EASYCELL CELL LOCATOR

K092116 · Medica Corp. · JOY · May 12, 2010 · Hematology

Device Facts

• Record ID: K092116
• Device Name: EASYCELL CELL LOCATOR
• Applicant: Medica Corp.
• Product Code: JOY · Hematology
• Decision Date: May 12, 2010
• 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	Not specified	Correlation coefficients (r): Neutrophil 0.99, Lymphocyte 0.98, Monocyte 0.93, Eosinophil 0.97	Not specified	Method Comparison Study: 304 specimens (155 normal, 149 with specific disease conditions) analyzed at three sites.
Morphological Abnormality Detection	Not specified	Efficiency: 82%, Sensitivity: 84%, Specificity: 82%	Not specified	Method Comparison Study: 304 specimens (155 normal, 149 with specific disease conditions) analyzed at three sites.
Distributional Abnormality Detection	Not specified	Efficiency: 89%, Sensitivity: 92%, Specificity: 87%	Not specified	Method Comparison Study: 304 specimens (155 normal, 149 with specific disease conditions) analyzed at three sites.

Intended Use

The EasyCell is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

Device Story

EasyCell automates peripheral blood smear analysis; scans slides via 10X/100X microscopes with CCD cameras; captures images of WBCs, RBCs, and platelets. Neural-network classifier (ASSIST function) pre-classifies WBCs into eight categories (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, NRBC, Smudge, Other). Technologist reviews pre-classified images on screen; accepts or manually reclassifies cells; performs RBC morphology evaluation and platelet estimation. Used in clinical laboratories; operated by trained technologists. Output includes digital cell images and differential counts; facilitates clinical decision-making by providing standardized, reviewable cell data; improves efficiency over manual microscopy.

Clinical Evidence

Method comparison study (n=304 specimens: 155 normal, 149 diseased) across three sites compared EasyCell to manual WBC differential. Deming regression showed high correlation (r=0.93-0.99) for major WBC types. Overall agreement for morphological/distributional abnormalities was 84% (91% sensitivity, 72% specificity). Platelet estimate agreement (Cohen's kappa 0.7) and RBC morphology agreement (>90%) demonstrated clinical utility. Precision/reproducibility studies (20 days, 20 slides/site) showed performance similar to manual methods. Skip rate was 0.66%.

Technological Characteristics

System includes two microscopes (10X, 100X), 30-position slide carousel, slide gripper, positioning system, and CCD cameras. Uses Romanowsky-stained glass slides. Connectivity: network-ready for LIS integration. Software utilizes deterministic artificial neural networks for image pre-classification. Calibration: internal target-based positional and optical (white balance) calibration. Sterilization: N/A (in vitro diagnostic instrument).

Indications for Use

Indicated for use by qualified technologists to assist in WBC differential, RBC morphology evaluation, and platelet estimation from fixed and stained peripheral blood smears in patients requiring hematological assessment.

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 Automatic Hematology Analyzer (k033840)

Submission Summary (Full Text)

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# Medica Corporation 510(k) Submission K092116

# 510(k) Summary

Device Name and Classification 1. Trade or Proprietary Name: EasyCell Automated Cell-Locating Device Common or Usual Name: JOY Product Code: Product Classification: Class 2 Hematology Review Panel; Regulation Number: 21CFR864.5260

MAY 1 2 2010

.. •

#### 2. Description of the Device

The EasyCell automatically locates and presents images of blood cells on peripheral smears. The operator reviews the suggested classification of each white cell according to type and may manually change the suggested classification of any cell. The operator can characterize red cell morphology and estimate platelets based on observed images. The EasyCell is intended to be used by skilled operators, trained in the use of the device and in the identification of blood cells.

#### 3. Substantial Equivalency

The EasyCell is substantially equivalent to the CellaVision DM96 Automatic Hematology Analyzer.

Predicate Device Information

| Manufacturer: | CellaVision AB, Lund, Sweden |
|----------------|------------------------------------------------|
| Product: | CellaVision DM96 Automatic Hematology Analyzer |
| 510(k) number: | K033840 |

#### 4. Intended Use

The EasyCell is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

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# Medica Corporation
510(k) Submission K092116

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| Characteristic | Predicate Device | EasyCell | Equivalent |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended use | Automated cell-locating device for cell-<br>location, and identification, for in-vitro<br>use. Verification of results by human<br>operator. | The EasyCell is intended to locate and display<br>images of white cells, red cells, and platelets<br>acquired from fixed and stained peripheral blood<br>smears and assists a qualified technologist in<br>conducting a WBC differential, RBC morphology<br>evaluation, and platelet estimate using those<br>images. For in vitro diagnostic use only. For<br>professional use only. | ✓ |
| Sample type | Stained blood film on glass slides of<br>peripheral whole blood. | Stained blood film on glass slides of peripheral<br>whole blood. | ✓ |
| Sample<br>preparation | Romanowsky stain | Romanowsky stain | ✓ |
| $f$<br>/sis<br>1...nique:<br>White Blood<br>Cells | Cells are located/counted by moving<br>according to the battlement track pattern.<br>Cell images are analyzed using standard<br>mathematical methods, including<br>deterministic artificial neural networks<br>(ANN's) trained to distinguish between<br>classes of white blood cells.<br>The cell images are pre-classified and the<br>operator verifies the suggested<br>classification by accepting or reclassifying | Cells are located/counted by moving according to<br>the battlement track pattern. Cell images are<br>analyzed using standard mathematical methods,<br>including deterministic artificial neural networks<br>(ANN's) trained to distinguish between classes of<br>white blood cells.<br>The cell images are pre-classified and the<br>operator reviews the suggested<br>classification, and accepts or reclassifies the<br>images. | ✓ |
| Red Blood<br>Cells | The device presents an overview image.<br>The reviewer characterizes red blood cell<br>morphology from the image. | The device presents a series of images.<br>The reviewer characterizes red blood cell<br>morphology from the images. | ✓ |
| Platelets | The device presents an overview image.<br>The reviewers manually count and estimate<br>the platelet concentration from the<br>overview image according to a<br>standardized procedure. | The device presents a series of images.<br>The reviewers manually count and estimate the<br>platelet concentration from the images according<br>to a procedure in the Operator's Manual. | ✓ |

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# Medica Corporation 510(k) Submission K092116

#### 5. Performance Characteristics

## Method Comparison

A Method Comparison was conducted to compare the EasyCell using Examiner Review (the Test Method) to the Reference Method. The Reference Method is a manual differential microscopic examination of the peripheral blood slides by a trained technologist. A total of 304 specimens were collected and analyzed at three sites. 155 specimens were from normal (healthy) subjects and 149 were from subjects with specific disease conditions (see Table 3). Slides were prepared from each specimen. The slides were randomly selected, blinded and read by two technologists at each site.

## Table 1

# Correlation between Reference Method and Test Method

| Cell Type | Correlation<br>Coefficient (r) | Slope | Intercept |
|------------|--------------------------------|-------|-----------|
| Neutrophil | 0.99 | 1.00 | 0.39 |
| Lymphocyte | 0.98 | 1.00 | 0.88 |
| Monocyte | 0.93 | 0.85 | 0.59 |
| Eosinophil | 0.97 | 0.95 | 0.066 |

# Sensitivity and Specificity

The number of normal and abnormal slides determined by each method was compared to determine the clinical sensitivity and specificity of the EasyCell.

## Table 2

| | Morphological | Distributional | Overall |
|--------------------------|---------------|----------------|---------|
| Efficiency (% agreement) | 82% | 89% | 84% |
| Sensitivity | 84% | 92% | 91% |
| Specificity | 82% | 87% | 72% |

# Platelet Estimate Accuracy

Platelet counts were estimated by each method as decreased, normal, or increased; and a corresponding value of 1, 2, or 3 was entered in the database. A Cohen's kappa statistic was calculated to demonstrate the agreement between the Test Method and the Reference Method for each technologist. The data show a good agreement between platelet estimates using the Reference Method and using the Test Method.

# Red Blood Cell Morphology Accuracy

For each slide, the technologists classified the red blood cells according to morphology. This was done for both methods. The results showed >90% agreement between methods.

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# Between Run Precision

20 slides were made from one normal patient sample at each site. Each slide was labeled. Each day for 20 days a slide was chosen at random and a 200-cell differential count was made using both the Reference Method and the Test Method. The results show the Test Method has equivalent precision to the Reference Method.

## 100 vs 200 Total Cell Count

In order to confirm the equivalence of total cell counts of 100 and 200 cells, data from three sites were compared. 304 slides were evaluated using a total count of 100 cells.

The 100 cell results were compared to the 200 cell count Reference Method results. The data showed good correlation between the Reference method and the 100-cell counts.

# Table 3 Correlation between Reference Method and Test Method by Cell Type

| Cell Type | Correlation<br>Coefficient (r) | Slope | Intercept |
|------------|--------------------------------|-------|-----------|
| Neutrophil | 0.96 | 0.99 | -0.15 |
| Lymphocyte | 0.95 | 1.00 | 0.73 |
| Monocyte | 0.83 | 0.83 | 0.72 |
| Eosinophil | 0.93 | 0.99 | -0.01 |

# Table 4

#### Comparison of Test Method to Reference Method Results (200 vs 100 cells)

| | Test method<br>(200 cells) | Test Method<br>(100 cells) |
|--------------------------|----------------------------|----------------------------|
| Efficiency (% agreement) | 84% | 83% |
| Sensitivity | 91% | 90% |
| Specificity | 72% | 70% |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Medica Corporation c/o Ms. Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915

MAY 1 2 2010

Re: k092116

Trade/Device Name: EasyCell Cell Locator Regulation Number: 21 CFR §864.5260 Regulation Name: Automated Cell-Locating Device Regulatory Class: Class II Product Code: JOY Dated: March 24, 2010 Received: April 28, 2010

Dear Ms. White:

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 class II (Special Controls), 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 fruther 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 not he 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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(b) premarket

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Page 2 - Ms. Fran White

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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 cham

Maria M. Chan, Ph.D 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

Indications for Use

510(k) Number (if known): K092116

Device Name: EasyCell Cell Locator

Indications for Use: The EasyCell is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Sharrow man

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Kogall 6

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#### CONFIDENTIAL