(93 days)
No
The summary describes image processing and quantitative analysis performed by trained analysts using the software, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML models.
No.
The device is described as a "diagnostic device software application" that "produces quantified metrics and composite images from magnetic resonance medical image data" to "assist in clinical decisions" and provide "insight into the composition of muscle and fat of a patient." It is not described as providing treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "VitruvianScan is indicated for use as a magnetic resonance diagnostic device software application." Furthermore, it mentions that the output "yield information that may assist in clinical decisions."
Yes
The device description explicitly states "VitruvianScan is a standalone, post processing software medical device." It processes existing MRI image data and does not include any hardware components.
Based on the provided information, VitruvianScan is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves analyzing blood, urine, tissue samples, or other bodily fluids.
- VitruvianScan processes medical image data (MRI images). It does not analyze biological specimens.
- The intended use and device description clearly state that VitruvianScan works with magnetic resonance medical image data.
Therefore, VitruvianScan falls under the category of a medical image processing software device, not an IVD.
N/A
Intended Use / Indications for Use
VitruvianScan is indicated for use as a magnetic resonance diagnostic device software application for non-invasive fat and muscle evaluation that enables the generation, display and review of magnetic resonance medical image data.
VitruvianScan produces quantified metrics and composite images from magnetic resonance medical image data which when interpreted by a trained healthcare professional, yield information that may assist in clinical decisions.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
VitruvianScan is a standalone, post processing software medical device. VitruvianScan enables the generation, display and review of magnetic resonance (MR) medical image data from a single timepoint (one patient visit).
When a referring healthcare professional requests quantitative analysis using VitruvianScan, relevant images are acquired from patients at MRI scanning clinics and are transferred to the Perspectum portal through established secure gateways. Perspectum trained analysts use the VitruvianScan software medical device to process the MRI images and produce the quantitative metrics and composite images. The device output information is then sent to the healthcare professionals for their clinical use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance imaging systems
Anatomical Site
Abdomen.
Indicated Patient Age Range
General population - VitruvianScan has no demographic or population restrictions.
Intended User / Care Setting
Perspectum trained analysts use the device to analyze MRI data and produce output.
Trained healthcare professionals interpret the device output for additional support in their clinical decision pathways.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
VitruvianScan underwent performance testing under controlled conditions to corroborate that it is safe and effective when used as intended. The performance testing conducted demonstrates that the subject device is at least as safe and effective as the predicate device.
The performance was tested for the following aspects:
- a. Repeatability of metrics for the same subject, on the same manufacturer and field strength, acquired on the same day
- b. Reproducibility of metrics for the same subject, on the same manufacturer but a different field strength, acquired on the same day
- c. Characterization of inter-operator variability
- d. Characterization of intra-operator variability
- e. Results from testing using the subject device were compared with the results from testing using reference requlated device `OSIRIX MD' for benchmarking performance
- f. Comparative testing between the operators' results and the gold standard (mean of 3 radiologists results)
All aspects of the performance tests met the defined acceptance criteria, thereby assuring robust clinical performance of the device across different scanners, field strengths and patient characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 2, 2024
Perspectum Ltd Bhaskar Chikkanna Director of Regulatory Affairs Gemini One. 5520 John Smith Drive Oxford, OX4 2LL United Kingdom
Re: K241925
Trade/Device Name: VitruvianScan (v1.0) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: September 11, 2024 Received: September 11, 2024
Dear Bhaskar Chikkanna:
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 (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
1
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).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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
2
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,
Daniel M. Krainak, 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
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
VitruvianScan (v1.0)
Indications for Use (Describe)
VitruvianScan is indicated for use as a magnetic resonance diagnostic device software application for non-invasive fat and muscle evaluation that enables the generation, display and review of magnetic resonance medical image data.
VitruvianScan produces quantified metrics and composite images from magnetic resonance medical image data which when interpreted by a trained healthcare professional, yield information that may assist in clinical decisions.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Date Prepared:
25th June 2024
10056574
1 Applicant Details
Applicant Name and Address:
25th June 2024
Perspectum Ltd Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford, OX4 2LL
Owner/Operator Number: Establishment Registration Number: Applicant Contact Name: Applicant Contact Email: Applicant Contact Phone:
3014232555 Bhaskar Chikkanna bhaskar.chikkanna@perspectum.com +44 (0) 1865 655329
2 Subject and Predicate Device
Subject Device | Predicate Device | Reference Device | |
---|---|---|---|
510(k) number | K241925 | K211983 | K101342 |
Legal Manufacturer | Perspectum Ltd. | AMRA Medical AB | PIXMEO SARL |
Device Trade Name | VitruvianScan (v1.0) | AMRA Profiler | OSIRIX MD |
Common Name | Software as a Medical | ||
Device | Software as a Medical | ||
Device | Picture Archiving | ||
Communications System | |||
Panel | Radiology | Radiology | Radiology |
Regulation | 892.1000 | 892.1000 | 892.2050 |
Risk Class | Class II | Class II | Class II |
Product Class code | LNH | LNH | LLZ |
Regulation Name | Magnetic Resonance | ||
Diagnostic Device | Magnetic Resonance | ||
Diagnostic Device | Picture archiving and | ||
communications system |
Subject Device Description ന
3.1 General Description
VitruvianScan is a standalone, post processing software medical device. VitruvianScan enables the generation, display and review of magnetic resonance (MR) medical image data from a single timepoint (one patient visit).
When a referring healthcare professional requests quantitative analysis using VitruvianScan, relevant images are acquired from patients at MRI scanning clinics and are transferred to the Perspectum portal through established secure gateways. Perspectum trained analysts use the VitruvianScan software medical device to process the MRI images and produce the quantitative metrics and composite images. The device output information is then sent to the healthcare professionals for their clinical use.
5
Image /page/5/Picture/1 description: The image shows the word "Perspectum" in a bold, blue font. To the right of the word is a circular logo with four different colored sections: light blue, green, pink, and dark blue. The dark blue section is at the bottom of the circle, and the other three colors are arranged in a clockwise direction.
The metrics produced by VitruvianScan are intended to provide insight into the composition of muscle and fat of a patient. The device is intended to be used as part of an overall assessment of a patient's health and wellness and should be interpreted whilst considering the device's limitations when reviewing or interpreting images. Therefore, VitruvianScan presents a low level of concern with respect to patient safety since its metrics only augment the clinical information utilized by trained Healthcare Professionals for the management of patients.
VitruvianScan is only used within Perspectum's secure infrastructure by trained analysts to process clinical images and generate metrics. The metrics and composite images output by VitruvianScan are then sent to trained Healthcare Professionals who then utilize these to make clinical decisions in combination with other relevant information obtained from other clinical sources.
3.2 Intended Use
VitruvianScan is a software medical device intended to assist trained healthcare professionals in the noninvasive evaluation of body fat and muscle composition in the general population.
3.3 Indications for Use
VitruvianScan is indicated for use as a magnetic resonance diagnostic device software application for noninvasive fat and muscle evaluation that enables the generation, display and review of magnetic resonance medical image data.
VitruvianScan produces quantified metrics and composite images from magnetic resonance medical image data which when interpreted by a trained healthcare professional, yield information that may assist in clinical decisions.
3.4 Intended Patient Population
General population - VitruvianScan has no demographic or population restrictions.
3.5 Contraindications
- None Software only device .
3.6 Warnings/Precautions
- VitruvianScan must not be used for direct diagnosis of patients. o
- o VitruvianScan generated metrics must only be interpreted by trained healthcare professionals.
- VitruvianScan output must not be used on its own to make any treatment decisions relating o to any specific diseases or health conditions.
Substantial Equivalence ব
Table below provides a comparison of attributes between the subject device and the predicate device to demonstrate substantial equivalence. Differences between the devices are commented.
Attributes | Subject Device | Predicate Device | Comments |
---|---|---|---|
Device trade name | VitruvianScan | AMRA Profiler | N/A |
Manufacturer | Perspectum Ltd | AMRA Medical AB | N/A |
510(k) number (if | |||
assigned) | TBD | K211983 | N/A |
Regulation | 892.1000 | 892.1000 | No difference |
Product Code | LNH | LNH | No difference |
Intended use | VitruvianScan is a | ||
software medical device | Not defined | Subject device has a separate | |
intended use statement. | |||
intended to assist trained | |||
healthcare professionals | |||
in the non-invasive | |||
evaluation of body fat | |||
and muscle composition | |||
in the general population | |||
Indications for use | VitruvianScan is indicated | ||
for use as a magnetic | |||
resonance diagnostic | |||
device software | |||
application for non- | |||
invasive fat and muscle | |||
evaluation that enables | |||
the generation, display | |||
and review of magnetic | |||
resonance medical image | |||
data. | |||
VitruvianScan produces | |||
quantified metrics and | |||
composite images from | |||
magnetic resonance | |||
medical image data which | |||
when interpreted by a | |||
trained healthcare | |||
professional, yield | |||
information that may | |||
assist in clinical | |||
decisions. | Indicated for use as a | ||
magnetic resonance | |||
diagnostic device | |||
software application for | |||
non- invasive fat and | |||
muscle evaluation that | |||
enables the generation, | |||
display and review of 2D | |||
magnetic resonance | |||
medical image data. | |||
Designed to utilize | |||
DICOM 3.0 compliant | |||
magnetic resonance | |||
image datasets, acquired | |||
from compatible MR | |||
Systems, to display the | |||
internal structure of the | |||
body including the liver. | |||
Other physical | |||
parameters derived from | |||
the images may also be | |||
produced. Provides a | |||
number of quantification | |||
tools, such as Region of | |||
Interest (ROI) | |||
placements, to be used | |||
for the assessment of | |||
regions of an image to | |||
quantify liver tissue | |||
characteristics, including | |||
the determination of fat | |||
fraction in the liver, T2 * | |||
and muscle volume. | |||
These images and the | |||
physical parameters | |||
derived from the images, | |||
when interpreted by a | |||
trained clinician, yield | |||
information that may | |||
assist in diagnosis. | Subject device does not | ||
quantify liver tissue | |||
characteristics, liver fat | |||
fraction, T2* and muscle | |||
volume. Other than these | |||
differences, both the subject | |||
device and the predicate | |||
device are indicated for non- | |||
invasive fat and muscle | |||
evaluation. | |||
Intended users | Perspectum trained | ||
analysts use the device to | |||
analyze MRI data and | |||
produce output. | AMRA operators use the | ||
device to analyze MRI | |||
data and produce | |||
results. | Similar users | ||
Trained healthcare | |||
professionals interpret | |||
the device output for | |||
additional support in their | |||
clinical decision | |||
pathways. | Trained clinicians | ||
interpret the results. | |||
Application | Health and wellness | Health and wellness | No difference |
Anatomy and | |||
measurements | Abdomen. | Abdomen and Thighs. | Subject device anatomy and |
measurements are a subset of | |||
the predicate device anatomy | |||
and measurements | |||
Visceral Fat | Visceral Fat | ||
Subcutaneous Fat | Subcutaneous Fat | ||
Muscle Area | Muscle Fat | ||
Muscle Volume | |||
Liver Fat | |||
Target population | General population | Adults | Subject device is intended for |
all ages who are suitable for | |||
MRI scans | |||
Contraindications | None, Software only | None, Software only | No difference |
Imaging modality | Magnetic resonance | ||
imaging systems | Magnetic resonance | ||
imaging systems | No difference | ||
Data format | DICOM 3.0 compliant MR | ||
image datasets from | |||
compatible MR scanners | DICOM 3.0 compliant MR | ||
image datasets from | |||
compatible MR scanners | No difference | ||
MRI Scanners | GE, Siemens and Philips | GE, Siemens and Philips | No difference |
MR field strength | 1.5T and 3T | 1.5T and 3T | No difference |
6
Perspectu D
7
Image /page/7/Picture/1 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a bold, sans-serif font in blue color. To the right of the word is a circular graphic made up of different colored segments. The segments are blue, light blue, green, and pink.
5 Software Testing
VitruvianScan is a software medical device. The documentation document justifies only basic documentation is applicable to VitruvianScan as per FDA guidance, Content of Premarket Submissions for Device Software Functions for Industry and Food and Drug Administration Staff Document issued on June 14, 2023. The device has undergone the following tests and successfully passed the acceptance criteria with no residual anomalies.
- a. Unit testing
- b. Integration testing
- c. Software system verification
- d. Software system validation
- e. User acceptance tests
6 Performance Testing
VitruvianScan underwent performance testing under controlled conditions to corroborate that it is safe and effective when used as intended. The performance testing conducted demonstrates that the subject device is at least as safe and effective as the predicate device.
Scanners Assessed |
---|
Siemens 1.5T |
Siemens 3T |
GE 1.5T |
GE 3T |
Philips 1.5T |
8
Image /page/8/Picture/1 description: The image shows the word "Perspectum" in a bold, dark blue font. To the right of the word is a circular logo with four colored sections: light blue, green, pink, and dark blue. The dark blue section is at the bottom of the circle and has a white line running through it.
Philips 3T
The performance was tested for the following aspects:
- Repeatability of metrics for the same subject, on the same manufacturer and field strength, a. acquired on the same day
- b. Reproducibility of metrics for the same subject, on the same manufacturer but a different field strength, acquired on the same day
- c. Characterization of inter-operator variability
- d. Characterization of intra-operator variability
- e. Results from testing using the subject device were compared with the results from testing using reference requlated device `OSIRIX MD' for benchmarking performance
- f. Comparative testing between the operators' results and the gold standard (mean of 3 radiologists results)
All aspects of the performance tests met the defined acceptance criteria, thereby assuring robust clinical performance of the device across different scanners, field strengths and patient characteristics.
7 Conclusion
The subject device and the predicate device have similar indications for use and are meant for the same application in health and wellness. The differences highlighted do not constitute a new intended use, are accompanied by information that demonstrates that the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate.