KIMAX QMA

K022585 · Medical Metrics, Inc. · LLZ · Oct 11, 2002 · Radiology

Device Facts

• Record ID: K022585
• Device Name: KIMAX QMA
• Applicant: Medical Metrics, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

KIMAX QMA™ is a quantitative imaging software application. It is designed for physicians and clinical professions who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. KIMAX QMA™ permits users to review static and dynamic digital images acquired from a variety of radiographic to review static and dynamic argultative assessment of motion in radiographic . Information obout the matiative assessment of motion in radiographic ... Information obout th Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts and text.

Device Story

KIMAX QMA™ is a quantitative imaging software application for musculoskeletal motion analysis. It accepts static and dynamic digital radiographic images as input. The software processes these images to perform quantitative assessments of motion for selected objects, such as bone structures. It generates a 'motion analysis' report containing graphics, charts, and text. Used by physicians and clinical professionals in clinical settings to review images and analyze motion. The output assists healthcare providers in evaluating musculoskeletal motion, potentially aiding in clinical decision-making regarding patient condition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Quantitative imaging software application for motion analysis. Operates on digital radiographic images. Provides motion analysis reports with graphics, charts, and text. Software-based.

Indications for Use

Indicated for physicians and clinical professionals requiring quantitative analysis of motion in medical images, specifically musculoskeletal images, to assess motion of objects such as bone structures.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle symbol, with three curved lines representing the eagle's body and wings. The eagle faces to the right.

## Public Health Service

02

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark Lamp President Medical Metrics, Inc 10540 Rockley Road Suite 200 HOUSTON TX 77099

## Re: K022585

Trade/Device Name: KIMAX QMA™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: July 18, 2002 Received: August 5, 2002

Dear Mr. Lamp:

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); 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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Premarket Notification Indication for Use Statement

Medical Metrics, Inc.

510K Device Number:

Product:

Sponsor:

KIMAX OMATM

Indication for Use:

## Statement of Intended Use 1.0 .

KIMAX QMA™ is a quantitative imaging software application. It is designed for physicians and clinical professions who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. KIMAX QMA™ permits users to review static and dynamic digital images acquired from a variety of radiographic to review static and dynamic argultative assessment of motion in radiographic .
Information obout the matiative assessment of motion in radiographic ...
Information obout th Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts and text.

**Prescription Use**
(Per 21 CFR 801.109)

David C. Ingram

0/300/ Hugo/

(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number