(73 days)
Not Found
Not Found
No
The summary describes a mechanical positioner for MR scanning and does not mention any software or algorithms that would suggest AI/ML.
No.
The device is described as a Kinematic Positioner that provides support for imaging (MR scanning) of anatomical sites like the ankle, wrist, and cervical spine. Its purpose is to facilitate imaging, not diagnose, treat, or prevent disease.
No
The device is described as a Kinematic Positioner that provides support for MR scanning and allows for imaging of anatomical structures in dynamic and kinematic motions. It expands the capability of an existing MR system and is not described as analyzing or interpreting images to provide a diagnosis or aid in diagnosis.
No
The device description explicitly states it provides "support for the ankle, wrist and cervical spine for MR scanning," indicating a physical, hardware component. The performance studies also refer to "International Safety Standards IEC 601-1 and IEC 601-2-33," which are standards for medical electrical equipment, further suggesting a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that the Kinematic Positioner is a physical device used to support and position parts of the body (ankle, wrist, cervical spine) during MR scanning. It facilitates imaging of these structures, both when fixed and in motion.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is purely related to patient positioning for imaging.
- Input Modality: The input modality is MR scanning, which is an imaging technique, not a method for analyzing biological samples.
Therefore, the Signa Profile Kinematic Positioner Options are a medical device used in conjunction with an MR scanner, but they do not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
LNH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, wrist, cervical spine
Indicated Patient Age Range
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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__________________________________________________________________________________________________________________________________________________________