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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stepping Kinematic Imaging Platform (SKIP™) device:

Important Note: The provided 510(k) summary explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This means the device did not undergo dedicated clinical trials to prove its performance against acceptance criteria in the way a diagnostic AI device would. Instead, its substantial equivalence was based on non-clinical tests and comparison to predicate devices. Therefore, many of the requested fields below will reflect this lack of direct clinical performance data.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments
Intended Use Equivalence	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.	The device's intended use is identical to its predicate device (MobiTrak™ Package). This is a primary criterion for 510(k) substantial equivalence.
Technological Characteristics Equivalence	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.	The device is described as having "similar technological characteristics" to the predicate, with the key difference being manual versus electronic movement. The non-ferromagnetic nature and lack of electronic hardware or software are presented as equivalent features from a safety perspective.
Safety and Effectiveness	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.	This is a general statement that the non-clinical tests and comparisons to predicates address safety and effectiveness. No specific performance metrics (e.g., accuracy, precision of movement) are provided.
Non-Clinical Test Compliance	Applicable questions outlined from the DRAED "Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Device" were covered.	Implies the device met all relevant non-clinical testing requirements for MRI devices, likely focused on MRI compatibility (e.g., ferromagnetism, RF interference). No specific pass/fail criteria or results are detailed.

Study Details for Performance Evaluation

Given that the document states "Discussion of Clinical Tests Performed: Not Applicable," the following section will address how the device's "performance" was established for 510(k) clearance, which primarily revolves around substantial equivalence rather than a direct clinical performance study.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No clinical test set was used for performance validation in the traditional sense.
- Data Provenance: Not applicable. The evaluation relied on non-clinical testing and comparison to existing predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no clinical test set was used, no ground truth needed to be established by experts for performance evaluation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or adjudication process was described or conducted.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a mechanical patient positioning platform, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is entirely irrelevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The SKIP™ device is a manual mechanical accessory. It does not have an "algorithm" or standalone "performance" in the way an AI diagnostic involves. Its function is to facilitate patient movement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this type of device (a manual patient positioning accessory), the "ground truth" for its function is its ability to physically move a patient accurately within the MRI bore without interfering with the imaging or posing a safety risk. This was assessed through non-clinical means (e.g., mechanical design review, material testing, compatibility testing with MRI systems) rather than clinical ground truth derived from expert consensus, pathology, or outcomes.
The sample size for the training set:
- Not applicable. This device is a mechanical accessory, not a machine learning model. Therefore, there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth establishment for one.

Summary of Approach for SKIP™ Clearance:

The clearance for the Stepping Kinematic Imaging Platform (SKIP™) under 510(k) relied entirely on demonstrating substantial equivalence to predicate devices through:

Identical Intended Use: The device performs the same function as its predicate.
Similar Technological Characteristics: While the manual movement differs from the electronic movement of a predicate, the core safety and functional principles (non-ferromagnetic, accessory for patient repositioning) are considered similar.
Non-Clinical Testing: Compliance with guidance documents for MR diagnostic devices, focusing on properties like lack of ferromagnetism and not interfering with MRI operation. Biocompatibility of materials was also likely considered.
Lack of New Safety/Effectiveness Questions: The core argument for substantial equivalence is that any differences do not introduce new questions regarding safety or effectiveness that are not already addressed by the predicate devices or standard non-clinical testing for MRI compatibility.

This approach is typical for mechanical accessories where their primary function is to enable or facilitate an existing medical procedure without directly producing diagnostic data or having a complex computational component.

Summary

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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:

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5. Intended Use:

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.

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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.

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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

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Exhibit B

Page 1 of 1

510(k) Number (if known): __ K 992 892

Device Name: Stepping Kinematic Imaging Platform (SKIP™)

Indications For Use:

(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)

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

Regulation Number and Section

§ 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.