CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER

K033840 · CellaVision AB · JOY · Feb 10, 2004 · Hematology

Device Facts

• Record ID: K033840
• Device Name: CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
• Applicant: CellaVision AB
• Product Code: JOY · Hematology
• Decision Date: Feb 10, 2004
• 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
White Blood Cell Differential Count	Equivalent to manual light microscopic process (predicate method) per NCCLS H-20A standard.	Equivalent in accuracy, precision, clinical sensitivity, and specificity to the predicate device (DiffMaster Octavia).	Not specified.	Clinical evaluation performed according to NCCLS document H-20A (Reference Leukocyte Differential Count and Evaluation of Instrumental Method) to confirm equivalence with the predicate method DiffMaster Octavia.

Intended Use

DM96 is an automated cell-locating device. DM96 automatically locates and presents images of blood cells on peripheral blood smears. 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

DM96 is an automated hematology analyzer for peripheral blood smears. System includes slide feeder, microscope, camera, and computer with CellaVision Blood Differential software. Device scans stained glass slides to locate white blood cells, stores digital images, and presents them to the operator. Software uses deterministic artificial neural networks (ANNs) to pre-classify cells. Operator reviews images on a display to verify, accept, or modify suggested classifications. Device also provides overview images for red blood cell morphology characterization and platelet estimation. Used in clinical settings by trained laboratory personnel. Output aids in differential count procedures, improving efficiency and standardization of cell identification compared to manual microscopy.

Clinical Evidence

Clinical evaluation performed per NCCLS H-20A protocol. Study assessed accuracy for cell-location, accuracy and precision of verified cell classification, and clinical sensitivity/specificity. Results demonstrated equivalence to the DiffMaster Octavia™ predicate method.

Technological Characteristics

Automated cell-locating device; includes slide feeder, microscope, and camera. Analyzes Romanowsky-stained peripheral blood smears. Uses deterministic artificial neural networks (ANNs) for image classification. System is computer-based with proprietary acquisition and classification software. Class II device (21 CFR 864.5260).

Indications for Use

Indicated for automated location and presentation of blood cell images on peripheral blood smears to assist skilled, trained operators in performing differential counts, red blood cell morphology characterization, and platelet estimation.

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

• DiffMaster Octavia™ Hematology Analyzer (K003301)

Submission Summary (Full Text)

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

# Section 2. SUMMARY AND CERTIFICATION

# 2.1. 510 (k) Summary

#### 2.1.1. Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the 510(k) summary for DM96.

| SUBMITTER'S NAME: | CellaVision AB |
|---------------------|---------------------------------------------|
| ADDRESS: | Ideon Research Park, SE-223 70 Lund, Sweden |
| CONTACT PERSON: | Constance G. Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-571-2437 |
| DATE OF SUBMISSION: | December 9, 2003 |

#### 1. Identification of device

Proprietary Name: CellaVision DM96 Automatic Hematology Analyzer Common Name: DM96 Classification Status: Class II per regulations 21CFR 864.5260 Product Codes: JOY

#### 2. Equivalent devices

CellaVision AB believes DM96 is substantially equivalent to the Romanowsky stain manual light microscopic process for cell classification (21CFR 864.3600 Class I exempted from premarket notification procedure) and DiffMaster Octavia™ Hematology Analyzer, 510(k) number K003301, CellaVision AB.

#### 3. Description of the device

DM96 is an automated cell-locating device for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation. DM96 consists of a slidescanning unit (a slide feeder, a microscope and a camera) and a computer system containing the acquisition and classification software "CellaVision Blood Differential software".

#### 4. Intended use

DM96 is an automated cell-locating device.

DM96 automatically locates and presents images of blood cells on peripheral blood smears. 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.

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

#### 5. Technological characteristics, comparison to predicate device

Like the predicate device, DM96 locates white blood cells, stores digital images of the cells and displays the images in an organized manner and suggests a cell class for each cell to aid operators in performing the differential count procedure. A competent operator is required to confirm or modify the suggested classification of each cell. It is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells. Like the predicate device, DM96 presents an overview image from which it is possible to characterize red blood cells regarding size, shape and color. In addition, the DM96 presents an overview image and facilitates platelet estimation.

Brief discussion of non-clinical factors supporting a determination of substantial equivalence: The method requires a competent human examiner to review the microscopic images of the cells as does the predicate method and device. See substantial equivalence comparisons below.

Brief discussion of clinical tests supporting a determination of substantial equivalence: A clinical evaluation has been performed to confirm equivalence with the predicate method DiffMaster Octavia™ for differentiation of white blood cells. The study has been performed according to a predefined protocol based upon the approved standard, NCCLS, vol. 23, no 1, document H-20A. March 1992: Reference Leukocyte Differential Count (proportional) and Evaluation of Instrumental Method. Complementary tests have been performed to confirm celllocation, precision and overview image quality.

#### Conclusions drawn from clinical tests:

The following information was obtained from the clinical tests:

- · accuracy for cell-location
- · accuracy for the verified classification for each cell class
- · precision for the verified classification for each cell class
- · clinical sensitivity and specificity

The results show that the DM96 is equivalent in accuracy, precision and clinical sensitivity and specificity and fulfilled the pre-defined requirements for overview image quality.

| Characteristic | Manual light<br>microscopic process | DiffMaster Octavia™ DM 96 | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Manual method for<br>cell-location and<br>identification, for in-<br>vitro use.<br><br>Verification of results<br>by human operator. | Automated cell-<br>locating device for<br>cell-location, and<br>identification, for in-<br>vitro use.<br><br>Verification of results<br>by human operator. | Automated cell-<br>locating device for<br>cell-location, and<br>identification, for in-<br>vitro use.<br><br>Verification of results<br>by human operator. |
| Sample type | Stained blood film on<br>glass slides of<br>peripheral whole<br>blood. | Stained blood film on<br>glass slides of<br>peripheral whole<br>blood. | Stained blood film on<br>glass slides of<br>peripheral whole<br>blood. |
| Characteristic | Manual light<br>microscopic process | DiffMaster Octavia™ | DM 96 |
| Sample<br>preparation | Romanowsky stain | Romanowsky stain | Romanowsky stain |
| Analysis<br>technique | 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<br>white blood cells. | 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<br>deterministic artificial<br>neural networks<br>(ANN's) trained to<br>distinguish between<br>classes of white blood<br>cells.<br>The cell images are<br>pre-classified and the<br>operator verifies the<br>suggested<br>classification by<br>accepting or<br>reclassifying. | 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<br>deterministic artificial<br>neural networks<br>(ANN's) trained to<br>distinguish between<br>classes of white blood<br>cells.<br>The cell images are<br>pre-classified and the<br>operator verifies the<br>suggested<br>classification by<br>accepting or<br>reclassifying. |
| | Red blood cells:<br>The examiners<br>characterize red blood<br>cell morphology from<br>an overview. | Red blood cells:<br>The device presents an<br>overview image.<br>The examiners<br>characterize red blood<br>cell morphology from<br>the image. | Red blood cells:<br>The device presents an<br>overview image.<br>The examiners<br>characterize red blood<br>cell morphology from<br>the image. |
| | Platelets:<br>The examiners<br>manually count and<br>estimate the platelet<br>concentration from an<br>overview according to<br>a standardized<br>procedure (21 CFR<br>864.6160 Manual<br>blood cell counting<br>device, Class I). | | Platelets:<br>The device presents an<br>overview image.<br>The examiners<br>manually count and<br>estimate the platelet<br>concentration from the<br>overview image<br>according to a<br>standardized<br>procedure. |

#### Comparative features of DM96 compared with the predicate devices:

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

:

·

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

# 6. Discussion of Performance Testing.

An extensive collection of tests has been conducted and successfully completed, including tests to ensure safety, effectiveness, and compliance with product requirements.

The following tests were conducted and successfully completed:

a) Evaluation of:

- Performance (accuracy and precision, clinical sensitivity, specificity, cell-location)

- Safety

b) Inspections to verify that all design features are as intended and that all authorized design changes have been accomplished and recorded.

c) Validation of the system (including efficacy of user interface)

### 7. Conclusion

Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of CellaVision AB that DM96 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

FEB 1 0 2004

CellaVision AB c/o Ms. Constance G. Bundy C. G. Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, MN 55432

Re: k033840

> Trade/Device Name: CellaVision DM96 Regulation Number: 21 CFR 864.5260 Regulation Name: Automated cell-locating device Regulatory Class: Class II Product Code: JOY: GKZ Dated: December 9, 2003 Received: December 10, 2003

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 adultcration.

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).

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

#### Page 2

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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Aven Antman, m.D.

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

# 1.2. Indications for Use

510(k) Number_ K 033840

Device Name: CellaVision DM96

#### Indications for Use:

DM96 is an automated cell-locating device.

DM96 automatically locates and presents images of blood cells on peripheral blood smears. 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.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use ﺳ (Per 21 CFR 801.109)

Over the Counter Use_ ________________________________________________________________________________________________________________________________________________________

Maria Chen for Joseph Bautista
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K 053840