(119 days)
Not Found
Yes
The device description explicitly states that the system provides "suggested classification of each automatically detected WBC" and "suggested platelets estimation," which implies the use of algorithms that learn from data to make these suggestions, characteristic of AI/ML. Additionally, the input explicitly states "Mentions AI, DNN, or ML: Yes".
No
This device is for in vitro diagnostic use, assisting a technologist in evaluating blood smears for diagnostic purposes and does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" states that the device is for "in vitro diagnostic use only" and "assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate". These activities are directly related to diagnosing conditions based on analyses of biological samples.
No
The device description explicitly mentions hardware components like a slide loader, cassettes, and the X100 for scanning and analysis. The performance studies also include hardware verification and validation testing, EMC testing, and safety testing related to electrical equipment.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only."
Furthermore, the device's function of analyzing fixed and stained peripheral blood smears to assist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate aligns perfectly with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JOY
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Not Found
Anatomical Site
Peripheral whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
skilled users, trained in the use of the device and in the identification of blood cells. For in vitro diagnostic use only. For professional use only.
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)
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.
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
§ 864.5260 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).
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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.
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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
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Indications for Use
510(k) Number (if known)
Device Name
X100HT with Full Field Peripheral Blood Smear (PBS) Application
Indications for Use (Describe)
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.
| 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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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 Street | ||
| Tel Aviv 6578313 | ||
| Israel | ||
| Sponsor Email: | info@scopiolabs.com | |
| Contact Person: | Shahar Karny | |
| COO | ||
| Scopio 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
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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.
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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.
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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 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. | 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 Romanowsky
stain. (Either manually or by third party device) | Same |
| Sample Identification | Sample's microscope slide is identified by a unique
barcode label. (Barcode label is applied either manually
or by third party device). | Same |
| Sample Cover
Slipping | The X100HT automatically applies mounting media and a
glass cover slip onto the sample's microscope slide. | User manually applies
mounting media and a
glass cover slip onto the
sample's microscope slide. |
| Sample Loading | The user manually places up to 30 slides into 3
extractable cassettes, and inserts them into the Slide
Loader. The Slide Loader sequentially inserts the slides
into the X100 scanner. | User manually inserts up
to 3 slides into an
extractable tray, and
manually inserts the tray in
to the X100 scanner. |
| High-Resolution
Image Acquisition | Fully automated scan and image acquisition.
Captures multiple images under plurality of illumination
conditions and reconstructs a 100X magnification image
of the viewed area, without the need for immersion oil. | Same. |
| Analysis Technique:
White Blood Cells | WBC are located/counted by moving according to the
battlement pattern (ensuring that each cell is counted only
once). Cell images are analyzed using standard
mathematical methods, including deterministic artificial
neural networks (ANN's) trained to distinguish between
classes of white blood cells. The cell images are pre-
classified, and the user reviews the suggested
classification, 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 morphology
from the image. | Same |
| Daily QC | The QC procedure controls for slide preparation (both
smearing and staining) and device performance. If the QC
procedure does not pass, the operator must resolve the
problem and rerun the QC before processing samples. | Same |
| Analysis Technique:
Platelets | Platelets are automatically located/counted by moving
according to the battlement pattern (ensuring that each
cell is counted only once). The user reviews the suggested
estimate of the platelet concentration, and accepts or
modifies 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 39cm
Length 42cm
Height 55cm | Width 32cm
Length 32cm
Height 35cm |
| Weight | 33 Kg | 14 Kg |
| Power Source | 120/100 - 240V, 1.5A, 50 - 60 Hz | Same |
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D Scopio
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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.