(56 days)
The Browne Rapicide Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Rapicide® High-Level Disinfectant and Sterilant. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperature-sensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%.
The Browne Rapicide Glutaraldehyde Indicator is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The Browne Rapicide Glutaraldehyde Indicator has been developed to monitor the active glutaraldehyde concentration of Rapicide® High-Level Disinfectant (K993042) and Sterilant solution at 35 °C that has an MRC of 1.5% glutaraldehyde.
The provided text does not contain detailed information about specific acceptance criteria and a structured study demonstrating the device's performance against them. The document is a 510(k) summary for a glutaraldehyde indicator, focusing on its substantial equivalence to a predicate device, intended use, and general product description.
However, based on the intended use described, we can infer the primary performance characteristic that would be subject to acceptance criteria: accuracy in determining if the glutaraldehyde concentration is above 1.5%.
Let's try to extract relevant information and identify what is missing for a complete answer based on your request.
Inferred Acceptance Criteria and Reported Device Performance (Table):
| Acceptance Criterion (Inferred from Intended Use) | Reported Device Performance (Based on provided text) |
|---|---|
| Accurately indicate when glutaraldehyde concentration is ≥ 1.5% (Minimum Recommended Concentration - MRC). | The Browne Rapicide Glutaraldehyde Indicator has been developed to monitor the active glutaraldehyde concentration of Rapicide® High-Level Disinfectant (K993042) and Sterilant solution at 35 °C that has an MRC of 1.5% glutaraldehyde. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperature-sensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%. Essentially, the claim is made that it performs this function, but the specific data from a study proving this accuracy (e.g., sensitivity, specificity, PPV, NPV) with numerical results is not provided in this document. |
| Accurately indicate when glutaraldehyde concentration is < 1.5%. | (Inferring the converse of the above) The document implies it would indicate below 1.5% to prevent reuse, but specific performance metrics are not provided. |
Missing Information (Not available in the provided text):
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This document does not provide details on the study's sample size, data provenance, or whether the tests were retrospective or prospective. It only states that the device was "developed to monitor" and its "purpose is to determine."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. For chemical indicators, the "ground truth" would typically come from analytical chemistry methods (e.g., titration or spectrophotometry) rather than expert human interpretation of the indicator itself.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned given the nature of a chemical indicator. The ground truth would be chemical analysis.
- 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: This is not applicable to this device. This device is a chemical indicator that produces a color change, not an AI-based diagnostic tool requiring human interpretation improvement studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is inherently "standalone" in its operation as a chemical indicator, but the performance metrics of this standalone operation are not detailed (e.g., how accurate it is compared to a gold standard chemical test).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a chemical indicator, the ground truth would be established by a quantitative chemical analysis (e.g., titration, spectrophotometry, or other validated analytical methods) of the glutaraldehyde concentration in the solution. This is not explicitly stated but is the standard for such devices.
- The sample size for the training set: Not applicable and not mentioned. Chemical indicators are typically designed and tested based on chemical reactions, not "trained" like AI models.
- How the ground truth for the training set was established: Not applicable for a chemical indicator. Chemical indicators are developed based on known chemical reactions and their visual manifestation.
Summary of available information regarding the study mentioned and its proof of acceptance criteria:
The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than providing a detailed technical report of the studies performed. It states:
- Study Implication: The device "has been developed to monitor" the glutaraldehyde concentration and its "purpose is to determine whether the glutaraldehyde concentration... is above the minimum recommended concentration." This implies that testing was conducted to ensure it fulfills this purpose.
- Proof: The "Description of Safety and Substantial Equivalence" (Section 5) states: "The proposed and predicate devices are all single use indicators used to monitor glutaraldehyde concentration in specific solutions. The differences between the proposed Browne Rapicide Glutaraldehyde Indicator and predicate devices are limited to differences in the device design and materials. These differences do not raise any new issues of safety and efficacy." It also mentions "A summary of the technological characteristics of the new device in comparison to those of the predicate devices is provided in Section 12 of this premarket notification," but Section 12 is not included in the provided text.
Conclusion:
While the document clearly states the intended function of the device (to indicate if glutaraldehyde concentration is > 1.5%), it does not provide the specific performance data, study design, sample sizes, ground truth establishment methods, or expert qualifications that would comprehensively answer your request regarding acceptance criteria and their proof. It focuses on regulatory substantial equivalence rather than a detailed scientific study report.
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Image /page/0/Picture/0 description: The image shows the word "K080750" at the top left corner and the phrase "page 1 of 3" at the top right corner. Below that is the word "STERIS" in large, bold letters. At the bottom of the image, there is a graphic of several horizontal wavy lines stacked on top of each other.
MAY 12 2008
510(k) Summary For Browne Rapicide Glutaraldehyde Indicator
Albert Browne Ltd., a subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom Phone: +44 116 276 8636 Fax No: +44 116 276 8639
Contact:
John Robert (Jack) Scoville. Fellow Regulatory Affairs Telephone:(440) 392-7330 Fax No: (440) 392-9198
Summary Date:
March 13, 2008
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
March 13, 2008
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1. Device Name
| Trade Name: | Browne Rapicide Glutaraldehyde Indicator |
|---|---|
| Common/usual Name: | Browne Rapicide Test Strip |
| Classification Name: | Physical/chemical sterilization process indicator (21CFR 880.2800 (b), Product Code JOJ). |
2. Predicate Device
- K915170 3M™ ComplyTM Cold Sterilog™ Glutaraldehyde Monitor ● 3983MM.
3. Description of Device
The Browne Rapicide Glutaraldehyde Indicator is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The Browne Rapicide Glutaraldehyde Indicator has been developed to monitor the active glutaraldehyde concentration of Rapicide® High-Level Disinfectant (K993042) and Sterilant solution at 35 °C that has an MRC of 1.5% glutaraldehyde.
4. Intended Use
The Browne Rapicide Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Rapicide® High-Level Disinfectant and Sterilant at 35 °C cleared under K993042. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperaturesensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%.
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K080750
page 3 of 3
Description of Safety and Substantial Equivalence 5.
The proposed and predicate devices are all single use indicators used to monitor glutaraldehyde concentration in specific solutions. The differences between the proposed Browne Rapicide Glutaraldehyde Indicator and predicate devices are limited to differences in the device design and materials. These differences do not raise any new issues of safety and efficacy.
A summary of the technological characteristics of the new device in comparison to those of the predicate devices is provided in Section 12 of this premarket notification.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like bird with its wings spread, positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Scoville Fellow Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
MAY 12 2008
Re: K080750
Trade/Device Name: Browne Rapicide Glutaraldehyde Indicator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: March 13, 2008 Received: March 17, 2008
Dear Mr. Scoville:
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 - Mr. Scoville
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/industry/support/index.html.
Sincerely yours.
Sydtie y. Michael Davis
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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Indications for Use
KO80750 510(k) Number (if known):
Device Name: Browne Rapicide Glutaraldehyde Indicator
Indications for Use:
The Browne Rapicide Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Rapicide® High-Level Disinfectant and Sterilant. The purpose of the Browne Rapicide Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of a Rapicide® High-Level Disinfectant and Sterilant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperature-sensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.5%.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ____ X (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)
Shale A. Murphy, 4
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Kos0730
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).