(88 days)
No
The summary describes a system for creating and viewing digital images of slides, focusing on image quality and display compatibility. There is no mention of AI, ML, or any algorithms that perform analysis or interpretation of the images beyond basic viewing and management. The performance studies focus on technical aspects like color accuracy and display compatibility, not on diagnostic performance metrics typically associated with AI/ML-powered image analysis.
No.
Explanation: The device is an automated digital slide creation, viewing, and management system intended for in vitro diagnostic use as an aid to pathologists for reviewing and interpreting digital images of surgical pathology slides. It does not directly treat or diagnose a disease or condition in a patient, but rather aids in the diagnostic process by facilitating the viewing of digital images of slides.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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."
No
The device description explicitly states that the system is comprised of a slide scanner (hardware), software, and a compatible display (hardware). The performance studies also include testing of hardware components like the display.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "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." This is the most direct indicator.
- Purpose of the Device: The device is used to create and view digital images of biological specimens (surgical pathology slides) for the purpose of aiding a pathologist in making a diagnosis. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
Yes
The letter explicitly states that the "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)".
Intended Use / 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.
Product codes
PSY
Device Description
The NanoZoomer S360MD Slide scanner system is an automated system for creating, viewing, and managing digital slides. The NanoZoomer S360MD Slide scanner system creates diagnosticquality digital images of glass slides containing formalin-fixed paraffin-embedded ("FFPE") tissue. Each digital image covers an entire slide and typically contains billions of image pixels. Slide images may be viewed, stored, retrieved, duplicated, and/or shared, permitting the pathologist to make a primary diagnosis without needing to view the original glass slides through a light microscope.
The NanoZoomer S360MD Slide scanner system is comprised of the NanoZoomer S360MD Slide scanner, NZViewMD image viewing software and compatible display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanned Glass Slides (digital images)
Anatomical Site
Formalin-fixed paraffin-embedded ("FFPE") tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist / 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)
Study Type: Non-clinical tests to determine compatibility of the NanoZoomer S360MD Slide scanner system with the BARCO MDPC-8127 Display, specifically testing parameters described under 21 C.F.R. § 864.3700.
Sample Size: Not specified for individual tests, but "three NanoZoomer Systems with BARCO MDPC-8127 displays" were used for color reproducibility testing.
Key Results:
Tests performed include: Spatial resolution, Pixel defects (count and map), Artifacts, Maximum and minimum luminance, Luminance uniformity and Mura test, Grayscale, Stability of luminance and chromaticity, Bidirectional reflection distribution function, Grav tracking, Color difference (the display only), Temporal response.
Color reproducibility testing was conducted using a color calibration slide and a chroma meter. The differences between the ground truth and the measured colors were evaluated using the △E2000 CIEDE2000 metric. Test data demonstrated that the product met the acceptance criteria for color accuracy.
Software verification was performed for the BARCO MDPC-8127 display's calibration software, QA-WEB, to confirm it did not introduce any issues with the NanoZoomer S360MD software performance.
No clinical studies were required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Color accuracy was evaluated using △E2000 CIEDE2000 metric and met acceptance criteria.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP), titled "NanoZoomer S360MD Slide scanner system Predetermined Change Control Plan (PCCP) for the use of additional FDA-cleared monitors" (Document Number 2311-0329, Version 01).
The purpose of this Abbreviated 510(k) Premarket Notification is to Establish a Pre-Determined Change Control Plan (PCCP) for qualifying and adding . additional FDA-cleared displays as interoperable components to the NanoZoomer S360 MD Slide scanner system.
This submission provided a PCCP that Hamamatsu will follow to validate compatibility of additional FDA-cleared displays with the NanoZoomer S360MD Slide scanner system, including specific performance requirements that must be met prior to updating the device labeling to reference the newly added displays. The PCCP also includes verification that any display-specific software will not impact performance of the NanoZoomer S360MD software. With inclusion of the PCCP, future changes to add additional FDA-cleared displays to the labeling can be made in accordance with the PCCP without a premarket submission. The Hamamatsu website will provide information on additional displays that are compatible with the NanoZoomer S360MD Slide scanner system and allow users to request updated versions of the system labeling.
§ 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
December 22, 2023
Image /page/0/Picture/1 description: The image contains 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 the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Hamamatsu Photonics K.K. % Adrienne Lenz Principal Medical Device Regulatory Expert Hyman, Phelps & McNamara, P.C. 700 Thirteenth St., N.W. Suite 1200 Washington, District of Columbia 20005
Re: K233027
Trade/Device Name: NanoZoomer S360MD Slide scanner system Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: PSY Dated: September 22, 2023 Received: September 25, 2023
Dear Adrienne Lenz:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/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.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP), titled "NanoZoomer S360MD Slide scanner system Predetermined Change Control Plan (PCCP) for the use of additional FDA-cleared monitors" (Document Number 2311-0329.
1
Version 01). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(0) of the Act, respectively.
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 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
2
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 2 OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233027
Device Name NanoZoomer S360MD Slide scanner system
Indications for Use (Describe)
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-FPE 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.
| 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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4
510(k) Summary NanoZoomer S360MD Slide Scanner System
Date Prepared: December 22, 2023
Submitter
Shinichi Fujisaka HAMAMATSU PHOTONICS, K.K. 812, Joko-cho, Higashi-ku Hamamatsu City, Shizuoka Pref. Japan 431-3196 T: (81) 53-431-0155
Contact Person
Adrienne Lenz Principal Medical Device Regulatory Expert Hyman, Phelps, & McNamara, P.C. T: (202) 737-4292
Secondary Contact Person
Jeffrey N. Gibbs, JD Director Hyman, Phelps, & McNamara, P.C. T: (202) 737-4288
DEVICE
| Proprietary Name: | NanoZoomer S360MD Slide scanner system |
|---|---|
| Common Name: | Whole Slide Imaging System |
| Classification Name: | Whole Slide Imaging System |
| Regulation Section: | 21 CFR 864.3700 |
| Regulatory | Classification: Class II |
| Product Code: | PSY |
| Review Panel: | 88 – Pathology |
PREDICATE DEVICE
| Proprietary Name: | NanoZoomer S360MD Slide scanner system |
|---|---|
| Submission Number: | K213883 |
5
PURPOSE OF THE SUBMISSION
The purpose of this Abbreviated 510(k) Premarket Notification is as follows:
- Add the BARCO MDPC-8127 Display (monitor), cleared independently in K203364 to . the NanoZoomer S360 MD Slide scanner system originally cleared in K213883.
- Establish a Pre-Determined Change Control Plan (PCCP) for qualifying and adding . additional FDA-cleared displays as interoperable components to the NanoZoomer S360 MD Slide scanner system.
DEVICE DESCRIPTION
The NanoZoomer S360MD Slide scanner system is an automated system for creating, viewing, and managing digital slides. The NanoZoomer S360MD Slide scanner system creates diagnosticquality digital images of glass slides containing formalin-fixed paraffin-embedded ("FFPE") tissue. Each digital image covers an entire slide and typically contains billions of image pixels. Slide images may be viewed, stored, retrieved, duplicated, and/or shared, permitting the pathologist to make a primary diagnosis without needing to view the original glass slides through a light microscope.
The NanoZoomer S360MD Slide scanner system is comprised of the NanoZoomer S360MD Slide scanner, NZViewMD image viewing software and compatible display.
INTENDED 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.
TECHNOLOGY
The proposed NanoZoomer System has the same indications for use, and uses the same fundamental technology, as the legally marketed predicate device to which substantial equivalency is claimed, the NanoZoomer S360MD Slide scanner system (K213883). This
6
submission introduced compatibility with the BARCO MDPC-8127 Display with the NanoZoomer S360 MD Slide scanner system. In addition, this submission provided a Predetermined Change Control Plan (PCCP) that Hamamatsu will follow to validate compatibility with and that performance requirements are met for use of the system with additional FDA-cleared displays prior to updating the labeling to reference the display. With inclusion of the PCCP, future changes to add additional FDA-cleared displays to the labeling will be made in accordance with the PCCP without a premarket submission. The Hamamatsu website will provide information on additional displays that are compatible with the NanoZoomer S360MD Slide scanner system and allow users to request updated versions of the system labeling.
| Specification | Predicate Device
NanoZoomer S360MD Slide
scanner system (K213883) | Subject Device
NanoZoomer S360MD Slide
scanner system (K233027) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | PSY | PSY |
| Regulation | 21 C.F.R. § 864.3700 | 21 C.F.R. § 864.3700 |
| Regulation Name | Whole Slide Imaging System | Whole Slide Imaging System |
| Classification | II | II |
| Intended Use | Intended for use in primary surgical
pathology diagnosis in lieu of light
microscopy | Intended for use in primary surgical
pathology diagnosis in lieu of light
microscopy |
| 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 | 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 |
| Specification | Predicate Device
NanoZoomer S360MD Slide
scanner system (K213883) | Subject Device
NanoZoomer S360MD Slide
scanner system (K233027) |
| | NZViewMD Software and the JVC
Kenwood JD-C240BN01A display.
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. | 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. |
| Slide Feeder | 360 slides | 360 slides |
| Scanner | NanoZoomer S360MD Slide
scanner | NanoZoomer S360MD Slide
scanner |
| Viewer | NZViewMD | NZViewMD |
| Compatible
Display | JVC Kenwood JD-C24BN01A | JVC Kenwood JD-C24BN01A
BARCO MDPC-8127 Display, or
FDA-cleared display validated per
the PCCP to ensure performance
requirements are met prior to
modifications being implemented. |
Table 1: Comparison of Subject and Predicate Devices
7
8
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
SUMMARY OF NON-CLINICAL TESTS
Compatibility of the NanoZoomer S360MD Slide scanner system with the BARCO MDPC-8127 Display (K203364) was determined based on testing the below specified parameters and per Special Controls described under 21 C.F.R. § 864.3700. This test includes:
-
- Spatial resolution
-
- Pixel defects (count and map)
-
- Artifacts
-
- Maximum and minimum luminance
-
- Luminance uniformity and Mura test
-
- Grayscale
-
- Stability of luminance and chromaticity
-
- Bidirectional reflection distribution function
-
- Grav tracking
-
- Color difference (the display only)
-
- Color gamut volume
-
- Temporal response
In addition to the above, as a system-level test, color reproducibility testing was performed to validate performance of the NanoZoomer System with the BARCO MDPC-8127 Display. The test used three NanoZoomer Systems with BARCO MDPC-8127 displays and was conducted using a color calibration slide and a chroma meter. The differences between the ground truth and the measured colors were evaluated using the △E2000 CIEDE2000 metric. Test data to quantify the accuracy and precision of the color transformation from the slide to the display monitor was provided and demonstrated that the product met the acceptance criteria for color accuracy.
Justifications to retest or not to retest each special control described under 21 C.F.R. § 864.3700 were also provided.
The BARCO MDPC-8127 display also has calibration software, QA-WEB, that runs on the NanoZoomer System Scan and Viewing PCs. Software verification was performed to confirm this additional software did not introduce any issues with performance of the NanoZoomer S360MD software.
SUMMARY OF CLINICAL TESTS
No clinical studies were required to demonstrate substantial equivalence of the modified NanoZoomer S360MD Slide scanner system.
Predetermined Change Control Plan (PCCP)
This submission provided a PCCP that Hamamatsu will follow to validate compatibility of additional FDA-cleared displays with the NanoZoomer S360MD Slide scanner system, including
9
specific performance requirements that must be met prior to updating the device labeling to reference the newly added displays. The PCCP also includes verification that any displayspecific software will not impact performance of the NanoZoomer S360MD software. With inclusion of the PCCP, future changes to add additional FDA-cleared displays to the labeling can be made in accordance with the PCCP without a premarket submission. The Hamamatsu website will provide information on additional displays that are compatible with the NanoZoomer S360MD Slide scanner system and allow users to request updated versions of the system labeling.
CONCLUSION
Hamamatsu Photonics K.K. considers the modified NanoZoomer S360MD Slide scanner system to be substantially equivalent to the predicate version of the device cleared in K213883.