(105 days)
Not Found
No
The description mentions "image processing" and an "algorithm" for femoral head detection, but there is no explicit mention of AI, ML, deep learning, or any related terms. The algorithm is stated to be based on a previous predicate device's algorithm, suggesting a more traditional image processing approach rather than a learned model.
No.
The device provides static localization information and assists surgeons with quantitative measurements, but does not directly treat or prevent a disease or condition.
No
The device assists the surgeon in determining quantitative measurements (alpha angle) during a procedure. It provides information to inform clinical decision making, but it does not make a diagnosis on its own.
No
The device is described as software provided pre-installed on a mobile touchscreen tablet, implying the tablet is part of the medical device system being submitted for clearance, not just a general-purpose computing platform. The description also mentions testing for compatibility with this specific tablet.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HipCheck's Function: HipCheck processes intra-operatively acquired X-ray images and provides static localization information and virtual measurement tools superimposed on those images. It assists the surgeon in making measurements during a surgical procedure.
- No Sample Analysis: HipCheck does not analyze any biological samples taken from the patient. Its input is medical imaging data.
Therefore, HipCheck falls under the category of medical devices that process and display medical imaging data to aid in surgical procedures, rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
HipCheck provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images. HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures.
Product codes
LLZ
Device Description
HipCheck enables the surgeon to intraoperatively measure alpha angle during hip arthroscopy procedures for femoroacetabular impingement. The software is provided to the user pre-installed on a mobile touchscreen tablet for which it has been tested for compatibility.
Alpha angle is a value used to indicate cam deformity of the femoral head, seen in patients presenting with femoroacetabular impingement. HipCheck provides a visualization tool for surgeons to determine the alpha angle intraoperatively, using virtual measurement tools superimposed on X-ray images collected during the procedure, which informs clinical decision making.
HipCheck is not patient contacting. The user is instructed to appropriately drape the tablet when used in the sterile field.
The femoral head detection algorithm on which the alpha angle algorithm is built, is based on the Femoral Head Detector algorithm used in the FluoroMap 1.0 software, which belongs to the secondary predicate device, the FluoroMap Computer Assisted Surgery System (K103400).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray images
Anatomical Site
Hip (femoroacetabular impingement)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons and clinical staff.
Surgical suite.
Postoperative case review.
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)
Design verification testing was performed on HipCheck as a result of the risk analysis and product requirements. Testing included software and bench verification testing, as well as design validation. Design validation testing was conducted in a simulated-use environment by surgeon and nurse users. Users were successfully able to use the HipCheck as intended to determine the alpha angle and utilize the virtual measurement and visualization tools.
Software testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to be of "moderate" level of concern since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator.
Alpha angle performance was evaluated in both verification and validation testing performed for HipCheck. Verification testing was conducted based on the identified design requirements and software requirement specifications of the Alpha Angle Core Algorithm. Additionally, validation testing was conducted to ensure applicable user needs were met for generating, manipulating, and using the overlay to determine the alpha angle. All testing had overall passing results.
Mechanical functionality testing included the following to ensure the device design meets user needs in the environment of use:
- Battery life -
- -Tablet weight
- -Tablet securement and attachment force to evaluate the connection between the tablet and its docking interface on the compatible operating table mounting arm
- -User interface temperature and functionality at operating temperatures
- RF ablation interference -
- -Mounting arm staying force
- Simulated-use testing -
Electrical safety and EMC testing was conducted on the compatible touchscreen tablet that the HipCheck software is provided pre-installed on. The tablet complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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December 13, 2018
Stryker Corp. Cara Mellits Sr. Regulatory Affairs Specialist 5900 Optical Ct SAN JOSE, CA 95138
Re: K182359
Trade/Device Name: HipCheck Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: November 12, 2018 Received: November 14, 2018
Dear Cara Mellits:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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
Indications for Use
510(k) Number (if known)
Device Name
HipCheck
Indications for Use (Describe)
HipCheck provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images.
HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures.
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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I. SUBMITTER
Stryker Corp. 5900 Optical Court San Jose, CA 95138 Phone: 408-754-2367 Email: cara.mellits@stryker.com Contact Person: Cara Mellits Date Prepared: August 28, 2018
II. DEVICE
Name of Device: HipCheck Common or Usual Name: HipCheck Classification Name: Picture Archiving and Communications System (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ
III. PREDICATE DEVICES
Primary Predicate:
Dyonics Plan Hip Impingement Planning Software, K132636
Secondary Predicate:
FluoroMap Computer Assisted Surgery System, K103400
Neither predicate has been subject to a design-related recall.
IV. DEVICE DESCRIPTION
HipCheck enables the surgeon to intraoperatively measure alpha angle during hip arthroscopy procedures for femoroacetabular impingement. The software is provided to the user pre-installed on a mobile touchscreen tablet for which it has been tested for compatibility.
Alpha angle is a value used to indicate cam deformity of the femoral head, seen in patients presenting with femoroacetabular impingement. HipCheck provides a visualization tool for surgeons to determine the alpha angle intraoperatively, using virtual measurement tools superimposed on X-ray images collected during the procedure, which informs clinical decision making.
4
HipCheck is not patient contacting. The user is instructed to appropriately drape the tablet when used in the sterile field.
The femoral head detection algorithm on which the alpha angle algorithm is built, is based on the Femoral Head Detector algorithm used in the FluoroMap 1.0 software, which belongs to the secondary predicate device, the FluoroMap Computer Assisted Surgery System (K103400).
V. INTENDED USE
HipCheck provides static localization information derived from image processing of intraoperatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images.
VI. INDICATIONS FOR USE
HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures.
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| Characteristic | Subject Device | Primary Predicate Device
Dyonics Plan Hip Impingement
Planning Software | Secondary Predicate Device
FluoroMap Computer Assisted Surgery
System |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | HipCheck provides static
localization information derived
from image processing of intra-
operatively acquired X-ray images,
by superposition of virtual
measurement tools onto those X-
ray images. | 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. | FluoroMap is a computer controlled
stereotaxic image guided surgery
system.
It provides static localization
information derived from image
processing of intra-operatively
acquired X-ray images, by
superposition of virtual implants and
instruments onto those X-ray images. |
| Indications for Use
Statement | HipCheck assists the surgeon to
determine quantitative
measurements during
femoroacetabular impingement
procedures. | 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. | FluoroMap assists the surgeon to
determine the needed size and
position of orthopedic implants
during proximal femur fracture
surgery using the Stryker Gamma3
Nail system.
The system should be operated only
by trained personnel such as
surgeons and clinical staff. |
| Product Code(s) | Same as predicate. | LLZ | OLO, LLZ |
| Regulation Number | Same as predicate. | 892.2050 | 882.4560 |
| Intended Patient
Population | Same as predicate. | Patients undergoing orthopedic
surgery. | Patients undergoing orthopedic
surgery. |
| Surgical Approach | Orthopedic surgery, specifically
femoroacetabular impingement. | Orthopedic surgery, specifically hip
preservation treatment options. | Orthopedic surgery, specifically at the
proximal femur. |
| Intended Users | Same as predicate. | Orthopedic surgeons and other
healthcare professionals. | Surgeons and clinical staff. |
| Operational
Environment | Surgical suite.
Postoperative case review. | Preoperative planning.
Postoperative case review. | Surgical suite. |
| Primary Device
Function | Locate the femoral head and neck
to determine the alpha angle using
intra-operative X-ray images. | Visualization and assessment of hip
preservation surgical treatment
options using CT images. | Assistance in planning and
positioning of orthopedic implants
using intra-operative X-ray images. |
| Main System
Components | Same as predicate. | - Software | - Software
-
Reference device for C-arm
-
Reference device for
instrumentation |
| User Interface | Tablet. | Personal Computer (PC). | Computer and monitor. |
| Body Contact and Use | Same as predicate. | N/A – Device does not have any
patient contact. | Reference device for instrumentation
(closed tube clip) has patient contact. |
| Sterile, Single-use | Same as predicate. | N/A – Device is not provided sterile
or as a single use product. | Reference device for instrumentation
(closed tube clip) is delivered sterile
and as a single use product. |
| Design | - Workstation for viewing software -
Dedicated software for image
processing and display of virtual
measurement tools | - Installed and run locally on a PC -
Software for image processing
-
Provides virtual measurement
tools, surgical simulation and
planning tools | - Reference frames containing metal
marker spheres -
Reference frames are attached to the
implant system and to the C-arm -
Workstation for viewing software
-
Dedicated software for image
processing and display of positional
information |
| Principles of Operation | Acquire intra-operative X-ray
images, process the images and | Stand-alone software for computer
assisted surgical planning, via | Acquire intra-operative X-ray images,
register the images through metal |
| | display the virtual measurement
tools onto images. | import of CT scans in DICOM format,
provides image processing and
measurement tools. | marker detection and display the
actual position of instruments and
implants onto images. |
| Function | Display on a tablet screen virtual
measurement tools in relationship
to X-ray images. | Display on a computer screen
virtual measurement and surgical
planning tools in relationship to 2D
views and 3D renderings generated
from CT scans. | Display on a computer screen
navigated instruments and implants
in relationship to X-ray images. |
| Image Processing | - Transfer X-ray images from C-arm
to computer platform -
Overlay virtual measurement
tools onto images | - Import DICOM images from CT
scans to computer platform. -
Process images to display various
2D views and 3D renderings. -
Provide virtual measurement
tools, surgical simulation and
planning tools. | - Transfer X-ray images from C-arm to
computer platform -
Remove image distortions
-
Register images to patient space
-
Overlay instruments and implants
onto images |
| Energy Source | Same as predicate. | No energy applied to the patient or
operating staff. | No energy applied to the patient or
operating staff. |
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
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Discussion of Similarities and Differences
Primary Predicate (Dyonics Plan, K132636): Dyonics Plan is a surgical planning tool, in that its operational environment is primarily pre-operative, thereby outside the surgical suite. However, the software allows for the export of the plan in PDF or HTML format, which can be referenced intraoperatively. As such, the Dyonics Plan utilizes CT preoperative imaging for displaying 2D views and 3D renderings and provides virtual measurement tools for visualization and analysis of hip preservation treatment options. HipCheck's operational environment is primarily intraoperative, within the surgical suite. Since HipCheck is primarily used intraoperatively, it displays intraoperatively collected X-ray images, likewise providing virtual measurement tools for visualization purposes during femoroacetabular impingement procedures.
While the operational environment may differ, the intended use is the same. Dyonics Plan utilizes image processing of preoperative CT images and virtual measurement tools to visualize hip anatomy and plan preservation procedures. HipCheck utilizes image processing of intraoperatively collected X-ray images and virtual measurement tools to visualize hip anatomy during femoroacetabular impingement procedures. The Dyonics Plan and HipCheck have the same intended use, as defined in their shared regulation 21 CFR 892.2050. Though their indications for use statements differ, both are used in the treatment of femoroacetabular impingement.
Secondary Predicate (FluoroMap, K103400): In addition to its clearance as an orthopedic stereotaxic instrument (OLO; 21 CFR 882.4560), FluoroMap is also cleared as a picture archiving and communications system (LLZ; 21 CFR 892.2050). This is due to the core functionality of FluoroMap's software that supports the acceptance, display, and digital processing of X-ray images in order for FluoroMap to function as intended. FluoroMap software facilitates image manipulation and quantification in order to achieve visualization of the placement of virtual implants and instruments.
Similarly, HipCheck shares this core functionality to achieve visualization of the placement of virtual measurement tools for the determination of alpha angle. HipCheck's Alpha Angle algorithm is built directly on the Femoral Head Detector algorithm within the FluoroMap software (K103400). HipCheck leverages the Femoral Head Detector algorithm from FluoroMap for its same intended purpose, simply in a different application.
While the primary function of FluoroMap is as a navigated surgical system for placing orthopedic implants, the how behind the device's ability to achieve its intended purpose is important in the substantial equivalence discussion for HipCheck.
9
VIII. PERFRMANCE DATA/NON-CLINICAL TESTING
Design verification testing was performed on HipCheck as a result of the risk analysis and product requirements. Testing included software and bench verification testing, as well as design validation. Design validation testing was conducted in a simulated-use environment by surgeon and nurse users. Users were successfully able to use the HipCheck as intended to determine the alpha angle and utilize the virtual measurement and visualization tools.
Software testing
Software testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to be of "moderate" level of concern since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator.
Alpha Angle Performance Testing
Alpha angle performance was evaluated in both verification and validation testing performed for HipCheck. Verification testing was conducted based on the identified design requirements and software requirement specifications of the Alpha Angle Core Algorithm. Additionally, validation testing was conducted to ensure applicable user needs were met for generating, manipulating, and using the overlay to determine the alpha angle. All testing had overall passing results.
Mechanical testing
Mechanical functionality testing included the following to ensure the device design meets user needs in the environment of use:
- Battery life -
- -Tablet weight
- -Tablet securement and attachment force to evaluate the connection between the tablet and its docking interface on the compatible operating table mounting arm
- -User interface temperature and functionality at operating temperatures
- RF ablation interference -
- -Mounting arm staying force
- Simulated-use testing -
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted on the compatible touchscreen tablet that the HipCheck software is provided pre-installed on. The tablet complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
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Animal Study
No animal testing was conducted to determine the safety and effectiveness of HipCheck.
Clinical Studies
No human clinical testing was conducted to determine the safety and effectiveness of HipCheck.
IX. CONCLUSIONS
Based on the shared technological characteristics and intended use, HipCheck is substantially equivalent to the primary predicate, Dyonics Plan Hip Impingement Planning Software (K132636), and the secondary predicate, FluoroMap Computer Assisted Surgery System (K103400). Differences between the subject and predicate devices' technological characteristics do not raise different questions of safety and effectiveness of HipCheck. The results of the non-clinical testing conducted supports the safety of the device and demonstrates that HipCheck performs as intended in the specified use conditions.