(75 days)
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
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.
The provided document is a 510(k) premarket notification for the Picker MR Spectroscopy Package. It asserts substantial equivalence to predicate devices rather than proving specific acceptance criteria through a dedicated study with quantitative performance metrics. Therefore, many of the requested sections (e.g., sample sizes, ground truth establishment, MRMC studies) are not applicable as they would be for an AI/ML-based device seeking de novo authorization or a device with new performance claims.
Here's a breakdown of the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of quantitative performance thresholds for a novel device. Instead, it demonstrates substantial equivalence to legally marketed predicate devices by comparing various technological characteristics and intended uses. The "performance" reported is essentially the device's feature set and capabilities, shown to be similar to the predicates.
| Parameter | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Picker MR Spectroscopy Option) |
|---|---|---|
| Nucleus | Proton (as per predicate devices) | Proton |
| Type of Spectroscopy | Single Voxel and Chemical Shift Imaging | Single Voxel and Chemical Shift Imaging |
| Spectroscopic Hardware | Phantom for QA | Phantom for QA |
| Shimming Technique | Automated | Automated |
| Solvent Suppression | Automated (e.g., CHESS) | Automated (MOIST, MOIST2, FATFREE, DUALSAT) |
| Localization Techniques | STEAM and PRESS | STEAM and PRESS |
| Voxel Positioning | Alphanumerical or Graphical Positioning | Graphical positioning |
| Minimum Voxel Size | 10 x 10 x 10 mm3 (as per predicate Siemens K951650) | 5 x 5 x 5 mm3 (Picker's is smaller, thus potentially better or equivalent for clinical utility) |
| Minimum TE | STEAM – 10ms, PRESS – 35ms (as per predicate GE K930265) | STEAM – 20ms, PRESS – 35 ms |
| Typical TR Range | 1.5 – 6 sec (as per predicate GE K930265) | 1.5 – 3 sec |
| Acquisition Time | Approximately 10 minutes (as per predicate GE K930265) | Approximately 3 – 7 minutes (Picker's is faster, thus potentially better or equivalent for clinical utility) |
| Post-processing Features | Zero filling, water reference, baseline/phase correction, FFT, apodization, curve fitting, peak info, labeling | Phase correction, filtering, data zeroing, retrospective voxel boundary shifting, FFT, baseline correction, peak fitting/analysis, chemical shift assignment, variable smoothing/differentiation |
| Key Metabolites | NAA, Cr/PCr, Cho, lipids, and others at short TEs | NAA, Cr, Cho, mI, Glx, and Lac |
| Data Display Options | Spectra, results of fit, images of metabolite distributions/ratios | Spectra, results of fit, images showing metabolite distributions or ratios |
| Output Type | Archived to database, various print/digital formats | Archived to database, film, post-script printer |
| Indications for Use | Similar to predicates (e.g., Brain, any anatomy with little fat) | Head, whole body |
| Intended Use | Non-invasive diagnostic device providing metabolite concentration information for diagnosis when interpreted by trained practitioner | Non-invasive diagnostic device providing metabolite concentration information for diagnosis when interpreted by trained practitioner |
Note on Acceptance Criteria: In this context, "acceptance criteria" is interpreted as demonstrating that the device's technical specifications and intended use are sufficiently similar to (or improved upon, while maintaining safety and effectiveness) those of already legally marketed predicate devices. The FDA's issuance of the 510(k) clearance acts as the "proof" that these criteria for substantial equivalence have been met.
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission asserting substantial equivalence based on a comparison of device specifications and intended use, not a clinical trial with a test set of patient data to measure performance against a quantitative endpoint.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert-established ground truth was part of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was part of this 510(k) submission.
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
Not applicable. The device described is an MR Spectroscopy Package, a hardware/software option for an MRI system that provides spectral data, not an AI-assisted diagnostic tool designed to directly improve human reader performance in interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic tool that provides data for interpretation by a trained medical practitioner ("human-in-the-loop"), as stated in its intended use. It is not a standalone algorithm providing diagnoses without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As this is a substantial equivalence claim for a diagnostic tool's specifications, there was no ground truth validation required for clinical performance in the manner an AI/ML algorithm would need.
8. The sample size for the training set
Not applicable. This device does not appear to involve machine learning models that would require a "training set" in the conventional sense. The submission focuses on the technical characteristics and intended use of the spectroscopy package.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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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 IIMagnetic Resonance Imaging (MRI) Option |
|---|---|
| Common/Usual Name: | Magnetic Resonance Spectroscopy Option |
| Proprietary Name: | MR Spectroscopy Package |
| Establishment Registration: | Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143Contact: Elaine K. Keeler, Ph.D.Phone: (440) 473-3000FDA Owner Number: #1580240FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have beenissued under section 514 of the Food, Drug andCosmetic 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 MRSpectroscopy Option | Predicate Devices: GE Probe(K930265), Siemens (K951650) |
|---|---|---|
| Nucleus | Same. | Proton. (Both predicates) |
| Type of Spectroscopy | Same. | Single Voxel and Chemical ShiftImaging. (See K951650) |
| SpectroscopicHardware | Same. | Phantom for QA. (See K951650) |
| Shimming Technique | Same. | Automated. (See K930265) |
| Solvent Suppression | Automated with the choice ofMOIST, MOIST2, FATFREE andDUALSAT. | Automated CHESS. (See K930265) |
| LocalizationTechniques | Same. | STEAM and PRESS. (See K930265) |
| Voxel positioning | Graphical positioning. | Alphanumerical or graphicalpositioning. (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. (SeeK930265) |
| Post-processingfeatures | Phase correction, filtering, datazeroing, retrospective voxelboundary shifting, FFT, baselinecorrection, peak fitting andanalysis, chemical shift assignment,variable smoothing anddifferentiation. | Zero filling, water referenceprocessing, FID shifting, baselinecorrection, phase correction, FFT,apodization, Curve fitting, peakinformation display, spectrum labeling.(See K951650) |
| Key Metabolites | NAA, Cr, Cho, mI, Glx and Lac. | NAA, Cr/PCr, Cho, lipids and someother metabolites only at short TEs.(See K951650) |
SUBSTANTIAL EQUIVALENCE TABLE
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| Picker MRSpectroscopy Option | Predicate Devices: GE Probe (K930265), Siemens (K951650) | |
|---|---|---|
| Parameter | ||
| Data display options | Same. | Spectra, results of fit, images showingmetabolite distributions or ratios. (SeeK951650) |
| Output type | Archived to database, film, post-script printer. | Archived in database, Windows bitmapformat, laser camera, standard paperlaser printer, digital printer. (SeeK951650) |
| Indications for use | Head, whole body. | Brain and any anatomy containing littleor no fat. (See K930265) |
| Intended Use | The Picker MR SpectroscopyPackage is intended for use as anon-invasive diagnostic device thatprovides information based onrelative concentrations ofmetabolites in body tissues. ThisNMR data in the form of spectraor spectral images reflect the NMRproperties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), andchemical shift. When interpretedby a trained medical practitioner,these spectral data provideinformation that can be useful inmaking a diagnosis. | The GE Signa Advantage MRdiagnostic system is indicated for useas a diagnostic medical device thatproduces computer processed,localized spectra that display theinternal biochemical characteristics ofthe human body. Other parametersderived from the spectra may also bedisplayed. The spectra reflect thefrequency distribution of severalbiologically relevant nuclei exhibitingnuclear magnetic resonance (NMR).The NMR properties that determinethe spectral appearance are nucleardensity, spin-lattice relaxation time(T1), spin-spin relaxation time (T2),chemical shift in resonant frequency,and fluid flow. When interpreted by atrained specialist, these spectra provideinformation that may be useful in thedetermination of a diagnosis. (SeeK930265) |
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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
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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) |
|---|---|
| ------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.