Pre-Sure

Basic Information

• Brand Name: Pre-Sure
• Primary DI: G18910
• Version / Model: 1
• Company Name: Lazarus 3d, Inc.
• Labeler DUNS: 031182581
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-08
• Public Version: 1
• Public Version Date: 2023-09-18
• Public Version Status: New
• Public Device Record Key: 7ee55515-f63d-4e6c-b427-c9ac26d1a292

Device Description

End Users of the PRE-SURE device receive digital and/or physical patient anatomical models from Lazarus 3D. The physical models are intended for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection of genitourinary applications. Digital models may be viewed by End Users using any program cleared for their intended use. The PRE-SURE patient modeling system is a method for the creation of patient models. This system will be used exclusively by Lazarus 3D, with some physician input and feedback, to produce models for End Users. Importantly, and unlike other 3D modeling systems, in the PRE-SURE process the design and production of patient models is performed by Lazarus 3D and not by the End User or a third party. The internal process within Lazarus 3D used for creating PRE-SURE patient models includes use of an FDA cleared stand-alone software package. As a part of the PRE-SURE production process, this software is intended for internal use within Lazarus 3D to create digital anatomical models from patient radiological data that can be used by End Users for a variety of uses such as training, education, and pre-operative surgical planning. The patient specific digital anatomical models may be further used as an input to a 3D printing-based production process performed by Lazarus 3D to create physical patient models. Each individual patient’s model can be created rapidly from the patient’s radiological data using Lazarus 3D’s patented rapid prototyping technology. 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44087	Radiology information system application software	An application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G18910	HIBCC