KNEEKG

K091000 · Emovi · LXJ · Oct 26, 2009 · Physical Medicine

Device Facts

• Record ID: K091000
• Device Name: KNEEKG
• Applicant: Emovi
• Product Code: LXJ · Physical Medicine
• Decision Date: Oct 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2

Intended Use

Measure and analyze 3D position and movement by placing markers on the knees of patients whose movement function is to be assessed.

Device Story

KneeKG measures/analyzes 3D position and movement of electromagnetic markers placed on patient knees; data acquired into host PC; PC analyzes/displays movement data via graphs and printed reports. Used in clinical settings to assess knee motion in patients with orthopaedic movement impairments. Healthcare providers use output to evaluate movement function and inform clinical decision-making regarding orthopaedic conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench-level comparison of motion tracking capabilities.

Technological Characteristics

Electromagnetic position sensing system; host PC for data processing and display; markers placed on limbs. System measures 3D position and movement. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients 18 years or older with impaired knee movement function of an orthopaedic cause. Not intended for children.

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

• Code CX1 Motion Analysis System (K033514)
• InstaTrak with Multiple dataset Navigation (K040050)

Submission Summary (Full Text)

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K091000

# 510(k) Summary

## OCT 2 3 2009

- Michelle Laflamme, president, represented by Emmanuel Montini 1. Submitters Name: f from BCF Certificaiton inc.
- 2. Addess : Émovi inc. 3095 Autoroute Laval Ouest 2e étage Laval, H7P 4W5 CANADA
- 3. Telephone : [phone] Fax : [phone]
- 4. Date Summary Prepared : March 27, 2009
- ર. Device Name : KneeKG
- 6. Predicates Devices : Code CX1 Motion Analysis System (K033514) InstaTrak with Multiple dataset Navigation (K040050)

#### 7. Device Description :

The KneeKG measures and analyzes the 3D position and movement of electromagnetic markers placed on the knee of patients whose movement function is to be assessed. The movement data are acquired into a host PC which then analyses and displays the data on graphs and printed reports.

#### Intented Used : 8.

General application for the measurement and recording of 3D position and movement.

#### 9. Indication for Use:

Measure and analyze 3Dposition and movement by placing markers on the limbs of patients whose movement function is to be assessed.

#### 10. Target Population:

Appropriate for assessing the 3D motion of the knee of patients who have impaired movement functions off an orthopaedic cause. Not intended for children (i.e. patients must be 18 old or older.

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

The KneeKG is substantially equivalent to the Coda CX1 Motion analysis system (K033514) manufactured by Charnwook Dynamics Ltd as a means of measuring the three-dimensional movements of subjects, including such activities as walking. Both systems acquire the movement data into a host PC, which then analyzes and displays motion data onscreen or in printed reports. The predicate Coda CX1 Motion analysis system (K033514) is using an optical method and

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the KneeKG is using an electromagnetic position system. For this characteristic, the KneeKG is compared with the second predicate, the InstaTrak with Multiple dataset Navigation (K040050) manufactured by GE Medical Systems Navigation and Visualization, which is using the same technology.

12. Conclusion Drawn:

:

,

Substantially equivalent to the cited predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

OCT 2 3 2009

Émovi Inc. % BCF Certification Inc. Mr. Emmanuel Montini 1100, BOUL. Rene-Levesque Ouest 25 Fifth Floor Montreal, Quebec Canada H3B 5C9

Re: K091000

Trade/Device Name: KneeKG Regulatory Class: Unclassified Product Code: LXJ Dated: October 20, 2009 Received: October 22, 2009

Dear Mr. Montini:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Emmanuel Montini

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

. . . .

510(k) Number (if known):

Device Name: KneeKG

Indications For Use:

Measure and analyze 3D position and movement by placing markers on the knees of patients whose movement function is to be assessed.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M. MELKERSON

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091000