(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.
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K040660 plofa.
NOV 1 5 2004
SteriChek® Glutaraldchyde Reagent Strips 510(k) Submission Environmental Test Systems, Inc.
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | March 4, 2004 |
|---|---|
| Submitter: | Hach Company/Environmental Test Systems |
| Address: | 23575 County Road 106Elkhart, IN 46514U.S.A.(219) 262-2060 |
| Contact: | David A. Morris, Ph.D.Director of Technology |
| Device Trade/Proprietary Name: | SteriChek® Glutaraldehyde Reagent Strips |
| Device CommonName: | Glutaraldehyde Reagent Strips |
| Classification Name: | Class IICH |
| Predicate Device: | Serim™ Glutaraldehyde Test Strips |
| Device Description: | The device is made up of a 0.20 inch square light red reagent pad that hasbeen chemically treated to test the concentration of Glutaraldehyde insolutions for disinfecting dialyzers used in Hemodialysis. The pad isaffixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrenestrip. |
| ntended Use: | SteriChek Glutaraldehyde Reagent Strips provide a convenient means oftesting the concentration of Glutaraldehyde in dialyzer disinfectingsolutions. The test is not intended to replace microbiological tests orquantitative determinations of concentrations of stock solutions ofGlutaraldehyde. The test may be used on a random sample of reprocesseddialyzers in order to document the presence of the agent during storage.SteriChek Glutaraldehyde Reagent Strips do not measure residual levels ofGlutaraldehyde. |
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K040660 p2§2
SteriChek® Glutaraldehyde Reagent Strip 510(k) Submissic Environmental Test Systems, In-
Technological The device is a qualitative reagent strip method to measure Glutaraldchydc Characteristics: solution by color change caused by the sample on a pad containing dry reagents and indicators. Glycine in the reagent pad reacts with Glutaraldchyde and releases acid. The resulting pH change is detected with a colorimetric indicator. The active components are the pH indicator Methyl Red (CAS #845-10-3), and Glycine (CAS #56-40-6). Assessment of The performance characteristics of SteriChek Glutaraldehyde Reagent Performance: Strips are based on analytical studies using samples of Glutaraldehyde solutions of various concentrations. 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 Aldehydes and Ketones".) The SteriChek® Glutaraldchyde Reagent Strips have the same intended Conclusion: use as the predicate device. The predicate device's indicator system is different than that of the SteriChek Glutaraldehyde Reagent Strips. However, both systems effectively measure the pH or hydrogen ion concentration. The SteriChek® Glutaraldehyde Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
NOV 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Dr. David A. Morris Director of Technology Hach Company/ETS 23575 County Road 106 Elkhart, Indiana 46514
Re: K040660
Trade/Device Name: SteriChek® Glutaraldehyde Reagent Strips Regulation Number: None Regulation Name: None Regulatory Class: II Product Code: LIF Dated: October 25, 2004 Received: October 28, 2004
Dear Dr. Morris:
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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Page 2 – Dr. Morris
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SteriChek® Glutaraldehyde Reagent Strips 510(k) Submission Environmental Test Systems, Inc.
510(k) Number (if known)
Device Name: SteriChek® Glutaraldehyde Reagent Strips.
Indications for Use:
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
Luis
OR
Division Sign-Off) Division of Sign-Off
Division of Anesthesiology, General Hospital, Andelen of Anesthesiology, Infection Control, Dental D
510(k) Number: K040660
Page 6
§ 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.