(134 days)
No
The description focuses on image guidance, visualization, and calculations based on user-defined targets, without mentioning AI/ML algorithms for image analysis, prediction, or automated decision-making. The performance study also focuses on accuracy of needle placement based on the guidance system, not on the performance of an AI/ML model.
No
A therapeutic device actively treats or cures a condition. This software is an image-guidance accessory for treatment planning and guiding diagnostic/interventional procedures, but it does not directly perform the therapy.
No
The device is described as an "image-guidance accessory" that helps physicians guide biopsy instrumentation, providing "image analysis and display" for "treatment planning and guidance for clinical, interventional, and/or diagnostic procedures of the prostate." While it is used in conjunction with diagnostic procedures, its primary function is guidance and planning, not making a diagnosis itself. It facilitates a diagnostic procedure (biopsy) but does not perform the diagnosis.
No
The device description explicitly states "ProBx Software along with ProBx Hardware accessories is used for in-bore Magnetic Resonance Imaging (MRI) guided interventional and diagnostic procedures of the prostate." This indicates the device includes hardware components in addition to the software.
Based on the provided information, the ProBx Software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- ProBx Software's Intended Use: The ProBx Software is clearly described as an image-guidance accessory used in conjunction with MRI systems and interventional devices. Its purpose is to assist physicians in guiding biopsy instrumentation to targets within the prostate based on MRI images. It provides visualization, planning tools, and positioning confirmation during a procedure.
- No Specimen Examination: The software does not analyze or process any biological specimens. It works directly with medical images (MRI) and helps guide physical instruments within the body.
Therefore, the ProBx Software falls under the category of a medical device used for image-guided procedures, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ProBx Software is intended for use as follows:
- ProBx Software is a computer-based image-guidance accessory intended for use in conjunction with commercially available Magnetic Resonance Imaging (MRI) systems and interventional devices.
- ProBx Software helps physicians guide biopsy instrumentation to targets that have been defined by the physician in MRI. The Software provides the clinician with image analysis and display of pre-procedural MRI images of tracked accessory hardware and the target organs, along with the projected path to the Software displays an MRI image of the current location of the interventional instrument for positioning confirmation.
- ProBx Software is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures of the prostate.
Product codes
LLZ
Device Description
ProBx Software along with ProBx Hardware accessories is used for in-bore Magnetic Resonance Imaging (MRI) guided interventional and diagnostic procedures of the prostate. The ProBx Software is intended to be loaded onto a commercially available workstation and used as an accessory to commercially available MRI systems. The software receives pre-procedural and intra-procedural DICOM images and provides 2D and 3D visualization for treatment planning. The Software performs calculations on user-selected target locations to assist the clinician in manually utilizing the tracked accessory hardware to reach targets. The Software also provides MRI scan confirmation of positioning during the procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in a clinical setting
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
Bench testing was performed using acceptable scientific methods to validate the fiducial registration technique and determine substantial equivalence to the predicate. This includes validation of the software with the ProBx Hardware in a simulated clinical use phantom study that showed our device can achieve end-to end needle placement accuracy of 1.88 mm. This result shows the ProBx Software is non-inferior to the published endto end needle placement accuracy of DynaCAD.
Key Metrics
end-to end needle placement accuracy of 1.88 mm.
Predicate Device(s)
Reference Device(s)
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Harmonus Inc. Nandini Murthy Regulatory Consultant 110 Canal St 3rd Floor Lowell, Massachusetts 01852
March 2, 2018
Re: K173312
Trade/Device Name: ProBx Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: January 16, 2018 Received: January 18, 2018
Dear Nandini Murthy:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Nandini Murthy
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
SECTION 4
INDICATIONS FOR USE STATEMENT
A completed Indications for Use Statement follows this page.
CONFIDENTIAL
3
Indications for Use
510(k) Number (if known) K173312
Device Name
ProBx Software
Indications for Use (Describe)
ProBx Software is intended for use as follows:
· ProBx Software is a computer-based image-guidance accessory intended for use in conjunction with commercially available Magnetic Resonance Imaging (MRI) systems and interventional devices.
· ProBx Software helps physicians guide biopsy instrumentation to targets that have been defined by the physician in MRI. The Software provides the clinician with image analysis and display of pre-procedural MRI images of tracked accessory hardware and the target organs, along with the projected path to the Software displays an MRI image of the current location of the interventional instrument for positioning confirmation.
· ProBx Software is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures of the prostate.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| -- | ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Traditional 510(k) Premarket Notification Submission
SECTION 5
510(k) SUMMARY
| Submitter Name: | Harmonus, Inc. |
|---|---|
| Submitter Address: | 110 Canal St. Lowell, MA 01852 |
| Contact Person: | Nicole Mauro, CEO |
| Phone Number: | (617) 702-2271 |
| Date Prepared: | 10/18/2017 |
| Device Trade Name: | ProBx Software |
| Device Common Name: | Image-guided, interventional planning software |
| Classification Name: | System, Image Processing, Radiological, LLZ |
| Classification regulation: | 21 CFR 892.2050, Product Code LLZ |
| Predicate Device: | DynaCAD/Prostate Interventional, K133030 |
Device Description:
ProBx Software along with ProBx Hardware accessories is used for in-bore Magnetic Resonance Imaging (MRI) guided interventional and diagnostic procedures of the prostate. The ProBx Software is intended to be loaded onto a commercially available workstation and used as an accessory to commercially available MRI systems. The software receives pre-procedural and intra-procedural DICOM images and provides 2D and 3D visualization for treatment planning. The Software performs calculations on user-selected target locations to assist the clinician in manually utilizing the tracked accessory hardware to reach targets. The Software also provides MRI scan confirmation of positioning during the procedure.
Indications for Use:
ProBx Software is intended for use as follows:
- ProBx Software is a computer-based image-guidance accessory intended for use in conjunction with commercially available Magnetic Resonance Imaging (MRI) systems and interventional devices.
- ProBx Software helps physicians guide biopsy instrumentation to targets that have been defined by the physician in MRI. The Software provides the clinician with image analysis and display of pre-procedural and intra-procedural MRI images of tracked accessory hardware and the target organs, along with the projected path to the target. The Software displays an MRI image of the current location of the interventional instrument for positioning confirmation.
5
Traditional 510(k) Premarket Notification Submission
- ProBx Software is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures of the prostate.
| Submitted Device | Predicate Device #1 | Reference Device #1 | |
|---|---|---|---|
| Proprietary/Trade Name | ProBx Software | DynaCAD/Prostate | |
| Interventional | SmartTarget | ||
| 510(k) Number | n/a | K133030 | K170250 |
| Product Code | LLZ | LLZ | LLZ |
| Class | II | II | II |
| Target Anatomy | Prostate | Prostate | Prostate |
| Anatomy access | Transperineal | Transrectal | Transperineal |
| Modality | MR | MR | US fusion with MR, CT |
| Software | |||
| Windows OS | Yes | Yes | Yes |
| Kiosk | Yes | Yes | Not known |
| Medical Imaging Software | Yes | Yes | Yes |
| Connectivity | |||
| DICOM Import | Yes | Yes | Yes |
| Image Display | |||
| General Image 2D/3D | |||
| Review | Yes | Yes | Yes |
| Image Processing | |||
| Registration: Fiducial- | |||
| tracked Instrumentation | |||
| in relation to patient | |||
| anatomy | Yes | Yes | Yes |
| Required instrument | |||
| registration and | |||
| verification images prior | |||
| to intervention | Yes | Yes | Yes |
| Planning and Navigation | |||
| Interventional | |||
| Hardware/Positioning | |||
| Device | Yes (ProBx Grid with | ||
| Calibrator and Patient | |||
| Support) | Yes (DynaTrim Needle | ||
| Guide and Patient | |||
| Support) | Yes (3rd party | ||
| Gridplate and Stepper) | |||
| Add Targets | Yes | Yes | Yes |
| Plan/Marks Location | Yes | Yes | Yes |
| MR-guided interventional | |||
| planning with | |||
| interventional hardware | Yes | Yes | Fusion with US |
Rationale for Substantial Equivalence:
Table 5.1 Comparison of ProBx to Predicate Devices
6
Traditional 510(k) Premarket Notification Submission
The ProBx software application is substantially equivalent to the predicate device (DynaCAD, K133030) in the areas of technological characteristics such as basic design, function, method of operation, application, and intended use.
Both software:
- operate in Windows and function as a kiosk.
- are able to import DICOM image from various sources and provide 2D and 3D image display.
- are used with a positioning device and interventional hardware.
- register fiducial-tracked instrumentation in relation to the patient anatomy.
- provide verification images of instrumentation placement.
- do not steer or in any way control the positioning of instruments used. ●
- allow the procedure to be repeated based on operator judgement.
- are intended for use in MR-guided procedures involving the prostate.
ProBx differs slightly from the DynaCAD in the anatomy access point, fiducial placement and type of needle guide hardware. The transperineal approach using a grid in ProBx is used in reference devices (SmartTarget, K170250). The placement of fiducials is accounted for in an equivalent technique of instrumentation registration. Therefore, the new device does not raise any new potential questions related to safety or performance, and is equivalent to the existing legally marketed devices.
Performance Data:
The ProBx software proposed indications for use are supported by preclinical software verification and validation testing. Bench testing was performed using acceptable scientific methods to validate the fiducial registration technique and determine substantial equivalence to the predicate. This includes validation of the software with the ProBx Hardware in a simulated clinical use phantom study that showed our device can achieve end-to end needle placement accuracy of 1.88 mm. This result shows the ProBx Software is non-inferior to the published endto end needle placement accuracy of DynaCAD.
The following are the referenced standards during design and development of the ProBx Software:
- ISO 15223-1:2016, Medical devices Symbols to be used with medical device labels, labeling and information to be supplied
- ISO 14971:2007, Medical Devices Application of Risk Management to Medical Devices
- IEC 62304:2006, Medical Device Software Software Life Cycle Processes
Conclusion:
ProBx Software has similar indications statements as the predicate device. Both devices are used for MR-guided interventional planning with interventional hardware for procedures involving the prostate. The functionality of the ProBx Software and the predicate device is
7
Traditional 510(k) Premarket Notification Submission
identical. The results of software verification and validation testing support that ProBx Software functions as intended when used with ProBx Hardware accessories for prostate interventional procedures. Therefore, ProBx Software is substantially equivalent to the predicate device.