Immunophenotyping in clinical laboratories, using previously cleared in vitro . diagnostic assays for flow cytometry.
Identification and enumeration of lymphocyte subsets in human cells in . suspension.
For in vitro diagnostic use. .
For use with or without the BD FACS Sample Prep Assistant II. .

Device Description

The BD FACSCanto II system is comprised of a flow cytometer, a fluidics cart, and a computer workstation. The fluidics cart contains operational fluids, the flow cytometer acquires and analyzes the sample, and the computer displays and prints the analysis. The flow cytometer utilizes three subsystems: fluidics, optics, and electronics. The computer workstation runs two software packages: BD FACSCanto clinical software for automatic immunophenotyping of assays prepared using the lyse/no-wash method, and BD FACSDiva software for manual immunophenotyping of assays prepared using the lyse/wash method.

The BD FACSCanto II system can optionally be used with the BD FACS Loader for automatic sample introduction, a standalone barcode reader for data input into BD FACSCanto clinical software, and with the BD FACS Sample Prep Assistant II for automatic sample preparation of assays utilizing the lyse/no-wash method.

The BD FACSCanto II system is a modification of the BD FACSCanto system, bearing the same intended use, indications for use, and operating principle as its predicate device. Modifications have been made to the fluidics, optics, and electronics subsystems. Changes were also made to the sample introduction system, the BD FACS Loader option, and to the two software applications. These changes have been made to enhance the system's usability.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the performance studies. Instead, it indicates whether the device met the criteria by stating "acceptable" or "comparable accuracy." The performance is evaluated relative to a predicate device or established CLSI guidelines.

Study	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison	Comparable accuracy to predicate device (CLSI EP9-A2)	Demonstrated comparable accuracy relative to the predicate
Precision	Acceptable precision (CLSI EP5-A2)	Demonstrated acceptable precision
Linearity	Acceptable linearity (CLSI EP6-A)	Demonstrated acceptable linearity
% Agreement	Acceptable % agreement (CLSI EP12-A)	Demonstrated acceptable % agreement
Reproducibility	Acceptable reproducibility	Demonstrated acceptable reproducibility
Carryover	Acceptable carryover (FDA Special Controls Guidance, Dec 4, 2001)	Demonstrated acceptable carryover

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

The document does not specify the exact sample sizes used for the test sets in any of the performance studies (Method Comparison, Precision, Linearity, % Agreement, Reproducibility, Carryover).

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, the studies refer to CLSI (Clinical and Laboratory Standards Institute) documents, which are international standards, implying a robust design. The mention of "patient samples" in the Method Comparison study suggests the use of clinical specimens.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in any of the performance studies. It describes various study designs (e.g., "multiple operators" for reproducibility), but not how a definitive "ground truth" was established for each measurement.

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned in the provided text, nor is there any information about the effect size of human readers improving with or without AI assistance. The device is an automated differential cell counter, which implies it performs the analysis rather than assisting human readers in interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, the performance studies described (Method Comparison, Precision, Linearity, % Agreement, Reproducibility, Carryover) represent standalone performance of the BD FACSCanto II system. The system is designed for "automatic immunophenotyping" and "identification and enumeration of lymphocyte subsets," indicating an algorithm-only workflow for these specific functions.

7. The Type of Ground Truth Used

The concept of "ground truth" in this context refers to the reference method or established standard against which the device's performance is compared.

Method Comparison: The predicate device (BD FACSCanto system) is implicitly the "ground truth" or reference method for comparison.
Precision, Linearity, % Agreement, Reproducibility, Carryover: For these studies, the "ground truth" is typically defined by the established and validated methods and controls as outlined in the referenced CLSI documents and FDA guidance. This would involve highly accurate and precise reference measurements or accepted ranges for the parameters being tested. For example, in linearity, the "truth" for different concentrations would be prepared reference materials.

8. The Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This is a 510(k) summary for a modified device, primarily focused on demonstrating substantial equivalence to a predicate. The device performs automated functions based on established flow cytometry principles and likely relies on pre-defined algorithms rather than a dynamically trained AI model in the modern sense.

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

As no training set is described or implied to exist in the context of a modern machine learning model, the document does not discuss how ground truth for a training set was established. The device utilizes fixed algorithms for immunophenotyping.

Summary

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510(k) Summary

SEP 1 4 2006

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is _ KO 62087

Submitter Information

Submitter:	BD Biosciences2350 Qume DriveSan Jose, CA 9513
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Contact: Carter Navarro Regulatory Affairs Specialist Tel .: (408) 954-2469 Fax: (408) 954-2495 carter navarro@bd.com
Summary Date: July 20, 2006

Device Name / Classification

Name: BD FACSCanto II system Class II (21 CFR 864.5220) – Automated differential cell counter Classification:

Substantially Equivalent / Predicate Device

The BD FACSCanto II system is substantially equivalent to the BD FACSCanto system with BD FACSCanto clinical software and BD FACSDiva software (premarket notifications K041074 and K040725).

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Device Description

Intended Use

The BD FACSCanto II system is intended for use as an in vitro diagnostic device for the identification and enumeration of lymphocyte subsets in human cells in suspension.

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Technological Characteristics

The following summary table describes the similarities and differences between the BD FACSCanto II system and the BD FACSCanto system.

Characteristic	BD FACSCanto system(predicate)	BD FACSCanto II system(new family member)
Intended use	In vitro diagnostic device foridentification and enumeration oflymphocyte subsets in human cellsin suspension using the lyse/washand lyse/no-wash samplepreparation methods for flowcytometry.	Same.
Device classification andproduct code	Automated Differential CellCounter21 CFR 864.5220Product Code: GKZ	Same.
Lasers	Red - 488-nm argon ionBlue - 635-nm diode	Same.
Optics	Laser light delivered by fiber opticsand prisms.Emitted light delivered bycollection and fiber optics.	Same.
Electronics	Multiple electronics boardscontaining acquisition electronicscomponents.	One consolidated acquisitionelectronics board.
Maximum parameterdetection	Eight(FSC, SSC, and six fluorophores).	Same.
Software	BD FACSCanto clinical softwarev.1.0 or higher andBD FACSDiva software v.4.0 orhigher.	BD FACSCanto clinical softwarev.2.1 or higher andBD FACSDiva software v.5.0.1 orhigher.
Instrument setup andquality control	Automated setup using BDFACSCanto clinical software andBD FACS 7-color setup beads.	Same.
Sample introduction	Manual, or automated with theoptional BD FACS Loader.	Same.
Sample preparation	Manual pipetting for the lyse/washor lyse/no-wash methods, orautomated with the BD FACSSample Prep Assistant II for thelyse/no-wash method.	Same.
Characteristic	BD FACSCanto system(predicate)	BD FACSCanto II system(new family member)
Sample type	Whole blood.	Same.
Accessories	Optional standalone barcode reader.	Same.

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Performance Data

Study	Study Design	Results
MethodComparison	Based on Method Comparison and BiasEstimation Using Patient Samples, CLSIdocument EP9-A2.	The BD FACSCanto II systemdemonstrated comparable accuracyrelative to the predicate whenrunning the BD Multitest IMK kitand BD Multitest 6-color TBNKassays.
Precision	Based on Evaluation of PrecisionPerformance of Clinical Chemistry Devices,CLSI document EP5-A2.	The BD FACSCanto II systemdemonstrated acceptable precisionwhen running the BD Multitest IMKkit and BD Multitest 6-color TBNKassays.
Linearity	Based on Evaluation of the Linearity ofQuantitative Measurement Approaches: AStatistical Approach, CLSI documentEP6-A.	The BD FACSCanto II systemdemonstrated acceptable linearitywhen running the BD Multitest IMKkit and BD Multitest 6-color TBNKassays.
% Agreement	Based on User Protocol for Evaluation ofQualitative Test Performance, CLSI EP12- A.	The BD FACSCanto II systemdemonstrated acceptable %agreement when running the BDHLA-B27 assay.
Reproducibility	Pairs (positive & negative) of specimens weretested in duplicate by multiple operators,twice daily for multiple operating days acrossdifferent instruments.	The BD FACSCanto II systemdemonstrated acceptablereproducibility when running the BDHLA-B27 assay.
Carryover	Based on recommendations contained in ClassII Special Controls Guidance Document:Premarket Notifications for Immature orAbnormal Blood Cells; Final Guidance forIndustry and FDA, December 4, 2001.	The BD FACSCanto II systemdemonstrated acceptable carryover.

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Conclusions from Performance Data

. . . . .

The BD FACSCanto II system demonstrates substantial equivalence to the predicate device.

100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP I 4 2006

BD Biosciences Immunocytometry Systems 2350 Oume Dr. San Jose, CA 95131 ATTN: Carter Navarro

Re: K062087

Trade/Device Name: BD FACSCanto II flow cytometer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: July 20, 2006 Received: July 24, 2006

Dear Mr. Navarro:

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

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Page 2 –

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 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 (240) 276-0484. 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Rockey

Robert L. Becker, Jr., MD, Phe 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: K062087
(if known)

Device Name: BD FACSCanto II System

Indications for Use:

Immunophenotyping in clinical laboratories, using previously cleared in vitro . diagnostic assays for flow cytometry.
Identification and enumeration of lymphocyte subsets in human cells in . suspension.
For in vitro diagnostic use. .
For use with or without the BD FACS Sample Prep Assistant II. .

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE OF NEEDED

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K062087
al 510(k) Device Modification Notification

BD Biosciences Special 510(k) Device Modification Notifica
BD FACSCanto II System
07/20/2006

Page 1 of

Section Page 6 of 19

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.”