The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/ disorders, oncology patients, critically ill patients, or children under the age of 2.

Device Description

The XW-100 Automated Hematology Analyzer for CLIA Waived Use is an electrical resistance type blood cell counter. This technology may be variously referred to as direct current (DC) or impedance. The analyzer uses a human whole blood specimen and produces results for 12 hematology parameters, including the basic complete blood count (CBC), 3 part white blood cell (WBC) differential, and MCV.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Sysmex America, Inc. regarding their XW-100 Automated Hematology Analyzer. It primarily details the device's intended use, technological principles, and a comparison to a predicate device, focusing on a software update.

Crucially, this document does not contain the detailed study information typically requested for acceptance criteria and device performance proofs. It explicitly states that the device is "as safe and effective as the predicate device" and that "The results of the design control activities demonstrate that the device is substantially equivalent to the predicate device." This suggests that the detailed performance studies were likely conducted for the original predicate device (K172604/CW170012), and for this new submission (K210346), the focus was on demonstrating that the software update did not negatively impact the previously established safety and effectiveness.

Therefore, many of the requested fields cannot be directly answered from the provided text. However, I can infer some information based on the context of a 510(k) submission for a software update.

Here's an attempt to answer the questions based on the provided text and general 510(k) submission understanding for software updates:

Acceptance Criteria and Device Performance Study Information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific reported device performance metrics for the XW-100 with software version 1.14. It relies on the principle of "substantial equivalence" to the predicate device (XW-100 with software version 1.03). The acceptance criterion for this submission is that "the device is as safe and effective as the predicate device" and that the "proposed software update was implemented in accordance to design controls and risk management."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any test set or the data provenance. For a software update submission, testing would typically involve verifying that the new software performs identically or acceptably compared to the previous version across a range of samples. This would likely be internal validation data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned. The device is an automated hematology analyzer, and its "ground truth" for parameters like WBC, RBC, etc., is typically established by reference methods or validated calibrated instruments, not subjective expert interpretations as would be the case for imaging diagnostics. The context here is a software update for an already cleared device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. No human expert adjudication method would be used for an automated hematology analyzer's numerical output for the specified parameters.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an automated hematology analyzer, not an AI-assisted diagnostic tool that human readers would use to improve their interpretation of images or data. It produces direct numerical measurements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device (the XW-100 Automated Hematology Analyzer) inherently operates in a "standalone" fashion, as it is an automated instrument performing quantitative measurements. The evaluation for this 510(k) was focused on the software update (version 1.03 to 1.14) and ensuring it maintained the performance of the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For an automated hematology analyzer, the "ground truth" for its measurements (WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#) is established through:

Reference methods: Highly accurate and precise laboratory methods.
Validated reference materials/calibrators: Materials with known and traceable values.
Comparison to predicate devices: As stated, the updated device is compared to the original XW-100 with version 1.03.

8. The sample size for the training set

Not applicable/Not mentioned. This document pertains to a 510(k) software update for an automated instrument, not a de novo AI/ML algorithm that requires a distinct "training set" in the context of machine learning model development. The software update is likely to be code changes rather than a re-trained model.

9. How the ground truth for the training set was established

Not applicable/Not mentioned, as there is no mention of a typical "training set" for an AI/ML model for this software update.

Summary

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November 8, 2022

Sysmex America, INC. Yvonne Doswell Senior Scientist, Regulatory Affairs 577 Aptakisic Road Lincolnshire, Illinois 60069-4325

Re: K210346

Trade/Device Name: Sysmex XW-100 Automated Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: June 20, 2022 Received: June 21, 2022

Dear Yvonne Doswell:

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

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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,

Image /page/1/Picture/5 description: The image shows the text "Min Wu-S" in a large, bold, sans-serif font. The text is black and is set against a white background. There is a light blue watermark in the background that is partially obscuring the text.

Min Wu 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

XW-100 Automated Hematology Analyzer for CLIA Waived Use

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)

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

Submitter's name, address, telephone number, a contact person, and date the summary was prepared:

Submitter's Name:	Yvonne Doswell
Submitter's Address:	577 Aptakisic RoadLincolnshire, IL 60069
Submitter's Telephone:	224-543-9708
Submitter's Email:	Doswelly@sysmex.com
Date 510(k) Prepared:	09/29/2022

Name of the device, including the trade or proprietary name, the common or usual name, and the classification name:

Proprietary Name:	XW-100 Automated Hematology Analyzer for CLIA Waived Use
Common Name:	Automated Hematology Analyzer
Regulation Description:	Automated Differential Cell Counter
Regulation Section:	21 CFR 864.5220
Device Class:	2
Product Code:	GKZ
Predicate Device/510(k):

XW-100 Automated Hematology Analyzer for CLIA Waived Use K172604, dual submission CLIA Waiver by Application CW170012

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INTENDED USE/INDICATIONS FOR USE

The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/disorders, oncology patients, critically ill patients, or children under the age of 2.

Special Conditions for Use Statement(s):

The XW-100 is intended to be used by operators with a minimum of an earned high school diploma or equivalent.

DEVICE DESCRIPTION

Principles of Operation

The XW-100 uses direct current with hydrodynamic focusing for all parameters except hemoglobin, which is measured photometrically. The patient sample is aspirated, diluted with diluent (and Lyse for WBC measurement), then fed into a transducer by means of a hydrodynamic focusing nozzle. The transducer chamber has a minute hole, or aperture. Electrodes are mounted on both sides of the aperture chamber, through which flows the DC. Blood cells suspended in the diluted sample are injected through the aperture by the hydrodynamic focusing nozzle. The hydrodynamic focusing nozzle is positioned in front of the aperture and in line with the aperture's center. This method improves cell counting accuracy because all blood cells are separated from each other and can only pass through the aperture in one direction, one at a time. When a cell passes through the aperture, it causes a change in the direct current resistance that is directly proportional to its size. These resistance changes are captured as electric pulses. The various blood cell counts are calculated by counting the pulses that occur in each cell size category. The analyzer then determines blood cell volume and identifies rare and pathological cells by creating and analyzing histograms of the various cell populations using their respective pulse heights. Hemoglobin is measured photometrically using a noncyanide methodology, which reduces the presence of hazardous materials in the analyzer waste stream.

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Quality Controls

The quality controls that are used with the XW-100 Automated Hematology Analyzer for CLIA Waived Use comprise XW QC CHECK, which contains stabilized red blood cell component(s), stabilized WBC component(s), and stabilized platelet component(s) in a preserving medium. XW OC CHECK components are packaged in glass vials with screw caps containing 2 mL. The vials are packaged in a welled vacuum-formed clamshell container. XW QC CHECK is stored at room temperature (15°C-25°C).

SUMMARY OF SUBSTANTIAL EQUIVALENCE

The proposed modified device, XW-100 Automated Hematology Analyzer for CLIA Waived Use has the same intended use, labeling, and fundamental scientific technology as the predicate device, the XW-100 Automated Analyzer for CLIA Waived Use.

Similarities
Item	Predicate Device	Modified Device
510(k) Number	K172604	N/A
Device Name	XW-100 Automated HematologyAnalyzer for CLIA Waived Use	Same
Intended Use	The XW-100 Automated HematologyAnalyzer (XW-100) is a quantitativeautomated hematology analyzer intendedfor in vitro diagnostic CLIA waived use toclassify and enumerate the followingparameters for venous whole bloodanticoagulated with K2/K3 EDTA: WBC,RBC, HGB, HCT, MCV, PLT, LYM%,Other WBC%, NEUT%, LYM#, OtherWBC#, and NEUT#. It is not for use indiagnosing or monitoring patients withprimary or secondary chronic hematologicdiseases/disorders, oncology patients,critically ill patients, or children under theage of 2.	Same
Test Principle	Impedance technology (direct currentdetection) with hydrodynamic focusing forall parameters except hemoglobin, which ismeasured photometrically.	Same
Measuring Channel	Single hydrodynamic focusedimpedance chamber	Same
Sample Type	Anticoagulated (K2EDTA or K3EDTA)venous whole blood	Same
Sample aspirationvolume	15 µL	Same

Comparison to the Predicate Device:

Sysmex America, Inc. XW-100 Automated Hematology Analyzer for CLIA Waived Use

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Similarities
Item	Predicate Device	Modified Device
Analysis Reagents	XW Pack L (lyse) XWPack D (diluent)	Same
System Throughput	20 cycles per hour	Same
Test SystemDimensions	Width: 7 inchesHeight: 14 inchesDepth: 18 inches	Same
Mode of Operation	Whole blood mode	Same
Calibration andQuality Control	XW QC CHECK (K143577)SCSTM-1000 calibrator (K943268)	Same
Differences
Item	Predicate Device	Modified Device
Software	Version 1.03	Version 1.14

Differences:

There is no difference between the XW-100 Automated Hematology Analyzer for CLIA Waived Use and the modified device aside from a software update from Version 1.03 to Version 1.14.

CONCLUSION:

The proposed software update was implemented in accordance to design controls and risk management. The risk analysis and well-established methods of verification and validation activities conducted, demonstrate that the XW-100 Automated Hematology Analyzer for CLIA Waived Use with the proposed software version 1.14 is as safe and effective as the predicate device. The results of the design control activities demonstrate that the device is substantially equivalent to the predicate device, XW-100 Automated Hematology Analyzer for CLIA Waived Use (K172604/CW170012).

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”