(458 days)
The neo315 is a magnetic resonance diagnostic device which 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 resonance. Other physical parameters derived from the images and/or spectra may also be produced.
The device includes hydrogen-1 (proton) imaging, hydrogen-1 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). The intended group of patients for the neo315 can be found in the pediatric environment. The exclusion of patients is determined by the dimensions of the patient bed and excludes patients that exceed a 120 cm length and a diameter of 26 cm. The weight of the patient shall not exceed 18 kg.
The neo315 is a conductively cooled 1.5T whole body magnetic resonance diagnostic device (MRDD) which generates images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Its intended group of patients for the neo315 can be found in the pediatric environment. The neo315 consists of the Field Generating Unit (FGU), two technical cabinets (consoles) and gets operated via the operating software ScanUI.
The provided text does not contain information about specific acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies for the neo315 device.
The document primarily focuses on the FDA's 510(k) clearance for the neo315, stating its substantial equivalence to a predicate device (Siemens MAGNETOM Avanto syngo MR B19A). It outlines the device's indications for use, technological comparison, and compliance with recognized standards.
Therefore, I cannot fulfill all parts of your request based on the provided text. I can only extract information related to the device's general intended use and the standards it complies with.
Here's what can be inferred from the text, though it doesn't meet the specific requirements of your request regarding detailed study results:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of metrics like sensitivity, specificity, accuracy, or specific imaging quality parameters. It generally asserts that "The performance testing results demonstrate the safety and performance as expected."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information is provided regarding the sample size used for any test set or the provenance of data (e.g., country of origin, retrospective/prospective). The document mentions "performance testing results" but does not detail the methodology or datasets used.
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):
No information is provided about the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information is provided about any adjudication method.
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:
The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The neo315 is described as a Magnetic Resonance Diagnostic Device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document doesn't detail performance studies of the device in isolation or as part of an algorithm. It focuses on the substantial equivalence of the hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
No information is provided regarding the type of ground truth used.
8. The sample size for the training set:
No information is provided regarding the sample size of any training set.
9. How the ground truth for the training set was established:
No information is provided on how ground truth was established for any training set.
Summary of available information related to performance and standards:
The document states that the neo315 is claimed to comply with several applicable FDA recognized standards, which implicitly define "acceptance criteria" in terms of technical performance expected of an MR diagnostic device. These standards establish various performance benchmarks for MR systems.
| Category | Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance |
|---|---|---|
| I. Imaging Performance | ||
| Signal-to-Noise Ratio (SNR) | Compliance with NEMA MS-1-2008 (R2020) - Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging. This standard defines methods for measuring SNR, and the device is expected to meet SNR levels appropriate for diagnostic use. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical SNR values reported.) |
| Geometric Distortion/Accuracy | Compliance with NEMA MS 2-2008 (R2020) - Determination of Two-Dimensional Geometric Magnostic Magnetic Resonance Images. This standard defines methods for evaluating geometric accuracy in MR images. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical distortion or accuracy values reported.) |
| Image Uniformity | Compliance with NEMA MS 3-2008 (R2020) - Determination of Image Uniformity in Diagnostic Resonance Images. This standard defines methods for evaluating the uniformity of signal intensity across an image. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical uniformity values reported.) |
| Slice Thickness | Compliance with NEMA MS 5-2018 - Determination of Slice Thickness in Diagnostic Resonance Imaging. This standard defines methods for measuring the actual thickness of acquired image slices. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical slice thickness deviation values reported.) |
| II. Safety and Electrical Performance | ||
| Acoustic Noise | Compliance with NEMA MS 4-2010 - Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices. This standard defines methods for measuring the acoustic noise generated by the MR system. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical acoustic noise levels reported.) |
| Specific Absorption Rate (SAR) | Compliance with NEMA MS 8-2016 - Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems. This standard addresses the measurement and characterization of SAR, which relates to patient heating. | "The performance testing results demonstrate the safety and performance as expected." (No specific numerical SAR values or compliance margins reported.) |
| Electrical Safety & Essential Performance | Compliance with IEC 60601-1-2 Edition 4.1, 2020-09 (EMC) and IEC 60601-1 Edition 3.2 2020-08 (General requirements for basic safety and essential performance). These standards cover electrical safety, electromagnetic compatibility, and fundamental safe operation. | "The performance testing results demonstrate the safety and performance as expected." |
| III. Software & Usability | ||
| Software Life Cycle Processes | Compliance with IEC 62304 Edition 1.1 2015-06 - Medical Device Software - Software life cycle processes. This standard defines requirements for the software development and maintenance processes of medical devices. | "The performance testing results demonstrate the safety and performance as expected." |
| Usability Engineering | Compliance with IEC 62366-1 Edition 1.0 2015-02 - Medical devices - Part 1: Application of usability engineering to medical devices. This standard ensures the device is safe and effective through proper usability design. | "The performance testing results demonstrate the safety and performance as expected." |
| IV. Biological & Risk Management | ||
| Biological Evaluation | Compliance with ISO 10993-1 Fifth edition 2018-08 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. This standard addresses the biocompatibility of materials in contact with a patient. | "The performance testing results demonstrate the safety and performance as expected." |
| Risk Management | Compliance with ISO 14971 Third Edition 2019-12 - Medical devices - Application of risk management to medical devices. This standard outlines a process for managing risks associated with medical devices. | "The performance testing results demonstrate the safety and performance as expected." |
Conclusion from available text:
The provided document asserts that the neo315 meets the "safety and performance as expected" by complying with a list of recognized industry standards for Magnetic Resonance Imaging devices. However, it does not provide granular details about the specific quantitative acceptance criteria or the numerical results of performance testing that would directly fulfill the detailed requirements of your prompt. The FDA's 510(k) clearance process often relies on substantial equivalence to predicate devices and compliance with recognized standards without requiring novel clinical performance studies unless significant differences or new risks are identified.
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July 22, 2024
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Neoscan Solution GmbH Roell Stefan Executive Director Joseph-von-Fraunhofer-Str. 6 Magdeburg, 39106 GERMANY
Re: K231133
Trade/Device Name: neo315 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: June 18, 2024 Received: June 18, 2024
Dear Roell Stefan:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
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820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Locon Weidner
Lora D. Weidner, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
| Submission Number ( if known ) | K231133 |
|---|---|
| Device Name | neo315 |
Indications for Use (Describe)
The neo315 is a magnetic resonance diagnostic device which 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, hydrogen-1 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). The intended group of patients for the neo315 can be found in the pediatric environment. The exclusion of patients is determined by the dimensions of the patient bed and excludes patients that exceed a 120 cm length and a diameter of 26 cm. The weight of the patient shall not exceed 18 kg.
Type of Use (Select one or both, as applicable)
scription Use (Part 21 CFR 801 Subpart D)
The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: | K231133 |
|---|---|
| 510(k) Summary | |
| Prepared on: 2024-06-18 | |
| Contact Details | 21 CFR 807.92(a)(1) |
| Applicant Name | Neoscan Solutions GmbH |
| Applicant Address | Joseph-von-Fraunhofer-Str. 6 Magdeburg 39106 Germany |
| Applicant Contact Telephone | +491728444690 |
| Applicant Contact | Mr. Roell Stefan |
| Applicant Contact Email | roell@neoscan-solutions.com |
| Device Name | 21 CFR 807.92(a)(2) |
| Device Trade Name | neo315 |
| Common Name | Magnetic resonance diagnostic device |
| Classification Name | System, Nuclear Magnetic Resonance Imaging |
| Regulation Number | 892.1000 |
| Product Code | LNH |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) |
| K123938 | Siemens MAGNETOM Avanto syngo MR B19A |
| Product Code | |
| LNH | |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The neo315 is a conductively cooled 1.5T whole body magnetic resonance diagnostic device (MRDD) which generates images which
reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear
magnetic resonance. Its intended group of patients for the neo315 can be found in the pediatric environment. The neo315 consists of
the Field Generating Unit (FGU), two technical cabinets (consoles) and gets operated via the operating software ScanUI.
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
|---|---|
| ---------------------------------- | --------------------- |
The neo315 is a magnetic resonance diagnostic device which 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, hydrogen-1 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). The intended group of patients for the neo315 can be found in the pediatric environment. The exclusion of patients is determined by the patient bed and excludes patients that exceed a 120 cm length and a diameter of 26 cm.The weight of the patient shall not exceed 18 kg.
Indications for Use Comparison
The major difference between neo315 and the predicate device is a 30 cm patient bore, allowing only to image the pediatric patients. The reduced size of the patient tunnel allows however neo315 to be more compact, and occupy only a quarter of the footprint of the predicate device.
21 CFR 807.92(a)(5)
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Neo315 has the same major indications for use as the predicate devices produce transverse, sagittal, coronal and oblique cross-sectional images and/or spectra, and that display the the internal structure and/or function of the head, body, or extremities.
The above described differences do not constitute a new intended use nor a safety and effectiveness issue.
Technological Comparison
21 CFR 807.92(a)(6)
The selected equivalent device is directly comparable with the medical device under evaluation. The clinical, and biological characteristics are similar or even identical with the neo315. In terms of clinical and biological characteristics, the two devices do not differ at all. All the aspects investigated are the same here. Only the technical characteristics have minor differences which result mainly from the different size of the devices. The discussed aspects have no influence on the clinical performance or safety of the device. The neo315 is as secure as an MAGNETOM Avanto in terms of safety and can be used for diagnostics with the same clinical performance as an MAGNETOM Avanto.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The neo315 is claimed to comply with the following applicable FDA recognized standards:
NEMA MS-1-2008 (R2020) - Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
NEMA MS 2-2008 (R2020) - Determination of Two-Dimensional Geometric Magnostic Magnetic Resonance Images
NEMA MS 3-2008 (R2020) - Determination of Image Uniformity in Diagnostic Resonance Images
NEMA MS 4-2010 - Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
NEMA MS 5-2018 - Determination of Slice Thickness in Diagnostic Resonance Imaging
NEMA MS 8-2016 - Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
IEC 60601-1-2 Edition 4.1, 2020-09 CONSOLIDATED Version - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
IEC 60601-2-33 Ed. 3.2 b2015 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of Magnetic Resonance Equipment for Medical Diagnostic
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION - Medical Device Software - Software life cycle processes
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
ISO 10993-1 Fifth edition 2018-08 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
IEC 62366-1 Edition 1.0 2015-02 - Medical devices - Part 1: Application of usability engineering to medical devices
ISO 14971 Third Edition 2019-12 - Medical devices - Application of risk management to medical devices
The performance testing results demonstrate the safety and performance as expected. Therefore, the neo315 is substantially equivalent to the legally marketed predicate device.
§ 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.