ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT

K041984 · Best Sanitizers, Inc. · MED · May 11, 2005 · General Hospital

Device Facts

• Record ID: K041984
• Device Name: ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
• Applicant: Best Sanitizers, Inc.
• Product Code: MED · General Hospital
• Decision Date: May 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

Intended Use

Acecide High-Level Disinfectant and Sterilant is intended to be used for automated sterilization or high-level disinfection of clean, heat sensitive, critical and semisterifical medical devices that are not compatible with other sterilization or highlevel disinfection processes that can be biologically monitored. Acecide High-Level Disinfectant and Sterilant should be used under the following contact conditions: Sterilization: 5 hours, 25°C, 1900 ppm Minimum Recommended Concentration of Peracetic Acid; High-Level Disinfection: 5 minutes, 25°C, 1900 ppm Minimum Recommended Concentration of Peracetic Acid. Acecide Peracetic Acid Test Strips are intended for verifying the minimum recommended concentration of peracetic acid in Acecide High-Level Disinfectant and Sterilant during reuse.

Device Story

Acecide High-Level Disinfectant and Sterilant is a two-part liquid germicide (peracetic acid and hydrogen peroxide) used for automated reprocessing of heat-sensitive medical devices. The mechanism of action involves oxidation of sulfhydryl and sulfur bonds on microbial proteins and enzymes. The device is used in clinical settings to achieve sterilization (5 hours) or high-level disinfection (5 minutes) at 25°C. Acecide Peracetic Acid Test Strips are used to verify the minimum recommended concentration (1900 ppm) of peracetic acid during reuse. The system ensures effective microbial reduction (sporicidal, tuberculocidal, virucidal, fungicidal, bactericidal) while maintaining material compatibility with endoscopes and other devices. Clinical benefit includes safe, effective reprocessing of heat-sensitive instruments that cannot undergo standard thermal sterilization.

Clinical Evidence

Bench testing included AOAC sporicidal, tuberculocidal, virucidal, fungicidal, and bactericidal assays. Simulated-use testing performed on endoscopes confirmed efficacy as a sterilant and high-level disinfectant. Biocompatibility testing (cytotoxicity, hemolysis, acute toxicity) confirmed patient safety. Material compatibility testing confirmed suitability for endoscopes over their estimated lifetime. Clinical testing of used endoscopes confirmed that chemical residues after rinsing were not significant.

Technological Characteristics

Two-part liquid chemical germicide; active ingredients: peracetic acid and hydrogen peroxide. Packaging: High Density Polyethylene (HDPE) bottles. Mechanism: Oxidative microbial inactivation. Includes chemical test strips for concentration verification (1900 ppm MRC).

Indications for Use

Indicated for automated sterilization or high-level disinfection of clean, heat-sensitive, critical, or semi-critical medical devices incompatible with other biologically monitorable sterilization/disinfection processes.

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

• Peract® 20 Liquid Sterilant/Disinfectant
• Medivators Rapicide™ High Level Disinfectant and Sterilant

Submission Summary (Full Text)

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## MAY 1 1 2005

K05//984

## ACECIDE™ HIGH-LEVEL DISINFECTANT AND STERILANT AND ACECIDE™ PERACETIC ACID TEST STRIPS

510(k) Summary of Safety and Effectiveness

| <b>Sponsor/Applicant:</b> |
|---------------------------|
| <b>Address:</b> |

Best Sanitizers, Inc. P.O. Box 1360 17320 Penn Valley Drive Penn Valley, CA 95946 USA

Contact:

Mohammed R. Hay Director, Manufacturing 888-225-3267 Fax: [phone]

| Submission Correspondent: | Richard M. Ormsbee |
|---------------------------|-------------------------------------|
| Address: | Minntech Corporation |
| | 14605 28 ^th Avenue North |
| | Minneapolis, MN 55428 |
| | 763-551-2689 |
| | Fax: [phone] |

Best Sanitizers has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalency of the Acecide™ High-Level Disinfectant and Sterilant to other sterilants currently in distribution in the United States.

#### Device Description 1.

Acecide High-Level Disinfectant and Sterilant is a germicide that requires the combination of two parts, Solution 1 and Solution 2, within the Solution 2 bottle. The product is used full strength without dilution. It is packaged in two High Density Polyethylene bottles.

The active ingredients in Acecide High-Level Disinfectant and Sterilant are peracetic acid and hydrogen peroxide. As discussed in Block's' article, the mechanism of microbial action is believed to be oxidizing sulthydryl and sulfur bonds on proteins and enzymes, particularly in the cell walls.

¹ Block, Seymour S., Disinfection, Sterilization and Preservation; Chapter 9 Peroxygen Compounds (pages 167-181), Lea & Febiger, 1991.

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Acecide Peracetic Acid Test Strops are provided to verify that the minimum receide Fordection, 1900 ppm peracetic acid (PAA) of Acecide High-Level Disinfectant and Sterilant is present.

#### Intended Use 2.

Acecide High-Level Disinfectant and Sterilant is intended to be used for automated sterilization or high-level disinfection of clean, heat sensitive, critical and semisterifical medical devices that are not compatible with other sterilization or highlevel disinfection processes that can be biologically monitored.

Acecide High-Level Disinfectant and Sterilant should be used under the following contact conditions:

| | Time | Temperature | Minimum<br>Recommended<br>Concentration of<br>Peracetic Acid |
|----------------------------|-----------|-------------|--------------------------------------------------------------|
| Sterilization | 5 hours | 25°C | 1900 ppm |
| High-Level<br>Disinfection | 5 minutes | 25°C | 1900 ppm |

Acecide Peracetic Acid Test Strips are intended for verifying the minimum recommended concentration of peracetic acid in Acecide High-Level Disinfectant and Sterilant during reuse.

### Comparison to Another Device in Commercial Distribution Within the United 3. States

Acecide High-Level Disinfectant and Sterilant is comparable in its intended use to other liguid sterilants currently on the market in the United States. Acecide High-Level Disinfectant and Sterilant is similar in use and product claims to Minntech's Peract® 20 Liquid Sterilant/Disinfectant and Medivators Rapicide™ High Level Disinfectant and Sterilant.

#### Summary 4.

Best Sanitizers has performed testing to demonstrate that Acecide High-Level Disinfectant and Sterilant and Acecide Peracetic Acid Test Strips are safe and effective when used according to the respective instructions for use.

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#### Efficacy Testing 5.

The following efficacy testing was performed on Acecide High-Level Disinfectant The following cirrealy the following conditions: at the minimum of its and oternant with an or attessed to the end of its reuse period and at its MRC (1900 ppm PAA). The testing showed the product to be sporicidal, tuberculocidal, virucidal, fungicidal and bactericidal.

AOAC sporicidal testing was performed on three lots of Acecide High-Level Disinfectant and Sterilant with the above noted conditions. Sporicidal simulateduse testing was also performed on endoscopes to show efficacy as a sterilant on actual devices.

Tuberculocidal testing was performed on three lots of Acecide High-Level Disinfectant and Sterilant with the above noted conditions. Tuberculocidal simulated-use testing was also performed on endoscopes to show efficacy as a high-level disinfectant on actual devices.

Acecide High-Level Disinfectant and Sterilant was determined to be virucidal when tested against Poliovirus Type 2, Human Immunodeficiency Virus Type 1 and Hernes simplex virus Type 1. Acecide High-Level Disinfectant and Sterilant was considered fungicidal when tested against Trichophyton mentagrophytes . Was Collution testing showed the efficacy of Acecide High-Level Disinfectant and Sterilant against Staphylococcus aureus, Salmonella choleraesuis and Pseudomonas aeruginosa.

Clinical testing of used endoscopes further supports the efficacy of Acecide High-Level Disinfectant and Sterilant when used under the directions of the Directions for Use. Testing determined residues of Acecide High-Level Disinfectant and Sterilant remaining on endoscopes after sterilization or high-level disinfection and rinsing were not significant.

#### Biocompatibility Testing 6.

Standard patient toxicity testing evaluated the effect of residues. Testing included: cytotoxicity, hemolysis and acute toxicity testing.

Biocompatibility testing has demonstrated that Acecide High-Level Disinfectant and Sterilant is safe for the patient when used according to the Directions for Use.

#### Material Compatibility 7.

Material compatibility testing demonstrates that Acecide High-Level Disinfectant and Sterilant can be used with endoscopes and a wide range of materials. Testing included soaking and reprocessing of common materials and endoscopes for the estimated lifetime of the items.

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Material compatibility testing has demonstrated that Acecide High-Level Maichar compatibility tecting may stible with the materials and devices listed and used according to the Directions for Use.

#### Stability 8.

Stability studies were performed according to the FDA Content and Format of Statinty studios .vere p[510(k)] Submissions for Liquid Chemical Sterilants/High I remarket Notification for of the posses (1-3-2000). Studies demonstrated that the chemical and physical stability of Acecide High-Level Disinfectant and Sterilant were within specifications at the labeled expiration date.

#### Test Strip 9.

Acecide Peracetic Acid Test Strips demonstrated the ability to consistently and accurately test the germicide at its MRC of 1900 ppm peracetic acid when used according to the Directions for Use.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 2005

Best Sanitizers, Incorporated C/O Mr. Richard M. Ormsbee Senior Regulatory Affairs Specialist Minntech Corporation 14605 28th Avenue North Minneapolis, Minnesota 55447-4822

Re: K041984

Ko+176+
Trade/Device Name: Acecide™ High-Level Disinfectant and Sterilant Regulation Number: 880.6885 Regulation Name: Liquid Chemical Sterilants/ High Level Disinfectants Regulatory Class: II Product Code: MED Dated: March 29, 2005 Received: March 30, 2005

Dear Mr. Ormsbee:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater mined the device is substantially equivalent (for the relerenced above and have acternines re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments prior to they are reclassified in accordance with the provisions of Ameliunients, or to actives that in tic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, und Ocenners, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include confors provisions of the rist ston, listing of devices, good manufacturing practice, lequirements roohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classinod (See as 10) is a may be regulations affecting (PMA), it may of subject to sach adame fraderal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Souce of Peech one of the Federal Register.

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Page 2 - Mr. Ormsbee

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease to act rood a determination that your device complies with other requirements moun that 1 Dr mas muse statutes and regulations administered by other Federal agencies. or the receively with all the Act's requirements, including, but not limited to: registration r ou must comply with art 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 er read on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form nroduct 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) This letter will anow yourse sogger and all equivalence of your device to a premarket notifed.com - 11.0 evice 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), If you desire specific accorpliance at [phone]. 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 may obtain 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 yours,

Shiu-Ling, Ph.D.

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

0(k) Number (if known): Kc 4 1984

Device Name: Acecide™ High-Level Disinfectant and Stcrilant

ndications for Use:

cecide High-Level Disinfectant and Sterilant is intended to be used for the automated Accede High-Level disinfection of clean, heat sensitive, critical or semi-critical medical steritzation or mgn 1070 atballevith other sterilization or high-level disinfection processes that an be biologically monitored.

ecide High-Level Disinfectant and Sterilant should be used under the following contact ditions:

| | Time | Temperature | Minimum<br>Recommended<br>Concentration of<br>Peracetic Acid |
|----------------------------|-----------|-------------|--------------------------------------------------------------|
| Sterilization | 5 hours | 25°C | 1900 ppm |
| High-Level<br>Disinfection | 5 minutes | 25°C | 1900 ppm |

cecide Peracetic Acid Test Strips are intended for verifying the minimum recommended oncentration of peracetic acid in Acecide High-Level Disinfectant and Sterilant during reuse.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

× Over-The-Counter Use (21 CFR 801 Subpart C)

LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shadi T. Mughrabi, MD

Jusion Sign-Off wision of Anesthesiology, General Hospital, Intection Control, Dental Devices

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510(k) Number: K041984