CODA CX1 MOTION ANALYSIS SYSTEM

K033514 · Charnwood Dynamics , Ltd. · LXJ · Jan 6, 2004 · Physical Medicine

Device Facts

• Record ID: K033514
• Device Name: CODA CX1 MOTION ANALYSIS SYSTEM
• Applicant: Charnwood Dynamics , Ltd.
• Product Code: LXJ · Physical Medicine
• Decision Date: Jan 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2

Intended Use

The Coda cx1 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.

Device Story

Coda cx1 is an optical/electronic motion analysis system; measures/records 3D position and movement of markers placed on patient limbs. System uses infra-red light to track markers; acquires movement data into a host PC. PC software analyzes data; produces graphical and mechanical reports on gait and other movements. Used in clinical settings for patients with neurological or orthopaedic movement impairments. Healthcare providers use output to assess movement function and inform clinical decision-making. Benefits include objective, non-intrusive measurement of movement patterns.

Clinical Evidence

Bench testing only. Effectiveness in measuring 3D motion and producing graphical/mechanical gait data compared against predicate device. Results demonstrated improved resolution and sampling duration; all other performance aspects were similar to the predicate.

Technological Characteristics

Optical/electronic system; infra-red light sensing. Dimensions: 800mm x 112mm x 81mm. Weight: 2kg. Connectivity: Host PC. Electrical safety: EN 61010. EMC: EN 60601-1-2:2002. No electrical patient connection; no thermal or ionizing radiation hazards.

Indications for Use

Indicated for assessment of 3D motion of limbs and body in patients with neurological or orthopaedic movement function impairment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CODA mpx30 (K982425)

Submission Summary (Full Text)

{0}------------------------------------------------

JAN - 6 2004

# F

## PREMARKET NOTIFICATION 510(K) SUMMARY

| 1. | Submitters Name: | David L Mitchelson |
|----|----------------------------------------|------------------------------------------------|
| 2. | Address: | Charnwood Dynamics Limited |
| | | Victoria Mills |
| | | Fowke Street |
| | | Rothley |
| | | Leicestershire |
| | | LE7 7PJ |
| | | United Kingdom |
| 3. | Telephone No: | [phone] |
| | Facsimile: | [phone] |
| 4. | Date Prepared: | 31 ^st October 2003 |
| 5. | Trade Name: | Coda cx1 Motion Analysis System |
| 6. | Common Name: | Codamotion System |
| 7. | Classification Name: | System / Optical Position / Movement Recording |
| 8. | Identification of Predicate Device(s): | |

CODA mpx30 (K982425)

### ਹੈ. Device Description:

Coda cx1 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: 800mm long x 112mm high x 81mm deep

Weight: ર kg

{1}------------------------------------------------

#### 10. Intended use:

The Coda cx1 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.

#### 11. Technological characteristics in comparison with predicate device.

The Coda cx1 system is substantially equivalent to the CODA mpx30 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.

#### l 2. Safety and Effectiveness Summary:

The Coda cx1 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 cx1 system has been tested to EN60601-1-2:2002, the Medical electrical equipment - electromagnetic compatibility standard.

The Coda cx1 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 at which the data were acquired by the Coda cx1 system and the sampling duration were significantly improved. 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 cx1 system performs the same measurement functions using substantially similar technology as the predicate device and meets all relevant safety standards. Consequently it is substantially equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like strokes above two wave-like strokes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 6 2004

Mr. David L. Mitchelson Managing Director Charnwood Dynamics Ltd Unit 2, Victoria Mills Fowke Street Rothley, Leicestershire United Kingdom LE7 7PJ

Re: K033514

Trade/Device Name: Coda cx1 Motion Analysis System Regulatory Class: Unclassified Product Code: LXJ Dated: October 31, 2003 Received: November 6, 2003

Dear Mr. Mitchelson:

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). and Oosmetter fore, 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 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 (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.

{3}------------------------------------------------

Page 2 - Mr. David L. Mitchelson

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter natification. The FDA finding of substantial equivalcnce of your device to a legally premated 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, Connect the Office of Companise notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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.

R. Mark A. Milkenson

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### Indications for Use

510(k) Number (if known): K033514

Device Name: Coda cx1 Motion Analysis System

Indications For Use:

The Coda cx1 Motion Analysis 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.

Prescription Use (Part 21 CFR 80) 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)

Page 1 of 1

Mark A. Millerson

al. Restorative and Neurolo

510(k) Number: K033574