(201 days)
Not Found
No
The summary describes data acquisition and analysis but does not mention AI or ML, and the "Mentions AI, DNN, or ML" field is "Not Found".
No
The device measures and analyzes movement function for assessment purposes, it does not provide treatment or therapy.
Yes
The device "Measures and analyzes 3D position and movement" of the knee, which is a form of assessment. Although "diagnostic" is not explicitly stated, the function of measuring and analyzing movement in patients to assess their movement function typically falls under diagnostic purposes to identify or evaluate a condition. The output includes "graphs and printed reports," further supporting its use in assessment.
No
The device description explicitly states it measures and analyzes 3D position and movement using "electromagnetic markers placed on the knee" and an "electromagnetic position system" as the input modality. This indicates the device includes hardware components (markers and the position system) in addition to the software for data acquisition, analysis, and display.
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 description clearly states that the device measures and analyzes the 3D position and movement of electromagnetic markers placed on the knees of patients. This is a measurement of physical movement and position, not an analysis of biological samples.
- Intended Use: The intended use is to "measure and analyze 3D position and movement... to be assessed." This aligns with a biomechanical or motion analysis device, not an IVD.
- Input Modality: The input modality is an "Electromagnetic position system," which is used for tracking physical location, not for analyzing biological properties of a sample.
Therefore, the KneeKG device, as described, falls under the category of a medical device used for motion analysis, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LXJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electromagnetic
Anatomical Site
Knees
Indicated Patient Age Range
patients must be 18 old or older
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
510(k) Summary
OCT 2 3 2009
- Michelle Laflamme, president, represented by Emmanuel Montini 1. Submitters Name: f from BCF Certificaiton inc.
-
- Addess : Émovi inc. 3095 Autoroute Laval Ouest 2e étage Laval, H7P 4W5 CANADA
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- Telephone : 514-397-8500 Fax : 514-397-8515
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- Date Summary Prepared : March 27, 2009
- ર. Device Name : KneeKG
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
1
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.
- Conclusion Drawn:
:
,
Substantially equivalent to the cited predicate devices.
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" around the perimeter. Inside the circle is an abstract image of an eagle.
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
3
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 (800) 638-2041 or (301) 796-7100 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