID: K033193
• Device Name: SONOSENS
• Applicant: Friendly Sensors AG
• Product Code: NKI · Orthopedic
• Decision Date: Jan 23, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.1500
• Device Class: Class 2

Intended Use

Continuous real-time measurement of range of motion.

Device Story

sonoSens® is a non-invasive range of motion measurement device. It consists of a monitor CPU, power supply, and eight sensors attached to the patient's skin via disposable adhesive pads. The system uses low-intensity ultrasound energy emitted between sensors; the device measures the travel time of ultrasonic signals between sender and receiver sensors to calculate motion. Data is transferred to a personal computer via an infrared interface. The software allows for immediate viewing, storage, and generation of graphical/tabular reports. Used in clinical settings to assist healthcare providers in assessing patient range of motion, the device provides objective data to support clinical decision-making and monitor patient progress.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises a monitor CPU, power supply, and eight sensors. Sensing principle: low-intensity ultrasound time-of-flight measurement. Connectivity: infrared interface for data transfer to a PC. Software: PC-based application for data visualization, analysis, and report generation (tables, graphs, text).

Indications for Use

Indicated for continuous real-time measurement of range of motion in patients requiring such assessment.

Regulatory Classification

Identification

A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.

Special Controls

*Classification.* (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of: (i) The performance standard under part 898 of this chapter, and (ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.

Predicate Devices

• 3-D Spine
• Dualer IQ™ Inclinometer and Tracker ROM™ Computerized Dual Inclinometry System

Submission Summary (Full Text)

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| | JAN 2 3 2004 |
|-------------------------------------------|----------------------------------------|
| 7.0 PREMARKET NOTIFICATION 510(K) SUMMARY | |
| Sponsor: | friendly sensors AG |
| | August-Bebel-Str. 10 |
| | 07743 Jena |
| | GERMANY |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Contact: Dr. Werner Schwarze |
| Manufacturer: | OLPE Jena GmbH |
| | Friedrich-Hund-Straße 3 |
| | 07745 Jena GERMANY |
| | Telephone: [phone] |
| | Facsimile: [phone] |
| | Contact: Mr. Nissel |
| Registration: | To be assigned |
| Contact Person: | Trish Landry |
| | M Squared Associates, Inc. |
| | 719 A Street, NE |
| | Washington DC 20002 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Trade Name of Device: | sonoSens® |
| Common Name: | Range of Motion Measurement Device |
| Classification name: | Goniometer with Electrodes |
| Product Code: | NKI |
| Regulation Class: | Class II |
| Regulation Number: | §888.1500 |

CONFIDENTIAL

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The sonoSens® is a non-invasive device indicated for use in real-Device Description: The measuring device time measurement of range of motion. consists of a monitor central processing unit (CPU), the power supply, and an infrared interface for data transfer. The device is connected to cight sensors via cables. Each sensor is directly attached to the skin with an adhesive pad.

Continuous real-time measurement of range of motion. Indications for Use:

## Basis for Substantial Equivalence

sonoSens® (proposed device): The friendly sensors sonoSens® requires that eight small sensors be attached to the area of the body being measured using disposable adhesive pads. Low-intensity ultrasound energy is emitted between sensors applied to the sender sensor sends an ultrasonic signal to the receiver sensor). The amount of time that the ultrasonic signal takes to travel from the sending sensor to the receiving sensor is measured by the sonoSens®. The data recorded by the monitor is transferred to the personal computer via an infrared interface. The data may be viewed immediately or stored on the hard disk of the computer for further analysis. The computer software enables the development of graphical displays of the patient range of motion data. The system has a report generator capability that provides reports, including tables, graphs and text.

3-D Spine (predicate device): The 3-D Spinc requires that a small passive receiver/sensor be attached to the forehead, using a neoprene head strap, and a second strap be attached at other spinal locations, using double-sided adhesive tape. The relative motion of the two sensors, as detected by the change in the field strength, and orientation of the magnetic field lines, is compared to the resulting angular changes recorded by the monitor. The relative difference in displacement and orientation between the two sensors describes the precise 3-D motion performed by the patient. Data is received by the monitor and displayed on the computer monitor. The data may be viewed immediately or stored on the hard disk of the computer for further analysis. The computer software enables the development of three-dimensional and graphical displays of the patient range of motion data. The system has a report generator capability that provides a flexible or customized report, including tables, graphs and text.

CONFIDENTIAL

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Dualer IQTM Inclinometer and Tracker ROM™ Computerized Dual Inclinometry System (predicate device): The Dualer IQTM Inclinometer and Tracker ROM™ Computerized Dual Inclinometry range of motion measurement system involves the use of two handheld monitors that measure the angles of the patient's range of motion based on gravitational pull. The angle measured The monitors are either held directly on the patient by the shows on a liquid crystal display. practitioner or attached to the patient using straps. The data recorded on the monitors are transferred to a personal computer by plugging the monitors into a central unit, the Tracker ROM™ device. The Tracker ROM™ device functions as an interface between the Dualer IQ™ Inclinometer monitors and the personal computer. The data from the monitors are transferred to a personal computer in which the Tracker ROM™ software is used to provide customized reports of range of motion data.

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's wings. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2004

Friendly Sensors AG C/o Ms. Trish Landry M Squared Associates, Inc. 719 A Street, NE Washington, DC 20002

Re: K033193

Tradc/Device Name: sonoSens® Regulation Number: 21 CFR 888.1500 Regulation Name: Goniometer Regulatory Class: II Product Code: NKI Dated: October 1, 2003 Received: October 27, 2003

Dear Ms. Landry:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have detcrmined 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. Ilsting 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 such 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.

Please be advised that I'DA'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); 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.

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Page 2 - Ms. Trish Landry

This letter will allow you to begin marketing your device as described in vour Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C Provost

Celia M. Witten, Ph.D., M.D. 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): K033193

Device Name: sonoSens®

Indications For Use: Continuous real-time measurement of range of motion.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

ിവാഹം പ്രധാനം(Off) Inton of Goncral, Restorative . Neurological Devices

K033143

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