The X100HT with Full Field Peripheral Blood Smear (PBS) Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

Device Description

X100HT with Full Field Peripheral Blood Smear (PBS) Application automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears. The user browses through the imaged smear to gain high-level general impressions of the sample. In conducting white blood cells (WBC) differential, the user reviews the X100HT with Full Field PBS suggested classification of each automatically detected WBC and may manually change the suggested classification of any cell. In conducting red blood cells (RBC) morphology evaluation, the user can characterize RBC morphology on observed images. In conducting platelets estimation, the user reviews each automatically detected platelet and the suggested platelets estimation and may manually change the detections or the estimation. The X100HT with Full Field PBS enables efficient slide loading by providing three cassettes, each can be loaded with up to ten peripheral blood smear slides. The slide loader automatically adds mounting media and coverslips to the slides and loads them into the X100 for scanning and analysis. The X100HT with Full Field PBS is intended to be used by skilled users, trained in the use of the device and in the identification of blood cells.

AI/ML Overview

The provided text describes the regulatory clearance of the Scopio X100HT with Full Field Peripheral Blood Smear (PBS) Application, comparing it to a predicate device (X100 with Full Field PBS Application). While it outlines the device's intended use and the general types of testing performed (software, hardware, EMC, safety), it does not contain explicit details on the acceptance criteria or the specific study results that prove the device meets these criteria for the AI/automation components of the system.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, particularly highlighting the addition of a 'Slide Loader' and minor software modifications for workflow efficiency, rather than a detailed performance study of the AI's diagnostic capabilities. The core image analysis and AI components ("standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells") are stated to be "identical" to the predicate device. Therefore, a comprehensive performance study as requested, particularly regarding the AI's diagnostic accuracy against a ground truth and comparative effectiveness with human readers, is not present in this document.

However, based on the information provided, here's what can be extracted and inferred, with acknowledgments of missing details:

Acceptance Criteria and Device Performance (Inferred/General)

Since the core AI/analysis technique is stated to be "identical" to the predicate device, it's implied that the performance of the X100HT (regarding cell classification accuracy, etc.) would be similar to what was demonstrated for the predicate device's clearance. The document focuses on the new functionality (slide loader) and how it does not raise new questions of safety or effectiveness, meaning the existing performance of the analytical portion is presumed acceptable.

Table 1: Acceptance Criteria and Reported Device Performance

Performance Metric Category	Acceptance Criteria (Inferred from Predicate's Clearance, not explicitly stated for X100HT in this doc)	Reported Device Performance (Inferred, as core AI is identical to predicate)
WBC Differential Accuracy	(Not explicitly stated for X100HT; performance equivalent to predicate expected)	Achieves pre-classified WBC categorization using ANNs, to be reviewed by user.
RBC Morphology Evaluation Presentation	(Not explicitly stated for X100HT)	Presents an overview image for examiner characterization.
Platelet Estimation Accuracy	(Not explicitly stated for X100HT; performance equivalent to predicate expected)	Automatically locates/counts platelets, provides estimate for user review.
Functional Equivalence to Predicate	The device's results (images and suggested classifications) are substantively equivalent to the predicate.	Stated to be "identical" analysis technology to K201301 predicate.
Software Functionality (Slide Loader)	Integration of slide loader enhances workflow without compromising core analysis or safety.	Replaces manual steps of mounting media/coverslipping and slide loading.
Safety and EMC	Compliance with IEC/EN standards for safety and EMC.	Successfully passed IEC 60601-1-2, FCC Part 15 Subpart B, IEC 61010-2-101, IEC 61010-1, IEC 62471.

Details on the Study Proving Device Meets Acceptance Criteria:

Sample Size Used for the Test Set and Data Provenance:
- Not specified in the provided text. The document states "Verification and validation testing was conducted and documentation was updated," but does not list sample sizes for these tests, nor the origin (country) or nature (retrospective/prospective) of the data. Given the device's classification and the focus on "substantial equivalence," it's possible detailed clinical performance data was not a primary requirement for this 510(k), as the core AI was already cleared.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not specified in the provided text. The document mentions the device "assists a qualified technologist" and is for "skilled users, trained in the use of the device and in the identification of blood cells," but does not detail the experts used for ground truth generation in any validation studies.
Adjudication Method for the Test Set:
- Not specified in the provided text.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not specified in the provided text. The document emphasizes that the user "reviews the suggested classification" and "may manually change the suggested classification," indicating a human-in-the-loop workflow. However, an MRMC study comparing human performance with and without AI assistance is not described.
Standalone (Algorithm Only) Performance:
- A standalone performance study of the algorithm's accuracy in classifying cells (without human review/override) is not explicitly detailed in the provided text for the X100HT. The description of the device's function clearly outlines a "pre-classified" stage where the ANN suggests classifications, which are then reviewed and potentially modified by a human user. The performance reported is thus implicitly a human-in-the-loop performance, but the standalone accuracy is not quantified.
Type of Ground Truth Used:
- Not specified in the provided text. Since the device "pre-classifies" cells, the ground truth for training and validating the ANN would likely involve expert consensus or manual expert classification of blood cells. However, this is not explicitly stated.
Sample Size for the Training Set:
- Not specified in the provided text. The document mentions "deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells," but the size of the training dataset is not provided.
How the Ground Truth for the Training Set Was Established:
- Not specified in the provided text. Similar to point 6, it can be inferred that expert classification was used, but the specific process (e.g., number of experts, consensus methods) is not described.

Summary of Missing Information:

The provided 510(k) summary focuses almost entirely on demonstrating that the X100HT, with its new slide loader, is substantially equivalent to an already cleared predicate device (K201301). It highlights that the core analytical software and imaging technology responsible for AI-assisted cell classification are "identical" to the predicate. Therefore, details regarding new performance studies for the AI component itself (acceptance criteria, test set sizes, ground truth establishment, MRMC studies) are not present in this document, as the performance aspect of the AI was likely covered in the predicate device's clearance. This document serves to demonstrate that the modifications (primarily the slide loader) do not negatively impact the previously established safety and effectiveness.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

May 3, 2022

Scopio Labs Ltd. % Randy Prebula Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004

Re: K220013

Trade/Device Name: X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application Regulation Number: 21 CFR 864.5260 Regulation Name: Automated Cell-Locating Device Regulatory Class: Class II Product Code: JOY Dated: January 4, 2022 Received: January 4, 2022

Dear Randy Prebula:

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.

{1}------------------------------------------------

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 803) 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 (QS) 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.

Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

X100HT with Full Field Peripheral Blood Smear (PBS) Application

Indications for Use (Describe)

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.

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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Scopio. To the left of the word "Scopio" is a square made of a dark blue outline with a pink square in the bottom left corner. The word "Scopio" is written in a dark blue sans-serif font.

510(k) SUMMARY

This 510(k) Premarket Notification Summary is prepared in accordance with 21 CFR 807.92.

I.	Submitter Information
	Sponsor Name:	Scopio Labs Ltd.
	Sponsor Address:	Scopio Labs Ltd.10 Ha'Sharon StreetTel Aviv 6578313Israel
	Sponsor Email:	info@scopiolabs.com
	Contact Person:	Shahar KarnyCOOScopio Labs
	Contact Email:	shahar@scopiolabs.com
	Date Summary Prepared:	December 23, 2021
II.	Device
	Trade (Proprietary) Name:	X100HT with Full Field Peripheral Blood Smear(PBS) Application
	Regulation Number:	21CFR§864.5260
	Regulation Name:	Automated cell-locating device
	Regulatory Class:	II
	Product Code:	JOY
	Product Panel:	Hematology

III. Predicate Device

Predicate A Device Name:

Device 510(k):

Manufacturer

X100 with Full Field Peripheral Blood Smear (PBS) Application K201301 Scopio Labs

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "Scopio" in a dark blue font. To the left of the word is a logo consisting of two overlapping squares. The square in the back is a dark purple color, and the square in the front is a dark blue color.

IV. Device Description

X100HT with Full Field Peripheral Blood Smear (PBS) Application automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears.

The user browses through the imaged smear to gain high-level general impressions of the sample. In conducting white blood cells (WBC) differential, the user reviews the X100HT with Full Field PBS suggested classification of each automatically detected WBC and may manually change the suggested classification of any cell. In conducting red blood cells (RBC) morphology evaluation, the user can characterize RBC morphology on observed images. In conducting platelets estimation, the user reviews each automatically detected platelet and the suggested platelets estimation and may manually change the detections or the estimation.

The X100HT with Full Field PBS enables efficient slide loading by providing three cassettes, each can be loaded with up to ten peripheral blood smear slides. The slide loader automatically adds mounting media and coverslips to the slides and loads them into the X100 for scanning and analysis.

The X100HT with Full Field PBS is intended to be used by skilled users, trained in the use of the device and in the identification of blood cells.

V. Intended Use

The X100HT with Full Field Peripheral Blood Smear (PBS) Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential. RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

VI. Comparison of Technological Characteristics with the Predicate Devices

The X100HT with Full Field Peripheral Blood Smear (PBS) Application is substantially equivalent to its predicate device, the X100 with Full Field Peripheral Blood Smear (PBS) Application (K201301). The subject device has the same intended use as the predicate in that both devices are intended to assist a qualified user in conducting evaluations of white blood cells, red blood cells and platelets within a fixed and stained peripheral blood smear. Additionally, both devices are also substantially equivalent with respect to technological characteristics. In both the X100HT and X100 with Full Field PBS, the X100 hardware is identical. Moreover, the Full Field PBS software application module responsible for the imaging and analysis is identical. The main differences between the subject device and the predicate are the addition of a Slide Loader add-on which encapsulates the X100, additional slide locks were added to the X100 tray, and a minor modification to the Full Field PBS application module responsible for scan initiation was implemented. The Slide Loader replaces required manual user actions of mounting media and slide cover-slipping and slide-tray loading.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image contains the logo for Scopio. The logo consists of a square made up of two overlapping squares, one pink and one dark blue, followed by the word "Scopio" in dark blue font. The logo is simple and modern, and the colors are eye-catching.

The additional tray locks were introduced to verify reliable slide positioning. The modified Full Field PBS application module enables the three-cassette workflow rather than the three slides workflow. As with the predicate, the preparation of the stained blood smear and bar coding of the slide are identical for the X100HT and are still externally prepared by the user, either manually or by third party devices. While the manual steps of mounting media and coverslip addition were replaced by a mechanical module, and the minor change of scan initiation interface, the analysis information provided by both devices uses the identical technology that was originally 510(k)cleared and must be interpreted and confirmed or adjusted by the trained user. Thus, the minor differences do not raise different questions of safety or effectiveness.

The similarities and differences between the subject device and the predicate devices are summarized in Table 1 below.

{6}------------------------------------------------

Table 1. Comparison of Characteristics of the X100HT with the Predicate Device

Item	X100HT with Full Field PBS	X100 with Full Field PBS(Predicate, K201301)
Intended Use	The X100HT with Full Field Peripheral Blood Smear(PBS) Application is intended to locate and displayimages of white cells, red cells, and platelets acquiredfrom fixed and stained peripheral blood smears andassists a qualified technologist in conducting a WBCdifferential, RBC morphology evaluation, and plateletestimate using those images. For in vitro diagnostic useonly. For professional use only.	Same
Sample Type	Peripheral whole blood	Same
Sample Smear	Sample is smeared on a glass microscope slide(Either manually or by third party device).	Same
Sample Staining	Sample's smear is fixated and stained with Romanowskystain. (Either manually or by third party device)	Same
Sample Identification	Sample's microscope slide is identified by a uniquebarcode label. (Barcode label is applied either manuallyor by third party device).	Same
Sample CoverSlipping	The X100HT automatically applies mounting media and aglass cover slip onto the sample's microscope slide.	User manually appliesmounting media and aglass cover slip onto thesample's microscope slide.
Sample Loading	The user manually places up to 30 slides into 3extractable cassettes, and inserts them into the SlideLoader. The Slide Loader sequentially inserts the slidesinto the X100 scanner.	User manually inserts upto 3 slides into anextractable tray, andmanually inserts the tray into the X100 scanner.
High-ResolutionImage Acquisition	Fully automated scan and image acquisition.Captures multiple images under plurality of illuminationconditions and reconstructs a 100X magnification imageof the viewed area, without the need for immersion oil.	Same.
Analysis Technique:White Blood Cells	WBC are located/counted by moving according to thebattlement pattern (ensuring that each cell is counted onlyonce). Cell images are analyzed using standardmathematical methods, including deterministic artificialneural networks (ANN's) trained to distinguish betweenclasses of white blood cells. The cell images are pre-classified, and the user reviews the suggestedclassification, and accepts or reclassifies the images.	Same
Analysis Technique:Red Blood Cells	Red blood cells: The device presents an overview image.The examiners characterize red blood cell morphologyfrom the image.	Same
Daily QC	The QC procedure controls for slide preparation (bothsmearing and staining) and device performance. If the QCprocedure does not pass, the operator must resolve theproblem and rerun the QC before processing samples.	Same
Analysis Technique:Platelets	Platelets are automatically located/counted by movingaccording to the battlement pattern (ensuring that eachcell is counted only once). The user reviews the suggestedestimate of the platelet concentration, and accepts ormodifies the result.	Same
Item	X100HT with Full Field PBS	X100 with Full Field PBS(Predicate, K201301)
Pre-classified WBC	Cell images are grouped into eighteen (18) categories:• Band Neutrophils• Segmented Neutrophils• Lymphocytes• Atypical Lymphocytes• Large Granular Lymphocytes• Aberrant Lymphocytes• Monocytes• Eosinophils• Basophils• Promyelocyte• Metamyelocytes• Myelocytes• Blasts• Plasma Cells• Nucleated Red Blood Cells• Unclassified• Smudge cells• Dirt	Same
Dimensions	Width 39cmLength 42cmHeight 55cm	Width 32cmLength 32cmHeight 35cm
Weight	33 Kg	14 Kg
Power Source	120/100 - 240V, 1.5A, 50 - 60 Hz	Same

{7}------------------------------------------------

D Scopio

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image contains the word "Scopio" in a bold, dark blue font. To the left of the word is a logo consisting of two overlapping squares. The square in the back is pink, and the square in the front is dark blue and slightly transparent, allowing the pink square to be seen through it.

VII. Testing

Software and Hardware Verification and Validation Testing

A comprehensive risk analysis was conducted and documentation was provided as recommended by FDA's guidance. Verification and validation testing was conducted and documentation was updated. The application was considered as a "moderate" level of concern, since a malfunction failure or latent design flaw in the software could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that could lead to a minor injury.

EMC Testing

The X100HT with Full Field PBS successfully passed EMC testing in compliance with IEC 60601-1-2 4th edition (2014) standard and FCC CFR 47 Part 15 Subpart B, ANSI C63.4:2014.

Safety Testing

The X100HT with Full Field PBS successfully passed Safety testing in compliance with IEC 61010-2-101:2015 / EN 61010-2-101: 2017 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment as well as IEC / EN 61010-1: 2010 (3rd Edition) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements and IEC 62471:2006 / EN 62471:2008 Photobiological safety of lamps and lamp systems.

VIII. Conclusion

Risk analysis and testing results demonstrated that X100HT with Full Field PBS is substantially equivalent to the predicate device.

Regulation Number and Section

§ 864.5260 Automated cell-locating device.

(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).