(29 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Presero 3D Scanning System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria or quantifiable device performance results for wound measurement accuracy. Instead, it makes a general statement about meeting design requirements and user needs.
| Metric/Criteria (Implicit) | Reported Device Performance |
|---|---|
| Ability to process, review, analyze, communicate, and interchange multi-dimensional digital images. | The Presero 3D Scanning System is capable of these functions. |
| Ability to capture visual images to measure diameter, surface area, perimeter, and volume of wounds. | The device is indicated for this use. |
| Compliance with relevant medical device standards (e.g., IEC 62304, NEMA PS 3.1, IEC 60601-1-2). | "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: [List of standards provided]." Additionally, "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”." |
| Mitigation of potential risks. | "Potential risks were analyzed and satisfactorily mitigated in the device design." |
| Meets design requirements and user needs. | "Results of performance testing demonstrated that the device met the design requirements and as well as the user needs." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" and its sample size for evaluating the device's performance in measuring wounds. It mentions "verification and validation testing... in simulated use conditions," but provides no details on the number of cases or the nature of the data. The data provenance (country of origin, retrospective/prospective) is also not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The method for establishing ground truth for any performance evaluation is not detailed.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study comparing human readers with and without AI assistance is mentioned. The device is described as an "imaging tool" to "assist the healthcare professional," implying it provides measurements rather than assisting in diagnosis like some AI tools.
6. Standalone (Algorithm Only) Performance Study
While the document indicates that the device has undergone "verification and validation testing," it does not explicitly detail a standalone performance study in terms of specific metrics like sensitivity, specificity, or accuracy compared to a ground truth for wound measurements. The focus seems to be on the system's ability to perform its stated functions and comply with regulatory standards.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any performance evaluation. Given the device's function to measure wound characteristics, it is likely that a physical measurement (e.g., manual measurement with rulers, digital planimetry from other validated systems, or 3D models) would be used as a ground truth, but this is not confirmed in the provided text.
8. Sample Size for the Training Set
The document does not provide information on the sample size of a training set. This is often the case for 510(k) submissions of devices that are not primarily AI/machine learning diagnosis or detection tools where extensive training data might be discussed. The Presero 3D Scanning System is described as having "proprietary software application" and uses a "commercial off the shelf 3D camera," suggesting its primary function is measurement based on 3D scanning, which may rely more on geometric algorithms than machine learning requiring a large training set for image interpretation.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or detailed, there is no information on how its ground truth might have been established.
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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
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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 NeilR Ogden -S |
|---|---|
| Ogden -S | Date: 2019.02.1414:34:08 -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
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Indications for Use
510(k) Number (if known)
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)
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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 NorthPompano Beach, FL 33064 |
| Submitter's Phone No: | 954-628-5908 |
| Submitter's Fax No. | 954-206-1692 |
| Regulatory Contact: | Charnelle ThomasRegulatory Consultant404-360-6188Mailing address for regulatory correspondence:159 Lake Reserve WayCanton, 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 CFR892.2050 (LLZ), 21 CFR 878.4160 FXN |
| Classification Panel: | Radiological |
| Regulatory Class: | Class II |
| Product Code: | LLZ, FXN |
| Legally marketed deviceto which equivalency isclaimed: | EchoPixel True 3D Viewer (K142107) |
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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 thatallows the processing, review, analysis, communication andmedia interchange of multi-dimensional digital images acquiredfrom a 3D imaging device.The Presero 3D Scanning System, does not contact the patient, nordoes it control any life sustaining devices. A physician, providingample opportunity for competent human intervention interpretsimages and information being displayed and printed.The Presero 3D Scanning System is comprised of a commercial offthe shelf 3D camera fitted on a commercial off the shelf tablet,equipped with a proprietary software application that enables ahealth care professional to visualize and interact with 3D woundimages, via a pen-like stylus, to assist in clinical decision making.The complete system (tablet, camera and software) integrates witha cloud back-end system. The cloud back-end system stores allpatient data, operator details and other information allowing 2-waysynchronization between the Presero 3D Scanning System and thecloud with the ability to fully support multiple systems within asingle clinical facility. |
|---|---|
| Indications for Use: | The Presero 3D Scanning System is an imaging tool that allows theprocessing, review, analysis, communication and media interchangeof multi-dimensional digital images acquired from a 3D imagingdevice. It is indicated for the use of capturing visual images tomeasure the diameter, surface area, perimeter and volume ofwounds. The Presero 3D Scanning System is designed for use byhealth care professionals and is intended to assist the healthcareprofessional who is responsible for making all final patientmanagement decisions. |
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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 oftechnologicalcharacteristicscompared tothe predicatedevice: | The Presero® 3D Scanning System is similar to the "primary" predicate device,the EchoPixel True 3D Viewer (K142107) with regard to its intended use andcore technological characteristics with the exception of the source used toobtain the 3D images and the type of images evaluated by health careprofessionals in final patient management decisions. The Woundvision® WoundMeasuring and Monitoring device (K131596) is a "reference" device and has anintended use and core technology that is also substantially equivalent to thePresero® 3D Scanning System. | ||
|---|---|---|---|
| Substantial | Primary Predicate | Reference Device | Subject Device |
| Equivalence: | Echo Pixel True 3DViewer(K141207) | Wondvision WoundMeasuring &Monitoring Device(K131596) | Presero 3D ScanningSystem |
| Intended Use: | Intended as a medicaldiagnostic imagingsystem that allows theprocessing, review,analysis,communication andmedia interchange ofmulti-dimensionaldigital images acquiredfrom CT or MR imagingdevices. It is alsointended as pre-operative software forsimulating / evaluatingsurgical treatmentoptions. The True 3DViewer is designed foruse by health careprofessionals and isintended to assist theclinician who isresponsible for makingall final patientmanagement decisions. | The Scout is acombination digitalcamera and long-waveinfrared camera. Thedigital camera isindicated for the use ofcapturing visual imagesto measure the diameter,surface area, andperimeter of a part of thebody or two bodysurfaces. The long-waveinfrared camera isindicated for the use ofcapturing thermalimages to measure thethermal intensity data ofa part of the body or twobody surfaces: Bothcomponents of the Scoutare non-contact withrespect to the patientand provide anadjunctive tool to help atrained and qualifiedhealth care professional | The Presero 3DScanning System is amedical diagnosticimaging system thatallows the processing,review, analysis,communication andmedia interchange ofmulti-dimensionaldigital images acquiredfrom a 3D imagingdevice. It is alsointended as a pre-operative software forevaluating treatmentoptions. The Presero3D Scanning System isdesigned for use byhealth careprofessionals and isintended to assist thehealthcare professionalwho is responsible formaking all final patientmanagement decisions. |
| Primary PredicateEcho PixelTrue 3D Viewer(K142107) | Reference DeviceWoundvision WoundMeasuring &Monitoring Device(K131596) | Subject DevicePresero 3D ScanningSystem | |
| Intended Users:IntendedEnvironment forCare: | Health CareProfessionalsHealthcare Facilitiessuch as hospitals andclinicsClass II21 CFR 892.2050; LLZ | Health CareProfessionalsHealthcare Facilitiessuch as hospitals andclinicsClass I21 CFR 878.4160; FXN | Health CareProfessionalsHealthcare Facilitiessuch as hospitals andclinicsClass II21 CFR 892.2050; LLZ |
| Image AnalysisFeature: | Image analysis features:interactivemanipulation, tag,annotate, measure,segment | measure | Image analysisfeatures: interactivemanipulation, tag,annotate, measure,segment |
| ComputerPlatform:(minimumplatform) | HP Z440 Workstation | Minimum requirement:Intel Core i53rd generation (orequivalent) or better | Microsoft Surface Pro4 or Microsoft NewSurface Pro |
| SystemRAM: | 8 GB of systemmemory; NvidiaQuadro GraphicsProcessing Unit (GPU)with 4GB of videomemory | 4GB or greater | 8 GB of systemmemory |
| OperatingSystem: | Windows 7 or 10(64bit) | Windows 7 SP1 or later | Windows 10 (64bit) |
| ImageAcquisition: | CT and MR DICOMImages | Scout imaging device | Intel RealSense 3Dcamera |
| PerformanceData: | Every specification of the Presero® 3D Scanning Software has been validatedaccording to the company's documented development and test procedures. Theverification and validation testing conducted included testing to the followingapplicable standards:ISO/IEC/IEEE 29148:2011, Systems and software Engineering — LifeCycle Processes — Requirements Engineering ISO/IEC/IEEE 24765:2010 - Systems and software engineering - |
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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.
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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 inMedicine (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 essentialperformance - 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) Medicalelectrical equipment - Part 1: General requirements for basic safetyand essential performance (IEC 60601-1:2005, MOD) Verification and validation testing were completed in accordance with thecompany's Design Control process in compliance with 21 CFR Part 820.30,which included testing that fulfills the requirements of FDA "Guidance onSoftware Contained in Medical Devices". Potential risks were analyzed andsatisfactorily mitigated in the device design. Verification and validation wasperformed on qualified device as well as in simulated use conditions | |
|---|---|
| Conclusions: | The Presero® 3D Scanning System is substantially equivalent to the primarypredicate device with regards to intended use and technological characteristics.It is also substantially equivalent to the reference device. Results ofperformance testing demonstrated that the device met the design requirementsand as well as the user needs |
§ 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).