The HPC (hematopoietic progenitor cell) parameter of the IMI Channel on the Sysmex® SE-9500 and XE-2100 for in Vitro Diagnostics is used as a screen for the optimal presence of hematopoietic progenitor cells in peripheral blood and cord blood samples.

Device Description

The SE-9500 and XE-2100 have an immature myeloid information (IMI) channel, which identifies and enumerates immature cells in addition to the traditionally reported parameters of an automated cell differential. (Note: Special software/hardware is required to obtain results described.)

AI/ML Overview

The provided text describes a 510(k) submission for the "HPC (Hematopoietic Progenitor Cell) parameter on the IMI Channel of the Sysmex® SE-9500 and XE-2100, Automated Hematology Analyzer." The document does not explicitly state "acceptance criteria" and "reported device performance" in a structured table or use these specific terms. However, it does present a "Comparison Table to Predicate Methods" that outlines the characteristics and performance of the new HPC parameter in relation to predicate devices (Colony Forming Unit (CFU) and Total Nucleated Count (TNC)) and a routine method (Flow Cytometry CD34+).

Based on the provided information, here's an attempt to extract the requested details:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly define quantitative "acceptance criteria" like thresholds for accuracy, sensitivity, or specificity. Instead, it relies on demonstrating "substantial equivalence" to predicate methods, particularly in terms of "accuracy" (correlation to CFU).

Acceptance Criteria (Inferred from comparison to predicates)	Reported Device Performance (HPC parameter of IMI Channel)
Intended Use: Screen for optimal presence of progenitor cells in stem cell harvest & cord blood.	Same as predicate methods (CFU, TNC, Flow Cytometry CD34+).
Methodology: Hematopoietic progenitor cell count from hematology analyzer.	Hematopoietic progenitor cell count from hematology analyzer.
Anticoagulant Type: EDTA (for HPC).	EDTA.
Specimen Type: Peripheral blood & cord blood.	Peripheral blood & cord blood.
Accuracy: Comparison to CFU should show good correlation.	Comparison to CFU showed good correlation.
Time Required (per sample): Short (90 seconds, comparable to TNC).	90 seconds.
Cost (per sample): Low (Approx $1.35, comparable to TNC).	Approx $1.35.
Quality of Technical Support: Hematology laboratory personnel; Run in duplicate.	Hematology laboratory personnel; Run in duplicate.

Study Proving Acceptance Criteria (Substantial Equivalence)

The study described is a comparison of the new HPC parameter to established predicate methods.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states: "the HPC parameter to the predica indicated equivalent performance. The performance data demonstrated substantial equivalence."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication method for the test set

The document does not describe any adjudication method.

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

This is not an MRMC study. The device is an automated hematology analyzer parameter, not an AI-assisted interpretation tool for human readers. Therefore, this question is not applicable.

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

Yes, the performance described is that of the standalone device (HPC parameter on the Sysmex® SE-9500 and XE-2100 automated hematology analyzers). It functions without human-in-the-loop interpretation for its primary output. The "Quality of Technical Support" section mentions "Hematology laboratory personnel; Run in duplicate," which refers to the operation of the device and quality control checks, not human interpretation of the device's primary result.

7. The type of ground truth used

The primary ground truth appears to be the Colony Forming Unit (CFU) method. The document states: "Method of real counting of progenitor cells established as reference method" for CFU, and the accuracy of the HPC parameter (as well as TNC and Flow Cytometry CD34+) is assessed by "Comparison to CFU showed good correlation."

8. The sample size for the training set

The document does not provide information on the sample size used for training, nor does it explicitly describe a distinct "training set" in the context of typical machine learning models. This is a hematology analyzer parameter, and its development would likely involve calibration and validation rather than what is typically understood as an ML training set.

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

Since a "training set" in the machine learning sense is not explicitly discussed, the establishment of ground truth for development/calibration would inherently rely on the same established methods, primarily the Colony Forming Unit (CFU) method, which is considered the "reference method" for real counting of progenitor cells.

Summary

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SYSMEX CORPORATION OF AMERICA 6699 Wildlife Way Long Grove IL 60047-9596 (800) 379-7639 (847) 726-3505 Facsimile

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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: KOZO40 0 .

1. Submitted by:	Sysmex Corporation of America6699 Wildlife WayLong Grove, IL 60047Phone: (847) 726-3675 FAX: (847) 726-3559Contact person: Nina GamperlingDate prepared: February 13, 2002
2. Name of Device:	Trade or proprietary name: HPC (Hematopoietic Progenitor Cell)parameter on the IMI Channel of the Sysmex® SE-9500 and XE-2100, Automated Hematology Analyzer.
	Common name: HPC parameter
	Classification name: HPC parameter on the IMI Channel,Automated Differential Cell Counter, Sysmex® SE-9500 and XE-2100 (21 CFR 864.5220)
3. Predicate Device:	The HPC parameter of the IMI channel on the Sysmex® SE-9500and XE-2100 is substantially equivalent to Colony Forming Unit(CFU) and Total Nucleated Count (TNC) methods used in theUnited States prior to 1976.
4. Device Description:	The SE-9500 and XE-2100 have an immature myeloidinformation (IMI) channel, which identifies and enumeratesimmature cells in addition to the traditionally reported parametersof an automated cell differential. (Note: Specialsoftware/hardware is required to obtain results described.)
5. Intended Use:	The HPC (hematopoietic progenitor cell) parameter of the IMIChannel on the Sysmex® SE-950 and XE-2100 for in VitroDiagnostics is used as a screen for the optimal presence ofhematopoietic progenitor cells in peripheral blood and cord bloodsamples.
6. Substantialequivalence-similaritiesand differences	The following table compares the HPC parameter of the IMIChannel with predicate methods.

HPC parameter of the IMI Channel on Sysmex® SE-9500 & XE-2100, Automated Hematology Analyzers 510(k) FDA Submission

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SYSMEX CORPORATION OF AMERICA 6699 Wildlife Way Long Grove IL 60047-9596 (800) 379-7639 (847) 726-3505 Facsimile

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

	Colony FormingUnit (CFU)	TNC	Flow CytometryCD34+	HPC parameterof IMI Channel
	Predicate	Predicate	Routine	New method
Intended Use	To count the numberof progenitor cellcolonies on a growthmedium plate	To screen foroptimal presenceof progenitorcells in stem cellharvest & cordblood samples	CD34+ is asurrogate markerto screen foroptimal presenceof progenitorcells in stem cellharvest & cordblood samples	To screen foroptimal presenceof progenitorcells in stem cellharvest & cordblood
Methodology	Real counting ofprogenitor cells ongrowth mediumplates.	Total nucleatedcount fromhematologyanalyzer.	Enumeration ofCD34+ cells byflow cytometry.	Hematopoieticprogenitor cellcount fromhematologyanalyzer
Type ofAnticoagulant	Heparin	EDTA	Heparin andEDTA	EDTA
Specimen Type	Peripheral blood,apheresis product &cord blood samples	Peripheral blood,apheresis product& cord blood	Peripheral blood,apheresis product& cord blood	Peripheral blood& cord blood
Accuracy	Method of realcounting ofprogenitor cellsestablished asreference method.	Comparison toCFU showedgood correlation.	Comparison toCFU showedgood correlation.	Comparison toCFU showedgood correlation.
Time Required(per sample)for method	14 days	90 seconds	2 hours	90 seconds
Cost (persample) formethod	Approximately $300	Approx $1.35	$35-$105	Approx $1.35
Quality ofTechnicalSupport	Highly specializedlaboratory personnel;Run in duplicate.	Hematologylaboratorypersonnel.	Highlyspecialized labpersonnel; Run induplicate.	Hematologylaboratorypersonnel; Run induplicate.

Comparison Table to Predicate Methods

the HPC parameter to the predica indicated equivalent performance. The performance data demonstrated substantial 8. Conclusions: equivalence.

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HPC parameter of the IMI Channel on Sysmex® SE-9500 & XE-2100, Automated Hematology Analyzers 510(k) FDA Submission

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex Corporation of America 6699 Wildlife Way Long Grove, Illinois 60047-9596

1. 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 2 2002

K020496 Re:

Trade/Device Name: Hematopoietic Progenitor Cell (HPC) parameter of the IMI Channel on the Sysmex® SE-9500™ and XE-2100™, Automated Hematology Analyzers Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: February 13, 2002 Received: February 14, 2002

Dear Ms. Gamperling:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Hematopoietic Progenitor Cell (HPC) parameter of the IMI Channel on the Sysmex SE-9500™ and XE-2100™, Automated Hematology Analyzers

Indications For Use:

Josephine Bautz Jr.

vision of Clinical Laboratory Devices

510(k) Number K020496

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

Concurrence of CHRD, Office of Device Evaluation (ODE)

Prescription Use _/

Over-The-Counter Use

HPC parameter of the IMI Channel on Sysmex® SE-9500 & XE-2100, Automated Hematology Analyzers 510(k) FDA Submission

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.”