(246 days)
Not Found
No
The summary describes a software device for viewing and managing digital pathology images, focusing on image display accuracy, turnaround time, and measurement capabilities. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis or interpretation beyond basic viewing and management. The performance studies focus on technical aspects of image display and system performance, not on diagnostic or analytical capabilities that would typically involve AI/ML.
No.
The device is for In Vitro Diagnostic Use and is intended for viewing and managing digital images of pathology slides to aid pathologists in primary diagnosis, not for treating a disease or condition.
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 for the primary diagnosis of surgical pathology slides.
Yes
The device description explicitly states "aetherSlide, version 101692 is a web-based, software only device". While it interacts with hardware (Philips Ultra Fast Scanner and Philips PS27QHDCR monitor), the device itself, as described, is solely the software component for viewing and managing digital images.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section begins with "For In Vitro Diagnostic Use".
- Nature of Use: The device is intended for viewing and managing digital images of scanned surgical pathology slides prepared from tissue. This process is part of the in vitro examination of human specimens to obtain information for diagnostic purposes.
- Aid to Pathologist for Primary Diagnosis: The device is described 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 performed outside of the body (in vitro).
While the device itself is software and doesn't directly interact with the biological specimen, it is an essential tool used in the in vitro diagnostic workflow of examining pathology slides for diagnosis.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
aetherSlide is a software-only device intended for viewing and managing 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. aetherSlide 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. aetherSlide is intended for use with the Philips Ultra Fast Scanner (UFS) and the Philips PS27QHDCR monitor.
Product codes
QKQ
Device Description
aetherSlide, version 101692 is a web-based, software only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue obtained from Philips Ultra Fast Scanner (UFS). It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.
aetherSlide is operated as follows:
-
- Image acquisition is performed using the Philips UFS. The operator conducts quality control of the digital slides according to Philips UFS instructions and laboratory specifications to determine if re-scans are necessary.
- Once the WSI is acquired using Philips UFS, it becomes available in the Philips IntelliSite Pathology Solution (PIPS) database file systems. The operator then exports the WSI in iSyntax format from PIPS Image Management System (IMS) to a designated storage path.
-
- The operator can manually upload the exported WSI into aetherSlide via aetherSlide Gateway, which is a separate medical image communications software. Alternatively, the aetherSlide Gateway can automatically initiate the upload of the WSI into aetherSlide when the auto-upload function is activated on the settings page of aetherSlide Gateway. Once the WSI is uploaded, the reading pathologist uses the device to perform the following actions:
- . View slide image
- . Zoom and pan the image
- Measure distances in the image
- . Annotate the image
-
- 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).
aetherSlide is designed to be deployed to a customer-managed infrastructure and may be accessed on the user's workstation browser. aetherSlide operates with and is validated for use with the components specified the tables below:
Components:
Scanner: Philips Medical Systems Nederland B.V., Model: Ultra Fast Scanner
Display: Philips Medical Systems Nederland B.V., Model: PS27QHDCR Monitor
Computer Environment/System Requirements:
Client PC - Hardware:
Processor: Intel or AMD with 64-bit support, at least 2 GHz, at least 2 cores
Memory: 4 GB RAM or higher
Storage: 128 GB SSD or higher
Network: 100 Mbps Ethernet or above
Client PC - Software:
Operating System: Microsoft Windows 11
Browser: Google Chrome (122 or higher)
Gateway Workstation - Hardware:
Processor: Intel or AMD with 64-bit support, at least 2 GHz, at least 2 cores
Memory: 4 GB RAM or higher
Storage: 128 GB SSD or higher
Network: 100 Mbps Ethernet or above
Gateway Workstation - Software:
Operating System: Microsoft Windows 11
Server - Hardware:
Processor: Intel or AMD with 64-bit support, at least 2 GHz, at least 8 cores
Memory: 16 GB RAM or higher
Storage: 512 GB SSD or higher
Network: 1 Gbps or above
Server - Software:
Operating System: Ubuntu 22.04 LTS
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanned digital images of surgical pathology slides
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified pathologist / For In Vitro Diagnostic Use
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)
A series of tests were performed to assess the safety and effectiveness of aetherSlide. All the test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use.
The following performance tests were conducted per FDA guidance "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device (2016)''
Pixel-wise comparison: Pixel-wise comparison study was conducted to compare images reproduced by aetherSlide and PIPS IMS for the same iSyntax file to validate identical image reproduction. Test results showed that the 95th percentile of pixelwise differences between aetherSlide 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 aetherSlide were visually adequate with respect to its intended use.
Turnaround time: The system requirements have been fulfilled:
· When selecting a case, it should not take longer than 10 seconds until the image is fully loaded.
· When panning the image (one quarter of the monitor) it shall not take longer than 7 seconds until the image is fully loaded.
Turnaround times for opening an image and panning have 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 grid micrometer. aetherSlide 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
May 30, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
AetherAI Co., Ltd. Leticia Hong Team Leader of RA 15F & 15F-1., No. 508, Sec. 7 Zhongxiao E. Rd., Nangang Dist. Taipei City. 115011 Taiwan
Re: K233126
Trade/Device Name: aetherSlide Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: QKQ Dated: September 15, 2023 Received: September 27, 2023
Dear Leticia Hong:
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 OS 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 (OS) 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 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).
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
2
Indications for Use
510(k) Number (if known) K233126
Device Name aetherSlide
Indications for Use (Describe)
For In Vitro Diagnostic Use
aetherSlide is a software-only device intended for viewing and managing 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. aetherSlide 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. aetherSlide is intended for use with the Philips Ultra Fast Scanner (UFS) and the Philips PS27QHDCR monitor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
1. Date of Summary: 05/30/2024
-
- Submitter: aetherAI Co., Ltd.
| Address: | 15F & 15F-1, No. 508, Sec. 7, Zhongxiao E. Rd., Nangang Dist., Taipei City 115011, Taiwan (R.O.C.) |
|---|---|
| Phone: | +886-2-27856892 |
| Contact: | Leticia Hong (leticiahong@aetherai.com) |
3. Identification of the Subject Device:
| Proprietary/Trade Name: | aetherSlide |
|---|---|
| Version: | 101692 |
| Classification Product Code: | QKQ |
| Regulation Number: | 21 CFR 864.3700 |
| Regulation Description: | Digital Pathology Image Viewing and |
| Management Software | |
| Review Panel: | 88 - Pathology |
| Device Class: | II |
| 510 (k) Submission | |
| Number: | K233126 |
4. Identification of the Predicate Device:
| Predicate Device Name: | Philips IntelliSite Pathology Solution
(PIPS) |
|------------------------------|--------------------------------------------------|
| Applicant: | Philips Medical Systems Nederland B.V |
| Classification Product Code: | PSY |
| Regulation number: | 21 CFR 864.3700 |
| Device Class: | II |
| Submission Number: | DEN160056 |
4
ട. Indications for Use / Intended Use of the Device
For In Vitro Diagnostic Use
aetherSlide is a software-only device intended for viewing and managing 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. aetherSlide 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. aetherSlide is intended for use with the Philips Ultra Fast Scanner (UFS) and the Philips PS27QHDCR monitor.
6. Description of the Device
aetherSlide, version 101692 is a web-based, software only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue obtained from Philips Ultra Fast Scanner (UFS). It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.
aetherSlide is operated as follows:
-
- Image acquisition is performed using the Philips UFS. The operator conducts quality control of the digital slides according to Philips UFS instructions and laboratory specifications to determine if re-scans are necessary.
- Once the WSI is acquired using Philips UFS, it becomes available in the 2. Philips IntelliSite Pathology Solution (PIPS) database file systems. The operator then exports the WSI in iSyntax format from PIPS Image Management System (IMS) to a designated storage path.
-
- The operator can manually upload the exported WSI into aetherSlide via
5
aetherSlide Gateway, which is a separate medical image communications software. Alternatively, the aetherSlide Gateway can automatically initiate the upload of the WSI into aetherSlide when the auto-upload function is activated on the settings page of aetherSlide Gateway. Once the WSI is uploaded, the reading pathologist uses the device to perform the following actions:
- . View slide image
- . Zoom and pan the image
- Measure distances in the image
- . Annotate the image
-
- 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).
aetherSlide is designed to be deployed to a customer-managed infrastructure and may be accessed on the user's workstation browser. aetherSlide operates with and is validated for use with the components specified the tables below:
| Components | Manufacturer | Model |
|---|---|---|
| Scanner | Philips Medical | |
| Systems Nederland | ||
| B.V. | Ultra Fast Scanner | |
| Display | Philips Medical | |
| Systems Nederland | ||
| B.V. | PS27QHDCR Monitor |
Table 1. Interoperable Components for Use with aetherSlide
| Table 2. Computer Environment/Svstem Requirements | ||
|---|---|---|
| --------------------------------------------------- | -- | -- |
| Environment | Component | Minimum Requirements |
|---|---|---|
| Client PC | ||
| Hardware | Processor | Intel or AMD with 64-bit support, at least 2 GHz, at least 2 cores |
| Memory | 4 GB RAM or higher | |
| Storage | 128 GB SSD or higher | |
| Network | 100 Mbps Ethernet or above |
6
| Environment | Component | Minimum Requirements |
|---|---|---|
| Software | Operating System | Microsoft Windows 11 |
| Browser | Google Chrome (122 or higher) | |
| Gateway Workstation | ||
| Hardware | Processor | Intel or AMD with 64-bit support, at least 2 GHz, at least 2 cores |
| Memory | 4 GB RAM or higher | |
| Storage | 128 GB SSD or higher | |
| Network | 100 Mbps Ethernet or above | |
| Software | Operating System | Microsoft Windows 11 |
| Server | ||
| Hardware | Processor | Intel or AMD with 64-bit support, at least 2 GHz, at least 8 cores |
| Memory | 16 GB RAM or higher | |
| Storage | 512 GB SSD or higher | |
| Network | 1 Gbps or above | |
| Software | Operating System | Ubuntu 22.04 LTS |
7. Summary of Performance Testing
A series of tests were performed to assess the safety and effectiveness of aetherSlide. All the test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use.
The following performance tests were conducted per FDA guidance "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device (2016)''
| Test | Result |
|---|---|
| Pixel-wise comparison | Pixel-wise comparison study was conducted to compare images reproduced by aetherSlide and PIPS IMS for the same iSyntax file to validate identical image reproduction. Test results showed that the 95th percentile of pixelwise differences between aetherSlide and PIPS IMS was less than 3 CIEDE2000, indicating that their output images |
7
| | are pixel-wise identical. Therefore, it was
determined that color images reproduced by
aetherSlide were visually adequate with respect to
its intended use. |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Turnaround time | The system requirements have been fulfilled:
· When selecting a case, it should not take longer
than 10 seconds until the image is fully loaded.
· When panning the image (one quarter of the
monitor) it shall not take longer than 7 seconds
until the image is fully loaded.
Turnaround times for opening an image and
panning have 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 grid micrometer. aetherSlide
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. |
8. Substantial Equivalence Determination
The aetherSlide submitted in this 510(k) file is substantially equivalent in intended use, safety and performance claims to the cleared device, Philips IntelliSite Pathology Solution (PIPS) (DEN160056).
8
| Item | Subject Device | Predicate Device | Substantial Equivalence
Discussion |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | aetherAI Co., Ltd. | Philips Medical Systems Nederland B.V. | |
| Trade Name | aetherSlide | Philips IntelliSite Pathology Solution (PIPS) | |
| Submission No. | K233126 | DEN160056 | |
| Indications for
Use/Intended Use | For In Vitro Diagnostic Use
aetherSlide is a software-only device intended
for viewing and managing 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.
aetherSlide 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. aetherSlide is | 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) 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 | |
| Item | Subject Device | Predicate Device | Substantial Equivalence
Discussion |
| Manufacturer | aetherAI Co., Ltd. | Philips Medical Systems Nederland B.V. | |
| Trade Name | aetherSlide | Philips IntelliSite Pathology Solution (PIPS) | |
| Submission No. | K233126 | DEN160056 | |
| | intended for use with the Philips Ultra Fast
Scanner (UFS) and the Philips PS27QHDCR
monitor. | 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 PIPS. | |
| Specimen Type | Digitized surgical pathology slides prepared
from FFPE tissue | Surgical pathology slides prepared from FFPE
tissue | Similar
The specimen type of the
subject device is the digitized
slides, which is obtained from
the PIPIS UFS, and the
predicate device includes the
creation of digital images
used PIPS UFS. Thus, the
equivalence would not be
affected. |
| Image File Format | iSyntax | iSyntax | Same |
| Image
Manipulation | Panning, zooming, color manipulation
function, annotations, and measurements | Panning, zooming, color manipulation
function, annotations, and measurements | Similar
The performance of the |
| Item | Subject Device | Predicate Device | Substantial Equivalence Discussion |
| Manufacturer | aetherAI Co., Ltd. | Philips Medical Systems Nederland B.V. | |
| Trade Name | aetherSlide | Philips IntelliSite Pathology Solution (PIPS) | |
| Submission No. | K233126 | DEN160056 | |
| Functions | (only for distance) | (distance & area) | subject device is not affected
and meet the requirements.
Thus, it would not affect the
equivalence. |
| Type of Software
Application | Internet browser-based application | Internet browser-based application | Same |
| Device
Components | aetherSlide imaging viewing software,
aetherSlide Gateway | Ultra Fast Scanner (UFS), Image
Management System (IMS), Display | Similar
The aetherSlide Gateway is
used for uploading the slide
into aetherSlide. This
difference would not affect
the performance of the
subject device and its
equivalence. |
| Principle of
Operation | After WSI images are successfully acquired
by using PIPS UFS, the WSI images are stored
in the image storage provided by the end user.
During review, the pathologist opens WSI | 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 | Similar
The performance of the
subject device is not affected
and meet the requirements |
| Item | Subject Device | Predicate Device | Substantial Equivalence
Discussion |
| Manufacturer | aetherAI Co., Ltd. | Philips Medical Systems Nederland B.V. | |
| Trade Name | aetherSlide | Philips IntelliSite Pathology Solution (PIPS) | |
| Submission No. | K233126 | DEN160056 | |
| | images from storage, performs further QC and
reads WSI images of the slides to make a
diagnosis. | 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 WSI images of the slides to make a
diagnosis. | Thus, it would not affect the
equivalence. |
| Image Storage | Images are stored in an end user provided
image storage attached to the local network. | Images are stored in the end user provided
image storage (PIPS IMS Application Server
& Storage) attached to the local network. | Similar
The performance associated
with image storage of subject
device is not affected and
meet the requirements. Thus,
it would not affect the
equivalence. |
Table 3. Summary of Technological Characteristics
9
10
11
12
9. Similarity and Difference
The subject device has similar indications for use/intended use, similar technology/principle of operation, technological characteristics, and safety and performance to the predicate device, when used with the PIPS UFS scanner and the Philips PS27QHDCR monitor.
However, there is slight difference between the subject device and the predicate device which include the following aspect:
- . Medical image communication software
Once a slide image is acquired using PIPS UFS, according to its Instructions for Use, and becomes available in scanner database file systems, aetherSlide contains a Gateway which will automatically initiate uploading the slide image and corresponding metadata to the storage (not part of the device), or allow the operator to manually upload the slide image via aetherSlide Gateway. aetherSlide Gateway will perform integrity checks at the time of upload when data is copied to storage.
Nevertheless, verification activities were conducted on the subject device, and all tests were verified to meet the required acceptance criteria. The result of the verification tests indicated that aforementioned differences do not affect the indications for use/intended use of the subject device or raise any unresolved issues. Consequently, any differences between the subject device and the predicate device are insignificant and do not present any substantial equivalence concerns. The subject device is substantially equivalent to the predicate device as claimed.
10. Conclusion
After analyzing non-clinical safety and performance testing data, it can be concluded that when aetherSlide is used with the PIPS UFS scanner and the Philips PS27QHDCR monitor, it is substantially equivalent to the predicate device.