The body fluid application is intended for differential count of white blood cells. The system automatically locates and presents images of cells on cytocentrifuged body fluid preparations. The operator identifies and verifies the suggested classification of each cell according to type.

DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.

Device Description

The CellaVision DM96 with the body fluid application is a laboratory instrument used to perform differential analysis by locating, digitally storing and displaying cells in human body fluid preparations.

The CellaVision DM96 with the body fluid application is a new intended use that follows the same process as the currently cleared DM96 with white blood cell differential, RBC characterization and platelet estimation (K033840).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the CellaVision DM96 with the body fluid application, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative "acceptance criteria" or specific "reported device performance" metrics (like accuracy percentages, sensitivity, specificity) for the CellaVision DM96 with the body fluid application. Instead, it focuses on demonstrating substantial equivalence to existing devices and validating its performance through various tests.

However, based on the context, the implied acceptance criteria were likely:

Accuracy: The device's ability to correctly classify white blood cells in body fluid preparations when compared to manual microscopic methods.
Precision: The consistency and reproducibility of the device's cell classification.
Cell Location: The device's ability to effectively locate white blood cells for an operator to review.
Substantial Equivalence: The device performing as well as or better than the predicate devices and the manual method without raising new safety or effectiveness concerns.

Acceptance Criterion (Implied)	Reported Device Performance (Summary)
Accuracy	"Tests on cytocentrifuged body fluid preparations... were conducted and successfully completed... Tests were also conducted to validate performance including accuracy..."
Precision	"...and precision..." (from the summary of testing)
Cell Location	"...and cell-location." (from the summary of testing)
Substantial Equivalence	"Based on extensive performance testing including comparison to the predicate devices, it is the conclusion of CellaVision AB that DM96 with the body fluid application is substantially equivalent to devices already on the market..."

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

Sample Size: The text states, "Tests on cytocentrifuged body fluid preparations including specimen types such as cerebrospinal fluid, serous fluid and related fluids were conducted and successfully completed." However, the exact numerical sample size for the test set is not specified.
Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It just mentions "Tests on cytocentrifuged body fluid preparations."

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

Number of Experts: The text does not specify the number of experts used to establish ground truth or details about their involvement in the "accuracy" testing.
Qualifications of Experts: The intended use section states, "DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells." This implies that the comparison or ground truth would be based on the assessment of such "skilled operators" or experts, but their specific qualifications (e.g., years of experience, certifications) are not detailed within the provided snippets. The comparison table mentions "The examiners usually locate/count white blood cells..." which suggests manual review by trained personnel.

4. Adjudication Method for the Test Set

The text does not specify an explicit adjudication method (e.g., 2+1, 3+1). It only mentions that "the operator identifies and verifies the suggested classification of each cell according to type" which implies a human-in-the-loop review process as the final step.

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

MRMC Study: The provided text does not explicitly mention a "Multi Reader Multi Case (MRMC) comparative effectiveness study." The focus is on demonstrating substantial equivalence to manual methods rather than quantifying the improvement of human readers with AI assistance versus without AI assistance.
Effect Size: Therefore, no effect size for human reader improvement with AI assistance is reported. The device's function is to "pre-classify" cells, which are then "verified" by an operator, implying assistance rather than a direct comparison of assisted vs. unassisted reader performance metrics.

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

Standalone Performance: The core function of the CellaVision DM96 is described as "The cell images are pre-classified and the operator verifies the suggested classification by accepting or reclassifying." This clearly indicates that the device operates with a human-in-the-loop. Therefore, a standalone (algorithm only) performance study and its results are not provided or implied by this documentation, as the device is not intended for standalone use for final diagnosis. The device's regulatory pathway is likely as an aid to the human operator.

7. The Type of Ground Truth Used

The ground truth appears to be expert consensus or expert review (manual light microscopic process). The comparison table repeatedly references the "Manual light microscopic process" as the standard against which the device's functionality is compared. The device's output is also subject to "verification of results by skilled human operator."

8. The Sample Size for the Training Set

The text does not provide any information regarding the sample size used for the training set for the artificial neural networks (ANNs).

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

The text states that the device uses "deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells." However, it does not elaborate on how the ground truth for this training data was established. Based on the overall context, it would logically be established by expert morphologists/pathologists classifying cells.

Summary

{0}------------------------------------------------

Kososss

2 510(k) Summary

11 11 14 11 11 12 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Submitter:	CellaVision ABIdeon Science ParkSE-223 70 LundSweden	DEC 0 5 2008
ContactInformation:	C. G. Bundy Associates, Inc.6470 Riverview TerraceFridley, MN 55432
SubmissionDate:	February 27, 2008
Device NameandClassification:	CellaVision DM96 with the body fluid application21 CFR 864.5220 and 21 CFR 864.5260 Class II medical devices.
EquivalentDeviceIdentification:	CellaVision AB believes that DM96 with the additional body fluid application issubstantially equivalent to the DM96 for peripheral blood regarding technologyand function. The additional intended use of body fluid is substantially equivalentto the Romanowsky stain manual light microscopic process for cell classification(21CFR 864.3600 Class I exempted from pre-market notification procedure)
DeviceDescription:	The CellaVision DM96 with the body fluid application is a laboratory instrumentused to perform differential analysis by locating, digitally storing and displayingcells in human body fluid preparations.The CellaVision DM96 with the body fluid application is a new intended use thatfollows the same process as the currently cleared DM96 with white blood celldifferential, RBC characterization and platelet estimation (K033840).
Intended Use:	DM96 is an automated cell-locating device.The body fluid application is intended for differential count of white blood cells. Thesystem automatically locates and presents images of cells on cytocentrifuged bodyfluid preparations. The operator identifies and verifies the suggested classification ofeach cell according to type.

DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells

{1}------------------------------------------------

Comparison Table:

Comparative features of DM96 with Body Fluid application compared with the predicate device: A CONTINE CONTRACTOR COLLECTION CONTROL CONTINE OF CONTINE OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF

Characteristic	DM96 with Body Fluid Application	Manual light microscopic process	DM 96
Intended use	Automated cell-locating device forcell-location andidentification ofcytocentrifuged bodyfluids, for in-vitrodiagnostic use.	Manual method forcell-location andidentification of bloodsmears andcytocentrifuged bodyfluids, for in-vitrodiagnostic use.	Automated cell-locating device forcell-location andidentification of bloodsmears, for in-vitrodiagnostic use.
	Verification of resultsby skilled humanoperator.	Verification of resultsby skilled humanoperator.	Verification of resultsby skilled humanoperator.
Specimen type	Body fluids such ascerebrospinal fluid,serous fluid,bronchoalveolarlavage, and relatedfluids.	Peripheral blood andbody fluids such ascerebrospinal fluid,serous fluid,bronchoalveolarlavage, and relatedfluids.	Peripheral blood.
Samplepreparation	Body fluid samples areprepared by using acytocentrifuge andstained withRomanowsky stain.	Romanowsky stainedblood film on glassslides of peripheralblood.Body fluid samples areprepared by using acytocentrifuge andstained withRomanowsky stain.	Romanowsky stainedblood film on glassslides of peripheralblood.
Analysistechnique	White blood cells:Cells arelocated/counted bymoving according tothe battlement trackpattern. Cell imagesare analyzed usingstandard mathematicalmethods, including	White blood cells:The examiners usuallylocate/count whiteblood cells by movingaccording to thebattlement trackpattern on the smearand distinguishbetween classes of	White blood cells:Cells arelocated/counted bymoving according tothe battlement trackpattern. Cell imagesare analyzed usingstandard mathematicalmethods, including
Characteristic	DM96 with Body Fluid Application	Manual light microscopic process	DM 96
	deterministic artificial neural networks(ANN's) trained to distinguish between classes of white blood cells.The cell images are pre-classified and the operator verifies the suggested classification by accepting or reclassifying.	white blood cells.	deterministic artificial neural networks(ANN's) trained to distinguish between classes of white blood cells.The cell images are pre-classified and the operator verifies the suggested classification by accepting or reclassifying.
Overview image	The device presents an overview image. The image gives the operator possibilities to get an overview on parts of or the whole slide in different magnifications.	The operator scans the slide to get an overview on parts of or the whole slide in different magnifications.	The device presents an overview image of a part of the slide. The image gives the operator possibilities to get an overview of the part in different magnifications.

{2}------------------------------------------------

Summary of Testing:

The CellaVision DM96 was cleared by the FDA in 2004. The intended use has been modified to include presentation of white blood cells on cytocentrifuged body fluid preparations.

Tests on cytocentrifuged body fluid preparations including specimen types such as cerebrospinal fluid, serous fluid and related fluids were conducted and successfully completed.

Tests were also conducted to validate performance including accuracy, precision and celllocation.

{3}------------------------------------------------

Conclusion:

Based on extensive performance testing including comparison to the predicate devices, it is the conclusion of CellaVision AB that DM96 with the body fluid application is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal features the department's logo, which is a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular pattern around the logo.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

CELLAVISION AB c/o Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, Minnesota 55432 ATTN: Constance G. Bundy

Re: K080595

Trade/Device Name: CELLAVISION DM96 with the Body Fluid Application Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ, JOY Dated: November 17, 2008 Received: November 21, 2008

DEC 0 5 2008

Dear Ms. Bundy:

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

{5}------------------------------------------------

Page 2 - Ms. Bundy

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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html.

Sincerely yours,

ia m chan

Maria M. Chan. Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

K080595 510(k) Number (if known):

Device Name: CellaVision DM96 with the body fluid application

Indications For Use:

DM96 is an automated cell-locating device.

DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.

Prescription Use
(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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080595

Page 1 of 1

Regulation Number and Section

§ 864.5260 Automated cell-locating device.

(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).