(49 days)
The HHF I MR system is an imaging device, and is intended to provide the use of ion I he HHF I MK system is an maging de nee, and is non-invasively and without the use of ionizing physiological and cinical information, obtained notital, oblique, and curved crossradiation. The MR system produces transverse, coronal, sand had as assessmities. The radiation. The MK produces thansverse, contine thead, body, or extremities. The sectional images that display the methal structure of any of protons (hydrogen nuclei)
images produced by the MR system reflect the spatial distribution of protons arc mages produced by the MR System reneve the spance that determine the image appearance are
exhibiting magnetic resonance. The NMR properties that determine time (T2), and flo exhibiting magnetic resoliatics. The Nink properates spin relaxation time (T2), and flow.
proton density, spin-lattice relaxation time (T1), spin-spin relaxation that segment proton density, spin-latice relaxation inne (11), spill spill spin relation that can be useful in diagnosis determination.
The HHF1 is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in an open gantry configuration. The HHF1 is designed to enhance clinical utility as compared to Open MRI system. The imaging properties of the HHF1 are based on the Altaire imaging properties of the 1.5T magnet.
This FDA submission (K052172) is for a Magnetic Resonance Imaging System (HHF1 MRDD). It is a 510(k) premarket notification, which means the manufacturer is asserting substantial equivalence to a predicate device, rather than submitting a de novo application or PMA which would typically present extensive clinical trial data.
As such, this submission does not contain acceptance criteria or a study proving the device meets those criteria in the way one might expect for a novel or high-risk device requiring significant clinical validation. This type of submission relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed predicate device.
Here's a breakdown of why the requested information isn't present in this document and what is provided:
1. A table of acceptance criteria and the reported device performance
- Not Applicable: For a 510(k) submission asserting substantial equivalence for an MRI system, a table of specific acceptance criteria (e.g., specific sensitivity/specificity thresholds for a diagnostic task) and reported device performance against those criteria is generally not required in the same way it would be for a diagnostic AI algorithm or a novel therapy.
- What is provided: The submission states that the HHF1 MRI system's technological characteristics are "similar to the primary predicate Hitachi Altaire MRI System (K050602)" and that "The control and image processing hardware and the base elements of the system software are identical to the predicate device." It also highlights the physical and performance characteristics of MRI in general (high quality anatomical images, differences in image contrast based on T1, T2, proton density, blood flow, etc.). The "performance" being demonstrated here is the ability to produce images comparable to the predicate device, which itself was approved based on its known performance as an MRI.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: There is no specific test set data or clinical study detailed in this 510(k) submission to assess the HHF1's diagnostic performance in a clinical setting. The FDA's review for substantial equivalence in this context focuses on engineering specifications, software validation (which is generally internal to the company and not fully disclosed in the public 510k summary), and comparisons to the predicate device's established performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: Since no specific clinical performance study with a test set is presented, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As there's no test set described, an adjudication method is not applicable.
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 a diagnostic imaging system (MRI), not an AI-powered diagnostic aide. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is an MRI system, not a standalone algorithm. Its performance is intrinsically tied to human operation and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: No ground truth data is discussed as there's no clinical performance study presented.
8. The sample size for the training set
- Not Applicable: This device is an MRI system. There is no "training set" in the context of machine learning, as it's not an AI/ML algorithm. The performance is based on the physics of MRI and established engineering principles.
9. How the ground truth for the training set was established
- Not Applicable: As above, there is no training set mentioned.
Summary of the 510(k) Submission's Approach to Demonstrating Safety and Effectiveness:
Instead of presenting new clinical data, this 510(k) relies on substantial equivalence to an existing, legally marketed device (Hitachi Altaire MRI System, K050602). The key arguments for demonstrating safety and effectiveness are:
- Identical Intended Use: The HHF1 MRI system is intended for the same diagnostic purposes (imaging internal structures of the head, body, extremities to provide physiological and clinical information) as the predicate device.
- Similar Technological Characteristics: The device utilizes a 1.5 Tesla superconducting magnet, similar to the predicate. The "control and image processing hardware and the base elements of the system software are identical to the predicate device."
- Established Scientific Concepts: The fundamental scientific principles of MRI (proton density, T1, T2 relaxation times) are well-understood and are the basis for both the new and predicate devices.
The FDA's letter confirms that they have determined the device to be "substantially equivalent" to legally marketed predicate devices, meaning it has been found to be as safe and effective as those devices.
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SEP 2 7 2005
Section 2
510(k) Summary of Safety and Effectiveness
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Submitter Information 1.0
| 1.1 | Submitter: | Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44080-2371ph: (330) 425-1313fax: (330) 425-1410 |
|---|---|---|
| 1.2 | Contact: | Douglas J. Thistlethwaite |
- 8/1/05 1.3 Date:
Device Name 2.0
| 2.1 Classification Name: | System, Nuclear Magnetic Resonance Imaging |
|---|---|
| 2.2 Classification Number: | 90LNH |
| 2.3 Trade/Proprietary Name: | HHF1 Magnetic Resonance Imaging System |
| 2.4 Predicate Device(s): | Hitachi Altaire MRI System (K050602) |
Device Intended Use 3.0
The MR system is an imaging device and is intended to provide the physician with The Mrs system is an maging do rise anbrained non-invasively and without the use of physiological and chilical information, obtailed is as thansverse, coronal, sagittal, oblique, and fonizing radiation. The NH system produces anternal structure of the head, body, or curved cross-scenonal images that =2.p.g 1R system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that protons (first of nage appearance are proton density, spin-lattice relaxation time (TI), spindetermine the miage appearance are promic eented by a trained physician, these images provide information that can be useful in diagnosis determination.
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Device Description 4.0
4.1 Function
The HHF1 is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla The First I is a Magnetic Resolunce antinging and based on the Altaire superconducting magnet in an open ganaly coorgined to enhance clinical utility as compared to Open MRT system. The imaging properties of the imaging properties of the 1.5T magnet.
4.2 Scientific Concepts
Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have Magnetic resolutice magniz (1112) is an to act as small spinning bar magnets. The most electionaglicit propertios that bases it the primary nuclei currently used in ubiquitous of these nacier is nydrogen, which a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization nector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength vecific to the magnetic field strength and to the atomic nuclei under consideration can specific to the magnetization vector. When the RF excitation is removed, cause a re-onemation of the magnetiation vor. The rate of relaxation is exponential and the prototts than and retaril to their originand its adjacent molecular environment. This revalles will the character of the provential relaxation times, called T1 and T2.
A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three elimensional matrix. Spatial localization is encoded into the echoes by varying the RF unnensional mattin. Spatial locallents in the x, y, and z directions, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial changing the direction and strenger of sean be reconstructed by using image processing techniques similar to those used in computed tomography.
4.3 Physical and Performance Characteristics
MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are loifferent from those responsible for x-ray image contrast. In MR imaging, difference in different noin those responsible for in ag ming and contribute to image proton delisity, blood now, and 11 anse characteristics, the resulting images can emphasize TI, T2, proton density, or the molecular diffusion of water or other proton containing molecules.
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Device Technological Characteristics 5.0
The technological characteristics of this device are similar to the primary predicate I he tcembological enaracteribles of the 1.5 Tesla superconducting magnet. The control and image processing hardware and the base elements of the system software are identical to the predicate device.
Conclusions 6.0
It is the opinion of Hitachi Medical Systems America, Inc. that HHF1 MRI system is it is the opinion of Intellisted predicate device. The intended use is identical to the listed predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
SEP 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Douglas Thistlewaite Manager of Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K052172 Trade/Device Name: HHF1 MRDD, w/V1.0 Operating System Software Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 1, 2005 Received: August 9, 2005
Dear Mr. Thistlewaite:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have teviewed your becaled by equivalent (for the indications for use stated in above and nave determined the ac redicate devices marketed in interstate commerce prior to the enclosure) to regally mancede production in the Medical Device Amendments, or to devices that have been May 20, 1770, the chaoinent acte 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 do not require approval of a promance approvisions of the Act. The general controls provisions of the Act device, subject to the general contons provisions 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 (Premarket If your device is olassilied (500 such additional controls. Existing major regulations affecting your Apploval), it thay be subject to basil adains 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 I Toase or devisou that 1 Driver that your device complies with other requirements of the Act or any FDA has made a decemination that your as a ministered by other Federal agencies. You must comply with all the I cut at statues and regulations administed 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) (21 Crici Cric Part 820); and if applicable, the electronic product radiation control provisions . (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manceling your device of your device to a legally premarket notification. The PDA Intentig of substantial of 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 If you desire spective advice for your device on our labeling org the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation childer, "Wisonaining on your responsibilities under the Act from the 180 807.97). You may obtain other general information your of your of its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
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长05 2172 510(k) Number (if known): HHF1 MRDD, w/V1.0 Operating System Software Device Name:
Indications for Use:
Indications for USC.
The HHF I MR system is an imaging device, and is intended to provide the use of ion I he HHF I MK system is an maging de nee, and is non-invasively and without the use of ionizing physiological and cinical information, obtained notital, oblique, and curved crossradiation. The MR system produces transverse, coronal, sand had as assessmities. The radiation. The MK system produces thansverse, contine thead, body, or extremities. The sectional images that display the methal structure of any of protons (hydrogen nuclei)
images produced by the MR system reflect the spatial distribution of protons arc mages produced by the MR System reneve the spance that determine the image appearance are
exhibiting magnetic resonance. The NMR properties that determine time (T2), and flo exhibiting magnetic resoliatics. The Nink properates spin relaxation time (T2), and flow.
proton density, spin-lattice relaxation time (T1), spin-spin relaxation that segment proton density, spin-latice relaxation inne (11), spill spill spin relation that can be useful in diagnosis determination.
| Anatomical Region: | Head, Body, Spine, Extremities |
|---|---|
| Nucleus excited: | Proton |
| Diagnostic uses: | T1, T2, proton density weighted imaging |
| Diffusion weighted imaging | |
| MR Angiography | |
| Image processing |
| Prescription Use | X |
|---|---|
| ------------------ | --- |
Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Bergdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
§ 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.