(78 days)
SteriChek™ Chlorine Reagent Strips provide. a convenient means for measuring the concentration of chlorine bleach remaining in water being used to rinse out dialysate lines following disinfection of hemodialysis equipment.
The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
SteriChek™ Chlorine Reagent Strips contain syringaldazine, a colorless compound which serves as an indicator, potassium iodide, and a pH buffer.
The reagent strips react with both free chlorine and combined chlorine (monochloramines). Free chlorine oxidizes syringaldazine to form a colored oxidation product. Combined chlorine in the form of monochloramines oxidize potassium iodide to iodine which in turn oxidizes syringaldazine to the colored form.
The SteriChek™ Chlorine Reagent Strips are intended for measuring the concentration of chlorine bleach in water used to rinse dialysate lines after disinfecting hemodialysis equipment. This device is a new brand name for an existing product, the Serim™ Chlorine Reagent Strips, manufactured by the same company. The submission states that the new device is identical in performance to the predicate device because it uses the same materials and manufacturing processes. Therefore, specific acceptance criteria and detailed study results as typically seen for new device performance validation are not explicitly provided in this summary. Instead, the focus is on demonstrating substantial equivalence to the existing, already-marketed device.
Here's an attempt to extract and synthesize the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of this 510(k) submission as a rebranding:
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the format of a table. Instead, the core assertion is that the "SteriChek™ Chlorine Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions" and are "identical in performance to the marketed device" (Serim™ Chlorine Reagent Strips).
Given this, the implicit acceptance criterion is demonstration of identical performance to the predicate device, the Serim™ Chlorine Reagent Strips.
Table: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Identical performance to the predicate device (Serim™ Chlorine Reagent Strips) in measuring chlorine concentration. | The SteriChek™ Chlorine Reagent Strips are manufactured using the same bill of materials and the same manufacturing and quality assurance procedures as the predicate device, resulting in a product identical in performance. |
| No new technological characteristics that raise safety or effectiveness concerns. | The device has no changes in design, materials, or other features compared to the predicate device, apart from a change in the trade name. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The submission indicates that the new device is identical to the predicate device due to manufacturing consistency, implying no new performance studies with a distinct test set were conducted.
- Data Provenance: Not explicitly stated for performance testing. The claim of identical performance is based on manufacturing processes, not new testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/Not provided. New performance studies requiring expert-established ground truth for a test set are not described.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The device is a diagnostic reagent strip for chemical detection, not an image-reading or human-interpretation-dependent device that would typically involve an MRMC study.
- Effect Size of Human Readers Improvement: Not applicable.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study Done: Not explicitly described as a new study for the SteriChek™ strips. The "performance" assessment relies on the established performance of the predicate device, which is considered identical. The device itself is a chemical reagent, not an algorithm in the typical sense.
7. Type of Ground Truth Used
- Type of Ground Truth: For the predicate device's original validation (which is being leveraged here), the ground truth for chlorine concentration would typically be established using laboratory reference methods (e.g., titrimetric methods, spectrophotometry) known to accurately measure free and combined chlorine. This is inferred, as direct ground truth establishment for the new device is not documented.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not provided. This type of chemical test strip does not involve a "training set" in the context of machine learning or complex algorithmic development. Its "training" is in its chemical formulation and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable/Not provided.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets its (implicit) acceptance criteria is the assertion of manufacturing identicality to the predicate device. The submitter states:
- "The predicate device has been manufactured by Environmental Test Systems, Inc. since its introduction by Serim Research Corporation."
- "ETS will manufacture the SteriChek™ Chlorine Reagent Strips using the same bill of materials and the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device, but with a new name."
- "The SteriChek™ Chlorine 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 the trade or proprietary name of the device."
- "The SteriChek™ Chlorine Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions."
This approach fundamentally relies on the FDA's "substantial equivalence" pathway, where if a new device is shown to be identical or very similar to a legally marketed predicate device, extensive new performance studies may not be required beyond demonstrating that similarity. In this case, identical manufacturing processes and materials are presented as sufficient evidence for identical performance.
§ 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.