The BD FACSCanto System with BD FACSDiva software is intended for use as an In Vitro Diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse wash sample preparation method for flow cytometry.

Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse wash sample preparation method.
Immunophenotyping of lymphocyte subsets including CD3CD8, CD3 CD4, CD3 CD16* and/or CD56*, CD3 -CD19*, and CD3*.

Device Description

The BD FACSCanto System with BD FACSDiva software is comprised of a flow cytometer, a wet cart, and a computer. The wet 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 sub-systems; fluidics, optics and electronics. It contains one software package for manual immunophenotyping and is compatible with the BD FACSLoader for automatic sample introduction.

AI/ML Overview

Here's an analysis of the provided text regarding the BD FACSCanto System with BD FACSDiva software, focusing on the requested acceptance criteria and study information:

The provided document is a 510(k) summary for the BD FACSCanto System with BD FACSDiva software. It's important to note that a 510(k) submission generally aims to demonstrate substantial equivalence to a predicate device, rather than proving that a device meets specific, pre-defined acceptance criteria in the same way a novel device might with a comprehensive clinical trial. The performance data presented here are primarily to support this claim of substantial equivalence.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each performance metric in the way a clinical study protocol might. Instead, it refers to industry guidelines and a comparative assessment against a predicate device. The "acceptance criteria" are implied by the statement that the new device "demonstrated comparable accuracy relative to the predicate" or "demonstrated acceptable system precision/carryover/linearity."

Performance Metric	Implied Acceptance Criteria (from document)	Reported Device Performance (BD FACSCanto)
Accuracy	Comparable to the predicate device (BD FACSCalibur), as assessed based on NCCLS document EP9-A2.	The BD FACSCanto demonstrated comparable accuracy relative to the predicate.
Precision	Acceptable system precision, as assessed based on NCCLS document EP5-A.	The BD FACSCanto demonstrated acceptable system precision.
Carryover	Acceptable system carryover, as assessed based on "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters..." (December 4, 2001).	The BD FACSCanto demonstrated acceptable system carryover.
Linearity	Acceptable system linearity, as assessed based on "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters..." (December 4, 2001).	The BD FACSCanto demonstrated acceptable system linearity.

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

Sample Size: The document does not specify the sample size used for any of the performance studies (Accuracy, Precision, Carryover, Linearity).
Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. The studies are cited as being based on NCCLS (now CLSI) documents, which are general guidelines for laboratory methods, not specific to a data set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts or the establishment of a ground truth through expert review for any of the performance studies. These types of studies (accuracy, precision, carryover, linearity for a flow cytometer) typically rely on quantitative measurements against known standards or reference methods rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable, as no expert review or adjudication process is mentioned or implied by the type of studies conducted.

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

No, an MRMC comparative effectiveness study was not done. The studies listed are technical performance evaluations (accuracy, precision, carryover, linearity) of the instrument itself, not studies involving human readers or AI assistance. The document is for a flow cytometer system, not an image interpretation or diagnostic AI device in the context of human readers.

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

This question is not directly applicable in the context of this device. The BD FACSCanto System with BD FACSDiva software is an automated differential cell counter (flow cytometer) that generates quantitative data. While it contains software ("algorithm"), its performance is evaluated in terms of instrument accuracy, precision, linearity, and carryover, rather than a standalone diagnostic "algorithm" that interprets images or makes diagnoses without human interaction in the clinical workflow. Its function is to count and identify cells, which is then used by a human operator for diagnostic purposes.

7. The Type of Ground Truth Used

For the studies mentioned:

Accuracy: Implied ground truth would be a reference method or predicate device performance, adhering to NCCLS guidance.
Precision, Carryover, Linearity: Implied ground truth would be quantitative measurements against internal controls, reference materials, or known dilutions, assessed according to NCCLS and FDA guidance documents for these specific performance characteristics of an automated counter. The device's output (cell counts, percentages) is compared against expected values or its own repeatability/reproducibility.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is a 510(k) submission for a medical device (flow cytometer system) with associated software, not a machine learning model that typically goes through a distinct training phase on a data set. The software likely contains algorithms and predefined parameters, but these are developed through engineering and design processes, not typically "trained" on a large dataset in the way a modern AI model would be before its performance is evaluated.

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

Not applicable, as no training set (in the context of machine learning) is mentioned or implied. The functional specifications and performance characteristics are likely established through engineering specifications and validation against reference methods during device development.

Summary

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Attachment D 510(k) Summary

BD FACSCanto System with BD FACSDiva software 510(k) Summary

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 K040725.

Submitter Information (21 CFR 807.92(a)(1))

Becton Dickinson Immunocytometry Systems Submitter: 2350 Qume Drive San Jose, CA 95131

Contact: Kim Fonda Sr. Regulatory Affairs Specialist (408) 954-2329 (408) 954-2495 (FAX) kim fonda(@)bd.com
March 19, 2004 Summary date:

Device Name and Classification (21 CFR 807.92(a)(2))

BD FACSCanto™ System with BD FACSDiva™ software Name: Classification: Class II (21 CFR 864.5220), Automated differential cell counter

Substantially Equivalent / Predicate Device (21 CFR 807.92(a)(3))

The BD FACSCanto System with BD FACSDiva software is substantially equivalent to the BD FACSCalibur™ with 4-color option for immunophenotyping using SimulTEST reagents and associated software. FACSCalibur 4-color instrument was cleared with FACSComp Software and CaliBRITE Beads by the Center for Devices and Radiological Health, under K973483 on 2/17/98. The BD FACSCanto System with BD FACSDiva software and BD FACSCalibur have similar intended uses, measure the same sample types and have similar performance characteristics.

Device Description (21 CFR 807.92(a)(4))

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manual immunophenotyping and is compatible with the BD FACSLoader for automatic sample introduction.

Intended Use (21 CFR 807.92(a)(5))

Technological Characteristics (21 CFR 807.92(a)(6))

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

Characteristic	FACSCalibur System(predicate)	BD FACSCanto System withBD FACSDiva software(new family member)
Intended Use	For identification and enumerationof leucocyte subsets in human cells insuspension	For identification andenumeration of lymphocytesubsets in human cells insuspension using a lyse washsample preparation method forflow cytometry.
Deviceclassification andproduct code	Automated Differential Cell Counter21 CFR 864.5220Product Code: GKZ	Same
Lasers	Blue—488 nm argon ionRed—635 nm diode laser	488 nm solid state633 nm HeNe
Detectors	1 FSC photodiode1 SSC photomultiplier tube (PMT)4 fluorescence detector PMTs	Same FSCSame SSCSame 4 plus 2 additionalfluorescence detector PMTs
Optics	FACSCalibur flow cell	Same
	Laser light delivered by mirrors, prismsand lensesEmitted light delivered by mirrors	Laser light delivered by fiberoptics, prisms and lasersEmitted light delivered bycollection and fiber optics
Electronics	Analog	Digital
Automated sampleintroduction	FACS Loader:K953302, 11/20/95	Same

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Characteristic	FACSCalibur System(predicate)	BD FACSCanto System withBD FACSDiva software(new family member)
Computer platform	Macintosh	PC

Performance Data (21 CFR 807.92(b)(1)and (2))

Study	Study Design	Results
Accuracy	Based on NCCLS document EP9-A2.(September 2002)	The BD FACSCanto demonstratedcomparable accuracy relative to thepredicate.
Precision	Based on NCCLS document EP5-A.(February 1999)	The BD FACSCanto demonstratedacceptable system precision.
Carryover	Based on recommendations contained in"Class II Special Controls GuidanceDocument: Premarket Notifications forAutomated Differential Cell Counters forImmature or Abnormal Blood Cells; FinalGuidance for Industry and FDA."(December 4, 2001)	The BD FACSCanto demonstratedacceptable system carryover.
Linearity	Based on recommendations contained in"Class II Special Controls GuidanceDocument: Premarket Notifications forAutomated Differential Cell Counters forImmature or Abnormal Blood Cells; FinalGuidance for Industry and FDA."(December 4, 2001)	The BD FACSCanto demonstratedacceptable system linearity.

Conclusions from Performance Data (21 CFR 807.92(b)(3))

The BD FACSCanto System with BD FACSDiva software demonstrates substantial equivalence

to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kim Fonda Sr. Regulatory Affairs Specialist Becton Dickinson Immunocytometry Systems 2350 Qume Drive

SEP 1 0 2004

San Jose, CA 95131

SEP 10 2004

K040725 Re: Trade/Device Name: BD FACSCanto System with BD FACSDiva software Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 4, 2004 Received: August 6, 2004

Dear Ms. Fonda

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 r ou mayy attols 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. 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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Attachment G Indications for Use Statement

Indications for Use

510(k) Number: K040725

Device Name: BD FACSCanto System with BD FACSDiva software

Indications for Use:

. Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse wash sample preparation method.
. Immunophenotyping of lymphocyte subsets including CD3CD8, CD3 CD4, CD3 CD16* and/or CD56*, CD3 -CD19*, and CD3*.

Clinical Significance:

I For In Vitro Diagnostic Use.
Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use -AND/OR (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040725

Becton Dickinson Immunocytometry Systems 510(k) Notification BD FACSCanto System 3/19/04 Replacement Page 9/7/04

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.”