(144 days)
The BD FACSCanto System with BD FACSCanto software is intended for use as an In Vitro Diagnostic device for identification and cnumeration of lymphocyte subsets in human cells in suspension using a lyse no-wash sample preparation method for flow cytometry.
Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse no-wash sample preparation method.
Immunophenotyping of lymphocyte subsets including CD3CD8, . CD3CD4, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*
The BD FACSCanto System with BD FACSCanto software is comprised of a flow cytometer, a fluidics cart, and a computer. 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 sub-systems; fluidics, optics and electronics. It contains two software packages, one for manual immunophenotyping and one for automatic immunophenotyping, and is compatible with the BD FACS Loader for automatic sample introduction.
The provided text describes the BD FACSCanto System with BD FACSCanto software, an automated differential cell counter. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study | Acceptance Criteria (Implicit from "equivalent/acceptable") | Reported Device Performance |
|---|---|---|
| Accuracy | Comparable accuracy to the predicate device | The BD FACSCanto with BD FACSCanto software demonstrated comparable accuracy relative to the predicate. |
| Precision | Acceptable system precision | The BD FACSCanto with BD FACSCanto software demonstrated acceptable system precision. |
| Linearity | Acceptable system linearity | The BD FACSCanto with BD FACSCanto software demonstrated acceptable system linearity. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the accuracy, precision, and linearity studies (test sets). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the studies). It only refers to NCCLS documents for the study designs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the test set. Given the nature of the device (automated cell counter), ground truth for performance studies typically involves comparison to a gold standard method or highly calibrated reference instruments, rather than direct expert consensus on images.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method 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 explicitly mentioned or described. The performance studies focus on the device's accuracy, precision, and linearity as a standalone automated system, not on its assistance to human readers.
6. Standalone Performance (Algorithm only without human-in-the-loop performance):
Yes, the performance studies described (accuracy, precision, linearity) represent standalone performance of the BD FACSCanto System. The device is an "Automated differential cell counter," implying its function is to perform cell counting and immunophenotyping automatically without direct human intervention in the primary measurement.
7. Type of Ground Truth Used:
The document refers to NCCLS (National Committee for Clinical Laboratory Standards) documents (now CLSI - Clinical and Laboratory Standards Institute) for study design. For an automated differential cell counter, ground truth for accuracy, precision, and linearity is typically established by:
- Reference Methods: Comparing the device's results to a recognized gold standard method or another highly accurate and precise instrument.
- Certified Reference Materials: Using materials with known and verified concentrations or characteristics.
- Inter-laboratory Concordance: Comparing results across multiple well-controlled laboratories or instruments.
The document states the device "demonstrated comparable accuracy relative to the predicate," suggesting the predicate device or its established performance served as a form of ground truth or benchmark.
8. Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. This type of device (flow cytometer with software for immunophenotyping) often relies on established algorithms and calibration rather than a machine learning "training set" in the modern sense. If there were any learning components, they are not detailed here.
9. How the Ground Truth for the Training Set Was Established:
Since no training set information is provided, there is no description of how ground truth was established for it.
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Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a stacked formation. The profiles are black against a white background. The text "HEALTH & HL" and "SERVICES - USA" are arranged around the logo.
1 2004 OCT
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kim Fonda Senior Regulatory Affairs Specialist Becton Dickinson Immunocytometry Systems 2350 Qume Drive San Jose, California 95131
K041074 Trade/Device Name: BD FACSCanto System with BD FACSCanto software Regulation Number: 21 CFR & 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 11, 2004 Received: August 13, 2004
Dear Ms. Fonda:
Re:
This letter corrects our signed letter of September 17, 2004, regarding the typo to the device name. 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 (OS) 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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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, h
Robert L. Becker, Jr., M.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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Attachment D 510(k) Summary
BD FACSCanto with BD FACSCanto 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 K041074.
Submitter Information (21 CFR 807.92(a)(1))
| Submitter: | Becton Dickinson Immunocytometry Systems |
|---|---|
| 2350 Qume Drive | |
| San Jose, CA 95131 |
- Kim Fonda Contact: Sr. Regulatory Affairs Specialist 、 (408) 954-2329 (408) 954-2495 (FAX) kim_fonda@bd.com
Summary date: April 22, 2004
Device Name and Classification (21 CFR 807.92(a)(2))
BD FACSCanto™ System with BD FACSCanto 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 FACSCanto software is substantially equivalent to the BD FACSCalibur™ with 4-color option for immunophenotyping using BD Multitest reagents and BD Multiset software. The BD 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 with BD FACSCanto 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))
The BD FACSCanto System with BD FACSCanto software is comprised of a flow cytometer, a fluidics cart, and a computer. The fluidics cart contains operational fluids, the
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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 two software packages, one for manual immunophenotyping and one for automatic immunophenotyping, and is compatible with the BD FACS Loader for automatic sample introduction.
Intended Use (21 CFR 807.92(a)(5))
The BD FACSCanto System with BD FACSCanto software is intended for use as an In Vitro Diagnostic device for identification and cnumeration of lymphocyte subsets in human cells in suspension using a lyse no-wash sample preparation method for flow cytometry.
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(new family member) |
|---|---|---|
| Intended Use | For identification and enumeration ofleucocyte subsets in human cells insuspension | For identification andenumeration of lymphocytesubsets in human cells insuspension using a lyse no-wash sample preparationmethod for flow cytometry |
| Deviceclassification andproduct code | Automated Differential Cell Counter, 21CFR 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 cellLaser light delivered by mirrors, prismsand lensesEmitted light delivered by mirrors | SameLaser light delivered by fiberoptics, prisms and lasersEmitted light delivered bycollection and fiber optics |
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:
| Characteristic | FACSCalibur System(predicate) | BD FACSCanto System(new family member) |
|---|---|---|
| Electronics | Analog | Digital |
| Automated sampleintroduction | FACS Loader:K95330211/20/95 | Same |
| 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 with BD FACSCantosoftware demonstrated comparableaccuracy relative to the predicate. |
| Precision | Based on NCCLS document, EP5-A.(February 1999) | The BD FACSCanto with BD FACSCantosoftware demonstrated acceptable systemprecision. |
| Linearity | Based on NCCLS document, EP6-A.(April 2003) | The BD FACSCanto with BD FACSCantosoftware demonstrated acceptable systemlinearity. |
Conclusions from Performance Data (21 CFR 807.92(b)(3))
The BD FACSCanto System demonstrates substantial equivalence to the predicate device.
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Attachment G Indications for Use Statement
Indications for Use
510(k) Number: K041074
Device Name: BD FACSCanto System with BD FACSCanto software
Indications for Use:
- s Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse no-wash sample preparation method.
- Immunophenotyping of lymphocyte subsets including CD3CD8, . CD3CD4, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*
Clinical Significance:
- For In Vitro Diagnostic Use. i
X Prescription Use (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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Diagnostic DeviceOffice of In Vitro Diagnostic Device Office tion and Safety
510(k) K041074
Becton Dickinson Immunocytometry Systems 510(k) Notification BD FACSCanto System with BD FACSCanto software 4/22/04 Replacement Page 9/7/04
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§ 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.”