(78 days)
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No
The description mentions "automated intelligent microscopy" but provides no details or evidence of AI/ML algorithms being used for image analysis or interpretation. The performance studies compare detection rates with a predicate device, which is standard for microscopy systems and doesn't inherently indicate AI/ML. There is no mention of training or test sets, which are typical for AI/ML development.
No
The device performs diagnostic functions (routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination) rather than providing treatment or therapy.
Yes
The "900UDx Urine Pathology System performs routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination," which are all diagnostic activities.
No
The device description explicitly mentions hardware components such as an autosampler, an independent ViewStation computer, and integration with an external chemistry analyzer (Boehringer Mannheim Hitachi CHEMSTRIP® Super UA Urine AnalyzerTM). This indicates it is a system with both hardware and software components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system "performs routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination." Urinalysis is a common in vitro diagnostic test.
- Device Description: The description details how the system analyzes urine samples ("Specimens are aspirated by an autosampler," "Microscopic examination results are displayed," "Chemistry results... are automatically consolidated"). This process of analyzing a biological sample outside of the body is characteristic of an IVD.
- Anatomical Site: The anatomical site is listed as "Urine," which is a biological specimen collected from the body for diagnostic testing.
- Performance Studies: The summary of performance studies describes a comparison with a predicate device for the "Microscopic analysis performance" and "Detection of RBC, WBC, squamous epithelial cells, pathologic casts, and yeast." These are all components analyzed in a diagnostic urinalysis.
- Predicate Device: The predicate devices listed are "The Yellow IRIS® Urinalysis Workstation with CHEMSTRIP® Reader" and "The IRIS Flow Microscope." These are known IVD devices used for urinalysis.
All of these factors strongly indicate that the 900UDx Urine Pathology System is designed to perform diagnostic tests on a biological sample (urine) outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 900UDx Urine Pathology System performs routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination.
Product codes
21 CFR 862.2900, 21 CFR 862.3600
Device Description
The 900UDx Urine Pathology System provides automatic sample handling for automated intelligent microscopy and improved data presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Microscopic examination results are displayed on an independent ViewStation computer with higher image resolution, and operators can confirm and release reports off-line for enhanced convenience. Chemistry results from the external Boehringer Mannheim Hitachi CHEMSTRIP® Super UA Urine AnalyzerTM are automatically consolidated by the ViewStation for display and reporting.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies
Microscopic analysis performance of the 900UDx Urine Pathology System was compared with that of The Yellow IRIS Urinalysis Workstation.
Key Metrics
Detection of RBC, WBC, squamous epithelial cells, pathologic casts, and yeast was found to be equivalent to that of the predicate device. The 900UDx Urine Pathology System had greater sensitivity for detection of renal epithelial cells and crystals as well as for overall detection of abnormal urines. Reproducibility was equivalent to that of the predicate device. The 900UDx Urine Pathology System has been shown to be suitable for its intended use.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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International Remote Imaging Systems, Inc. 9162 Eton Avenue, Chatsworth, CA 91311
800-776-4747 818-709-1244 FAX 818-700-9661 Mar 2 2
510(k) SUMMARY
510(k) Submission K960054
IRIS 900UDx™ Urine Pathology System
General Information:
| Date of Submission: | December 30, 1995 |
|---|---|
| Trade Name of Device: | 900UDx Urine Pathology System |
| Common Name of | |
| Device: | Automated urinalysis system |
| Classification Name: | Automated urinalysis system, |
| 21 CFR 862.2900, Class I | |
| Microscope, 21 CFR 862.3600, Class I | |
| Submittor's Name: | Alan E. Koontz, Ph.D. |
| Vice President, Marketing and Business Development | |
| International Remote Imaging Systems, Inc. | |
| 9162 Eton Avenue, Chatsworth, CA 91311 | |
| Intended Use: | The 900UDx Urine Pathology System performs |
| routine urinalysis, including urine chemistry, specific | |
| gravity, and sediment microscopic examination. | |
| Substantial Equivalence | |
| to Predicate Device: | The 900UDx Urine Pathology System is substantially |
| equivalent under Section 510(k) of the Food, Drug, | |
| and Cosmetic Act to The Yellow IRIS® Urinalysis | |
| Workstation with CHEMSTRIP® Reader, and the IRIS | |
| Flow Microscope. | |
| Summary of | |
| Technological | |
| Characteristics: | The 900UDx Urine Pathology System provides |
| automatic sample handling for automated | |
| intelligent microscopy and improved data | |
| presentation and management. Specimens are |
1
| | aspirated by an autosampler rather than poured
manually. Microscopic examination results are
displayed on an independent ViewStation computer
with higher image resolution, and operators can
confirm and release reports off-line for enhanced
convenience. Chemistry results from the external
Boehringer Mannheim Hitachi CHEMSTRIP® Super
UA Urine AnalyzerTM are automatically consolidated
by the ViewStation for display and reporting. |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Studies: | Microscopic analysis performance of the 900UDx
Urine Pathology System was compared with that of
The Yellow IRIS Urinalysis Workstation. |
| Conclusions Drawn
From Clinical Tests: | Detection of RBC, WBC, squamous epithelial cells,
pathologic casts, and yeast was found to be
equivalent to that of the predicate device. The
900UDx Urine Pathology System had greater
sensitivity for detection of renal epithelial cells and
crystals as well as for overall detection of abnormal
urines. Reproducibility was equivalent to that of the
predicate device. The 900UDx Urine Pathology
System has been shown to be suitable for its intended
use. |
. . . .