(75 days)
BoneVue is a software tool for 3D visualization of bone micro-architecture using MRI datasets with the possibility of manual or automated measurements of descriptive parameters regarding cortical and trabecular morphology. BoneVue is a workflow tool intended to assist a trained physician in the assessment of high-resolution MRI datasets of bone.
BoneVye evaluates high-resolution MRI datasets containing bone tissue and provides 3D visualization of trabecular structures as well as measurements of descriptive parameters regarding cortical and trabecular morphology.
The following cortical measurements are reported: average cortical inner diameter, average cortical outer diameter, and average cortical thickness.
The following trabecular measurements are reported: average measures of bone volume/total volume, trabecular thickness, trabecular number, and trabecular separation.
The 3D visualization module is used to display a high resolution 3D model of the trabecular bone and its micro-architecture. The 3D visualization helps a trained physician make a qualitative assessment of bone micro-architecture, which may be viewed from different angles. BoneVue allows standard surface rendering views as well as standard maximum intensity projection views.
Additionally, BoneVue offers the display of a standard "bone plug", a surface rendering of a central cylinder of trabecular tissue, as a representative sample of the bone microarchitecture.
This submission for MicroMRI's BoneVue Software v1 provides a limited amount of information regarding its performance testing. Based on the provided text, a comprehensive study description is not available.
Here's an analysis of what can be extracted and the information that is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets established acceptance criteria (general statement) | BoneVue has been successfully tested and has met acceptance criteria previously established in accordance with documented procedures. |
Missing Information: The document does not specify what the actual quantitative or qualitative acceptance criteria were, nor does it provide any specific numerical or categorical results for the device's performance against these criteria. It only states that the criteria were met.
2. Sample Size Used for the Test Set and Data Provenance:
Missing Information: The document does not state the sample size used for the test set or the provenance (country of origin, retrospective/prospective) of the data used in performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Missing Information: The document does not mention the number of experts, their qualifications, or how ground truth was established for the test set.
4. Adjudication Method for the Test Set:
Missing Information: The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Missing Information: The document does not mention whether an MRMC comparative effectiveness study was conducted, nor does it provide any effect size for human readers with or without AI assistance. The device is described as a "workflow tool intended to assist a trained physician," implying human-in-the-loop, but no comparative study is detailed.
6. Standalone (Algorithm Only) Performance Study:
Missing Information: The document does not detail a standalone performance study. The description focuses on its function as a tool to assist trained physicians, rather than as an independent diagnostic algorithm.
7. Type of Ground Truth Used for the Test Set:
Missing Information: The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set:
Missing Information: The document does not provide any information about a training set or its sample size.
9. How Ground Truth for the Training Set Was Established:
Missing Information: As no training set is mentioned, there is also no information on how its ground truth might have been established.
Summary of what is known from the provided text:
- Device: BoneVue Software v1, developed by MicroMRI, Inc.
- Purpose: 3D visualization of bone micro-architecture from MRI datasets and measurements of cortical and trabecular morphology.
- Indication for Use: A workflow tool to assist a trained physician in assessing high-resolution MRI datasets of bone.
- Performance Claim: "BoneVue has been successfully tested and has met acceptance criteria previously established in accordance with documented procedures." (This is a general statement of compliance, not a detailed report of the study itself.)
Crucially, the provided 510(k) summary does not contain the detailed study that proves the device meets specific acceptance criteria. It only states that such testing was performed and successful. Regulatory submissions often summarize performance testing rather than including the full study report.
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KC083691/
510 (k) BoneVue Software v1
December 11, 2008
XII. 510(k) SUMMARY .
美女女女
FEB 2 5 2009
This 510(K) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
Submitter's Information:
| Manufacturer: | MicroMRI, Inc. |
|---|---|
| 580 Middletown Boulevard | |
| Suite D-150. | |
| Langhorne, PA 19047 |
| Contact: | Richard Elrath |
|---|---|
| Manager Quality Assurance and Regulatory Affairs | |
| MicroMRI, Inc. | |
| Phone: | 267 212-1119 |
| Facsimile: | 267 212-1101 |
| Email: | relrath@micromri.com |
Trade Name, Common Name and Classification:
| Trade Name: | BoneVue |
|---|---|
| Common Names: | Image processing software |
| Classification Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |
Predicate Devices:
| 510k Reference No. & Date | Device Name | Manufacturer |
|---|---|---|
| K070831May 22, 2007 | Voxar 3D™ | Barco View MIS2 Anderson PlaceEdingburgh, EH6 5NP,UK |
| K011142May 8, 2001 | Aquarius Workstation™ | TeraRecon, Inc.2955 Campus Drive,Suite 325San Mateo, CA 94403 |
| K053281September 3, 2004 | EVMS™ EnterpriseVisual Medical System | Emageon UV, Inc.131 Wilson StreetSuite 700Madison, WI 53703 |
| K071331May 25, 2007 | Vitrea® Version 4.0Medical ImageProcessing Software | Vital Images, Inc.5850 Opus Parkway,Suite 300Minnetonka, MN 55343 |
Confidential and Proprietary
Page 39 of 218
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Image /page/1/Picture/2 description: The image contains the word "microMRI" in a stylized font. Below the word "microMRI" is the phrase "bone micro-architecture". The text is in a simple sans-serif font. The image appears to be a logo or title for a product or service related to bone micro-architecture imaging.
Device Description:
BoneVye evaluates high-resolution MRI datasets containing bone tissue and provides 3D visualization of trabecular structures as well as measurements of descriptive parameters regarding cortical and trabecular morphology.
The following cortical measurements are reported: average cortical inner diameter, average cortical outer diameter, and average cortical thickness.
The following trabecular measurements are reported: average measures of bone volume/total volume, trabecular thickness, trabecular number, and trabecular separation.
The 3D visualization module is used to display a high resolution 3D model of the trabecular bone and its micro-architecture. The 3D visualization helps a trained physician make a qualitative assessment of bone micro-architecture, which may be viewed from different angles. BoneVue allows standard surface rendering views as well as standard maximum intensity projection views.
Additionally, BoneVue offers the display of a standard "bone plug", a surface rendering of a central cylinder of trabecular tissue, as a representative sample of the bone microarchitecture.
Indications for Use:
BoneVue is a software tool for 3D visualization of bone micro-architecture using MRI datasets with the possibility of manual or automated measurements of descriptive parameters regarding cortical and trabecular morphology. BoneVue is a workflow tool intended to assist a trained physician in the assessment of high-resolution MRI datasets of bone.
Technological Characteristics:
BoneVue software does not control image acquisition and can be used with a variety of commercially available pulse sequences and imaging coils. BoneVue does not contact the patient, nor does it control any life sustaining devices. A trained physician interprets the data and information being displaved.
Performance Testing:
BoneVue has been successfully tested and has met acceptance criteria previously established in accordance with documented procedures.
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Image /page/2/Picture/0 description: The image shows the word "MicroMRI" in a stylized font. Below the word "MicroMRI" is the phrase "bone micro-architecture". The text is in a light color, and the background is white.
510 (k) BoneVue Software v1 December 11, 2008
Conclusion:
The 510(k) Pre-Market Notification contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate devices. BoneVue has been developed, and will be manufactured in accordance with the MicroMRI's established Quality Policy Manual, which meets all of the requirements of 21 CFR Part 820, Quality System Regulation and ISO 13485, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. The submission contains the results of a hazard analysis and the "Level of Concern" for potential hazards has been classified as "Minor".
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FB 2 5 2009
Mr. Richard Elrath Manager of Quality Assurance and Regulatory Affairs MicroMRI, Inc. 580 Middletown Boulevard, Suite D-150 LANGHORNE PA 19047
Re: K083691
Trade/Device Name: BoneVue
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Regulatory Class: II
Product Code: LLZ
Dated: December 8, 2008
Received: December 15, 2008
Dear Mr. Elrath:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Laurie B. Morris
anine M. Morris Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510 (k) BoneVue Software v1
December 11, 2008
XIII. STATEMENT of INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): _ NA
Device Name: _BoneVue
Indications for Use:
BoneVue is a software tool for 3D visualization of bone micro-architecture using MRI datasets with the possibility of manual or automated measurements of descriptive parameters regarding cortical and trabecular morphology. BoneVue is a workflow tool intended to assist a trained physician in the assessment of high-resolution MRI datasets of bone.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
| Concurrence/of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
08369 510(k) Number _
Confidential and Proprietary
§ 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).