(64 days)
The Sysmex UF-50 is a fully automated urine cell analyzer intended for in vitro diagnostic use in urinalysis within the clinical laboratory. The UF-50 replaces microscopic review of normal/abnormal specimens and flags specimens containing certain abnormalities which indicate the need for further testing. Laboratorians are responsible for final microscopic review of flagged abnormalities.
The UF-50 is a fully automated urine cell analyzer for urinalysis in clinical laboratories. It analyzes formed elements in urine using flow cytometry technology.
The provided document describes the Sysmex UF-50, a fully automated urine cell analyzer. The document focuses on its substantial equivalence to a predicate device, the Sysmex UF-100.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for the UF-50. Instead, the primary "acceptance criterion" is demonstrated by establishing substantial equivalence to the predicate device, the Sysmex UF-100. The reported device performance is that the "correlation results performance correlated to those of the two analyzers, therefore supporting the claim of substantial equivalence."
Since exact numerical criteria are not given, a table would not be directly comparable. However, the qualitative performance is aligned with the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample size for the correlation studies. It generally refers to "correlation studies."
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.
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 explicitly provided. Given that the study focuses on correlating the UF-50 to a predicate device (UF-100) and that the UF-50 flags specimens for "final microscopic review of abnormalities" by laboratorians, it's highly probable that a "ground truth" might have involved microscopic review by qualified laboratorians, but the number and qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for establishing ground truth, as the primary comparison is between the UF-50 and UF-100.
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
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. The study compares the UF-50 (an automated analyzer) to another automated analyzer (UF-100), not human readers with and without AI assistance.
- Effect Size: Not applicable, as no such study was performed. The device is intended to flag specimens for human review, not to improve human reader performance directly.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone study of the algorithm's performance was done. The "Clinical Performance Data" section describes "Correlation studies were performed to evaluate the equivalency of the UF-50 performance compared to the predicate device, the UF-100." This indicates that the UF-50's performance was evaluated independently, comparing its output directly to the predicate device's output. The device itself is described as a "fully automated urine cell analyzer" performing "in vitro diagnostic use," implying standalone operation to generate results that are then compared.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the correlation studies appears to be the results obtained from the predicate device, the Sysmex UF-100. The study "evaluate[d] the equivalency of the UF-50 performance compared to the predicate device, the UF-100." Therefore, the UF-100's performance served as the reference for determining the UF-50's equivalency.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning. The UF-50 is described as using "flow cytometry technology," which is a well-established analytical method, not typically associated with machine learning training sets in the same way an AI algorithm might be.
9. How the ground truth for the training set was established
Not applicable, as no machine learning training set is described.
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Image /page/0/Picture/1 description: The image shows the word "Sysmex" in a stylized, double-lined font. The letters are bold and black, and the word is followed by the superscript letters "TM". The logo appears to be a company logo. The font is sans-serif.
SYSMEX CORPORATION GILMER ROAD 6699RFD Long Grove, IL 60047-9596 (800) 379-7639 (847) 726-3505 Facsimile
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is _KO12372
Submitted By: 1.
Chris Stukel
Sysmex Corporation of America Gilmer Road, 6699 RFD Long Grove, IL 60047 1-847-726-3523 (PHONE) 1-847-726-3559 (FAX) July 25, 2001
Name of Device:
Trade Name- Sysmex UF-50TM
Common Name- Fully Automated Urine Cell Analyzer
Classification Name- Urine Particle Counter
Sysmex UF-100TM
Predicate Device:
Device Description: 4.
The UF-50 is a fully automated urine cell analyzer for urinalysis in clinical laboratories. It analyzes formed elements in urine using flow cytometry technology.
న్. Intended Use:
The UF-50 is intended for in vitro diagnostic use in urinalysis in clinical laboratories. The instrument is a medical device which flags specimens containing certain abnormalities. Laboratorians are responsible for final microscopic review of abnormalities.
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Technology Characteristics: 6.
| UF-50 | UF-100 | |
|---|---|---|
| Flow Cytometry detectionwith Argon laser beam for allparameters? | YES | YES |
| Flow Cytometry plus Electricimpedance detection for threeparameters? | NO | YES |
Clinical Performance Data: 7.
Correlation studies were performed to evaluate the equivalency of the UF-50 performance compared to the predicate device, the UF-100. The comparison results performance ochipated to mapce of the two analyzers, therefore supporting the claim of substantial equivalence.
Conclusions: 8.
. .
The performance data demonstrated substantial equivalence.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Chris Stukel, BSMT (ASCP) Regulatory Affairs Specialist Sysmex Corporation Gilmer Road 6699 RFD Long Grove, Illinois 60047-9596
SEP 2 8 2001
K012372 Re:
Trade/Device Name: Sysmex™ UF-50TM Regulation Number: 21 CFR § 864.5200 Regulation Name: Counter, Urine Particle Regulatory Class: II Product Code: LKM, GKZ Dated: July 25, 2001 Received: July 26, 2001
Dear Mr. Stukel:
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 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); good manufacturing practice requirements as set
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Sutman
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
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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known) | K012372 |
|---|---|
| Device Name | Sysmex UF-50™ |
| Indications for Use | The Sysmex UF-50 is a fully automated urine cell analyzer intended for in vitro diagnostic use in urinalysis within the clinical laboratory. The UF-50 replaces microscopic review of normal/abnormal specimens and flags specimens containing certain abnormalities which indicate the need for further testing. Laboratorians are responsible for final microscopic review of flagged abnormalities. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Clinical Laboratory Devices
510(k) Number K012372
Prescription Use_
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
UF-50 510(k) Attachment 4
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§ 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).