(88 days)
HALO AP Dx is a software only device intended as an aid to the pathologist to review, interpret and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. HALO AP Dx 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. HALO AP Dx is intended for use with the interoperable components specified in the Table below.
HALO AP Dx, version 2.4 (abbreviated as v2.4), is a browser-based software-only device intended to aid pathology professionals in viewing, manipulating, management, and interpretation of digital pathology whole slide images (WSI) of glass slides obtained from the Hamamatsu Photonics K.K. NanoZoomer S360MD scanner or the Leica Biosystems Imaging, Inc. Aperio GT 450 DX.
HALO AP Dx is typically operated as follows:
-
Image acquisition is performed using the predicate device. The operator performs quality control of the digital slides per the instructions of the predicate device and lab specifications to determine if re-scans are necessary.
-
Once image acquisition is complete, according to its Instructions for Use, the unaltered image is saved in an external image storage location. HALO AP Dx ingests the image, and a copy of image metadata is stored in the subject device's database to improve viewing response times.
-
Depending upon a laboratory's workflow, the scanned images may first be reviewed by histotechnicians to confirm image quality and initiate any re-scans. After review, the histotechnician may modify the case status and make it available to the pathologist.
-
The reading pathologist selects a patient case from a selected worklist within HALO AP Dx whereby the subject device fetches the associated images from external image storage.
-
The reading pathologist uses the subject device to view the images and can perform the following actions, as needed:
a. Zoom and pan the image.
b. Measure distances and areas in the image.
c. Annotate images.
d. View multiple images side by side in a synchronized fashion. -
The above steps are repeated as necessary.
After viewing all images belonging to a particular case (patient), the pathologist will make a diagnosis which is documented in another system, such as a Laboratory Information System.
HALO AP Dx operates and is validated for use with the FDA cleared components listed in the intended use statement table above.
N/A
FDA 510(k) Clearance Letter - HALO AP Dx
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
November 25, 2025
Indica Labs, LLC
Michele Fredrickson
Director, Quality & Regulatory Affairs
8700 Education Pl NW, Building B
Albuquerque, NM 87114
Re: K252762
Trade/Device Name: HALO AP Dx
Regulation Number: 21 CFR 864.3700
Regulation Name: Whole Slide Imaging System
Regulatory Class: Class II
Product Code: QKQ
Dated: August 25, 2025
Received: August 29, 2025
Dear Michele Fredrickson:
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.
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K252762 - Michele Fredrickson
Page 2
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).
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 (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-safety-reporting-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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K252762 - Michele Fredrickson
Page 3
assistance/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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K252762
Device Name
HALO AP Dx
Indications for Use (Describe)
HALO AP Dx is a software only device intended as an aid to the pathologist to review, interpret and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. HALO AP Dx 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. HALO AP Dx is intended for use with the interoperable components specified in the Table below.
Table: Interoperable Components of HALO AP Dx
| Scanner Hardware | Scanner Output File Format | Interoperable Displays |
|---|---|---|
| Leica Aperio GT 450 DX scanner | SVS | Dell U3223QE |
| Barco MDPC-8127 | ||
| DICOM | Dell U3223QE | |
| Hamamatsu NanoZoomer S360MD Slide scanner | NDPI | Barco MDPC-8127 |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary
HALO AP Dx
Date Prepared: November 24, 2025
Submitter
Indica Labs, LLC
8700 Education Place NW, Building B
Albuquerque, NM, 87114 USA
Contact Person
Michele Fredrickson, Director Quality & Regulatory
Tel: 505-492-0972
Device
Proprietary/Trade Name: HALO AP Dx
Version Number: 2.4
Regulation Name: Whole Slide Imaging System
Regulation: 21 CFR §864.3700
Regulatory Class: Class II
Product Classification Code: QKQ
Review Panel: 88 – Pathology
510 (k) Submission Number: K252762
Predicate Devices
Predicate Manufacturer: Hamamatsu Photonics K.K.
Predicate Trade Name: NanoZoomer S360MD Slide scanner system
Predicate 510(k): K233027
Predicate Manufacturer: Leica Biosystems Imaging, Inc.
Predicate Trade Name: Aperio GT 450 DX
Predicate 510(k): K232202
No reference devices were used in this submission.
Intended Use
HALO AP Dx is a software only device intended as an aid to the pathologist to review, interpret and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. HALO AP Dx 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
Page 6
review when making a diagnostic decision. HALO AP Dx is intended for use with the interoperable components specified in the Table below.
Table: Interoperable Components of HALO AP Dx
| Scanner Hardware | Scanner Output File Format | Interoperable Displays |
|---|---|---|
| Leica Aperio GT 450 DX scanner | SVS | Dell U3223QE, Barco MDPC-8127 |
| DICOM | Dell U3223QE | |
| Hamamatsu NanoZoomer S360MD Slide scanner | NDPI | Barco MDPC-8127 |
Device Description
HALO AP Dx, version 2.4 (abbreviated as v2.4), is a browser-based software-only device intended to aid pathology professionals in viewing, manipulating, management, and interpretation of digital pathology whole slide images (WSI) of glass slides obtained from the Hamamatsu Photonics K.K. NanoZoomer S360MD scanner or the Leica Biosystems Imaging, Inc. Aperio GT 450 DX.
HALO AP Dx is typically operated as follows:
-
Image acquisition is performed using the predicate device. The operator performs quality control of the digital slides per the instructions of the predicate device and lab specifications to determine if re-scans are necessary.
-
Once image acquisition is complete, according to its Instructions for Use, the unaltered image is saved in an external image storage location. HALO AP Dx ingests the image, and a copy of image metadata is stored in the subject device's database to improve viewing response times.
-
Depending upon a laboratory's workflow, the scanned images may first be reviewed by histotechnicians to confirm image quality and initiate any re-scans. After review, the histotechnician may modify the case status and make it available to the pathologist.
-
The reading pathologist selects a patient case from a selected worklist within HALO AP Dx whereby the subject device fetches the associated images from external image storage.
-
The reading pathologist uses the subject device to view the images and can perform the following actions, as needed:
a. Zoom and pan the image.
b. Measure distances and areas in the image.
c. Annotate images.
d. View multiple images side by side in a synchronized fashion. -
The above steps are repeated as necessary.
After viewing all images belonging to a particular case (patient), the pathologist will make a diagnosis which is documented in another system, such as a Laboratory Information System.
HALO AP Dx operates and is validated for use with the FDA cleared components listed in the intended use statement table above.
Page 7
Table 1: Computer Environment / System for Use with HALO AP Dx
| Component | Requirement |
|---|---|
| Operating System | Windows 11 |
| Memory | 16 GB or more |
| Processor | Intel Core i7 CPU |
| Supported Browsers | Google Chrome version 138 or higher, Microsoft Edge version 138 or higher |
Table 2: Server System Requirements
| Server | Operating System | Memory | Processor |
|---|---|---|---|
| Component Server, Processing Node Server, File Monitor Server | Windows Server 2022 Only x64 (64 bit) operating systems are supported | 16 GB or more | 8 CPU cores or more |
| Traefik Reverse Proxy | Windows Server 2022, Ubuntu 22.04 | 2GB, per 150 concurrent users | 2 CPU Cores, per 150 concurrent users |
| MySQL Server | Windows Server 2022, Ubuntu 22.04 Only x64 (64 bit) operating systems are supported | 16 GB or more | 4 CPU Cores or more |
Table 3: Server Configurations
| Component | Specifications |
|---|---|
| Network Connectivity | 1 Gbps (10 Gbps recommended) LAN connection between services |
| Antivirus Software | The following antivirus software has been validated for use with Windows Server: - Microsoft Windows Defender - Trend Micro - Webroot |
Page 8
Summary of Technological Characteristics
Comparison with Predicate – Hamamatsu NanoZoomer S360MD Slide scanner system
| Item | Predicate (K233027) | Subject Device (K252762) |
|---|---|---|
| Device Trade Name | Hamamatsu NanoZoomer S360MD Slide scanner system | HALO AP Dx |
| Indications for Use | 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 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. | HALO AP Dx is a software only device intended as an aid to the pathologist to review, interpret and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. HALO AP Dx 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. HALO AP Dx is intended for use with the interoperable components specified in the Table below. Table: Interoperable Components of HALO AP Dx Scanner Hardware: Leica Aperio GT 450 DX scanner, Hamamatsu NanoZoomer S360MD Slide scanner; Scanner Output File Format: SVS, DICOM, NDPI; Interoperable Displays: Dell U3223QE, Barco MDPC-8127 |
| Specimen Type | Surgical pathology slides prepared from FFPE tissue | Same |
Page 9
Comparison with Predicate – Aperio GT 450 DX
| Item | Predicate (K233027) | Subject Device (K252762) |
|---|---|---|
| Diagnostic Image File Format | Hamamatsu NDPI File | SVS and DICOM – Aperio GT 450 DX, NDPI – Hamamatsu NanoZoomer S360MD Slide scanner system |
| Image Manipulation and Review Functions | Functions for continuous panning and zooming, annotations, distance/area measurements, track visited areas, and image adjustments. | Same |
| Type of Software Application | PC-based installed application | Internet browser-based application |
| Principle of Operation | During review, the pathologist opens the WSI images acquired with the scanner from the network storage, performs further QC, and reviews and interprets the WSI images to make a diagnosis. | Same |
| Image Storage | User-supplied network attached storage | Same |
| End User's Interface | NZViewMD | HALO AP Dx |
| Scanner | Hamamatsu NanoZoomer S360MD | Aperio GT 450 DX, Hamamatsu Nanozoomer S360MD |
| Item | Predicate (K232202) | Subject Device (K252762) |
|---|---|---|
| Device Trade Name | Aperio GT 450 DX | HALO AP Dx |
| Indications for Use | The Aperio GT 450 DX is an automated digital slide creation and viewing system. The Aperio GT 450 DX 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 Aperio GT 450 DX is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. | HALO AP Dx is a software only device intended as an aid to the pathologist to review, interpret and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. HALO AP Dx 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. |
Page 10
| Item | Predicate (K232202) | Subject Device (K252762) |
|---|---|---|
| Aperio GT 450 DX is comprised of the Aperio GT 450 DX scanner, which generates images in the Digital Imaging and Communications in Medicine (DICOM) and in the ScanScope Virtual Slide (SVS) file formats, the Aperio WebViewer DX viewer, and the displays. The Aperio GT 450 DX is intended to be used with the interoperable components specified in Table 1. Table 1: Interoperable components of Aperio GT 450 DX Scanner Hardware: Leica Aperio GT 450 DX scanner; Scanner Output File Format: SVS, DICOM; Interoperable Viewing Software: Aperio WebViewer DX, Sectra Digital Pathology Module (3.3); Interoperable Displays: Barco MDPC8127, Dell UP3017, Dell U3023E, Dell U3223QE. The Aperio GT 450 DX 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 validity of the interpretation of images obtained using the Aperio GT 450 DX. | HALO AP Dx is intended for use with the interoperable components specified in the Table below. Table: Interoperable Components of HALO AP Dx Scanner Hardware: Leica Aperio GT 450 DX scanner, Hamamatsu NanoZoomer S360MD Slide scanner; Scanner Output File Format: SVS, DICOM, NDPI; Interoperable Displays: Dell U3223QE, Barco MDPC8127 | |
| Specimen Type | Surgical pathology slides prepared from FFPE tissue | Same |
| Diagnostic Image File Format | SVS and DICOM | SVS and DICOM – Aperio GT 450 DX, NDPI – Hamamatsu NanoZoomer S360MD Slide scanner system |
| Image Manipulation and | Functions for continuous panning and zooming, annotations, distance/area | Same |
Page 11
| Item | Predicate (K232202) | Subject Device (K252762) |
|---|---|---|
| Review Functions | measurements, track visited areas, and image adjustments. | |
| Type of Software Application | Internet browser-based application | Same |
| Principle of Operation | During review, the pathologist opens the WSI images acquired with the scanner from the network storage, performs further QC, and reviews and interprets the WSI images to make a diagnosis. | Same |
| Image Storage | User-supplied network attached storage | Same |
| End User's Interface | WebViewer DX for Leica SVS, Sectra Digital Pathology Module (3.3) for Leica SVS and DICOM | HALO AP Dx |
| Scanner | Aperio GT 450 DX | Aperio GT 450 DX, NanoZoomer S360MD Slide scanner |
Summary of Studies (Performance Data)
| Performance Data | Description |
|---|---|
| Identical image reproduction | Pixel-level comparisons were made to compare images displayed by HALO AP Dx (v2.4) and the predicate devices' image review and manipulation software (IRMS) as described below for the same scanned image file format as captured from the same FDA cleared scanning system to validate identical image display on the same compatible display monitors. |
| Scanning System | File Format | Predicate Device IRMS | Subject Device | Display |
|---|---|---|---|---|
| Aperio GT 450 DX | SVS | WebViewer DX (Google Chrome) | HALO AP Dx (Google Chrome) | Barco MDPC8127 |
| WebViewer DX (Microsoft Edge) | HALO AP Dx (Microsoft Edge) | Dell U3223QE | ||
| DICOM | Sectra Digital Pathology Module (IDS7) | HALO AP Dx (Google Chrome) | Dell U3223QE | |
| Sectra Digital Pathology Module (IDS7) | HALO AP Dx (Microsoft Edge) | |||
| Hamamatsu NanoZoomer S360MD Slide scanner | NDPI | NZViewMD | HALO AP Dx (Google Chrome) | Barco MDPC8127 |
| NZViewMD | HALO AP Dx (Microsoft Edge) |
Page 12
Thirty (30) formalin-fixed paraffin-embedded (FFPE) slides representing a range of anatomical sites and diagnoses were scanned on the predicate scanning systems at 40x magnification. Three ROIs were identified per slide and captured at two magnification levels (10x and 40x) across each viewer, browser (if applicable), and display combination. Each predicate IRMS and subject device ROI was registered and the difference between each pixel was computed using the 2000 International Commission on Illumination color difference CIEDE2000 metric (ΔE00). The 95th percentile of the pixelwise ΔE00 differences for each ROI in the compared image sets was reported. An acceptance criterion where each analyzed ROI image pair shall not have a 95th percentile of the pixelwise ΔE00 differences value greater than 3 was applied.
The final test results showed that 95th percentile of the pixelwise ΔE00 differences for each ROI was less than 3 for all compared image sets. Therefore, HALO AP Dx and the predicate IRMS image display has been found to be pixelwise equivalent.
| Performance Data | Description |
|---|---|
| Turnaround time | Turnaround times for image loading, panning, and zooming have been determined and found to be adequate for the intended use of the subject device. The system requirements have been fulfilled: • When selecting a case, it should not take longer than 4 seconds until the image is fully loaded. • When panning the image, it should not take longer than 3 seconds until the image is fully loaded. |
| Measurements | Measurement accuracy has been verified using a test image containing objects with known sizes. |
| Human factors testing | A human factors study was conducted per FDA's Guidance on Applying Human Factors and Usability Engineering to Medical Devices (2016). The study was designed around critical and essential user tasks and use scenarios performed by representative users was conducted for previously cleared HALO AP Dx (version 2.1) in K232833. No new human factors study was performed for HALO AP Dx (version 2.4). |
Substantial Equivalence Comparison
The proposed subject device has similar Indications for Use, principles of operation, and technical characteristics as compared to each predicate device's IRMS. Performance testing results confirm equivalent image reproducibility, measurement accuracy, and similar or better turnaround times for common operations. Therefore, the subject device is confirmed to be substantially equivalent to the predicate devices.
Conclusion
Based on the information provided, when HALO AP Dx is used with the Hamamatsu Photonics K.K. NanoZoomer S360MD Slide scanner or Leica Biosystems Imaging, Inc. Aperio GT 450 DX and the interoperable monitor displays, it has similar Indications for Use, Functional, and Technological Characteristics as the applicable predicate IRMS. The performance data support substantial equivalence of HALO AP Dx to the predicate devices.
§ 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.