CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127

K092868 · CellaVision AB · JOY · Nov 20, 2009 · Hematology

Device Facts

• Record ID: K092868
• Device Name: CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
• Applicant: CellaVision AB
• Product Code: JOY · Hematology
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5260
• Device Class: Class 2

Intended Use

DM1200 is an automated cell-locating device. DM1200 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. DM1200 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.

Device Story

DM1200 is an automated hematology analyzer for peripheral blood smears. System components include a slide scanning unit with a robot gripper, microscope, and camera, integrated with CellaVision DM software. The device automatically locates blood cells, captures digital images, and suggests cell classifications. A skilled operator reviews these images on a computer screen to verify the classification and perform the differential count. The device also provides an overview image for characterizing red blood cell size, shape, and color. Used in clinical laboratory settings, the system aids the operator in the differential count procedure, improving efficiency while maintaining the requirement for human expert verification of cell identification.

Clinical Evidence

Performance testing compared the DM1200 to the predicate DM96. Studies followed CLSI H20-A2 (Reference Leukocyte Differential Count) and EP05-A2 (Precision Performance) guidelines. Metrics evaluated included accuracy for cell location, accuracy for verified classification per cell class, precision for verified classification, and clinical sensitivity and specificity. Results met all pre-defined requirements, confirming equivalence.

Technological Characteristics

Automated hematology analyzer. Modifications: robot gripper slide/magazine feeder; LED light source (replacing halogen). Fundamental scientific technology unchanged. Design controls per 21 CFR 820.30 applied.

Indications for Use

Indicated for use as an automated hematology analyzer for the analysis of blood smears.

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 Automated Hematology Analyzer (K033840)

Submission Summary (Full Text)

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K092868

| 2 510(k) Summary | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) owner: | CellaVision AB<br>Ideon Science Park<br>SE-223 70 Lund<br>Sweden<br>Phone: [phone]<br>Fax: [phone] |
| Contact<br>Information: | C. G. Bundy Associates, Inc.<br>435 Rice Creek Terrace NE<br>Fridley, MN 55432<br>USA<br>Phone: [phone]<br>Fax: [phone] |
| Date of<br>summary: | September 14, 2009<br>NOV 20 2009 |
| Device Name: | Proprietary Name: CellaVision® DM1200 Automated Hematology Analyzer Common/Classification Name: Automated Cell-locating device |
| Classification<br>Regulation: | 21 CFR 864.5260 Class II medical device |
| Product<br>Code: | JOY; GKZ |
| Predicate<br>Device<br>Identification: | CellaVision AB believes that DM1200 is substantially equivalent to the legally<br>marketed (unmodified) device DM96 (K033840) regarding technology and<br>function. |
| Device<br>Description: | DM1200 is an automated cell-locating device for differential count of white blood<br>cells, characterization of red blood cell morphology and platelet estimation.<br>DM1200 consists of a slide scanning unit (a robot gripper, a microscope and a<br>camera) and a computer system containing the acquisition and classification<br>software "CellaVision® DM software". |
| Intended Use: | DM1200 is an automated cell-locating device.<br><br>DM1200 automatically locates and presents images of blood cells on peripheral<br>blood smears. The operator identifies and verifies the suggested classification of<br>each cell according to type.<br><br>DM1200 is intended to be used by skilled operators, trained in the use of the<br>device and in recognition of blood cells. |

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## Technological characteristics, comparison to predicate device

I the predicate device, DM1200 locates white blood cells, stores digital images of the cells Elke the proditories an organized manner and suggests a cell class for each cell to aid and displays the whiles of the differential count procedure. A competent operator is required to operation in poify the suggested classification of each cell. It is intended to be used by skilled conimm of the segged in the use of the device and in recognition of blood cells. Like the predicate operators, thathed in the everview image from which it is possible to characterize red blood cells regarding size, shape and color.

Brief discussion of non-clinical factors supporting a determination of substantial equivalence: Drici dioublion of non circuires a competent human examiner to review the microscopic images of the cells as does the predicate method and device.

Brief discussion of clinical tests supporting a determination of substantial equivalence: Direr unsussion or timbur tools cappend to confirm equivalence with the predicate device DM96 for differentiation of white blood cells. The study has been performed according to a preceifined for unflerentiation of the approved standard CLSI, H20-A2, Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; 200 Ed. and the Dinerential Outlik (Froportional) and Evaluation of Precision Performance of Quantative approved guidenne OEU. Complementary tests have been performed to confirm celllocation.

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 fulfilled the pre-defined requirements.

## Conclusion:

Conclusion.
Based on the performance testing where DM1200 was compared to the predicate devices, it is Based on the performanoc tooling while of 200 is substantially equivalent to devices already on the market (cleared by the 510(k) process).

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

CellaVision AB c/o Constance G. Bundy C.G. Bundy Associates Inc. 435 Rice Creek Terrace NE Fridley, MN 55432

NOV 2 0 2009

Re: k092868

Trade/Device Name: CellaVision® DM1200 Automated Hematology Analyzer Regulation Number: 21 CFR §864.5260 Regulation Name: Automated cell-locating device Regulatory Class: Class II Product Code: JOY, GKZ Dated: November 09, 2009 Received: November 13, 2009

Dear Constance G. 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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems

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Page 2 - Constance G. Bundy

(QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ia mchen

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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## 1 Indication for use statement

510(k) Number (if known): K0938(s

Device Name: CellaVision® DM1200 Automated Hematology Analyzer

## Indications for Use:

DM1200 is an automated cell-locating device.

DM1200 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.

.DM1200 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

m chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K092868

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