(211 days)
The Reprocessing Products Corporation (RPC) E-Z Chek® Ozone Test Strips (K100-0111) are designed to indicate the presence of ozone in water used in hemodialysis. The test strips will measure equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and >0.5 mg/L.
Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals, which change color upon contact with Ozone. The pad is attached to a plastic strip for handling.
Here's an analysis of the provided text regarding the E-Z Chek® Ozone Test Strips, focusing on acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly performance-driven, relating to the ability of the test strips to accurately detect and differentiate ozone concentrations.
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Designed to indicate the presence of ozone in water used in hemodialysis. | The data confirms the product consistently generates color change which meets the color block for the reference solution concentration. These data demonstrate appropriate performance for use in hemodialysis water used in treatment. (Implies successful indication of ozone presence) |
| Will measure equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and >0.5 mg/L. (Specificity of measurable concentrations) | The data confirms the product consistently generates color change which meets the color block for the reference solution concentration. (Implies accuracy across the specified range when compared to reference solutions.) |
| Will detect ozone concentrations equal to and above 0.0 ppm (mg/L) for Ozone in water used to prepare dialysate. (Lower detection limit) | The data confirms the product consistently generates color change which meets the color block for the reference solution concentration. (Implies successful detection at or above 0.0 ppm.) |
| Produce a color change which correlates to the concentration of ozone in the test water. (Accuracy and correlation) | The data confirms the product consistently generates color change which meets the color block for the reference solution concentration. (This directly addresses the correlation and accuracy of the color change.) |
Study Information:
The provided document offers a high-level summary of the device's performance but lacks detailed information about the specific study design and methodology. Due to this limitation, many of the requested points cannot be fully addressed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document states "The data confirms the product consistently generates color change...", but does not provide numbers of tests, samples, or replicates.
- Data Provenance: Not specified. It's highly probable the testing was conducted internally by Reprocessing Products Corporation, but the location and whether it was retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable/not specified. This device is a chemical test strip with a visual color change. The ground truth would be established by preparing water samples with known, precise concentrations of ozone (reference solutions), not by expert interpretation of the test strip results in a clinical setting.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As noted above, the assessment likely involves comparing the color change on the strip to a pre-defined color chart, with the "ground truth" being the known ozone concentration of the reference solution. This is a direct chemical measurement, not a subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC study was not done. These studies are typically for imaging or diagnostic devices where human readers interpret results, often with and without AI assistance to measure reader improvement. The E-Z Chek® Ozone Test Strips are a direct chemical test.
- Effect Size of Human Reader Improvement: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: While the principle of comparing the strip's color to a color chart is "standalone" in that a human is reading the result from the strip itself, there isn't an "algorithm" in the typical sense of AI/machine learning. The device is the algorithm (chemical reaction + color change). The performance data is the standalone performance of the physical test strip.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used would be reference solutions with known, precisely measured concentrations of ozone. The test strips' color changes are then compared against these known concentrations. This is implied by the statement "The data confirms the product consistently generates color change which meets the color block for the reference solution concentration."
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. Chemical test strips are developed through chemical formulation and calibration, not typically by training a machine learning model on a "training set" of data in the way an AI-powered diagnostic device would be. The development likely involved numerous trials to achieve the desired chemical reaction and color scale, but this isn't a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable in the context of an AI training set. For chemical test strip development, the "ground truth" in development would be the precisely prepared and verified ozone concentrations of water samples used to calibrate the color scale and ensure the chemical reagents react appropriately. This typically involves analytical chemistry techniques to confirm the actual ozone levels in control solutions.
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K132344
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510(k) SUMMARY
| Prepared: | February 05, 2014 |
|---|---|
| Submitter: | Reprocessing Products Corporation (RPC) |
| Address: | 1643 W. Modern CourtTucson, AZ 85705 |
| Phone: | 520-888-5551 |
| Fax: | (Fax) 520-888-5557 |
| Contact: | Michael Honstein, Chief Operating Officer |
| Device Trade Name: | E-Z Chek® Ozone Test Strips (K100-0111) |
| Common or Usual Name: | Ozone Test Strips |
| Device Classification Name: | Strip, Hemodialysis Water, Ozone detector |
| Product Code: | MSY |
| Class: | II |
| Regulation Number: | 875.5665, 876.5820 |
| Substantial Equivalence: | The Reprocessing Products Corporation(RPC) E-Z Chek® Ozone Test Strips(K100-0111) are substantially equivalent tothe Ultra Low Total Chlorine (K100-0118)and E-Z Chek® Sensitive Total Chlorine(K100-0106) Test Strips |
| Device Description: | Device is semi-quantitative, reagent teststrip comprised of a pad impregnated withchemicals, which change color uponcontact with Ozone. The pad is attached toa plastic strip for handling. |
| Intended Use: | The Reprocessing Products Corporation(RPC) E-Z Chek® Ozone Test Strips(K100-0111) are designed to indicate thepresence of ozone in water used inhemodialysis. The test strips will measureequal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and>0.5 mg/L. |
| Technological Characteristics: | The E-Z Chek® Ozone Test Strips (K100-0111) will detect ozone concentrationsequal to and above 0.0 ppm for Ozone inwater used to prepare dialysate. The teststrip pad contains a specialized chemicalreagent that reacts with Ozone in water.The reaction results in a color changewhich correlates to the concentration of |
| ozone in the test water. | |
| Performance: | The data confirms the product consistentlygenerates color change which meets thecolor block for the reference solutionconcentration. These data demonstrateappropriate performance for use inhemodialysis water used in treatment. |
| Conclusion: | The Reprocessing Products Corporation(RPC) E-Z Chek® Ozone Test Strips(K100-0111) have the same intended use asthe predicate device. Both the test stripsand the meters are designed to detect thepresence of ozone in water. TheReprocessing Products Corporation (RPC)E-Z Chek® Ozone Test Strips (K100-0111) has no characteristics which raisenew types of safety and effectivenessquestions. The Reprocessing ProductsCorporation (RPC) E-Z Chek® Ozone TestStrips (K100-0111) can be used to detectthe presence of ozone in water |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2014
Reprocessing Products Corporation Ted Williams Director of Quality and Regulatory Affairs 1643 W. Modern Court Tucson, AZ 85705
K132344 Re:
Trade/Device Name: E-Z Chek® Ozone Test Strips (K100-011) Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: MSY Dated: February 5, 2014 Received: February 7, 2014
Dear Ted Williams,
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. Iisting 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.
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Page 2 - Ted Williams
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Benjamin Asher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132344
Device Name
E-Z Chek® Ozone Test Strips (K100-0111)
Indications for Use (Describe)
The Reprocessing Products Corporation (RPC) E-Z Chek® Ozone Test Strips (K100-0111) are designed to indicate the presence of ozone in water used in hemodialysis. The test strips will measure equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and >0.5 mg/L.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
ード FOR FOR FOR FOR FOA USE ONLY - 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 14 - 3 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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ﺎ ﺣ
§ 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.