ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT

• K Number: K091210
• Device Name: ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT
• Manufacturer: BEST SANITIZERS, INC.
• Date Cleared: 2010-02-05 ( 287 days)
• Product Code: MED
• Regulation Number: 880.6885

Intended Use

ACECIDE-C is a high level disinfectant intended to disinfect reusable clean heatsensitive semi-critical medical devices (such as flexible endoscopes) which contact mucous membranes when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 7.0 minutes at 20°C. ACECIDE-C is a sterilant intended to sterilize reusable clean heat-sensitive critical and semi-critical medical devices (such as flexible endoscopes) which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization, when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 2.0 hours at 20℃. ACECIDE Test Strips are used with ACECIDE-C High Level Disinfectant and Sterilant use solution to ensure that the level of peracetic acid is above the minimum recommended concentration of 2000 ppm.

Device Description

ACECIDE-C High-Level Disinfectant and Sterilant is packaged in two separate plastic bottles: ACECIDE-C 6.8% Peracetic Acid Concentrate Solution 1 is a concentrate of acetic acid and hydrogen peroxide, which react with each other in the presence of a catalyst and stabilizer to form 6.2 - 6.8 % w/w peracetic acid at a pH value of <1. ACECIDE-C Buffer Concentrate Solution 2 contains a sequestrant, an anti-corrosive, and buffer salts for a pH value of about 8.7 to 9.7. At the time of use, one part of ACECIDE-C 6.8% Peracetic Acid Concentrate Solution 1 and one part of the ACECIDE-C Buffer Concentrate Solution 2 is mixed with 18 parts of tap water at 20℃ for a final concentration of 3100 - 3400 ppm peracetic acid. ACECIDE Test Strips are used with ACECIDE-C use solution to ensure that the level of peracetic acid is above the minimum recommended concentration of 2000 ppm. The test strips are based on the same basic chemistry as other peracetic acid test strips and assay methods. Peracetic acid oxidizes iodide to iodine with starch forming a visible blue-gray/blue-black compound with iodine. This color change in the indicator paper is the visual basis for the tests strips and their reading.

Predicate Devices

K041984

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on chemical disinfection and sterilization processes, with no mention of AI or ML technologies.

Therapeutic

No
This device is a high-level disinfectant/sterilant for medical devices, not a therapeutic device intended for direct treatment or diagnosis of a disease.

Diagnostic

No.

The device, ACECIDE-C, is a high-level disinfectant and sterilant for medical devices. The ACECIDE Test Strips are used to ensure the concentration of the disinfectant solution is above a minimum recommended level. Neither of these functions involves diagnosing a disease or medical condition in a patient.

SaMD (Software as a Medical Device)

No

The device described is a chemical disinfectant and sterilant (ACECIDE-C) and associated test strips (ACECIDE Test Strips), which are physical products, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, the ACECIDE-C High-Level Disinfectant and Sterilant is not an In Vitro Diagnostic (IVD) device.

Here's why:

• Intended Use: The intended use clearly states that ACECIDE-C is a high-level disinfectant and sterilant for reusable medical devices. It is used to kill microorganisms on these devices, not to diagnose or provide information about a patient's health condition.
• Device Description: The description details the chemical composition and how the solution is prepared for disinfecting and sterilizing medical devices.
• Performance Studies: The performance studies focus on the efficacy of ACECIDE-C in killing various microorganisms (bacteria, fungi, viruses, spores) on medical devices and test carriers. These are tests of the disinfectant's performance, not diagnostic tests on patient samples.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples from a patient (blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening of a disease or condition.

The ACECIDE Test Strips, while used with ACECIDE-C, are also not IVDs. Their purpose is to verify the concentration of the disinfectant solution, which is a quality control measure for the disinfectant itself, not a diagnostic test on a patient sample.

Therefore, based on the provided information, ACECIDE-C and its associated test strips are classified as disinfectants/sterilants for medical devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ACECIDE-C is a high level disinfectant intended to disinfect reusable clean heatsensitive semi-critical medical devices (such as flexible endoscopes) which contact mucous membranes when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 7.0 minutes at 20°C.

ACECIDE-C is a sterilant intended to sterilize reusable clean heat-sensitive critical and semi-critical medical devices (such as flexible endoscopes) which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization, when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 2.0 hours at 20℃.

ACECIDE Test Strips are used with ACECIDE-C High Level Disinfectant and Sterilant use solution to ensure that the level of peracetic acid is above the minimum recommended concentration of 2000 ppm.

Product codes (comma separated list FDA assigned to the subject device)

MED

Device Description

ACECIDE-C High-Level Disinfectant and Sterilant is packaged in two separate plastic bottles: ACECIDE-C 6.8% Peracetic Acid Concentrate Solution 1 is a concentrate of acetic acid and hydrogen peroxide, which react with each other in the presence of a catalyst and stabilizer to form 6.2 - 6.8 % w/w peracetic acid at a pH value of

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.

Summary

0

FEB - 5 2010

Section C 510(k) Summary ACECIDE-C High-Level Disinfectant and Sterilant

Date of Application: April 23, 2009

• 1. Summary of the safety and effectiveness of ACECIDE-C High-Level Disinfectant and Sterilant, a liquid chemical high-level disinfectant and sterilant.
  • Applicant/Sponsor a.

Laura King Best Sanitizers Inc. 154 Mullen Drive Walton, KY 41094

Phone: [phone] Fax: [phone]

• b. Application Correspondent
  Norman Miner, Ph.D. MicroChem Laboratory, Inc. 1107 - C South Airport Circle Euless (Dallas), TX 76040

Phone: (817) 283 - 9100 (817) 283 - 9110 Fax:

• Name of the Device C.
  Trade Name: ACECIDE-C High-Level Disinfectant and Sterilant Common Name: Liquid Chemical High-Level Disinfectant and Sterilant Classification Name: Not Classified

• d. Predicate Name
  Acecide High Level Disinfectant and Sterilant (K041984)

• Summary of the substantial equivalence (SE) of ACECIDE-C High-Level e. Disinfectant and Sterilant to the predicate Acecide High Level Disinfectant and Sterilant.
  Both ACECIDE-C High-Level Disinfectant (HLD) and Sterilant and Acecide High Level Disinfectant and Sterilant are two part products which are mixed and diluted with water (ACECIDE-C only) at the time of use. Solution 1 for both ACECIDE-C

1

K091210
p2of5

and Acecide contains concentrations of the chemicals that react to produce peracetic acid (hydrogen peroxide and acetic acid) at low pH values of about 1.0 or less. ACECIDE-C Solution 2 is a concentrated buffer solution, while Acecide Solution 2 is a dilute buffer solution. The mixed use solutions contain antimicrobial concentrations of 3100 to 3800 ppm peracetic acid. ACECIDE-C has a final pH value of about 3.4 to 3.7 and Acecide has a final pH value of about 4.0 to 4.5. Both of these products are intended for the high-level disinfection and/or sterilization of clean. heat-sensitive devices for which there is no other practical method for disinfection or sterilization. Acecide is a legally marketed sterilant. For these reasons, Acecide is an appropriate predicate device for comparisons of substantial equivalence to ACECIDE-C.

f. Summary description of ACECIDE-C High-Level Disinfectant and Sterilant.

ACECIDE-C High-Level Disinfectant and Sterilant is packaged in two separate plastic bottles: ACECIDE-C 6.8% Peracetic Acid Concentrate Solution 1 is a concentrate of acetic acid and hydrogen peroxide, which react with each other in the presence of a catalyst and stabilizer to form 6.2 - 6.8 % w/w peracetic acid at a pH value of