(87 days)
The Reprocessing Product Corporation (RPC) Total Chlorine Test Strips are indicated for detection of Free Chlorine and Total Chlorine in water. These Test Strips are indicated for testing water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine).
Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Free Chlorine or Chloramines. The pad is attached to a plastic strip for handling. The color change is interpreted by the use of color blocks on two separate (ranges) color charts. Gradations for the Ultra-Low Total Chlorine (K100-0118) color chart include 0 ppm, 0.01 ppm, 0.02 ppm, 0.05ppm, 0.1ppm, 0.15ppm, 0.2 ppm. Gradations for the E-Z Chek® Sensitive Total Chlorine (K100-0106) color chart include 0 ppm, 0.1 ppm, 0.5 ppm and 3.0 ppm.
The provided document describes the Reprocessing Products Corporation (RPC) Total Chlorine Test Strips. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative pass/fail format with specific thresholds. Instead, it describes the intended performance and then presents data confirming that performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection of Chlorine Concentrations: | The data confirm the product consistently generates color change which correlates with the color block for the Reference solution concentration. |
| For water to prepare dialysate: | These data demonstrate accurate detection performance, below, equal to, and above the dialysis level of 0.1 ppm for Chloramines (measured as Total Chlorine). |
| Detection of Total Chlorine (Chloramines) at 0.1 ppm | |
| For dialysis equipment rinse water: | These data demonstrate accurate detection performance, below, equal to, and above the dialysis level of 0.5 ppm for Free Chlorine. |
| Detection of Free Chlorine at 0.5 ppm | |
| Consistency of Color Change and Correlation with Reference Solutions | The data confirm the product consistently generates color change which correlates with the color block for the Reference solution concentration. Reference solutions were used to evaluate performance between 0 and 10 ppm Chlorine. These data demonstrate appropriate performance for use in testing dialysis equipment rinse water and for testing water for dialysate preparation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Reference solutions were used to evaluate performance between 0 and 10 ppm Chlorine." However, it does not specify the number of individual tests or measurements performed with these reference solutions. It does list the specific gradations for each test strip range (e.g., 0 ppm, 0.01 ppm, 0.02 ppm for Ultra-Low Total Chlorine).
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective. Given the nature of a 510(k) submission for a test strip, it's highly likely that the performance evaluation was conducted prospectively in a laboratory setting using prepared reference solutions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of testing for chemical reagent strips does not typically involve human experts establishing "ground truth" in the same way as medical imaging or clinical diagnoses. The "ground truth" is established by the known concentrations of the reference solutions themselves. Therefore, information on the number and qualifications of experts for ground truth is not applicable in this context.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used when there's subjective interpretation or disagreement among human readers/experts. For these test strips, "ground truth" is determined by the precisely known concentrations of the reference solutions. The interpretation of the color change on the strip is then compared against a pre-defined color chart.
The document indicates: "The color change is interpreted by the use of color blocks on two separate (ranges) color charts." This suggests a direct comparison method rather than an adjudication process. Any discrepancies would likely point to a failure of the strip or the reading process, not an issue with establishing ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of device. MRMC studies are used to evaluate the impact of a device (often AI) on human reader performance in interpreting medical images or clinical data. This device is a semi-quantitative chemical test strip; its performance is assessed against known chemical concentrations, not through human diagnostic accuracy with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was performed. The entire performance section "The data confirm the product consistently generates color change which correlates with the color block for the Reference solution concentration. Reference solutions were used to evaluate performance between 0 and 10 ppm Chlorine..." describes the device's performance in isolation using reference solutions. It does not involve human readers interpreting results in a variable "human-in-the-loop" setting.
7. Type of Ground Truth Used
The type of ground truth used is known chemical concentrations (reference solutions). The performance of the test strips is validated by comparing the color change produced by the strip when exposed to these reference solutions against the expected color block for that known concentration.
8. Sample Size for the Training Set
The concept of a "training set" is primarily relevant for machine learning algorithms. Since this device is a chemical reagent test strip, it does not involve a machine learning algorithm and therefore does not have a "training set" in the conventional sense. The development of the chemical formulation and color chart would involve R&D and calibration, but not a dataset for algorithm training.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for a machine learning algorithm, this question is not applicable. The ground truth for the performance evaluation (test set) was established by using precisely prepared reference solutions with known concentrations of chlorine.
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Traditional 510k Premarket Notification Total Chlorine Test Strips
Page 1 of 2
MAY - 8 2009
510(k) SUMMARY
| Prepared: | February 6, 2009 |
|---|---|
| Submitter: | Reprocessing Products Corporation (RPC) |
| Address: | 3655 N. Oracle RoadTucson, AZ 85705 |
| Phone: | 520-888-5551 |
| Fax: | (Fax) 520-888-5557 |
| Contact: | Michael Honstein, Chief Operating Officer |
| Device Trade Name: | Two ranges:Ultra Low Total Chlorine (K100-0118) andE-Z Chek® Sensitive Total Chlorine(K100-0106) Test Strips |
| Common or Usual Name: | Total Chlorine Test Strips |
| Device Classification Name: | Strip, Test, Reagent, Residuals forDialysate, Disinfectant |
| Product Code: | MSY |
| Class: | II |
| Regulation Number: | 875.5665 |
| Substantial Equivalence: | The RPC Total Chlorine Test Strips aresubstantially equivalent to the SERIM®HISENSE ULTRA 0.1TM |
| Device Description: | Device is semi-quantitative, reagent teststrip comprised of a pad impregnated withchemicals which change color upon contactwith Free Chlorine or Chloramines. Thepad is attached to a plastic strip forhandling. |
| Intended Use: | The RPC Total Chlorine Test Strips areindicated for use in the monitoring ofchlorine in water used to prepare dialysateand water used to rinse dialysis equipment. |
| Technological Characteristics: | The Test Strips will detect chlorineconcentrations equal to, above and below0.1 ppm for Total Chlorine in water used toprepare dialysate and 0.5 ppm for FreeChlorine in dialysis equipment rinse water.The test strip pad contains a specializedchemical reagent that reacts with FreeChlorine and Chloramines in water. Thereaction results in a color change which iscorrelatable to the concentration of chlorinein the test water |
This document contains information considered CONFIDENTIAL to Reprocessing Products Corporation
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Traditional 510k Premarket Notification Total Chlorine Test Strips
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| 090338 | 262 |
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| cationStrips |
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| Page 2 of 2 | The color change is interpreted by the useof color blocks on two separate (ranges)color charts. Gradations for the Ultra-LowTotal Chlorine (K100-0118) color chartinclude 0 ppm, 0.01 ppm, 0.02 ppm,0.05ppm, 0.1ppm, 0.15ppm, 0.2 ppm.Gradations for the E-Z Chek® SensitiveTotal Chlorine (K100-0106) color chartinclude 0 ppm, 0.1 ppm, 0.5 ppm and 3.0ppm. |
|---|---|
| Performance: | The data confirm the product consistentlygenerates color change which correlateswith the color block for the Referencesolution concentration. Referencesolutions were used to evaluateperformance between 0 and 10 ppmChlorine. These data demonstrate accuratedetection performance, below, equal to, andabove the dialysis level of 0.5 ppm for FreeChlorine and below, equal to, and abovethe dialysis level of 0.1 ppm forChloramines (measured as Total Chlorine).These data demonstrate appropriateperformance for use in testing dialysisequipment rinse water and for testing waterfor dialysate preparation. |
| Conclusion: | The RPC Total Chlorine Test Strips havethe same intended use as the predicatedevice. Both test strips measure totalchlorine (free chlorine/chloramines) levelsin water. The RPC Total Chlorine TestStrips have no characteristics which raisenew types of safety and effectivenessquestions. The RPC Total Chlorine TestStrips can be used to monitor the level oftotal chlorine (free chlorine/chloramines)present in water used for preparation ofdialysate. The test strips can also be used todetect residual chlorine levels in rinsewater from dialysis equipment afterdisinfection. |
This document contains information considered CONFIDENTIAL to Reprocessing Products Corporation
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three wavy lines that resemble a caduceus, a symbol often associated with healthcare.
Public Health Service
- 8 2009 MAY
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Reprocessing Products Corporation c/o Mr. Wally Jansen President MedReg Consulting 8662 Comstock Lane N MAPLE GROVE MN 55311
Re: K090338
Trade/Device Name: Ultra Low Total Chlorine (K100-0118) and E-Z Check® Sensitive Total Chlorine (K100-0106) Test Strips Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: MSY Dated: February 6, 2009 Received: February 24, 2009
Dear Mr. Jansen:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at onc of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K090338
Device Name:
Ultra Low Total Chlorine (K100-0118) and E-Z Check ® Sensitive Total Chlorine (K100-0106) Test Strips
Indications For Use:
The Reprocessing Product Corporation (RPC) Total Chlorine Test Strips are indicated for detection of Free Chlorine and Total Chlorine in water. These Test Strips are indicated for testing water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Colin A. Pollard
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devi 510(k) Number
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.