(248 days)
SteriChek® Glutaraldehyde Reagent Strips provide a convenient means of testing the concentration of Glutaraldehyde in dialyzer disinfecting solutions. The test is not intended to replace microbiological tests or quantitative determinations of concentrations of stock solutions of Glutaraldehyde. The test may be used on a random sample of reprocessed dialyzers in order to document the presence of the agent during storage. SteriChek® Glutaraldehyde Reagent Strips do not measure residual levels of Glutaraldehyde
The device is made up of a 0.20 inch square light red reagent pad that has been chemically treated to test the concentration of Glutaraldehyde in solutions for disinfecting dialyzers used in Hemodialysis. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
The provided text describes the SteriChek® Glutaraldehyde Reagent Strips, a qualitative reagent strip method designed to measure Glutaraldehyde concentration in dialyzer disinfecting solutions. The regulatory submission (K040660) focuses on establishing substantial equivalence to a predicate device, the Serim™ Glutaraldehyde Test Strips.
Here's an analysis of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format of a table. However, it indicates the device's performance characteristics are based on analytical studies and that it effectively measures the pH or hydrogen ion concentration, which is the underlying mechanism for both the proposed device and its predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Qualitative Measurement of Glutaraldehyde Concentration | The device is a "qualitative reagent strip method to measure Glutaraldehyde solution by color change." |
| Effective Measurement of pH/Hydrogen Ion Concentration | "both systems [proposed and predicate] effectively measure the pH or hydrogen ion concentration." |
| Equivalence to Predicate Device's Intended Use | "The SteriChek® Glutaraldehyde Reagent Strips have the same intended use as the predicate device." |
| No New Safety or Effectiveness Questions | "The SteriChek® Glutaraldehyde Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Assessment of The performance characteristics of SteriChek Glutaraldehyde Reagent Performance: Strips are based on analytical studies using samples of Glutaraldehyde solutions of various concentrations."
- Sample Size for Test Set: Not specified. The document only mentions "samples of Glutaraldehyde solutions of various concentrations."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Due to the nature of the device (reagent strips for chemical testing), it's highly likely to be prospective laboratory studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The ground truth was established by a reference method, not by human experts interpreting the device's output.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by an analytical reference method for Glutaraldehyde concentration, not by human interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or clinical interpretation where human readers are involved. This device is a chemical reagent strip.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone chemical test; therefore, its performance assessment is inherently standalone. The study evaluates the reagent strip's ability to react to Glutaraldehyde solutions. There is no "algorithm" in the modern sense as this device is a chemical indicator system.
7. The Type of Ground Truth Used
The ground truth for the performance assessment was established using a reference chemical assay method: "The reference method for determination of Glutaraldehyde is based on the reaction of Glutaraldehyde with hydroxylamine hydrochloride followed by titration of the released acid (Aldrich Chemical Company, "Basics Assay Method for Determination of Determination of Aldehydes and Ketones".)"
8. The Sample Size for the Training Set
Not applicable. The device is a chemical reagent strip. There is no machine learning "training set" in the context of this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The chemical formulation and performance were likely developed through standard chemical and product development processes.
§ 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.