(90 days)
SteriChek™ Peracetic Acid Reagent Strips provide a convenient means for determining the effective levels of peracetic acid in dialyzer reprocessing in hemodialysis.
The device is made up of a 0.20 inch square faint-yellow reagent pad that has been chemically treated to detect peracetic acid in dialyzer reprocessing mix. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
The provided text describes a 510(k) submission for a medical device called "SteriChek™ Peracetic Acid Reagent Strips." This device is a reagent strip designed to detect peracetic acid levels in dialyzer reprocessing. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with detailed acceptance criteria and performance metrics for a novel technology.
Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from this type of regulatory document. This document is a premarket notification for a Class II device, where the primary goal is to show equivalence to an already marketed device, not to present a de novo study with strict performance criteria.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided text. The document refers to "identical in performance" to the predicate device, but no specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy against a gold standard) for the SteriChek device itself are given. The performance description is qualitative:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative Performance Equivalence to Predicate Device: The device should perform identically to the predicate device, "Serim™ Peracetic Acid Reagent Strips." | "ETS will manufacture the SteriChek™ Peracetic Acid Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device..." |
| Color development for peracetic acid detection: | "None or minimal color after 10 seconds indicates insufficient levels of peracetic acid and dark color (gray/purple) or black indicates acceptable levels of peracetic acid." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document does not describe a new clinical or laboratory study with a separate test set. The claim is based on manufacturing an identical product to a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not available in the provided text. No specific ground truth establishment process for a new test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. No adjudication method is mentioned as a new study was not conducted on this new device.
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
This information is not applicable/available. This device is a simple chemical reagent strip, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/available. The device is a reagent strip that changes color, which is read by a human. There is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the SteriChek device, the "ground truth" implicitly relies on the established performance and chemical properties of the predicate device, Serim™ Peracetic Acid Reagent Strips. The underlying chemical reaction (iodide oxidation to iodine forming a color with starch) is the scientific basis. No new independent 'ground truth' study is discussed for this specific submission as it relies on equivalence.
8. The sample size for the training set
This information is not applicable/available. This is a chemical reagent strip, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/available. As explained above, there is no training set for this type of device.
Study Proving Device Meets Acceptance Criteria:
The document states: "The predicate device has been manufactured by Environmental Test Assessment of Performance: Systems, Inc. since its introduction by Serim Research Corporation. ETS will manufacture the SteriChek™ Peracetic Acid Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device, but with a new name. The change in formulation provides for different color development but follow the same test principles as the predicate device."
Conclusion regarding the "study":
The "study" or justification for meeting acceptance criteria is essentially the claim of manufacturing identity and adherence to the same quality assurance procedures as the predicate device. The regulatory approach here is Substantial Equivalence (SE), meaning the device is considered safe and effective because it is essentially the same as a legally marketed predicate device. No new standalone performance study (as would be typical for novel devices or AI) is presented or required for this 510(k) submission. The "proof" is the assertion of identical manufacturing processes and shared underlying chemical principles with an already approved device.
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APR 1 6 1998
Image /page/0/Picture/2 description: The image shows the logo for Environmental Test Systems, Inc. The logo consists of the letters "ETS" in a bold, stylized font. The letters are black and have a thick, horizontal line above and below them. Below the logo, the words "Environmental Test Systems, Inc." are printed in a smaller, regular font.
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | January 15, 1998 |
|---|---|
| Submitter: | Environmental Test Systems, Inc. |
| Address: | 23575 County Road 106Elkhart, IN 46514-0659U.S.A.(219) 262-2060 |
| Contact: | Bruce G. Piekarski, Director-Business Development |
| Device Trade/Proprietary Name: | SteriChek™ Peracetic Acid Reagent Strips |
| Device CommonName: | ETS Peracetic Acid Reagent Strips |
| Classification Name: | Class IICH |
| Predicate Device: | Serim™ Peracetic Acid Reagent StripsManufactured by Environmental Test Systems, Inc. (for SerimResearch Corporation) |
| Device Description: | The device is made up of a 0.20 inch square faint-yellow reagent pad thathas been chemically treated to detect peracetic acid in dialyzerreprocessing mix. The pad is affixed to one end of a 3.25 inch by 0.20inch white opaque polystyrene strip. |
| Intended Use: | SteriChek Peracetic Acid Reagent Strips provide a convenient means fordetermining the effective levels of peracetic acid in dialyzerreprocessing. The chemically treated pad changes color relative to theamount of peracetic acid in the dialyzer reprocessing mix. |
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98064
SteriChek Peracetic Acid Reagent Strips 510(k) Safety and Effectiveness Summary - January 15, 1998 Environmental Test Systems, Inc. (Page 2 of 2)
The concentration of peracetic acid in dialyzer reprocessing is obtained Technological Characteristics: by observing the absence or concentration of color. None or minimal color after 10 seconds indicates insufficient levels of peracetic acid and dark color (gray/purple) or black indicates acceptable levels of peracetic acid.
SteriChek™ Peracetic Acid Reagent Strips contain starch, potassium iodide and a pH buffer. When reacted with peracetic acid, the iodide is oxidized to iodine, forming a gray/purple color with starch.
The predicate device has been manufactured by Environmental Test Assessment of Performance: Systems, Inc. since its introduction by Serim Research Corporation. ETS will manufacture the SteriChek™ Peracetic Acid Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device, but with a new name. The change in formulation provides for different color development but follow the same test principles as the predicate device.
Conclusion: The SteriChek™ Peracetic Acid Reagent Strips have the same intended use as the predicate device. There will be no changes in the design, materials, or other features compared to the predicate device, other than a change in color development and the trade or proprietary name of the The SteriChek™ Peracetic Acid Reagent Strips have no device. technological characteristics that raise new types of safety or effectiveness questions.
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 1998
Mr. Bruce G. Piekarski Director-Business Development Environmental Test Systems, Inc. P.O. Box 4659 Elkhart, IN 46514-0659
Re: K980164
SteriChek™ Peracetic Acid Reagent Strips Dated: January 15, 1998 Received: January 16, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 MSY & LIF
Dear Mr. Piekarski:
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 equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 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 807.97). 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 yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SteriChek Peracetic Acid Reagent Strips 510(k) Submission - January 15, 1998 Environmental Test Systems, Inc.
510(k) Number (if known)
Device Name: SteriChek™ Peracetic Acid Regent Strips
Indications for Use:
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SteriChek™ Peracetic Acid Reagent Strips provide a convenient means for determining the effective levels of peracetic acid in dialyzer reprocessing in hemodialysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Roler R. Ratluy
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number. (98-0164
.
Prescription Use レ (Per 21 CFR 801.109)
OR
Over-The Counter Use
§ 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.