(226 days)
Hamamatsu NanoZoomer S360MD Slide scanner, BARCO MDPC-8127 display
No
The description focuses on image viewing, navigation, and management functionalities, with no mention of AI or ML algorithms for image analysis or interpretation. The performance studies also focus on image reproduction, turnaround time, measurements, and usability, not on the performance of any AI/ML-driven diagnostic aid.
No.
The device is intended for in vitro diagnostic use as an aid to pathologists for reviewing, interpreting, and managing digital pathology images for primary diagnosis. It is not used to directly treat patients.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For In Vitro Diagnostic Use," and describes the device as an "aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis." These statements clearly indicate the device's role in the diagnostic process.
Yes
The device description explicitly states "Viewer+ is a web-based software device" and describes its function as facilitating the viewing and navigating of digitized images. While it interacts with hardware (scanner and display), the device itself is presented as purely software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use".
- Intended Use: The device is intended for "viewing and management of digital images of scanned surgical pathology slides... as an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis." This directly relates to the diagnostic process of examining biological specimens outside the body (in vitro).
- Context: The device is used with scanned pathology slides, which are prepared from tissue specimens for diagnostic purposes.
The other details in the description, such as the specific scanner and display it's intended for use with, the workflow, and the performance studies, all support its role within the in vitro diagnostic workflow of a pathology lab.
No
The document explicitly states "Predetermined Change Control Plan (PCCP) - All Relevant Information: Not Found". This indicates that a PCCP was not authorized for this device.
Intended Use / Indications for Use
For In Vitro Diagnostic Use
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.
Product codes
QKQ
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:
- 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.
- 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.
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanned surgical pathology slides
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified pathologist
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
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)".
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
95th percentile of pixelwise differences between Viewer+ and NZViewMD was less than 3 CIEDE2000.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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).
1
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
3
Indications for Use
510(k) Number (if known) K242244
Device Name Viewer+
Indications for Use (Describe) For In Vitro Diagnostic Use
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.
| 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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4
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
5
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.
6. 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:
-
- 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.
-
- 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.
-
- 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.
6
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)".
7
| 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 &
Predicate
Device(s): | K242244 | K233027 | Substantial
Equivalence
Determination |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade
Name | Viewer+ | NanoZoomer S360MD
Slide scanner system | N/A |
| General Device
Characteristic
Similarities | | | |
| Intended
Use/Indications
for Use | For In Vitro Diagnostic
Use
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 | The NanoZoomer
S360MD Slide scanner
system (“NanoZoomer
System”) is an automated
digital slide creation,
viewing, and management
system. The NanoZoomer
System is intended for in
vitro diagnostic use as an
aid to the pathologist to
review and interpret
digital images of surgical
pathology slides prepared
from formalin-fixed
paraffin embedded
(“FFPE”) tissue. The
NanoZoomer System is
not intended for use with
frozen section, cytology,
or non-FFPE
hematopathology
specimens.
The NanoZoomer System
comprises the
NanoZoomer S360MD
Slide scanner, the
NZViewMD Software and
a compatible display that
has been 510(k) cleared
for use with the
NanoZoomer system or a
510(k)-cleared display that
has been assessed in
accordance with the
Predetermined Change
Control Plan (PCCP) for
qualifying additional | Same
Both software are
designed to view
and manage the
digital image of
scanned surgical
pathology slides
prepared from
formalin-fixed
paraffin
embedded
(FFPE) tissue. |
| Device &
Predicate
Device(s): | K242244 | K233027 | Substantial
Equivalence
Determination |
| | NanoZoomer S360MD
Slide scanner and
BARCO MDPC-8127
display. | compatible displays. The
NanoZoomer System is
for creation and viewing
of digital images of
scanned glass slides that
would otherwise be
appropriate for manual
visualization by
conventional light
microscopy. 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
NanoZoomer System. | |
| Specimen Type | Surgical pathology slides
prepared from FFPE
tissue | Surgical pathology slides
prepared from FFPE tissue | Same |
| Diagnostic
Image File
Format | Hamamatsu NDPI File | Hamamatsu NDPI File | Same |
| Image Storage | Same | User-supplied network
attached storage | Same |
| General Device
Characteristic
Differences | | | |
| Image
Manipulation
and Review
Functions | Functions for continuous
panning and zooming,
annotations, image
adjustments,
distance/area
measurements, organize
workload and view
patient data, export
images, and display of
diagnostic status of
images. | Functions for continuous
panning and zooming,
annotations, distance/area
measurements, track
visited areas, export
images, discrete Z-axis
displacement, and display
of diagnostic status of
images. | Similar
Same image
manipulation
function where
subject device
only measures
distance/area |
| Type of
Software
Application | Internet browser-based
application | PC-based installed
application | Different |
| Device &
Predicate
Device(s): | K242244 | K233027 | Substantial
Equivalence
Determination |
| | | | The difference in
software
application does
not raise new
safety and
effectiveness
questions |
9
10
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.