(86 days)
K 890076
K 890076
No
The summary describes an optical/electronic system for measuring 3D position and movement using markers, with no mention of AI or ML technologies. The improvements noted relate to resolution, sampling rate, and automatic marker recognition, which are not inherently AI/ML features.
No
The device is used for measurement and assessment of movement, not for treatment or therapy.
Yes
Explanation: The device is used for "assessment of the 3D motion of the limbs and body of patients who have some impairment of movement functions," which indicates a diagnostic purpose.
No
The device description explicitly states it is an "optical/electronic system" with physical dimensions and weight, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the measurement and recording of 3D position and movement of the human body and limbs. This is a physical measurement, not a test performed on biological samples (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Device Description: The device description confirms it's an optical/electronic system that measures the position and movement of markers placed on the body. This aligns with a physical measurement device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on biological markers.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device operates in vivo (on the body) to measure physical movement.
N/A
Intended Use / Indications for Use
The Coda mpx30 system has general application to measurement and recording of 3D position and movement, including human movement. It is appropriate for use in assessment of the 3D motion of the limbs and body of patients who have some impairment of movement functions of either a neurological or orthopaedic cause.
Product codes
LXJ
Device Description
CODA mpx30 is an optical/electronic system which measures and analyses the 3D position and movement of markers placed on the limbs of patients whose movement function is to be assessed.
Dimensions: 30mm wide x 114mm high x 250mm deep Weight : 11 kg
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs and body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The CODA mpx30 system has been tested for its effectiveness in measuring 3-D motion and producing graphical and mechanical data on gait and other movements as compared with the predicate device. The resolution and sampling rate at which the data were acquired by the CODA mpx30 system were significantly improved. Also the speed with which the analysed data became available was improved due to the automatic recognition of marker identity. All other aspects of the system performance were similar to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K 890076
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K/82425
PREMARKET NOTIFICATION 510(K) SUMMARY
F
| 1. | Submitters Name: | David L Mitchelson |
|---|---|---|
| 2. | Address: | Charnwood Dynamics Limited |
| 17 South Street, Barrow Upon Soar, | ||
| Leicestershire, LE12 8LY, | ||
| United Kingdom | ||
| 3. | Telephone No: | |
| Facsimile: | +44 (0) 1509 620 388 | |
| +44 (0) 1509 416 791 | ||
| 4. | Date Prepared: | 24th June 1998 |
| 5. | Trade Name: | CODA mpx30 Motion Analysis System |
| 6. | Common Name: | Motion Analysis System |
| 7. | Classification Name: | System / Optical Position / Movement Recording |
| 8. | Identification of Predicate Device(s): | |
| OrthoTrak II (K 890076) |
ರು. Device Description:
CODA mpx30 is an optical/electronic system which measures and analyses the 3D position and movement of markers placed on the limbs of patients whose movement function is to be assessed.
Dimensions: 30mm wide x 114mm high x 250mm deep Weight : 11 kg
- Intended use: 10.
1
The Coda mpx30 system has general application to measurement and recording of 3D position and movement, including human movement. It is appropriate for use in assessment of the 3D motion of the limbs and body of patients who have some impairment of movement functions of either a neurological or orthopaedic cause.
Technological characteristics in comparison with predicate device: l 1 .
The Coda mpx30 system is substantially equivalent to the Ortho Trak system as a means of measuring the general three dimensional movement of patients, including such activities as walking. Both systems provide a non-intrusive optical method of measuring the movements using infra-red light. Both systems acquire the movement data into a host PC which then analyses and displays the data on graphs and printed reports.
The Coda system provides the advantages of LED markers which are automatically identified, whereas the Ortho Trak system uses reflective markers which have no intrinsic identity.
12. Safety and Effectiveness Summary:
The Coda system is designed and manufactured to meet the electrical safety requirements of EN 61010. There is no electrical connection to the patient of any kind. The system does not produce sources of localised heat so no thermal safety hazard arises. The system does not generate any ionising radiation.
The CODA mpx30 system has been tested for its effectiveness in measuring 3-D motion and producing graphical and mechanical data on gait and other movements as compared with the predicate device. The resolution and sampling rate at which the data were acquired by the CODA mpx30 system were significantly improved. Also the speed with which the analysed data became available was improved due to the automatic recognition of marker identity. All other aspects of the system performance were similar to the predicate device.
13. 510 (K) Number: Not assigned at the time of submission.
14. Conclusion:
The CODA mpx30 system performs the same measurement functions using substantially similar technology as the predicate device.
The LED markers used provide for greater effectiveness in performance and the CODA mpx30 system meets all relevant safety standards. Consequently it is substantially equivalent to the predicate device.
2
Image /page/2/Picture/2 description: The image shows a circular logo with text around the perimeter and a stylized eagle-like symbol in the center. The text around the perimeter appears to be part of a government agency or organization's name, possibly related to health and human services. The eagle-like symbol is abstract, with three curved lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 1998
Mr. Lee A. Barnes President Pinsco, Inc. dba B & L Engineering 3002 Dow Avenue, Suite 416 Tustin, California 92780
K982425 Re: CODA mpx30 Motion Analysis System Trade Name: Requlatory Class: Unclassified Product Code: LXJ Dated: June 24, 1998 Received: July 13, 1998
Dear Mr. Barnes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਚ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
3
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
ria M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Fvaluation Center for Devices and Radiological Health
Enclosure
4
D
STATEMENT OF INDICATIONS FOR USE
The Coda mpx30 system has general application to measurement and recording of 3D position and movement, including human movement. It is appropriate for use in assessment of the 3D motion of the limbs and body of patients who have some impairment of movement functions of either a neurological or orthopaedic cause.
Over-the-Counter Use X
Signature
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982425