DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

K003301 · CellaVision AB · JOY · Mar 15, 2001 · Hematology

Device Facts

• Record ID: K003301
• Device Name: DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
• Applicant: CellaVision AB
• Product Code: JOY · Hematology
• Decision Date: Mar 15, 2001
• 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	Results equal to the reference method (Romanowski (MGG)-Stain manual light microscopic process) as per NCCLS document H-20A.	Results equal to the reference method.	Not specified.	Two clinical trials performed according to NCCLS, vol. 23, no 1, document H-20A, March 1992: Reference Leukocyte Differential Count (proportional) and Evaluation of Instrumental Method.

Intended Use

The DiffMaster Octavia™ is an automated cell locating device. DiffMaster Octavia automatically locates and presents images of blood cells on peripheral blood specimens. The operator identifies and verifies the suggested classification of each cell according to type. DiffMaster Octavia is intended to be used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.

Device Story

DiffMaster Octavia is an automated hematology analyzer for peripheral blood specimens. System components include a slide positioning system, microscope, camera, and Cytologica software. Device automatically scans stained blood film slides to locate white blood cells (WBCs), captures digital images, and presents them to the operator. Software uses deterministic artificial neural networks (ANNs) to suggest cell classifications. Used in clinical laboratory settings by trained technologists. The operator reviews the suggested classifications, confirming or modifying them as necessary. This process aids the technologist in performing the WBC differential procedure, improving efficiency in cell identification compared to manual microscopic methods.

Clinical Evidence

Two clinical trials were conducted comparing DiffMaster Octavia results to the Romanowski (MGG)-Stain manual reference method, following NCCLS document H-20A (1992). Endpoints included accuracy of suggested cell classification, precision of cell location/display, instrument reproducibility, and sensitivity/specificity (false positives/negatives). Results demonstrated performance equivalent to the manual reference method.

Technological Characteristics

System comprises a positioning system, microscope, camera, and Cytologica software. Analyzes stained peripheral blood film slides (Wright, Wright Giemsa, or May Grünwald Giemsa). Employs deterministic artificial neural networks for cell classification. Operates as an automated cell locating and imaging system requiring human verification.

Indications for Use

Indicated for automated location and presentation of peripheral blood cell images for classification. Intended for use by skilled operators trained in leukocyte recognition to assist in performing white blood cell differentials.

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

• IMI MICRO21 with WBC Diff (K925670/A)
• Romanowski (MGG)-Stain manual light microscopic process

Submission Summary (Full Text)

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K003301

# SECTION 2. SUMMARY AND CERTIFICATION

# A. 510(K) SUMMARY

## Summary of Safety and Effectiveness

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

| SUBMITTER'S NAME: | CellaVision AB |
|---------------------|------------------------------------------|
| ADDRESS: | Ideon Research Park, 223 70 Lund, Sweden |
| CONTACT PERSON: | Constance G. Bundy |
| TELEPHONE NUMBER: | 612-574-1976 |
| FAX NUMBER: | 612-571-2437 |
| DATE OF SUBMISSION: | October 19, 2000 |

### Identification of device 1.

Proprietary Name: DiffMaster Octavia™ Automatic Hematology Analyzer Common Name: DiffMaster Octavia™ Classification Status: Class II per regulations 864-5260 Product Codes: JOY

### Equivalent devices 2.

CellaVision AB believes the DiffMaster Octavia™is substantially equivalent to the Romanowski (MGG)-Stain manual light microscopic process for cell classification and the IMI MICRO21 with WBC Diff (White blood cell Differential, 510(k) number K925670/A).

### 3. Description of the Device

The DiffMaster-Octavia™ is an automated cell locating device for differential count of white blood cells and characterization of red morphology. It is based on a CellaVision AB developed software system Cytologica. DiffMaster Octavia™consists of a commercially available positioning system for the slides, a commercially available microscope, a commercially available camera and the software system.

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### Intended use 4.

The DiffMaster Octavia™ is an automated cell locating device.

DiffMaster Octavia automatically locates and presents images of blood cells on peripheral blood specimens. The operator identifies and verifies the suggested classification of each cell according to type.

DiffMaster Octavia is intended to be used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.

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

Like the predicate device, the DiffMaster Octavia™ instrument locates WBCs, stores digital images of the cells and displays the images in an organized manner and suggests a cell class for each cell to aid technologists in performing the WBC differential procedure. A competent technologist 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 instrument and in recognition of leukocyte classes.

### Brief Discussion of Non clinical factors supporting a determination of substantial equivalence:

The method involves a competent human observer to examine the microscopic images of the cells as does the predicate method and device. See attached substantial equivalence comparisons.

Brief discussion of clinical tests supporting a determination of substantial equivalence: Two clinical trials have been performed to confirm equivalence with the predicate method Romanowski (MGG)-Stain manual light microscopic process for cell classification. The studies have been performed according to the approved standard, NCCLS, vol. 23, no 1, document H-20A, March 1992: Reference Leukocyte Differential Count (proportional) and Evaluation of Instrumental Method. Complementary nonclinical tests have been performed to confirm cell location and display of found cells.

### Conclusions drawn from clinical tests:

The following information was obtained from the clinical tests comparing the DiffMaster Octavia™ cell classification results to the manual reference method results:

- the accuracy of the suggested classification for each cell type (DiffMaster Octavia™ . results compared to the light microscope manual diff count results)
- the precision for location and display of the cells found .
- the precision of the instrument (reproducibility) ●
- the sensitivity and the specificity of the instrument (false positive and false negatives ● found)

Results equal to the reference method was provided by use of the DiffMaster Octavia™ instrument.

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Comparative features of the DiffMaster Octavia compared with the predicate device and method

| Characteristic | IMI Micro21 | Manual light microscopic process | DiffMaster Octavia™ |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Automated cell location device for cell location and identification, for in-vitro use. Verification of results by human observer | Manual method for cell location and identification, for in-vitro use. Verification of results by human observer | Automated cell locating device for cell location, and identification, for in-vitro use. Verification of results by human observer |
| Sample type | Bloodfilm on glass slides of peripheral whole blood, stained | Bloodfilm on glass slides of peripheral whole blood, stained | Bloodfilm on glass slides of peripheral whole blood, stained |
| Sample preparation | Wright, Wright Giemsa, May Grünwald stain | May Grünwald Giemsa stain (MGG) | May Grünwald Giemsa stain (MGG) |
| Analysis technique | Cells are located using the NCCLS scanning procedure. Cell images are analyzed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells | | Cells are located using the NCCLS scanning procedure. Cell images are analyzed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells |

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### Discussion of performance testing. ર.

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 as prototype tests and successfully completed: a) Evaluation of:

a) Draianon on 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 the DiffMaster Octavia™ is substantially equivalent to devices already on the marked (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 shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle, with three curved lines forming the body and wings.

# MAR 1 5 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Public Health Service

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

Re: K003301

Trade Name: DiffMaster Octavia™ Automatic Hematology Analyzer Regulatory Class: II Product Code: JOY Dated: February 16, 2001 Received: February 20, 2001

Dear Ms. Bundy:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 910(x) notifically equivalent (for the indications for use above and we nave determined the actrices marketed predicate devices marketed in interstate commerce stated in the enclosure) to legally maneces processes in the Medical Device Amendments, or to devices that prior to May 26, 1970, the chaouncen and of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). Tourmaly, morolors, manov as as f the Act include requirements for annual provisions of the Act. "The general controle practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Fremarket Approval), it they of sayses in one of Federal Regulations, Title 21, Parts 800 to 895. allecting your device our of tournination assumes compliance with the Current Good A Substantially Cquiralient determinates set forth in the Quality System Regulation (QS) for Manufacturing Fridence required in (21 CFR Part 820) and that, through periodic QS Medical Devices. General regulation (FDA) will verify such assumptions. Failure to Inspections, the Food and Drug Temninesult in regulatory action. In addition, FDA may publish Comply with the GMT Togatator may readeral Register. Please note: this response to your premarket notification submission does not affect any obligation you might Its polise to your premarked noursearch start for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket a This letter will allow you to begin marketing your do nee of your device to a legally marketed notification. The FDA Inding of substantial equivalise of your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 809.10 for in vitto diagnostions on the promotion and advertising of your device, [phone]. Additionally, for questions on the predictions of Areas note the regulation please contact the Office of Comphanoo at (301) 37 - 407.97 - 10.07.9 Directed entitled, "Misoranding of telefone to pennation in the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from information on your responsibilities and its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## B. INDICATIONS FOR USE

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Device Name: DiffMaster Octavia™

Indications for Use:

The DiffMaster Octavia™ is an automated cell locating device.

DiffMaster Octavia automatically locates and presents images of blood cells on Diffiviaster Octavia adtomations focults identifies and verifies the suggested classification of each cell according to type.

DiffMaster Octavia is intended to be used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.

J. Roberts

(Division Sign-Off) (Division of Clinical Laboratory Deyices o 3,30 L 510(k) Number -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) ાર

Over the Counter Use _________________________________________________________________________________________________________________________________________________________