(54 days)
SERIM® HiSENSE ULTRA 0.1 TM Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.
The device is a semi-quantitative or qualitative, single use, reagent test strip made up of a 0.20 inch square reagent pad that has been chemically treated to detect total chlorine (free chlorine/chloramines) in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
This document is a 510(k) summary for the SERIM® HiSENSE ULTRA 0.1™ Test for Total Chlorine. It describes the device, its intended use, technological characteristics, and performance evaluation.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detect total chlorine concentrations | Reliably detect concentrations of 0.1 ppm total chlorine. Device detects concentrations between 0 and 3 ppm. |
| Substantial equivalence to predicate device (SteriChek Sensitive Total Chlorine Reagent Strips) | Performance is substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for the test set. It mentions: "The performance of the Serim HiSENSE ULTRA 0.1 Test Strips were evaluated using water samples in which either sodium hypochlorite or chloramines were added to give a range of total chlorine (free chlorine/chloramines) levels."
- Sample Size: Not explicitly stated as a number of samples. The evaluation used "water samples."
- Data Provenance: The water samples were prepared by adding sodium hypochlorite or chloramines to achieve varying total chlorine levels. While the country of origin isn't specified, it's implied to be an in-house laboratory evaluation based on the nature of the test. It is a prospective evaluation, as samples were prepared for the purpose of testing the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for the prepared water samples would typically be established by precise chemical measurements (e.g., using a reference method or analytical chemistry techniques) rather than human experts interpreting results.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of a semi-quantitative chemical test strip, the adjudication method would likely involve comparing the color change on the strip to a color chart provided with the device, and subsequently comparing that reading to the known concentration of the prepared water sample.
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 manual chemical test strip, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device requires human interpretation of the color change on the test strip against a color chart. It is not an automated algorithm.
7. The Type of Ground Truth Used
The ground truth for the test set was established by prepared water samples with known concentrations of total chlorine. These known concentrations would have been determined through precise chemical methods, making it an analytical truth.
8. The Sample Size for the Training Set
This information is not provided in the document. As a chemical test strip, it's unlikely to have a "training set" in the sense of machine learning algorithms. The design and calibration of the test strip's chemical formulation and color chart would be based on chemical principles and experimental validation, but the term "training set" is not applicable here.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8. The "ground truth" for developing such a device would reside in the chemical reactions and the correlation of color intensity to chlorine concentration, established through laboratory experiments and chemical analysis during the product's R&D phase.
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SERIM Research Corporation 510(k) Premarket Notification Serim® HiSENSE ULTRA 0.1™ Test for Total Chlorine
Image /page/0/Picture/1 description: The image shows the text "K080712" in a large, bold font at the top left. Below this, the word "CONFIDENTIAL" is printed in a smaller, block-letter font. To the right of these words, the text "1 of 2" is written in a similar style to the text at the top left. The image appears to be a scan or photocopy of a document.
MAY - 6 2008
510 (K) SUMMARY
March 11, 2008 Prepared:
Serim Research Corporation Submitter: P.O. Box 4002 Address Elkhart IN 46514
574-264-3440 Phone: 574-266-6222 Fax:
Patricia A. Rupchock Contact: Director of Regulatory Affairs
Strips: K001194
Total Chlorine Reagent Strips
SERIM® HISENSE ULTRA 0.1TM Device Trade Name:
Common or Usual Name:
Device Classification Name:
Strip, Test, Reagent, Residuals for Dialysate, Disinfectant
The SERIM® HiSENSE ULTRA 0.1™ is substantially
equivalent to Sterichek Sensitive Total Chlorine Reagent
Product Code: MSY
Class: II
Regulation Number: 876.5665
Substantial Equivalence:
Device Description:
The device is a semi-quantitative or qualitative, single use, reagent test strip made up of a 0.20 inch square reagent pad that has been chemically treated to detect total chlorine (free chlorine/chloramines) in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
Intended Use:
SERIM® HiSENSE ULTRA 0.1™ Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.
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K080712
CONFIDENTIAL 2 of 2
Technological Characteristics:
The SERIM® HiSENSE ULTRA 0.1™ Test Strips contain two indicators, a non-ionic surfactant, potassium iodide, and other inactive ingredients. Total chlorine (free chlorine/chloramines) reacts with the indicators to form a blue-purple complex. The amount of blue-purple color formed is dependent on the concentration of total chlorine in the sample. The color blocks on the label are related to chlorine concentration in terms of parts per million (ppm). The device is used to detect total chlorine concentrations between 0 and 3 ppm. The device will reliably detect concentrations of 0.1 ppm total chlorine.
Performance:
The performance of the Serim HiSENSE ULTRA 0.1 Test Strips were evaluated using water samples in which either sodium hypochlorite or chloramines were added to give a range of total chlorine (free chlorine/chloramines) levels. The performance of the Serim HiSENSE ULTRA 0.1 Test Strips is substantially equivalent to the predicate device, SteriChek Total Chlorine Reagent Strips.
Conclusion:
The Serim HiSENSE ULTRA 0.1 Test Strips have the same intended use as the predicate device. Both test strips measure the total chlorine (free chlorine/chloramines) levels in water. The Serim HiSENSE ULTRA 0.1 Test Strips have no characteristics that raise new types of safety or effectiveness questions. The Serim HiSENSE ULTRA 0.1 Test Strips can be used to monitor the level of total chlorine (free chlorine/chloramines) that may be present in water used to prepare dialysate. The test strips can also be used to detect residual chlorine levels in rinse water from dialysis equipment which had been disinfected with chlorine bleach.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines representing wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2008
Ms. Patricia Rupchock Director of Regulatory Affairs Serim Research Corporation 3506 Reedy Drive ELKHART IN 46561
Re: K080712
Trade/Device Name: Serim® HiSENSE ULTRA 0.1" Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: MSY Dated: March 11, 2008 Received: March 13, 2008
Dear Ms. Runchock:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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K080712
CONFIDENTIAL
SERIM Research Corporation 510(k) Premarket Notification Serim® HiSENSE ULTRA 0.1TM Test for Total Chlorine
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Serim® HiSENSE ULTRA 0.1TM
:
Indications For Use: SERIM® HiSENSE ULTRA 0.1 TM Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.
Prescription Use (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off (Division Sigil-On)
Division of Reproductive, Abdominal,
Division of P.H.P.
and Radiological Devices
510(k) Number K080
§ 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.