(90 days)
Not Found
No
The document describes software for viewing and managing digital pathology images, focusing on basic image manipulation and display. There is no mention of AI, ML, or any advanced analytical capabilities that would typically involve these technologies. The performance studies focus on image reproduction, speed, measurements, and usability, not on algorithmic performance related to diagnosis or analysis.
No.
The device is described as a software-only device for viewing and managing digital images of pathology slides, intended as an aid for pathologists in primary diagnosis. It does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an aid to the pathologist to review, interpret, and manage digital images of pathology slides for primary diagnosis." Primary diagnosis is a key step in diagnostic medicine.
Yes
The device description explicitly states "FullFocus is a web-based software-only device". While it relies on images from a specific scanner and validated monitors, the device itself is presented as purely software for viewing and manipulating those images.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that FullFocus is "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 on biological specimens (tissue slides).
- Specimen Type: The device is intended for use with "digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue." This is a classic type of in vitro diagnostic specimen.
- Role in Diagnosis: While it's a software-only device and an "aid" to the pathologist, its function is to facilitate the review and interpretation of images that are used to make a primary diagnosis. This places it within the scope of IVD devices, which are used to examine specimens from the human body to provide information for diagnostic purposes.
- Predicate Device: The predicate device listed, Philips IntelliSite Pathology Solution (PIPS), is also an IVD device. This further supports the classification of FullFocus as an IVD.
The fact that it's software-only and processes digital images doesn't exclude it from being an IVD. The key is its intended use in the diagnostic process involving in vitro specimens.
N/A
Intended Use / Indications for Use
FullFocus™ is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended for use with Philips Ultra Fast Scanner and monitor displays validated with verified test methods to meet required performance characteristics.
Product codes (comma separated list FDA assigned to the subject device)
QKQ
Device Description
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus reproduces the whole slide images and is an aid to the pathologist to review. interpret and manage digital images of pathology slides for primary diagnosis.
The subject device is typically operated as follows:
-
- The image acquisition is performed using the predicate device, PIPS UFS. The operator performs quality control of the digital slides per the instructions of PIPS and lab specifications to determine if re-scans are necessary.
-
- Once slide image is acquired using PIPS UFS, according to its Instructions for Use, and becomes available in scanner database file systems, a separate medical image communications software (not part of the device) will automatically initiate uploading the slide image and corresponding metadata to persistent cloud storage. Integrity checks are being performed at upload time when data is copied to storage.
-
- The reading pathologist uses the subject device to select a case (patient), view the images and is able to perform the following actions, as needed:
- a. Zoom and pan the image
- b. Measure distances and areas in the image
- c. Annotate images
After viewing all images belonging to a particular case (patient), the pathologist will make a diagnosis.
FullFocus is compatible with:
- Monitor displays:
- Barco PP27QHD
- Philips PS27QHDCR
- FDA-cleared scanners:
- Philips Ultra Fast Scanner
- Browsers:
- Google Chrome
- Microsoft Edge
- Firefox
Additional monitor displays will be validated with verified test methods to meet required performance characteristics.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images of scanned surgical pathology slides
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)
Non-clinical test results
Conducted per FDA's Guidance on Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices:
Pixel-wise comparison study was conducted to compare color images reproduced by FullFocus and PIPS IMS. It was determined that color images reproduced by FullFocus were visually adequate with respect to its intended use.
Turnaround times for panning and zooming have been determined and found to be adequate for the intended use of the subject device.
The subject device has been found to perform accurate measurements with respect to its intended use.
Conducted per FDA's Guidance on Applying Human Factors and Usability Engineering to Medical Devices:
Task-based usability tests verified the FullFocus user interface to be intuitive, safe, and effective for the range of intended users.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.3700 Whole slide imaging system.
(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.
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July 15, 2020
Jillian Sue, MS Product Manager Paige.AI, Inc. 11 Times Square, 37th Floor New York, NY 10036
Re: K201005
Trade/Device Name: FullFocus Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: QKQ Dated: April 16, 2020 Received: April 16, 2020
Dear Jillian Sue:
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 (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 located 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.
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
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Soma Ghosh, Ph.D. Chief Molecular Pathology and Cytology Branch Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K201005
Device Name
FullFocus™
Indications for Use (Describe)
FullFocus™ is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended for use with Philips Ultra Fast Scanner and monitor displays validated with verified test methods to meet required performance characteristics.
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 FullFocus™
Date Prepared: July 15, 2020
Submitter
Paige.AI, Inc. 11 Times Square, 37th Floor New York, NY 10036
Contact Person
Jillian Sue Product Manager 11 Times Square, 37th Floor New York, NY 10036 jillian.sue@paige.ai Phone: (646) 849-5088
Device
| Proprietary Name of the Device: | FullFocus |
|---|---|
| Classification Name: | Whole Slide Imaging System |
| Regulation Number: | 21 CFR 864.3700 |
| Product Codes: | QKQ |
| Device Class: | Class II |
| Review Panel: | 88 – Pathology |
| Common Name: | The FullFocus Viewer |
| Predicate Device |
Proprietary/Trade Name: Philips IntelliSite Pathology Solution (PIPS) Submission Number: DEN160056
Device Description
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus reproduces the whole slide images and is an aid to the pathologist to review. interpret and manage digital images of pathology slides for primary diagnosis.
The subject device is typically operated as follows:
-
- The image acquisition is performed using the predicate device, PIPS UFS. The operator performs quality control of the digital slides per the instructions of PIPS and lab specifications to determine if re-scans are necessary.
4
-
- Once slide image is acquired using PIPS UFS, according to its Instructions for Use, and becomes available in scanner database file systems, a separate medical image communications software (not part of the device) will automatically initiate uploading the slide image and corresponding metadata to persistent cloud storage. Integrity checks are being performed at upload time when data is copied to storage.
-
- The reading pathologist uses the subject device to select a case (patient), view the images and is able to perform the following actions, as needed:
- a. Zoom and pan the image
- b. Measure distances and areas in the image
- Annotate images C.
After viewing all images belonging to a particular case (patient), the pathologist will make a diagnosis.
FullFocus is compatible with:
- Monitor displays:
- Barco PP27QHD o
- o Philips PS27QHDCR
- FDA-cleared scanners: ●
- o Philips Ultra Fast Scanner
- Browsers:
- o Google Chrome
- O Microsoft Edge
- o Firefox
Additional monitor displays will be validated with verified test methods to meet required performance characteristics.
Intended Use
FullFocus is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended for use with Philips Ultra Fast Scanner and monitor displays validated with verified test methods to meet required performance characteristics.
| Item | Subject Device (K201005) | Predicate (DEN160056) |
|---|---|---|
| Device Trade | ||
| Name | FullFocus | Philips IntelliSite Pathology Solution |
| Indications for Use | FullFocus is a software only | |
| device intended for viewing and | ||
| management of digital images of | ||
| scanned surgical pathology slides | ||
| prepared from formalin-fixed | ||
| paraffin embedded (FFPE) tissue. | ||
| It is an aid to the pathologist to | 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 | ||
| review, interpret, and manage | ||
| digital images of pathology slides | ||
| for primary diagnosis. FullFocus | ||
| is not intended for use with frozen | ||
| sections, cytology, or non-FFPE | ||
| hematopathology specimens. | ||
| It is the responsibility of a | ||
| qualified pathologist to employ | ||
| appropriate procedures and | ||
| safeguards to assure the quality of | ||
| the images obtained and, where | ||
| necessary, use conventional light | ||
| microscopy review when making | ||
| a diagnostic decision. FullFocus | ||
| is intended for use with Philips | ||
| Ultra Fast Scanner and monitor | ||
| displays validated with verified | ||
| test methods to meet required | ||
| performance characteristics. | 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 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 | ||
| Image file format | iSyntax | Same |
| Image | ||
| Manipulation | ||
| Functions | Panning, zooming, color | |
| manipulation function, | ||
| annotations, and measurements | ||
| (distance & area) | Same | |
| Type of | ||
| Software | ||
| Application | Internet browser-based | |
| application | Same | |
| Device | ||
| Components | FullFocus image viewing | |
| software | Ultra Fast Scanner (UFS), Image | |
| Management System (IMS), Display | ||
| Principle of | ||
| Operation | After WSI images are successfully | |
| acquired by using PIPS UFS, the | ||
| WSI images are stored in the | ||
| cloud. During review, the | ||
| pathologist opens WSI images | ||
| from 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 | ||
| WSI images of the slides to make a | ||
| diagnosis. | ||
| Image Storage | Images are stored in the cloud. | Images are stored in an end user |
| provided image storage (PIPS IMS | ||
| Application Server & Storage) | ||
| attached to the local network |
Summary of Technological Characteristics
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6
| Performance data | Description |
|---|---|
| Pixel-wise comparison | Based on pixel-wise comparison to PIPS, including zooming and |
| panning operations across multiple tiles, FullFocus has been found | |
| to visually adequately reproduce digital pathology images to | |
| human readers 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. | |
| Measurements | Measurement accuracy has been verified using a test image |
| containing objects with known sizes. | |
| Human factors testing | FullFocus has been found to be safe and effective for the intended |
| users, uses, and use environments. |
Substantial Equivalence Comparison
The major difference between the subject and predicate device is that the predicate device includes the Ultra Fast Scanner (UFS) and Philips PS27QHDCR monitor display, whereas the subject device is only the review software and indicated for use with the same scanner and monitor. The indications for use are slightly different since the PIPS Indication for Use includes the creation of digital images and FullFocus Indication for use solely describes viewing and managing those digital images.
When FullFocus is used with the PIPS UFS scanner and Philips PS27QHDCR monitor, the software has similar Indications for Use. Functional, and Technological Characteristics to the predicate Image Management System (IMS) application software and is therefore substantially equivalent to the predicate device (DEN160056).
Summary of Studies
Non-clinical test results
Conducted per FDA's Guidance on Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices:
Pixel-wise comparison study was conducted to compare color images reproduced by FullFocus and PIPS IMS. It was determined that color images reproduced by FullFocus were visually adequate with respect to its intended use.
Turnaround times for panning and zooming have been determined and found to be adequate for the intended use of the subject device.
The subject device has been found to perform accurate measurements with respect to its intended use.
7
Conducted per FDA's Guidance on Applying Human Factors and Usability Engineering to Medical Devices:
Task-based usability tests verified the FullFocus user interface to be intuitive, safe, and effective for the range of intended users.
Conclusion:
When FullFocus is used with the PIPS UFS scanner and PS27QHDCR monitor display, it has similar Indications for Use, Functional, and Technological Characteristics as the predicate IMS viewer application software. The results of non-clinical testing demonstrate the device is substantially equivalent to the PIPS (DEN160056).