(308 days)
This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance.
The Prestige 24i with Ion Selective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in samples, using indirect potentiometry.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured as requested:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Prestige 24i (and equivalent models) details performance characteristics. The acceptance criteria themselves are not explicitly stated as pass/fail thresholds in the document. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Roche Cobas Mira Plus) through correlation, linearity, and precision. The reported performance is presented to support this claim of equivalence.
Given this, the table below presents the reported performance values. The implied acceptance criteria are that these values should be comparable to or within acceptable ranges for similar clinical chemistry analyzers for the measurement of sodium, potassium, and chloride, especially when compared to the predicate device.
| Performance Characteristic | Analyte | Reported Device Performance (Prestige 24i) | Implied Acceptance Criteria (Based on Substantial Equivalence) |
|---|---|---|---|
| Correlation Analysis | Correlation Coefficient (r): High (e.g., typically >0.95 for good agreement, though specific threshold not stated). Slope (Least-Squares): Close to 1.0 (indicating proportional agreement). Y-axis intercept: Close to 0 (indicating minimal constant bias). Values presented are considered acceptable for substantial equivalence. | ||
| Sodium | r = 0.97, Slope = 0.95, Intercept = +6.8625 mmol/L | ||
| Potassium | r = 0.99, Slope = 0.98, Intercept = -0.0135 mmol/L | ||
| Chloride | r = 0.98, Slope = 0.97, Intercept = +3.2579 mmol/L | ||
| Linearity | The device should be linear over the clinically relevant range for each analyte; the reported ranges are considered acceptable. | ||
| Sodium | 70 - 200 mmol/L (Serum) | ||
| Potassium | 1 - 50 mmol/L (Serum) | ||
| Chloride | 70 - 200 mmol/L (Serum) | ||
| Precision (Within Run) | Coefficient of Variation (%CV): Low (typically <5% for clinical chemistry, though specific thresholds are not stated). Values presented are considered acceptable. | ||
| Sodium | Sample 1: 1.0%, Sample 2: 0.6% | ||
| Potassium | Sample 1: 1.7%, Sample 2: 1.0% | ||
| Chloride | Sample 1: 0.5%, Sample 2: 0.8% | ||
| Precision (Day by Day) | Coefficient of Variation (%CV): Low (typically <5% for clinical chemistry, though specific thresholds are not stated). Values presented are considered acceptable. | ||
| Sodium | Sample 1: 1.4%, Sample 2: 1.3% | ||
| Potassium | Sample 1: 1.5%, Sample 2: 1.3% | ||
| Chloride | Sample 1: 2.5%, Sample 2: 2.3% |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the total number of patient samples or data points used for the correlation or linearity studies.
- For the precision test, the "N=20" indicates 20 measurements were taken for both "Within Run" and "Day by Day" precision calculations for each analyte (Sodium, Potassium, Chloride) and for two different samples (Sample 1 and Sample 2). This refers to the number of replicates, not necessarily unique patient samples.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- This device is a clinical chemistry analyzer, which measures analytes directly. Therefore, the "ground truth" for the test set is established by the measurement itself from a reference method (the predicate device, Roche Cobas Mira Plus) or controlled samples with known concentrations for linearity and precision.
- No human experts (e.g., radiologists) were involved in establishing the ground truth for this type of device performance study.
4. Adjudication Method for Test Set
- Not applicable. As a clinical chemistry analyzer, the "ground truth" is based on the analytical measurements from a reference method or known concentrations, not on expert interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for image-interpretation devices where human readers' performance is assessed. For a clinical chemistry analyzer measuring analytes, the direct comparison is between the new device's readings and a reference method's readings.
- Therefore, there is no effect size reported for human readers' improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance
- This is a standalone device in the sense that its measurements are directly compared to a predicate device. The performance characteristics (correlation, linearity, precision) are measures of the algorithm/device's analytical performance on its own. It's not an "AI algorithm" in the typical sense of interpreting complex data like images, but rather an automated analytical instrument.
7. Type of Ground Truth Used
- The ground truth for the correlation study was established by comparison to a legally marketed predicate device (Roche Cobas Mira Plus).
- For the linearity test, the ground truth would be samples with known, incrementally varied concentrations of the analytes.
- For the precision test, the ground truth would be repeated measurements of control or patient samples to assess the variability.
8. Sample Size for Training Set
- The document does not specify a separate "training set" or its sample size. Clinical chemistry analyzers are typically developed and validated using a range of samples and controls, but the concept of a "training set" like in machine learning models is not explicitly mentioned or typically applicable in the same way for these types of analytical instruments. The performance data presented are from validation studies, which serve to demonstrate the device's accuracy and reliability.
9. How Ground Truth for Training Set Was Established
- Given that a "training set" is not explicitly defined or described in the context of this device in the provided text, the method for establishing its ground truth is not specified. The validation relies on comparisons to known materials and a predicate device as described in point 7.
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<040958
Aug 1 of 3
Tokyo Boeki Medical System Ltd.
FEB 1 5 20953, 2-chome Ninomiyahigashi Akiruno-shi Tokyo 19-0815 Japan
Short Short Collection 10-10-10-10-10-10-19 19-19-19 15-19-15 Japan Phone: +81-42-550-7271 Fax: +81-42-550-7277
510(k) SUMMARY
Submitter's Name/Address
| Submitter's Name: | Tokyo Boeki Medical System Ltd. |
|---|---|
| Submitter's Address: | 3-63, 2-chome NinomiyahigashiAkiruno-shi Tokyo 197-0815 Japan |
| Phone: | +81-42-550-7271 |
| Fax: | +81-42-550-7277 |
| Establishment Registration Number: | 3004378324 |
| Owner/Operator Number: | 9060135 |
Contact Person (United States Agent)
| Name of Agent: | James M. Clinton |
|---|---|
| Agent's Business Name: | Quality and Regulatory Consulting, LLC |
| Street Address: | 5304 Golden Moss Trail, Raleigh,NC 27613-5662 |
| Phone: | 919-247-0479 |
| Fax: | 919-957-7911 |
| E-mail address: | clintonjim@earthlink.net |
| Date of Preparation of this Summary: | November 5, 2004 |
| Device Trade or Proprietary Name : | Prestige 24i, Sirrus, MGC 240(These are the same models except the names.For convenience of explanation, the Prestige 24i isrepresented of the three in this summary.) |
| Device Common Name: | Clinical Chemistry Analyzer(with optional ISE Module) |
| Classification Numbers/Class: | 75JJE, Class I75JGS, Class II75CEM, Class II75CGZ, Class II75JIX Class II |
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page 2 of 3
510(k) Summary:
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 : ______________________________________________________________________________________________________________________________________________
Description:
The Prestige 24i with Ion Selective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in samples, using indirect potentiometry.
Substantial Equivalence:
Substantial equivalence has been demonstrated between the Roche Cobas Mira Plus (K851172) and the Prestige 24i. Both analyzers are used to analyze for electrolytes. Both analyzers are calibrated with known concentration calibrator material and both utilize Ion Selective Electrodes.
Intended Use:
This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in samples.
Performance Characteristics:
A correlation analysis between Roche Cobas Mira Plus and the Prestige 24i yielded the following results :
| Representative Method | Correlation Coefficient | Slope (Least-Squares) | Y-axis intercept | |
|---|---|---|---|---|
| 1 | Sodium | 0.97 | 0.95 | +6.8625 mmol/L |
| 2 | Potassium | 0.99 | 0.98 | - 0.0135 mmol/L |
| 3 | Chloride | 0.98 | 0.97 | +3.2579 mmol/L |
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The linearity test yielded the following results:
| RepresentativeMethod | Linearity | |
|---|---|---|
| Sodium | 70 - 200 mmol/L (Serum) | |
| Potassium | 1 - 50 mmol/L (Serum) | |
| Chloride | 70 - 200 mmol/L (Serum) |
The precision test results:
| Item | Sample 1 %CV | Sample 2 %CV | ||
|---|---|---|---|---|
| 4 | Within RunN=20 | Sodium | 1.0 | 0.6 |
| Potassium | 1.7 | 1.0 | ||
| Chloride | 0.5 | 0.8 | ||
| 5 | Day by Day-RunN=20 | Sodium | 1.4 | 1.3 |
| Potassium | 1.5 | 1.3 | ||
| Chloride | 2.5 | 2.3 |
Conclusion
The data demonstrates that Prestige 24i is substantially equivalent to the Roche Cobas Mira (K851172).
3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a seal or emblem.
FEB 1 5 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tokyo Boeki Medical System LTD. c/o Mr. James M. Clinton United States Agent Quality & Regulatory Consulting, LLC 5304 Golden Moss Trail Raleigh, NC 27613-5662
Re: K040958
Trade/Device Name: Prestige models 24i and 400 and MGC model 240 Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium Test System Regulatory Class: Class II Product Code: CEM, CGZ, JGS, JIX, JJE Dated: January 28, 2005 Received: January 31, 2005
Dear Mr. Clinton:
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).
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Page 2 -
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 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)276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sean M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K040958
Prestige 24i; Sirrus; MGC 240 (three identical models varying in Device Name: name only) This device with an optional Ion Selective Electrode (ISE) module Indications For Use: is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance.
Yes Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
No Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
petinj
/(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1070958
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(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.