(73 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard 3D modeling and planning tools, not AI/ML-driven analysis or recommendations.
No.
The Preview Shoulder software is a surgical planning tool used by orthopedic surgeons to develop pre-operative plans. It does not directly treat or diagnose patients.
No
The "Intended Use / Indications for Use" section explicitly states, "It is to be used for adult patients only and should not be used for diagnostic purposes." Additionally, the "Device Description" notes that "Preview Shoulder does not provide a diagnosis or surgical recommendation."
Yes
The device is explicitly described as a "standalone software application" and its functions are solely related to processing digital images and creating digital representations and reports. There is no mention of any accompanying hardware components that are part of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study." It is used for surgical planning, not for diagnosing a disease or condition.
- Exclusion of Diagnostic Use: The "Intended Use / Indications for Use" section clearly states, "It is to be used for adult patients only and should not be used for diagnostic purposes."
- Function: The primary function is to process CT images, create 3D models, and allow surgeons to digitally place implants for planning. It does not perform any tests on biological samples or provide diagnostic information.
- No Mention of Biological Samples: IVD devices typically involve testing biological samples (blood, urine, tissue, etc.). This device only uses medical images.
In summary, the Preview Shoulder software is a surgical planning tool that utilizes medical imaging data, not an in vitro diagnostic device that analyzes biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study.
The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source.
3D digital representations of various implant models are available in the planning software. Preview Shoulder allows the user to digitally perform the surgical planning a representation of the patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy.
The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Product codes
QIH
Device Description
The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty. Preview Shoulder includes 3D digital representations of implants for placement in images used for surgical planning. Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users.
The primary function of Preview Shoulder is to receive and process DICOM CT image(s) of patients. Preview Shoulder can be used to place an implant in the original CT image and place an implant in the 3D model of reconstructed bone. The Preview Shoulder allow the user to perform surgical planning and generate an output surgical report. Preview Shoulder does not provide a diagnosis or surgical recommendation. The surgeon is responsible for selecting and placing the implant model for pre-surgical planning purposes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging study, DICOM CT scan series, CT image(s)
Anatomical Site
Shoulder
Indicated Patient Age Range
Adults
Intended User / Care Setting
Orthopedic surgeons, Surgeons
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
All validation testing was performed on a fully configured system using anonymized patient shoulder CT images to emulate intended use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation testing was performed on the Preview Shoulder, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions". The software is considered as a "basic documentation level" since a failure or latent design flaw would not present a hazardous situation with a probable risk of death or serious injury to either a patient, user of the device, or others in the environment of use, prior to the implementation of risk control measures. The Verification and Validation testing was performed to assess the safety and effectiveness of the device, to demonstrate the processing of patient images to produce accurate and repeatable 3D reconstructed bones and surgical coordinates provided to the surgeon. Testing verified that the system performs as intended. The software has been verified via code reviews and automated and manual testing. The measurement capabilities of the Preview Shoulder were validated to be significantly equivalent to a benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342). All validation testing was performed on a fully configured system using anonymized patient shoulder CT images to emulate intended use. All user features have been validated by surgeons.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Genesis Software Innovations, Preview Shoulder (K210556)
Reference Device(s)
Pixmeo SARL, Osirix MD (K101342)
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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Genesis Software Innovations Matt Miller Director of Technology Development 2851 Charlevoix Dr. SE Suite 327 Grand Rapids, MI 49546
Re: K240172
April 4, 2024
Trade/Device Name: Preview Shoulder Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: March 7, 2024 Received: March 7, 2024
Dear Matt Miller:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
K240172
Device Name
Preview Shoulder
Indications for Use (Describe)
The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study.
The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source.
3D digital representations of various implant models are available in the planning software. Preview Shoulder allows the user to digitally perform the surgical planning a representation of the patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy.
The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
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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Image /page/3/Picture/0 description: The image shows the logo for Genesis Software Innovations. The logo features two interlocking squares on the left side. To the right of the squares is the word "GENESIS" in a bold, sans-serif font. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in a smaller, sans-serif font.
510(k) Summary
| Date Prepared: | March 7, 2024 |
|---|---|
| Submitter: | Genesis Software Innovations |
| 2851 Charlevoix Dr. SE Suite 327 | |
| Grand Rapids, MI 49546 | |
| Contact: | Matt Miller |
| Director of Technology Development | |
| Genesis Software Innovations | |
| (616) 294-1026 Ext. 5 | |
| matt.miller@genesissoftwareinnovations.com | |
| Proprietary Name: | Preview Shoulder |
| Common Name: | Pre-operative planning software |
| Classification Name: | Picture archiving and communications system |
| Regulation Number: | 21 CFR Section 892.2050 |
| Classification Code: | QIH |
| Review Panel: | Radiology |
| Substantially | |
| Equivalent Device: | Genesis Software Innovations, Preview Shoulder (K210556) |
| Reference Device: | Pixmeo SARL, Osirix MD (K101342) |
Device Description:
The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty. Preview Shoulder includes 3D digital representations of implants for placement in images used for surgical planning. Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users.
The primary function of Preview Shoulder is to receive and process DICOM CT image(s) of patients. Preview Shoulder can be used to place an implant in the original
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Image /page/4/Picture/1 description: The image shows the logo for Genesis Software Innovations. The logo consists of two overlapping blue squares on the left, followed by the word "GENESIS" in blue, block letters. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in smaller, gray letters.
CT image and place an implant in the 3D model of reconstructed bone. The Preview Shoulder allow the user to perform surgical planning and generate an output surgical report. Preview Shoulder does not provide a diagnosis or surgical recommendation. The surgeon is responsible for selecting and placing the implant model for pre-surgical planning purposes.
Indications for Use:
The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study.
The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source.
3D digital representations of various implant models are available in the planning software. Preview Shoulder allows the user to digitally perform the surgical planning by showing a representation of the patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy.
The software allows the surgeon to generate a report, detailing the output of the planning activity.
Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Comparison of Technological Characteristics:
The Preview Shoulder fundamental technological characteristics are similar to those of the predicate device as noted in the following table.
| Characteristic | Proposed Device
Genesis Software
Innovations
Preview Shoulder
(K240172) | Predicate Device
Genesis Software
Innovations
Preview Shoulder
(K210556) | Significant Differences |
|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | QIH | QIH | N/A |
| Regulation
Number | 21 CFR 892.2050 | 21 CFR 892.2050 | N/A |
| Intended Use | Preoperative planning
software for surgery | Preoperative planning
software for surgery | N/A |
| Indications for use | The Preview Shoulder
software is intended to be | The Preview Shoulder
software is intended to be | N/A |
| | used as a tool for
orthopedic surgeons to
develop pre-operative
shoulder plans based on
a patient CT imaging
study. | used as a tool for
orthopedic surgeons to
develop pre-operative
shoulder plans based on
a patient CT imaging
study. | |
| | The import process allows
the user to select a
DICOM CT scan series
from any location that the
user's computer sees as
an available file source.
3D digital representations
of various implant models
are available in the
planning software.
Preview Shoulder allows
the user to digitally
perform the surgical
planning by showing a
representation of the
patient's shoulder
anatomy as a 3D model
and allows the surgeon to
place the implant in the
patient's anatomy.
The software allows the
surgeon to generate a
report, detailing the output
of the planning activity.
Experience in usage and
a clinical assessment are | The import process allows
the user to select a
DICOM CT scan series
from any location that the
user's computer sees as
an available file source.
3D digital representations
of various implant models
are available in the
planning software.
Preview Shoulder allows
the user to digitally
perform the surgical
planning by showing a
representation of the
patient's shoulder
anatomy as a 3D model
and allows the surgeon to
place the implant in the
patient's anatomy.
The software allows the
surgeon to generate a
report, detailing the output
of the planning activity.
Experience in usage and
a clinical assessment are | |
| | necessary for a proper
use of the software. It is
to be used for adult
patients only and should
not be used for diagnostic
purposes. | necessary for a proper
use of the software. It is
to be used for adult
patients only and should
not be used for diagnostic
purposes. | |
| Subspecialties | Preview Shoulder allows
the surgeon to perform
the pre-surgical planning
for the following
subspeciality:
Upper Limb: Total
Shoulder Replacement | Preview Shoulder allows
the surgeon to perform
the pre-surgical planning
for the following
subspeciality:
Upper Limb: Total
Shoulder Replacement | N/A |
| Type of Use | Prescription Only | Prescription Only | N/A |
| Patient
Population | Adults | Adults | N/A |
| End User | Surgeons | Surgeons | N/A |
| Computer | Personal Computer or
Workstation | Personal Computer or
Workstation | N/A |
| Operating
System | Windows or MacOS | Windows or MacOS | N/A |
| | | | |
| Device
Availability | The software is installed
and started from the
user's computer. | The software is installed
and started from the
user's computer. | N/A |
| Images source | Receives medical images
from various sources
locally available to the
user's computer. | Receives medical images
from various sources
locally available to the
user's computer. | N/A |
| | Preview Shoulder does
not communicate directly
to a PACS system. | Preview Shoulder does
not communicate directly
to a PACS system. | |
| Data
processing | The software processes
the CT image, which
allows the implant to be
overlapped/ placed in
both the original scan
images and/or the 3D
model reconstruction of
the bone for surgical
planning. | The software processes
the CT image, which
allows the implant to be
overlapped/ placed in
both the original scan
images and/or the 3D
model reconstruction of
the bone for surgical
planning. | Similar
Post-processing algorithm
is added to further refine
the 3D mesh quality.
Algorithm is added to
calculate humerus-side
features used for implant
selection, placement, and
pre-surgical planning. |
| Digital overlap
of
prosthetic
material | The software allows the
implant rendering to be
overlapped/placed in the
3D model reconstruction
of the bone that results
from the processed CT
image(s).
The software facilitates
the placement and
rendering of scapula and
humerus implants for
anatomic partial or total
shoulder arthroplasty and
reverse total shoulder
arthroplasty. | The software allows the
implant rendering to be
overlapped/placed in the
3D model reconstruction
of the bone that results
from the processed CT
image(s).
The software facilitates
the placement and
rendering of scapula
implants for anatomic
partial or total shoulder
arthroplasty and reverse
total shoulder
arthroplasty. | Similar
Humerus implants are
added to implant planning
library. |
| Interactive
model
positioning | Yes | Yes | N/A |
| Interactive
model
dimensioning | Yes | Yes | N/A |
| Model rotation | Yes | Yes | N/A |
| Support for
digital
prosthetic
materials
provided by
the
manufacturers | Yes | Yes | N/A |
| Automatic
Calibration | No | No | N/A |
| Pre-surgical
planning | Yes | Yes | N/A |
| Contact with
the patient | No | No | N/A |
| Control of life
supporting
devices | No | No | N/A |
| Human
intervention for
image
interpretation | Yes | Yes | N/A |
| Ability to add
additional
modules when
available | Yes | Yes | N/A |
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Image /page/5/Picture/0 description: The image shows the alphanumeric string "K240172" in a clear, sans-serif font. The characters are uniformly sized and spaced, making the string easily readable. The black text stands out against the white background, ensuring high contrast and visibility. The string appears to be a code or identifier, possibly a serial number or product key.
Image /page/5/Picture/1 description: The image shows the logo for Genesis Software Innovations. The logo consists of two interlocking blue squares on the left, followed by the word "GENESIS" in large, blue, sans-serif font. Below the word "GENESIS" are the words "SOFTWARE INNOVATIONS" in a smaller, sans-serif font.
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Image /page/6/Picture/0 description: The image contains the alphanumeric string "K240172" in a simple, sans-serif font. The text is black against a white background, and the letters and numbers are evenly spaced. The text appears to be a code or identifier.
Image /page/6/Picture/1 description: The image contains the logo for Genesis Software Innovations. The logo consists of two overlapping blue squares that are rotated 45 degrees. To the right of the squares is the word "GENESIS" in blue, and below that is the phrase "SOFTWARE INNOVATIONS" in a smaller font.
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Image /page/7/Picture/1 description: The image shows the logo for Genesis Software Innovations. The logo consists of two interlocking blue squares on the left, followed by the word "GENESIS" in large, bold, blue letters. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in smaller, gray letters.
Non-Clinical Testing Summary:
Software Verification and Validation testing was performed on the Preview Shoulder, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions". The software is considered as a "basic documentation level" since a failure or latent design flaw would not present a hazardous situation with a probable risk of death or serious injury to either a patient, user of the device, or others in the environment of use, prior to the implementation of risk control measures. The Verification and Validation testing was performed to assess the safety and effectiveness of the device, to demonstrate the processing of patient images to produce accurate and repeatable 3D reconstructed bones and surgical coordinates provided to the surgeon. Testing verified that the system performs as intended. The software has been verified via code reviews and automated and manual testing. The measurement capabilities of the Preview Shoulder were validated to be significantly equivalent to a benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342). All validation testing was performed on a fully configured system using anonymized patient shoulder CT images to emulate intended use. All user features have been validated by surgeons.
Clinical Testing Summary:
Clinical testing was not necessary to demonstrate substantial equivalence of the Preview Shoulder to the predicate device.
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Image /page/8/Picture/1 description: The image shows the logo for Genesis Software Innovations. The logo consists of two interlocking blue squares on the left, followed by the word "GENESIS" in blue, sans-serif font. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in a smaller, sans-serif font.
Overall Conclusio
Based on the information presented in this submission, Genesis Software Innovations concludes that the Preview Shoulder is similar to the predicate devices in regard to indications, principles of operation, and technological characteristics. Additionally, verification and validation tests demonstrate the safety and efficacy of the device to meet its intended use and specifications. Genesis Software Innovations believes that the proposed device, Preview Shoulder, is similar to its identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.