(75 days)
Not Found
No
The document describes standard MR spectroscopy techniques (SVP and CSI) and their use in analyzing metabolite concentrations. There is no mention of AI, ML, or any related terms in the intended use, device description, or specific sections for AI/ML information. The interpretation is explicitly stated to be performed by a trained medical practitioner.
No.
The device is described as a non-invasive diagnostic device that provides information useful in making a diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Picker MR Spectroscopy Package is intended for use as a non-invasive diagnostic device".
No
The device is described as a "software option" for an existing MR system and processes data from an MRI scanner, which is a hardware device. While the submission focuses on the software package, it is dependent on and integrated with a hardware system for data acquisition.
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.
- Device Description: The Picker MR Spectroscopy Package is described as a "non-invasive diagnostic device" that uses Magnetic Resonance (MR) data from "body tissues." It analyzes the NMR properties of protons within the body directly, without requiring a sample to be taken from the body.
- Intended Use: The intended use describes obtaining information based on relative concentrations of metabolites in body tissues, not from a sample taken from the body.
Therefore, because the device operates non-invasively on the body itself rather than on a sample taken from the body, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Picker MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.
This package is indicated for use as follows:
Anatomical region: Head, whole body
Nuclei Excited: 1H
Product codes
90 LNI
Device Description
Picker's MR Spectroscopy Package described in this submission is a proton ('H) spectroscopy software option. The package includes both capabilities for single voxel proton (SVP) spectroscopy and chemical shift imaging (CSI). These techniques provide a non-invasive method for analyzing metabolite concentrations in the brain and throughout the body. The MR Spectroscopy Package does not include any additional risks to the patient other than those for standard MR imaging.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioner
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 Found
Key Metrics
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
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letters 'K99' followed by the numbers '1568'. The characters are written in a casual, slightly slanted style, giving it a personal touch. The image is simple, focusing solely on the handwritten text.
SUMMARY OF SAFETY AND EFFECTIVENESS
(As required by 21 CFR 807.92)
General Information 1.
| Classification: | Class II
Magnetic Resonance Imaging (MRI) Option |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Spectroscopy Option |
| Proprietary Name: | MR Spectroscopy Package |
| Establishment Registration: | 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 and Indications for Use
The Picker MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.
| This package is indicated for use as follows: | |
|---|---|
| Anatomical region: | Head, whole body |
| Nuclei Excited: | $^{1}H$ |
3. Device Description
Picker's MR Spectroscopy Package described in this submission is a proton ('H) spectroscopy software option. The package includes both capabilities for single voxel proton (SVP) spectroscopy and chemical shift imaging (CSI). These techniques provide a non-invasive method for analyzing metabolite concentrations in the brain and throughout
PICKER INTERNATIONAL, INC. 4/27/99 I - I (SPEC)
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the body. The MR Spectroscopy Package does not include any additional risks to the patient other than those for standard MR imaging.
4. Safety and Effectiveness
The Picker MR Spectroscopy Package is similar in technological characteristics and intended use to the Siemens Clinical Proton Spectroscopy Package and the GE Probe/SV Option. The following table has been created to demonstrate their substantial equivalence.
| Parameter | Picker MR
Spectroscopy Option | Predicate Devices: GE Probe
(K930265), Siemens (K951650) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nucleus | Same. | Proton. (Both predicates) |
| Type of Spectroscopy | Same. | Single Voxel and Chemical Shift
Imaging. (See K951650) |
| Spectroscopic
Hardware | Same. | Phantom for QA. (See K951650) |
| Shimming Technique | Same. | Automated. (See K930265) |
| Solvent Suppression | Automated with the choice of
MOIST, MOIST2, FATFREE and
DUALSAT. | Automated CHESS. (See K930265) |
| Localization
Techniques | Same. | STEAM and PRESS. (See K930265) |
| Voxel positioning | Graphical positioning. | Alphanumerical or graphical
positioning. (Both predicates) |
| Minimum voxel size | 5 x 5 x 5 mm3. | 10 x 10 x 10 mm3. (See K951650) |
| Minimum TE | STEAM – 20ms, PRESS – 35 ms. | STEAM – 10ms, PRESS – 35ms.
(See K930265) |
| Typical TR Range | 1.5 – 3 sec. | 1.5 – 6 sec. (See K930265) |
| Acquisition Time | Approximately 3 – 7 minutes. | Approximately 10 minutes. (See
K930265) |
| Post-processing
features | Phase correction, filtering, data
zeroing, retrospective voxel
boundary shifting, FFT, baseline
correction, peak fitting and
analysis, chemical shift assignment,
variable smoothing and
differentiation. | Zero filling, water reference
processing, FID shifting, baseline
correction, phase correction, FFT,
apodization, Curve fitting, peak
information display, spectrum labeling.
(See K951650) |
| Key Metabolites | NAA, Cr, Cho, mI, Glx and Lac. | NAA, Cr/PCr, Cho, lipids and some
other metabolites only at short TEs.
(See K951650) |
SUBSTANTIAL EQUIVALENCE TABLE
PICKER INTERNATIONAL, INC. (SPEC) I - 2 4/27/99
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| | Picker MR
Spectroscopy Option | Predicate Devices: GE Probe (K930265), Siemens (K951650) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | | |
| Data display options | Same. | Spectra, results of fit, images showing
metabolite distributions or ratios. (See
K951650) |
| Output type | Archived to database, film, post-
script printer. | Archived in database, Windows bitmap
format, laser camera, standard paper
laser printer, digital printer. (See
K951650) |
| Indications for use | Head, whole body. | Brain and any anatomy containing little
or no fat. (See K930265) |
| Intended Use | The Picker MR Spectroscopy
Package is intended for use as a
non-invasive diagnostic device that
provides information based on
relative concentrations of
metabolites in body tissues. This
NMR data in the form of spectra
or spectral images reflect the NMR
properties of proton density, spin-
lattice relaxation time (T1), spin-
spin relaxation time (T2), and
chemical shift. When interpreted
by a trained medical practitioner,
these spectral data provide
information that can be useful in
making a diagnosis. | The GE Signa Advantage MR
diagnostic system is indicated for use
as a diagnostic medical device that
produces computer processed,
localized spectra that display the
internal biochemical characteristics of
the human body. Other parameters
derived from the spectra may also be
displayed. The spectra reflect the
frequency distribution of several
biologically relevant nuclei exhibiting
nuclear magnetic resonance (NMR).
The NMR properties that determine
the spectral appearance are nuclear
density, spin-lattice relaxation time
(T1), spin-spin relaxation time (T2),
chemical shift in resonant frequency,
and fluid flow. When interpreted by a
trained specialist, these spectra provide
information that may be useful in the
determination of a diagnosis. (See
K930265) |
PICKER INTERNATIONAL, INC.
(SPEC)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/16 description: The image shows a partial view of a logo or emblem. The visible portion includes a stylized graphic of three curved lines stacked on top of each other, resembling a simplified representation of waves or motion. To the left of the graphic, there is a partial arc of text, suggesting the presence of a circular border or frame around the logo. The text is oriented along the curve, indicating that it is part of the emblem's design.
JUL 1 9 1999
Elaine Keeler, Ph.D. Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143 RE:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K991568 Magnetic Resonance Spectroscopy Package Dated: April 30, 1999 Received: May 5, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNI
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 (Special Controls) or 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 requlation 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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MR Spectroscopy Package
Indications for Use:
The Picker MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.
This package is indicated for use as follows:
Head, whole body Anatomical region: Nuclei Excited: ,H
(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 | K991568 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|