(28 days)
No
The summary describes a system that overlays graphics and predicts a path based on MR images and respiratory compensation, but there is no mention of AI, ML, or any learning-based algorithms. The performance studies rely on bench tests and equivalence to a predicate device, not on training or testing data sets typically associated with AI/ML.
No.
The device is a guiding accessory for imaging systems, assisting with the placement of instruments, but it does not directly treat or diagnose a disease itself.
No
The device is described as a "frameless stereotactic guiding accessory" for MR systems, intended for guiding interventional instruments like biopsy needles. It displays the simulated path of an instrument on an MR image, emphasizing its role in guiding surgical or interventional procedures, not in identifying or diagnosing medical conditions.
No
The device description explicitly states it is a "frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems" and mentions "visual guiding information of the interventional instrument by overlaying graphics depicting its relative position and its predicted future path on the MR image". This implies a hardware component that interacts with the MR system and the interventional instrument to provide this positional information, even if the display is on a computer monitor. The non-clinical tests also mention "bench tests for electrical safety and electromagnetic compatibility" and "Accuracy tests were done in phantoms," which are typical for hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The MR-Guide 2000 system is a guiding accessory used during clinical interventions directly on the patient. It uses MR imaging of the patient's internal organs to guide the insertion of instruments like needles.
- The device's function is to provide visual guidance for a procedure, not to analyze biological samples.
Therefore, the MR-Guide 2000 falls under the category of a surgical or interventional guidance system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Indications for USC.
The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic The MR-Guide 2000 systems a maneness iconceing the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a Itigid interventional instrument, sach as a crops of the target organs. MR-Guide Computer monitor berebes monitoring the respiratory phase of the patient.
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.
Product codes
90 LNH
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Anatomical structures where magnetic resonance is currently used for visualizing such structures.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
2 Page B
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
1
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.
2
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.
3
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
4
Page / of of __ / ____________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
MR-Guide 2000 Device Name:
Indications for Use:
Indications for USC.
The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic The MR-Guide 2000 systems a maneness iconceing the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a Itigid interventional instrument, sach as a crops of the target organs. MR-Guide Computer monitor berebes monitoring the respiratory phase of the patient.
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