(75 days)
Not Found
No
The summary describes a traditional optical tracking system for guiding procedures using existing MRI images and software for image reformatting. There is no mention of AI, ML, or any features that suggest learning from data or complex pattern recognition beyond standard image processing and guidance based on tracking data.
No
The device is described as an NMR device that produces images for diagnosis and a tracking unit that supports and guides diagnostic and therapeutic interventional procedures, but it does not directly perform therapy.
Yes
Justification: The "Intended Use / Indications for Use" section explicitly states that the images produced "yield information that can be useful in the determination of a diagnosis." Additionally, the MRGP Optical Tracking Unit is designed to "support and guide diagnostic and therapeutic interventional procedures."
No
The device description explicitly mentions "infrared digitizer hardware" and "specialized tools and tracking devices for procedures," indicating the presence of hardware components beyond just software.
No, 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.
- Device Function: The Outlook system and the MRGP Optical Tracking Unit are imaging and guidance devices used in vivo (within the living body). They produce images and provide guidance for procedures based on physical properties (NMR) and spatial tracking, not by analyzing biological samples.
- Intended Use: The intended use clearly describes the device as an NMR device that produces images of the head and whole body and a tracking unit for interventional procedures. This is consistent with medical imaging and surgical guidance, not in vitro testing.
Therefore, based on the provided information, this device falls under the category of medical imaging and guidance systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The MRGP Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.
Product codes
LNH
Device Description
The main features in the Optical Tracking Unit include: 1) infrared digitizer hardware; 2) specialized tools and tracking devices for procedures; 3) software that guides the imaging plane based on information from the digitizer; 4) software utilities that allow for slice reformatting of 3D image sets and 5) MRGP graphical overlays for planning and intraoperative use.
This guidance mechanism shortens the time needed to find the correct imaging plane, and is useful in cases that require a difficult trajectory (i.e. double oblique imaging planes).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head and whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Not Found
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
AUG 23 1999
99 1943
SUMMARY OF SAFETY AND EFFECTIVENESS
(As required by 21 CFR 807.92)
General Information 1.
| Classification: | Class II
Magnetic Resonance Imaging (MRI) System |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) Option |
| Proprietary Name: | MRGP Optical Tracking Unit |
| Establishment Registration: | Manufacturer:
Picker Nordstar, Inc.
Ayritie 4, Vantaa
FIN-01510 Vantaa Finland
FDA Facility Registration: #9680194
United States Representative:
Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
Contact: Elaine K. Keeler, Ph.D.
Phone: (440) 473-3000
FDA Owner Number: #1580240
FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have been
issued under section 514 of the Food, Drug and
Cosmetic Act. |
2. Intended Uses
The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The MRGP Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.
| PICKER INTERNATIONAL, INC. | (MRGP-OP) | 05/27/99 | I.- |
|---|---|---|---|
| ---------------------------- | ----------- | ---------- | ----- |
1
3. Device Description
,
The main features in the Optical Tracking Unit include: 1) infrared digitizer hardware; 2) specialized tools and tracking devices for procedures; 3) software that guides the imaging plane based on information from the digitizer; 4) software utilities that allow for slice reformatting of 3D image sets and 5) MRGP graphical overlays for planning and intraoperative use.
This guidance mechanism shortens the time needed to find the correct imaging plane, and is useful in cases that require a difficult trajectory (i.e. double oblique imaging planes).
Safety and Effectiveness 4.
The following substantial equivalence chart has been compiled to demonstrate the equivalence of the MRGP Optical Tracking Unit described in this submission with the Picker MRGP Basic Package (K983342) and the Picker ViewPoint Passive Tool Option (K990868).
| Parameter | MRGP Optical Tracking
Unit | Predicate Devices |
|-------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| System Compatibility | Same. | 0.23T Outlook,
0.23T Outlook Proview
(See K983342) |
| Software | Special MRGP Software for
the Outlook. | Standard Outlook Software.
(See K983342) |
| Imaging Plane Selection | Optically Guided. | Manual. (See K983342) |
| Sequence type | Same. | 2D/3D Gradient echo, FSE, Single-
shot FSE. (See K983342) |
| Sequence capabilities | Same. | Dynamic imaging with auto start and
keyhole imaging capabilities.
Typical reconstruction of 200 ms
per image. (See K983342) |
| Sequence resolution | Same. | FOV- 4 to 40 cm
Slice thickness-
2D: 1-100mm (0.1mm steps)
3D: 0.4-100mm (0.1mm steps)
Matrix- up to 512
(See K983342) |
Substantial Equivalence Chart
PICKER INTERNATIONAL, INC.
(MRGP-OP)
2
| Parameter | MRGP Optical Tracking
Unit | Predicate Devices |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of Digitizer | Same. | Infrared signals emitted from the
Position Sensor Assembly (PSA) are
reflected off reflective markers
mounted on the tool. The reflected
signal is detected by the PSA with
two optical detectors.
(See K990868) |
| Max. Digitizer Rate | Same. | 30 Hz for one or two tools; for three
tools, the rate is 30 Hz for one of
the tools and 15 Hz for the other
two. (See K990868) |
| Active Digitizer Volume | Same. | Silo shape, with 1 meter diameter
and 1 meter length. (See K990868) |
| Type of Sterilization | Same. | Tool bodies are steam sterilized and
the reflective spheres are sterilized
with ETO. (See K990868) |
| Material Composition of
tool bodies | Polyethermide and
Polyphenylsulfone | Aluminum, titanium or stainless steel
(See K990868) |
| Indications for Use | The MRGP Optical Tracking
Unit is designed to support and
guide diagnostic and
therapeutic interventional
procedures, such as needle
biopsies and drainages. | The MRGP Basic Package is
designed to support and guide
diagnostic interventional procedures,
such as needle biopsies and
drainages. (See K983342) |
PICKER INTERNATIONAL, INC.
:
(MRGP-OP)
05/27/99
.
I - 3
.
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present. The background is white.
Image /page/3/Picture/1 description: The image contains a logo of the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, topped by a circle. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 1999
Elaine Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143
K991943 Re:
MRGP Optical Tracking Unit (Interventional MRI Accessory) Dated: June 7, 1999 Received: June 9, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Dr. Keeler:
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 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 Requlations, 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
Page I of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
MRGP Optical Tracking Unit Device Name:
Indications for Use:
The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (TI), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The MRGP Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K991943 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |