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.

Device Description

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 active ingredient in Resert XL HLD, which exerts its germicidal action via a strong oxidation reaction of cellular components.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Resert™ XL HLD High Level Disinfectant, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Criterion	Acceptance Criteria (Implied by equivalence)	Reported Device Performance (Resert XL HLD)
Microbiological Efficacy
AOAC Sporicidal Test (B. subtilis, C. sporogenes)	Meets sporicidal efficacy requirements (as demonstrated by predicate)	Meets sporicidal efficacy requirements
AOAC Use-Dilution Test (P. aeruginosa, S. aureus, S. enterica)	Bactericidal (as demonstrated by predicate)	Stressed solution is bactericidal
AOAC Fungicidal Test (T. mentagrophytes)	Fungicidal (as demonstrated by predicate)	Stressed solution is fungicidal
EPA Virucidal Test (Poliovirus Type I, Herpes Simplex Type 1, Adenovirus Type 5)	Virucidal (as demonstrated by predicate)	Stressed Solution is virucidal
Tuberculocidal Activity Test (M. terrae)	Tuberculocidal (as demonstrated by predicate - M. bovis)	Stressed solution is tuberculocidal
Simulated Use Test (M. terrae)	Meets efficacy requirements (as demonstrated by predicate)	Meets efficacy requirements (≥ 6 log10 reduction of test organism for endoscope sets after 8 minutes contact with stressed solution)
Toxicological Evaluation
Primary dermal Irritation	Comparable to predicate (SPOROX: Moderate irritant)	Slight irritant
Acute Dermal Toxicity	Dermal LD50 >5000 mg/kg body weight (as demonstrated by predicate)	Dermal LD50 >5000 mg/kg body weight
Ocular Irritation	Comparable to predicate (SPOROX: Severe irritant)	Mild irritant
Acute Oral Toxicity	Oral LD50 >5000 mg/kg body weight (as demonstrated by predicate)	Oral LD50 >5000 mg/kg body weight
Skin sensitization	Non-sensitizing (as demonstrated by predicate)	Non-sensitizing
Bacterial Reverse Mutation Assay (Ames Test)	Non-mutagenic (as demonstrated by predicate)	Non-mutagenic
Material Compatibility	No significant cosmetic changes or functional alteration after exposure	Validated through testing on various plastics, metals, and elastomers for up to 134 hours (1005 disinfectant cycles) at 25±2°C. No significant cosmetic changes or functional alteration observed on flexible endoscopes after 134 hours immersion.
Stability/Shelf-Life	At least 1 year shelf-life (unopened), and 21 days reuse life (opened)	At least 1 year shelf-life (unopened); reused for up to 21 days at minimum 20°C (68°F)
In-Use Efficacy (Clinical Endoscopes)	Effectively high level disinfected	Effectively high level disinfected (pre-cleaned, representative patient soiled endoscopes manually reprocessed for 8 minutes at ≥ 20°C)

Study Details:

2. Sample Size Used for the Test Set and Data Provenance:

Microbiological Efficacy Testing: Not explicitly stated for each individual test, but the methods (AOAC, EPA) generally involve specific numbers of replicates for bacterial/fungal/viral challenges.
Toxicological Evaluation: Not explicitly stated. Standard toxicology tests involve specific numbers of animal subjects per group as per regulatory guidelines.
Material Compatibility:
- Generic Materials: "A number of different plastic, metals, and elastomers" were evaluated. No specific count is given.
- Actual Devices: Two Fujinon and Olympus flexible colonoscope sets (including procedural and cleaning/reprocessing accessories) were tested.
Simulated Use Testing: Five clinical endoscope sets (comprised of flexible endoscopes, procedural endoscope accessories, and cleaning accessories) were tested.
In Use Testing: Not explicitly stated, but refers to "Pre-cleaned, representative patient soiled endoscopes".
Data Provenance: The document does not specify the country of origin for the data. The testing appears to be prospective bench testing and simulated/in-use testing conducted by STERIS Corporation to demonstrate the device's performance.

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 studies are primarily lab-based performance tests (microbiological, toxicological, material compatibility) rather than studies requiring expert human interpretation of results in a clinical setting. The "ground truth" for these tests is established by published regulatory standards (e.g., AOAC, EPA methods) for determining efficacy.

4. Adjudication Method for the Test Set:

Not Applicable. The studies described are laboratory and simulated/in-use performance tests, not clinical studies requiring human reader adjudication to establish ground truth.

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:

No. This device is a high-level disinfectant, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. All the reported performance tests (microbiological, toxicological, material compatibility, simulated use) are "standalone" in the sense that they evaluate the disinfectant's efficacy directly against established standards without human intervention in the disinfection process or its immediate outcome assessment. The "device" (the chemical disinfectant) functions independently of human interpretation for its primary action.

7. The Type of Ground Truth Used:

Regulatory/Standardized Test Methods and Measurable Outcomes:
- Microbiological Efficacy: Ground truth is established by the ability to achieve specific log reductions of test organisms (e.g., ≥ 6 log10 reduction for Mycobacterium terrae), as defined by standardized test methods like AOAC and EPA.
- Toxicological Evaluation: Ground truth is defined by specific quantitative thresholds (e.g., LD50 values) and qualitative observations (e.g., "slight irritant," "non-sensitizing") as determined by standardized toxicology protocols.
- Material Compatibility: Ground truth is determined by the absence of "significant cosmetic changes" and the maintenance of "functional" integrity, evaluated against visual and functional criteria after exposure.
- Stability: Ground truth is the ability to maintain efficacy (e.g., retain minimum recommended concentration) and physical properties over time as per shelf-life and reuse claims.

8. The Sample Size for the Training Set:

Not Applicable. This is a chemical disinfectant, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As no training set is involved, there is no ground truth to be established for it.

Summary

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SEP - 2 2008

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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:	John R. (Jack) Scoville, Jr.STERIS Corporation5960 Heisley RoadMentor, Ohio 44060
	Telephone: (440) 392-7330Fax No: (440) 357-9198
Summary Date:	June 05, 2008

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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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.

2. Predicate Device

SPOROX® Sterilizing and Disinfecting Solution (K970230) manufactured by Rickitt & Colman, Inc.

3. Description of Device

4. Intended Use

ട. Description of Safety and Substantial Equivalence

Both Resert XL HLD High Level Disinfectant and SPOROX Sterilizing and Disinfecting Solution (SPOROX) formulations have common features and use indications. Their active ingredient is hydrogen peroxide. The major difference is

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that Resert XL HLD has a nominal 2.0% hydrogen peroxide solution, buffered with furoic acid and phosphorous acids, while SPOROX has a 7.5% nominal hydrogen peroxide concentration, buffered with phosphoric acid, and they have high level disinfection contact times of 8 minutes and 30 minutes respectively.

The Resert XL HLD High Level Disinfectant has the same technological characteristics (i.e., design, material, chemical composition) as the predicate SPOROX device.

6. Device Comparison Table

A summary of the technological characteristics of the Resert XL HLD High Level Disinfectant in comparison to those of the predicate device is shown in Table 5-1.

Feature	Resert XL HLD	SPOROX
Intended Use	Resert XL HLD is intendedto be used by health carepractioners in clinicalsetting as a high leveldisinfectant when usedaccording to the labeledspecified directions	SPOROX is intended to beused by health carepractioners in clinicalsetting as a Liquid chemicalsterilant and/or high leveldisinfectant when usedaccording to the labeledspecified directions
Active Ingredient	2.0% hydrogen peroxide	7.5% hydrogen peroxide
Surfactants	Yes	Yes
Corrosion Inhibitor	Yes	Yes
Dilution required	No	No
Contact Time - HighLevel Disinfection	8 minutes @ 20°C	30 minutes @20°C
Use-Reuse Period	21 days	21 days
Accessories	Resert Chemical Indicator	SPOROX ChemicalIndicator
Primary Packaging	4 Liter Polyethylene bottle	1 gal. Polyethylene bottle
Secondary Packaging	4-4 Liter bottles per case	4-1 gal bottles per case
Closure System	Vented	Vented
Storage Conditions	Cool dry place	Cool dry place
Shelf-life	1 year un-opened	2 years un-opened

Table 5-1. Comparison Matrix for Resert XL HLD and SPOROX

7. Performance Testing Summary - Bench

All AOAC/EPA Potency testing was conducted with Resert XL HLD solution, formulated to below the minimum manufacturing specification for hydrogen

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peroxide, stressed to the end of its 21 day reuse life, and challenged with 5% organic challenge and 400 ppm hard water. The testing demonstrated the bactericidal, fungicidal, virucidal, sporicidal and tuberculocidal efficacy of Resert XL HLD, utilizing appropriate test methods. Also, Resert XL HLD was assessed for acute dermal toxicity, acute oral toxicity, primary skin irritation, skin sensitization, primary eye irritation, mutagenicity, and residue toxicity, according to the FDA Guidance on biocompatibility testing.

A stability program has been implemented to demonstrate a shelf-life for Resert XL HLD of at least 1 year, if unopened and stored according to label instructions, and reused for up to 21 days at a minimum temperature of 20℃ (68°F).

The test method criteria and a summary of results are presented in Tables 5-2 and 5-3.

SPOROX Microbiological Efficacy Testing
Test Method	Resert XL HLD	SPOROX
AOAC Sporicidal TestBacillus subtilisClostridium sporogenes	Meets sporicidal efficacyrequirements	Same
AOAC Use-Dilution TestPseudomonas aeruginosaStaphylococcus aureusSalmonella enterica	Stressed solution isbactericidal	Same
AOAC Fungicidal TestTrichophytonmentagrophytes	Stressed solution isfungicidal	Same
EPA Virucidal TestPoliovirus Type IHerpes Simplex Type 1Adenovirus Type 5	Stressed Solution isvirucidal	Same
Tuberculocidal Activity TestMycobacterium terrae	Stressed solution istuberculocidal	Same(M. bovis)
Simulated Use TestMycobacterium terrae	Meets efficacy requirements	Same

Table 5-2. Comparison Matrix for Resert XL HLD and SPOROX Microbiological Efficacy Testing

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P	A1.511-	7
	to

Toxicology Test	Resert XL HLD	SPOROX
Primary dermal Irritation	Slight irritant	Moderate irritant
Acute Dermal Toxicity	$Dermal LD_{50} >5000$mg/kg body weight	$Dermal LD_{50} >$5000 mg/kg bodyweight
Ocular Irritation	Mild irritant	Severe irritant
Acute Oral Toxicity	$OralLD_{50} >5000$ mg/kgbody weight	$OralLD_{50} >5000$mg/kg bodyweight
Skin sensitization	Non-sensitizing	Non-sensitizing
Bacterial Reverse Mutation Assay(Mutagenicity Ames Test)	Non-mutagenic	Non-mutagenic

Table 5-3. Comparison Matrix for Resert XL HLD and SPOROX Toxicological Evaluation

8. Device /Material Compatibility Studies

STERIS Corporation demonstrated the material compatibility of Resert XL HLD with medical devices and device materials, as identified in the product labeling, by conducting studies with actual devices, in both Simulated and In Use applications, and by conducting rigorous evaluations of a number of different plastic, metals, and elastomers commonly used in the construction of medical devices. The materials were exposed to Resert XL HLD solution, formulated above its maximum manufacturing specification for hydrogen peroxide, for up to 134 hours at 25+2°C (equivalent up to 1005 disinfectant cycles). A comparison of the compatible and incompatible materials for Resert XL HLD and the predicate device is shown in Table 5-4.

Materials Compatible	Resert XL HLD	SPOROX
Plastics:
Teflon	X	X
Polyester	X	X
Polystyrene	X	X
Polycarbonate	X	X
Polypropylene	X	X
Acrylic	X	X
Polyvinyl Chloride (PVC)	X	X
Acrylonitrile- butadiene-styrene (ABS)	X	X
Nylon	X	X
Metals:
Stainless Steel (302,316, 410)	X	X
Chrome Plate (Steel)	X	X

Table 5-4. Comparison Matrix for Resert XL HLD and SPOROX Material Compatibility

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12080420 STERIS Response to 053008 Request for Additional Information - Appendix B K080420 / Resert XL HLD High Level Disinfectant

Materials Compatible	Resert XL HLD	SPOROX
Platinum	P	X
Aluminum	X	X
Anodized Aluminum (6061)	X	X
Gold Plated Steel	X	P
Mild Steel	X	P
Solder 70/30	X	P
Nickel-Silver Alloy	P	N
Monel S	N	X
Brass	N	N
Copper	N	N
Nickel-Plated Steel	N	N
Tungsten Carbide	N	P
Silver	N	P
Elastomers:
Polyurethane	X	X
Neoprene	X	X
Silicone rubber	X	X
Ethylene Propylene Diene Terpolymer (EPDM)	X	X
Viton A	X	P
Red Natural Rubber	X	X
Black Natural Rubber	P	X

X= Compatible, N= Not Compatible, P= Not Performed

Material compatibility was confirmed with two Fujinon and Olympus flexible colonoscope sets, which included procedural and cleaning/reprocessing accessories. The devices were immersed in Resert XL HLD for 134 hours (1005 cycles) at 25 ±2℃, and showed no significant cosmetic changes, and were not functionally altered at study completion.

9. Simulated Use Testing

Five clinical endoscope sets comprised of flexible endoscopes, procedural endoscope accessories (i.e. valves), and cleaning accessories were challenged with Mycobacterium terrae ATCC 15755 under worst-case temperatures (18-19°C), and organic (5% serum, final v/v), and inorganic (400 ppm AOAC hard water) conditions. A ≥ 6 log10 reduction of test organism was achieved for all of the endoscope sets after 8 minutes of contact with Resert XL HLD test solution, formulated to below the minimum manufacturing specification for hydrogen peroxide and stressed to the end of its reuse life.

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K080420

10. In Use testing

Pre-cleaned, representative patient soiled endoscopes were manually reprocessed in Resert XL HLD for 8 minutes at ≥ 20°C, and shown to be effectively high level disinfected under In Use test conditions.

11. Resert XL HLD Stability

Resert XL HLD will have at least a 1 year shelf life or real time test data to support claimed expiry.

12. Conclusion

The above nonclinical and device /material compatibility studies demonstrate that Resert XL HLD High Level Disinfectant is as safe and effective as the predicate.

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Image /page/7/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2008

Mr. John R. Jack Scoville, Jr. Fellow, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

Re: K080420

Trade/Device Name: Resert™ XL HLD High Level Disinfectant Regulation Number: 880.6885 Regulation Name: Liquid Chemical Sterilants/ High Level Disinfectants Regulatory Class: II Product Code: MED Dated: August 26, 2008 Received: August 27, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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/cdrh/industry/support/index.html.

Sincerely vours.

TK. Samuels, m.d. for 11

Chiu S. Lin, Ph. D Division 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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STERIS Response to 053008 Request for Additional Information -- Appendix A K080420 / Resert XL HLD High Level Disinfectant

Indications for Use

510(k) Number (if known):

KO80420

Device Name:

Resert™ XL HLD High Level Disinfectant

Indications for Use:

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)

Shula H. Murphy, MD
(Division Sign-Off)

Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number:

Page 1 of 1

CONFIDENTIAL

Regulation Number and Section

§ 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.