MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT

K091022 · STERIS Corporation · MED · Apr 12, 2010 · General Hospital

Device Facts

• Record ID: K091022
• Device Name: MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
• Applicant: STERIS Corporation
• Product Code: MED · General Hospital
• Decision Date: Apr 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

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.

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. Requires minimum 8-minute immersion at 20°C (68°F). Solution can be reused for up to 21 days if concentration remains above 1.5% MRC. Output is a disinfected medical device.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

2.0% hydrogen peroxide solution buffered with furoic and phosphorous acids. Liquid chemical disinfectant. Minimum recommended concentration (MRC) 1.5%.

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

• Resert™ XL HLD High Level Disinfectant (K080420)

Submission Summary (Full Text)

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K091022

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: [phone] Fax No: [phone]

.

Contact:

Robert F. Sullivan Senior Director, Regulatory Affairs Telephone: [phone] [phone] 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 Affairs<br>STERIS Corporation<br>5960 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 [phone] or [phone] 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**

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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:

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