(292 days)
Acecide High-Level Disinfectant and Sterilant is intended to be used for the automated sterilization or high-level disinfection of clean, heat sensitive, critical or semi-critical medical devices that are not compatible with other sterilization or high-level disinfection processes that can be biologically monitored.
Acecide High-Level Disinfectant and Sterilant should be used under the following contact conditions:
Sterilization: Time 5 hours, Temperature 25°C, Minimum Recommended Concentration of Peracetic Acid 1900 ppm
High-Level Disinfection: Time 5 minutes, Temperature 25°C, Minimum Recommended Concentration of Peracetic Acid 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.
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.
Acecide Peracetic Acid Test Strops are provided to verify that the minimum recommended concentration, 1900 ppm peracetic acid (PAA) of Acecide High-Level Disinfectant and Sterilant is present.
The provided text describes the regulatory submission for the Acecide™ High-Level Disinfectant and Sterilant and Acecide™ Peracetic Acid Test Strips. It outlines the efficacy testing performed for the disinfectant and sterilant, and the performance of the test strips.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Minimum Requirements for Efficacy) | Reported Device Performance |
|---|---|
| Acecide High-Level Disinfectant and Sterilant: | |
| Sporicidal activity | Demonstrated sporicidal activity against spores |
| Tuberculocidal activity | Demonstrated tuberculocidal activity |
| Virucidal activity | Demonstrated virucidal activity against Poliovirus Type 2, Human Immunodeficiency Virus Type 1, and Herpes simplex virus Type 1 |
| Fungicidal activity | Demonstrated fungicidal activity against Trichophyton mentagrophytes |
| Bactericidal activity | Demonstrated bactericidal activity against Staphylococcus aureus, Salmonella choleraesuis, and Pseudomonas aeruginosa |
| Material compatibility | Demonstrated compatibility with endoscopes and a wide range of materials (soaked and reprocessed for estimated lifetime) |
| Biocompatibility | Safe for patients when used according to Directions for Use (cytotoxicity, hemolysis, acute toxicity testing) |
| Stability | Chemical and physical stability within specifications at labeled expiration date |
| Acecide Peracetic Acid Test Strips: | |
| Ability to consistently and accurately test at 1900 ppm PAA | Demonstrated ability to consistently and accurately test the germicide at its MRC of 1900 ppm peracetic acid |
2. Sample size used for the test set and the data provenance
- Acecide High-Level Disinfectant and Sterilant - Efficacy Testing:
- Sporicidal: Three lots of Acecide High-Level Disinfectant and Sterilant were used for AOAC sporicidal testing. Sporicidal simulated-use testing was also performed on endoscopes (specific number of endoscopes not provided).
- Tuberculocidal: Three lots of Acecide High-Level Disinfectant and Sterilant were used. Tuberculocidal simulated-use testing was also performed on endoscopes (specific number of endoscopes not provided).
- Virucidal, Fungicidal, Bactericidal: The text indicates general testing for these categories without specifying lot numbers or detailed sample sizes beyond "three lots" for sporicidal and tuberculocidal.
- Clinical Testing (Residues): "Clinical testing of used endoscopes" was performed to determine residue levels (specific number of endoscopes not provided).
- Acecide Peracetic Acid Test Strips: Sample size for testing strip accuracy is not explicitly stated.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission, it's generally expected that the studies were conducted prospectively to demonstrate compliance with regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a "ground truth" in the way it might be applied to, for example, image interpretation by radiologists. Instead, the "ground truth" for the disinfectant and test strip efficacy is based on standardized microbiological testing methods (e.g., AOAC sporicidal testing) and chemical analysis. The qualifications of the personnel conducting these tests are not provided.
4. Adjudication method for the test set
Not applicable. The efficacy studies for a disinfectant and sterilant rely on direct measurements and adherence to established protocols, not on expert adjudication of ambiguous cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a chemical disinfectant/sterilant and test strips, not an AI-powered diagnostic device that involves human reader interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The described "efficacy testing" for the Acecide High-Level Disinfectant and Sterilant is essentially a standalone performance evaluation of the chemical agent itself under various conditions. The Acecide Peracetic Acid Test Strips also have a standalone performance in terms of their ability to accurately measure the chemical concentration. There is no "human-in-the-loop" aspect to these performance tests, as the devices are not diagnostic decision-support tools.
7. The type of ground truth used
- Acecide High-Level Disinfectant and Sterilant: The ground truth for efficacy is established by the ability to kill specific microorganisms (spores, mycobacteria, viruses, fungi, bacteria) and by adhering to established standards for these classifications (e.g., "sporicidal," "tuberculocidal," "virucidal," "fungicidal," "bactericidal"). For biocompatibility and material compatibility, the ground truth is established by chemical testing for residues, cytotoxicity, hemolysis, acute toxicity, and visual/physical inspection of materials after exposure.
- Acecide Peracetic Acid Test Strips: The ground truth for the test strips is their accuracy in measuring the concentration of peracetic acid, likely against a known standard or validated chemical assay.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such products involves formulation development and process optimization, not algorithm training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of an AI/ML algorithm.
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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
| Sponsor/Applicant: |
|---|
| Address: |
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: 530-432-0752
| Submission Correspondent: | Richard M. Ormsbee |
|---|---|
| Address: | Minntech Corporation |
| 14605 28 th Avenue North | |
| Minneapolis, MN 55428 | |
| 763-551-2689 | |
| Fax: 763-509-1601 |
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 | MinimumRecommendedConcentration ofPeracetic Acid | |
|---|---|---|---|
| Sterilization | 5 hours | 25°C | 1900 ppm |
| High-LevelDisinfection | 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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 | MinimumRecommendedConcentration ofPeracetic Acid | |
|---|---|---|---|
| Sterilization | 5 hours | 25°C | 1900 ppm |
| High-LevelDisinfection | 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
Page 1 of 1
510(k) Number: K041984
§ 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.