Who is the manufacturer of Preview Shoulder?

Genesis Software Innovations filed the 510(k) submission for Preview Shoulder (K240172).

What is the FDA product code for Preview Shoulder?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Preview Shoulder?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Preview Shoulder?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Preview Shoulder

Q: What are the predicate devices for Preview Shoulder?

Genesis Software Innovations, Preview Shoulder (K210556).

K240172 · Genesis Software Innovations · QIH · Apr 4, 2024 · Radiology

Device Facts

Record ID	K240172
Device Name	Preview Shoulder
Applicant	Genesis Software Innovations
Product Code	QIH · Radiology
Decision Date	Apr 4, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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.

Device Story

Standalone software for pre-operative planning of shoulder arthroplasty; inputs DICOM CT scans; transforms images into 3D bone reconstructions; allows surgeon to place 3D digital implant models (scapula and humerus) into anatomy; generates surgical planning report. Used in clinical settings by orthopedic surgeons; output assists in surgical implant selection and positioning. Does not provide diagnosis or surgical recommendations; surgeon retains responsibility for all planning decisions. Benefits include improved pre-surgical visualization and planning accuracy.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation performed per FDA guidance. Measurement capabilities validated against Osirix MD (K101342) using anonymized patient CT images. System performance verified via code reviews, automated, and manual testing.

Technological Characteristics

Standalone software application for Windows/MacOS. Processes DICOM CT images to generate 3D bone models. Features include 3D mesh reconstruction, implant library integration, and interactive model positioning/dimensioning. Software documentation level: basic. No patient contact. No life-supporting function.

Indications for Use

Indicated for adult patients requiring pre-operative planning for anatomic partial/total shoulder arthroplasty or reverse total shoulder arthroplasty. Used by orthopedic surgeons.

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

Genesis Software Innovations, Preview Shoulder (K210556)

Reference Devices

Pixmeo SARL, Osirix MD (K101342)

Related Devices

K210556 — Preview Shoulder · Genesis Software Innovations · Apr 21, 2021
K241292 — MyShoulder Planner (5.3SSWPL) · Medacta International S.A. · Jan 30, 2025
K133367 — ORTHOVIS PREOPERATIVE PLAN · Custom Orthopaedic Solutions · Dec 20, 2013
K213779 — Customize · 3D-Side S.A. · Mar 16, 2022
K201928 — e-Ortho Shoulder Software · FH Industrie · Sep 30, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ 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). {1}------------------------------------------------ 2 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 | {5}------------------------------------------------ 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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.