(20 days)
K# 980645, K# 940541, K# 942604, K# 931544
K# 960973
No
The device description focuses on mechanical components for patient repositioning and does not mention any software or algorithms that would suggest AI/ML is used. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as a patient positioning system within an MRI machine for imaging purposes, not for treating any medical condition. Its function is to facilitate diagnostic imaging.
No
The device description indicates it is a patient positioning table used to translate patients within an MRI machine, not to acquire or process medical images for diagnostic purposes.
No
The device description clearly outlines physical components like platforms, wheels, rollers, straps, and a plastic mount, indicating it is 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device, the "SKIP™" table, is a mechanical device used to physically reposition a patient within an MRI machine. Its purpose is to facilitate imaging of different anatomical regions by moving the patient relative to the magnetic field.
- Lack of Biological Sample Analysis: The device does not interact with or analyze any biological samples from the patient. It is purely a patient positioning and handling tool used during an imaging procedure.
Therefore, the function and intended use of the "SKIP™" table clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to translate (reposition) the patient manually within a magnetic resonance imaging machine, through the magnet bore, in order to center different regions-of-interest at the center of the magnetic field for either multistation MRA with single dose injection or multistation MRI, using existing system hardware, software and imaging coils.
Product codes
90 LNH
Device Description
The "SKIP™" table consists of three major components: two platforms consisting of a multitude of nonferromagnetic wheels, or rollers, which contain glass bearings and one overlying movable table. The matrix of all major components consist of plastic material. The axels of the wheels or rollers are also made of plastic material. Small minor components of the device include several straps attached to plastic connectors which are used to immobilize the patient on the moving table and, finally, a plastic mount for suspending the existing MRI imaging surface coil over the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Not Found
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
Not Applicable (Non-Clinical Tests were performed according to "Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Device". Clinical Tests were not applicable.)
Key Metrics
Not Found
Predicate Device(s)
K# 980645, K# 940541, K# 942604, K# 931544
Reference Device(s)
K# 960973
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
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K 992892
1. Submitter's Identification:
Magnetic Moments, LLC P.O. Box 721425 Berkley, MI 48072-0425
Date Summary Prepared: August 1999
Contact: Anil N. Shetty, Ph.D
2. Name of the Device:
Stepping Kinematic Imaging Platform (SKIP™)
3. Predicate Device Information:
- Philips Gyroscan NT Platform with MobiTrak™ Package, K# 980645, a. Philips Medical Systems, NA, Shelton, CT
- Siemens Magnetom Vision, K# 940541, Siemens, CA b.
- General Electric Signa Horizon LX, K# 942604, General Electric Medical C. Systems
- Picker Eclipse VISTA, K# 931544, Picker International, Inc. ರ.
4. Device Description:
The "SKIP™" table consists of three major components: two platforms consisting of a multitude of nonferromagnetic wheels, or rollers, which contain glass bearings and one overlying movable table. The matrix of all major components consist of plastic material. The axels of the wheels or rollers are also made of plastic material. Small minor components of the device include several straps attached to plastic connectors which are used to immobilize the patient on the moving table and, finally, a plastic mount for suspending the existing MRI imaging surface coil over the patient.
1
5. Intended Use:
The device is intended to translate (reposition) the patient manually within a magnetic resonance imaging machine, through the magnet bore, in order to center different regions-of-interest at the center of the magnetic field for either multistation MRA with single dose injection or multistation MRI, using existing system hardware, software and imaging coils.
6. Comparison to Predicate Devices:
The "SKIP™" device is substantially equivalent to previously cleared 510(k)'s with MRI tables, and, particularly, the Philips Gyroscan NT Platform with MobiTrak™ Package, K# 960973.
The MobiTrak™ Package accessory to the Gyroscan NT MR Scanner (Philips) is capable of rapid translation of patient to center different anatomical imaging site in to the center of the magnet. The repositioning of patient is performed without actually removing the patient as done in conventional scanners and is performed between measurements when no data is acquired. The MobiTrak™ Package allows rapid evaluation of the aorta and the lower extremity vasculature with a single dose of contrast. It incorporates standard existing contrast-enhanced MRA imaging software with the addition of table movement between two successive measurements to overcome the limitation of a single field-of-view in relation to the large field-of-view of interest. Currently, the package allows for moving existing patient table electronically.
Regarding our device, Stepping Kinematic Imaging Platform (SKIP™) has the same intended use as MobiTrak™. SKIP™ also allows for rapid repositioning of patient inside the magnet. The accessory device fits on any 1.5T MR scanner (GE, Picker, Siemens) and allows for rapid evaluation of the aorta and lower extremity vasculature with native contrast-enhanced MRA software. The present version incorporates the motion of a retrofitted table or platform, which is placed on the existing system-inherent MRI table. The SKIP™ is an accessory device that is non-ferromagnetic, requiring no additional electronic hardware or software for operation. The entire platform is moved back and forth manually instead of electronically.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Applicable questions outlined from the DRAED "Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Device" were covered.
2
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
The Stepping Kinematic Imaging Platform ("SKIP™") has the same intended use and similar technological characteristics as the predicate device's table claims. Moreover, biocompatibility testing, clinical literature and specification parameters demonstrate that any difference in their technological characteristics do not raise any new questions as to safety and effectiveness. Thus, the Stepping Kinematic Imaging Platform ("SKIP™") is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains 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 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1999
Ms. Susan D. Goldstein-Falk Magnetic Moments, LLC C/O mdi Consultants, Inc. 55 Northern Boulevard Suite 200 Great Neck, NY 11021
Re:
K992892 Stepping Kinematic Imaging Platform (SKIP™) Dated: August 25, 1999 Received: August 27, 1999 Regulatory Class: II (TWO) Product Code: 90 LNH 21 CFR 892.1000
Dear Ms. Goldstein-Falk:
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 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). 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 dass 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 the Electronic Product 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 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 and additionally 809.10 for in vitro 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit B
Page 1 of 1
510(k) Number (if known): __ K 992 892
Device Name: Stepping Kinematic Imaging Platform (SKIP™)
Indications For Use:
The device is intended to translate (reposition) the patient manually within a magnetic resonance imaging machine, through the magnet bore, in order to center different regions-of-interest at the center of the magnetic field for either multistation MRA with single dose injection or multistation MRI, using existing system hardware, software and imaging coils.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
David A. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number