(71 days)
Not Found
No
The description focuses on standard kinematic and kinetic calculations using established algorithms and templates, without mentioning AI or ML techniques for analysis or interpretation.
No
The device is used for assessment and training purposes in physical therapy, but it does not directly apply or provide therapy.
Yes
The intended use explicitly states the device is used for "assessment and training of limb or body motion in gait analysis, prosthetic design, pre/post rehabilitation evaluation, physical therapy." The term "assessment" directly implies a diagnostic purpose, as it involves evaluating a patient's condition to determine the nature and extent of a problem or to monitor progress.
No
The device description explicitly states that the system includes hardware components such as a computer workstation with proprietary boards, cameras, VCRs, lights, calibration frames, video/optical-capture/analog-acquisition boards, an event synchronization unit, and analog EMG and force-platform systems. While software is a key component, it is not the sole component.
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 described device analyzes and quantifies human movement patterns using video and sensor data. It focuses on the physical mechanics of the body, not on analyzing biological samples.
- Intended Use: The intended uses listed (gait analysis, prosthetic design, rehabilitation evaluation, physical therapy) all relate to assessing and training physical movement.
- Device Description: The description details the hardware and software used to capture and analyze motion, not to perform laboratory tests on biological specimens.
Therefore, the device falls under the category of a medical device used for physical assessment and analysis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in gait analysis, prosthetic design, pre/post rehabilitation evaluation, physical therapy, and the like.
Product codes (comma separated list FDA assigned to the subject device)
LXJ
Device Description
The system uses off-the-shelf video cameras, sensors, and computers to collect, quantify, and document human movement in two-dimensional or three-dimensional space. The proprietary elements of the system are Peak's software applications, which run on Microsoft Windows, and an interface box, which can mix and synchronize multiple digital and analog inputs when active data capture is used. The system can effect the capture of real-time video images of motion along with associated sensor information, then sequence the coordinate and sensor information for recording on the computer. Alternatively, the system can use video recordings to provide the motion information. Motion and sensor data are recorded, analyzed, and displayed or reported from the computer.
A typical study involves recording the locations of small reflective markers on subjects as movement occurs. This provides instant coordinate data. Coordinate data may also be gathered from digitized video sequences. Analog sensors, such as force platforms or EMG systems, may also be part of the instrumentation during movement. Their information can be synchronized, processed, and displayed along with the coordinate information. The system can calculate standard 2-D or 3-D kinematic and kinetic parameters using specific calculation modules. A report generation package displays and reports the data: in raw or processed form. step-by-step, or sequentially.
The Peak Motus system may include software modules, such as
- Advanced video or 3D-optical-motion-capture module
- 2D and/or 3D kinematic calculation and display software
- Analog acquisition module
- 3D pan and tilt module
- KineCalc mathematical analysis module
- Peak Motus Gait Analysis Template
Its hardware comprises a Microsoft Windows computer workstation with proprietary synchronizing and processing boards, and a variety of equipment setups, including
- Purchased cameras, VCRs, lights, calibration frames, high-speed video
- Video, optical-capture, and analog-acquisition boards
- Event synchronization unit
- Analog EMG and force-platform systems and analog-to-digital interface unit (accepts up to 64 sensors)
Movement tracking can be done with or without markers in virtually any collection environment—indoors, outdoors, or even under water. For most medical applications, the tracking is done indoors in a controlled laboratory environment with markers.
The Peak Motus System has standard data reduction algorithms for editing, filtering and calculating linear and anqular displacements, velocities, and accelerations. Specialized templates are available for custom calculations: for example, the Peak Motus 3D Gait Analysis Template provides industry-standard gait-analysis calculations such as body segment angles. joint forces, moments, and powers.
The systems' report and display package can print standard reports or can display data on the computer screen through a multimedia-display tool. Parametric data created with the system may be displayed as line graphs, x-y plots, bar graphs, stick figures (with vector overlays), text, and data tables.
Mentions image processing
Digitized video sequences
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video, optical-capture
Anatomical Site
limb or body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical settings, laboratory environment
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)
Safety is not an issue with the system. The system uses commonly available consumer and technical equipment with demonstrated safety. The equipment are passive sensing and recording devices; most of which never contact the subject.
Extensive in-house testing has demonstrated the effectiveness of this system.
In-house and clinical testing by independent third parties has been reported that demonstrates the system's effectiveness and fitness for use in this application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
MAY 1 6 2003
Peak Motus Motion Measurement System 510(k) Summary
Submitter
| Company: | Peak Performance Technologies, Inc.
7388 S Revere Pkwy 901, Centennial, Colorado 80112 USA
Tel 303 799 8686, Fax 303 799 8690 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Larry Scheirman |
| Prepared: | 28 February 2003 |
| Device Name | |
| Trade: | Peak Motus Motion Measurement System |
| Common: | Motion measurement system |
| Classification: | System, Optical Position/Movement Recording |
| Product code: | LXJ |
| Predicate Devices | |
| Trade Name: | CODA mpx30 Motion Analysis System |
| 510(k) Number: | K982425 |
| Manufacturer: | Charnwood Dynamics Ltd |
Introduction
The Peak Motus Motion Measuring System is a mature product. It has been marketed for years for biomechanical research and performance evaluation. The manufacturer has become aware that the system has demonstrated-value and increasing use in medical settings. Therefore, this 510(k) notification is being submitted to properly notify authorities and recognize the system as a legally marketed medical device.
Device Description
The system uses off-the-shelf video cameras, sensors, and computers to collect, quantify, and document human movement in two-dimensional or three-dimensional space. The proprietary elements of the system are Peak's software applications, which run on Microsoft Windows, and an interface box, which can mix and synchronize multiple digital and analog inputs when active data capture is used. The system can effect the capture of real-time video images of motion along with associated sensor information, then sequence the coordinate and sensor information for recording on the computer. Alternatively, the system can use video recordings to provide the motion information. Motion and sensor data are recorded, analyzed, and displayed or reported from the computer.
A typical study involves recording the locations of small reflective markers on subjects as movement occurs. This provides instant coordinate data. Coordinate data may also be gathered from digitized video sequences. Analog sensors, such as force platforms or EMG systems, may also be part of the instrumentation during movement. Their information can be
1
synchronized, processed, and displayed along with the coordinate information. The system can calculate standard 2-D or 3-D kinematic and kinetic parameters using specific calculation modules. A report generation package displays and reports the data: in raw or processed form. step-by-step, or sequentially.
The Peak Motus system may include software modules, such as
-
- Advanced video or 3D-optical-motion-capture module
-
- 2D and/or 3D kinematic calculation and display software
-
- Analog acquisition module
-
- 3D pan and tilt module
-
- KineCalc mathematical analysis module
-
- Peak Motus Gait Analysis Template
Its hardware comprises a Microsoft Windows computer workstation with proprietary synchronizing and processing boards, and a variety of equipment setups, including
-
- Purchased cameras, VCRs, lights, calibration frames, high-speed video
-
- Video, optical-capture, and analog-acquisition boards
-
- Event synchronization unit
- Analog EMG and force-platform systems and analog-to-digital interface unit (accepts up to 64 sensors)
Movement tracking can be done with or without markers in virtually any collection environment—indoors, outdoors, or even under water. For most medical applications, the tracking is done indoors in a controlled laboratory environment with markers.
The Peak Motus System has standard data reduction algorithms for editing, filtering and calculating linear and anqular displacements, velocities, and accelerations. Specialized templates are available for custom calculations: for example, the Peak Motus 3D Gait Analysis Template provides industry-standard gait-analysis calculations such as body segment angles. joint forces, moments, and powers.
The systems' report and display package can print standard reports or can display data on the computer screen through a multimedia-display tool. Parametric data created with the system may be displayed as line graphs, x-y plots, bar graphs, stick figures (with vector overlays), text, and data tables.
Indications for Use
Computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in gait analysis, prosthetic design, pre/post rehabilitation evaluation, physical therapy, and the like.
Summary of Technological Characteristics
The Peak Motus Motion Measurement System is substantially equivalent to the CODA mpx30 system from Charnwood Dynamics. Both systems acquire motion patterns by optical capture directly linked into a PC computer in real time; using multiple cameras to gather threedimensional information. In addition, the Peak Motus can acquire these patterns from recorded video. Both systems provide standard biomechanical kinetic analyses: displaying the data in tables and graphs on-screen and in printed reports.
2
Summary of Non-Clinical Performance
Safety
Safety is not an issue with the system. The system uses commonly available consumer and technical equipment with demonstrated safety. The equipment are passive sensing and recording devices; most of which never contact the subject.
Effectiveness
Extensive in-house testing has demonstrated the effectiveness of this system.
Summary of Clinical Performance
In-house and clinical testing by independent third parties has been reported that demonstrates the system's effectiveness and fitness for use in this application.
Equivalence to Predicate Devices
The Peak Motus Motion Measurement System is substantially equivalent to the CODA mpx30 system as a means of measuring the general three-dimensional movements of subjects, including such activities as walking. Both systems provide a non-intrusive optical method of measuring the movement. Both systems acquire the movement data into a host PC, which then analyzes and displays motion data onscreen or in printed reports. Specific, standard gait analysis and other analysis programs are available for these calculations and reports.
The CODA system uses proprietary cameras and LED markers with automatic identification while the Peak Motus system can be used with or without markers with standard video equipment. In addition, the Peak Motus system can use recorded video images to obtain motion information and can incorporate concurrent analog sensor data with its measurements.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles forming a wing-like shape, which is a common symbol associated with the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Larry Scheirman President Peak Performance Technologies, Inc. 7388 S. Revere Parkway 901 Centennial, CO 80112
Re: K030714
Trade/Device Name: Peak Motus Motion Measurement System Regulatory Class: Unclassified Product Code: LXJ Dated: February 28, 2003 Received: March 6, 2003
Dear Mr. Scheirman:
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.
MAY 1 6 2003
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 - Mr. Larry Scheirman
This letter will allow you to begin marketing your device as described in your 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/cdrf/dsma/dsmamain.html
Sincerely yours,
Mark A. Melluson
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
510(k) Supplement:
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Peak Motus Motion Measurement System Device Name: __
Indications for Use:
Computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in gait analysis, prosthetic design, pre/post rehabilitation evaluation, physical therapy, and the like.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Mark N. Milliken
Restorative
510(k) Number
(Optional Format 3-10-98)
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