(113 days)
Not Found
Not Found
No
The description focuses on hardware components (CPU, sensors, cables) and infrared data transfer, with no mention of AI/ML terms or capabilities. The intended use is a direct measurement, not an interpretation or prediction that would typically involve AI/ML.
No.
The device is used for measurement of range of motion, which is a diagnostic function, not a therapeutic one.
No
The device measures range of motion, which is a physiological parameter, but it does not diagnose a disease or condition. While the information gathered may be used in conjunction with other diagnostic tools, the device itself is a measurement tool rather than a diagnostic one.
No
The device description explicitly mentions hardware components such as a monitor CPU, power supply, infrared interface, and sensors connected via cables.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The sonoSens® measures the range of motion of the body. This is a physical measurement of movement, not an analysis of biological samples.
- Intended Use: The intended use is "Continuous real-time measurement of range of motion," which aligns with a physical measurement device, not an IVD.
- Device Description: The description details sensors attached to the skin to measure movement, not components for analyzing biological samples.
Therefore, the sonoSens® falls under the category of a physical measurement or monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The sonoSens® is a non-invasive device indicated for use in real-time measurement of range of motion.
Continuous real-time measurement of range of motion.
Product codes (comma separated list FDA assigned to the subject device)
NKI
Device Description
The measuring device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.1500 Goniometer.
(a)
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.(b)
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.
0
| JAN 2 3 2004 | |
|---|---|
| 7.0 PREMARKET NOTIFICATION 510(K) SUMMARY | |
| Sponsor: | friendly sensors AG |
| August-Bebel-Str. 10 | |
| 07743 Jena | |
| GERMANY | |
| Telephone: +49 3641-637343 | |
| Fax: +49-3641-6373-11 | |
| Contact: Dr. Werner Schwarze | |
| Manufacturer: | OLPE Jena GmbH |
| Friedrich-Hund-Straße 3 | |
| 07745 Jena GERMANY | |
| Telephone: +49 (36 41) 65 30 85 | |
| Facsimile: +49 (36 41) 65 36 76 | |
| Contact: Mr. Nissel | |
| Registration: | To be assigned |
| Contact Person: | Trish Landry |
| M Squared Associates, Inc. | |
| 719 A Street, NE | |
| Washington DC 20002 | |
| Telephone: 202-546-1262 | |
| Fax: 202-546-3848 | |
| E-mail: tlandry@msquaredassociates.com | |
| 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
page 1 of 3
1
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
2
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.
3
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.
4
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
5
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
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