(57 days)
Not Found
No
The document describes a standard PACS system for viewing, storing, and managing medical images and related records. There is no mention of AI, ML, or any advanced analytical capabilities that would typically be associated with these technologies. The focus is on image processing, storage, and integration with other healthcare systems.
No
Explanation: The device is a software for viewing and manipulating medical images and records. It is used for displaying, processing, managing, storing, and communicating data, and is not intended to treat or prevent a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the eVolve PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA. eVolve PACS is not intended for diagnostic review or other diagnostic uses on mobile devices." This indicates that the device is not intended for primary diagnostic interpretation.
Yes
The device description explicitly states "eVolve PACS, is a software device" and describes its function as a server application with a web-based user interface, handling digital medical images and records. While it interacts with hardware (imaging devices, computers), the device itself, as described, is the software component.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that eVolve PACS is used for viewing, manipulating, storing, and communicating medical images and other healthcare-related electronic records. It processes data from imaging modalities and other electronic systems, not biological specimens.
- The focus is on medical imaging and related data. The entire description revolves around handling and managing medical images (X-rays, CT scans, MRIs, etc.) and associated patient information and reports.
- There is no mention of analyzing biological samples. The text does not describe any process involving blood, urine, tissue, or any other type of biological specimen.
Therefore, eVolve PACS falls under the category of a medical image management and viewing system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
e Volve PACS, is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT, MR, US, RF, and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging gateways, other imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software.
e Volve PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. eVolve PACS, may also be integrated with the facility's Teleradiology Provider's systems. These integrations provide seamless operation and access for Providers and other caregivers to the entire spectrum of a patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the eVolve PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA. eVolve PACS is not intended for diagnostic review or other diagnostic uses on mobile devices.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
eVolve PACS, uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access eVolve PACS (and RIS) systems. Whether on-site or from another location, physicians can manage, edit, view and move diagnostic exams quickly and efficiently. As part of eVolve PACS support, eVolve PACS Inc., performs virtually all the system maintenance. eVolve PACS, has been designed to be expandable, with storage beginning at 2 TB and growing to 25 TB onboard or 256 TB expansion.
eVolve PACS is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:
- . To store and retrieve various kinds of DICOM Objects such as:
- -Images from multiple modalities,
- -Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
- -Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note,
- -Structured Reports [SR].
- To process HL7 notification messages from the Order Filler, about Procedure ● Scheduling, Procedure Updates and Patient Information Updates,
- . To process DICOM Modality Performed Procedure Step [MPPS] messages from modalities and forward them to the Order Filler.
eVolve PACS is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators.
eVolve PACS, was developed with special emphasis on its telerad features for those facilities that use teleradiology either full time or for night reads.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DR, CR, CT, MR, US, RF, and 2D/3D mammography
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Providers and other caregivers; Facilities that use teleradiology.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing is not necessary to show substantial equivalence for the subject device. Successful Bench Testing should be sufficient in demonstrating substantial equivalence.
Nonclinical Testing:
The eVolve PACS, has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate output functions, and actions performed by eVolve PACS Inc. and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
Summary:
Based on the performance as documented in the Validation Testing, eVolve PACS, was found to have a safe and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
InstaRISPACS / InstaZFP / InstaMobi V5.0 (K182572)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of the square.
eVolve PACS Inc. % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive McKINNEY TX 75071
August 12, 2021
Re: K211863
Trade/Device Name: eVolve PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 27, 2021 Received: June 16, 2021
Dear Mr. Alletto:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211863
Device Name eVolve PACS
Indications for Use (Describe)
e Volve PACS, is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT, MR, US, RF, and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging gateways, other imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software.
e Volve PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. eVolve PACS, may also be integrated with the facility's Teleradiology Provider's systems. These integrations provide seamless operation and access for Providers and other caregivers to the entire spectrum of a patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the eVolve PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA. eVolve PACS is not intended for diagnostic review or other diagnostic uses on mobile devices.
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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3
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submission number: K211863
I. SUBMITTER
Mr. David Donahue Chief Financial Officer eVolve PACS Inc. 3924 Bryn Mawr Drive, Dallas, TX 75225 Phone: 972.567.7300 Email ddonahue@xfinitisolutions.com
Date Prepared: June 3, 2021
II. DEVICE
Name of Device: eVolve PACS Common or Usual Name: Regulation Name: Medical Image Management and Processing System Classification Name: system, image processing, radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ
III. PREDICATE DEVICES
The predicate device is: InstaRISPACS / InstaZFP / InstaMobi V5.0 (K182572), Class II, regulation number; 892.2050, product code LLZ.
IV. DEVICE DESCRIPTION
eVolve PACS, uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access eVolve PACS (and RIS) systems. Whether on-site or from another location, physicians can manage, edit, view and move diagnostic exams quickly and efficiently. As part of eVolve PACS support, eVolve PACS Inc., performs virtually all the system maintenance. eVolve PACS, has been designed to be expandable, with storage beginning at 2 TB and growing to 25 TB onboard or 256 TB expansion.
eVolve PACS is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:
- . To store and retrieve various kinds of DICOM Objects such as:
- -Images from multiple modalities,
- -Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
- -Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note,
- -Structured Reports [SR].
- To process HL7 notification messages from the Order Filler, about Procedure ● Scheduling, Procedure Updates and Patient Information Updates,
- . To process DICOM Modality Performed Procedure Step [MPPS] messages from modalities and forward them to the Order Filler.
eVolve PACS is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators.
4
Image /page/4/Picture/0 description: The image shows the logo for "eVolve, PACS". The text is in a sans-serif font and is a gradient of blue, with the top of the letters being a darker blue and the bottom being a lighter blue. The word "eVolve" is in lowercase, and the word "PACS" is in uppercase.
eVolve PACS, was developed with special emphasis on its telerad features for those facilities that use teleradiology either full time or for night reads.
Key Feature List
- . Web-based technology for access from anywhere
- . Integration with any modality. RIS. HIS or EMR via DICOM. HL7. desktop Integration. and custom integration
- Turnkey installations including all PACS professional services
- . eVolve PACS, "off-site" disaster recovery service
- eVolve PACS, Net managed VPNs ●
- Transmission speed monitors and eVolve PACS, Track to monitor exams sent over . the Internet
- eVolve PACS, Secure internal firewall and security features help prevent . unauthorized access to the PACS
- Automatic management reports ●
- Detailed HIPAA log of all PACS transactions ●
- . Exam scheduling
- DICOM editing ●
- DICOM modality worklist
- HL7 Interface engine
- Automatic radiology report distribution
- Diagnostic viewer ●
- CD burning with viewer .
- Quick viewer with auto Cobb Angle calculation ●
- . Accelerated transmissions
- eVolve PACS, Scan for document imaging
- . eVolve PACS, eDOCS electronic forms to reduce scanning documents
- Pre-fetch
- . Multiple worklists
The eVolve PACS, device does not intend to replace the skills and judgment of a qualified physician/radiologist and must be used only by people who are properly trained in the system's functions and capabilities.
The User must be aware of the accuracy and precision limitations of the data displayed, printed or exported from eVolve PACS. The quality of these data depends on the information received, user interaction, and the features in the display device and printer, among others.
V. INDICATIONS FOR USE
eVolve PACS, is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT. MR. US. RF. and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging gateways, other imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software.
5
Image /page/5/Picture/0 description: The image shows the logo for "eVolve PACS". The text is in a sans-serif font and is a gradient of blue, with the top of the letters being a lighter blue and the bottom being a darker blue. The word "eVolve" is in lowercase, while "PACS" is in uppercase. There is a slight shadow effect on the letters, giving them a 3D appearance.
eVolve PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. eVolve PACS, may also be integrated with the facility's Teleradiology Provider's systems. These integrations provide seamless operation and access for Providers and other careqivers to the entire spectrum of a patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports).
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the eVolve PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA.
eVolve PACS is not intended for diagnostic review or other diagnostic uses on mobile devices.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The subject and predicate devices are both medical image management and processing systems, which are indicated for medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device and the predicate device are substantially equivalent in the areas of general function, application, and intended use.
Any differences between the subject and predicate devices have no negative impact on the device safety or efficacy and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.
| Feature/Functions | Subject Device - eVolve PACS | Predicate InstaRISPACS/ InstaZFP/ InstaMobi K182572 |
|---|---|---|
| System | ||
| Indications for Use | Medical image management and processing system | Medical image management and processing system |
| Workstation | ||
| Client | ||
| Hardware | ||
| (recommended) | Processor | |
| Intel Core i5 | Core i7 / Quad Core Xeon | |
| Operating System | ||
| Windows 10 (64 bit) | Windows 8.1 (64 bit) | |
| Display | ||
| Medical Grade Monitor is recommended. Resolution depends on the modality type. | Medical Grade Monitor is recommended. Resolution depends on the modality type. | |
| RAM | ||
| Minimum 8GB RAM | Minimum 8GB RAM | |
| Hard Disk | ||
| 500 GB | 750GB minimum | |
| Server features | System Architecture | |
| Web based | Web based | |
| Hardware | ||
| Vendor Agnostic | Vendor Agnostic | |
| Security | ||
| Log-on user ID & password | Log-on user ID & password | |
| Remote monitoring | ||
| Yes | Yes | |
| Database | ||
| PostgresSQL | MySQLv5.7 | |
| Viewer | ||
| Features: | Image Viewing Layout | |
| Std. formats (up to 4*4) | Std. formats (up to 4*4) | |
| WW/WL | ||
| Yes | Yes |
6
. S D
| 510(k) Summary | |
|---|---|
| -- | ---------------- |
| Feature/Functions | Subject Device - eVolve
PACS | Predicate InstaRISPACS/
InstaZFP/InstaMobi
K182572 | |
|----------------------------------|-----------------------------------------------------|----------------------------------------------------------|-------------------------------------------|
| Zoom in/Zoom
out | yes | yes | |
| Hounsfield
Measurement | Yes | Yes | |
| Linear and angle
measurements | Yes | Yes | |
| Series
Comparison | Yes | Yes | |
| Scout line
display | Yes | Yes | |
| MPR/MIP
capabilities | Yes | Yes | |
| Stack mode | Yes | Yes | |
| Gray scale
invert | Yes | Yes | |
| Filters | Yes | Yes | |
| Rotate | Yes | Yes | |
| Key Image
selection | Yes | Yes | |
| DICOM Print | Yes | Yes | |
| Windows print | Yes | Yes | |
| Query/Retrieve | Yes | Yes | |
| Image
compression | Lossless streaming | Lossless streaming | |
| Selection tools | Thumbnails | Thumbnails | |
| Reporting
module | Reporting
Interface | Can be opened from the
from study list | Can be opened from the
from study list |
| | Report Template
Support | User Defined templates | User Defined templates |
| | Digital Signature | Yes | Yes |
| | Report Formats | MS office formats: PDF, rtf,
text, Docx | MS word |
| Other features | Link to Hospital
Information
System (HIS) | Yes | Yes |
| | Link to
Radiology
Information
System RIIS) | Yes | Yes |
| | Electronic
patient record | Through Broker Software | Through Broker Software |
| | HIPAA | Compliant | Compliant |
| Configurations | PACS Server | Yes | Yes |
7
Image /page/7/Picture/0 description: The image shows the words "eVolve, PACS" in a stylized font. The words are in a light blue color that fades to white at the bottom. The word "eVolve" is written in lowercase letters, while the word "PACS" is written in uppercase letters. There is a small comma between the two words.
| Feature/Functions | Subject Device - eVolve
PACS | Predicate InstaRISPACS/
InstaZFP/ InstaMobi
K182572 |
|--------------------------|---------------------------------|-----------------------------------------------------------|
| Radiology
Workstation | Yes | Yes |
| Basic Image
Viewer) | Yes | Yes |
| Mobile app
viewer | Yes | Yes |
VII. PERFORMANCE DATA
Clinical testing is not necessary to show substantial equivalence for the subject device. Successful Bench Testing should be sufficient in demonstrating substantial equivalence.
Nonclinical Testing:
The eVolve PACS, has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate output functions, and actions performed by eVolve PACS Inc. and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.
Summary:
Based on the performance as documented in the Validation Testing, eVolve PACS, was found to have a safe and effectiveness profile that is similar to the predicate device.
The following Standards were used to develop eVolve PACS, and the device has met all the requirements listed in the Standards except for inapplicable requirements:
| Title of Standard | Date Of
Recognition | Specialty
Task
Group Area | FDA
Recognition
Number | Standard
Developing
Organization | Standard
Designation
Number and
Date |
|-----------------------------------------------------------------------------------------------------------------------|------------------------|---------------------------------|------------------------------|----------------------------------------|-----------------------------------------------|
| Digital Imaging
and
Communications
in Medicine
(DICOM) Set | 06/27/2016 | Radiology | 12-300 | NEMA | PS 3.1 - 3.20
(2016) |
| Analysis
techniques for
system reliability -
Procedure for
failure mode and
effects analysis
(FMEA) | 01/14/2019 | Radiology | 5-120 | IEC | 60812 Edition
3.0 2018-08, |
| Medical device
software -
Software life cycle
processes
[Including
Amendment 1
(2016)] | 01/14/2019 | Software/
Informatics | 13-79 | ANSI AAMI
IEC | 62304:2006/A
1:2016 |
8
Image /page/8/Picture/0 description: The image shows the logo for "eVolve, PACS". The text is in a sans-serif font and is a gradient of blue, with the top of the letters being a darker blue and the bottom being a lighter blue. The word "eVolve" is in lowercase, and the word "PACS" is in uppercase.
- FDA Guidance on Cyber Security: Content of Premarket Submissions for . Management of Cybersecurity in Medical Devices Document Issued on: October 2, 2014
- FDA Guidance for the Content of Premarket Submissions for Software Contained in . Medical Devices Document issued on: May 11, 2005
VIII. CONCLUSIONS
The 510(k) Pre-Market Notification for eVolve PACS, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
Nonclinical tests demonstrate that the device is as safe, as effective, and performs comparably to the predicate devices.