Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly mentions the use of "deterministic artificial neural networks (ANN's)" for analyzing cell images and distinguishing between classes of white blood cells.

Therapeutic

No
The document states the device is a laboratory instrument for differential analysis of cells in body fluid, which is a diagnostic process, not a therapeutic one.

Diagnostic

Yes

The DM96 is used for the differential count of white blood cells in body fluid preparations, which is a diagnostic procedure to identify and classify cells, aiding in the diagnosis of various conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "laboratory instrument" and describes a physical process of locating, digitally storing, and displaying cells, implying hardware components beyond just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for the "differential count of white blood cells" in "body fluid preparations." This is a diagnostic test performed on a sample taken from the human body.
Device Description: The device is described as a "laboratory instrument used to perform differential analysis" on "human body fluid preparations." This further reinforces its use in a laboratory setting for diagnostic purposes.
Predicate Device: The predicate device (K033840) is the CellaVision DM96, which is already cleared for white blood cell differential, RBC characterization, and platelet estimation. These are all common IVD applications.

The device analyzes body fluid samples to provide information about the composition of white blood cells, which is used to aid in diagnosis or monitoring of various conditions. This aligns perfectly with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this device; it only states "Not Found" under the "Control Plan Authorized (PCCP) and relevant text" section.

Overview

Intended Use / Indications for Use

DM96 is an automated cell-locating device.

The body fluid application is intended for differential count of white blood cells. The system automatically locates and presents images of cells on cytocentrifuged body fluid preparations. 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.

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

GKZ, JOY

Device Description

The CellaVision DM96 with the body fluid application is a laboratory instrument used to perform differential analysis by locating, digitally storing and displaying cells in human body fluid preparations.

The CellaVision DM96 with the body fluid application is a new intended use that follows the same process as the currently cleared DM96 with white blood cell differential, RBC characterization and platelet estimation (K033840).

Mentions image processing

Cells are located/counted by moving according to the battlement track pattern. Cell images are analyzed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells. The cell images are pre-classified and the operator verifies the suggested classification by accepting or reclassifying.

Mentions AI, DNN, or ML

deterministic artificial neural networks (ANN's)

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

DM96 is intended to be used by 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

Tests on cytocentrifuged body fluid preparations including specimen types such as cerebrospinal fluid, serous fluid and related fluids were conducted and successfully completed.

Tests were also conducted to validate performance including accuracy, precision and celllocation.

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

Based on extensive performance testing including comparison to the predicate devices, it is the conclusion of CellaVision AB that DM96 with the body fluid application is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

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

Not Found

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

Regulation Number and Section

§ 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).

Summary

0

Kososss

2 510(k) Summary

:

11 11 14 11 11 12 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

| Submitter: | CellaVision AB
Ideon Science Park
SE-223 70 Lund
Sweden | DEC 0 5 2008 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact
Information: | C. G. Bundy Associates, Inc.
6470 Riverview Terrace
Fridley, MN 55432 | |
| Submission
Date: | February 27, 2008 | |
| Device Name
and
Classification: | CellaVision DM96 with the body fluid application
21 CFR 864.5220 and 21 CFR 864.5260 Class II medical devices. | |
| Equivalent
Device
Identification: | CellaVision AB believes that DM96 with the additional body fluid application is
substantially equivalent to the DM96 for peripheral blood regarding technology
and function. The additional intended use of body fluid is substantially equivalent
to the Romanowsky stain manual light microscopic process for cell classification
(21CFR 864.3600 Class I exempted from pre-market notification procedure) | |
| Device
Description: | The CellaVision DM96 with the body fluid application is a laboratory instrument
used to perform differential analysis by locating, digitally storing and displaying
cells in human body fluid preparations.

The CellaVision DM96 with the body fluid application is a new intended use that
follows the same process as the currently cleared DM96 with white blood cell
differential, RBC characterization and platelet estimation (K033840). | |
| Intended Use: | DM96 is an automated cell-locating device.

The body fluid application is intended for differential count of white blood cells. The
system automatically locates and presents images of cells on cytocentrifuged body
fluid preparations. 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

:

.

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Comparison Table:

Comparative features of DM96 with Body Fluid application compared with the predicate device: A CONTINE CONTRACTOR COLLECTION CONTROL CONTINE OF CONTINE OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF

Characteristic	DM96 with Body Fluid Application	Manual light microscopic process	DM 96
Intended use	Automated cell-
locating device for
cell-location and
identification of
cytocentrifuged body
fluids, for in-vitro
diagnostic use.	Manual method for
cell-location and
identification of blood
smears and
cytocentrifuged body
fluids, for in-vitro
diagnostic use.	Automated cell-
locating device for
cell-location and
identification of blood
smears, for in-vitro
diagnostic use.
	Verification of results
by skilled human
operator.	Verification of results
by skilled human
operator.	Verification of results
by skilled human
operator.
Specimen type	Body fluids such as
cerebrospinal fluid,
serous fluid,
bronchoalveolar
lavage, and related
fluids.	Peripheral blood and
body fluids such as
cerebrospinal fluid,
serous fluid,
bronchoalveolar
lavage, and related
fluids.	Peripheral blood.
Sample
preparation	Body fluid samples are
prepared by using a
cytocentrifuge and
stained with
Romanowsky stain.	Romanowsky stained
blood film on glass
slides of peripheral
blood.
Body fluid samples are
prepared by using a
cytocentrifuge and
stained with
Romanowsky stain.	Romanowsky stained
blood film on glass
slides of peripheral
blood.
Analysis
technique	White blood cells:
Cells are
located/counted by
moving according to
the battlement track
pattern. Cell images
are analyzed using
standard mathematical
methods, including	White blood cells:
The examiners usually
locate/count white
blood cells by moving
according to the
battlement track
pattern on the smear
and distinguish
between classes of	White blood cells:
Cells are
located/counted by
moving according to
the battlement track
pattern. Cell images
are analyzed using
standard mathematical
methods, including
Characteristic	DM96 with Body Fluid Application	Manual light microscopic process	DM 96
	deterministic artificial neural networks
(ANN's) trained to distinguish between classes of white blood cells.
The cell images are pre-classified and the operator verifies the suggested classification by accepting or reclassifying.	white blood cells.	deterministic artificial neural networks
(ANN's) trained to distinguish between classes of white blood cells.
The cell images are pre-classified and the operator verifies the suggested classification by accepting or reclassifying.
Overview image	The device presents an overview image. The image gives the operator possibilities to get an overview on parts of or the whole slide in different magnifications.	The operator scans the slide to get an overview on parts of or the whole slide in different magnifications.	The device presents an overview image of a part of the slide. The image gives the operator possibilities to get an overview of the part in different magnifications.

2

Summary of Testing:

The CellaVision DM96 was cleared by the FDA in 2004. The intended use has been modified to include presentation of white blood cells on cytocentrifuged body fluid preparations.

Tests on cytocentrifuged body fluid preparations including specimen types such as cerebrospinal fluid, serous fluid and related fluids were conducted and successfully completed.

Tests were also conducted to validate performance including accuracy, precision and celllocation.

3

Conclusion:

Based on extensive performance testing including comparison to the predicate devices, it is the conclusion of CellaVision AB that DM96 with the body fluid application 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 is a seal for the U.S. Department of Health & Human Services. The seal features the department's logo, which is a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular pattern around the logo.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

CELLAVISION AB c/o Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, Minnesota 55432 ATTN: Constance G. Bundy

Re: K080595

Trade/Device Name: CELLAVISION DM96 with the Body Fluid Application Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ, JOY Dated: November 17, 2008 Received: November 21, 2008

DEC 0 5 2008

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 adulteration.

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). 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

5

Page 2 - Ms. Bundy

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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ia m chan

Maria M. Chan. Ph.D. Acting Division 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

K080595 510(k) Number (if known):

Device Name: CellaVision DM96 with the body fluid application

Indications For Use:

DM96 is an automated cell-locating device.

The body fluid application is intended for differential count of white blood cells. The system automatically locates and presents images of cells on cytocentrifuged body fluid preparations. 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.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080595

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