(146 days)
K925670/A
Not Found
Yes
The document explicitly states that "Cells are located using the NCCLS scanning procedure. Cell images are analyzed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells." This directly indicates the use of a type of artificial intelligence (ANNs) for cell analysis.
No
The device is used for automated cell locating and image presentation of blood cells for identification and classification by a skilled operator, 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 specimens, which are diagnostic indicators. Although the operator ultimately verifies the classification, the device performs automated cell locating and presents images for analysis, thereby contributing to the diagnostic process.
No
The device description explicitly states that the DiffMaster-Octavia™ consists of commercially available hardware components: a positioning system for slides, a microscope, and a camera, in addition to the software system. This indicates it is a hardware and software system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to be used on "peripheral blood specimens" to "automatically locate and present images of blood cells" for the purpose of "differential count of white blood cells and characterization of red morphology." This clearly indicates it's used to examine biological samples (blood) in vitro (outside the body) to provide information about a patient's health status (blood cell counts and morphology).
- Device Description: It uses a microscope, camera, and software to analyze blood cells on slides. This is a typical setup for an IVD device used in hematology.
- Anatomical Site: "peripheral blood specimens" confirms the use of biological samples.
- Performance Studies: The description of clinical trials comparing the device to a "manual light microscopic process for cell classification" and referencing standards like NCCLS document H-20A further supports its classification as an IVD, as these are common requirements for validating IVD devices.
- Predicate Device: The mention of a predicate device (K925670/A IMI MICRO21 with WBC Diff) which is also an IVD device used for similar purposes, strengthens the case for the DiffMaster Octavia™ being an IVD.
The device performs an analysis on a biological sample (blood) in vitro to provide diagnostic information (differential white blood cell count and red cell morphology), which is the core definition of an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The DiffMaster Octavia™ is an automated cell locating device.
DiffMaster Octavia automatically locates and presents images of blood cells on peripheral blood specimens. The operator identifies and verifies the suggested classification of each cell according to type.
DiffMaster Octavia is intended to be used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.
Product codes (comma separated list FDA assigned to the subject device)
JOY
Device Description
The DiffMaster-Octavia™ is an automated cell locating device for differential count of white blood cells and characterization of red morphology. It is based on a CellaVision AB developed software system Cytologica. DiffMaster Octavia™consists of a commercially available positioning system for the slides, a commercially available microscope, a commercially available camera and the software system.
Mentions image processing
Cells are located using the NCCLS scanning procedure. Cell images are analyzed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells
Mentions AI, DNN, or ML
Cells are located using the NCCLS scanning procedure. 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
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
DiffMaster Octavia is intended to be used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.
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)
Two clinical trials have been performed to confirm equivalence with the predicate method Romanowski (MGG)-Stain manual light microscopic process for cell classification. The studies have been performed according to the approved standard, NCCLS, vol. 23, no 1, document H-20A, March 1992: Reference Leukocyte Differential Count (proportional) and Evaluation of Instrumental Method. Complementary nonclinical tests have been performed to confirm cell location and display of found cells.
The following information was obtained from the clinical tests comparing the DiffMaster Octavia™ cell classification results to the manual reference method results:
- the accuracy of the suggested classification for each cell type (DiffMaster Octavia™ . results compared to the light microscope manual diff count results)
- the precision for location and display of the cells found .
- the precision of the instrument (reproducibility) ●
- the sensitivity and the specificity of the instrument (false positive and false negatives ● found)
Results equal to the reference method was provided by use of the DiffMaster Octavia™ instrument.
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 as prototype tests and successfully completed: a) Evaluation of:
a) Draianon on 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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The sensitivity and the specificity of the instrument (false positive and false negatives ● 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.
K925670/A
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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SECTION 2. SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the 510(k) summary for the DiffMaster Octavia™.
| SUBMITTER'S NAME: | CellaVision AB |
|---|---|
| ADDRESS: | Ideon Research Park, 223 70 Lund, Sweden |
| CONTACT PERSON: | Constance G. Bundy |
| TELEPHONE NUMBER: | 612-574-1976 |
| FAX NUMBER: | 612-571-2437 |
| DATE OF SUBMISSION: | October 19, 2000 |
Identification of device 1.
Proprietary Name: DiffMaster Octavia™ Automatic Hematology Analyzer Common Name: DiffMaster Octavia™ Classification Status: Class II per regulations 864-5260 Product Codes: JOY
Equivalent devices 2.
CellaVision AB believes the DiffMaster Octavia™is substantially equivalent to the Romanowski (MGG)-Stain manual light microscopic process for cell classification and the IMI MICRO21 with WBC Diff (White blood cell Differential, 510(k) number K925670/A).
3. Description of the Device
The DiffMaster-Octavia™ is an automated cell locating device for differential count of white blood cells and characterization of red morphology. It is based on a CellaVision AB developed software system Cytologica. DiffMaster Octavia™consists of a commercially available positioning system for the slides, a commercially available microscope, a commercially available camera and the software system.
1
Intended use 4.
The DiffMaster Octavia™ is an automated cell locating device.
DiffMaster Octavia automatically locates and presents images of blood cells on peripheral blood specimens. The operator identifies and verifies the suggested classification of each cell according to type.
DiffMaster Octavia is intended to be used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.
Technological characteristics, comparison to predicate device 5.
Like the predicate device, the DiffMaster Octavia™ instrument locates WBCs, stores digital images of the cells and displays the images in an organized manner and suggests a cell class for each cell to aid technologists in performing the WBC differential procedure. A competent technologist 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 instrument and in recognition of leukocyte classes.
Brief Discussion of Non clinical factors supporting a determination of substantial equivalence:
The method involves a competent human observer to examine the microscopic images of the cells as does the predicate method and device. See attached substantial equivalence comparisons.
Brief discussion of clinical tests supporting a determination of substantial equivalence: Two clinical trials have been performed to confirm equivalence with the predicate method Romanowski (MGG)-Stain manual light microscopic process for cell classification. The studies have been performed according to the approved standard, NCCLS, vol. 23, no 1, document H-20A, March 1992: Reference Leukocyte Differential Count (proportional) and Evaluation of Instrumental Method. Complementary nonclinical tests have been performed to confirm cell location and display of found cells.
Conclusions drawn from clinical tests:
The following information was obtained from the clinical tests comparing the DiffMaster Octavia™ cell classification results to the manual reference method results:
- the accuracy of the suggested classification for each cell type (DiffMaster Octavia™ . results compared to the light microscope manual diff count results)
- the precision for location and display of the cells found .
- the precision of the instrument (reproducibility) ●
- the sensitivity and the specificity of the instrument (false positive and false negatives ● found)
Results equal to the reference method was provided by use of the DiffMaster Octavia™ instrument.
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Comparative features of the DiffMaster Octavia compared with the predicate device and method
| Characteristic | IMI Micro21 | Manual light microscopic process | DiffMaster Octavia™ |
|---|---|---|---|
| Intended use | Automated cell location device for cell location and identification, for in-vitro use. Verification of results by human observer | Manual method for cell location and identification, for in-vitro use. Verification of results by human observer | Automated cell locating device for cell location, and identification, for in-vitro use. Verification of results by human observer |
| Sample type | Bloodfilm on glass slides of peripheral whole blood, stained | Bloodfilm on glass slides of peripheral whole blood, stained | Bloodfilm on glass slides of peripheral whole blood, stained |
| Sample preparation | Wright, Wright Giemsa, May Grünwald stain | May Grünwald Giemsa stain (MGG) | May Grünwald Giemsa stain (MGG) |
| Analysis technique | Cells are located using the NCCLS scanning procedure. Cell images are analyzed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells | Cells are located using the NCCLS scanning procedure. Cell images are analyzed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells |
・
:
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Discussion of performance testing. ર.
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 as prototype tests and successfully completed: a) Evaluation of:
a) Draianon on 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 the DiffMaster Octavia™ is substantially equivalent to devices already on the marked (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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle, with three curved lines forming the body and wings.
MAR 1 5 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Public Health Service
CellaVision AB c/o Ms. Constance G. Bundy C.G. Bundy Associates, Inc. 6740 Riverview Terrace Minneapolis, Minnesota 55432
Re: K003301
Trade Name: DiffMaster Octavia™ Automatic Hematology Analyzer Regulatory Class: II Product Code: JOY Dated: February 16, 2001 Received: February 20, 2001
Dear Ms. Bundy:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 910(x) notifically equivalent (for the indications for use above and we nave determined the actrices marketed predicate devices marketed in interstate commerce stated in the enclosure) to legally maneces processes in the Medical Device Amendments, or to devices that prior to May 26, 1970, the chaouncen and of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). Tourmaly, morolors, manov as as f the Act include requirements for annual provisions of the Act. "The general controle practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Fremarket Approval), it they of sayses in one of Federal Regulations, Title 21, Parts 800 to 895. allecting your device our of tournination assumes compliance with the Current Good A Substantially Cquiralient determinates set forth in the Quality System Regulation (QS) for Manufacturing Fridence required in (21 CFR Part 820) and that, through periodic QS Medical Devices. General regulation (FDA) will verify such assumptions. Failure to Inspections, the Food and Drug Temninesult in regulatory action. In addition, FDA may publish Comply with the GMT Togatator may readeral Register. Please note: this response to your premarket notification submission does not affect any obligation you might Its polise to your premarked noursearch start for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket a This letter will allow you to begin marketing your do nee of your device to a legally marketed notification. The FDA Inding of substantial equivalise of your device and thus, permits your device to procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 809.10 for in vitto diagnostions on the promotion and advertising of your device, (301) 594-4588. Additionally, for questions on the predictions of Areas note the regulation please contact the Office of Comphanoo at (301) 37 - 407.97 - 10.07.9 Directed entitled, "Misoranding of telefone to pennation in the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from information on your responsibilities and 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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B. INDICATIONS FOR USE
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Device Name: DiffMaster Octavia™
Indications for Use:
The DiffMaster Octavia™ is an automated cell locating device.
DiffMaster Octavia automatically locates and presents images of blood cells on Diffiviaster Octavia adtomations focults identifies and verifies the suggested classification of each cell according to type.
DiffMaster Octavia is intended to be used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.
J. Roberts
(Division Sign-Off) (Division of Clinical Laboratory Deyices o 3,30 L 510(k) Number -
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) ાર
Over the Counter Use _________________________________________________________________________________________________________________________________________________________