(31 days)
The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY ™ Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilingen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.
iChemVELOCITY strips are intended for use only with the iChem Velocity analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.
The iChemVELOCITY is an automated urine chemistry system performing measurements of defined physical and chemical constituents in urine. The system utilizes iChemVELOCITY urine chemistry test strips which are read in the Strip Reader Module (SRM) by measuring light reflectance, in addition the iChemVELOCITY measures color and clarity using light transmittance through Color/Clarity Module (CCM) and specific gravity using refractive index through Specific Gravity Module (SGM).
The subject of this submission is a design change to the Color/Clarity Module (CCM) of the Color/Clarity/Specific Gravity Module (CGM) subassembly of the iChemVELOCITY. The CCM measures the color and clarity of a urine sample using transmitted and scattered light, incident on a color sensor. An algorithm then converts the output of the different channels of the sensor into semi-quantitative colors. The CCM is being changed to replace end-of-life components (color sensor and scatter light source) and update the color detection algorithm.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: iChem®VELOCITY™ Automated Urine Chemistry System with redesigned Color/Clarity Module (CCM)
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" with numerical targets for the redesigned CCM. Instead, it aims to demonstrate substantial equivalence to the predicate device (iChemVELOCITY with the original CCM). Therefore, the reported performance is compared to the predicate's expected performance, with the implicit criterion being that the redesigned CCM performs at least as well as, or is in agreement with, the predicate.
Here's an interpretation of the performance data in the context of implied acceptance:
| Feature/Metric | Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (Redesigned CCM vs. Predicate) |
|---|---|---|
| Color Agreement | High percentage of exact match and ±1 block agreement with predicate device's color readings. | Refer to "Method Comparison Results Summary" and "Precision Results Summary" below for detailed numbers. All ±1 block agreement is 100% or 99.6%. Exact match ranges from 36% (Straw) to 100%. |
| Clarity Agreement | High percentage of exact match and ±1 block agreement with predicate device's clarity readings. | Refer to "Method Comparison Results Summary" and "Precision Results Summary" below for detailed numbers. All ±1 block agreement is 100% or 97.2%. Exact match ranges from 29.2% (Slightly Cloudy) to 100%. |
| Fit | The redesigned CCM must remain unchanged in fit within the iChemVELOCITY system. | "All testing successfully passed the acceptance criteria, and the test results demonstrated equivalence to the predicate." "The testing results confirmed that the redesigned CCM was fit..." |
| Function | The redesigned CCM must produce equivalent results to the predicate design. | "All testing successfully passed the acceptance criteria, and the test results demonstrated equivalence to the predicate." "The testing results confirmed that the redesigned CCM was...functionally compatible and equivalent to the original CCM." |
| New Hazards | No new hazards introduced by the design change. | "no new hazards were introduced with the implementation of this change and therefore safety associated with the operation of this device remains unchanged." |
| User Experience | The design change should not negatively impact the user experience. | "did not negatively impact the user experience." |
Detailed Performance Tables from the Document:
Method Comparison Results Summary (Page 8):
| Redesigned CCM / Comparator | Colorless | Straw | Yellow | Amber | Red | Blue |
|---|---|---|---|---|---|---|
| Color | ||||||
| Blue | 18 | |||||
| Red | 3 | 18 | ||||
| Amber | 5 | 18 | ||||
| Yellow | 11 | 61 | 9 | |||
| Straw | 13 | |||||
| Colorless | 18 | 12 | ||||
| Exact match: | 100.0% | 36% | 92% | 60.0% | 100.0% | 100.0% |
| ± 1 Block: | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| Redesigned CCM / Comparator | Clear | Slightly Cloudy | Cloudy | Turbid |
|---|---|---|---|---|
| Clarity | ||||
| Turbid | 32 | |||
| Cloudy | 1 | 22 | 1 | |
| Slightly Cloudy | 7 | 13 | ||
| Clear | 87 | 16 | 1 | |
| Exact match: | 100.0% | 29.2% | 61.1% | 97.0% |
| ± 1 Block: | 100.0% | 100.0% | 97.2% | 100.0% |
Precision Results Summary (Page 9):
| Color/Clarity | Test level | Number (Total) | Exact agree | ±1 block agree | % Exact agreement | % ±1 block agreement |
|---|---|---|---|---|---|---|
| Color | Colorless | 240 | 240 | 240 | 100% | 100% |
| Straw | 240 | 238 | 240 | 99.2% | 100% | |
| Yellow | 240 | 240 | 240 | 100% | 100% | |
| Amber | 240 | 240 | 240 | 100% | 100% | |
| Red | 240 | 237 | 239 | 98.8% | 99.6% | |
| Blue | 240 | 240 | 240 | 100% | 100% | |
| Clarity | Clear | 240 | 240 | 240 | 100% | 100% |
| Slightly Cloudy | 240 | 228 | 240 | 95.0% | 100% | |
| Cloudy | 240 | 240 | 240 | 100% | 100% | |
| Turbid | 240 | 240 | 240 | 100% | 100% |
2. Sample size used for the test set and the data provenance
- Sample Size: The "Precision Results Summary" table on page 9 indicates that for each color and clarity level category, 240 samples were tested.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that "Performance testing of the iChemVELOCITY with the redesigned CCM was conducted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts used or their qualifications for establishing ground truth. The "Method Comparison" results compare the "Redesigned CCM" to a "Comparator." Given the context of a design change to an existing device, the "Comparator" likely refers to the predicate iChemVELOCITY device with the original CCM. The ground truth, in this case, would be the results generated by the predicate device, not necessarily external human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method, as the comparison is primarily machine-to-machine (redesigned CCM vs. predicate CCM).
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated urine chemistry system, and the study focuses on the performance of the redesigned CCM against its predicate, not on human reader performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The entire study focuses on the performance of the automated iChemVELOCITY system with the redesigned CCM. There is no mention of human-in-the-loop performance evaluation for the color and clarity measurements. The device is intended "for clinical laboratory and in vitro diagnostic use only" and "is not intended for visual reading."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The primary ground truth for the performance study is the predicate device's performance. The study aims to show that the redesigned CCM produces results equivalent to the iChemVELOCITY with the original CCM, which was previously cleared.
8. The sample size for the training set
The document does not specify a separate training set size. The study describes a design change to existing hardware/software components, including an updated algorithm. It's possible that the "new firmware has been written and installed on the CCM's microprocessor... to update the CCM algorithm" implies some form of development/training, but the specifics and size are not provided in this regulatory summary.
9. How the ground truth for the training set was established
Since no specific training set and its size are explicitly mentioned, the method for establishing its ground truth is also not described. If algorithm development involved training, the ground truth would likely have been established using reference methods during the design phase of the original or updated algorithm, but this is not detailed in the provided text. The document focuses on the verification that the redesigned component performs equivalently to the existing, cleared device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2017
IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL NANCY NADLER DIRECTOR, REGULATORY AFFAIRS 9172 ETON AVE CHATSWORTH, CA 91311
Re: K171083
Trade/Device Name: iChemVELOCITY Automated Urine Chemistry System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JRE, JMA, KQO Dated: April 10, 2017 Received: April 11, 2017
Dear Nancy Nadler:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171083
Device Name
iChem®VELOCITY™ Automated Urine Chemistry System
Indications for Use (Describe)
The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY ™ Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iO®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilingen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.
iChemVELOCITY strips are intended for use only with the iChem Velocity analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the text "BECKMAN" on the first line and "COULTER" on the second line. The text is in a bold, sans-serif font.
iris
510(k) Summary for iChem®VELOCITY™ Automated Urine Chemistry System – CGM Design Change
510(k) Owner / Submitter Information
Nancy Nadler Director, Regulatory Affairs Iris Diagnostics, a Division of Iris International 9172 Eton Avenue Chatsworth, California 91311 Telephone: 305-380-4191 Fax: 786-639-4191 Email: nancy.nadler@beckmancoulter.com
Date Submitted: April 10, 2017
Device Information
Trade Name: iChem® VELOCITY™ Automated Urine Chemistry System Common Name: Urine Chemistry Analyzer
| Classification Name | ProductCode | DeviceClass | RegulationNumber |
|---|---|---|---|
| Urinary glucose (non-quantitative) testsystem | JIL | II | 21 CFR§862.1340 |
| Occult blood test | JIO | II | 21 CFR§864.6550 |
| Urinary urobilinogen (non-quantitative) test system | CDM | I | 21 CFR§862.1785 |
| Urinary bilirubin and its conjugates(non-quantitative) test system | JJB | I | 21 CFR§862.1115 |
| Ketones (non-quantitative test system) | JIN | I | 21 CFR§862.1435 |
| Urinary protein or albumin (non-quantitative) test system | JIR | I | 21 CFR§862.1645 |
| Nitrite (non-quantitative) test system | JMT | I | 21 CFR§862.1510 |
| Leukocyte peroxidase test | LJX | I | 21 CFR§864.7675 |
| Urinary pH (non-quantitative) testsystem | CEN | I | 21 CFR§862.1550 |
| Refractometer for Clinical Use | JRE | I | 21 CFR§862.2800 |
| Ascorbic Acid Test System | JMA | I | 21 CFR§862.1095 |
| Automated Urinalysis System | KOO | I | 21 CFR§862.2900 |
Table 1: Regulatory Information
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Image /page/4/Picture/0 description: The image contains the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the words "BECKMAN" and "COULTER" stacked on top of each other in black, bold font. The logo is simple and modern, with a focus on the company's name.
| Candidate | Predicate | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|---|
| iChemVELOCITYwith re-designedCGM | iChemVELOCITY | Iris Diagnostics,a Division of IrisInternational Inc | K101852 | 03/23/2011 |
Predicate Device Information
Device Description
The iChemVELOCITY is an automated urine chemistry system performing measurements of defined physical and chemical constituents in urine. The system utilizes iChemVELOCITY urine chemistry test strips which are read in the Strip Reader Module (SRM) by measuring light reflectance, in addition the iChemVELOCITY measures color and clarity using light transmittance through Color/Clarity Module (CCM) and specific gravity using refractive index through Specific Gravity Module (SGM).
The subject of this submission is a design change to the Color/Clarity Module (CCM) of the Color/Clarity/Specific Gravity Module (CGM) subassembly of the iChemVELOCITY. The CCM measures the color and clarity of a urine sample using transmitted and scattered light, incident on a color sensor. An algorithm then converts the output of the different channels of the sensor into semi-quantitative colors. The CCM is being changed to replace end-of-life components (color sensor and scatter light source) and update the color detection algorithm.
Intended Use/Indications for Use:
The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY TM Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.
iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
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Image /page/5/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, placed to the left of the company name. The text "BECKMAN COULTER" is written in bold, black letters, with "BECKMAN" on the top line and "COULTER" on the bottom line.
Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.
Comparison to Predicate
The design change applied to the CCM is to replace the color sensor Taos TCS230 with Taos TCS3200 color sensor, along with the scatter LED due to end-of-life of the components. These components were chosen because of their similar characteristics to the components they replace. In addition to the electronic components, new firmware has been written and installed on the CCM's microprocessor to control the new components and to update the CCM algorithm.
Color and clarity result categories are not changed with this design change, and the change is fit and functionally compatible with the subassembly as cleared in K101852. The CCM change is intended to provide a substantially equivalent subassembly with equivalent output to the original design as cleared in K101852.
Similarities and Differences between iChemVELOCITY as cleared in K101872 and the iChemVELOCITY with the redesigned CCM are shown in the table below.
| iChemVELOCITY AnalyzerK101852 (cleared on 3/23/2011) | Proposed DeviceiChemVELOCITY withRedesigned CCM | |
|---|---|---|
| Intended use | The iChem® VELOCITY™automated urine chemistry system isan in vitro diagnostic device used toautomate the urine chemistryanalysis profile using iChem®VELOCITY ™ Urine ChemistryStrips. The iChemVELOCITY canbe used as a stand-alone system, aswell as in an iQ®200 Series system,a configuration given the proprietaryname iRICELL™ as it is designed tobe hardware and softwarecompatible with iQ200 Seriessystems. It produces quantitativeresults for specific gravity; semi-quantitative results for glucose,blood, leukocyte esterase, bilirubin,urobilinogen, pH, protein, ketonesand ascorbic acid; and qualitative | Same |
| iChemVELOCITY AnalyzerK101852 (cleared on 3/23/2011) | Proposed DeviceiChemVELOCITY withRedesigned CCM | |
| results for nitrites, color and clarity.iChemVELOCITY strips areintended for use only with theiChemVELOCITY analyzer. Inparticular, they are not intended forvisual reading. TheiChemVELOCITY is not intended tobe used as a Point of Care (POC)analyzer. | ||
| These measurements are used to aidin the diagnosis of metabolicdisorders, kidney functionanomalies, urinary tract infections,and liver function. Tests performedusing the iChemVELOCITY areintended for clinical laboratory andin vitro diagnostic use only. | ||
| Specimenanalyzed | Urine collected in cup or othercontainer, and transferred to a tube forsampling onto iChemVELOCITY teststrips. | Same |
| Method ofOperation | Color change on the pads of theiChemVELOCITY strips are analyzedfor percent reflectance and converted toresults through an algorithmUrine color and clarity are obtained bymeasuring absorbance or scattering ofwhite light through a flowcell.Intensities of RGB wavelengths aremeasured with a solid-statephotodetector array.Specific gravity is measured bydetermining the refractive index of thespecimen | Same |
| Energy Source | AC power is converted to DC by aninternal switching mode power supply | Same |
| iChemVELOCITY AnalyzerK101852 (cleared on 3/23/2011) | Proposed DeviceiChemVELOCITY withRedesigned CCM | |
| Color Sensor | Taos TCS230 | Taos TCS3200Due to an obsolescence of thesensor |
| Scatter LED | Luxeonstar/Lumileds LXHL-LW3C | Luxeonstar/Lumileds SR-01-WC100 |
| Microcontroller | PIC 18F25 | Same |
| Boardcommunications | UART | Same |
| Firmware | The CCM measures the light intensityin RGB channels. Then it corrects eachchannel using iChemVELOCITY washsolution as a reference source. Thecompensated RGB data is converted toproject in 2 dimensional HSL colorplane | Same method for the HSL colorspace, however boundaries forcolor bins were modified and anOhta Color plane was added torefine color measurements alongthe boundaries of the HSLcalculations. |
| Result format | Semi-quantitative results are presentedfor color and clarity. Specifically: | Same |
| Color - Red, Blue, Amber, Yellow,Straw, and Colorless | ||
| Clarity - Turbid, Cloudy, SlightlyCloudy, and Clear |
Table 2: Comparison Between Proposed Device and Predicate Device
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Image /page/6/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular symbol with two curved white lines inside, resembling an abstract representation of a wave or a double helix. To the right of the symbol, the words "BECKMAN" and "COULTER" are written in bold, black, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.
iris
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Image /page/7/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the company name "BECKMAN COULTER" in bold, black letters. The word "BECKMAN" is stacked on top of the word "COULTER".
Image /page/7/Picture/1 description: The image shows the word "Iris" in a stylized, sans-serif font. The letters are in a gray color, and the word is slightly slanted to the right. The "i" is lowercase, and the rest of the letters are also lowercase. The word appears to be a logo or brand name.
Substantial Equivalence Conclusion
In order to demonstrate substantially equivalent performance of the proposed device to the predicate device for this design change, verification studies were designed and performed to ensure that the fit of the CCM in the iChemVELOCITY remained unchanged, and that the function of the CCM produced equivalent results to the predicate design. All testing successfully passed the acceptance criteria, and the test results demonstrated equivalence to the predicate.
In addition, no new hazards were introduced with the implementation of this change and therefore safety associated with the operation of this device remains unchanged.
In summary, the iChemVELOCITY with the redesigned CCM is substantially equivalent to the predicate device in regard to safety, effectiveness, and performance characteristics.
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Image /page/8/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, resembling a stylized representation of a wave or a double helix. To the right of the circle, the words "BECKMAN" and "COULTER" are written in bold, black, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.
Summary of Performance Data
This design change is transparent to the user and does not alter any performance claims of the device. Various tests were conducted on the redesigned CCM to verify that fit and function of the subassembly did not impact the user experience or the performance characteristics of the iChemVELOCITY system. Verification studies were designed based on the risk analysis to verify that the proposed design performed better or equivalently to the predicate.
Performance testing of the iChemVELOCITY with the redesigned CCM was conducted to ensure that the system as a whole demonstrates equivalent performance to the predicate design. This testing included:
- o Method Comparison
- Precision o
Performance Test Summary
Table 3: Method Comparison Results Summary
| Comparator | |||||||
|---|---|---|---|---|---|---|---|
| RedesignedCCM | Blue | 18 | |||||
| Red | 3 | 18 | |||||
| Amber | 5 | 18 | |||||
| Yellow | 11 | 61 | 9 | ||||
| Straw | 13 | ||||||
| Colorless | 18 | 12 | |||||
| Colorless | Straw | Yellow | Amber | Red | Blue | ||
| Exact match: | 100.0% | 36% | 92% | 60.0% | 100.0% | 100.0% | |
| ± 1 Block: | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| Comparator | |||||
|---|---|---|---|---|---|
| RedesignedCCM | Turbid | 32 | |||
| Cloudy | 1 | 22 | 1 | ||
| Slightly Cloudy | 7 | 13 | |||
| Clear | 87 | 16 | 1 | ||
| Clear | SlightlyCloudy | Cloudy | Turbid | ||
| Exact match: | 100.0% | 29.2% | 61.1% | 97.0% | |
| ± 1 Block: | 100.0% | 100.0% | 97.2% | 100.0% |
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Image /page/9/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the words "BECKMAN" in bold black letters above the word "COULTER" in bold black letters. To the left of the logo is a short black line.
| Color/Clarity | Test level | Number | % Exactagreement | % ±1 blockagreement | ||
|---|---|---|---|---|---|---|
| Total | Exactagree | ±1 blockagree | ||||
| Color | Colorless | 240 | 240 | 240 | 100% | 100% |
| Straw | 240 | 238 | 240 | 99.2% | 100% | |
| Yellow | 240 | 240 | 240 | 100% | 100% | |
| Amber | 240 | 240 | 240 | 100% | 100% | |
| Red | 240 | 237 | 239 | 98.8% | 99.6% | |
| Blue | 240 | 240 | 240 | 100% | 100% | |
| Clarity | Clear | 240 | 240 | 240 | 100% | 100% |
| Slightly Cloudy | 240 | 228 | 240 | 95.0% | 100% | |
| Cloudy | 240 | 240 | 240 | 100% | 100% | |
| Turbid | 240 | 240 | 240 | 100% | 100% |
Table 4: Precision Results Summary
Conclusion
Testing results verified that the iChemVELOCITY with the redesigned CCM produced results within the performance characteristics of the device and did not negatively impact the user experience.
The data presented in this Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.
The testing results confirmed that the redesigned CCM was fit, functionally compatible and equivalent to the original CCM.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.