(28 days)
The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems. The system is MRI-compatible. It displays the simulated image of a rigid insertion instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the MR image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.
The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance is currently used for visualizing such structures.
The MR-Guide 2000 provides visual guiding information of the interventional instrument by overlaying graphics depicting its relative position and its predicted future path on the MR image of the internal organs all displayed on the monitor of a personal computer.
This document describes the UltraGuide MR-Guide 2000, a guiding system for interventional instruments used with Magnetic Resonance (MR) imaging.
Here's an analysis of the provided text in relation to acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific numerical acceptance criteria for performance (e.g., accuracy thresholds, precision values, sensitivity, specificity). Instead, it relies on a claim of "equivalence to predicate devices in safety and efficacy."
However, it does mention "Accuracy tests were done in phantoms." While no specific accuracy values are reported in this summary, the success of the 510(k) suggests that the accuracy achieved in phantom testing was deemed acceptable by the FDA for demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Accuracy (in phantoms) | Achieved acceptable accuracy |
| Safety and Efficacy substantially equivalent to predicate devices | Deemed substantially equivalent by FDA |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "Accuracy tests were done in phantoms." It does not specify the number of phantoms or the number of measurements taken within those tests.
- Data Provenance: The "Accuracy tests were done in phantoms" implies a synthetic/benchtop, experimental setting. The country of origin of this data is not specified, but the applicant is UltraGuide Ltd. located in Israel. The nature of the test is non-clinical/bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For phantom accuracy tests, the "ground truth" is typically established by the known physical properties and measurements of the phantom itself, often using highly precise measurement tools, not human experts.
4. Adjudication method for the test set
Not applicable. As noted above, the ground truth for phantom tests is not typically established by human experts requiring adjudication.
5. 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 MRMC comparative effectiveness study was performed or reported. The device is a guiding system, not an AI-assisted diagnostic tool that would typically involve human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance evaluation was done through the "Accuracy tests done in phantoms." This type of testing evaluates the device's inherent capability to track and display information accurately without direct human interaction influencing the measurement itself (though human operators would set up and execute the tests).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the accuracy tests mentioned, the ground truth would be the known physical dimensions and positions within the phantoms, established through precise measurements independent of the device being tested.
8. The sample size for the training set
Not applicable. This device is a "frameless stereotactic guiding accessory" that uses a magnetic tracking system for real-time guidance. It is not an AI/machine learning algorithm that typically undergoes distinct "training" with a dataset in the way a diagnostic image analysis algorithm would. Its function is based on physical principles of magnetic tracking and geometric calculations, not learned patterns from a training dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set or AI/machine learning model in the traditional sense outlined in the filing.
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OCT 1 8 2001
UltraGuide Ltd.
KO13150
510(k) Summary
MR-Guide 2000
I. Submitter Information
A. Name: UltraGuide Ltd.
Tirat Hacarmel Industrial Park B. Address: POB 2070 Tirat Hacarmel 30200 Israel
C. Contact Person: Dr. George Myers, 201-727-1703, Fax 201-727-1708
January 2, 2001 D. Date of preparation:
II. Device Data
A. Trade Name: UltraGuide MR - Guide 2000
B. Common Name: Guiding System for Interventional Instruments for clinical interventions performed under imaging by magnetic resonance
C. Classification Name: Accessory for System, Nuclear Magnetic Resonance Imaging, 90 LNH, Regulation Number 892.1000
III. Legally marketed predicate devices.
A. MR-Guide 3000, K011418
B. CT-Guide 1010, K002258
IV. Description
The MR-Guide 2000 provides visual guiding information of the interventional instrument by overlaying graphics depicting its relative position and its predicted future path on the MR image of the internal organs all displayed on the monitor of a personal computer.
V. Intended Use
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The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems. The system is MRI-compatible. It displays the simulated image of a rigid insertion instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the MR image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.
The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance is currently used for visualizing such structures.
VI. Technological characteristics
The device uses a magnetic tracking system comprising transmitters and sensors, sold under the trade name "MiniBird," to determine the location and orientation of the interventional instrument. This magnetic tracking system has been used on medical devices cleared by the FDA. The position and orientations of the interventional device tool, and the MRI images acquired by the MRI scanner, are transmitted to a data processor (computer), which makes the necessary calculations to provide the guidance graphic overlay depicting the interventional instrument on the MRI image.
VII. Testing
A. Non-clinical tests
The MR-Guide 2000 has undergone extensive bench tests for electrical safety and electromagnetic compatibility to validate all design changes. The major components (the computer and optical tracker) are all commercial devices with published environmental and physical specifications.
Accuracy tests were done in phantoms.
B. Clinical Test
Since this system uses the same technology as the predicate device, a clinical test is not necessary.
VIII. Conclusion
The tests show that the UltraGuide MR-Guide 2000 is equivalent to the predicate devices in safety and efficacy.
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Image /page/2/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission. The words "DEPARTMENT OF HEALTH &" are visible along the left side of the logo, curving to follow the circular shape. The words "HUMAN SERVICES" are visible along the right side of the logo, curving to follow the circular shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2001
UltraGuide, Ltd. % George H. Myers, Sc.D. Medsys Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07601 Re: K013150
Trade/Device Name: UltraGuide MR-Guide 2000, Guilding System for Interventional Instruments Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: July 27, 2001 Received: September 20, 2001
Dear Dr. Myers:
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 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 (800) 638-2041 or (301) 443-6597 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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Page / of of __ / ____________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
MR-Guide 2000 Device Name:
Indications for Use:
Indications for USC.
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The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance imaging is currently used for visualizing such structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
Nancy Bearden
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013150
510(k) Number
§ 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.