Who is the manufacturer of Presero 3D Scanning System?

Certis Health filed the 510(k) submission for Presero 3D Scanning System (K190074).

What is the FDA product code for Presero 3D Scanning System?

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

What is the regulatory pathway for Presero 3D Scanning System?

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

Who can help prepare an FDA 510(k) submission like Presero 3D Scanning System?

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.

Presero 3D Scanning System

Q: What are the predicate devices for Presero 3D Scanning System?

EchoPixel True 3D Viewer (K142107).

K190074 · Certis Health · LLZ · Feb 14, 2019 · Radiology

Device Facts

Record ID	K190074
Device Name	Presero 3D Scanning System
Applicant	Certis Health
Product Code	LLZ · Radiology
Decision Date	Feb 14, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	3rd-Party Reviewed

Indications for Use

The Presero 3D Scanning System is an imaging tool that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a 3D imaging device. It is indicated for the use of capturing visual images to measure the diameter, surface area, perimeter and volume of wounds. The Presero 3D Scanning System is designed for use by health care professionals and is intended to assist the healthcare professional who is responsible for making all final patient management decisions.

Device Story

Tablet-based system using Intel RealSense 3D camera to capture multi-dimensional wound images; proprietary software enables visualization and interaction via pen-like stylus. Used by healthcare professionals in clinical facilities (hospitals/clinics) to assist in clinical decision-making. System integrates with cloud back-end for storage and 2-way synchronization of patient data and operator details. Healthcare provider interprets displayed images to make final patient management decisions; device does not contact patient or control life-sustaining equipment.

Clinical Evidence

Bench testing only. Verification and validation performed on qualified device and in simulated use conditions in accordance with 21 CFR 820.30 and FDA software guidance. No clinical data presented.

Technological Characteristics

Tablet-based system (Microsoft Surface Pro 4/New Surface Pro) with Intel RealSense 3D camera. Software-based image processing. Standards: IEC 62304 (software life-cycle), NEMA PS 3.1-3.20 (DICOM), IEC 60601-1-2 (EMC), ANSI AAMI ES60601-1 (safety). Cloud-integrated for data storage/sync.

Indications for Use

Indicated for health care professionals to capture visual images and measure diameter, surface area, perimeter, and volume of wounds.

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

EchoPixel True 3D Viewer (K142107)

Reference Devices

Woundvision Wound Measuring and Monitoring device (K131596)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below. Certis Health % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313 February 14, 2019 Re: K190074 Trade/Device Name: Presero 3D Scanning System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, FXN Dated: January 14, 2019 Received: January 16, 2019 Dear Mark Job: 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 {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. | Neil R | Digitally signed by Neil R Ogden -S | |----------|----------------------------------------| | Ogden -S | Date: 2019.02.14 14:34:08 -05'00' | For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K190074 Device Name Presero 3D Scanning System ### Indications for Use (Describe) The Presero 3D Scanning System is an imaging tool that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a 3D imaging device. It is indicated for the use of capturing visual images to measure the diameter, surface area, perimeter and volume of wounds. The Presero 3D Scanning System is designed for use by health care professionals and is intended to assist the healthcare professional who is responsible for making all final patient management decisions. Type of Use (Select one or both, as applicable) X 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 CertisHealth. The logo consists of three overlapping ellipses in yellow and teal, followed by the word "CERTISHEALTH" in green. The word is written in a sans-serif font, with the letters "CERTIS" in a darker shade of green than the letters "HEALTH". ## Section 5. 510(k) SUMMARY ### SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION | Submitter's Name: | Certis Health® | |----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Address: | 3630 Park Central Boulevard North Pompano Beach, FL 33064 | | Submitter's Phone No: | 954-628-5908 | | Submitter's Fax No. | 954-206-1692 | | Regulatory Contact: | Charnelle Thomas Regulatory Consultant 404-360-6188 Mailing address for regulatory correspondence: 159 Lake Reserve Way Canton, GA 30115 | | Date of Preparation: | February 13, 2019 | | Device Information: Trade Name: | Presero™ 3D Scanning System | | Common Name: | Imaging Software System | | Classification Name: | Picture archiving and communications system | | Review Category: | System, image processing, radiological 21 CFR 892.2050 (LLZ), 21 CFR 878.4160 FXN | | Classification Panel: | Radiological | | Regulatory Class: | Class II | | Product Code: | LLZ, FXN | | Legally marketed device to which equivalency is claimed: | EchoPixel True 3D Viewer (K142107) | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the CertisHealth logo. The logo consists of three overlapping circles in yellow and green on the left, followed by the word "CERTISHEALTH" in green. The font is sans-serif and the letters are evenly spaced. | Description of the device: | The Presero 3D Scanning System is a tablet-based system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a 3D imaging device. The Presero 3D Scanning System, does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. The Presero 3D Scanning System is comprised of a commercial off the shelf 3D camera fitted on a commercial off the shelf tablet, equipped with a proprietary software application that enables a health care professional to visualize and interact with 3D wound images, via a pen-like stylus, to assist in clinical decision making. The complete system (tablet, camera and software) integrates with a cloud back-end system. The cloud back-end system stores all patient data, operator details and other information allowing 2-way synchronization between the Presero 3D Scanning System and the cloud with the ability to fully support multiple systems within a single clinical facility. | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | The Presero 3D Scanning System is an imaging tool that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a 3D imaging device. It is indicated for the use of capturing visual images to measure the diameter, surface area, perimeter and volume of wounds. The Presero 3D Scanning System is designed for use by health care professionals and is intended to assist the healthcare professional who is responsible for making all final patient management decisions. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for CertisHealth. The logo consists of three overlapping ellipses in yellow and green, followed by the word "CERTISHEALTH" in green sans-serif font. The ellipses are positioned to the left of the text, with the yellow ellipse encircling the two green ellipses. # SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (Continued) | Summary of technological characteristics compared to the predicate device: | The Presero® 3D Scanning System is similar to the "primary" predicate device, the EchoPixel True 3D Viewer (K142107) with regard to its intended use and core technological characteristics with the exception of the source used to obtain the 3D images and the type of images evaluated by health care professionals in final patient management decisions. The Woundvision® Wound Measuring and Monitoring device (K131596) is a "reference" device and has an intended use and core technology that is also substantially equivalent to the Presero® 3D Scanning System. | | | |-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial | Primary Predicate | Reference Device | Subject Device | | Equivalence: | Echo Pixel True 3D Viewer (K141207) | Wondvision Wound Measuring & Monitoring Device (K131596) | Presero 3D Scanning System | | Intended Use: | Intended as a medical diagnostic imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as pre- operative software for simulating / evaluating surgical treatment options. The True 3D Viewer is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. | The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces: Both components of the Scout are non-contact with respect to the patient and provide an adjunctive tool to help a trained and qualified health care professional | The Presero 3D Scanning System is a medical diagnostic imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a 3D imaging device. It is also intended as a pre- operative software for evaluating treatment options. The Presero 3D Scanning System is designed for use by health care professionals and is intended to assist the healthcare professional who is responsible for making all final patient management decisions. | | | Primary Predicate Echo Pixel True 3D Viewer (K142107) | Reference Device Woundvision Wound Measuring & Monitoring Device (K131596) | Subject Device Presero 3D Scanning System | | Intended Users: Intended Environment for Care: | Health Care Professionals Healthcare Facilities such as hospitals and clinics Class II 21 CFR 892.2050; LLZ | Health Care Professionals Healthcare Facilities such as hospitals and clinics Class I 21 CFR 878.4160; FXN | Health Care Professionals Healthcare Facilities such as hospitals and clinics Class II 21 CFR 892.2050; LLZ | | Image Analysis Feature: | Image analysis features: interactive manipulation, tag, annotate, measure, segment | measure | Image analysis features: interactive manipulation, tag, annotate, measure, segment | | Computer Platform: (minimum platform) | HP Z440 Workstation | Minimum requirement: Intel Core i5 3rd generation (or equivalent) or better | Microsoft Surface Pro 4 or Microsoft New Surface Pro | | System RAM: | 8 GB of system memory; Nvidia Quadro Graphics Processing Unit (GPU) with 4GB of video memory | 4GB or greater | 8 GB of system memory | | Operating System: | Windows 7 or 10 (64bit) | Windows 7 SP1 or later | Windows 10 (64bit) | | Image Acquisition: | CT and MR DICOM Images | Scout imaging device | Intel RealSense 3D camera | | Performance Data: | Every specification of the Presero® 3D Scanning Software has been validated according to the company's documented development and test procedures. The verification and validation testing conducted included testing to the following applicable standards: ISO/IEC/IEEE 29148:2011, Systems and software Engineering — Life Cycle Processes — Requirements Engineering ISO/IEC/IEEE 24765:2010 - Systems and software engineering - | | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for CertisHealth. The logo consists of three overlapping ellipses in different shades of green and yellow on the left. To the right of the ellipses is the word "CERTISHEALTH" in green sans-serif font. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for CertisHealth. The logo consists of three overlapping circles in shades of green and yellow on the left. To the right of the circles is the word "CERTISHEALTH" in green. The first part of the word, "CERTIS", is a darker shade of green than the second part, "HEALTH". | | Vocabulary IEC 62304:2006+AMD1:2015 CSV, Medical Device software – software Life-Cycle Processes NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set PS 3.1 IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks were analyzed and satisfactorily mitigated in the device design. Verification and validation was performed on qualified device as well as in simulated use conditions | |--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusions: | The Presero® 3D Scanning System is substantially equivalent to the primary predicate device with regards to intended use and technological characteristics. It is also substantially equivalent to the reference device. Results of performance testing demonstrated that the device met the design requirements and as well as the user needs |

Presero 3D Scanning System

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Indications for Use

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Indications for Use

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