The FlowCare System is an automated immune hematology system intended for in vitro diagnostic use in the direct enumeration of White Blood Cell populations and certain T-lymphocyte subsets from human whole blood.

Whole blood samples can be analyzed with the FlowCare™ System for the following parameters:

White Blood Cell Count .
Lymphocyte Percentage (of White Blood Cells)
. Lymphocyte Number
CD4 T-Lymphocyte Count .
CD4 Percentage (of total Lymphocytes) .

The FlowCare System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.

Device Description

The FlowCare System is a compact benchtop immune hematology system that reports CD4 T-Lymphocyte count and percentage in conjunction with White Blood Cell (WBC) count, and total Lymphocyte count and percentage from analysis of a whole blood sample. The FlowCare System is comprised of an analysis instrument, a touch screen computer and a standard inkjet printer. The FlowCare CD4 Reagent Kit is used in conjunction with the FlowCare System.

All assay steps are performed on whole blood with capped bar-coded reagent tubes designed for use on the FlowCare System. All assay aspiration, dispensing and mixing steps are automated. The FlowCare System reports parameter results on the basis of software analysis of light scatter measurements with the use of nonfluorescent reagents. Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FlowCare™ System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the performance of the FlowCare™ System in various studies but does not explicitly state quantitative acceptance criteria or thresholds for metrics like accuracy, sensitivity, or specificity. Instead, it uses qualitative statements about the results. Therefore, the table below reflects the qualitative findings as reported.

Acceptance Criterion (Implicit)	Reported Device Performance
Electrical Safety	Found to be in compliance with applicable requirements of UL 61010A-1, CSA C22.2 1010-1, EN 61326-1, and EN 55011 (CISPR 11).
Precision (Within-run & Total)	Acceptable precision demonstrated by replicate measurements of control materials for three days and within-day precision using whole blood samples.
Linearity	Linearity was demonstrated for all measured parameters (including CD4 count in the low range) over a wide range of cell concentrations.
Carryover	Negligible carryover was observed.
Clinical Performance (Comparison to Reference Methods)	Analyses of pooled data showed comparable means and ranges for the FlowCare™ and reference method parameters. (Specific metrics like correlation coefficients, bias, or agreement rates are not provided in this summary.)
Establishment of Normal Values Reference Range	An expected normal values reference range for the FlowCare™ method was determined.

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

Sample Size for Test Set: A total of 414 evaluable samples were analyzed in the multi-site prospective clinical study.
Data Provenance: The study was a prospective study conducted at four investigational sites. The country of origin of the data is not explicitly stated, but given the FDA review and the sponsor's location (Ashland, MA), it is highly likely that the data originated from the United States.

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

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. It states that "analyses were performed for comparison of the FlowCare method to the reference methods," implying that the reference methods provided the ground truth.

4. Adjudication Method:

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The clinical study compares the FlowCare™ System's performance to "other commercially available methods" (reference methods), not the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance study was done. The FlowCare™ System is described as an "automated immune hematology system" where "automated cell population cluster analysis is performed by the software and results provided with no operator interpretation." This indicates that the device operates as an algorithm-only (standalone) system without direct human intervention in the interpretation of results for the listed parameters. The clinical testing evaluates this standalone performance against reference methods.

7. Type of Ground Truth Used:

The ground truth used for the clinical study was based on "other commercially available methods" (reference methods). These reference methods would likely be established and validated laboratory tests (e.g., flow cytometry or hematology analyzers) that are considered the standard for measuring White Blood Cell populations and T-lymphocyte subsets.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set. It only describes the performance and clinical validation studies. As it is a 510(k) summary, specific details about the internal algorithm development and training data are typically not included.

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

The document does not provide information on how the ground truth for the training set was established. This detail would typically be part of the algorithm development process, which is not described in this 510(k) summary.

Summary

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K041882

510(k) Summary for FlowCare™ System

1. SPONSOR

PointCare Technologies, Inc. 200 Homer Avenue M100 Ashland, MA 01721

Contact Person: Dwight Kirkpatrick, Ph.D., Director of Product Development Telephone: 508-881-7303

Date Prepared: July 8, 2004

2. DEVICE NAME

Proprietary Name:	FlowCare™ System
Common/Usual Name:	Automated Immune Hematology System
Classification Name:	Automated Differential Cell Counter

3. PREDICATE DEVICES

Coulter® Gen-S Hematology Analyzer . Beckman Coulter, Inc. K962988
. Coulter® LH750 Hematology Analyzer Beckman Coulter, Inc. K032342 and K011342
Coulter® tetraONE™ System for EPICS XL Flow Cytometry Systems . Beckman Coulter, Inc. K990172

4. DEVICE DESCRIPTION

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a touch screen computer and a standard inkjet printer. The FlowCare CD4 Reagent Kit is used in conjunction with the FlowCare System.

ડ. INTENDED USE

Whole blood samples can be analyzed with the FlowCare System for the following parameters:

. White Blood Cell Count
. Lymphocyte Percentage (of White Blood Cells)
. Lymphocyte Number
� CD4 T-Lymphocyte Count
. CD4 Percentage (of total Lymphocytes)

The FlowCare System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The FlowCare System reports CD4 T-Lymphocyte counts and percentage in conjunction with White Blood Cell (WBC) count and total Lymphocyte count information, on the basis of software analysis of light scatter measurements with the use of non-fluorescent reagents. The FlowCare System and predicate devices are all intended for the determination of well-established parameters. All of the devices utilize anticoagulated whole blood as the initial specimen. Additionally, all of the devices employ flow-based technologies. The primary difference between the FlowCare System and the predicate devices is that the FlowCare System includes a single compact instrument whereas the predicate hematology analyzer and flow

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cytometer are larger, more complex systems that must be used in conjunction with each other to provide results for the five parameters included in this 510(k) Premarket Notification.

7. PERFORMANCE TESTING

Electrical Testing

The FlowCare Instrument underwent electrical safety testing and electromagnetic compatibility testing. The instrument was found to be in compliance with applicable requirements of UL 61010A-1, CSA C22.2 1010-1, EN 61326-1 and EN 55011 (CISPR 11).

Nonclinical Testing

A precision study was performed to assess the within-run and total precision of the FlowCare System by replicate measurements of control materials for three days. On cach day, testing consisted of three separate runs of three replicates each with each level of control material. In addition, another precision study was performed to assess within-day precision using whole blood samples. The samples were analyzed in three separate runs of three replicates each over the course of one day. Results of these studies demonstrated acceptable precision of the FlowCare System.

A linearity study was performed to assess the performance of the FlowCare System over a wide range of cell concentrations for the measured parameters. CD4 count was further evaluated in the low range. The results were tested for linearity and least squares regression analysis was performed. Linearity was demonstrated in all cases.

A carryover study was performed to assess the effect of a whole blood sample on background counts in subsequent analyses for the measured parameters. Negligible carryover was observed.

Clinical Testing

A multi-site prospective study was conducted at four investigational sites to evaluate the performance of the FlowCare System with other commercially available methods. A total of 414 evaluable samples were analyzed across all participating sites. Data analyses were performed for comparison of the FlowCare method to the reference methods, and for the determination of an expected normal values reference range for the FlowCare method. The analyses of the pooled data showed comparable means and ranges for the FlowCare and reference method parameters,

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. The image is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

PointCare Technologies, Inc. c/o Ms. Cynthia A. Sinclair, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

NOV 2 3 2004

Re: K041882

Trade/Device Name: PointCare Technologies, Inc., FlowCare™ System Regulation Number: 21 CFR & 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: October 18, 2004 Received: October 20, 2004

Dear Ms. Sinclair:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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Page 2

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K041882

Device Name: FlowCareTM System

Indications for Use:

The FlowCare System is an automated immune hematology system intended for in vitro diagnostic use in the direct enumeration of White Blood Cell populations and certain Tlymphocyte subsets from human whole blood.

Whole blood samples can be analyzed with the FlowCare™ System for the following parameters:

White Blood Cell Count .
Lymphocyte Percentage (of White Blood Cells)
. Lymphocyte Number
CD4 T-Lymphocyte Count .
CD4 Percentage (of total Lymphocytes) .

The FlowCare System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Muschin-Buttisti
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

51" K041882

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.”