The Pre-Sure software system is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as pre-operative software for surgical planning. For this purpose, the output file may be used to produce a physical replica is intended for adjunctive use along with other diagnostic tools and expert clinical judgment for diagnosis, patient management, and/or treatment selection of genitourinary, cardiovascular, neurological, respiratory, musculoskeletal, gastrointestinal, craniofacial, and pediatric applications.

Device Description

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 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.

AI/ML Overview

The provided document describes the Pre-Sure device, a software system and physical replica production process for surgical planning and adjunctive use with other diagnostic tools. The document primarily focuses on non-clinical performance data (accuracy studies and materials testing) to support the device's substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that during the various accuracy and materials testing, "measurements fell within predefined acceptance criteria" and "Results show that sufficient accuracy can be achieved" or "can reproduce complex [anatomical] conditions with sufficient accuracy for the intended use." However, it does not explicitly define these predefined acceptance criteria or provide specific quantitative performance metrics for each study. It only offers qualitative statements of success.

Since the document does not provide a table with specific acceptance criteria and detailed quantitative performance results, I will summarize the findings qualitatively based on the text.

Acceptance Criteria Category	Acceptance Criteria (Qualitative)	Reported Device Performance (Qualitative)
Production Process Accuracy	Model dimensions should fall within predefined accuracy (in-silico comparison).	Measurements fell within predefined acceptance criteria.
Digital & Physical Model Accuracy	Measurements from the entire workflow (MRI/CT to 3D/physical model) should fall within predefined acceptance criteria when compared to predicate.	Measurements fell within predefined acceptance criteria.
Build Envelope Accuracy	Models built in any orientation/position on the 3D printer should achieve sufficient accuracy.	Sufficient accuracy can be achieved for models built in any orientation or position.
Materials Testing Accuracy	All material combinations (including difficult ones) should produce models of sufficient accuracy.	All material combinations produce models of sufficient accuracy.
Materials Bonding	All tested materials should bond well with all other tested materials.	All tested materials bond well with all other tested materials.
Complex Case Reproduction (Genitourinary, Cardiovascular, Neurological, Respiratory, Musculoskeletal, Gastrointestinal, Craniofacial, Pediatric)	Pre-Sure 3D manufacturing should reproduce complex conditions with sufficient accuracy.	Pre-Sure 3D manufacturing can reproduce complex conditions with sufficient accuracy for the intended use.
Hard and Soft Material Bonding Durability	Models with hard and soft materials should maintain integrity and accuracy during shipping and intended use.	Models are sufficiently robust to maintain integrity and accuracy during shipping and intended use.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Sizes:
- Production Process Accuracy Study: "Models of various dimensions were created." Specific number not provided.
- Digital and Physical Model Accuracy Study: "MRI and CT scan input data from actual cases were analyzed." Specific number not provided.
- Build Envelope Testing: "Models of genitourinary conditions were built using 3D prints from different locations... and in different orientations." Specific number not provided.
- Materials Testing: "genitourinary conditions using combinations of the most difficult to use materials..." Specific number not provided.
- Challenging Case Studies (all anatomical regions): "Multiple replicates were produced for several different [anatomical] conditions." Specific numbers not provided for cases or replicates.
- Hard and Soft Material Bonding: "Many models with worst case designs and materials..." Specific number not provided.
Data Provenance: The document implies the use of "actual cases" for the "Digital and Physical Model Accuracy Study," suggesting real patient data, but it does not specify the country of origin, nor does it explicitly state if the data was retrospective or prospective. For the "Production Process Accuracy Study," it refers to "dimensions pre-defined in silico," indicating synthetic/computer-generated data. The other studies involve manufacturing physical models based on designs, but the origin of those designs is not detailed in terms of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not explicitly mention the number of experts used or their qualifications for establishing ground truth in any of the accuracy studies. The comparisons are described as being against "in-silico input data" or "digital design" for physical models, and against the predicate device's output.

4. Adjudication Method:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for reviewing or establishing ground truth for the test sets.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The studies described are focused on the accuracy of the device's output (digital designs and physical models) compared to expected values or the predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

The document describes studies that evaluate the accuracy of the "Pre-Sure patient model production processes" and "the entire Pre-Sure workflow" from MRI/CT input to physical models. This evaluates the performance of the system as an algorithm/process, independent of human interaction during the model generation itself but for use alongside expert clinical judgment. However, the exact "standalone" performance of the software interface and image segmentation system component (which is part of the device indications for use) is not separately detailed with specific metrics beyond "measurements fell within predefined acceptance criteria." The primary focus is on the output model accuracy.

7. Type of Ground Truth Used:

Production Process Accuracy Study: "In-silico input data" (computer-generated/defined ground truth).
Digital and Physical Model Accuracy Study: Implicitly, the initial medical image data (MRI/CT scans) and likely the output from the predicate device serve as a reference point for comparison. The definition of "ground truth" for this study is not explicitly stated but appears to be based on consistency with the source data and predicate.
Challenging Case Studies (all anatomical regions): The "digital design" is used as the ground truth against which the manufactured physical models are compared volumetrically via CT scanning.

8. Sample Size for the Training Set:

The document does not provide any information about the sample size used for a training set. The descriptions focus on V&V (Verification and Validation) testing rather than algorithm development/training data.

9. How Ground Truth for the Training Set Was Established:

Since no information on a training set is provided, there is no information on how its ground truth was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Lazarus 3D % Elisa Maldonado-Holmertz RA Consultant Obelix Consulting, LLC 806 JEFFERSON ST. BASTROP TX 78602

May 26, 2023

Re: K230044

Trade/Device Name: Pre-Sure Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 2, 2023 Received: May 4, 2023

Dear Elisa Maldonado-Holmertz:

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

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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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230044

Device Name Pre-Sure

Indications for Use (Describe)

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 is a logo for Lazarus 3D. The logo consists of a stylized square shape on the left, with the words "LAZARUS 3D" in bold, black letters to the right of the shape. Below the company name is the tagline "Operate with Confidence" in a smaller, sans-serif font.

Section 005 - 510(k) Summary

K230044

INTRODUCTION

This document contains the 510(k) summary for the Pre-Sure device. The content of this summary is based on the requirements of 21 CFR 807.92.

SUBMISSION SPONSOR

Name:	Lazarus 3D, Inc.
Address:	421 Water Ave. NE.Albany, OR 97321
Phone:	(541) 760 1805
Contact Name:	Dr. Smriti Zaneveld
Contact Email:	Smriti@laz3D.com
Additional Contact:	Dr. Jacques Zaneveld
Additional Email:	Zaneveld@laz3D.com
Submission CorrespondentName:	Obelix Consulting, LLC
Address:	806 Jefferson St.Bastrop, TX 78602
Phone:	(512) 431 6069
Contact Name:	Elisa Maldonado-Holmertz
Contact Email:	elisamh@obelixconsult.com

Date Prepared:11/28/2022

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Image /page/4/Picture/0 description: The image is a company logo for Lazarus 3D. The logo consists of a stylized square shape on the left, with the words "LAZARUS 3D" in bold, black letters to the right of the square. Below the company name is the phrase "Operate with Confidence" in a smaller, lighter font. The square shape is made up of two curved lines, one in blue and one in orange, that create a three-dimensional effect.

Device Identification

Type of 510(k) Submission: Traditional

Trade Name: Pre-Sure

Common Name: System, Image Processing, Radiological
Regulation Description: Medical Image Management and Processing System

Regulation Number: 21 CFR 892.2050

Product Code: LLZ

Class of Device: II

Review Panel: Radiology

Reason for Submission: New device

Prior Related Submissions: K201835

Multiple Devices: None

1. LEGALLY MARKETED PREDICATE DEVICE

The Preoperative Surgical Rehearsal (Pre-Sure) device is claimed to be substantially equivalent to the following legally marketed device:

. Pre-Sure, Lazarus 3D, Inc. (K201835).

2. DEVICE DESCRIPTION

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,

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Image /page/5/Picture/0 description: The image contains the logo for Lazarus 3D. The logo consists of a stylized square shape with rounded corners, colored in a gradient from blue to orange, placed to the left of the text "LAZARUS 3D" in bold, black letters. Below the company name is the tagline "Operate with Confidence" in a smaller, lighter font.

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 sutured, and in some cases can even bleed, and of hard plastic materials that can be sawed, drilled, and can accept screws.

3. INDICATIONS FOR USE

The Pre-Sure software system is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as pre-operative software for surgical planning. For this purpose, the output file may be used to produce a physical replica. The physical replica is intended for adjunctive use along with other diagnostic tools and expert clinical judgment for diagnosis, patient management, and/or treatment selection of genitourinary, cardiovascular, neurological, respiratory, musculoskeletal, gastrointestinal, craniofacial and pediatric applications.

4. SUBSTANTIAL EQUIVALENCE DISCUSSION

Pre-Sure employs identical fundamental technologies as the identified predicate device (which is an earlier version of Pre-Sure technology). These fundamental technologies include:

Viewing of medical imaging data in the axial, coronal, and sagittal views.
Ability to process, review and analyze medical imaging data
•Seamless production of a physical model of the patient's anatomy from the digital design.
Use of the physical model by the end-user for diagnosis, patient management and/or treatment selection.
· Opportunity to use the physical model for surgical rehearsals.

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Image /page/6/Picture/0 description: The image contains the logo for Lazarus 3D. The logo consists of a stylized square shape with rounded corners, colored in a gradient from blue to orange. To the right of the square is the text "LAZARUS 3D" in bold, black letters. Below the company name is the tagline "Operate with Confidence".

Two changes are included in the subject device. First, the subject version of Pre-Sure may use both silicone materials and hard plastic materials in models, while plastic materials were not used in predicate models. Second, while the predicate was only cleared for genitourinary applications, the subject device may be used for cardiovascular, neurological, respiratory, musculoskeletal, gastrointestinal, craniofacial and pediatric applications. Rigorous testing and investigation indicate that the present device has similar performance, intended use, and nearly identical technological characteristics as the predicate device, and raises no new questions regarding its safety or efficacy.

Comparison to Legally Marketed Device:

Manufacturer	Subject Device	Predicate Device	Significant Differences
	Lazarus 3d, Inc.	Lazarus 3d, Inc.
Trade Name	Pre-Sure	Pre-Sure	None
510(k) Number	-	K201835	-
Product Code	LLZ	LLZ	None
Regulation Number	892.2050	892.2050	None
Regulation Name	Medical ImageManagement andProcessing System	Medical Image Managementand Processing System	None
Common Name	System, Image Processing,Radiological	System, Image Processing,Radiological	None
Indications for Use	The Pre-Sure software isintended for use as asoftware interface andimage segmentationsystem for the transfer ofDICOM imaginginformation from amedical scanner to anoutput file. It is alsointended as pre-operativesoftware for surgicalplanning. For this purpose,the output file may beused to produce a physicalreplica. The physicalreplica is intended foradjunctive use and otherdiagnostic tools andexpert clinical judgment	The Pre-Sure software isintended for use as asoftware interface and imagesegmentation system fortransferring DICOM imaginginformation from a medicalscanner to an output file. It isalso intended as pre-operative software forsurgical planning. For thispurpose, the output file maybe used to produce aphysical replica. The physicalreplica is intended foradjunctive use along withother diagnostic tools andexpert clinical judgment fordiagnosis, patientmanagement and/or	Nearly identical, except thesubject device is onlyintended for use ingenitourinary applications,while the predicate device isintended for use incardiovascular, neurological,respiratory, musculoskeletal,gastrointestinal, craniofacialand pediatric applications.

Table 12A – Device Comparison Chart: Similarities and Differences

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Image /page/7/Picture/0 description: The image shows a stylized logo with a square shape formed by two curved bands. The left and bottom portions of the band are colored in shades of blue, while the top and right portions transition to shades of orange. The overall design is modern and abstract, suggesting a sense of connection or flow.

Image /page/7/Picture/1 description: This image is a table that describes the material and sterility of different products. The first column describes the use of the product for diagnosis, patient management, and treatment selection of cardiovascular, neurological, respiratory, musculoskeletal, gastrointestinal, craniofacial, and pediatric applications. The second column describes the use of the product for treatment selection of genitourinary applications. The table also lists the material and sterility of each product.

5. NON-CLINICAL PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Production Process Accuracy Study

The purpose of this accuracy study was to evaluate the accuracy of Pre-Sure patient model production processes. Models of various dimensions were created using Pre-Sure from computer models with dimensions pre-defined in silico. Comparisons were made between the physical models created using Pre-Sure and the in-silico input data, revealing that measurements fell within predefined acceptance criteria.

Digital and Physical Model Accuracy Study

The purpose of this accuracy study was to compare results from the entire Pre-Sure workflow to those of the predicate device. MRI and CT scan input data from actual cases were analyzed using the predicate and subject devices to create 3D computer models and physical models of the patient anatomy. These models were then compared, revealing that measurements fell within predefined acceptance criteria.

Build Envelope Testing - Accuracy Validation

The purpose of this study is to define where on the 3D printer, and in what orientation, models can be produced in sufficient accuracy for the intended use. Models of

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Image /page/8/Picture/0 description: The image is a logo for Lazarus 3D. The logo consists of a square shape with rounded corners that is split into two colors, orange and blue. To the right of the shape is the text "LAZARUS 3D" in a bold, sans-serif font. Below the text is the tagline "Operate with Confidence".

genitourinary conditions were built using 3D prints from different locations the 3D printer build plate, and in different orientations. Results show that sufficient accuracy can be achieved for models to be built in any orientation or position on the 3D printer.

Materials Testing - Accuracy Validation

The purpose of this study is to test the accuracy and bonding of the range of materials included in the build envelope for Pre-Sure physical patient models were produced for genitourinary conditions using combinations of the most difficult to use materials within the Pre-Sure build envelope. Testing shows that all material combinations produce models of sufficient accuracy for the intended use. Additionally, all tested materials bond well with all other tested materials and thus can be used together to form multi-material patient models.

Testing on Especially Challenging Genitourinary Cases

The purpose of this study is to test the accuracy of the subject production process when creating complex models for genitourinary applications. Multiple replicates were produced for several different genitourinary conditions. Designs were selected for difficulty, with highly complex designs being used for testing. The resulting physical models were analyzed using a CT scanner and volumetrically compared against the digital design. Results indicate that the Pre-Sure 3D manufacturing can reproduce complex genitourinary conditions with sufficient accuracy for the intended use.

Testing on Especially Challenging Cardiovascular Cases

The purpose of this study is to test the accuracy of the subject production process when creating complex models for cardiovascular applications. Multiple replicates were produced for several different cardiovascular conditions. Designs were selected for difficulty, with highly complex designs being used for testing. The resulting physical models were analyzed using a CT scanner and volumetrically compared against the digital design. Results indicate that the Pre-Sure 3D manufacturing can reproduce complex cardiovascular conditions with sufficient accuracy for the intended use.

Testing on Especially Challenging Neurological Cases

The purpose of this study is to test the accuracy of the subject production process when creating complex models for neurological applications. Multiple replicates were produced for several different neurological conditions. Designs were selected for difficulty, with highly complex designs being used for testing. The resulting physical models were analyzed using a CT scanner and volumetrically compared against the digital design. Results indicate

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Image /page/9/Picture/0 description: The image is a logo for Lazarus 3D. The logo consists of a square shape with rounded corners that is colored in a gradient of blue and orange. To the right of the square is the text "LAZARUS 3D" in a bold, sans-serif font. Below the company name is the tagline "Operate with Confidence".

that the Pre-Sure 3D manufacturing can reproduce complex neurological conditions with sufficient accuracy for the intended use.

Testing on Especially Challenging Respiratory Cases

The purpose of this study is to test the accuracy of the subject production process when creating complex models for respiratory applications. Multiple replicates were produced for several different respiratory conditions. Designs were selected for difficulty, with highly complex designs being used for testing. The resulting physical models were analyzed using a CT scanner and volumetrically compared against the digital design. Results indicate that the Pre-Sure 3D manufacturing can reproduce complex respiratory conditions with sufficient accuracy for the intended use.

Testing on Especially Challenging Musculoskeletal Cases

The purpose of this study is to test the accuracy of the subject production process when creating complex musculoskeletal models. Multiple replicates of models for several different musculoskeletal conditions that are difficult to produce for a variety of reasons were manufactured. These physical models were analyzed using a CT scanner and volumetrically compared against the digital design. Results indicate that the Pre-Sure 3D manufacturing can reproduce complex musculoskeletal conditions with sufficient accuracy for the intended use.

Testing on Especially Challenging Gastrointestinal Cases

The purpose of this study is to test the accuracy of the subject production process when creating complex gastrointestinal models. Multiple replicates of models for several different gastrointestinal conditions that are difficult to produce for a variety of reasons were manufactured. These physical models were analyzed using a CT scanner and volumetrically compared against the digital design. Results indicate that the Pre-Sure 3D manufacturing can reproduce complex gastrointestinal conditions with sufficient accuracy for the intended use.

Testing on Especially Challenging Craniofacial Cases

The purpose of this study is to test the accuracy of the subject production process when creating complex craniofacial models. Multiple replicates of models for several different craniofacial conditions that are difficult to produce for a variety of reasons were manufactured. These physical models were analyzed using a CT scanner and volumetrically compared against the digital design. Results indicate that the Pre-Sure 3D manufacturing can reproduce complex craniofacial conditions with sufficient accuracy for the intended use.

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Image /page/10/Picture/0 description: The image shows the logo for Lazarus 3D. The logo consists of a square shape with rounded corners that is colored in a gradient from blue to orange. To the right of the shape is the text "LAZARUS 3D" in a bold, sans-serif font. Below the company name is the text "Operate with Confidence".

Testing on Especially Challenging Pediatric Cases

The purpose of this study is to test the accuracy of the subject production process when creating complex pediatric models. Multiple replicates of models for several different pediatric conditions that are difficult to produce for a variety of reasons were manufactured. These physical models were analyzed using a CT scanner and volumetrically compared against the digital design. Results indicate that the Pre-Sure 3D manufacturing can reproduce complex pediatric conditions with sufficient accuracy for the intended use.

Testing on Hard and Soft Pre-Sure Material Bonding

The purpose of this study is to test if the bonding of hard and soft materials used in combination in Pre-Sure models is sufficient for them to maintain their integrity and accuracy during shipping and when used as intended. Many models with worst case designs and materials were subjected to a force in the worst case direction and orientation. Models were then measured to determine if they were damaged as a result of the force applied. Results indicate that the Pre-Sure models containing both hard and soft materials are sufficiently robust to maintain their integrity and accuracy during shipping and when used as intended.

Summary

All performance testing which was conducted as a result of risk analysis and design impact assessments showed conformity to pre-established specifications and acceptance criteria. The acceptance criteria were established in order to demonstrate the device performance and substantial equivalence to the predicate device.

6. STATEMENT OF SUBSTANTIAL EQUIVALENCE

Based on a comparison of the intended use and technological characteristics, the Pre-Sure device is substantially equivalent to the identified predicate device. Minor differences in technological characteristics and scope did not raise new or different questions of safety and effectiveness. Additionally, the validation data supports that the system performs in accordance with its intended use and is substantially equivalent to the predicate device.

Regulation Number and Section

N/A