(63 days)
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.
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".
Here's an analysis of the acceptance criteria and study details for the CellaVision® DM1200 Automated Hematology Analyzer, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary states that "The results fulfilled the pre-defined requirements" for accuracy for cell-location, accuracy for verified classification for each cell class, precision for verified classification for each cell class, and clinical sensitivity and specificity. However, the specific quantitative acceptance criteria or the reported performance metrics (e.g., specific accuracy percentages, precision values, sensitivity, and specificity thresholds) are not detailed in the provided document. The summary only generally claims that the results fulfilled these requirements.
To illustrate what such a table would look like if the data were present, here's a hypothetical structure:
Hypothetical Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| Accuracy for cell-location | > 95% | > 98% |
| Accuracy for verified classification | > 90% for all major cell classes | > 92% for all major cell classes |
| Precision for verified classification | CV < 5% for all major cell classes | CV < 3% for all major cell classes |
| Clinical Sensitivity (overall WBC diff) | > 90% | > 93% |
| Clinical Specificity (overall WBC diff) | > 85% | > 88% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The summary mentions "clinical tests" and "a pre-defined protocol for differentiation of the approved standard CLSI, H20-A2, Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods." While this indicates a formal study, the specific number of blood smears or cells included in the test set is not mentioned.
- Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data
- Retrospective or Prospective: Not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The study was performed according to CLSI H20-A2, which typically involves experienced morphologists. However, the specific qualifications (e.g., "radiologist with 10 years of experience") are not provided in the summary. The device's intended use also states it needs to be used by "skilled operators, trained in the use of the device and in recognition of blood cells," implying that the experts establishing ground truth would be highly skilled in blood cell morphology.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The CLSI H20-A2 standard, which the study adhered to, typically uses an agreement process among multiple experts to establish a reference differential, which could involve consensus or adjudication. However, the exact method (e.g., 2+1, 3+1, none) is not detailed in this summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: The summary discusses "comparison to the predicate device DM96 for differentiation of white blood cells" and "to confirm equivalence with the predicate device." However, it focuses on the device's performance against the predicate's results and adherence to standards, rather than a comparative effectiveness study showing human readers' improvement with AI vs. without AI assistance. The DM1200 is described as an "automated cell-locating device" where "The operator identifies and verifies the suggested classification of each cell." This indicates a human-in-the-loop system, but the study described does not quantify the improvement of human readers using the AI versus without it.
- Effect Size of Human Reader Improvement: Not applicable, as this specific type of MRMC study was not described.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Standalone Performance: No, a standalone performance study (algorithm only) was not explicitly described for the DM1200. The device's intended use clearly states: "The operator identifies and verifies the suggested classification of each cell according to type." This indicates that the device is designed to be used with a human reviewer in the loop, validating the AI's suggestions. The "accuracy for the verified classification" metric further supports this, suggesting the final classification is human-verified.
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus with adherence to the CLSI H20-A2, Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; 2nd Ed. standard. This standard provides guidelines for establishing reference differentials, which typically rely on experienced morphologists. The summary states: "performed according to a pre-defined protocol for differentiation of the approved standard CLSI, H20-A2."
8. Sample Size for the Training Set
- Sample Size for Training Set: Not mentioned. The summary focuses on the clinical tests for demonstrating equivalence, not on the details of the model's development or training data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not mentioned. Similar to the training set size, the details of how the training data's ground truth was established are not provided in the 510(k) summary.
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| 2 510(k) Summary | |
|---|---|
| 510(k) owner: | CellaVision ABIdeon Science ParkSE-223 70 LundSwedenPhone: +46-46 286 44 00Fax: +46-46 286 44 70 |
| ContactInformation: | C. G. Bundy Associates, Inc.435 Rice Creek Terrace NEFridley, MN 55432USAPhone: 763-574-1976Fax: 763-571-2437 |
| Date ofsummary: | September 14, 2009NOV 20 2009 |
| Device Name: | Proprietary Name: CellaVision® DM1200 Automated Hematology Analyzer Common/Classification Name: Automated Cell-locating device |
| ClassificationRegulation: | 21 CFR 864.5260 Class II medical device |
| ProductCode: | JOY; GKZ |
| PredicateDeviceIdentification: | CellaVision AB believes that DM1200 is substantially equivalent to the legallymarketed (unmodified) device DM96 (K033840) regarding technology andfunction. |
| DeviceDescription: | DM1200 is an automated cell-locating device for differential count of white bloodcells, characterization of red blood cell morphology and platelet estimation.DM1200 consists of a slide scanning unit (a robot gripper, a microscope and acamera) and a computer system containing the acquisition and classificationsoftware "CellaVision® DM software". |
| Intended Use: | DM1200 is an automated cell-locating device.DM1200 automatically locates and presents images of blood cells on peripheralblood smears. The operator identifies and verifies the suggested classification ofeach cell according to type.DM1200 is intended to be used by skilled operators, trained in the use of thedevice and in recognition of blood cells. |
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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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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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§ 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).