The EXCELL™ 22, is an in-vitro diagnostic instrument for use in counting blood cells, classifying white blood cells (WBC) and flagging specimens containing abnormal blood cells in clinical laboratories at diverse sites. Per NCCLS H20A section 4(9), flagging is defined as "identifying a sample or blood film for further attention or review".

Device Description

The EXCELL 22 is a DATACELL 18MS with an additional optical channel for performing a five-part white cell differential. The five-part optical white cell differential system is substantially equivalent to the Cell-Dyn 3000.

Modifications to the DATACELL 18MS present in the new instrument are:

Addition of a laser excited multi dimensional flow cytometer .
. addition of a reagent for the optical flow cell
provision for collecting data from the optical detectors .
replacing of AC motors with DC motors to make the product suitable . for international applications
replacing the internal PC computer and monitor with an external PC to . gain room for the optical detection system
. provision in the slide valve for the additional dilution for the WBC optical measurement
. addition of hydrodynamic focus sample injection system for the WBC
improved dilution logic to speed up the measurement .
improved platelet aperture system called the von Behrens silencer.

The operating modes are the same as the DATACELL 18MS.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter Category	Acceptance Criteria	Reported Device Performance
Linearity	Specified in Operator's Reference Manual	EXCELL 22 meets specified linearity.
Precision	Specified in Operator's Reference Manual	All values of variation are less than acceptable ranges and indicate satisfactory performance.
Accuracy (Correlation to Reference Instruments)	Correlation Coefficient: > 0.980 for WBC, RBC, Hgb, MCV, Plt.Correlation Coefficient: > 0.900 for RDW and WBC differential parameters (except basophils).Slope: 0.95 to 1.05 for RDW and WBC differential parameters.	EXCELL 22 exhibited correlation coefficients > 0.980 for WBC, RBC, Hgb, MCV, Plt. (Explicit values for slope and other cell types for WBC differential are not given, but the text states "The results of this study indicate that the EXCELL 22 is accurate and is substantially equivalent to the legally marketed reference instruments.")
Flagging Characteristics (False Negatives/Positives)	(Implicitly: no false negatives or minimal false positives for critical flags)	EXCELL 22 reported no false negatives and 1 false positive result for the DIFF flag.

2. Sample Size Used for the Test Set and Data Provenance

Study 1 (Accuracy/Correlation):
- Initial Sample Size: 390 whole blood samples.
- WBC Differential Count Portion: Reduced to 268 samples after eliminating morphological positive results on reference and test instruments (as recommended in NCCLS H20-A).
- PLT, RBC, MCV, RDW, HGB Portion: Reduced to 326 samples after eliminating morphological positive results on reference and test instruments (as recommended in NCCLS H20-A).
- Provenance: "Obtained from various sources including physicians' offices and hospital laboratories." (Likely domestic, but not explicitly stated. Retrospective for Study 1, as samples were collected and then tested without intervention to the patient population.)
Study 2 (Flagging Characteristics):
- Sample Size: 173 whole blood samples.
- Provenance: "Obtained from various sources." (Likely domestic, but not explicitly stated. Retrospective for Study 2, as samples were collected and then tested.)

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Three different technologists were used for the manual differential count in Study 2.
Qualifications: Not explicitly stated beyond "technologists." Standard practice for manual differentials implies proficiency and training in hematology.

4. Adjudication Method for the Test Set

For Study 2 (Flagging Characteristics), when a DIFF flag was reported by either the EXCELL 22 or Cell-Dyn 3000, "three different technologists performed a manual differential count. The manual count from each technologist was recorded, and the average result of all three was used in order to minimize the effects of human error and to improve statistical confidence of the observation." This is a form of 3-reader averaging.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study for human readers with and without AI assistance was not conducted or reported. This study focused on the performance of the automated device against predicate devices and manual counts, not on improving human reader performance with AI.

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

Yes, the entire study focuses on the standalone performance of the EXCELL 22 automated analyzer. Its performance is compared directly against predicate devices (Cell-Dyn 3000, Coulter S+IV) and, for flagging differences, against averaged manual differential counts.

7. The Type of Ground Truth Used

Accuracy/Correlation Studies (Study 1): The ground truth was established by two commercially available, legally marketed predicate devices: the Cell-Dyn 3000 (for WBC differential) and the Coulter S+IV (for basic hematology parameters). The text states: "Because no established standards are available for hematology analyzers, instruments were compared with a calibrator stated to be calibrated to a commercial standard for some parameters."
Flagging Characteristics (Study 2): When a DIFF flag was triggered, the ground truth was established by expert consensus (averaged manual differential count) performed by three different technologists.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The description of "linearity" suggests internal calibration and setting of parameters, but not a distinct, external training dataset in the context of machine learning. The EXCELL 22 is described as deriving its design from existing, proven instruments, implying its "training" or development would have been based on established hematology principles and previous generations of analyzers rather than a machine learning training dataset.

9. How the Ground Truth for the Training Set Was Established

As no explicit training set is mentioned in the context of machine learning, this information is not provided. The device's "training" would be tied to its design being "derived from the proven Danam DATACELL 18MS" and its WBC differential technology being "closely related to the technology utilized by the Cell-Dyn 3000." These predicate devices inherently embody prior knowledge and established methods as their "ground truth."

Summary

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510(k) Summary

MWI. Inc.

Common/Clasification Name:	Counter, Differential CellHematology Analyzer
Sponsor:	MWI, Inc.d.b.a. Danam Electronics4230 Shilling WayDallas, TX 75237Tel (214) 210-4900Fax (214) 210-4949
Contact:	Greg Witherspoon
Prepared:	April 29, 1999

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 K99639

LEGALLY MARKETED PREDICATE DEVICES A

To show that EXCELL 22 Is safe and effective, it is compared to two legally marketed devices. The Cell-Dyn 3000 WBC differential is well respected in the industry as being fundamentally sound in theory and implementation, but because of well known WBC fragile lymphocyte counting problems it is not used for the WBC count for this comparison. The design of the EXCELL 22 is derived from the proven Danam DATACELL 18MS that traces its performance equivalence to the Coulter S+IV. For this reason, the basic hematology parameters are compared to the Coulter S+IV and the white cell differential is compared to the Cell-Dyn 3000. The laser optical WBC differential that was added to the DATACELL 18MS is similar to that of the Cell-Dyn 3000.

The Coulter S+IV reproducibility and linearity is superior to the Cell-Dyn products and makes a better comparison for those parameters which are provided.

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The predicate devices are marketed under 510(k) clearance. The Cell-Dyn 3000 is manufactured by Sequoia Turner Corporation, (now Abbott Laboratories) under K890491. The DATACELL 18MS is manufactured by MWI, Inc. d.b.a. Danam Electronics under K945678.

B DEVICE DESCRIPTION

Modifications to the DATACELL 18MS present in the new instrument are:

Addition of a laser excited multi dimensional flow cytometer .
. addition of a reagent for the optical flow cell
provision for collecting data from the optical detectors .
replacing of AC motors with DC motors to make the product suitable . for international applications
replacing the internal PC computer and monitor with an external PC to . gain room for the optical detection system
. provision in the slide valve for the additional dilution for the WBC optical measurement
. addition of hydrodynamic focus sample injection system for the WBC
improved dilution logic to speed up the measurement .
� improved platelet aperture system called the von Behrens silencer.

The operating modes are the same as the DATACELL 18MS.

C INTENDED USE

The subject product, EXCELL 22, is an in vitro diagnostic instrument for use in counting blood cells, classifying white blood cells (WBC), and flagging specimens containing abnormal blood cells. The marketed instruments, DATACELL 18MS and Cell-Dyn 3000, have the same intended use.

D TECHNOLOGICAL CHARACTERISTICS

The subject product, EXCELL 22, has similar technological characteristics as the predicate devices. The EXCELL 22 is simply the addition of an optical five-part white cell differential to the Danam DATACELL 18MS. The white cell differential is closely related to the technology utilized by the Gell-Dyn 3000. The other changes are refinements of the technology used in the DATACELL 18MS.

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TESTING E

Evaluation of performance characteristics was done in the Danam OC
are and the contractions formas instruments are routinely maintained for Evaluation of performance characteristics was goutinely maintained for laboratory where the reference institutions and controls. The instruments
monitoring performance of Danam reagents and controls. The instruments monitoring performance of Danam reagents and Streek Laboratories Para
are controlled using Coulter 4C for the S+V and Streck Laboratories Para
Click Street C & L = 0000 Clic are controlled using Coulter 4C for the Services exist for the 12 plus for the Cell-Dyn 3000. Silght callsmands on the line the the the the the different brands of callbrator and control procusion applicians'
evaluation were obtained from various sources including physicians' evaluation were obtained not hospital laboratories.

Linearity

Linearity is set on all Danam Excell products by a serial dilution
is a set on all products and corporators against hemoglibin. Linearity is set on all Danam LXcoll production in hemoglobin. The
technique plotting all counted parameters against hemoglobin technique ploting all counted purchip to verify hemoglobin
hemoglobin is assayed for each dilution to verify hemoglobin hemogiobilitis assayed for ouch effectificant tochnique since the linearity. This is a particularly useful lochinique envous and cell counts.

The results of the linearity test indicate that the EXCELL 22 meets The results of the infounty toos contained in the Operator's Reference Manual.

Precision

Studies of instrument precision are used to confirm the Studies of instrument procision are assisted operation. Precision is reproducibility of the initial blood camping material. The precision evaluated by replicate analysos of solicates of high, normal, and studies consist of 10 consocutive repression test indicate that low control material. The rooms of the performance specifications contained in the Operator's Reference Manual.

To evaluate precision of day to day operations, statistics are TO evaluate precision of day to day open aterial when the testing of denved from the daily tooting or alsured are within patient samples was done. All values of variation are less than acceptable fanges and their disoned for the control product when it is the specifical IDSD .......................................................................................................................................................... expected range and indicate satisfactory performance of the EXCELL 22.

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Accuracy

Accuracy is evaluated by comparison of measured and calculated Accuracy is evaluated by companissn of clinical specimens by EXCELL 22 and parameters from testing of cirined opesifierential percential percentages and the reference instruments. The Cell-Dyn 3000. All other parameters were compared with the Coulter S+IV. Because no established were compared with the Oouler oology analyzers, instruments were standardo are avellable calibrator stated to be calibrated to a commorolains and the some parameters.

Comparison of results is made between samples counted by the Companson of roballer forence instruments. Two studies were performed. The first study is of a large number of samples comparing the EXCELL 22 and the reference instruments to companing the EXOLED accuracy of the subject instrument. The delemine correlation of acceration of reference method differential determination to resolve flag differences between the Cell-Dyn 3000 and the EXCELL 22.

Study 1

Study i
This study consisted of 390 whole blood samples obtained from I nis study consisted as defined in NCCLS H3-A2, intended to be representative of the universe that the EXCELL 22 is intended to serve. The specimens were tested during the period from February 08, 1999 to April 08, 1999.

Patient samples that gave a white blood cell differential morphological positive result on the Cell-Dyn 3000 reference instrument and the EXCELL 22 were eliminated from the white blood cell differential count portion of the correlation study, as recommended in NCCLS H20-A, resulting in a reduction of the samples for the WBC differential count portion to 268.

Patient samples giving a PLT/RBC morphological positive result on the reference instrument and instrument under evaluation were eliminated from the PLT, RBC, MCV, RDW, HGB portion of the correlation study, as recommended in NCCLS H20-A, resulting in a reduction of the samples to 326.

All samples were promptly analyzed on the EXCELL 22, Coulter S+IV, Cell-Dyn 3000 and the results recorded.

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The correlation coefficient, slope and y-Intercept were determined for each parameter. Measured parameter results (WBC, RBC, Hgb. MCV, Pit) obtained by the EXCELL 22 exhibited coefficients of correlation is greater than 0.980.

Calculated RDW and WBC differential parameter results are considered to be accurate when the slope of the line of correlation is within the range of 0.95 to 1.05 and the coefficient of correlation is greater than 0.900 for all cell types except the basophils. The basophil is an infrequently occurring cell type that is reduced in correlation coefficient due to the very small frequency range and the statistical noise caused by the low number of basophils observed.

The results of this study indicate that the EXCELL 22 is accurate and is substantially equivalent to the legally marketed reference instruments.

Study 2

The purpose of this study is to evaluate the flagging characteristics of the EXCELL 22. This study consisted of 173 whole blood samples obtained from various sources, collected as defined in NCCLS H3-A2, and intended to be representative of the universe that the EXCELL 22 is intended to serve. The specimens were tested during the period from March 10, 1999 to April 08, 1999.

All samples were promptly analyzed by the EXCELL 22, Cell-Dyn 3000 and the results recorded. A slide was made of each specimen for further analysis.

The EXCELL 22 and the Cell-Dyn 3000, both report a DIFF flag when they cannot reliably discriminate the cell clusters and produce a meaningful five part white cell differential. This is typically droo to the presence of highly abnormal cell distributions, abnormal cell morphology, or deterioration of sample condition.

On all samples reported with a DIFF flag by the Cell-Dyn 3000 and/or by the EXCELL 22, three different technologists performed a manual differential count. The manual count from each technologist was recorded, and the average result of all three was used in order to minimize the effects of human error and to improve statistical confidence of the observation.

The EXCELL 22 reported no false negative and 1 false positive result; the Cell-Dyn 3000 reported no false negative and 7 false positive results.

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The result of the EXCELL 22 flagging study indicated that no unreliable WBC differential results were reported.

F CONCLUSIONS

Careful analysis of the results of comparison of the EXCELL 22 with the Careful analysis of the results of companses of the substantial equivalence of the EXCELL 22 with the legally marketed devices. The EXCELL 22 is safe and effective for its intended use.

・

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

JUL - 1 1999

Mr. Gregory A. Witherspoon Manager, Quality Affairs and Regulatory Affairs MWI, Inc. dba DANAM Electronics 4230 Shilling Way Dallas, Texas 75237

K991539 Re: Trade Name: EXCELL™ 22 Regulatory Class: II Product Codc: GKZ Dated: April 30, 1999 Received: May 3, 1999

Dear Mr. Witherspoon:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 510(x) notifications in (for the indications for use indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the enclosure) to legally manoled processor in Medical Device Amendments, or to devices that prior to May 28, 1770, the chasinent and the provisions of the Federal Food, Drug, and have been reclassified in accordance with the provide device, subject to the general controls Cosmetic Act (Act). You may, morelors, manol isions of the Act include requirements for annual provisions of the Act. "The general obline provise stice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Premarket Apploval), it may of subject to ader as a learners , Title 21, Parts 800 to 895. allecting your device car o determination assumes compliance with the Current Good A suisfantially equirations as set forth in the Quality System Regulation (QS) for Manufacturing Practice requirements (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mispections, the rood and Drig reasult in regulatory action. In addition, FDA may publish comply wan and Greaterning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may
out of the may of the since if a leterroing if it does, you should contact the Under the Clinical Laboratory Improvement Anlenements of 1780 ( Under 1977)
require a CLIA complexity categorization. To determine if it does, you should contact the require a CLIA complexity Categorization - FC CC
Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket
s and the supportunity of any for the taskes of your device to a legally mark This letter will allow you to begin marketing your device to a legally marketed
notification. The FDA finding of Substantial equivalence of your device to notification. The FDA finding of substantial equivaled of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), presentials and vour device additionally 809.10 for in vitto diagnostions on the promotion and seriesing of your device, (301) 594-4588. Additionally, for questions on the promo. A lso, please note the regulation
please contact the Office of Compliance at (301) 594-4639. Also, please note the please contact the Office of Compliatic at (301) 34-4037. 7200 (FR 807.97). Other general
entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Oth entitled, "Misbranding by reference to prematics and reason (and the Division of Small
information on your responsibilities under the Act may be obtained from the Division of information on your responsibilities under (800) 638-2041 or (301) 443-6597, or at its
Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or a Manufacturers Assistance at to to to to to to to to to to to this.".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/8/Picture/0 description: The image shows the logo for MWI, INC. The logo includes a stylized waveform graphic to the left of the text. Below the company name, it says "dba DANAM3 ELECTRONICS" in a smaller font.

4230 SHILLING WA DALLAS, TEXAS 75237 (214) 210-4900 (800) 433-0945 FAX (214) 210-4949

Page 1 of 2

510(k) Number (if known): K991539

Device Name: EXCELL™ 22

Indication for Use: The EXCELL™ 22, is an in-vitro diagnostic

instrument for use in counting blood cells, classifying white blood cells (WBC) and flagging specimens containing abnormal blood cells in clinical laboratories at diverse sites. Per NCCLS H20A section 4(9), flagging is defined as "identifying a sample or blood film for further attention or review".

The EXCELL 22 reports on the following parameters:

White Blood Cells (Leukocytes) WBC
Red Blood Cells (Erythrocytes) RBC
Hemoglobin Concentration Hgb
Hematocrit (relative volume of erythtocytes) Hct
Mean Corpuscular (erythrocyte) Volume MCV
Mean Corpuscular (erythrocyte) Hemoglobin MCH
Mean Corpuscular (erythrocyte) Hemoglobin Concentration MCHC
Red Blood Cell (erythrocyte volume) Distribution Width RDW
Platelet or Thrombocyte Count Pit
Mean Platelet (thrombocyte) Volume MPV

Continued on next page

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/9/Picture/0 description: The image shows the logo for MWI, INC. The logo includes a stylized waveform graphic to the left of the text. Below the company name, it says "dba DANAM® ELECTRONICS" in a smaller font.

4230 SHILLING WA DALLAS, TEXAS (214) 210-

Page 2 of 2

510(k) Number (if known): K991539

Device Name: EXCELL™ 22

Parameters Continued:

Lymphocyte (number) LY#
Lymphocyte (percent of WBC) LY%
Monocyte (number) MO#
Monocyte (percent of WBC) MO%
Basophil (number) BA #
BA% Basophil (percent of WBC)
Neutrophil (number) NE#
Neutrophil (percent of WBC) NE%
Eosinophil (number) EO#
Eosinophil (percent of WBC) EO%

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Madeni

(Division Sign-Off)
Division of Clinical Laboratory Devices K991539
510(k) Number

Prescription -

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.”