Viewer+ is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. Viewer+ is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Viewer+ is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner and BARCO MDPC-8127 display.

Device Description

Viewer+, version 1.0.1, is a web-based software device that facilitates the viewing and navigating of digitized pathology images of slides prepared from FFPE-tissue specimens acquired from Hamamatsu NanoZoomer S360MD Slide scanner and viewed on BARCO MDPC-8127 display. Viewer+ renders these digitized pathology images for review, management, and navigation for pathology primary diagnosis.

Viewer+ is operated as follows:

1. Image acquisition is performed using the NanoZoomer S360MD Slide scanner according to its Instructions for Use. The operator performs quality control of the digital slides per the instructions of the NanoZoomer and lab specifications to determine if re-scans are necessary.
1. Once image acquisition is complete and the image becomes available in the scanner's database file system, a separate medical image communications software (not part of the device) automatically uploads the image and its corresponding metadata to persistent cloud storage. Image and data integrity checks are performed during the upload to ensure data accuracy.
1. The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and areas, and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Viewer+ device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Pixel-wise comparison (of images reproduced by Viewer+ and NZViewMD for the same file generated from NanoZoomer S360md Slide Scanner)	The 95th percentile of pixel-wise differences between Viewer+ and NZViewMD was less than 3 CIEDE2000, indicating their output images are pixel-wise identical and visually adequate.
Turnaround time (for opening, panning, and zooming an image)	Found to be adequate for the intended use of the device.
Measurement accuracy (using scanned images of biological slides)	Viewer+ was found to perform accurate measurements with respect to its intended use.
Usability testing	Demonstrated that the subject device is safe and effective for the intended users, uses, and use environments.

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

The document does not explicitly state the specific sample size of images or cases used for the "Test Set" in the performance studies. It mentions "scanned images of the biological slides" for measurement accuracy and "images reproduced by Viewer+ and NZViewMD for the same file" for pixel-wise comparison.

The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. It mentions that the device is "an aid to the pathologist" and that "It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision." However, this relates to the intended use and not a specific part of the performance testing described.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or evaluating the test set results. The pixel-wise comparison relies on quantitative color differences, and usability is assessed according to FDA guidance.

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

No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is mentioned or implied in the provided text. The device is a "viewer" and not an AI-assisted diagnostic tool that would typically involve such a study.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

The performance tests described (pixel-wise comparison, turnaround time, measurements) primarily relate to the technical functionality of the Viewer+ software itself, which is a viewing and management tool. These tests can be interpreted as standalone assessments of the software's performance in rendering images and providing basic functions like measurements. However, it's crucial to note that Viewer+ is an "aid to the pathologist" and not intended to provide automated diagnoses without human intervention. The "standalone" performance here refers to its core functionalities as a viewer, not as an autonomous diagnostic algorithm.

7. Type of Ground Truth Used

Pixel-wise comparison: The ground truth for this test was the image reproduced by the predicate device's software (NZViewMD) for the same scanned file. The comparison was quantitative (CIEDE2000).
Measurements: The ground truth would likely be established by known physical dimensions on the biological slides, verified by other means, or through precise calibration. The document states "Measurement accuracy has been verified using scanned images of the biological slides."
Usability testing: The ground truth here is the fulfillment of usability requirements and user satisfaction/safety criteria, as assessed against FDA guidance.

8. Sample Size for the Training Set

The document does not mention the existence of a "training set" in the context of the Viewer+ device. This is a software-only device for viewing and managing images, not an AI/ML algorithm that typically requires a training set for model development.

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

As no training set is mentioned for this device, information on how its ground truth was established is not applicable.

Summary

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March, 14, 2025

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Lumea, Inc. Emre Gulturk Regulatory Consultant 2889 Ashton Blvd #300 Lehi. UT 84043

Re: K242244

Trade/Device Name: Viewer+ Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: QKQ Dated: July 19, 2024 Received: July 31, 2024

Dear Emre Gulturk:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).

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Sincerely,

Shyam Kalavar -S

Shyam Kalavar Deputy Branch Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics 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) K242244

Device Name Viewer+

Indications for Use (Describe) For In Vitro Diagnostic Use

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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510(k) SUMMARY

1. Date of Summary: March 11, 2025

2. Submitter:	Lumea, Inc.
Address:	2889 Ashton Blvd #300
	Lehi, UT 84043 USA
Phone:	+1-612-396-1376
Contact:	Emre Gulturk
Email:	emre@lumeadigital.com

3. Identification of the Device:

Proprietary/Trade Name:	Viewer+
Version:	1.0.1
Regulation Description:	Whole Slide Imaging System
Review Panel:	88 - Pathology
Product Code:	QKQ
Device Class:	Class II
510(k) Submission Number:	K242244

4. Identification of the Predicate Device:

Predicate Device Name:	NanoZoomer S360md Slide Scanner System
510(k) Number:	K233027
Manufacturer:	Hamamatsu Photonics K.K.
Regulation Number:	21 CFR 864.3700
Product Code:	PSY
Device Class:	Class II

5. Intended Use/Indications for Use:

For In Vitro Diagnostic Use

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6. Device Description:

Viewer+ is operated as follows:

1. Image acquisition is performed using the NanoZoomer S360MD Slide scanner according to its Instructions for Use. The operator performs quality control of the digital slides per the instructions of the NanoZoomer and lab specifications to determine if re-scans are necessary.
1. Once image acquisition is complete and the image becomes available in the scanner's database file system, a separate medical image communications software (not part of the device) automatically uploads the image and its corresponding metadata to persistent cloud storage. Image and data integrity checks are performed during the upload to ensure data accuracy.
1. The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and areas, and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis.

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The interoperable components of Viewer+ and other systems are provided below:

Viewer+ operates with and is validated for use with the components specified the tables below:

Table 1. Interoperable Components for Use with Viewer 1
Components	Manufacturer	Model
Scanner	Hamamatsu Photonics K.K.	NanoZoomer S360MD Slide scanner
Display	BARCO	MDPC-8127

Table 1, Interoperable Components for Use with Viewer+

Table 2. Computer Environment/System Requirements

Environment	Component	Minimum Requirements
Client PC
Hardware	Processor	1 CPU 4 cores 2.0GHz Standard consumer GPU, such as Intel, AMD, or NVIDIA with 2GB VRAM
	Memory	8 GB or more
	Network	100 Mbps or faster (1 Gbps recommended)
Software	Operating System/Browser	Windows (10 or higher) for Google Chrome (130.06723.117 or higher) Microsoft Edge (132.0.2.2849.80 or higher) Mozilla Firefox (132.0.1 or higher) Apple OS (13.7.2 Ventura or higher) for Apple Safari (18.1 (20619.2.8.11.10) or higher)

7. Summary of Performance Testing

A series of tests were performed to assess the safety and effectiveness of the subject device, Viewer+.

The following performance tests were conducted per FDA guidance "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device (2016)" and "Applying Human Factors and Usability Engineering to Medical Devices (2016)".

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Test	Result
Pixel-wise comparison	Pixel-wise comparison study was conducted to compare images reproduced by Viewer+ and NZViewMD for the same file generated from NanoZoomer S360md Slide Scanner to validate identical image reproduction. Test results showed that the 95th percentile of pixelwise differences between Viewer+ and NZViewMD was less than 3 CIEDE2000, indicating that their output images are pixel-wise identical. Therefore, it was determined that color images reproduced by Viewer+ were visually adequate with respect to its intended use.
Turnaround time	The turnaround time of opening, panning and zooming an image has been determined and found to be adequate for the intended use of the subject device.
Measurements	Measurement accuracy has been verified using scanned images of the biological slides. Viewer+ has been found to perform accurate measurements with respect to its intended use.
Usability testing	The usability test was conducted per FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)". The test result demonstrated that the subject device has been found to be safe and effective for the intended users, uses, and use environments.

All test results demonstrate Viewer+ meets the requirements of its pre-defined acceptance criteria and intended use and is substantially equivalent to the predicate device.

8. Substantial Equivalence Determination

Viewer+ submitted in this 510(k) file is substantially equivalent in intended use, principles of operation, safety and performance to the cleared NanoZoomer S360md slide scanner system (K233027). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

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Device &PredicateDevice(s):	K242244	K233027	SubstantialEquivalenceDetermination
Device TradeName	Viewer+	NanoZoomer S360MDSlide scanner system	N/A
General DeviceCharacteristicSimilarities
IntendedUse/Indicationsfor Use	For In Vitro DiagnosticUseViewer+ is a softwareonly device intended forviewing and managementof digital images ofscanned surgicalpathology slides preparedfrom formalin-fixedparaffin embedded(FFPE) tissue. It is an aidto the pathologist toreview, interpret andmanage digital images ofpathology slides forprimary diagnosis.Viewer+ is not intendedfor use with frozensections, cytology, ornon-FFPEhematopathologyspecimens.It is the responsibility ofa qualified pathologist toemploy appropriateprocedures andsafeguards to assure thequality of the imagesobtained and, wherenecessary, useconventional lightmicroscopy review whenmaking a diagnosticdecision. Viewer+ isintended for use withHamamatsu	The NanoZoomerS360MD Slide scannersystem (“NanoZoomerSystem”) is an automateddigital slide creation,viewing, and managementsystem. The NanoZoomerSystem is intended for invitro diagnostic use as anaid to the pathologist toreview and interpretdigital images of surgicalpathology slides preparedfrom formalin-fixedparaffin embedded(“FFPE”) tissue. TheNanoZoomer System isnot intended for use withfrozen section, cytology,or non-FFPEhematopathologyspecimens.The NanoZoomer Systemcomprises theNanoZoomer S360MDSlide scanner, theNZViewMD Software anda compatible display thathas been 510(k) clearedfor use with theNanoZoomer system or a510(k)-cleared display thathas been assessed inaccordance with thePredetermined ChangeControl Plan (PCCP) forqualifying additional	SameBoth software aredesigned to viewand manage thedigital image ofscanned surgicalpathology slidesprepared fromformalin-fixedparaffinembedded(FFPE) tissue.
Device &PredicateDevice(s):	K242244	K233027	SubstantialEquivalenceDetermination
	NanoZoomer S360MDSlide scanner andBARCO MDPC-8127display.	compatible displays. TheNanoZoomer System isfor creation and viewingof digital images ofscanned glass slides thatwould otherwise beappropriate for manualvisualization byconventional lightmicroscopy. It is theresponsibility of aqualified pathologist toemploy appropriateprocedures and safeguardsto assure the validity ofthe interpretation ofimages obtained usingNanoZoomer System.
Specimen Type	Surgical pathology slidesprepared from FFPEtissue	Surgical pathology slidesprepared from FFPE tissue	Same
DiagnosticImage FileFormat	Hamamatsu NDPI File	Hamamatsu NDPI File	Same
Image Storage	Same	User-supplied networkattached storage	Same
General DeviceCharacteristicDifferences
ImageManipulationand ReviewFunctions	Functions for continuouspanning and zooming,annotations, imageadjustments,distance/areameasurements, organizeworkload and viewpatient data, exportimages, and display ofdiagnostic status ofimages.	Functions for continuouspanning and zooming,annotations, distance/areameasurements, trackvisited areas, exportimages, discrete Z-axisdisplacement, and displayof diagnostic status ofimages.	SimilarSame imagemanipulationfunction wheresubject deviceonly measuresdistance/area
Type ofSoftwareApplication	Internet browser-basedapplication	PC-based installedapplication	Different
Device &PredicateDevice(s):	K242244	K233027	SubstantialEquivalenceDetermination
			The difference insoftwareapplication doesnot raise newsafety andeffectivenessquestions

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9. Similarities and Differences

The subject device has similar indications for use/intended use and principle of operation as the predicate device.

There are differences between the subject device and the predicate device, including the software application, the device component and the image storage.

For the software application, the predicate device is a PC-based software, in contrast to the subject device which operates as an internet browser-based software. The difference does not raise new safety and effectiveness questions.

The subject device has undergone safety and performance tests, and the results complied with the test requests. The subject device is substantially equivalent to the predicate device in intended use, principles of operation, safety and performance claims.

10. Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that when Viewer+ is used with the NanoZoomer S360md scanner and the Barco MDPC-8127 display, it is substantially equivalent to the predicate device.

Regulation Number and Section

§ 864.3700 Whole slide imaging system.

(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.