(406 days)
Micro-X Residual Test Strips are intended for use as a semi-quantitative test of the residual presence of peracetic acid in dialyzers after reprocessing. This device may be used with all peroxyacetic/peracetic acid germicides used in the reprocessing of dialyzers, sanitation of water treatment systems and dialysis machine disinfection as part of an established quality assurance program.
Micro Xtm Residual Test Strips are approximately 0.25" x 4.75" packaged 100strips /container. The strips are labeled for use in Reprocessing Hemodialyzers. Micro X " Test Strips have a test pad, which is impregnated with peroxidase, which liberates oxygen from peracetic acid upon contact with the solution. The oxygen reacts with the chromophore, color indicator, which is also present on the test pad, resulting in a color change. The color change is compared to the color scale on the container and the result is read directly in mg/L.
The provided text focuses on the 510(k) summary for Micro X™ Residual Test Strips and the FDA's clearance letter. It describes the device, its intended use, and states that comparative testing was done. However, it does not contain enough information to fully describe the acceptance criteria and the study in the detail requested.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "Comparative testing between Micro Xtm Residual Strips" and states the device is "Substantially equivalent to Renalin Residual Test Strips." This implies the acceptance criterion was likely meeting or closely approximating the performance of the predicate device (Renalin Residual Test Strips). However, the specific metrics for comparison (e.g., sensitivity, specificity, accuracy, precision, detection limits, agreement percentage) and the actual numerical results are not provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance substantially equivalent to Renalin Residual Test Strips | Met (based on 510(k) clearance) |
| (Specific metrics and thresholds not provided in the document) | (Specific results not provided in the document) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document only states "Comparative testing." It does not specify the number of samples (e.g., how many tests were run, across what range of concentrations, or how many dialyzers/systems were tested).
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or from what country/locations the samples originated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. The testing seems to be a chemical/analytical comparison rather than relying on human interpretation directly for primary ground truth.
4. Adjudication method for the test set:
- Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No. This type of study is not applicable as the device is a chemical test strip, not an imaging or diagnostic device requiring human interpretation of complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone, non-algorithmic chemical test strip. Its performance is inherent to its chemical reaction and color change. Users read the color change against a scale, but the core "algorithm" is the strip's chemistry. Therefore, its performance is its standalone performance.
7. The type of ground truth used:
- Implied Ground Truth: The ground truth for this type of device would typically be:
- Known concentrations of peracetic acid: prepared standards measured by analytical chemistry methods (e.g., titration, spectrophotometry) as the gold standard.
- Comparison to a predicate device: The performance of the Renalin Residual Test Strips would serve as a reference in this comparative study.
- The document doesn't explicitly state how the ground truth was established, but it would logically involve creating solutions with known peracetic acid concentrations.
8. The sample size for the training set:
- Not applicable/Not mentioned. Chemical test strips typically do not have "training sets" in the same way machine learning algorithms do. Their performance is based on their chemical composition, which is developed and optimized, but not "trained" with data.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned for the reasons above.
In summary: The provided text is a high-level 510(k) summary and FDA clearance letter. It confirms that comparative testing was done to establish substantial equivalence with a predicate device for Residual Test Strips, but it lacks the detailed technical specifications and study results that would describe specific acceptance criteria and performance data.
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4 1998 DEC
K974064
Page 111
X. 510k Summary:
Trade Name - Micro Xtm Residual Test Strips
Common name - Residual test strips
Classification name - Dialyzer test strips
Substantially equivalent to Renalin Residual Test Strips
- Description Micro X 10 Residual Test Strips are approximately 0.25" x 4.75" packaged 100strips /container. The strips are labeled for use in Reprocessing Hemodialyzers.
- Intended Use -Micro Xm Residual Test Strips are intended for use in determining the level of peracetic acid present in dialyzers at the conclusion of the required rinse procedure, and prior to the initiation of dialysis. The strips are also used for the determination of residual peracetic levels present in the rinse solution of water treatment systems and dialysis machines following samitization/disinfection procedures.
- Characteristics Micro X " Test Strips have a test pad, which is impregnated with peroxidase, which liberates oxygen from peracetic acid upon contact with the solution. The oxygen reacts with the chromophore, color indicator, which is also present on the test pad, resulting in a color change. The color change is compared to the color scale on the container and the result is read directly in mg/L. This is an important characteristic as levels of peracetic acid above those indicated by the germicide manufacturer may compromise dialyzer biocompatibility. This test strip, when properly used, provides a measure of residual germicide within the fluid pathways of reprocessed dialyzers.
Test Data:
Comparative testing between Micro Xtm Residual Strips
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 7 1998
Mr. Michael Honstein Vice President of Operations Reprocessing Products Corporation 1661 W. Prince Rd., Suite 104 Tucson, Arizona 85705
Re: K974064 Micro X™ Residual Test Strips Dated: September 8, 1998 Received: September 8, 1998 Regulatory Class: II CFR 21 876.5820/Procode: 78 MSY
Dear Mr. Honstein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 307.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely your
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K974064
Device Name: MICRO-X RESIDUAL TEST STRIPS
Indications For Use:
Micro-X Residual Test Strips are intended for use as a semi-quantitative test of the residual presence of peracetic acid in dialyzers after reprocessing. This device may be used with all peroxyacetic/peracetic acid germicides used in the reprocessing of dialyzers, sanitation of water treatment systems and dialysis machine disinfection as part of an established quality assurance program.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K974064 |
|---|---|
| --------------- | --------- |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.