(88 days)
SteriChek™ Residual Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.
The device is made up of a 0.20 square inch off-white reagent pad that is chemically treated to detect peroxide in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics in the way a typical medical device study would describe. The document is a 510(k) Safety and Effectiveness Summary for the SteriChek™ Residual Peroxide Reagent Strips.
This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study against defined acceptance criteria.
However, based on the information provided, we can infer some aspects and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from intended use) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Detection of peroxide in water | Chemically treated pad detects peroxide |
| Measurement of peroxide concentration | Pad changes color relative to amount of peroxide |
| Ability to detect levels < 1.0 ppm | Used as a rapid screening method to detect levels of less than 1.0 ppm |
| Quantitative estimation 0-10 ppm | Used as a quantitative method to allow estimation of peroxide concentration between 0 and 10 ppm |
| Color blocks calibrated to ppm | Color blocks on label are calibrated in terms of peroxide concentration in parts per million (ppm) |
| Performance identical to predicate device | "ETS will manufacture the SteriChek™ Residual Peroxide Reagent Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device..." |
| Same test principles as predicate | "...the change in formulation provides for different color development but follows the same test principles as the predicate device." |
| No new safety/effectiveness questions arising from technological characteristics | "The SteriChek™ Residual Peroxide Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions." |
Missing Information:
- Specific numerical acceptance thresholds for accuracy, precision, sensitivity, or specificity.
- Quantitative data from direct comparison studies where the SteriChek™ strip's readings are compared against a gold standard or the predicate device at various concentrations.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states that the new device will be manufactured using the same manufacturing and quality assurance procedures as the predicate and will be identical in performance. This implies that no new, extensive test set was generated for direct comparison within this submission.
- Data Provenance: Not explicitly stated as a separate test set. The claim of "identical in performance" suggests reliance on the predicate device's established performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. There is no mention of human experts interpreting the results of the device for a test set, nor of defining a "ground truth" through expert consensus for a new study. The device itself produces a readily interpretable color change.
4. Adjudication method for the test set:
- Not applicable/Not specified. There is no mention of human interpretation requiring adjudication for a test set.
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:
- Not applicable. This device is a chemical reagent strip, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a chemical reagent strip, not an algorithm. The "standalone" performance is the color development and its proportional intensity to peroxide concentration.
7. The type of ground truth used:
- For the device's function: The "ground truth" for the device's function (color change proportional to peroxide concentration) would be established by analytical chemistry methods (e.g., spectrophotometry, titration) to accurately determine peroxide concentrations in reference solutions. The document implies that the color blocks on the label are "calibrated" against such a ground truth.
- For the submission: The "ground truth" for this 510(k) submission is the established performance and safety record of the predicate device (Serim™ Peroxide Reagent Strips). The new device aims to be substantially equivalent to this predicate.
8. The sample size for the training set:
- Not applicable. This is a chemical reagent strip, not a machine learning model. There is no "training set" in the context of AI.
9. How the ground truth for the training set was established:
- Not applicable (as above).
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Image /page/0/Picture/1 description: The image shows the logo for ETS, which stands for Educational Testing Service. The logo is in black and white and features the letters "ETS" in a bold, stylized font. There are two horizontal lines above and below the letters.
Environmental Test Systems, Inc.
PInz
¥974798
MAR 20 1998
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | December 12, 1997 |
|---|---|
| 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™ Residual Peroxide Reagent Strips |
| Device CommonName: | ETS Peroxide Reagent Strips |
| Classification Name: | Class IICH |
| Predicate Device: | Serim™ Peroxide Reagent StripsManufactured by Environmental Test Systems, Inc. (for SerimResearch Corporation) |
| Device Description: | The device is made up of a 0.20 square inch off-white reagent pad thatis chemically treated to detect peroxide in water. The pad is affixed toone end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. |
| Intended Use: | SteriChek™ Peroxide Reagent Strips provide a convenient means formeasuring the concentration of peroxide remaining in water beingused to rinse out dialysate lines and dialyzers following disinfectionwith peroxide/peracetic acid. The chemically treated pad changescolor relative to the amount of peroxide remaining in the rinse. |
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K974798
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SteriChek Residual Peroxide Reagent Strips 510(k) Safety and Effectiveness Summary - December 12, 1997 Environmental Test Systems, Inc. (Page 2 of 2)
The concentration of peroxide in rinse water is obtained by comparing Technological the color of the reagent pad with color blocks on the label. The color Characteristics: blocks are calibrated in terms of peroxide concentration in parts per million (ppm). The device is used as a rapid screening method to detect levels of less than 1.0 ppm, or as a quantitative method to allow estimation of peroxide concentration between 0 and 10 ppm.
SteriChek™ Peroxide Reagent Strips contain 4-Residual aminoantipyrine (4AAP) and 8-amino-2-naphthalene sulfonic acid (ANS), two colorless compounds which serve as the indicator system, peroxidase and a pH buffer. The reaction of the indicator reagents with hydrogen peroxide is catalyzed by peroxidase. This reaction of the indicators gives rise to a red-purple color. The intensity of the color is proportional to the concentration of the peroxide.
Assessment of The predicate device has been manufactured by Environmental Test Systems, Inc. since its introduction by Serim Research Corporation. Performance: ETS will manufacture the SteriChek™ Residual Peroxide Reagent 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 follows the same test principles as the predicate device.
The SteriChek™ Residual Peroxide Reagent Strips have the same Conclusion: 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 the change of indicators and the trade or proprietary name of the device. The SteriChek™ Residual Peroxide Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 20 1998
Mr. Bruce G. Piekarski Director - Business Development Environmental Test Systems, Inc. P.O. Box 4659 Elkhart, IN 46514-0659
Re: K974798
SteriChek™ Residual Peroxide Reagent Strips Dated: December 19, 1997 Received: December 22, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 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 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 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/cdrb/dsmamain.html".
Sincerely vours
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 Residual Peroxide Reagent Strips 510(k) Submission - December 12, 1997 Environmental Test Systems, Inc.
510(k) Number (if known)
Device Name: SteriChek™ Residual Peroxide Regent Strips
Indications for Use:
SteriChek™ Residual Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use | (Per 21 CFR 801.109)
Over-The Counter Use
OR
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.