Pre-Sure

GUDID G18920

The Pre-Sure patient modeling system is a method for the creation of patient models. Importantly, and unlike other 3D modeling systems, in the Pre-Sure process the design and production of patient models is performed by Lazarus 3D or its affiliates (with physician input), and not by the End User. The Pre-Sure software process is FDA cleared for the analysis of patient radiological data to create a digital patient design, referred to as a “Digital Twin”. Digital Twins can be used by End Users, when viewed in an appropriately cleared viewing program, for a variety of uses including training, education, and surgical planning. Patient specific Digital Twins may be further used as an input to a 3D printing-based production process performed by Lazarus 3D. This process creates physical patient models, referred to as Pre-Sure models. Each individual patient’s model can be created rapidly from the patient’s radiological data. The resulting physical models of patient anatomy are primarily composed of silicone materials that can be cut, can be sutured, and in some cases can even bleed, and of hard plastic materials that can be sawed, drilled, and can accept screws. End Users of the Preoperative Surgical Rehearsal (Pre-Sure) device receive digital and/or physical patient anatomical models from Lazarus 3D. Digital models may be viewed by End Users using any program cleared for their intended use. The physical models are intended for adjunctive use along with other diagnostic tools and expert clinical judgment for diagnosis, patient management, and/or treatment selection for genitourinary, cardiovascular, craniofacial, gastrointestinal, neurological, musculoskeletal, respiratory, and pediatric applications.

Lazarus 3d, Inc.

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• Primary Device ID: G18920
• NIH Device Record Key: 0793cc63-de67-46c6-a3e2-fee77659380b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pre-Sure
• Version Model Number: 1
• Company DUNS: 031182581
• Company Name: Lazarus 3d, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G18920 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-18
• Device Publish Date: 2023-09-08

On-Brand Devices [Pre-Sure]

• G18920: The Pre-Sure patient modeling system is a method for the creation of patient models. Importantly
• G18910: End Users of the PRE-SURE device receive digital and/or physical patient anatomical models from