(269 days)
Not Found
No
The description focuses on basic image viewing and manipulation tools (zoom, pan, measure, annotate) and does not mention any analytical or interpretive functions that would typically involve AI/ML. The performance studies also focus on image quality, speed, and usability, not diagnostic accuracy or algorithmic performance.
No
The device is described as an aid for pathologists to review, interpret, and manage digital images for diagnosis, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states: "MetaLite DX Digital Pathology Software ... is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides." This directly indicates its use in aiding diagnosis.
Yes
The device description explicitly states "MetaLite DX Digital Pathology Software is a software only device". While it is intended for use with specific hardware (scanner and display), the device itself, as described, is the software component.
Yes, this 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 software is intended for "viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis." This directly relates to examining biological specimens (tissue) outside of the body (in vitro) to aid in diagnosis.
- Role in Diagnosis: It is described as an "aid to the pathologist to review, interpret and manage digital images of pathology slides," which is a key function of an IVD in the context of pathology.
The other details in the description, such as the type of specimens used (FFPE tissue), the user (qualified pathologist), and the purpose (primary diagnosis), all align with the definition and function of an In Vitro Diagnostic device in the field of pathology.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
MetaLite DX Digital Pathology Software 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 for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides.
MetaLite DX Digital Pathology Software is not intended for use with frozen section, 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. MetaLite DX Digital Pathology Software is intended for use with Philips Ultra Fast Scanner and the Barco MDPC-8127 display.
Product codes
QKQ
Device Description
MetaLite DX Digital Pathology Software, Model MLDXUS, version 1.2.1 is software designed for viewing digital pathology images of glass slides from the Philips IntelliSite Pathology Solution Ultra-Fast Scanner (PIPS-UFS), version 1.8.4 on Barco MDPC-8127 display.
MetaLite DX Digital Pathology Software is operated as follows:
Before scanning the slide on the PIPS-UFS, the technician performs quality control on the tissue of interest. The images captured by the PIPS-UFS are compressed using Philips' proprietary iSyntax format and are transmitted to the Philips Image Management System (IMS).
- (1) After the Whole Slide Images (WSIs) are successfully, acquired by using PIPS-UFS, the WSIs are stored in the Local file system. A qualified pathologist will upload compatible iSyntax format digital pathology images, and the software will load them to the "Main Viewer" area of the graphical interface for the pathologist to view.
- (2) Once properly loaded, the pathologist will use the inherent features of the device (including tools that allow for adjusting the position and viewing angle of the image, measuring lengths between two coordinates, and adding annotations to specific regional areas).
- (3) After viewing all images for a patient (case), the pathologist will make a diagnosis. The diagnosis will be documented in another system, e.g., a Laboratory Information System (LIS).
The software has various features such as zoom-in and zoom-out functions, scale display, thumbnail view, measurement function, annotation function, and panning function to help pathologists interpret, diagnose and manage digital whole slide images. The MetaLite DX Digital Pathology Software is validated for use with the components specified the tables below.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Whole Slide Images (WSIs) captured by Philips Ultra Fast Scanner (UFS)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified pathologist / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)".
- Pixel-wise comparison: Pixel-wise comparison study was conducted to compare images reproduced by MetaLite DX Digital Pathology Software and PIPS IMS for the same iSyntax file generated from UFS 1.8.4 to validate identical image reproduction. Test results showed that the 95th percentile of pixelwise differences between MetaLite DX Digital Pathology Software and PIPS IMS was less than 3 CIEDE2000, indicating that their output images are pixel-wise identical. Therefore, it was determined that color images reproduced by MetaLite DX Digital Pathology Software were visually adequate with respect to its intended use.
- Turnaround time: The turnaround time of opening, panning and zooming an image is within 5 seconds, which has been determined and found to be adequate for the intended use of the subject device.
- Measurements: Measurement accuracy has been verified using a scanned image of the calibration scale slide. MetaLite DX Digital Pathology Software 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 MetaLite DX Digital Pathology Software 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.)
- Pixel-wise difference: 95th percentile of pixelwise differences between MetaLite DX Digital Pathology Software and PIPS IMS was less than 3 CIEDE2000.
- Turnaround time: within 5 seconds.
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.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
October 28, 2024
JelloX Biotech Inc. Tzu-Han Fan Medical Laboratory Scientist No. 66-5, Shengyi 5th Rd., Zhubei City, Hsinchu County, 302041 Taiwan
Re: K240303
Trade/Device Name: MetaLite DX Digital Pathology Software Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: QKQ Dated: December 13, 2023 Received: February 2, 2024
Dear Tzu-Han Fan:
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/cdrb/cfdocs/cfpm/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.
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K240303
Device Name MetaLite DX Digital Pathology Software
Indications for Use (Describe) For In Vitro Diagnostic Use
MetaLite DX Digital Pathology Software 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 for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides.
MetaLite DX Digital Pathology Software is not intended for use with frozen section, 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. MetaLite DX Digital Pathology Software is intended for use with Philips Ultra Fast Scanner and the Barco MDPC-8127 display.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
- October 28, 2024 1. Date of Summary:
-
- Submitter: JelloX Biotech Inc. Address: No. 66-5, Shengyi 5th Rd., Zhubei City, Hsinchu County, 302041, Taiwan (R.O.C) Phone: +886-3-6583058 ext 204 Contact: Tzu-Han Fan Email fancyhan@jellox.com
MetaLite DX Digital Pathology
-
- Identification of the Device: Proprietary/Trade Name:
| Software | |
|---|---|
| Model Number: | MLDXUS |
| Version: | 1.2.1 |
| Regulation Description: | Whole Slide Imaging System |
| Review Panel: | 88 – Pathology |
| Regulation Number: | 21 CFR 864.3700 |
| Product Code: | QKQ |
| Device Class: | Class II |
| 510(k) Submission Number: | K240303 |
-
- Identification of the Predicate Device:
| Predicate Device Name: | Philips IntelliSite Pathology
Solution (PIPS) |
|------------------------|--------------------------------------------------|
| Model Number: | N/A |
| 510(k) Number: | K203845 |
| Manufacturer: | Philips Medical Systems
Nederland B.V. |
| Regulation Number: | 21 CFR 864.3700 |
| Product Code: | PSY |
| Device Class: | Class II |
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ട. Intended Use/ Indications for Use of the Device
For In Vitro Diagnostic Use
MetaLite DX Digital Pathology Software 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 for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides.
MetaLite DX Digital Pathology Software is not intended for use with frozen section, 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. MetaLite DX Digital Pathology Software is intended for use with Philips Ultra Fast Scanner and the Barco MDPC-8127 display.
6. Device Description
MetaLite DX Digital Pathology Software, Model MLDXUS, version 1.2.1 is software designed for viewing digital pathology images of glass slides from the Philips IntelliSite Pathology Solution Ultra-Fast Scanner (PIPS-UFS), version 1.8.4 on Barco MDPC-8127 display.
MetaLite DX Digital Pathology Software is operated as follows:
Before scanning the slide on the PIPS-UFS, the technician performs quality control on the tissue of interest. The images captured by the PIPS-UFS are compressed using Philips' proprietary iSyntax format and are transmitted to the Philips Image Management System (IMS).
- (1) After the Whole Slide Images (WSIs) are successfully, acquired by using PIPS-UFS, the WSIs are stored in the Local file system. A qualified pathologist will upload compatible iSyntax format digital pathology images, and the software will load them to the "Main Viewer" area of the graphical
5
interface for the pathologist to view.
- (2) Once properly loaded, the pathologist will use the inherent features of the device (including tools that allow for adjusting the position and viewing angle of the image, measuring lengths between two coordinates, and adding annotations to specific regional areas).
- (3) After viewing all images for a patient (case), the pathologist will make a diagnosis. The diagnosis will be documented in another system, e.g., a Laboratory Information System (LIS).
The software has various features such as zoom-in and zoom-out functions, scale display, thumbnail view, measurement function, annotation function, and panning function to help pathologists interpret, diagnose and manage digital whole slide images. The MetaLite DX Digital Pathology Software is validated for use with the components specified the tables below.
Table 1. Interoperable Components for Use with MetaLite DX Digital Pathology Software
| Component | Manufacturer | Model |
|---|---|---|
| Scanner | Philips Medical Systems | |
| Nederland B.V. | Ultra Fast Scanner (UFS), | |
| Version 1.8.4 | ||
| Display | Barco NV | MDPC-8127 |
| Table 2. Computer Environment/System Requirements | |
|---|---|
| Environment | Component | Minimum Requirements |
|---|---|---|
| Client PC | ||
| Hardware | Processor | Intel® Core (TM) I7 11th Gen or above |
| Memory | 16GB or above | |
| Storage | USB Flash Drive 8GB or above | |
| Software | Operating System | Windows 10 or above |
Summary of Performance Testing 7.
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A series of tests were performed to assess the safety and effectiveness of the subject device, MetaLite DX Digital Pathology Software.
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)".
| Test | Result |
|---|---|
| Pixel-wise comparison | Pixel-wise comparison study was conducted to |
| compare images reproduced by MetaLite DX | |
| Digital Pathology Software and PIPS IMS for | |
| the same iSyntax file generated from UFS 1.8.4 | |
| to validate identical image reproduction. Test | |
| results showed that the 95th percentile of | |
| pixelwise differences between MetaLite DX | |
| Digital Pathology Software and PIPS IMS was | |
| less than 3 CIEDE2000, indicating that their | |
| output images are pixel-wise identical. | |
| Therefore, it was determined that color images | |
| reproduced by MetaLite DX Digital Pathology | |
| Software were visually adequate with respect | |
| to its intended use. | |
| Turnaround time | The turnaround time of opening, panning and |
| zooming an image is within 5 seconds, which | |
| has been determined and found to be | |
| adequate for the intended use of the subject | |
| device. | |
| Measurements | Measurement accuracy has been verified using |
| a scanned image of the calibration scale slide. | |
| MetaLite DX Digital Pathology Software 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. |
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All test results demonstrate MetaLite DX Digital Pathology Software meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
Substantial Equivalence Determination 8.
MetaLite DX Digital Pathology Software submitted in this 510(k) file is substantially equivalent in intended use, principles of operation, safety and performance to the cleared Philips IntelliSite Pathology Solution (PIPS) (K203845). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
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| Item | Subject device | Predicate device | Substantial
equivalence
determination |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K240303 | K203845 | |
| Proprietary Name | MetaLite DX Digital
Pathology Software | Philips IntelliSite Pathology
Solution (PIPS) | N/A |
| Manufacturer | JelloX Biotech Inc. | Philips Medical Systems
Nederland B.V. | |
| Product Code | QKQ | PSY | |
| Classification | Class II | Class II | Same |
| Intended Use | For In Vitro Diagnostic Use
MetaLite DX Digital
Pathology Software 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 for the purposes of | The Philips IntelliSite
Pathology Solution (PIPS) is an
automated digital slide creation,
viewing, and management
system. The PIPS 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) | 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. |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| | pathology primary diagnosis.
It is an aid to the pathologist
to review, interpret and
manage digital images of
pathology slides. | tissue. The PIPS is not intended
for use with frozen section,
cytology, or non-FFPE
hematopathology specimens.
The PIPS comprises the Image
Management System (IMS), the
Ultra Fast Scanner (UFS) and
Display. The PIPS 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 | |
| | MetaLite DX Digital
Pathology Software is not
intended for use with frozen
section, 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 | | |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| | light microscopy review
when making a diagnostic
decision. MetaLite DX
Digital Pathology Software is
intended for use with Philips
Ultra Fast Scanner and the
Barco MDPC-8127 display. | obtained using PIPS. | |
| Specimen Type | Digitized surgical pathology
slides prepared from FFPE
tissue | Surgical pathology slides
prepared from FFPE tissue | Same |
| Image file format | iSyntax | iSyntax | Same |
| Image
Manipulation
Functions | Panning, zooming, color
manipulation function,
annotations, and measurements
(distance) | Panning, zooming, color
manipulation function,
annotations, and measurements
(distance & area) | Similar
Same image manipulation
function where subject
device only measures
distance |
| Type of
Software
Application | Stand-alone software | Internet browser-based
application | Different
The difference in software
application does not raise |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| Device
Components | MetaLite DX Digital
Pathology Software | Ultra Fast Scanner (UFS),
Image Management System
(IMS) and Display | Different
The subject device can
substitute the IMS in the
predicate device and this
does not raise new safety
and effectiveness questions |
| Principle of
Operation | After WSI images are
successfully acquired by using
Philips IntelliSite Pathology
Solution Ultra Fast Scanner
(PIPS-UFS), the pathologist
performs further QC and reads
WSI images of the slides to
make a diagnosis | After WSI images are
successfully acquired by using
PIPS UFS, the WSI images are
stored in IMS Application
Server & Storage software that
is not provided as part of the
PIPS but may be located in a
central server room separate
from the workstation with the
IMS viewing software and
Display. During review, the | Same |
| Item | Subject device | Predicate device | Substantial equivalence determination |
| Image Storage | Images are stored in the local computer | pathologist opens WSI images from IMS Server & Storage, perform further QC and reads WSI images of the slides to make a diagnosis
After WSI images are successfully acquired by using PIPS UFS, the WSI images are stored in IMS Application Server & Storage software that is not provided as part of the PIPS, but may be located in a central server room separate from the workstation with the IMS viewing software and Display. During review, the pathologist opens WSI images from IMS Server & Storage, perform further QC and reads | Different
Network connectivity is not needed for subject software to function |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| | | WSI images of the slides to
make a diagnosis | |
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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 three differences between the subject device and the predicate device, including the software application, the device component and the image storage.
For the device component, both devices are intended for viewing digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The display used with subject product is Barco MDPC-8127, which has been confirmed to be substantially equivalent to the PS27QHDCR used in predicate device.
For the software application, the subject device is a stand-alone software, in contrast to the predicate device which operates as an internet browser-based software. The difference does not raise new safety and effectiveness questions.
Conversely, as the subject device does not require internet connectivity, it decreases the risk of vulnerability through the internet. The maintenance for the subject device includes installation and update is conducted by qualified specialist of JelloX Biotech Inc., this also enhances network security.
For the image storage, subject device would store images in local computer without using network to assess image data, compared to cloud storage, it significantly reduces the risk of data breaches.
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.
Conclusion 10.
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that when MetaLite DX Digital Pathology Software is used with the PIPS USF scanner and the Barco MDPC-8127 display, it is substantially equivalent to the predicate device.