DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
Device Facts
| Record ID | K133030 |
|---|---|
| Device Name | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) |
| Applicant | Invivo Corporation |
| Product Code | LLZ · Radiology |
| Decision Date | Jan 22, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
DynaCAD/Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices. The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/or projected path of the interventional instrument. The device 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.
Device Story
DynaCAD/Prostate Interventional is medical device software installed on a standard computer workstation. It functions as an image-guidance accessory for prostate interventions. The software imports DICOM MR images from a network or removable media. It processes these images to visualize and record simulated paths of tracked interventional tools (e.g., needle guides, sleeves) relative to patient anatomy. The physician uses the software to plan the procedure and manually adjust the DynaTRIM positioning device. The software does not control the scanner or interventional hardware; clinicians must verify positioning via MR verification scans. The system assists in clinical workflow by providing visual guidance for needle placement, potentially improving procedural accuracy and patient outcomes during prostate interventions.
Clinical Evidence
No clinical data. Safety and effectiveness supported by preclinical software verification and validation testing, including validation of the software with the DynaTRIM device in a simulated clinical use setting.
Technological Characteristics
Software-based image-guidance system; runs on Windows platform; imports DICOM MR images; displays fiducial-tracked instrumentation; kiosk-mode operation (no OS access); intended for use with DynaTRIM positioning hardware.
Indications for Use
Indicated for physicians performing treatment planning and guidance for clinical, interventional, or diagnostic prostate procedures using MR imaging systems and interventional devices.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- DynaCAD V1.0 (K041286)
Reference Devices
- PERCUNAV (K121498)
Submission Summary (Full Text)
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JAN 2 2 2014 3545 SW 47th Avenue ainesville, FL 32608 USA
1-800-524-1476
252-226-0010
www.inyivocorp.com
# Manufacturer/Owner:
Invivo Corporation 3545 SW 47th Avenue Gainesville, Florida 32608 USA
Contact Person (modified 2014-01-15): Michael S. Preto Regulatory Affairs Specialist Philips Medical Systems (Cleveland), Inc.
| Tel: | +1 440 483 2295 |
|---------|---------------------------|
| Fax: | +1 440 483 4918 |
| E-mail: | michael.preto@philips.com |
#### Date Prepared:
January 15. 2014
#### Proprietary Name/Classification Name:
Propriety/Trade Name: DynaCAD/Prostate Interventional Common Name: Image-guided, interventional planning software Classification Name: Picture archiving and communications system Class II: 21 CFR 892.2050 Product Code: LLZ
#### Predicate Device (to which equivalence is claimed) (modified 2014-01-15):
| Propriety/Trade Name: | DynaCAD V1.0 |
|-------------------------|---------------------------------------------------------------------------------------|
| Common Name: | Magnetic Resonance Diagnostic device &<br>Picture Archiving and Communications System |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging |
| Class II: | 21 CFR 892.1000, 21 CFR 892.2050 |
| Product Code: | LNH, LLZ |
| Premarket Notification: | K041286 |
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### Device Description:
DynaCAD/Prostate Interventional (a.k.a. Dynal.OC/Prostate) is medical device software that is intended to be loaded onto a commercially available computer workstation. The DynaLOC/Prostate software application is designed for use with the DynaTRIM positioning device. The software receives DICOM images from a pre-procedure magnetic resonance (MR) study and performs calculations to assist the clinician with adjustments to the DynaTRIM positioning device. The software does not directly control the Dynall'RIM device, the interventional accessories or the MR scanner. The users must manually adjust the DynaTRIM device and confirm proper positioning of the interventional accessories via an MR verification scan. Additionally, the users must manually control the MRI scanner to obtain the correct MR data sets.
### Indications for Use (modified 2014-01-15):
DynaCAD/Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.
The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/or projected path of the interventional instrument.
The device 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.
### Substantial Equivalence Discussion (modified 2014-01-15):
The DynaCAD/Prostate Interventional software (a.k.a. Dynal.OC/Prostate) is used to facilitate clinical workflow for magnetic resonance image (MRI)-assisted interventional procedures of the prostate. The Dynal.OC/Prostate software is used with the DynaTRIM positioning device and associated interventional accessories, which are supplied separately. The DynaLOC/Prostate software module is substantially equivalent to the DynaCAD V1.0 (K041286) system. The wording of the indications for use statement differs between the primary predicate and proposed device; however, the statements are equivalent with respect to use for MR-guided interventional planning with interventional hardware.
| | Predicate Device: | Reference Predicate |
|--------------------|------------------------------------|--------------------------------------------|
| 510(k) Name | DynaCAD V1.0 .<br>(DynaLOC module) | PERCUNAV<br>(preoperative planning module) |
| 510(k) Number | K041286 | K121498 |
| FDA Clearance Date | July 21, 2004 | December 14, 2012 |
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#### Device Similarities
The DynaLOC/Prostate 510(k) subject device and predicates have similar technologies for planning of interventional procedures. Both include software written to run on a Windows platform; both function as a kiosk, not allowing the end-user to access any operating system functions or system configuration panels: both have the ability to import magnetic resonance DICOM images from various sources, such as a computer network or removable media; both display fiducial-tracked instrumentation in relation to the patient anatomy; both require instrument registration and verification images prior to the actual intervention.
#### Device Differences
The software code base for the Dynal.OC/Prostate software is equivalent to the Dynal.OC module for primary predicate device. DynaCAD V1.0 (K041286). Both devices are used with interventional positioning devices; however. the type of hardware used differs because of the target anatomy and approach. The predicate is used with interventional devices that allow a percutaneous approach (e.g. breast biopsies). The proposed device is used with the DynaTRIM device for planning prostate interventions.
### Reference Predicate (modified 2014-01-15):
The key difference between the 510(k) subject device and reference PERCUNAV predicate from an overall system perspective is that PERCUNAV predicate offers realtime navigation capabilities using ultrasound technology and fusion of images from multiple modalities (MR, CT, PET. SPECT etc.), whereas the DynaCAD system uses only one image modality, magnetic resonance (MR) imaging. Although the PERCUNAV system includes a pre-procedure planning module that is similar to the Dynal.OC/Prostate module of the DynaCAD system, it is in a different regulation number (21 CFR 892.1750) than the 510(k) subject device. As such, it is considered a reference predicate for the purpose of the substantial equivalency discussion.
Another key difference is the PERCUNAV predicate does not include the DynaTRIM positioning device and accessories; however. PERCUNAV does include other interventional equipment, such as probes and needle assemblics. Although the PERCUNAV predicate offers more features than the 510(k) subject device, the preprocedure planning module of the PERCUNAV predicate closely matches the features and workflow for the DynaCAD/Prostate Interventional system. The PERCUNAV preprocedure planning software may be used with MR images alone (without ultrasound) and interventional devices in much the same manner as the Dynal.OC/Prostate software module is used with the DynaTRIM device.
#### Indications for Use Differences (modified 2014-01-15):
The DynaCAD/Prostate Interventional indications statement is not identical to that of the DynaCAD V1.0 (K041286) predicate:
- The features that do not apply to the 510(k) subject device were removed; .
- The limitation of percutancous procedures was removed; and .
- Reference to the prostate organ was added. .
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K133030
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These changes do not raise new issues of safety and effectiveness. Use of the DynaLOC/Prostate software with the DynaTRIM positioning device allows planning of standard prostate interventions (e.g. transrectal approach with biopsy guns).
#### Preclinical & Clinical Data
The safety and effectiveness of the DynaCAD/Interventional software (a.k.a. Dynal.OC/Prostate) for the proposed indications for use is supported by preclinical software verification and validation testing. This includes validation of the software with the DynaTRIM device is a simulated clinical use setting.
### Conclusion (modified 2014-01-15):
The DynaLOC/Prostate software application is similar to the Dynal.OC software for the predicate DynaCAD V1.0 (K041286) system. The wording of the indications for use statement differs between the primary predicate and proposed device; however, the statements are equivalent with respect to use for MR-guided interventional planning with interventional hardware. Since the proposed device is used with the Dyna'l RIM positioning device, reference to the prostate organ was added to the indications statement. Also, the predicate clearance includes statements related to the other modules of the DynaCAD software applications. Since these do not pertain to the Dynal.OC/Prostate module, they were not included in the proposed indications for use statement.
Since the DynaCAD VI.0 (K041286) clearance is limited to percutancous procedures (e.g. breast), the pre-procedure planning module of the PERCUNAV system (K121498) was selected as a reference predicate. The characteristics and workflow for the DynaLOC/Prostate software is similar to those of the preoperative planning module of the PERCUNAV predicate (K121498), which is not limited to percutaneous procedures.
The results of software verification and validation testing support that the Dynal.OC/Prostate software is safe and effective when used with the DynaTRIM device for prostate interventional procedures. Therefore, the DynaCAD/Prostate Interventional planning software (DynaLOC/Prostate) is substantially equivalent to the predicate DynaLOC software application cleared in K041286 (DynaCAD V1.0).
> VOL 001 / Section 006 Page 4 of 4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Invivo Corporation % Mr. Michael Preto Regulatory Affairs Specialist 3545 S W 47th Avenue GAINSVILLE FL 32608
Re: K133030
Trade/Device Name: DynaCAD/Prostate Interventional (aka DynaLOC/Prostate) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 12, 2013 Received: December 13, 2013
Dear Ms. Simpson:
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 (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.
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Page 2-Mr. Preto
. . . . .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
For
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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## SECTION 5 - Indications for Use DynaCAD/Prostate Interventional (revised 102113)
#### k133030 510(k) Number (if known):
Device Name: DynaCAD/Prostate Interventional
#### Indications for Use:
DynaCAD/Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.
The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/or projected path of the interventional instrument.
The device 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Michael D. O'Hara
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k):
VOL 001/Section_005 Page 1 of 1
