RESERT XL HLD HIGH LEVEL DISINFECTANT

K080420 · STERIS Corporation · MED · Sep 2, 2008 · General Hospital

Device Facts

• Record ID: K080420
• Device Name: RESERT XL HLD HIGH LEVEL DISINFECTANT
• Applicant: STERIS Corporation
• Product Code: MED · General Hospital
• Decision Date: Sep 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2
• Attributes: Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K080420 · Sep 2, 2008	RESERT XL HLD HIGH LEVEL DISINFECTANT	STERIS Corporation	Patient-soiled endoscopes from clinical use	In-use testing was conducted on pre-cleaned, patient-soiled endoscopes to verify the high-level disinfection efficacy of the device under actual clinical conditions.	In-use testing; Patient-soiled endoscopes; High-level disinfection

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
In-use clinical performance evaluation	Patient-soiled endoscopes	Not applicable for this study	High-level disinfection efficacy

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.

Device Story

Resert XL HLD is a ready-to-use 2.0% hydrogen peroxide solution buffered with furoic and phosphorous acids. It functions as a liquid chemical germicide via strong oxidation of cellular components. Used in clinical settings by healthcare practitioners for high-level disinfection of semi-critical medical devices (e.g., flexible endoscopes). The solution is applied via immersion for a minimum of 8 minutes at ≥20°C. It is reusable for up to 21 days. The device benefits patients by providing an effective disinfection method for heat-sensitive devices where other terminal reprocessing is not feasible. Output is a disinfected medical device ready for clinical use.

Clinical Evidence

Bench testing only. Efficacy validated via AOAC/EPA potency testing (bactericidal, fungicidal, virucidal, sporicidal, tuberculocidal) using stressed solutions (end of 21-day life, 5% organic challenge, 400 ppm hard water). Simulated use testing on endoscope sets achieved ≥6 log10 reduction of Mycobacterium terrae. Biocompatibility assessed per FDA guidance (acute dermal/oral toxicity, irritation, sensitization, mutagenicity). Material compatibility confirmed via 134-hour exposure (1005 cycles) on various plastics, metals, and elastomers.

Technological Characteristics

Liquid chemical disinfectant; 2.0% hydrogen peroxide solution buffered with furoic and phosphorous acids. Includes surfactants and corrosion inhibitors. Compatible with various plastics (Teflon, PVC, etc.) and metals (stainless steel, aluminum). Not compatible with brass, copper, or silver. Form factor: 4-liter polyethylene bottle. Shelf-life: 1 year unopened. No software or electronic components.

Indications for Use

Indicated for high-level disinfection of semi-critical medical devices in clinical settings by healthcare practitioners when alternative terminal reprocessing methods are unavailable or unsuitable.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SPOROX® Sterilizing and Disinfecting Solution (K970230)

Submission Summary (Full Text)

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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: [phone] Fax No: [phone]

| Contact: | John R. (Jack) Scoville, Jr.<br>STERIS Corporation<br>5960 Heisley Road<br>Mentor, Ohio 44060 |
|---------------|-----------------------------------------------------------------------------------------------|
| | Telephone: [phone]<br>Fax No: [phone] |
| 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

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.

#### 4. Intended 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.

#### 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 intended<br>to be used by health care<br>practioners in clinical<br>setting as a high level<br>disinfectant when used<br>according to the labeled<br>specified directions | SPOROX is intended to be<br>used by health care<br>practioners in clinical<br>setting as a Liquid chemical<br>sterilant and/or high level<br>disinfectant when used<br>according to the labeled<br>specified directions |
| Active Ingredient | 2.0% hydrogen peroxide | 7.5% hydrogen peroxide |
| Surfactants | Yes | Yes |
| Corrosion Inhibitor | Yes | Yes |
| Dilution required | No | No |
| Contact Time - High<br>Level Disinfection | 8 minutes @ 20°C | 30 minutes @20°C |
| Use-Reuse Period | 21 days | 21 days |
| Accessories | Resert Chemical Indicator | SPOROX Chemical<br>Indicator |
| 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 Test<br>Bacillus subtilis<br>Clostridium sporogenes | Meets sporicidal efficacy<br>requirements | Same |
| AOAC Use-Dilution Test<br>Pseudomonas aeruginosa<br>Staphylococcus aureus<br>Salmonella enterica | Stressed solution is<br>bactericidal | Same |
| AOAC Fungicidal Test<br>Trichophyton<br>mentagrophytes | Stressed solution is<br>fungicidal | Same |
| EPA Virucidal Test<br>Poliovirus Type I<br>Herpes Simplex Type 1<br>Adenovirus Type 5 | Stressed Solution is<br>virucidal | Same |
| Tuberculocidal Activity Test<br>Mycobacterium terrae | Stressed solution is<br>tuberculocidal | Same<br>(M. bovis) |
| Simulated Use Test<br>Mycobacterium terrae | Meets efficacy requirements | Same |

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

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| <br>P | A<br>1.5<br>11<br>- | 7 |
|-------|---------------------|---|
| | to | |

| Toxicology Test | Resert XL HLD | SPOROX |
|--------------------------------------------------------------|---------------------------------------------|-------------------------------------------------|
| Primary dermal Irritation | Slight irritant | Moderate irritant |
| Acute Dermal Toxicity | $Dermal LD_{50} >5000$<br>mg/kg body weight | $Dermal LD_{50} >$<br>5000 mg/kg body<br>weight |
| Ocular Irritation | Mild irritant | Severe irritant |
| Acute Oral Toxicity | $OralLD_{50} >5000$ mg/kg<br>body weight | $OralLD_{50} >5000$<br>mg/kg body<br>weight |
| Skin sensitization | Non-sensitizing | Non-sensitizing |
| Bacterial Reverse Mutation Assay<br>(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 [phone]. 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 [phone] or [phone] 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:

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 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:

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CONFIDENTIAL