(357 days)
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. ANNs are a type of machine learning algorithm.
No
A therapeutic device is used for treating or curing a disease. This device is for in-vitro diagnostic use, specifically for analysis of body fluids to identify and classify white blood cells, which is a diagnostic purpose, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that "DM1200 is an automated system intended for in-vitro diagnostic use."
No
The device description explicitly states "CellaVision DM1200 with the body fluid application automatically locates and presents images of nucleated cells on cytocentrifuged body fluid preparations." This indicates the device includes hardware components for image acquisition and presentation, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "DM1200 is an automated system intended for in-vitro diagnostic use."
- Purpose: The device is intended to perform a differential count of white blood cells in body fluid preparations, which is a diagnostic test performed in vitro (outside the living body) on a biological sample.
- Sample Type: It analyzes "cytocentrifuged body fluid preparations," which are biological samples.
- Diagnostic Information: The output of the device (differential white blood cell count) provides information used in the diagnosis and monitoring of various medical conditions.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
DM1200 is an automated system intended for in vitro diagnostic use.
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.
DM1200 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
Product codes
JOY
Device Description
CellaVision DM1200 with the body fluid application automatically locates and presents images of nucleated cells on cytocentrifuged body fluid preparations. The system suggests a classification for each cell and the operator verifies the classification and has the opportunity to change the suggested classification of any cell.
The system preclassifies to the following WBC classes: Unidentified, Neutrophils, Eosinophils, Lymphocytes, Macrophages (including Monocytes) and Other. Cells preclassified as Basophils, Lymphoma cells, Atypical lymphocytes, Blasts and Tumor cells are automatically forwarded to the cell class Other.
Unidentified is a class for cells and objects which the system has pre-classified with a low confidence level.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells.
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
Body fluid samples were collected from two sites. All samples were initially analyzed on a cell counter or counted in a hemocytometer to get the leukocyte concentration. From each sample two cytocentrifuged preparations were made. A 200-cell differential count was performed for each slide (400 cells/sample) with both the test method and the reference method. The results were then verified by skilled human operators. The comparison was based on the approved guideline, CLSI document EP9-A2.
Number of samples by Type:
CSF: 62
Serous fluid: 151
Synovial fluid: 47
Total: 260
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A method comparison was conducted to compare CellaVision DM1200 with the body fluid application (Test Method) to CellaVision DM96 with the body fluid application (Reference Method).
Accuracy was tested through scatter plots for each cell class based on 260 samples.
Neutrophils: y = 0.9969x + 0.0050, R^2=0.9932, 95% CI Slope: 0.9868-1.0070, 95% CI Intercept: 0.0004-0.0096
Lymphocytes: y = 0.9815x + 0.0016, R^2 = 0.9829, 95% CI Slope: 0.9656-0.9973, 95% CI Intercept: -0.0049-0.0081
Eosinophils: y = 1.1048x - 0.0002, R^2 = 0.9629, 95% CI Slope: 1.0782-1.1314, 95% CI Intercept: -0.0007-0.0003
Macrophages: y = 1.0067x - 0.0050, R^2 = 0.9823, 95% CI Slope: 0.9901-1.0232, 95% CI Intercept: -0.0125-0.0024
Other cells: y = 0.9534 + 0.0032, R^2 = 0.9273, 95% CI Slope: 0.9207-0.9861, 95% CI Intercept: -0.0002-0.0065
Precision/Reproducibility: The short-term imprecision results for all 260 samples showed that the short-term imprecision was equivalent for the test method and the reference method.
Neutrophils: Test Method Mean %: 32.0, SD %: 3.2; Reference Method Mean %: 31.6, SD %: 3.4
Lymphocytes: Test Method Mean %: 30.1, SD %: 5.6; Reference Method Mean %: 30.5, SD %: 5.7
Eosinophils: Test Method Mean %: 0.6, SD %: 0.7; Reference Method Mean %: 0.5, SD %: 0.6
Macrophages: Test Method Mean %: 35.3, SD %: 5.8; Reference Method Mean %: 35.5, SD %: 6.2
Other cells: Test Method Mean %: 2.1, SD %: 1.7; Reference Method Mean %: 1.9, SD %: 2.5
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
1 510(k) Summary
،
100 - 100 -
| Submitter: | CellaVision AB
Ideon Science Park
SE-223 70 Lund
Sweden
Phone: +46 46 286 44 00
Fax: +46 46 286 44 70 | SEP 16 2011 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact
Information: | C. G. Bundy Associates, Inc.
435 Rice Creek Terrace NE
Fridley, MN 55432
USA
Phone: 763-574-1976
Fax: 763-571-2437 | |
| Submission Date: | September 20, 2010 | |
| Device Name: | Proprietary name: CellaVision® DM1200 with the body fluid
application
Common/Classification name: Automated cell-locating device | |
| Classification
Regulation: | 21 CFR 864.5220 and 21 CFR 864.5260 Class II medical devices. | |
| Equivalent Device
Identification: | CellaVision AB believes that CellaVision DM1200 with the body fluid
application is substantially equivalent to the legally marketed
CellaVision DM96 with the body fluid application (K080595). | |
| Device
Description: | CellaVision DM1200 with the body fluid application automatically
locates and presents images of nucleated cells on cytocentrifuged body
fluid preparations. The system suggests a classification for each cell
and the operator verifies the classification and has the opportunity to
change the suggested classification of any cell.
The system preclassifies to the following WBC classes: Unidentified,
Neutrophils, Eosinophils, Lymphocytes, Macrophages (including
Monocytes) and Other. Cells preclassified as Basophils, Lymphoma
cells, Atypical lymphocytes, Blasts and Tumor cells are
automatically forwarded to the cell class Other. | |
| | Unidentified is a class for cells and objects which the system has pre-
classified with a low confidence level. | |
| Intended Use: | DM1200 is an automated system intended for in vitro diagnostic use.
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 | |
1
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.
2
| Characteristic | DM96 with the body fluid | DM1200 with the body | Equivalent |
|---|---|---|---|
| application (predicate - ) | fluid application | ||
| device) | |||
| Intended use | Automated cell-locating | Automated cell-locating | |
| device for cell-location and | device for cell-location and | ||
| identification of white blood | identification of white blood | ||
| cells in cytocentrifuged body | cells in cytocentrifuged body | ||
| fluid preparations, for in-vitro | fluid preparations, for in- | ||
| diagnostic use. | vitro diagnostic use. | ||
| Verification of results by | Verification of results by | ||
| skilled human operator. | skilled human operator. | ||
| Specimen type | Body fluids. | Body fluids. | |
| Sample | Body fluid samples are | Body fluid samples are | V |
| preparation | prepared using a | prepared using a | |
| cytocentrifuge and stained | cytocentrifuge and stained | ||
| with Romanowsky stain. | with Romanowsky stain. | ||
| Analysis | White blood cells: | White blood cells: | |
| technique | Nucleated cells are | Nucleated cells are | |
| located/counted by moving | located/counted by moving | ||
| according to the battlement | according to the battlement | ||
| track pattern. Cell images are | track pattern. Cell images are | ||
| analyzed using standard | analyzed using standard | ||
| mathematical methods, | mathematical methods, | ||
| including deterministic | including deterministic | ||
| artificial neural networks | artificial neural networks | ||
| (ANN's) trained to | (ANN's) trained to | ||
| distinguish between classes | distinguish between classes | ||
| of white blood cells. | of white blood cells. | ||
| The cell images are | |||
| preclassified by the system | The cell images are | ||
| preclassified by the system | |||
| and the operator verifies the | and the operator verifies the | ||
| suggested classification by | suggested classification by | ||
| either accepting or | either accepting or | ||
| reclassifying. | reclassifying. | ||
| Overview | The device presents an | The device presents an | |
| image | overview image. The image | overview image. The image | |
| gives the operator | gives the operator | ||
| possibilities to get an | possibilities to get an | ||
| overview on parts of or the | overview on parts of or the | ||
| whole slide in different | whole slide in different | ||
| magnifications. | magnifications. |
:
·
.
Table 3.1: Comparative features of CellaVision DM1200 with the body fluid application and the predicate device
3
Performance characteristics:
A method comparison was conducted to compare CellaVision DM1200 with the body fluid application (Test Method) to CellaVision DM96 with the body fluid application (Reference Method).
Body fluid samples were collected from two sites. All samples were initially analyzed on a cell counter or counted in a hemocytometer to get the leukocyte concentration. From each sample two cytocentrifuged preparations were made. A 200-cell differential count was performed for each slide (400 cells/sample) with both the test method and the reference method. The results were then verified by skilled human operators. The comparison was based on the approved guideline, CLSI document EP9-A2.
Accuracy:
The accuracy was tested through scatter plots for each cell class.
| Type | Number of samples |
|---|---|
| CSF | 62 |
| Serous fluid | 151 |
| Synovial fluid | 47 |
| Total | 260 |
Table 3.2: Samples included in the study.
Accuracy results for all samples included were as follows:
| Cell class | Accuracy | 95% CI Slope | 95% CI Intercept | Number of
samples |
|-------------|------------------------------------------|---------------|------------------|----------------------|
| Neutrophils | $y = 0.9969x + 0.0050$
$R^2=0.9932$ | 0.9868-1.0070 | 0.0004-0.0096 | 260 |
| Lymphocytes | $y = 0.9815x + 0.0016$
$R^2 = 0.9829$ | 0.9656-0.9973 | -0.0049-0.0081 | 260 |
| Eosinophils | $y = 1.1048x - 0.0002$
$R^2 = 0.9629$ | 1.0782-1.1314 | -0.0007-0.0003 | 260 |
| Macrophages | $y = 1.0067x - 0.0050$
$R^2 = 0.9823$ | 0.9901-1.0232 | -0.0125-0.0024 | 260 |
| Other cells | $y = 0.9534 + 0.0032$
$R^2 = 0.9273$ | 0.9207-0.9861 | -0.0002-0.0065 | 260 |
Table 3.3; Accuracy results. All samples included (nooled data).
4
Precision/Reproducibility:
The table below shows the short-term imprecision results found for all 260 samples included in the clinical evaluation. The short-term imprecision was found to be equivalent for the test method and the reference method.
| Test Method | Reference Method | |||
|---|---|---|---|---|
| Mean % * | SD % | Mean % * | SD % | |
| Neutrophils | 32.0 | 3.2 | 31.6 | 3.4 |
| Lymphocytes | 30.1 | 5.6 | 30.5 | 5.7 |
| Eosinophils | 0.6 | 0.7 | 0.5 | 0.6 |
| Macrophages | 35.3 | 5.8 | 35.5 | 6.2 |
| Other cells | 2.1 | 1.7 | 1.9 | 2.5 |
Table 3.4: Short-term imprecision (pooled data).
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Conclusion:
The body fluid application is a modification of the intended use of CellaVision DM1200 Automated Hematology Analyzer, cleared by FDA in 2009 (K092868). The intended use has been modified to also include presentation of white blood cells on cytocentrifuged body fluid preparations.
Based on extensive performance testing, including comparison to the predicate device, it is the conclusion of CellaVision AB that CellaVision DM1200 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 regarding safety and effectiveness.
5
Image /page/5/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 tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
CellaVision AB c/o Ms. Constance G. Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrace NE Fridley. MN 55432
P 1 6 2011
Re: K102778
Trade/Device Name: CellaVision® DM 1200 with body fluid application Regulation Number: 21 CFR 864.5260 Regulation Name: Automated cell-locating device Regulatory Class: Class II Product Code: JOY Dated: September 7, 2011 Received: September 9, 2011
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 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 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 a 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
6
Page 2 - Ms. Constance G. Bundy
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 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 Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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/cdrh/industry/support/index.html.
Sincerely yours.
Reena Philip
on 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
7
1 Indications for Use Statement
510(k) Number (if known): K102778
Device Name: CellaVision® DM1200 with the body fluid application
Indications for Use:
DM1200 is an automated system intended for in-vitro diagnostic use.
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.
DM1200 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
Prescription Use X (Part 21 CFR 801.109) OR
Over the Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _l
Reena Philip
Division Sign-Off
Office of In Vitro Diagnos Device Evaluation and S
S10K K102778