(53 days)
The Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell and Mucus.
The Sysmex® UF-1000i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists for three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The UF-1000i is equipped with a Sampler that provides continuous automated sampling for up to 50 tubes.
The instrument utilizes Sysmex flow cytometry using a red semiconductor laser for analyzing organized elements of urine. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using its own reagents, the UF-1000i automatically classifies organized elements of urine and carries out all processes automatically from aspiration of the sample to outputting the results.
Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.
The provided text does not contain detailed acceptance criteria or a study design to prove the device meets specific criteria for the Sysmex UF-1000i beyond general statements of equivalence to a predicate device. It primarily focuses on 510(k) submission information, device description, intended use, and a comparison table to its predicate.
Here's an analysis of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating "substantial equivalence" to a predicate device (Sysmex UF-100) through performance comparisons.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Implied by Equivalence) |
|---|---|
| Maintain performance for existing parameters (RBC, WBC, Epithelial Cells, Cast, Bacteria, Pathologic Cast, Crystal, Yeast-like cell, Sperm, Small Round Cell). | "Comparison to the UF-100 demonstrated excellent correlation." Data consisting of carryover, linearity, accuracy, and reproducibility show performance to the manufacturer's specifications. |
| Performance for the new "mucus flag" parameter. | Implied to be acceptable as part of the substantially equivalent determination. |
| Performance of the additional bacteria channel. | Implied to be acceptable as part of the substantially equivalent determination. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Data consisting of carryover, linearity, accuracy and reproducibility show performance to the manufacturer's specifications." However, it does not provide:
- The specific sample size used for these studies (test set).
- The data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document refers to "manufacturer's specifications" but does not detail how ground truth was established for the comparison studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The Sysmex UF-1000i is an automated urine particle analyzer, not an AI-assisted diagnostic tool that relies on human readers interpreting its output in a "multi-reader multi-case" study context. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device. It's a standalone automated analyzer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device is an "automated urine particle analyzer" and operates as an "algorithm only" system. The entire submission details its standalone performance in comparison to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for performance evaluation (e.g., manual microscopy by experts, culture results for bacteria). It relies on "comparison to the UF-100" and "manufacturer's specifications" for performance parameters like accuracy and reproducibility.
8. The sample size for the training set
The device described is a flow cytometry instrument that classifies particles based on physical properties (forward scatter, fluorescence, adaptive cluster analysis). While it utilizes "adaptive cluster analysis," which implies some form of algorithmic learning or classification, the document does not specify a "training set" sample size in the context of machine learning. The classification algorithms are likely pre-defined or trained during the instrument's development, but the specifics are not disclosed here.
9. How the ground truth for the training set was established
As with the test set, the document does not specify how ground truth for any potential training data or for the development of its classification algorithms was established.
Summary of missing information:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, quantitative acceptance criteria and a comprehensive study report for standalone performance. Many specific details regarding sample sizes, ground truth establishment, expert involvement, and study design are absent. This is common for 510(k) summaries which aim to provide a high-level overview required for regulatory submission. More detailed information would typically be found in the full 510(k) submission document, which is not provided here.
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5. 510(k) SUMMARY of the UF-1000i
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
| 1. Submitted by: | Sysmex America, Inc.One Nelson C. White ParkwayMundelein, IL 60060Phone: (847) 996-4675; FAX: (847) 996-4655Contact person: Nina GamperlingDate prepared: March 30, 2007 |
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| 2. Name of Device: | Trade or proprietary name: Sysmex® UF-1000iCommon name: Automated urine particle analyzer.Classification name:Urine Particle Counter (21 CFR 864.5200, Product Code LKM)Related Items:Sheath: UFII SHEATH (Product code: GIF)Stain: UFII SEARCH -SED (Product code: GJH)Diluent: UFII PACK -SED (Product code: GIF)Stain: UFII SEARCH -BAC (Product code: GJH)Diluent: UFII PACK -BAC (Product code: GIF)QC Material: UFII CONTROL (Product code: JIW)Calibrator: UFII CALIBRATOR (Product code: JJW)Option:Graph printerBar code ReaderRack Sampler Unit (UASU-3/UASU-4)PU-17 |
| 3. Predicate Method: | Sysmex® UF-100 (K961054-Cleared October 28, 1996) |
| 4. Device Description: | The Sysmex® UF-1000i, an automated urine particle analyzer, is adedicated system for the analysis of microscopic formed elements inurine specimens. The instrument consists for three principal units: (1)Main Unit which aspirates, dilutes, mixes and analyzes urine samples;(2) Auto Sampler Unit supplies samples to the Main Unit automatically;(3) IPU (Information Processing Unit) which processes data from theMain Unit and provides the operator interface with the system. The UF-1000i is equipped with a Sampler that provides continuous automatedsampling for up to 50 tubes.The instrument utilizes Sysmex flow cytometry using a redsemiconductor laser for analyzing organized elements of urine. Particlecharacterization and identification is based on detection of forwardscatter, fluorescence and adaptive cluster analysis. Using its ownreagents, the UF-1000i automatically classifies organized elements ofurine and carries out all processes automatically from aspiration of thesample to outputting the results.Analysis results and graphics are displayed on the IPU screen. Theycan be printed on any of the available printers or transmitted to a Host |
| computer. | |
| 5. Intended Use: | The Sysmex® UF-1000i is an automated urine particle analyzer for invitro diagnostic use in screening patient populations found in clinicallaboratories. The UF-1000i analyzes the following parameters in urinesamples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags thepresence of the following: Pathologic Cast, Crystal, Sperm, SmallRound Cell, Yeast like cell and Mucus. |
| 6. Substantialequivalence-Similarities andDifferences: | Table 1 shows substantial equivalence of the UF-1000i to the UF-100. |
| 7. Conclusion | The UF-1000i demonstrates substantial equivalence to the predicatedevice. |
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| Table 1: Substantial Equivalence—Similarities and Difference to UF-100 | |||
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| Sysmex UF-100Predicate | Sysmex UF-1000iModification of Predicate | Similarity/Difference | |
| Intended Use | The Sysmex™ UF-100 isintended for in vitrodiagnostic use in clinicallaboratories. The UF-100analyzes the followingparameters: RBC, WBC,Epithelial Cells, Cast, andBacteria and flags thepresence of the following:Pathologic Cast, Crystal,Yeast like cell, Sperm andSmall Round Cell. | The Sysmex® UF-1000i is anautomated urine particleanalyzer for in vitrodiagnostic use in screeningpatient populations found inclinical laboratories. The UF-1000i analyzes the followingparameters in urine samples:RBC, WBC, Epithelial Cells,Cast, and Bacteria and flagsthe presence of the following:Pathologic Cast, Crystal,Sperm, Small Round Cell,Yeast like cell and Mucus. | The intended usestatement is the same.The UF-1000ianalyzes the samebasic parameters buthas the addition of amucus flag. |
| Methodology | The instrument utilizesSysmex flow cytometryusing an argon laser foranalyzing organizedelements of urine. Incombination with flowcytometry the UF-100 usesan impedancemeasurement.The UF-100 uses flowcytometry with impedancemeasurement using adouble stain with twofluorescent dyes. Particlecharacterization andidentification is based ondetection of forward scatter,fluorescence andimpedance signals and onadaptive cluster analysis. | The instrument utilizesSysmex flow cytometry usinga red semiconductor laser foranalyzing organized elementsof urine. Particlecharacterization andidentification is based ondetection of forward scatter,fluorescence and adaptivecluster analysis.The UF-1000i uses the samemethodology as the UF-100with the addition of a newbacteria channel and sidescattered light signal. | Both systems use thesame methodologybut the UF-1000i hasan additional bacteriachannel and sidescattered light signal. |
| Reagents | URINOSHEATHURINOSEARCHURINOPACK | UFII SHEATHUFII SEARCH -SEDUFII PACK -SEDUFII SEARCH -BACUFII PACK -BAC | The UF-100 reagentshave been modifiedfor use on the UF-1000i with theaddition of UF IISEARCH -BAC andUF II PACK-BAC forthe bacteria channel. |
| QualityControl/Calibrator | UF-CHECK—3 levelsUF-CAL | UFII CONTROL—2 levelsUFII CALIBRATOR | UF-1000i controlmaterial has a similarformulation for two |
| Table 1: Substantial Equivalence-Similarities and Difference to UF-100 | ||
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| control levels insteadof three. Calibratormaterial is similar. | |||
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| Software/HardwareDifferences | One channel for sedimentonly. | Two channels for bacteria andsediment. | The UF-1000i has aseparate channel forthe detection ofbacteria. |
| SpecimenType | Random urine sample | Random urine sample | Both systems use thesame specimen type. |
| Throughput | Approx. 100 samples/hour | Same as UF-100 | Both systems have thesame throughput. |
| EquivalencyData: | Performance wasestablished in the UF-100510(k) submission(K961054). | Comparison to the UF-100demonstrated excellentcorrelation. | Data consisting ofcarryover, linearity,accuracy andreproducibility showperformance to themanufacturer'sspecifications. Thisanalysis supports theclaim that the UF-1000i is substantiallyequivalent to the UF-100. |
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Image /page/4/Picture/1 description: The image shows a circular seal with a stylized eagle in the center. The eagle is depicted with three curved lines forming its body and wings. The seal is surrounded by text, which is difficult to read due to the image quality. The overall design appears to be a government or organizational emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 5 2007
Nina M. Gamperling Sysmex America, Inc. One Nelson C. White Parkway Mundelein, Illinois 60060
Re: K070910
Trade/Device Name: Sysmex ® UF-1000i Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: LKM Dated: March 30, 2007 Received: April 2, 2007
Dear Ms. Gamperling:
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 application (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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robe Rete
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K070910 |
|---|---|
| --------------------------- | --------- |
Device Name: Sysmex® UF-1000i, Automated Urine Particle Analyzer
Indications For Use:
Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i analyzes the servering parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell and Mucus.
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Concurrence of CHRD, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
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| ------------------ | --- |
OR
| Over-The-Counter Use | |
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| ---------------------- | -- |
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K070910 |
|---|---|
| -------- | --------- |
Sysmex UF-1000i, Automated Urine Particle Analyzer 510(k) FDA Submission
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).