(62 days)
Not Found
Yes
The summary explicitly states that "Cell images are analyzed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells." Artificial Neural Networks are a type of machine learning algorithm.
No.
The device is used for locating blood cells on smears and assisting in their classification, which is a diagnostic function, not a therapeutic one.
Yes
The device aids in the differential count of white blood cells and characterization of red blood cell morphology on peripheral blood smears, which are diagnostic activities. The 'Intended Use' and 'Device Description' sections both state its purpose as an "automated cell-locating device for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation," which are steps in diagnosing various hematological conditions.
No
The device description explicitly states that the DM96 consists of a "slidescanning unit (a slide feeder, a microscope and a camera)" in addition to the computer system and software. This indicates the presence of hardware components beyond just software.
Based on the provided information, yes, this 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" for the operator to "identify and verify the suggested classification of each cell according to type." This directly involves the examination of biological specimens (blood) outside of the body to provide information for diagnostic purposes (differential count of white blood cells, characterization of red blood cell morphology and platelet estimation).
- Device Description: It describes 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: "peripheral blood smears" confirms the use of a biological sample.
- Clinical Evaluation: The description mentions a "clinical evaluation" performed to confirm "equivalence with the predicate method DiffMaster Octavia™ for differentiation of white blood cells." This type of evaluation is standard for IVD devices to demonstrate their performance for diagnostic use.
- Key Metrics: The mention of "clinical sensitivity and specificity" are key performance metrics used to evaluate the accuracy and reliability of diagnostic tests.
- Predicate Device: The predicate device, K003301 DiffMaster Octavia™ Hematology Analyzer, is also a device used for analyzing blood cells, which falls under the category of IVDs.
The device's function of analyzing blood cells from a peripheral blood smear to provide information about cell types and morphology for diagnostic purposes clearly aligns with the definition of an In Vitro Diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
DM96 is an automated cell-locating device.
DM96 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.
DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
Product codes
JOY, GKZ
Device Description
DM96 is an automated cell-locating device for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation. DM96 consists of a slidescanning unit (a slide feeder, a microscope and a camera) and a computer system containing the acquisition and classification software "CellaVision Blood Differential software".
Mentions image processing
DM96 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.
Mentions AI, DNN, or ML
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.
Input Imaging Modality
Not Found
Anatomical Site
peripheral blood smears
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
A clinical evaluation has been performed to confirm equivalence with the predicate method DiffMaster Octavia™ for differentiation of white blood cells. The study has been performed according to a predefined protocol based upon the approved standard, NCCLS, vol. 23, no 1, document H-20A. March 1992: Reference Leukocyte Differential Count (proportional) and Evaluation of Instrumental Method. Complementary tests have been performed to confirm celllocation, precision and overview image quality.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical evaluation has been performed to confirm equivalence with the predicate method DiffMaster Octavia™ for differentiation of white blood cells. The study has been performed according to a predefined protocol based upon the approved standard, NCCLS, vol. 23, no 1, document H-20A. March 1992: Reference Leukocyte Differential Count (proportional) and Evaluation of Instrumental Method. Complementary tests have been performed to confirm celllocation, precision and overview image quality.
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 show that the DM96 is equivalent in accuracy, precision and clinical sensitivity and specificity and fulfilled the pre-defined requirements for overview image quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
clinical sensitivity and specificity, accuracy, precision
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Section 2. SUMMARY AND CERTIFICATION
2.1. 510 (k) Summary
2.1.1. Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the 510(k) summary for DM96.
| SUBMITTER'S NAME: | CellaVision AB |
|---|---|
| ADDRESS: | Ideon Research Park, SE-223 70 Lund, Sweden |
| CONTACT PERSON: | Constance G. Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-571-2437 |
| DATE OF SUBMISSION: | December 9, 2003 |
1. Identification of device
Proprietary Name: CellaVision DM96 Automatic Hematology Analyzer Common Name: DM96 Classification Status: Class II per regulations 21CFR 864.5260 Product Codes: JOY
2. Equivalent devices
CellaVision AB believes DM96 is substantially equivalent to the Romanowsky stain manual light microscopic process for cell classification (21CFR 864.3600 Class I exempted from premarket notification procedure) and DiffMaster Octavia™ Hematology Analyzer, 510(k) number K003301, CellaVision AB.
3. Description of the device
DM96 is an automated cell-locating device for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation. DM96 consists of a slidescanning unit (a slide feeder, a microscope and a camera) and a computer system containing the acquisition and classification software "CellaVision Blood Differential software".
4. Intended use
DM96 is an automated cell-locating device.
DM96 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.
DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
1
5. Technological characteristics, comparison to predicate device
Like the predicate device, DM96 locates white blood cells, stores digital images of the cells and displays the images in an organized manner and suggests a cell class for each cell to aid operators in performing the differential count procedure. A competent operator is required to confirm or modify the suggested classification of each cell. It is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells. Like the predicate device, DM96 presents an overview image from which it is possible to characterize red blood cells regarding size, shape and color. In addition, the DM96 presents an overview image and facilitates platelet estimation.
Brief discussion of non-clinical factors supporting a determination of substantial equivalence: The method requires a competent human examiner to review the microscopic images of the cells as does the predicate method and device. See substantial equivalence comparisons below.
Brief discussion of clinical tests supporting a determination of substantial equivalence: A clinical evaluation has been performed to confirm equivalence with the predicate method DiffMaster Octavia™ for differentiation of white blood cells. The study has been performed according to a predefined protocol based upon the approved standard, NCCLS, vol. 23, no 1, document H-20A. March 1992: Reference Leukocyte Differential Count (proportional) and Evaluation of Instrumental Method. Complementary tests have been performed to confirm celllocation, precision and overview image quality.
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 show that the DM96 is equivalent in accuracy, precision and clinical sensitivity and specificity and fulfilled the pre-defined requirements for overview image quality.
| Characteristic | Manual light
microscopic process | DiffMaster Octavia™ DM 96 | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Manual method for
cell-location and
identification, for in-
vitro use.
Verification of results
by human operator. | Automated cell-
locating device for
cell-location, and
identification, for in-
vitro use.
Verification of results
by human operator. | Automated cell-
locating device for
cell-location, and
identification, for in-
vitro use.
Verification of results
by human operator. |
| Sample type | Stained blood film on
glass slides of
peripheral whole
blood. | Stained blood film on
glass slides of
peripheral whole
blood. | Stained blood film on
glass slides of
peripheral whole
blood. |
| Characteristic | Manual light
microscopic process | DiffMaster Octavia™ | DM 96 |
| Sample
preparation | Romanowsky stain | Romanowsky stain | Romanowsky stain |
| Analysis
technique | 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. | White blood cells:
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. | White blood cells:
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. |
| | Red blood cells:
The examiners
characterize red blood
cell morphology from
an overview. | Red blood cells:
The device presents an
overview image.
The examiners
characterize red blood
cell morphology from
the image. | Red blood cells:
The device presents an
overview image.
The examiners
characterize red blood
cell morphology from
the image. |
| | Platelets:
The examiners
manually count and
estimate the platelet
concentration from an
overview according to
a standardized
procedure (21 CFR
864.6160 Manual
blood cell counting
device, Class I). | | Platelets:
The device presents an
overview image.
The examiners
manually count and
estimate the platelet
concentration from the
overview image
according to a
standardized
procedure. |
Comparative features of DM96 compared with the predicate devices:
2
:
·
3
6. Discussion of Performance Testing.
An extensive collection of tests has been conducted and successfully completed, including tests to ensure safety, effectiveness, and compliance with product requirements.
The following tests were conducted and successfully completed:
a) Evaluation of:
-
Performance (accuracy and precision, clinical sensitivity, specificity, cell-location)
-
Safety
b) Inspections to verify that all design features are as intended and that all authorized design changes have been accomplished and recorded.
c) Validation of the system (including efficacy of user interface)
7. Conclusion
Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of CellaVision AB that DM96 is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
FEB 1 0 2004
CellaVision AB c/o Ms. Constance G. Bundy C. G. Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, MN 55432
Re: K033840
Trade/Device Name: CellaVision DM96 Regulation Number: 21 CFR 864.5260 Regulation Name: Automated cell-locating device Regulatory Class: Class II Product Code: JOY: GKZ Dated: December 9, 2003 Received: December 10, 2003
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 adultcration.
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).
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Page 2
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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Aven Antman, m.D.
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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1.2. Indications for Use
510(k) Number_ K 033840
Device Name: CellaVision DM96
Indications for Use:
DM96 is an automated cell-locating device.
DM96 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.
DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use ﺳ (Per 21 CFR 801.109)
Over the Counter Use_ ________________________________________________________________________________________________________________________________________________________
Maria Chen for Joseph Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 053840