(81 days)
K925670/A
Not Found
No
The description focuses on automated image location and display for technologist review, without mentioning AI/ML algorithms for image analysis or classification. The technologist is explicitly involved in confirming the reticulated cells.
No
Explanation: The device is used to aid technologists in performing the Reticulocyte Count procedure by locating, storing, and displaying reticulated red blood cells. This is a diagnostic function, not a therapeutic one.
Yes
The device aids in performing the Reticulocyte Count procedure, which is a laboratory test used to diagnose and monitor various blood conditions, thus making it a diagnostic device.
No
The device description explicitly states it is an "automated microscopic system" and describes physical components like a "frame holder" and "instrument" that slides are inserted into, indicating it includes hardware beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid the technologist in performing the Reticulocyte Count procedure." This procedure involves analyzing a blood sample to determine the percentage of reticulated red blood cells, which is a diagnostic test performed in vitro (outside the body) on a biological specimen.
- Device Description: The device processes a "blood wedge smear stained with a supravital stain." This clearly indicates the analysis of a biological sample (blood) using a staining technique, which is characteristic of in vitro diagnostic procedures.
- Performance Studies: The performance studies compare the device's results to a "manual retic count," which is a standard laboratory diagnostic procedure. The studies also evaluate the device's ability to locate and identify reticulated RBCs in blood smears.
- Predicate Device: The predicate device is the "MICRO21™ with WBC Diff (White Blood Cell Differential)," which is also an IVD device used for analyzing blood cells. This further supports the classification of the new device as an IVD.
The device is designed to perform a diagnostic test on a biological sample (blood) in a laboratory setting, which aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MICRO21™ with WBC Diff (White Blood Cell Differential) Ref. No. K925670/A is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 with Retic is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays reticulated red blood cells (retics) to aid the technologist in performing the Reticulocyte Count procedure.
Product codes
81JOY
Device Description
The MICRO21™ with WBC Diff (White Blood Cell Differential) Ref. No. K925670/A is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 process is substantially equivalent to the manual microscopic process.
The MICRO21 with Retic is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays reticulated red blood cells (retics) to aid the technologist in performing the Reticulocyte Count procedure. A retic is defined as a nomnucleated Red Blood Cell (RBC) that contains two or more blue-stained particles or granulofilamentous material after staining with a supravital stain. A summary of the MICRO21 with Retic process is as follows:
- Prepare a blood wedge smear stained with a supravital stain.
- Affix a bar code to each slide, place the slides into ; frame holder, and insert the frame into the MICRO21.
- The instrument locates 1000 RBCs.
- The reticulated RBCs are stored as high magnification color images (1000x magnification).
- The images of retics stored by the instrument are displayed on a color monitor for review by a technologist.
- The technologist confirms that each reticulated RBC image displayed contains retic markings. If the image does not contain retic markings, the image is eliminated by the technologist and consequently not included in the retic count.
- A report of the percent of retics per 1000 RBCs is printed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Microscopic
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Technologist
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
Two testing methods were performed to validate the safety and effectiveness of the MICRO21 with Retic process. To conduct the tests, two slides were created from forty patient samples, (80 slides in total) including normal and abnormal values.
Test Method One employed the NCCLS EP-9 requirements for qualifying a new methodology versus the manual methodology being replaced. Using forty specimens with two slides from each specimen for a total of 80 slides, two technologists independently performed a munual retic count on each of the 80 sides.
Test Method Two involved two certified technologists independently observing the MICRO21's ability to locate RBCs and reticulated RBCs on 39 slides.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two testing methods were performed to validate the safety and effectiveness of the MICRO21 with Retic process.
Test Method One: The same 80 slides were run on the MICRO21 with Retic with the two technologists reviewing the reticulated RBCs displayed by the MICRO21. The results of the 80 manual retic counts and the 80 MICRO21 retic counts were analyzed against the NCCLS EP-9 Mean Correlation Standard. The MICRO21 with Retic and the manual method showed a .95 mean correlation, which is within the NCCLS EP-9 requirements for a new methodology.
Test Method Two: Over 39,000 RBCs were located by the MICRO21 with a sensitivity (agreement with the technologist) of 99.7%.
Conclusion: The correlation determined by Test Method One, and the sensitivity determined by Test Method Two confirm the safety and effectiveness of the MICRO21 with Retic for the intended use of location, storage and display of reticulated RBC's to aid the technologist in performing the Retic Count procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean Correlation: 0.95 (Test Method One)
Sensitivity: 99.7% (Test Method Two)
Predicate Device(s)
K925670/A
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).
0
Image /page/0/Picture/0 description: The image shows the date "MAY 17 1996" in bold, black font. The month is written in all capital letters, followed by the day and year. The numbers are clearly visible and easily readable. The date appears to be printed or stamped onto a document.
Image /page/0/Picture/1 description: The image shows the logo for Intelligent Medical Imaging, Inc. The logo features the letters "IMI" in a bold, sans-serif font. To the left of the letters is a graphic of interconnected dots, resembling a network or constellation. The words "Intelligent Medical Imaging, Inc." are printed in a smaller font below the letters.
510(K) SUMMARY
| Prepared by: | Christine B. Harper, MBA,MT(ASCP) |
|---|---|
| Title: | Senior Product Development Manager |
| Date: | February 7, 1996 |
| Trade Name: | MICRO21 ™ with Retic |
|---|---|
| Classification Name: | Automated Cell Locating Device |
| Classification Number: | 81JOY |
| Class: | II |
| Regulation Number: | 864.5260 |
The MICRO21™ with WBC Diff (White Blood Cell Differential) Ref. No. K925670/A is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 process is substantially equivalent to the manual microscopic process.
Description:
The MICRO21 with Retic is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays reticulated red blood cells (retics) to aid the technologist in performing the Reticulocyte Count procedure. A retic is defined as a nomnucleated Red Blood Cell (RBC) that contains two or more blue-stained particles or granulofilamentous material after staining with a supravital stain. A summary of the MICRO21 with Retic process is as follows:
- Prepare a blood wedge smear stained with a supravital stain. 1 .
-
- Affix a bar code to each slide, place the slides into ; frame holder, and insert the frame into the MICRO21.
-
- The instrument locates 1000 RBCs.
- The reticulated RBCs are stored as high magnification color images (1000x magnification). 4.
- The images of retics stored by the instrument are displayed on a color monitor for review by a રું. technologist.
- The technologist confirms that each reticulated RBC image displayed contains retic markings. If 6. the image does not contain retic markings, the image is eliminated by the technologist and consequently not included in the retic count.
-
- A report of the percent of retics per 1000 RBCs is printed.
1
Image /page/1/Picture/0 description: The image shows the logo for Intelligent Medical Imaging, Inc. The logo features the letters "IMI" in a bold, stylized font. Above the letters is a graphic of interconnected dots, resembling a network or a constellation. The text "Intelligent Medical Imaging, Inc." is printed below the letters.
Test Methods:
Two testing methods were performed to validate the safety and effectiveness of the MICRO21 with Retic process. To conduct the tests, two slides were created from forty patient samples, (80 slides in total) including normal and abnormal values.
Test Method One employed the NCCLS EP-9 requirements for qualifying a new methodology versus the manual methodology being replaced. Using forty specimens with two slides from each specimen for a total of 80 slides, two technologists independently performed a munual retic count on each of the 80 sides. The same 80 slides were run on the MICRO21 with Retic with the two technologists reviewing the reticulated RBCs displayed by the MICRO21. The results of the 80 manual retic counts and the 80 MICRO21 retic counts were analyzed against the NCCLS EP-9 Mean Correlation Standard. The MICRO21 with Retic and the manual method showed a .95 mean correlation, which is within the NCCLS EP-9 requirements for a new methodology.
Test Method Two involved two certified technologists independently observing the MICRO21's ability to locate RBCs and reticulated RBCs on 39 slides. Over 39,000 RBCs were located by the MICRO21 with a sensitivity (agreement with the technologist) of 99.7%.
Conclusion:
The correlation determined by Test Method One, and the sensitivity determined by Test Method Two confirm the safety and effectiveness of the MICRO21 with Retic for the intended use of location, storage and display of reticulated RBC's to aid the technologist in performing the Retic Count procedure.