CELLAVISION DM96 WITH THE BODY FLUID APPLICATION

K080595 · CellaVision AB · JOY · Dec 5, 2008 · Hematology

Device Facts

• Record ID: K080595
• Device Name: CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
• Applicant: CellaVision AB
• Product Code: JOY · Hematology
• Decision Date: Dec 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5260
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Differential count of white blood cells in body fluids	Not specified	Not specified	Not specified	Tests on cytocentrifuged body fluid preparations including specimen types such as cerebrospinal fluid, serous fluid and related fluids.

Intended Use

DM96 is an automated cell-locating device. 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 Story

Laboratory instrument for automated differential analysis of human body fluid preparations; inputs include cytocentrifuged, Romanowsky-stained body fluid slides. Device uses automated cell-locating technology and deterministic artificial neural networks (ANNs) to identify and pre-classify white blood cells; presents cell images to operator for verification. Operated by skilled laboratory personnel; output consists of digital cell images and suggested classifications. Operator reviews, accepts, or reclassifies cells to finalize results. Enhances efficiency of manual microscopic differential counts; provides standardized cell presentation and classification assistance.

Clinical Evidence

Bench testing only. Performance validation conducted on cytocentrifuged body fluid preparations, including cerebrospinal fluid, serous fluid, and bronchoalveolar lavage. Testing evaluated accuracy, precision, and cell-location capabilities compared to manual light microscopic methods.

Technological Characteristics

System includes slide feeder, microscope, camera, and computer workstation. Uses standard Romanowsky-stained cytocentrifuged slides. Employs automated image acquisition and mathematical cell classification algorithms. Connectivity includes network access for Remote Review Stations. Software performs self-tests and hardware/software verification.

Indications for Use

Indicated for differential white blood cell counting in cytocentrifuged body fluid preparations (e.g., cerebrospinal, serous, bronchoalveolar lavage). Intended for use by trained, skilled operators in a laboratory setting.

Regulatory Classification

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.)

Predicate Devices

• CellaVision DM96 (K033840)

Submission Summary (Full Text)

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Kososss

#### 2 510(k) Summary

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| Submitter: | CellaVision AB<br>Ideon Science Park<br>SE-223 70 Lund<br>Sweden | DEC 0 5 2008 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact<br>Information: | C. G. Bundy Associates, Inc.<br>6470 Riverview Terrace<br>Fridley, MN 55432 | |
| Submission<br>Date: | February 27, 2008 | |
| Device Name<br>and<br>Classification: | CellaVision DM96 with the body fluid application<br>21 CFR 864.5220 and 21 CFR 864.5260 Class II medical devices. | |
| Equivalent<br>Device<br>Identification: | CellaVision AB believes that DM96 with the additional body fluid application is<br>substantially equivalent to the DM96 for peripheral blood regarding technology<br>and function. The additional intended use of body fluid is substantially equivalent<br>to the Romanowsky stain manual light microscopic process for cell classification<br>(21CFR 864.3600 Class I exempted from pre-market notification procedure) | |
| Device<br>Description: | The CellaVision DM96 with the body fluid application is a laboratory instrument<br>used to perform differential analysis by locating, digitally storing and displaying<br>cells in human body fluid preparations.<br><br>The CellaVision DM96 with the body fluid application is a new intended use that<br>follows the same process as the currently cleared DM96 with white blood cell<br>differential, RBC characterization and platelet estimation (K033840). | |
| Intended Use: | DM96 is an automated cell-locating device.<br><br>The body fluid application is intended for differential count of white blood cells. The<br>system automatically locates and presents images of cells on cytocentrifuged body<br>fluid preparations. The operator identifies and verifies the suggested classification of<br>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

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# 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-<br>locating device for<br>cell-location and<br>identification of<br>cytocentrifuged body<br>fluids, for in-vitro<br>diagnostic use. | Manual method for<br>cell-location and<br>identification of blood<br>smears and<br>cytocentrifuged body<br>fluids, for in-vitro<br>diagnostic use. | Automated cell-<br>locating device for<br>cell-location and<br>identification of blood<br>smears, for in-vitro<br>diagnostic use. |
| | Verification of results<br>by skilled human<br>operator. | Verification of results<br>by skilled human<br>operator. | Verification of results<br>by skilled human<br>operator. |
| Specimen type | Body fluids such as<br>cerebrospinal fluid,<br>serous fluid,<br>bronchoalveolar<br>lavage, and related<br>fluids. | Peripheral blood and<br>body fluids such as<br>cerebrospinal fluid,<br>serous fluid,<br>bronchoalveolar<br>lavage, and related<br>fluids. | Peripheral blood. |
| Sample<br>preparation | Body fluid samples are<br>prepared by using a<br>cytocentrifuge and<br>stained with<br>Romanowsky stain. | Romanowsky stained<br>blood film on glass<br>slides of peripheral<br>blood.<br>Body fluid samples are<br>prepared by using a<br>cytocentrifuge and<br>stained with<br>Romanowsky stain. | Romanowsky stained<br>blood film on glass<br>slides of peripheral<br>blood. |
| Analysis<br>technique | White blood cells:<br>Cells are<br>located/counted by<br>moving according to<br>the battlement track<br>pattern. Cell images<br>are analyzed using<br>standard mathematical<br>methods, including | White blood cells:<br>The examiners usually<br>locate/count white<br>blood cells by moving<br>according to the<br>battlement track<br>pattern on the smear<br>and distinguish<br>between classes of | White blood cells:<br>Cells are<br>located/counted by<br>moving according to<br>the battlement track<br>pattern. Cell images<br>are analyzed using<br>standard mathematical<br>methods, including |
| Characteristic | DM96 with Body Fluid Application | Manual light microscopic process | DM 96 |
| | deterministic artificial neural networks<br>(ANN's) trained to distinguish between classes of white blood cells.<br>The cell images are pre-classified and the operator verifies the suggested classification by accepting or reclassifying. | white blood cells. | deterministic artificial neural networks<br>(ANN's) trained to distinguish between classes of white blood cells.<br>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. |

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## 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.

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## 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.

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### 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

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

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# 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.

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.

**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

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