MICRO21 WITH URINE SEDIMENT ANALYSIS

{0}------------------------------------------------ AUG - 7 1998 Image /page/0/Picture/1 description: The image shows the logo for Intelligent Medical Imaging, Inc. The logo includes the letters "IMI" in a stylized font, with a network of lines and dots above the letters. Below the logo is the text "Intelligent Medical Imaging, Inc.". The number "K982301" is written below the company name. # 510(k) Summary Assigned 510(k) number : This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.2. | Designated Point of Contact: | R. Otto Stellner | |------------------------------|--------------------------------------------| | Title: | Vice President, Regulatory Compliance | | Project Management | Susan M. Steele BSMT | | Title: | Product Development Laboratory Coordinator | | Sean D. Murphy, Ph.D. | | | Title: | Product Development Technical Coordinator | | Date: | Tuesday, June 30, 1998 | | Trade Name: | MICRO21® with Urine Sediment Analysis | | Classification Name: | Automated Cell Locating Device | | Classification Number: | 81JOY | | Class: | II | | Regulation Number: | 864.5260 | ### Intended Use For In Vitro Diagnostic Use Intelligent Medical Imaging, Inc.'s MICRO21 @ with Urine Sediment Analysis is a laboratory instrument for locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result. ### Description: The MICRO21 with Urine Sediment Analysis, is an automated microscopic system that locates formed elements of wine sediment, digital stores images of the constituents and displays the images in an organized manner to aid technologists in performing an Urine Sediment Analysis procedure. The MICRO21 process is substantially equivalent to the manual microscopic process. A summary of the MICRO21 with Urine Sediment Analysis process is as follows: - Patient urine samples are prepared by a technologist pouring off 12mL of fresh urine into a centrifyge tube and capping 1. the tube. - 2. Each capped tube is then centrifuged at a relative centrifugal force of 400 for 5 minutes; approximately 1500 revolutions per minute with a 6 inch rotor radius (NCCLS Protocol GP 16-A). - 3. The tubes are then removed from the centrifyge without disturbing the sediment, uncapped and decanted to 1mL. - After resuspending the sediment, 20 ul of commercial urine sediment stain (Sternheimer-Malbin) are added to the 4. sediment and mixed. Herein referred to as Stained Sample. - One drop of the stained sample is placed into the designated well of the urine slide can hold up to 8 ર. individual stained samples. - 6. The technologist then enters the test order into the MCRO21 Review station Order Entry Screen, prints a barcode and places it on the urine slide. The barcode corresponds to the urine slide and wells allocated for the individual samples. - 7. The MCRO21 captures a minimum of 40 microscopic images, 16 at 100x magnification, 16 images at 200x magnification, and 8 images at 400x magnification, digitizes the images and stores them for display on a color monitor for review by a technologist. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Intelligent Medical Imaging, Inc. The logo consists of a stylized graphic element above the company name. The graphic element appears to be a network of interconnected lines and dots, possibly representing a neural network or a complex system. The text "Intelligent Medical Imaging, Inc." is written in a clear, bold font. - The technologist reviews the images and quantifies the results. 8. - A report of the results for each patient is printed. 9. ## Effectiveness Testing To demonstrate the validity of the procedure, performance testing was conducted to assess the instrument's precision, accuracy, linearity, and correlation with the manual method. A summary of each is presented. ### Test Method 1: Precision To confirm instrument precision, a stained specimen sample from one processed and reviewed 5 times on the 10 commin there specimens, one each from a low, normal and high range were tested. The results were reviewed and recorded for each samples. ### Test Method 2: Reproducibility To confirm linearity, specimens containing reportable ranges for RBC's and squamous epithelial cells were processed and reviewed on the MICRO21. RBC and WBC were recorded at 200x magnification. Squamous epithelial cells were recorded at 100x magnification. Selected highly concentrated specimens were used and dilutions of the specimen were made to obtain ranges. The results were reviewed and recorded for each sample. #### Test Method 3: Linearity To confirm linearity, specimens containing reportable ranges for RBC's and squamous epithelial cells were processed and reviewed on the MICRO21. The results were reviewed and recorded for each sample. #### Test Method 4: Correlation The MICRO21 with Urine Sediment Analysis results were compared to the manual urine microscopic reference method using standard correlation statistics. Results are reported as number of formed elements per reportable range, as recommended by NCCLS in GP16-A, Urinalysis and Collection, Transportation of Urine Specimens, Approved Guideline. For quantitative results, the average value from each range was used for computing the regression analysis values. For quantitative items. R values were used to demonstrate correlation. For qualitative results, correlation or equivalence was determined to be within one reporting range of each other, as recommended in NCCLS GP16-A, section 2.3.2 Microsopic Urinalysis. There were 182 stained samples were analyzed both manually and on theMICRO21 by three certified medical technologists. To generate a wider range of urinary constituents, 31 stained samples were created using serial dilution and enrichment. Using blinded experimental methods, the stained samples were reviewed manually, and processed by the MCRO21 and resultant images reviewed by the technologists. ### Conclusion There was no significant variation in the precision, reproducibility, and linear testing demonstrating the method. Correlation was demonstrated for RBC, WBC, Squamous Epithelial cells, Hyaline Casts, Amorphous, Calcium Oxalate, and Triple Phosphate Crystals, Mucous, Sperm and Yeast. The data presented support the claim that the MCCRO21 with Urine Sediment Analysis is safe and effective for it's intended use of locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result. Image /page/1/Picture/16 description: The image shows the text "Page 2 of 2". This indicates that the image is the second page of a two-page document. The text is written in a simple, sans-serif font and is positioned at the top of the image. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is slightly angled. The background is plain white. The text is the main focus of the image. Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three abstract head profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged vertically along the left side of the logo. AUG - 7 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. R. Otto Stellner Vice President, Regulatory Compliance Intelligent Medical Imaging, Inc.™ 4360 Northlake Boulevard, Suite 214 Palm Beach Gardens, Florida 33410 Re: K982301 Trade Name: MICRO21® with Urine Sediment Analysis Requlatory Class: II Product Code: JOY Dated: June 30, 1998 Received: July 1, 1998 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 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). 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 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 affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Reqister. 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. {3}------------------------------------------------ #### Page 2 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 requlation (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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Butman 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}------------------------------------------------ K982301 510(k) Number (if known): Device Name: べ MICRO21 with Urine Sediment Analysis Indications for Use: #### For In Vitro Diagnostic Use Intelligent Medical Imaging, Inc.'s MICRO21® with Urine Sediment Analysis is a laboratory instrument for locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result. INTELLIGENT MEDICAL IMAGING, INC. DOES NOT PROMOTE THE USE, PROVIDE SUPPORT FOR, MAKE CLAIMS OF EFFECTIVENESS OF, OR ASSUME LIABILITY OF THIS DEVICE IN ANY OTHER COMMERCIAL, EXPERIMENTAL OR INVESTIGATIONAL APPLICATION. Use of this device in any manner that is inconsistent with its intended use may be in violation of federal law. (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 1,1 Over-The-Counter Use (Optional Format 1-2-96) Audie Meson 8/5/98 (Dinsici Sign-Off) Division of Chincal Labo S . ciki Number -