(147 days)
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No
The description focuses on the instrument's ability to locate, store, and display cell images for review by a technologist, with no mention of automated classification or analysis using AI/ML. The technologist performs the cell classification.
No.
The device is described as a laboratory instrument used for cytological analysis, locating and displaying nucleated cells for review by a technologist. It performs an in vitro diagnostic function by analyzing samples, not by directly treating a disease or condition in a patient.
Yes
The device performs cytological analysis by locating, storing, and displaying nucleated cells in human cerebrospinal fluid preparations for examination of cellular morphology and classification, which is a key step in diagnosing diseases. The "Intended Use / Indications for Use" states it is a "laboratory instrument used to perform cytological analysis."
No
The device description explicitly states it is a "laboratory instrument" and details a process involving physical slides, a centrifuge, staining, a frame holder, and the MICRO21 itself, which locates and stores images. This indicates the device includes significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "laboratory instrument used to perform cytological analysis by locating, digitally storing and displaying nucleated cells in human cerebrospinal fluid preparations." This clearly indicates that the device is used to examine human specimens (cerebrospinal fluid) in vitro (outside the body) for diagnostic purposes (cytological analysis).
- Device Description: The description outlines a process that involves preparing and analyzing human CSF samples in a laboratory setting. This aligns with the definition of an IVD.
- Performance Studies: The performance studies described (Method Verification and Sensitivity, Precision, Correlation Study Performance) are typical studies conducted to validate the performance of an IVD device.
- Mentions image processing: While not a definitive indicator on its own, the use of image processing to analyze cells from a human specimen is consistent with IVD applications.
- Intended User / Care Setting: The intended users are "qualified individuals" in a "laboratory instrument" setting, which is the typical environment for IVD testing.
The device is designed to provide information about the cellular composition of cerebrospinal fluid, which is used by qualified individuals to make diagnostic decisions. This fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intelligent Modical Imaging, Inc.'s MICRO21 ™ with Cerebrospinal Fluid (CSP) is a laboratory instrument used to perform cytological analysis by locating, digitally storing and displaying nucleated colls in a reform used to perform cytological analyals of coulding elganisy morphology and classification must be performed by qualified individuals.
Product codes
81JOY
Device Description
The MICRO21™ with Cerebrospinal Fluid is a new procedure for the MICRUZ/ with the tollowing in vitro diagnostic intended use: Intelligent Medical Imaging, Inc.'s MICRO21™ with Cerebrospinal Fluid (CSF) is a laboratory instrument used to perform cytological analysis by locating, digitally storing and displaying nucleated cells in human cerebrospinal fluid preparations. Examination of cellular morphology and classification must be performed by qualified individuals.
A summary of the MICRO21 with Cerebrospinal Fluid process is as follows:
- Patient CSF samples are prepared using the cytocentrifugation method for specimen concentration 1. using the Cytospin® centrifuge. . .
- Each slide has a black mask over the non-frosted portion with a hole in the mask for specimen 2. placement.
-
- The slide is stained using Wright's stain.
- The slides are barcoded and placed into a frame holder, and the frame is placed on the MICRO21 for 4. processing.
- ડ. The MICRO21 locates nucleated cells.
- The nucleated cell images are stored by the instrument and displayed on a color monitor for review by 6. a technologist.
- The technologist reviews the images and confirms each cell type. 7.
-
- A report of the CSF result for each patient is printed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
laboratory instrument
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Ten slides were processed using a quality control protocol to determine the detection sensitivity of the instrument. The ability of the instrument to locate cells at low and high power was determined by manually confirming the location of real cells or the location of non-cells such as stain precipitate.
To confirm the MICRO21 intra-instrument precision, three CSF specimen slides were processed eight times, each in random order. Using blinded experimental methods, the resulting images were presented to a technologist for review. The results were correlated to provide intra-instrument within slide precision.
Fifty CSF specimens obtained from various geographic sites were used for the study. For the manual method, two technologists processed and examined each slide by bright-field microscopy. Depending on the cellularity of the specimen, a cumulative differential of up to 250 nucleated cells were counted and classified. Any non-nucleated cells or micro-organisms were recorded if present. In addition, any cell clustering or cell packing (confluent layer of cells) was noted.
The same slides were then loaded onto the MICRO21 and processed using the routine procedure as outlined in the Product Description. For each slide, up to 250 images were captured. The number of images captured varied depending on the cellularity of the specimen and preparation quality. Non-cellular images typically included stain precipitate, smudge cells and stained protein clumps which were recognized and discarded. The number of non-cells found was directly dependent upon the quality of the slide preparation and the nature of the specimen.
For differential analysis, two technologists independently reviewed the stored images for each specimen and classified all nucleated cells accordingly. In addition, any non-nucleated cells, micro-organisms, cell clustering or cell packing was also recorded if present.
In order to provide an accurate correlation measurement between the MICRO2/ and the Manual Methods, an equivalent number of cells was used for comparison analysis. The number of cells used for the comparative analysis was determined by cells counted by the MICRO21.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Verification and Sensitivity: Ten slides were processed using a quality control protocol to determine the detection sensitivity of the instrument. The ability of the instrument to locate cells at low and high power was determined by manually confirming the location of real cells or the location of non-cells such as stain precipitate.
Precision: To confirm the MICRO21 intra-instrument precision, three CSF specimen slides were processed eight times, each in random order. Using blinded experimental methods, the resulting images were presented to a technologist for review. The results were correlated to provide intra-instrument within slide precision.
Correlation Study Performance: Cerebrospinal Cell Differentials (CCDs) obtained from images located and displayed by the MICRO21 were correlated with CCDs performed manually by qualified technologists. Fifty CSF specimens obtained from various geographic sites were used for the study.
Conclusion: The method verification and sensitivity, precision and correlation testing performed in the Test Methods confirm the safety and effectiveness of the MICRO21 with CSF for the intended use of performing cytological analysis by locating, digitally storing and displaying nucleated cells in human Cerebrospinal Fluid preparations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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).
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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).
0
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be 'K171470'. The handwriting is somewhat stylized, with the 'K' having a distinct shape and the '7' characters having a curved top. The numbers are written in a simple, clear manner.
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. Above and to the left of the letters is a graphic of interconnected dots and lines. The full name of the company, "Intelligent Medical Imaging, Inc," is printed in a smaller font below the logo.
SEP 1 6 1997
510(k) Summary
| Prepared by: | Ronald Lee Bartley, B.S., MT, NCA (CLS/C |
|---|---|
| Title: | Sr. Product Development Manager |
| Date: | April 18, 1997 |
| Trade Name: | |
| Classification Name: | Automated Cell Locating Device |
| Classification Number: | 81JOY |
| Class: | II |
| Regulation Number: | 864.5260 |
Description:
The MICRO21™ with Cerebrospinal Fluid is a new procedure for the MICRUZ/ with the tollowing in vitro diagnostic intended use: Intelligent Medical Imaging, Inc.'s MICRO21™ with Cerebrospinal Fluid (CSF) is a laboratory instrument used to perform cytological analysis by locating, digitally storing and displaying nucleated cells in human cerebrospinal fluid preparations. Examination of cellular morphology and classification must be performed by qualified individuals.
A summary of the MICRO21 with Cerebrospinal Fluid process is as follows:
- Patient CSF samples are prepared using the cytocentrifugation method for specimen concentration 1. using the Cytospin® centrifuge. . .
- Each slide has a black mask over the non-frosted portion with a hole in the mask for specimen 2. placement.
-
- The slide is stained using Wright's stain.
- The slides are barcoded and placed into a frame holder, and the frame is placed on the MICRO21 for 4. processing.
- ડ. The MICRO21 locates nucleated cells.
- The nucleated cell images are stored by the instrument and displayed on a color monitor for review by 6. a technologist.
- The technologist reviews the images and confirms each cell type. 7.
-
- A report of the CSF result for each patient 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, sans-serif font. Above and to the left of the letters is a graphic of interconnected dots and lines. Below the letters is the full name of the company, "Intelligent Medical Imaging, Inc."
Test Method 1: Method Verification and Sensitivity
Ten slides were processed using a quality control protocol to determine the detection sensitivity of the instrument. The ability of the instrument to locate cells at low and high power was determined by manually confirming the location of real cells or the location of non-cells such as stain precipitate.
Test Method 2: Precision
To confirm the MICRO21 intra-instrument precision, three CSF specimen slides were processed eight times, each in random order. Using blinded experimental methods, the resulting images were presented to a technologist for review. The results were correlated to provide intra-instrument within slide precision.
Test Method 3: Correlation Study Performance
Cerebrospinal Cell Differentials (CCDs) obtained from images located and displayed by the MICRO21 were correlated with CCDs performed manually by qualified technologists. Fifty CSF specimens obtained from various geographic sites were used for the study.
For the manual method, two technologists processed and examined each slide by bright-field microscopy. Depending on the cellularity of the specimen, a cumulative differential of up to 250 nucleated cells were counted and classified. Any non-nucleated cells or micro-organisms were recorded if present. In addition, any cell clustering or cell packing (confluent layer of cells) was noted.
The same slides were then loaded onto the MICRO21 and processed using the routine procedure as outlined in the Product Description. For each slide, up to 250 images were captured. The number of images captured varied depending on the cellularity of the specimen and preparation quality. Non-cellular images typically included stain precipitate, smudge cells and stained protein clumps which were recognized and discarded. The number of non-cells found was directly dependent upon the quality of the slide preparation and the nature of the specimen.
For differential analysis, two technologists independently reviewed the stored images for each specimen and classified all nucleated cells accordingly. In addition, any non-nucleated cells, micro-organisms, cell clustering or cell packing was also recorded if present.
In order to provide an accurate correlation measurement between the MICRO2/ and the Manual Methods, an equivalent number of cells was used for comparison analysis. The number of cells used for the comparative analysis was determined by cells counted by the MICRO21.
Conclusion
The method verification and sensitivity, precision and correlation testing performed in the Test Methods confirm the safety and effectiveness of the MICRO21 with CSF for the intended use of performing cytological analysis by locating, digitally storing and displaying nucleated cells in human Cerebrospinal Fluid preparations.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing the figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. R. Otto Stellner Vice President, Requlatory Compliance Intelligent Medical Imaging, Inc. 4360 Northlake Boulevard SEP 1 6 1997 Suite 214 Palm Beach Gardens, Florida 33410 Re: K971470/S1 Trade Name: MICRO 21™ with Cerebrospinal Fluid
Regulatory Class: II Product Code: JOY Dated: July 21, 1997 Received: July 22, 1997
Dear Mr. Stellner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood manufacturing practice, labeling, and prohibitions aqainst 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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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
4
K971470 510(k) Number (if known):
Device Name: MICRO21™ with Cerebrospinal Fluid
Indications for Use:
For In Vitro Diagnostic Use
Intelligent Modical Imaging, Inc.'s MICRO21 ™ with Cerebrospinal Fluid (CSP) is a laboratory instrument used to perform cytological analysis by locating, digitally storing and displaying nucleated colls in a reform used to perform cytological analyals of coulding elganisy morphology and classification must be performed by qualified individuals.
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number