(314 days)
Not Found
No
The summary describes image processing and 3D rendering based on user input and measurements, but there is no mention of AI, ML, or any learning-based algorithms. The validation focuses on accuracy against phantom models and MRI, not on performance metrics typically associated with AI/ML models (like AUC, sensitivity, specificity on a clinical dataset).
No.
The device is a software application designed for diagnostic purposes (fibroid mapping and measurement) and treatment planning, not for direct therapeutic intervention.
Yes
The device is intended to assist qualified physicians in accurate diagnosis and planning of image-guided interventions for uterine fibroids by generating a 3D model that represents clinically relevant dimensions, including the location and dimensions of fibroids. This function directly supports the diagnostic process.
Yes
The device description explicitly states that FMRA is a "software that allows the user to load an existing ultrasound data into the application". It processes this data to generate a 3D model and measurements. There is no mention of accompanying hardware being part of the device itself, only that it receives data from existing ultrasound equipment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Fibroid Mapping Reviewer Application (FMRA) processes ultrasound images of the uterus, which are generated in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use is to generate a 3-D model from ultrasound images and aid in the measurement and mapping of fibroids. This is an image processing and visualization tool, not a diagnostic test performed on a biological sample.
Therefore, the FMRA falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Fibroid Mapping Reviewer Application (FMRA) is intended to be used by physicians in the clinic or hospital to generate a 3-D model from ultrasound images of the uterus of women with uterine fibroids. The model represents clinically relevant dimensions, including the location and dimensions of the fibroid (maximum length, width and depth).
Product codes
LLZ
Device Description
Fibroid Mapping Reviewer Application (FMRA) is a software that allows the user to load an existing ultrasound data into the application for calibration, review, annotation and generation of a 3D rendered uterus model. It aids in the measurement of fibroid dimensions and mapping the location of fibroids in the uterus.
The ultrasound data of the patient's uterus, exported from ultrasound equipment via storage media such as a USB drive, is loaded into the proposed software. The user marks the anatomical features of the uterus and the fibroid. The software post-processes the 2D volume ultrasound images of the uterus to obtain the mapping & measurement of fibroids which are represented in a 3D rendered uterus model. It allows the clinician to know the parameters of each fibroid (like fibroid size and location) by just selecting a fibroid in the model.
The proposed device is intended to assist qualified physicians in accurate diagnosis and planning of image guided interventional of uterine fibroids.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in the clinic or hospital
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
The overall verification & validation activities performed for FMRA includes the following:
- Product & Engineering specifications were verified & validated.
- Validation of FMRA included a comparison of the accuracy of FMRA output parameters on phantom models (i.e., incorporating simulated uterus and fibroids) with MRI values.
- MRI Imaging is considered to be the gold standard for imaging.
- Acceptance criteria between FMRA Output parameters & MRI Values -
- Location - Variation of spatial co-ordinate should be within +/- 2 MM
- Dimensions - Variation of fibroid dimensions should be within +/- 2 MM
- Validation testing was executed by 3 certified medical professionals, and the input images for FMRA were also collected from 3 different ultrasound machines.
Key results: FMRA passed all applicable testing in accordance with acceptance criteria and also relevant standards. The results demonstrate that the FMRA satisfies the performance, functional, and safety requirements relative to the product specifications, risk analyses, and Instructions for Use, and does not raise different questions of safety and effectiveness than the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The full name of the agency is "U.S. Food & Drug Administration".
Nesa Medtech Private Limited % Rob Packard President/Consultant Medical Device Academy, Inc. 345 Lincoln Hill Road SHREWSBURY VT 05738
July 17, 2023
Re: K222683
Trade/Device Name: Fibroid Mapping Reviewer Application (FMRA) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: September 6, 2022 Received: June 9, 2023
Dear Rob Packard:
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. 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 located 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.
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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,
Jessica Lamb
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222683
Device Name
Fibroid Mapping Reviewer Application (FMRA)
Indications for Use (Describe)
Fibroid Mapping Reviewer Application (FMRA) is intended to be used by physicians in the clinic or hospital to generate a 3-D model from ultrasound images of the uterus of women with uterine fibroids. The model represents clinically relevant dimensions, including the location and dimensions of the fibroid (maximum length, width and depth).
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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR $807.92:
I. SUBMITTER Nesa Medtech Private Limited 15, 33rd Main 7th Block Bhavani Colony, Banashankari 3rd Stage,
Banashankari, Bengaluru, Karnataka 560085, India
Contact Person: Sreekar Kothamachu Phone Number: +91 9900166988 Email: sreekar@nesamedtech.com
Date Prepared: October 25, 2022
| II.
| DEVICE | |
|---|---|
| Name of Device: | Fibroid Mapping Reviewer Application (FMRA) |
| Classification Name: | Medical Image Management and Processing System |
| Regulation: | 21 CFR §892.2050 |
| Regulatory Class: | Class II |
| Product Classification Code: | LLZ |
III. PREDICATE DEVICE
| Predicate Manufacturer: | Eigen LLC |
|---|---|
| Predicate Trade Name: | 3-D Imaging Workstation |
| Predicate 510(k): | K081093 |
IV. DEVICE DESCRIPTION
Fibroid Mapping Reviewer Application (FMRA) is a software that allows the user to load an existing ultrasound data into the application for calibration, review, annotation and generation of a 3D rendered uterus model. It aids in the measurement of fibroid dimensions and mapping the location of fibroids in the uterus.
The ultrasound data of the patient's uterus, exported from ultrasound equipment via storage media such as a USB drive, is loaded into the proposed software. The user marks the anatomical features of the uterus and the fibroid. The software post-processes the 2D volume ultrasound images of the uterus to obtain the mapping & measurement of fibroids which are represented in a 3D rendered uterus model. It allows the clinician to know the parameters of each fibroid (like fibroid size and location) by just selecting a fibroid in the model.
The proposed device is intended to assist qualified physicians in accurate diagnosis and planning of image guided interventional of uterine fibroids.
V. INDICATIONS FOR USE
Fibroid Mapping Reviewer Application (FMRA) is intended to be used by physicians in the clinic or hospital to generate a 3-D model from ultrasound images of the uterus of women with uterine fibroids. The model represents clinically relevant dimensions, including the location of the fibroid (maximum length, width and depth).
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
The following characteristics were compared between the subject device in order to demonstrate substantial equivalence:
| Feature | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Name | Fibroid Mapping Reviewer Application | ||
| (FMRA) | 3-D Imaging Workstation | N/A | |
| 510(k) | K081093 | N/A | |
| Indications for | |||
| Use | Fibroid Mapping Reviewer Application | ||
| (FMRA) is intended to be used by | |||
| physicians in the clinic or hospital to | |||
| generate a 3-D model from ultrasound | |||
| images of the uterus of women with | |||
| uterine fibroids. The model represents | |||
| clinically relevant dimensions, including | |||
| the location and dimensions of the | |||
| fibroid (maximum length, width and | |||
| depth). | The 3-D Imaging Workstation is | ||
| intended to be used by physicians in | |||
| the clinic or hospital for 2-D and 3-D | |||
| visualization of ultrasound images of | |||
| the prostate gland. Additional software | |||
| features include patient data | |||
| management, multi-planar | |||
| reconstruction, segmentation, image | |||
| measurement and 3-D image | |||
| registration. | The subject devices are indicated for | ||
| different targeted anatomies. The | |||
| intended use of visualizing | |||
| ultrasound images is the same. | |||
| Product Code | LLZ | LLZ | Same |
| Class | II | II | Same |
| Windows OS | Windows OS (10) | Windows OS | Same |
| Medical imaging | |||
| software | Yes | Yes | Same |
| General Image | |||
| 2DReview | 2D ultrasound frames can be reviewed | 2D ultrasound frames can be reviewed | Same |
| 3D Rendering | |||
| View | 2D ultrasound data is converted into 3D | ||
| rendered model | 2D ultrasound data is converted into | ||
| 3D rendered model | Same | ||
| Import/Export | Exported from commercially available ultrasound machines via storage media such as a USB drive | Live video received from commercially available ultrasound machines | Different. The difference in the method of import/export of data does not raise questions of safety and effectiveness. |
| Review Tools | Yes | Yes | Same |
| Measurement Tools | Yes | Yes | Same |
| Annotation Tools | Yes | Yes | Same |
| Patient data management | Yes | Yes | Same |
| Image Storage and Communication | .mov, .avi, .mp4 | DICOM, jpeg | Different. The difference in the format of data does not raise questions of safety and effectiveness. |
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VII. PERFORMANCE DATA
The overall verification & validation activities performed for FMRA includes the following:
- Product & Engineering specifications were verified & validated. ●
- Validation of FMRA included a comparison of the accuracy of FMRA output parameters on phantom models (i.e., incorporating simulated uterus and fibroids) with MRI values.
- o MRI Imaging is considered to be the gold standard for imaging.
- Acceptance criteria between FMRA Output parameters & MRI Values - O
- . Location - Variation of spatial co-ordinate should be within +/- 2 MM
- . Dimensions - Variation of fibroid dimensions should be within +/- 2 MM
- o Validation testing was executed by 3 certified medical professionals, and the input images for FMRA were also collected from 3 different ultrasound machines.
The following standards were followed in the development of the FMRA:
- ISO 14971: 2019 Medical Devices - Application of Risk Management to Medical Devices
- IEC 62304: 2015 Medical Device Software - Software Life Cycle Processes
FMRA passed all applicable testing in accordance with acceptance criteria and also relevant standards. The results demonstrate that the FMRA satisfies the performance, functional, and safety requirements relative to the product specifications, risk analyses, and Instructions for Use, and does not raise different questions of safety and effectiveness than the predicate device.
VIII. CONCLUSIONS
The Fibroid Mapping Reviewer Application i.e. FMRA has the same intended use as the predicate devices. Intended use of both the systems are to process the targeted features/ anatomies in 2-D ultrasound images deriving 3D representative models. The subject device is using this technology to visualize and measure fibroid dimension and location relative to other anatomy. The predicate device uses this technology to visualize the prostate gland. For both, ultrasound is the traditional method for evaluating the respective indicated uses, and both the subject device and predicate devices are software applications that improve the provider's ability to use the ultrasound information. Performance tests demonstrate that the FMRA has been tested to prove the same. The biological sex of the patient does not impact the performance of the ultrasound relating to its ability to capture images of targeted tissues and therefore does not impact the equivalence of the technology's performance in the respective sex. The method of acquisition (transvaginal vs. transrectal) is also not a substantial difference because the method and means of acquiring the image is not important, but what is important for each system is that the ultrasound views captured are within the required specifications for each software. This relates more to the specific indications as opposed to the general intended use