Sterilization: Aldahol III High-Level Disinfectant is a sterilant intended for the sterilization of reusable, clean, heat-sensitive medical devices when used as directed at or above its minimum recommended concentrations (MRC) of 2.1% alkaline glutaraldehyde and 15.0% isopropanol with an exposure of 10.0 hrs at 20 C.

High-Level Disinfection: Aldahol III High-Level Disinfectant is a high-level disinfectant intended for the disinfection of reusable, clean, heat-sensitive medical devices when used as directed at or above its MRC of 2.1% alkaline glutaraldehyde and 15.0% isopropanol with an exposure of 10.0 min at 20 C.

Device Description

Aldahol III High-Level Disinfectant is a liquid chemical sterilant and high-level disinfectant. It is a glutaraldehyde-based disinfectant with a glutaraldehyde concentration in the range of 2.4 to 3.4%. When activated with buffer salts to an alkaline pH value of about 7.6, the glutaraldehyde concentration can remain constant over a 14-day use and reuse life. It also contains about 25% isopropanol to enhance mycobactericidal (TB) activity.

AI/ML Overview

The provided text describes a liquid chemical sterilant and high-level disinfectant called "Aldahol III High-Level Disinfectant" and its substantial equivalence to the predicate device "Cidex Activated Dialdehyde Solution." The document focuses on the efficacy testing of Aldahol III.

Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text doesn't explicitly state "acceptance criteria" as a set of quantified thresholds in a table format. Instead, it describes various tests performed and the positive results achieved. The implicit acceptance criterion for each test is the complete elimination or reduction of the target microorganisms to undetectable levels within specified exposure times and conditions.

Acceptance Criteria (Implicit from Test Results)	Reported Device Performance (Aldahol III HLD)
High-level Disinfection:
Kill 100% of Salmonella choleraesuis	100% killed (3.0, 5.0, 10.0 min @ 20°C)
Kill 100% of Staphylococcus aureus	100% killed (3.0, 5.0, 10.0 min @ 20°C)
Kill 100% of Pseudomonas aeruginosa	100% killed (3.0, 5.0, 10.0 min @ 20°C)
Kill Trichophyton mentagrophytes	Killed (3.0, 5.0, 10.0 min @ 20°C)
Kill Aspergillus niger	Killed (3.0, 5.0, 10.0 min @ 20°C)
Kill Candida albicans	Killed (3.0, 5.0, 10.0 min @ 20°C)
Kill Poliovirus type 1	Killed within limits of detection (5.0 min @ 20°C)
Kill Influenza A Virus	Killed within limits of detection (5.0 min @ 20°C)
Kill Herpes Simplex Virus type 1	Killed within limits of detection (5.0 min @ 20°C)
Kill Adenovirus type 2	Killed within limits of detection (5.0 min @ 20°C)
Kill 6 log10 of M. terrae (mycobactericidal)	Killed 6 log10 of M. terrae (10.0 min @ 20°C)
Kill 6 log10 of M. terrae in flexible endoscope biopsy channels	Killed at least 6 log10 of M. terrae (5.0 min @ 20°C)
No bacteria recovered from clinically-used endoscopes after disinfection	No bacteria recovered (5.0 min @ 20°C)
Sterilization:
Pass AOAC Sporicidal Test for C. sporogenes and B. subtilis	Passed (10.0 hrs @ 20°C) for C. sporogenes and B. subtilis
Confirmatory Sporicidal Test	Passed (10.0 hrs @ 20°C)

Notes on reported performance:

All tests for Aldahol III HLD were conducted at a "worst case" glutaraldehyde concentration of 2.0% (from a 14-day EPA Re-Use Test), which is below its initial concentration of 3.4%.
The high-level disinfection goal exposure time is 10.0 minutes at 20°C.
The sterilization goal exposure time is 10.0 hours at 20°C.

2. Sample Size Used for the Test Set and Data Provenance

The text describes experimental setups rather than typical clinical trial sample sizes.

Bacterial Use Dilution Tests (i-1): Stainless steel "penicylinders" were labeled with cultures. The number of cylinders per test is not explicitly stated, but standard AOAC methods typically involve multiple replicates (e.g., 10-60 carriers per organism per disinfectant dilution). The data provenance is laboratory-based efficacy testing.
Fungicidal Tests (i-2): Cultures of Trichophyton mentagrophytes, Aspergillus niger, or Candida albicans were tested. Methodology similar to bacterial tests. Data provenance is laboratory-based efficacy testing.
Virucidal Tests (i-3): Poliovirus type 1, Influenza A Virus, Herpes Simplex Virus type 1, and Adenovirus type 2 were tested. Data provenance is laboratory-based efficacy testing.
Mycobactericidal Tests (i-4): M. terrae (6 log10 challenge). Data provenance is laboratory-based efficacy testing.
Sterilization Exposure Studies (i-5, i-6, i-7):
- Initial study (i-5) tested 40 spore-labeled carriers for C. sporogenes (4 positive at 4.0 hrs, all others disinfected). This indicates a sample size of 40 carriers per exposure time for initial optimization.
- Full three Lot test (i-6) passed the AOAC Sporicidal Test with an exposure of 10.0 hours. Standard AOAC Sporicidal Test (966.04) involves multiple spore carriers (often around 60 per condition/lot).
- Confirmatory Sporicidal Test (i-7) also passed. Implies similar sample sizes to the full Lot test.
- Data provenance is laboratory-based efficacy testing.
Simulated Use Tests with Flexible Endoscopes (i-8): Flexible endoscopes' biopsy channels were labeled with M. terrae. The number of endoscopes is not specified but usually involves a representative number for such tests (e.g., 3-10). Data provenance is simulated-use laboratory testing.
Clinical In-use Tests (i): "Various colonoscopes and gastroscopes" as received directly from patients at an endoscopy clinic. The exact number is not stated but implies real-world clinical samples. Data provenance is prospective clinical in-use testing, likely U.S. based given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

This type of submission is for a disinfectant, not for an image-based diagnostic or AI algorithm. Therefore, the concept of "experts establishing ground truth" in the medical imaging sense (e.g., radiologists, pathologists) is not directly applicable.

Instead, the "ground truth" is established by:

Standardized microbiological methods: Adherence to AOAC (Association of Official Analytical Chemists) protocols (e.g., 955.14, 955.15, 964.02 for bacteria; 955.17 for fungi; 966.04 for sporicidal) for determining the presence or absence of viable microorganisms.
Laboratory Technicians/Scientists: These individuals, qualified in microbiology and sterilization/disinfection testing, perform the tests and interpret the results according to the established protocols. Their qualification is implied by their ability to successfully execute these validated methods.
Clinical Personnel: For the clinical in-use tests, clinic personnel followed standard cleaning procedures and microbiologists determined the presence/absence of bacteria.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 consensus are typically used for subjective assessments in clinical trials or image interpretation. For microbiological efficacy testing, the outcome is generally objective: growth or no growth, colony count reduction, or presence/absence of detectable virus. The "adjudication" is inherent in the rigorous, standardized nature of the AOAC methods and the clear criteria for positive/negative results. Any discrepancies would likely trigger re-testing or investigation, but not a consensus process among human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not applicable to a liquid chemical sterilant/disinfectant. MRMC studies are used for evaluating the reader performance of diagnostic tools, particularly in medical imaging, and assessing the impact of AI assistance on human readers.

6. Standalone Performance

Yes, the studies described are all "standalone" in the sense that they evaluate the efficacy of the Aldahol III High-Level Disinfectant itself, without human intervention in the disinfection process beyond proper application. The results (e.g., 100% kill, 6 log10 reduction) directly reflect the algorithm's (the chemical formulation's) performance.

7. Type of Ground Truth Used

The ground truth used is primarily microbiological culture results and virological assays (for virucidal tests). This involves:

Direct observation of microbial growth/no growth: After exposure to the disinfectant, samples are cultured to see if any viable organisms remain.
Quantitative reduction: For some tests (e.g., mycobactericidal), the ground truth involves measuring the reduction in the number of colony-forming units (CFUs) or viral particles.
Absence of detectable organisms: The ultimate ground truth for disinfection and sterilization is the absence of the target microorganisms.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a chemical disinfectant, not a machine learning model. The formulation of Aldahol III HLD (3.4% glutaraldehyde, 25% isopropanol) and its activation (alkaline pH) are based on chemical and microbiological principles developed over time through research and previous product development, not through training a model on a dataset.

9. How the Ground Truth for the Training Set was Established

Again, the concept of a "training set" in the context of AI development does not apply. The "ground truth" for the development of glutaraldehyde-based disinfectants and the concept of enhanced mycobactericidal activity with alcohol are established through decades of traditional chemical and microbiological research, understanding of antiseptic mechanisms, and empirical testing. This would involve laboratory experiments, dose-response curves, kinetics studies, and comparisons with known effective agents, not a "training set" with established ground truth.

Summary

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K041360

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MAY - 5 2005 Section C. 510(k) Summary

Date of Application: May 10, 2004

510(k) Summary of the Safety and Effectiveness of Aldahol III High-Level Disinfectant, a liquid chemical sterilant and high-level disinfectant.

a. Applicant/Sponsor

John Feik Healthpoint, Ltd. 318 McCullough San Antonio, Texas 78215

Phone: (210) 476-8102 FAX: (210) 227-6132

b. Application Correspondent

Norman Miner, Ph.D. MicroChem Laboratory, Inc. 1107-C South Airport Circle Euless (Dallas). Texas 76040

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

c. Name of the Device:

Trade Name: Aldahol III High-Level Disinfectant Common Name: Liquid Chemical Sterilant and High-Level Disinfectant Classification Name: Not Classified

d. Predicate Name:

Cidex Activated Dialdehyde Solution

e. Summary of the substantial equivalence (SE) of Aldahol III High-Level Disinfectant to Cidex Activated Dialdehyde Solutuion.

Aldahol III High-Level Disinfectant and the predicate, Cidex Activated Dialdehyde Solution, are both glutaraldehyde-based disinfectants intended for the sterilization or high-level disinfection of reusable, clean, heat-sensitive devices. The glutaraldehyde concentration of both of these products is in the range of 2.4

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to 3.4%. When activated, both products have alkaline pH values. Cidex activated Dialdehyde Solution is a legally marketed product. For these reasons Aldahol III High-Level Disinfectant is substantially equivalent to Cidex Activated Dialdehyde Solution.

f. Summary description of Aldahol III High-Level Disinfectant.

It was discovered that relatively low concentrations of alcohol enhance the mycobactericidal (TB) activity of glutaraldehyde. When activated with buffer salts to an alkaline pH value of about 7.6, the glutaraldehyde concentration of Aldahol III High-Level Disinfectant can remain constant over a 14-day use and reuse life. The combination of stable alkaline glutaraldehyde at about 3.4%, plus about 25% isopropanol provides a solution able to provide high-level disinfection with an exposure of 10.0 min at 20 C.

g. Summary of the intended use of Aldahol III High-Level Disinfectant.

Activated Aldahol III High-Level Disinfectant is intended for use and reuse for 14 days, or until a glutaraldehyde monitor indicates that the glutaraldehyde has declined to 2.1%, whichever comes first, for the high-level disinfection or sterilization of reusable, clean, heat-sensitive devices. The exposure for highlevel disinfection is 10.0 min at 20 C, and the exposure for sterilization is 10.0 hrs at 20 C. Aldahol III High-Level Disinfectant can be used in an Automatic Endoscope Reprocessing (AER) machine where approved by the manufacturer of the AER.

h. Summary of the technological characteristics of Aldahol III High-Level Disinfectant in Comparison to Cidex Activated Dialdehyde Solution.

Aldahol III High-Level Disinfectant initially contains about 3.4% glutaraldehyde, and the glutaraldehyde concentration remains constant, independent of inadvertent dilution during use and reuse, during 14 days post-activation. By comparison, about 40% of the initial glutaraldehyde concentration of Cidex Solution is lost during 14 days post-activation, independent of use and reuse. For the purpose of enhanced mycobactericidal (TB) activity, Aldahol III High-Level Disinfectant contains about 25% isopropanol. Cidex Solution does not contain alcohol.

i-1. Summary of the Association of Official Analytical Chemists (AOAC) Use Dilution Tests.

Stainless steel penicylinders were labeled with cultures of Salmonella choleraesuis. Staphylococcus aureus, and Pseudomonas aeruginosa containing 5% animal serum, and tested according to the methods of the AOAC Use Dilution Tests 955.14, 955.15, and 964.02. When exposed to Aldahol III High-Level Disinfectant (HLD) at a worst case glutaraldehyde concentration of 2.0%, from a

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14-day EPA Re-Use Test, all (100%) of the bacteria-labeled cylinders were disinfected following exposures of 3.0, 5.0, and 10.0 min at 20 C.

i-2. Summary of the results of fungicidal tests using worst case Aldahol III HLD.

Cultures of Trichophyton mentagrophytes, Aspergillus niger, or Candida albicans with 5% animal serum were tested against worst case Aldahol III High-Level Disinfectant at 2.0% glutaraldehyde from a 14-day EPA Re-Use Test according to the methods of the AOAC Fungicidal Test 955.17. All of these surrogate fungi were killed with exposures of 3.0, 5.0, and 10.0 min at 20 C.

i-3. Summary of the results of virucidal tests using worst case Aldahol III HLD.

Poliovirus type 1, Influenza A Virus, Herpes Simplex Virus type 1, and Adenovirus type 2, all containing 5% animal serum, were killed within the limits of detection with an exposure for 5.0 min at 20 C to Aldahol III HLD from a 14day EPA Re-Use Test further diluted to 2.0% glutaraldehyde.

i-4. Summary of the results of mycobactericidal tests using worst case Aldahol III HLD.

Worst case Aldahol III HLD from a 14-day EPA Re-Use Test, further diluted to 2.0% glutaraldehyde, killed 6 log 10 of M. terrae with 5% animal serum, within 10.0 min at 20 C.

i-5. Summary of studies to determine the sterilization exposure for Aldahol III HLD.

Aldahol III HLD from an EPA 14-day Re-Use Test, further diluted to 2.0% glutaraldehyde, was tested against 40 spore-labeled carriers with exposures of 4.0, 6.0, 8.0, and 10.0 hrs at 20 C, according to the methods of the AOAC Sporicidal Test 966.04. Four (4) cylinders labeled with C. sporogenes were positive out of 40 tested with an exposure of 4.0 hrs at 20 C. All other spore-labeled carriers at all other exposure times were disinfected.

i-6. Summary of the results from a full three Lot test of Aldahol III HLD by the AOAC Sporicidal Test 966.04.

Three Lots of Aldahol III HLD from a 14-day EPA Re-Use, further diluted to 2.0% glutaraldehyde, passed the AOAC Sporicidal Test 966.04 with an exposure of 10.0 hrs at 20 C.

i-7. Summary of the results from a Confirmatory Sporicidal Test with Aldahol III HLD.

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Aldahol III HLD from an EPA 14-day Re-Use Test, further diluted to 2.0% glutaraldehyde, passed a Confirmatory AOAC Sporicidal Test 966.04 with an exposure of 10.0 hrs at 20 C.

i-8. Summary of the results of simulated use tests with flexible endoscopes labeled with M. terrae and exposed to Aldahol III HLD.

The biopsy channels of flexible endoscopes were labeled with a culture of M. terrae with 5% animal serum and dried for 60.0 min. The M. terrae-labeled endoscopes were then exposed to worst case Aldahol III HLD from a 14-day EPA Re-Use Test, further diluted to 2.0% glutaraldehyde, for 5.0 min at 20 C. At least 6 log 10 of the M. terrae was killed by the Aldahol III HLD.

i. Summary of the results of clinical in-use tests with Aldahol III HLD.

Various colonoscopes and gastroscopes as received directly from patients at an endoscopy clinic, and cleaned, but not disinfected, according to the standard cleaning procedures of the clinic, were exposed for 5.0 min at 20 C to worst case Aldahol III HLD from a 14-day EPA Re-Use Test, further diluted to 2.0% glutaraldehyde. No (zero) bacteria were recovered from these endoscopes after the exposure to Aldahol III HLD.

k. Summary of the conclusions drawn from the in-vitro, simulated use tests, and clinical in-use tests of Aldahol III HLD that demonstrate that it is as safe, and as effective, or more effective, than Cidex Activated Dialdehyde Solution.

We conclude that Aldahol III HLD is as safe as Cidex Activated Dialdehyde Solution because Aldahol III HLD contains about the same concentration of glutaraldehyde as Cidex solution. We conclude that Aldahol III HLD is as antimicrobial, or more antimicrobial, than Cidex Solution because the glutaraldehyde in activated Aldahol III HLD is stable as compared to Cidex Solution, and because Aldahol III HLD contains isopropanol that enhances the kill of mycobacteria by glutaraldehyde.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted in a simple, bold line drawing, and the text is in a clear, sans-serif font.

MAY - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Healthpoint, Limited C/O Dr. Norman Miner MicroChem Laboratory, Incorporated 1107-C South Airport Circle Euless (Dallas), Texas 76040

Re: K041360

Trade/Device Name: Aldahol III High-Level Disinfectant Regulation Number: 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: II Product Code: MED Dated: April 11, 2005 Received: April 12, 2005

Dear Dr. Miner:

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 mendie connects, or to devices that have been reclassified in accordance with the provisions of / Intendinently, or to do not cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Writ), It hay of budges in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routish further announcements concerning your device in the Federal Register.

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Page-2 Dr. Miner

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 modi that I Dr may Federal statutes and regulations administered by other Federal agencies. or the Free of any with all the Act's requirements, including, but not limited to: registration r od intest compty was a 807); labeling (21 CFR Part 801); good manufacturing practice and ifsing (21 CF reading systems (QS) regulation (21 CFR Part 820); and if requirences as bet form product 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) Frins letter wrification. The FDA finding of substantial equivalence of your device to a premiures netirements 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), rr you dostre specific at the office of Compliance 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 other general generalional 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,

Shin-Liang 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

510(k) Number (if known):_K 041360

Device Name:_Aldahol III High-Level Disinfectant

Indications For Use:

Sharly A. Murphy, MD

Insion Sion-Off) Civision of Anasthesiology, General Hospital, Infection Control. Dental Devices

CHECK Number: K 041 360

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

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.