(15 days)
Imaging of:
- . The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Myelography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] { K002531 }
- Fluid Visualization { K002531 } ●
- . 2D / 3D Imaging { K002531}
- . MR Angiography / MR Vascular Imaging {K002531}
- Blood Oxygenation Level Dependent (BOLD) imaging { K002531} ●
- Perfusion / Diffusion Imaging {K993803, K002531}
- . Proton Spectroscopy { K010129}
The EXCELART™ with Pianissimo XG/AG SPIN Edition system has the following features compared to the current EXCELART™ with Pianissimo XG/AG system.
- Extension of a receiving system is enabled a maximum of 8 ch. .
- Use of QD Torso SPEEDER corresponding to Parallel imaging which can shorten scan time is . enabled.
- The computer only for reconstruction was carried for high-speed image processing. .
- . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33 by the TrueSSFP sequence.
- Max. field strength is changed 25mT/m to 30mT/m. .
- . The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a sequence has been improved.
- The user interface of software was changed for the improvement of operativity. '
- . Gating unit was redesigned to improve the making triggers for sequence.
The provided text is a 510(k) summary of safety and effectiveness for a Magnetic Resonance Diagnostic Device Accessory. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document does not contain an independent study with acceptance criteria and a detailed analysis of device performance against those criteria in the way a clinical trial or performance study would typically be structured for a new device claiming improved diagnostic accuracy.
Instead, the submission aims to demonstrate substantial equivalence by showing that the new device (EXCELART™ with Pianissimo XG/AG SPIN Edition) has comparable safety and imaging performance parameters to its predicate device (current EXCELART™ with Pianissimo XG/AG, cleared under K002531), while highlighting specific hardware and software changes.
Therefore, the requested information elements related to acceptance criteria, a specific study proving it, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly present in this type of submission.
However, I can extract and present the available information in a structure that addresses your points where possible, along with explaining why other points cannot be answered from this document.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission does not present a standalone study with defined acceptance criteria for diagnostic performance of the device against a gold standard in the typical sense of a clinical trial for a new diagnostic claim.
Instead, the device seeks substantial equivalence to a predicate device (EXCELART™ with Pianissimo XG/AG, K002531). The "acceptance criteria" can be inferred as maintaining similar or improved safety and imaging performance characteristics as the predicate device, especially regarding the new features. The study, implicitly, is the comparison of technical specifications and performance against the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria with specific thresholds for performance metrics (like sensitivity, specificity, accuracy) are not provided in a 510(k) summary focused on substantial equivalence based on technical changes, I will present the key safety parameters where changes or comparisons were made. The "reported device performance" in this context refers to the parameters of the new device relative to the predicate.
| Parameter | Predicate Device (K002531) Performance / Criteria | New Device (EXCELART™ with Pianissimo XG/AG SPIN Edition) Performance |
|---|---|---|
| Safety Parameters | ||
| a. Static Field Strength | 1.5 T | Same (1.5 T) |
| b. Peak and A-weighted Acoustic Noise | 95.0 dB(A-weighted) | 95.4 dB(A-weighted) |
| c. Operational Modes | Normal operating mode | 1st operating mode for dB/dt |
| i. Safety Parameter Display | SAR | SAR, dB/dt |
| ii. Operating Mode Access Requirements | Not applicable | Same (Not applicable) |
| d. Maximum SAR | < 1.5 W/kg | Same (< 1.5 W/kg) |
| e. Maximum dB/dt and Gradient Coil Dimensions | 19.3 T/sec; 1050 x 1175 x 51 mm | 46 T/sec; 1050 x 1175 x 50 mm |
| f. Potential Emergency Conditions | Shut down by Emergency Ramp Down Unit | Same |
| g. Biocompatibility of Materials | Not applicable | Same |
| Imaging Performance Parameters | ||
| Overall Imaging Performance | (No explicit changes highlighted from K002531) | "No changes from the previous submission, K002531." |
| Marginal Performance (Min. TR/TE/Slice thickness/Imaging area) | (Implied by predicate) | Improved |
| Scan Time (with QD Torso SPEEDER & Parallel imaging) | (Implied by predicate) | Shortened (enabled by new features) |
| High-speed Image Processing | (Implied by predicate) | Enabled by dedicated reconstruction computer |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. This 510(k) summary focuses on technical specifications and comparisons rather than a clinical study with a patient test set for diagnostic performance. The "testing" appears to be largely engineering and phantom-based to verify new functionalities and safety parameters.
- Data Provenance: Not explicitly stated. Given it's a comparison to an existing device, and the manufacturing site is Japan, some internal testing or data may originate from there. However, it's not a dataset of patient images from a specific country.
- Retrospective/Prospective: Not applicable in the context of a clinical performance study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not specified. This document does not describe a clinical study where experts established ground truth for a diagnostic test set. The evaluation is primarily technical and comparative against a predicate device's specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring expert adjudication for ground truth is described.
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. This device is an MRI system and its accessory, not an AI-powered diagnostic algorithm or an assistance tool for human readers. Therefore, an MRMC study related to human-AI collaboration is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is an MRI hardware and software update, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implicitly, engineering specifications and measurements. For parameters like static field strength, acoustic noise, SAR, and dB/dt, the "ground truth" is derived from physical measurements and adherence to regulatory standards (e.g., IEC 60601-2-33). For "imaging performance," the claim is "no changes from the previous submission, K002531," implying that the imaging quality is at least equivalent to the already cleared predicate device, which would have undergone its own validation based on established imaging metrics.
8. The sample size for the training set
- Not applicable / Not specified. This is not an AI/ML device that requires a training set in that context. The "training" for the system would involve engineering development and quality control, not data-driven model training.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" in the context of machine learning for this device.
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ਤੇ ਨੇ ।।
5 2002 NOV
Appendix 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. DEVICE NAME: | Magnetic Resonance Diagnostic Device Accessory |
|---|---|
| Model Name: | MRT-1501/P3,P2 |
| Trade/Proprietary Name: | EXCELART™ with Pianissimo XG/AG SPIN Edition |
| 2. ESTABLISHMENT REGISTRATION: | 2020563 |
| 3. U.S. Agent Name and Address: | TOSHIBA AMERICA MEDICAL SYSTEMS, INC.2441 MICHELLE DRIVETUSTIN, CA 92780 |
| Contact Person: | Michaela Mahl(714) 730 - 5000 |
| 4. Manufacturing Site: | TOSHIBA CORPORATIONMEDICAL SYSTEMS COMPANY1385 ShimoishigamiOtawara-shi, Tochigi 324-8550, Japan |
| 5. DATE OF SUBMISSION: | September 27, 2002 |
DEVICE DESCRIPTION 6.
The EXCELART™ with Pianissimo XG/AG SPIN Edition system has the following features compared to the current EXCELART™ with Pianissimo XG/AG system.
- Extension of a receiving system is enabled a maximum of 8 ch. .
- Use of QD Torso SPEEDER corresponding to Parallel imaging which can shorten scan time is . enabled.
- The computer only for reconstruction was carried for high-speed image processing. .
- . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33 by the TrueSSFP sequence.
- Max. field strength is changed 25mT/m to 30mT/m. .
- . The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a sequence has been improved.
- The user interface of software was changed for the improvement of operativity. '
- . Gating unit was redesigned to improve the making triggers for sequence.
| Model Number with suffix | Trade/Proprietary Name |
|---|---|
| MRT-1501/P3 | EXCELART TM with Pianissimo XG SPIN Edition |
| MRT-1501/P2 | EXCELART TM with Pianissimo AG SPIN Edition |
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SUMMARY OF MAJOR HARDWARE CHANGES 6.1.
A. The computer only for reconstruction was carried for high-speed image processing.
- B. Gating unit was redesigned to improve the making triggers for sequence.
C: 8ch phased array kit is added in the optional items.
D. 70mm Circular coil is added in the optional items.
E. QD torso SPEEDER is added in the optional items.
F. QD Neurovascular array coil (K001870) is added in the optional items.
SUMMARY OF MAJOR SOFTWARE CHANGES 6.2.
A. Improved user interface.
- B. New RF coils control.
- C. dB/dt limitation control.
- D. True Steady State Free Precession (SSFP) sequence.
- E. Parallel imaging.
7. SAFETY PARAMETERS
| Current EXCELART™ withPianissimo XG/AG (No changesfrom the previous submission,K002531) | New EXCELART™with PianissimoXG/AG SPIN Edition | |
|---|---|---|
| a. Static field strength: | 1.5 T | Same |
| b. Peak and A-weighted acousticnoise: | 95.0 dB(A-weighted) | 95.4 dB(A-weighted) |
| c. Operational modes: | Normal operating mode | 1st operating mode fordB/dt |
| i. Safety parameter display: | SAR | SAR, dB/dt |
| ii. Operating mode accessrequirements: | Not applicable because usedonly in normal operating mode | Same |
| d. Maximum SAR | < 1.5 W/kg | Same |
| e. Maximum dB/dtand Gradient coil dimensions: | 19.3T/sec1050 x 1175 x 51(unit: mm) | 46 T/sec1050 x 1175 x 50(unit: mm) |
| f. Potential emergency conditionsand means provided for shutdown: | Shut down by Emergency RampDown Unit for collision hazardby ferromagnetic objects | Same |
| g. Biocompatibility of materials: | Not applicable | Same |
IMAGING PERFORMANCE PARAMETERS 8.
No changes from the previous submission, K002531.
9. INTENDED USE
No changes from the previous submission, K002531.
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10. EQUIVAALENCY INFORMATION
TOSHIBA Corporation Medical Systems Company believes that the new EXCELART™ with Pianissimo XG/AG SPIN Edition (model MRT-1501/P3, MRT-1501/P2) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART™ with Pianissimo XG/AG (model MRT-1501/P3, MRT-1501/P2) (K002531) cleared on October 26, 2000 except for new RF coils and dB/dt limitation.
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Image /page/3/Picture/1 description: The image shows a black and white logo of the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT of HEALTH & HUMAN SERVICES" are arranged vertically along the left side of the logo in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 2002 NOV
Toshiba America Medical Systems, Inc. % Mr. Mark Job 510(k) Program Manager TÜV America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112 Re: K023511
Trade/Device Name: EXCELART™ with Pianissimo XG, AG SPIN Edition Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH
Dated: October 17, 2002 Received: October 21, 2002
Dear Mr. Job:
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.
{4}------------------------------------------------
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. Snigdon
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 1
KO2 35 11 510(k) Number (if known).
Device Name: EXCELART™ with Pianissimo XG, AG SPIN Edition
Indications for Use:
Imaging of:
- . The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Myelography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] { K002531 }
- Fluid Visualization { K002531 } ●
- . 2D / 3D Imaging { K002531}
- . MR Angiography / MR Vascular Imaging {K002531}
- Blood Oxygenation Level Dependent (BOLD) imaging { K002531} ●
- Perfusion / Diffusion Imaging {K993803, K002531}
- . Proton Spectroscopy { K010129}
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR -
】【
Over-The-Counter Use
(Optional Format 1-2-96)
.
(Division Sign Off)
Division: Digestive, Abdominal,
and GI Devices
§ 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.