(56 days)
No
The summary describes image processing and analysis tools but does not mention AI, ML, or related concepts like deep learning or neural networks. The "automatically generates a default estimate" based on published literature suggests rule-based or algorithmic approaches, not necessarily AI/ML.
No
The device is a pre-operative/post-operative planning software used for simulating/evaluating hip preservation surgical treatment options and historical case review, not for direct therapeutic intervention.
No
The device is intended for planning, simulation, and analysis of hip preservation surgical treatment options, not for diagnosing a condition.
Yes
The device description explicitly states it is a "software product" designed to be installed and run on a standard PC. It processes existing medical images and provides analysis and simulation tools without including any proprietary hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device's intended use: The DYONICS PLAN software is intended for planning and evaluating surgical treatment options based on medical images (CT scans). It processes images of the hip joint to help surgeons visualize anatomy, simulate procedures, and assess outcomes.
- Lack of specimen analysis: The device does not analyze any biological specimens taken from the patient. Its input is medical imaging data, not biological samples.
Therefore, the DYONICS PLAN Hip Impingement Planning System software falls under the category of medical imaging software or surgical planning software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The DYONICS PLAN Hip Impingement Planning System software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.
Product codes
LLZ
Device Description
The Smith & Nephew DYONICS PLAN Hip Impingement Planning System (here in after referred to as DYONICS PLAN software) is a software product that allows orthopedic surgeons and other healthcare professionals to visualize and perform analysis of digital images for assessment of hip preservation treatment options pre-operatively or post-operatively. The software enables the user to import computed tomography (CT) images. display various 2D views of the images, execute image segmentation and 3D rendering of the femur and pelvis. generate anatomic measurements, identify the areas and devree of conflict and simulate the resection of bony lesions, perform a dynamic range of motion analysis of the hip joint, and export the results in an output report. The software automatically generates a default estimate for each step of the analysis based on published literature, and the surgeon should always verify and make adjustments of the parameters based on their clinical judgment. The purpose of the software is to support other clinical findings and patient examination when assessing hip preservation treatment options.
The software is designed to be installed and run locally on a PC-compatible personal computer with a Windows operating system and a graphics card that meets the specified minimum requirements. The software facilitates the importation of CT images in DICOM format and allows the export of the output report in PDF or HTML format which can be referenced pre-operatively, intraoperatively or post-operatively. The user is provided with installation instructions which include the following: a link to a secure website, steps to download the installation file along with a license activation code and password.
Mentions image processing
The proposed and predicate devices both provide image processing tools, . including image segmentation and 3D rendering tools
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT) images
Anatomical Site
Hip joint, femur, pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeons and other healthcare professionals
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)
Software verification and validation testing demonstrates that the DYONICS PLAN does not raise any new questions of safety and efficacy as compared to the predicate device Mimics cleared in K073468.
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
Endoscopy Smith & Nephew, Inc. 150 Minuteinan Road Andover MA 01810 USA
000-049-1000 F 978-749-1443 www.smilh-nephew.com
We are smith&nephew
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
DYONICS PLAN Hip Impingement Planning System
Date Prepared: August 21, 2013
OCT 17 2013
A. Submitter's Name:
Smith & Nephew. Inc., Endoscopy Division 150 Minuteman Road, Andover MA. 01810
B. Company Contact
Kathleen Solomon Sr. Regulatory Affairs Specialist T 978-749-1605 F 978-749-1443
C. Device Name
| Trade Name: | DYONICS PLAN Hip Impingement Planning System |
|---|---|
| Common Name: | Hip Impingement Planning System |
| Classification Name: | Picture archiving and communications system per CFR |
| 882.2050 |
D. Predicate Devices
The Smith & Nephew DYONICS PLAN is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Mimics cleared in K073468.
1
Description of Device E.
The Smith & Nephew DYONICS PLAN Hip Impingement Planning System (here in after referred to as DYONICS PLAN software) is a software product that allows orthopedic surgeons and other healthcare professionals to visualize and perform analysis of digital images for assessment of hip preservation treatment options pre-operatively or post-operatively. The software enables the user to import computed tomography (CT) images. display various 2D views of the images, execute image segmentation and 3D rendering of the femur and pelvis. generate anatomic measurements, identify the areas and devree of conflict and simulate the resection of bony lesions, perform a dynamic range of motion analysis of the hip joint, and export the results in an output report. The software automatically generates a default estimate for each step of the analysis based on published literature, and the surgeon should always verify and make adjustments of the parameters based on their clinical judgment. The purpose of the software is to support other clinical findings and patient examination when assessing hip preservation treatment options.
The software is designed to be installed and run locally on a PC-compatible personal computer with a Windows operating system and a graphics card that meets the specified minimum requirements. The software facilitates the importation of CT images in DICOM format and allows the export of the output report in PDF or HTML format which can be referenced pre-operatively, intraoperatively or post-operatively. The user is provided with installation instructions which include the following: a link to a secure website, steps to download the installation file along with a license activation code and password.
F. Intended Use
The DYONICS PLAN is intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review. respectively.
G. Comparison of Technological Characteristics
The proposed DYONICS PLAN has the following similarities as the predicate device Mimics cleared in K073468. In that:
- The proposed and predicate devices both have the same intended use: . surgical planning tool
- . The proposed and predicate devices both utilize the same principle of operation: stand-alone software for computer assisted surgical planning
- The proposed and predicate devices both import CT scans in DICOM . format
- The proposed and predicate devices both provide image processing tools, . including image segmentation and 3D rendering tools
- � The proposed and predicate devices both provide measurement tools
2
Endosconv Smith & Hephew, Inc. 150 Minuteman Road Andover, MA 01810 1150
078-749-1000 F 978-740-1443 www.smith-nephew.com
> We are smith&nephew
-
The proposed and predicate devices both have tools for surgical simulation . and planning
The major differences between the proposed DYONICS PLAN and the predicate device Mimics are: -
The DYONICS PLAN is only indicated for surgical planning for hip . preservation treatment options whereas Mimics is for general surgical planning
-
. The DYONICS PLAN provides output report which can be referenced pre-operatively, intra-operatively or post-operatively.
-
Mimics uses additional image formats such as JPEG. TIFF. BMP, or Raw . image data
-
In addition to CT scans, Mimics can also import MRI scans. .
The differences between the proposed and predicate device does not introduce new types of safety or effectiveness questions. The DYONICS PLAN is only a pre-planning surgical tool that provides surgeons an additional method for planning hip preservation surgeries.
H. Summary Performance Data
Software verification and validation testing demonstrates that the DYONICS PLAN does not raise any new questions of safety and efficacy as compared to the predicate device Mimics cleared in K073468.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center ~ WO66-G609 Silver Spring, MD 20993-0002
October 17, 2013
KATHLEEN SOLOMON SMITH & NEPHEW, INC. SR. RA SPECIALIST 150 MINUTEMAN RD, ANDOVER MA 01810
Re: K132636
Trade/Device Name: DYONICS PLAN Hip Impingement Planning System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 21, 2013 Received: August 22. 2013
Dear Ms. Solomon:
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.
4
Page 2-Ms. Solomon
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.fda.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/default.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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
FDA
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Premarket Notification Indications for Use Statement
K132636 510(k) Number (if known):
Device Name: DYONICS PLAN Hip Impingement Planning System
Indications for Use:
The DYONICS PLAN Hip Impingement Planning System software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)
Image /page/5/Picture/10 description: The image shows a stylized logo with the letters FDA. The letters are formed by a series of parallel lines that create a three-dimensional effect. The letters are interconnected, with the F and D sharing a common vertical line. The A is depicted as a triangle with a horizontal line through the middle.