(368 days)
Resert™ XL HLD is a ready -to-use liquid chemical germicide. The product is a 2.0% nominal hydrogen peroxide solution. The minimum recommended concentration (MRC) is 1.5%. Resert XL HLD is intended to be used by health care practitioners in clinical settings as a ready to use liquid chemical disinfectant for the high level disinfection of semi-critical medical devices for which alternative methods of terminal reprocessing are not suitable or available.
High Level Disinfectant: Resert™ XL HLD High Level Disinfectant is a high level disinfectant when used or reused undiluted for a maximum of 21 days at a minimum temperature of 20℃ (68°F) for a minimum immersion time of 8 minutes.
Resert XL HLD High Level Disinfectant is a nominal 2.0% hydrogen peroxide solution, buffered with furoic acid and phosphorous acids. Hydrogen peroxide is the sotive ingredient in Resert XL HLD, which exerts its germicidal action via a strong oxidation reaction of cellular components.
This document (K091022) is a 510(k) summary for a high-level disinfectant, Resert™ XL HLD. It asserts substantial equivalence to a previously cleared device (K080420) and mainly concerns a labeling change. As such, it does not contain the kind of detailed study information (like a description of a clinical study, sample sizes, ground truth establishment, or expert adjudications) that would be present for a novel medical device approval based on performance data.
Here's an analysis based on the provided text, outlining why most of the requested information cannot be found:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The device is stated to be "identical to the predicate cleared as K080420." The only change was the removal of the statement "It is not recommended to reprocess instruments for longer than 8 minutes." No other changes were made to the product or its labeling. The submission's purpose is "solely to to the producere on this revised labeling." The FDA concurred with this assessment. |
| High-Level Disinfection Efficacy | The document states the intended use and performance parameters for high-level disinfection, but does not present the results of a study demonstrating these. The stated parameters are: "when used or reused undiluted for a maximum of 21 days at a minimum temperature of 20℃ (68°F) for a minimum immersion time of 8 minutes." This is a claim of its efficacy, but not study results proving it. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a labeling change on a chemical disinfectant, asserting substantial equivalence to an existing product. It does not involve a "test set" of patient data or clinical images. The "test" here is effectively a review by the FDA for substantial equivalence based on product formulation and labeling.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As there is no "test set" of patient data, there is no ground truth established by experts in the context of diagnostic accuracy. Substantial equivalence is determined by the FDA.
4. Adjudication method for the test set
- Not Applicable. No test set requiring adjudication is described.
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 is a chemical disinfectant, not an AI-powered diagnostic device. An MRMC study is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a chemical disinfectant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" for this submission is the established safety and efficacy profile of the predicate device (Resert™ XL HLD, K080420), to which the current device is deemed "identical" except for the labeling change. The FDA's substantial equivalence determination functions as the "truth" in this regulatory context.
8. The sample size for the training set
- Not Applicable. This device is a chemical disinfectant, not a machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is irrelevant.
In summary: The provided document is a 510(k) submission for a minor labeling change for a high-level disinfectant. It relies on the substantial equivalence principle, meaning the device's safety and effectiveness are established by comparing it to a legally marketed predicate device. Therefore, it does not contain the detailed clinical study data typically associated with a novel device's performance evaluation against specific acceptance criteria using a test set, expert ground truth, or AI performance metrics.
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Image /page/0/Picture/1 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a serif font, with a registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal wavy lines stacked on top of each other.
APR 1 2 2010
510(k) Summary For Resert™ XL HLD High Level Disinfectant
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
.
Contact:
Robert F. Sullivan Senior Director, Regulatory Affairs Telephone: (440) 392-7695 (440) 357-9198 Fax No:
April 8, 2010 Summary Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
April 8, 2010
Appendix 2: Page 1 of 3
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1. Device Name
| Trade Name: | Resert™ XL HLD High Level Disinfectant |
|---|---|
| Common/Usual Name: | Liquid Chemical Sterilants/Disinfectants |
| Classification Name: | Liquid Chemical Sterilants/Disinfectants |
| Classification Number: | 21 CFR 880.6885 |
| Product Code: | MED |
| Contact Information: | Robert Sullivan, Sr Director Regulatory AffairsSTERIS Corporation5960 Heisley Rd • Mentor OH • 44060 |
2. Predicate Devices
Resert™ XL HLD High Level Disinfectant (K080420), manufactured by STERIS Corporation.
Description of Device 3.
Resert XL HLD High Level Disinfectant is a nominal 2.0% hydrogen peroxide solution, buffered with furoic acid and phosphorous acids. Hydrogen peroxide is the sotive ingredient in Resert XL HLD, which exerts its germicidal action via a strong oxidation reaction of cellular components.
Intended Use 4.
Resert XL HLD is a ready to use liquid chemical germicide. The product is a 2.0% nominal hydrogen peroxide solution. The minimum recommended concentration nominal ryalogen peromate betwis intended to be used by health care practitioners in clinical settings as a ready to use liquid chemical disinfectant for the high level ni enhibat bettings as ritical medical devices for which alternative methods of terminal reprocessing are not suitable or available.
High Level Disinfectant: Resert XL HLD High Level Disinfectant is a high level disinfectant when used or reused undiluted for a maximum of 21 days at a disninectant when about of 20℃ (68°F) for a minimum immersion time of 8 minutes.
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Description of Safety and Substantial Equivalence ડ.
The Resert XL HLD High Level Disinfectant is identical to the predicate cleared as K080420. The statement "It is not recommended to reprocess instruments for longer than 8 minutes." was removed from labeling. No other changes were made to the predicate product or its labeling. The purpose of this submission is solely to to the producere on this revised labeling. The proposed labeling changes do not raise any new concerns of safety and effectiveness when compared to the predicate.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked vertically.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G6()9 Silver Spring, MD 20993-0002
Ms. Marcia Benedict Director, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
APR 1 2 2010
Re: K091022
Trade/Device Name: Rester XL HLD High Level Disinfectant Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants / High Level Disinfectants Regulatory Class: II Product Code: MED Dated: March 4, 2010 Received: March 8, 2010
Dear Ms. Benedict:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Benedict
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Kunne
Anthony Watson, B.S., M.S., M.B.A. 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
510(k) Number (if known):
Device Name:
Resert™ XL HLD High Level Disinfectant
Indications For Use:
Resert™ XL HLD is a ready -to-use liquid chemical germicide. The product is a 2.0% nominal hydrogen peroxide solution. The minimum recommended concentration (MRC) is 1.5%. Resert XL HLD is intended to be used by health care practitioners in clinical settings as a ready to use liquid chemical disinfectant for the high level disinfection of semi-critical medical devices for which alternative methods of terminal reprocessing are not suitable or available.
High Level Disinfectant: Resert™ XL HLD High Level Disinfectant is a high level disinfectant when used or reused undiluted for a maximum of 21 days at a minimum temperature of 20℃ (68°F) for a minimum immersion time of 8 minutes.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Seventuare
Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
K091022 i10(k) Number:
Page 1 of 1
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.