KINEMATIC POSITIONERS

K972704 · Ge Medical Systems, Inc. · LNH · Sep 29, 1997 · Radiology

Device Facts

• Record ID: K972704
• Device Name: KINEMATIC POSITIONERS
• Applicant: Ge Medical Systems, Inc.
• Product Code: LNH · Radiology
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Indications for Use for the Signa Profile Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the ankle, wrist, cervical-spine and surrounding structures in a dynamic and kinematic motions.

Device Story

Signa Profile Kinematic Positioner Options are physical support accessories for MR scanning. Devices provide stabilization or support for ankle, wrist, and cervical spine during static or dynamic/kinematic imaging. Used in clinical MR environments by radiology staff. Positioners facilitate imaging of anatomical structures while in motion, allowing clinicians to assess joint or spine function under dynamic conditions. Benefits include improved visualization of musculoskeletal structures during movement, aiding diagnostic assessment.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with international safety standards IEC 601-1 and IEC 601-2-33. No clinical data provided.

Technological Characteristics

Mechanical support accessories for MR imaging. Designed for ankle, wrist, and cervical spine. Supports static and dynamic/kinematic positioning. Compliant with IEC 601-1 and IEC 601-2-33 safety standards.

Indications for Use

Indicated for patients requiring MR imaging of the ankle, wrist, cervical spine, and surrounding structures, including dynamic and kinematic motion studies.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Signa Profile System (K972704)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines and a vintage design, giving the logo a classic and recognizable appearance.

K972704
Sept 29, 1997

GE Medical Systems

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

## SUMMARY OF SAFETY AND EFFECTIVENESS

- This 510(k) summary of safety and effectiveness information is submitted in . accordance with the requirements of 21 CFR Part 807.87(h).
- Identification of Submitter ● Larry A. Kroger, Ph.D., 414-544-3894, July 17, 1997
- Identification of the Product . Signa Profile Kinematic Positioner Options

GE Yokogawa Medical Systems, Ltd. Manufacturer Address: 4-7-127, Asahigaoka, Hino-Shi Tokyo, 191 Japan

## Marketed Devices ●

The Signa Profile Systems on which the Kinematic Positioner Options are used are substantially equivalent to the currently marketed Signa Profile System (software and electronics).

## . Device Description

The Kinematic Positioners provide support for the ankle, wrist and cervical spine for MR scanning. They have two usage's; one is for a scan when the scanned area is fixed, and the other is while the scanned area is moving.

## Indications for Use ●

The Indications for Use for the Signa Profile Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioners accommodates and improves imaging of the cervical spine, wrist, ankle and surrounding structures in a dynamic and kinematic motion.

- Summary of Studies .
The Signa Profile Kinematic Positioner Options were evaluated to the International Safety Standards IEC 601-1 and IEC 601-2-33. The options performed to stated specifications and are in compliance with the IEC Standards.

- Conclusions .
It is the opinion of GE that the Signa Profile Systems on which the Kinematic Positioner Options are used are substantially equivalent to the presently marketed Signa Profile System. These options do not result in any new potential hazards.

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

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the symbol in a circular fashion.

Food and Orug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1997

Larry A. Kroger, Ph.D. Acting Manager, Safety & Regulatory Compliance GE Medical Systems, Inc. P.O. Box 414, W-709 Milwaukee, WI 53201

Re:

K972704 Kinematic Positioners ( Magnetic Resonance Diagnostic System Options) Dated: July 17, 1997 Received: July 18, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Dr. Kroger:

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, 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and hat, 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 action. In addition, FDA may publish further announcements 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 Radiation Control provisions, or other Federal laws or regulations.

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 marked 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 yitro diagnostic devices), please contact the Office of Compliance at [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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):_

Device Name: Signa Profile Kinematic Positioner Options

Indications For Use:

The Indications for Use for the Signa Profile Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the ankle, wrist, cervical-spine and surrounding structures in a dynamic and kinematic motions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vlind A. Seymon
**(Division Sign-Off)**

Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________