(30 days)
Not Found
No
The summary describes image processing and 3D reconstruction but does not mention AI, ML, or related terms.
No
The device is an imaging and visualization tool used to assist in procedures, not to directly treat a condition or provide therapy.
No
The device is intended for enhanced visualization and to assist clinicians in planning and performing image-guided interventional procedures (biopsies, placing instruments/markers), rather than providing a diagnosis itself. It offers additional 3D information for assessing abnormalities but still relies on the clinician's interpretation and actions.
No
The device description explicitly states it receives 2D live video from commercially available ultrasound machines and uses this video to reconstruct a 3D image. While the core functionality is software-based image processing and visualization, it relies on and integrates with external hardware (ultrasound machines, probes, needles, etc.) for its input data and intended use in image-guided procedures. It is not a standalone software application that operates independently of physical medical devices.
Based on the provided information, the Fusion Bx 2.0 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Fusion Bx 2.0 Function: The description clearly states that Fusion Bx 2.0 is an imaging device that enhances the visualization of ultrasound images of the prostate. It processes and displays images obtained directly from the patient's body using an ultrasound probe.
- No Specimen Handling: There is no mention of collecting, preparing, or examining any specimens taken from the patient's body. The device works with live or reconstructed images of the prostate itself.
Therefore, Fusion Bx 2.0 falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Fusion Bx 2.0 is intended for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review, manipulation, and analysis tools. Additional features include patient data management, multiplanar reconstruction, 3D image registration, segmentation, image annotation, and to record the biopsies were acquired during the procedure.
Product codes
LLZ
Device Description
Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians' existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle quides/templates and needle qun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration.
Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound imaging
Anatomical Site
prostate
Indicated Patient Age Range
adult men
Intended User / Care Setting
physicians / clinic and hospital settings
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)
Fusion Bx 2.0 was test according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (published on May 11, 2005) and Content of Premarket Submission for Management of Cybersecurity in Medical Devices (published on October 2, 2014). Verification and validation plans and reports are provided as a part of the submission to demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 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.
Focal Healthcare Inc. % Karen Zhou, JD, MS Senior Associate, Regulatory Affairs & Quality 10 Morrow Ave., Unit 101 Toronto, Ontario M6R 2J1 CANADA
June 15th, 2018
Re: K181290
Trade/Device Name: Fusion Bx 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 11, 2018 Received: May 31, 2018
Dear Ms. Zhou:
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. Iisting 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 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,
Jeff Rodges
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181290
Device Name Fusion Bx 2.0
Indications for Use (Describe)
Fusion Bx 2.0 is intended for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review, manipulation, and analysis tools. Additional features include patient data management, multiplanar reconstruction, 3D image registration, segmentation, image annotation, and to record the biopsies were acquired during the procedure.
| 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) |
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510(k) Summary
[As required by 21 CFR 807.92]
Submitter's Name: Submitter's Address:
Contact Name: Title: Phone Number: Fax Number: Email:
Focal Healthcare Inc. 10 Morrow Avenue, Suite 101 Toronto, ON M6R 2J1 Canada
Ms. Karen Zhou, JD, MS Senior Associate, Regulatory Affairs & Quality +1 647 479 9603 +1 647 479 9604 karen.zhou@focalhealthcare.com
Date Prepared:
Device Proprietary Name: Device Common or Usual Name: Classification Name: Product Code: Regulation Number: Requlation Description:
11 May 2018
Fusion Bx™ 2.0 Medical Image Processing Workstation System, Image Processing, Radiological LLZ 21 CFR 892.2050 Picture Archiving and Communications System
Predicate Device:
Substantial equivalence is claimed to the following device:
| Device Proprietary Name: | Fusion Bx™ |
|---|---|
| Manufacturer | Focal Healthcare Inc. |
| 510(k) Number | K153166 |
| Device Common or Usual Name: | Medical Image Processing Workstation |
| Classification Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Regulation Description: | Picture Archiving and Communications System |
Device Description and Summary of Technological Characteristics
Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians' existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle quides/templates and needle qun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration.
Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and
4
the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.
Intended Use/Indications for Use
The indications for use statement for Fusion Bx 2.0 is identical to the predicate device.
Indications for Use Statement:
Fusion Bx 2.0 is intended for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review. manipulation, and analysis tools. Additional features include patient data management, image measurement, multiplanar reconstruction, 3D image registration, segmentation, image annotation, and recording of the locations where the biopsies were acquired during the procedure.
This device will assist clinicians in planning and performing image-quided interventional procedures such as biopsies and placing instruments and markers in the device is intended for adult men with suspected prostate disorders such as cancer or other prostate problems.
The system will integrate into existing workflow by connecting to standard ultrasound equipment. This system will not prevent the clinician from using the standard ultrasound equipment.
Substantial Equivalence
Fusion Bx 2.0 has the same device description and intended use compared to the predicate device also manufactured by Focal Healthcare Inc. The difference includes software and minor hardware updates:
-
· Hardware
. -
o Hardware improvements for ease of use, ergonomics and aesthetics
-
Software
- O Code refactoring for more robust performance
- Buq fixes O
These differences do not raise any safety or effectiveness concerns.
Testing and Performance Data
The Fusion Bx has been designed to comply with the following standards:
- -ISO 14971: 2007 [2012]
- -IEC 62304: 2006
- -IEC 60601-1: 2005 + A1: 2012 (E)
- IEC 60601-1-2: 2007/2012 -
- -IEC 62366: 2008
- -NEMA PS 3.1 - 3.20: 2011 - Digital Imaging and Communications in Medicine (DICOM)
Fusion Bx 2.0 was test according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (published on May 11, 2005) and Content of Premarket
5
Submission for Management of Cybersecurity in Medical Devices (published on October 2, 2014). Verification and validation plans and reports are provided as a part of the submission to demonstrate substantial equivalence to the predicate device.
Conclusion
The results of comparing the intended use, function, technological characteristics, mode of operation and specifications of Fusion Bx 2.0 with those of the predicate device demonstrate that Fusion Bx 2.0 is substantially equivalent to the predicate device.
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