K Number
K092868
Device Name
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
Manufacturer
Date Cleared
2009-11-20

(63 days)

Product Code
Regulation Number
864.5260
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
DM1200 is an automated cell-locating device for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation. DM1200 consists of a slide scanning unit (a robot gripper, a microscope and a camera) and a computer system containing the acquisition and classification software "CellaVision® DM software".
More Information

Not Found

No
The description focuses on automated cell location and image presentation, with the operator performing the classification. There is no mention of the device itself performing automated classification or using AI/ML for analysis.

No
The device is used for locating and presenting images of blood cells for classification, which is a diagnostic function, not a therapeutic one. It assists operators in identifying and verifying cell types but does not treat or cure any condition.

Yes

Explanation: The device is described as assisting in the "differential count of white blood cells, characterization of red blood cell morphology and platelet estimation." These are diagnostic tasks performed on peripheral blood smears to assess patient health or diagnose conditions. The device "locates and presents images of blood cells," and the operator then "identifies and verifies the suggested classification of each cell according to type," which directly contributes to a diagnosis or evaluation of a patient's condition.

No

The device description explicitly states that the DM1200 consists of a slide scanning unit (a robot gripper, a microscope, and a camera) in addition to the computer system with software. This indicates significant hardware components are part of the device.

Yes, based on the provided information, the DM1200 device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The device is intended to be used on "peripheral blood smears" to "automatically locates and presents images of blood cells". This involves analyzing biological samples (blood) outside of the body (in vitro).
  • Device Description: It's described as an "automated cell-locating device for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation." These are all diagnostic tests performed on blood samples.
  • Anatomical Site: The analysis is performed on "Peripheral blood smears," which are prepared from blood samples.
  • Clinical Tests: The document mentions "Clinical tests were performed to confirm equivalence with the predicate device DM96 for differentiation of white blood cells." Clinical tests are a common requirement for IVD devices to demonstrate performance and safety.
  • Predicate Device: A predicate device (DM96) is mentioned, which is a common reference point for demonstrating substantial equivalence for new IVD devices seeking regulatory clearance.

The core function of the DM1200 is to assist in the diagnostic process by analyzing blood cells from a patient sample. This aligns directly with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

JOY, GKZ

Device Description

DM1200 is an automated cell-locating device for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation. DM1200 consists of a slide scanning unit (a robot gripper, a microscope and a camera) and a computer system containing the acquisition and classification software "CellaVision® DM software".

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

skilled operators, trained in the use of the device and in recognition of blood cells.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K033840

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 864.5260 Automated cell-locating device.

(a)
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.)(b)
Classification. Class II (performance standards).

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K092868

2 510(k) Summary
510(k) owner:CellaVision AB
Ideon Science Park
SE-223 70 Lund
Sweden
Phone: +46-46 286 44 00
Fax: +46-46 286 44 70
Contact
Information:C. G. Bundy Associates, Inc.
435 Rice Creek Terrace NE
Fridley, MN 55432
USA
Phone: 763-574-1976
Fax: 763-571-2437
Date of
summary:September 14, 2009
NOV 20 2009
Device Name:Proprietary Name: CellaVision® DM1200 Automated Hematology Analyzer Common/Classification Name: Automated Cell-locating device
Classification
Regulation:21 CFR 864.5260 Class II medical device
Product
Code:JOY; GKZ
Predicate
Device
Identification:CellaVision AB believes that DM1200 is substantially equivalent to the legally
marketed (unmodified) device DM96 (K033840) regarding technology and
function.
Device
Description:DM1200 is an automated cell-locating device for differential count of white blood
cells, characterization of red blood cell morphology and platelet estimation.
DM1200 consists of a slide scanning unit (a robot gripper, a microscope and a
camera) and a computer system containing the acquisition and classification
software "CellaVision® DM software".
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. |

:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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:


1

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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Image /page/2/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 its wings spread, facing to the right. The eagle is composed of three curved lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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 (800) 638-2041 or (301) 796-7100 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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