(217 days)
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No
The description details a simple chemical reagent strip and does not mention any computational analysis, image processing, or AI/ML terms.
No.
Explanation: The device is a reagent strip used to detect residual chlorine or peroxide in dialysis water and disinfecting solutions, not to treat any medical condition or disease.
No
Explanation: The device is described as detecting residual chlorine or peroxide in dialysis water and chlorine in disinfecting solutions, not in a human body or for the purpose of diagnosing a medical condition in a patient.
No
The device description explicitly states it is a "paper based dry chemistry reagent strip" with a "plastic handle," indicating it is a physical hardware device, not software only.
Based on the provided information, the WaterCleck™ CP Reagent Strip is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "detecting residual chlorine or peroxide in dialysis water" and "detection of effective high level of chlorine in the disinfecting solution." This involves testing a sample (water or disinfecting solution) in vitro (outside of the human body) to provide information relevant to a medical procedure (dialysis) or a process related to medical devices (disinfecting solutions).
- Device Description: The description of a "paper based dry chemistry reagent strip" that reacts with substances in a sample further supports its function as a diagnostic tool used outside the body.
- Reference Devices: The mention of "Predicate Device(s)" and "Reference Device(s)" like "Serim Residual Chlorine Strip" and "Renalin Residual Test Strips" strongly suggests that this device is being compared to other devices used for similar diagnostic purposes, which are typically IVDs.
While it doesn't directly test a human sample, testing the quality of water used in dialysis and the effectiveness of disinfecting solutions for medical equipment falls under the scope of IVDs as they provide information crucial for patient safety and the proper functioning of medical procedures.
N/A
Intended Use / Indications for Use
WaterCleck™ CP Reagent Strip is intended to be used in detecting residual chlorine or peroxide in dialysis water. It also is used for detection of effective high level of chlorine in the disinfecting solution.
Product codes
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Device Description
WaterCleck™ CP Reagent Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. The chemistry of the regent strip allows the same single reagent pad to react with either chlorine or peroxide. It is self-contained and is ready to use as a dip-and-read reagent strip without other additional reagent.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for Integrated Biomedical Technology, Inc. The logo features a stylized "i" with a circle on top and a horizontal line extending to the right. The text "integrated biomedical technology, inc." is written in a bold, italicized font to the right of the logo. Above the logo, the date "MAR 11 1996" is printed in a smaller font.
PHONE (219) 264-3823 FAX (219) 264-3828
New 24-Hour Fax Number: (219) 264-2273
510(k) SUMMARY
WaterCheck™ CP Reagent Strip for Chlorine and Peroxide
SUMITTER:
| Name: | Wen H. Wu, Ph. D. |
|---|---|
| Address: | 51819 Winding Waters Lane |
| Elkhart, IN 46514 | |
| Phone: | (219) 264-3823 |
| Fax: | (219) 264-2273 |
Date Prepared: August 23, 1995
Contact: Wen H. Wu, Ph. D.
DEVICE NAME:
WaterCheck™ CP Trade Name: Reagent Strip for Chlorine and Peroxide Common Name: Classification Name:
COMPARATIVE PRODUCTS:
Serim Residual Chlorine Strip - Manufactured and marketed by Serim Researc Corporation, Elkhart, IN 46514 Marketed by Renal Systems, Minneapolis, MI Renalin Residual Test Strips-
DESCRIPTION OF THE NEW DEVICE:
WaterCleck™ CP Reagent Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. The chemistry of the regent strip allows the same single reagent pad to react with either chlorine or peroxide. It is self-contained and is ready to use as a dip-and-read reagent strip without other additional reagent.
1
| Integrated Biomedical Technology, Inc. | Elkhart, IN 46514-1644 |
|---|---|
| 510(k) Summary - WaterCheck™ CP | Page 2 |
INTEDED USE:
WaterCleck™ CP Reagent Strip is intended to be used in detecting residual chlorine or peroxide in dialysis water. It also is used for detection of effective high level of chlorine in the disinfecting solution.
TECHNOLOGICAL COMPARISON:
For reaction with chlorine, both WaterCheck™ CP and Serim Residual Chlorine Strips are based on oxidation of a chromogenic indicator by chlorine. In Serim Strip, redox indicator, syringaldazine, is used in the strip formulation and it will turn purplish red when dip in chlorine solution. In WaterCheck™ CP strip, the redox indicator used is 3.3'5.5'-tetramethylbenzidine (TMB). The strip will turn blue in the presence of low level of chlorine. Both strips can detect chlorine level at 0.5 ppm or less. Since TMB will turn brown at a higher oxidation state, WaterCheck™ CP has also utilized this color shift to extended its detection range to high level of chlorine, 1000 ppm or more, where effective chlorine level is used for disinfection.
For reaction with peroxide, both WaterCheck™ CP and Renalin Test Strips are based on catalytic oxidation of 3,3'5,5'-tetramethylbenzidine (TMB) by hydrogen peroxide and acetyl peroxide. Both strips will detect as low as 1 ppm of hydrogen peroxide. WaterCheck™ CP, however, is stable at room temperature and is sensitive to 0.5 ppm or less of hydrogen peroxide. On the other hand, Renalin Test Strip requires refrigeration and is practically insensitive to 0.5 ppm of hydrogen peroxide.
SUBSTANTIAL EQUIVALENCE STATEMENT:
Both WaterCheck™ CP and Serim Residual Chlorine Strips are equally effective in detecting 0.5 ppm or less of residual chlorine. WaterCheck™ CP can further detect high level, 1000 ppm or more, of chlorine in disinfecting solution.
Both WaterCheck™ CP and Renalin Test Strip are equally effective in detecting 1.0 ppm of hydrogen peroxide. WaterCheck™ CP, however, is more effective over Renalin Strip in that WaterCheck™ CP is stable at room temperature and is sensitive to 0.5 ppm or less of hydrogen peroxide.
Submitter: Wen H. Wu, Ph. D. Date: Aug 23 95