PERACT 20 LIQUID STERILANT

K960513 · Minntech Corp. · MED · Oct 1, 1997 · General Hospital

Device Facts

• Record ID: K960513
• Device Name: PERACT 20 LIQUID STERILANT
• Applicant: Minntech Corp.
• Product Code: MED · General Hospital
• Decision Date: Oct 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

Indications for Use

Peract™ 20 Liquid Sterilant/Disinfectant is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion. Peract™ 20 Liquid Sterilant/Disinfectant should be used only with heat sensitive medical and surgical instruments that are not compatible with other sterilization or high level disinfection processes that can be biologically monitored. Peract™ 20 Liquid Sterilant/Disinfectant should be used under the following contact conditions: Sterilization: 8 hours, 68°F (20°C), 500 ppm; High Level Disinfection: 25 minutes, 68°F (20°C), 500 ppm. Peract™ 20 Indicator Test Strips are intended for verifying the minimum effective concentration of peracetic acid in Peract™ 20 Liquid Sterilant/Disinfectant during reuse.

Device Story

Peract™ 20 is a single-component liquid germicide containing peracetic acid and hydrogen peroxide; requires no mixing/activation. Used for submersion sterilization or high-level disinfection of heat-sensitive medical/surgical instruments. Mechanism involves oxidation of sulfhydryl/sulfur bonds in microbial proteins/enzymes. Accompanied by indicator test strips to verify minimum effective concentration (MEC) of 500 ppm peracetic acid. Healthcare providers (clinicians/technicians) perform manual submersion of instruments in the solution for specified contact times (25 mins for disinfection; 8 hours for sterilization) at 68°F. Output is a processed, disinfected/sterilized instrument. Benefits include effective microbial reduction (sporicidal, tuberculocidal, virucidal, fungicidal, bactericidal) for devices unable to withstand heat-based sterilization.

Clinical Evidence

Bench testing only. Efficacy demonstrated via AOAC sporicidal testing, tuberculocidal testing, and use-dilution testing against S. aureus, S. choleraesuis, and P. aeruginosa. Virucidal efficacy confirmed against Poliovirus Type 2, Influenza A2, HIV-1, and HSV-1. Fungicidal efficacy confirmed against T. mentagrophytes. Simulated-use testing performed on endoscopes. Biocompatibility testing (cytotoxicity, hemolysis, acute toxicity, mucosal irritation) and material compatibility testing confirmed safety and device integrity. Stability studies confirmed shelf life and performance at MEC.

Technological Characteristics

Single-component liquid germicide; active ingredients: peracetic acid and hydrogen peroxide. Packaged in 1-gallon polyethylene bottles. Indicator test strips utilize chemical reaction to verify 500 ppm peracetic acid MEC. Compatible with wide range of endoscope materials. Stability tested per Liquid Chemical Germicide Document section (III)(F)(3).

Indications for Use

Indicated for sterilization or high-level disinfection of heat-sensitive, immersible medical and surgical instruments incompatible with other monitorable 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

• ProCide® NS
• Cidex®

Submission Summary (Full Text)

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OCT-01-97 WED 10:04 AM MINNTECH
FAX NO. 6125533387
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K960513

# PERACT™ 20 LIQUID STERILANT/DISINFECTANT AND PERACT™ 20 INDICATOR TEST STRIPS

OCT - 1 1997

510(k) Summary of Safety and Effectiveness

Minntech Corporation, 14605 28th Ave. N, Mpls, MN 55447
Telephone: [phone]
Official Contact: Robert Johnson
Vice President, Regulatory Affairs and Quality Assurance

Minntech Corporation has provided the following information to the U.S. Food and Drug Administration to support that Peract™ 20 Liquid Sterilant/Disinfectant is substantially equivalent to other sterilants currently in commercial distribution in the United States.

## 1. Device Description

Peract™ 20 Liquid Sterilant/Disinfectant is a single component germicide which does not require mixing or activation. The product is used full strength, without dilution. It is packaged in one gallon polyethylene bottles and has a one year shelf life.

The active ingredient in Peract™ 20 are peracetic acid and hydrogen peroxide. As discussed in Block’s¹ article, the mechanism of microbial action is believed to be oxidizing sulfhydryl and sulfur bonds in proteins and enzymes, particularly in the cell walls.

Peract™ 20 Peracetic Acid Indicator Test Strips are provided to verify that the minimum effective concentration (MEC) (500 ppm peracetic acid) of Peract™ 20 is present. Three test strips are used with each application.

## 2. Intended Use

Peract™ 20 Liquid Sterilant/Disinfectant is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion.

Peract™ 20 Liquid Sterilant/Disinfectant should be used only with heat sensitive medical and surgical instruments that are not compatible with other sterilization or high level disinfection processes that can be biologically monitored.

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

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Peract™ 20 Liquid Sterilant/Disinfectant should be used under the following contact conditions:

| | Time | Temperature | Minimum Effective Concentration Peracetic Acid |
| --- | --- | --- | --- |
| Sterilization | 8 hours | 68°F (20°C) | 500 ppm |
| High Level Disinfection | 25 minutes | 68°F (20°C) | 500 ppm |

3. Comparison to another Device in Commercial Distribution within the United States:

Peract™ 20 Liquid Sterilant/Disinfectant is comparable in its intended use to other liquid sterilants currently on the market in the U.S. Peract™ 20 is similar in use and product claims to Cottrell’s ProCide® NS and Johnson & Johnson’s Cidex®.

4. Summary

Minntech Corporation has performed testing to demonstrate that Peract™ 20 Liquid Sterilant/Disinfectant and Peract™ 20 Indicator Test Strips are safe and effective when used according to the respective instructions for use.

4.1 Efficacy Testing

The following efficacy testing was performed on Peract™ 20 with all of the following conditions: at the minimum of its specifications, at the end of its shelf life, stressed to the end of its 14 day reuse period and at its MEC (500ppm PAA). The testing showed the product to be sporicidal, tuberculocidal, virucidal, fungicidal, and bactericidal.

AOAC sporicidal testing was performed on three lots of Peract™ 20 with the above noted conditions. Sporicidal simulated use testing was also performed on endoscopes to show efficacy as a sterilant on actual devices.

Tuberculocidal testing was performed on three lots of Peract™ 20 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.

Peract™ 20 was determined to be virucidal when tested against Poliovirus Type 2, Influenza A₂, Human Immunodeficiency Virus Type 1, and Herpes Simplex Virus Type 1. Peract™ 20 was considered fungicidal when tested against Trichophyton mentagrophytes. Use dilution testing showed the efficacy of Peract™ 20 against Staphylococcus aureus, Salmonella choleraesuis, Pseudomonas aeruginosa.

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Clinical testing of used scopes further supports the efficacy of the germicide when used under the instructions of the directions for use. Testing determined residues of Peract™ 20 remaining on endoscopes after sterilization/disinfection and rinsing were not significant.

## 4.2 Biocompatibility Testing

Standard patient toxicity testing evaluated the effect of residues, cytotoxicity, hemolysis, acute toxicity, and vaginal (mucosal membrane) irritation.

All biocompatibility testing demonstrated that Peract™ 20 is safe for the patient when used according to the instructions for use.

## 4.3 Material Compatibility

Material compatibility testing demonstrates that Peract™ 20 can be used with a wide range of materials and endoscopes. Testing included soaking and cycling common materials and endoscopes for the estimated lifetime of the items.

Material compatibility testing demonstrated that Peract™ 20 is compatible with the materials and devices listed when used according to the instructions for use.

## 4.4 Stability

Peract™ 20 has a shelf life of one year. Stability studies were performed according to section (III)(F)(3) of the Liquid Chemical Germicide Document. Studies demonstrated that the chemical and physical stability of Peract™ 20 were within specifications at the expiration date.

## 4.5 Test Strips

Peract™ 20 Indicator Test Strips demonstrated to consistently and accurately test the germicide at its minimum effective concentration of 500 ppm peracetic acid when three test strips were used.

Testing of the indicator strips was accomplished by showing: the efficacy of the strips when they were exposed to Peract™ 20; that they were stable over the labeled shelf life; and were stable in the opened bottle for 30 days. All of these tests were performed on a minimum of three lots of strips using Peract™ 20 diluted to various concentrations of PAA from much lower to much higher than the MEC of 500ppm PAA. The testing was also performed on solutions close to the MEC of 500ppm PAA to ensure the strips performed appropriately at concentrations around the MEC. The results of the testing showed the strips

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performed appropriately when three strips were used as called out in the directions for use.

## 5.0 Summary of Substantial Equivalence

Minntech Corporation has provided the above information within the 510(k) to support that Peract™ 20 Liquid Sterilant/Disinfectant and Peract™ 20 Indicator Test Strips are safe and effective when used according to the respective directions for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Ms. Lynn Lueders
Director, Regulatory Affairs
Minntech Corporation
14605 28th Avenue, North
Minneapolis, Minnesota 55447

OCT - 1 1997

Re: K960513
Trade Name: Peract™20 Liquid Sterilant/Disinfectant
Regulatory Class: Unclassified
Product Code: MED
Dated: July 14, 1997
Received: July 15, 1997

Dear Ms. Lueders:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Lueders

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

,Enclosure

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# Indications for Use

510(k) Number (if known): K960513

Device Name: Peract™ 20 Liquid Sterilant/Disinfectant and Peract™ 20 Indicator Test Strips

Intended Use:

Peract™ 20 Liquid Sterilant/Disinfectant is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion.

Peract™ 20 Liquid Sterilant/Disinfectant should be used only with heat sensitive medical and surgical instruments that are not compatible with other sterilization or high level disinfection processes that can be biologically monitored.

Peract™ 20 Liquid Sterilant/Disinfectant should be used under the following contact conditions:

| | Time | Temperature | Minimum Effective Concentration Peracetic Acid |
| --- | --- | --- | --- |
| Sterilization | 8 hours | 68°F (20°C) | 500 ppm |
| High Level Disinfection | 25 minutes | 68°F (20°C) | 500 ppm |

Peract™ 20 Indicator Test Strips are intended for verifying the minimum effective concentration of peracetic acid in Peract™ 20 Liquid Sterilant/Disinfectant during reuse.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☐ OR Over-the counter use ☑
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K960513