Banicide® Advanced is a reusable liquid chemical sterilant/high level disinfectant intended to (1) sterilize medical instruments at an exposure time of 10 hours and an exposure temperature of 25℃ and a minimum effective concentration of 1.8% glutaraldehyde; and (2) provide high level disinfection at an exposure time of 45 minutes and an exposure temperature of 25°C and a minimum effective concentration of 1.8% glutaraldehyde. It may be re-used for a period of 30 days provided the solution remains above the MEC as confirmed by a chemical indicator test strip.

Device Description

Single container glutaraldehyde solution for sterilization and high level disinfection

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details for the Banicide® Advanced device:

Acceptance Criteria and Device Performance

The acceptance criteria for Banicide® Advanced are derived from its intended use as a liquid chemical sterilant and high-level disinfectant, and its comparison to predicate devices. The study demonstrates the device's efficacy against various microorganisms under specified conditions.

Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (from intended use/predicate comparison)	Reported Device Performance (from efficacy tests)
Concentration (Active Ingredient)	Minimum Effective Concentration (MEC) of 1.8% glutaraldehyde	Tested at or below 1.8% MEC for sporicidal (full-scale re-test). Implicitly tested at 1.8% MEC for other efficacy tests as the product is stressed to simulate worst-case at 30 days of reuse.
Exposure Conditions for Sterilization	10 hours at 25°C	Passed AOAC Sporicidal Test against B. subtillis and C. sporogenes in 10 hours at 22°C (Note: Difference in temperature, but the re-test will be at 25°C).
Exposure Conditions for High-Level Disinfection	45 minutes at 25°C	- Passed AOAC Use Dilution Test (bactericidal) in 45 minutes at 22°C.- Achieved 6-log reduction in Mycobacterium bovis (tuberculocidal) in 45 minutes at 25°C.- Killed Trichophyton mentagrophytes (fungicidal) in 45 minutes at 22°C.- Effectively disinfected flexible fiber optic endoscopes (simulated in-use) after 45 minutes at 22°C.- Shown to be effective against a range of viruses (virucidal) in 45 minutes at 25°C.
Reuse Period	Up to 30 days, provided glutaraldehyde concentration remains ≥ MEC	All performance testing (bactericidal, fungicidal, tuberculocidal, virucidal, simulated in-use) was conducted after 30 days of manual stressing to simulate worst-case reuse conditions.
Sporicidal Activity	Kill B. subtillis and C. sporogenes spores	Passed AOAC Sporicidal Test against B. subtillis and C. sporogenes in 10 hours at 22°C. D-value of approximately one hour for B. subtillis.
Bactericidal Activity	Kill S. aureus, P. aeruginosa, S. cholerasuis	No growth observed on carriers following 45 min exposure to 30-day stressed Banicide Advanced at 22°C.
Tuberculocidal Activity	Kill Mycobacterium bovis	Achieved six-log reduction in Mycobacterium bovis in 45 minutes at 25°C.
Fungicidal Activity	Kill Trichophyton mentagrophytes	Killed Trichophyton mentagrophytes within 45 minutes at 22°C.
Virucidal Activity	Effective against relevant viruses	Effective against Cytomegalovirus, Coxsackievirus B-6, Hepatitis A, Influenza A2, Poliovirus Type II, Rhinovirus Type 14, Rotavirus Type WA, Respiratory Syncytial Virus, Herpes Simplex Types I and II, Duck Hepatitis B, Human Immunodeficiency Virus (HIV), and Adenovirus Type S in 45 minutes at 25°C.
Material Compatibility	Compatible with medical instruments, including endoscopes	Documentation of general glutaraldehyde compatibility. Supplemental study showed compatibility with endoscopes under actual use conditions.
Chemical Indicator Test Strip	Test strip available to verify MEC (1.8%)	Pascal confirmed the 3M Cold Sterilog™ 2.1% test strip is compatible. Test strip readings: no positive readings obtained at 1.8% or 1.7% glutaraldehyde, indicating it accurately detects below MEC.

Study Details

The provided text describes a series of laboratory and simulated-use studies conducted to demonstrate the efficacy of Banicide® Advanced. All efficacy tests were conducted after the device was "30-day stressed" to simulate worst-case reuse conditions.

Sample Size Used for the Test Set and Data Provenance:
- Sporicidal Tests:
  - AOAC Sporicidal Test: Used "silk suture loops and porcelain penicylinders" for B. subtillis and C. sporogenes. Specific n not provided.
  - End-point analysis: "porcelain penicylinder carriers" inoculated with C. sporogenes. Specific n not provided.
  - Spore rate-of-kill (D-value): B. subtillis. Specific n not provided.
- AOAC Use Dilution Test (Bactericidal): "steel penicylinder carriers" dried with S. aureus, P. aeruginosa, and S. cholerasuis. Specific n not provided.
- AOAC Tuberculocidal Test: Tested against Mycobacterium bovis. Specific n not provided.
- AOAC Fungicidal Test: Tested against Trichophyton mentagrophytes. Specific n not provided.
- Simulated In-Use Test: "flexible fiber optic endoscopes". Specific n not provided.
- Virucidal Efficacy Tests: Tested against 12 different viruses (Cytomegalovirus, Coxsackievirus B-6, Hepatitis A, Influenza A2, Poliovirus Type II, Rhinovirus Type 14, Rotavirus Type WA, Respiratory Syncytial Virus, Herpes Simplex Types I and II, Duck Hepatitis B, Human Immunodeficiency Virus (HIV), and Adenovirus Type S). Specific n not provided for each virus test.
- In-Use Test: "a variety of endoscopes taken from an actual clinical setting." Specific n not provided.
- Indicator Strip Testing: "Sets of 60 test strips were tested at each of 6 different concentrations" (2.4%, 2.2%, 2.0%, 1.8%, and 1.7% glutaraldehyde). This totals 60 strips/concentration * 5 concentrations = 300 test strips. (Note: The text states 6 concentrations, but only lists 5 specific ones. Assuming 6 unique concentrations were tested for the overall study design.)
- Data Provenance: The studies appear to be laboratory-based efficacy tests, likely conducted in the US. The "In-Use Test" used endoscopes from "an actual clinical setting," implying prospective data collection during clinical use for that specific test. The material compatibility study for endoscopes was "supplemental" and provided "under actual conditions of use."
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- The studies described are primarily laboratory-based microbiological efficacy tests following established AOAC (Association of Official Analytical Chemists) protocols. For such tests, the "ground truth" is typically the objective outcome of the assay (e.g., presence/absence of microbial growth, log reduction).
- The text does not mention the use of human experts to establish "ground truth" for the test set in the same way one might for diagnostic imaging studies. The interpretation of the test results (e.g., counting colony forming units, observing viability) would be performed by trained microbiologists or laboratory technicians, whose qualifications are implicit in their ability to conduct these standard scientific tests.
Adjudication Method for the Test Set:
- Not applicable as the tests are objective microbiological assays with clear pass/fail criteria or quantitative outcomes (e.g., log reduction, D-value). No mention of human adjudication for conflicting expert opinions.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images with and without AI assistance). Banicide® Advanced is a chemical sterilant/disinfectant, and its effectiveness is measured through microbiological and chemical efficacy, not human diagnostic performance.
Standalone (Algorithm Only) Performance:
- Yes, the performance tests described are inherently "standalone" in that they evaluate the efficacy of the chemical solution itself without human intervention in the germicidal process. The efficacy is attributed solely to the Banicide® Advanced product under the specified conditions. Human involvement is limited to product application and handling as per instructions, and laboratory personnel conducting the tests and observing results.
Type of Ground Truth Used:
- Microbiological Assay Results: For all sporicidal, bactericidal, tuberculocidal, fungicidal, and virucidal tests, the ground truth is the objective outcome of the microbiological assays (e.g., absence of growth, specific log reduction, viral inactivation).
- Chemical Concentration Measurement: For the indicator strip testing, the ground truth is the actual measured glutaraldehyde concentration (e.g., 1.8%, 1.7%).
- Direct Observation (In-Use/Material Compatibility): For the in-use tests on endoscopes and material compatibility, the ground truth is the direct observation of microbial recovery post-disinfection and absence of material damage.
Sample Size for the Training Set:
- Not applicable. Banicide® Advanced is a chemical product, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its formulation and the basis for its efficacy are derived from chemical properties and established antimicrobial principles of glutaraldehyde.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for this type of device. The efficacy is proven through direct testing rather than through an algorithmic learning process.

Summary

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MAY 27 2003

510(k) Summary (revised 5/03)

K012889

Banicide® Advanced For Sterilization and High Level Disinfection

Pascal Company, Inc. P.O. Box 1748 Bellevue, Washington 98009

Date of Summary: May 1, 2003

Contact Person

Vincent M. Tentarelli 425-827-4694

Name of Medical Device

Proprietary Name

Banicide® Advanced

Common or Usual Name

Single container glutaraldehyde solution for sterilization and high level disinfection

Classification Name

Liquid Chemical Sterilant/Disinfectant (Class II)

Substantial Equivalence to Predicate Product

Banicide Advanced is substantially equivalent to Wavicide 01, Cidex Plus 28-day Solution, and MetriCide 28 day Long-Life Activated Dialdehyde Solution. Substantial equivalence is based on the fact that Banicide Advanced has the same intended use (to sterilize and disinfect medical instruments) as the predicate products and relies on the same active ingredient (glutaraldehyde) to achieve the germicidal effect and has the same demonstrated efficacy. Banicide Advanced has a glutaraldehyde concentration and pH range comparable to that of Wavicide 01, Cidex Plus, and MetriCide. These products have comparable concentrations of glutaraldehyde (3.5% for Banicide Advanced, 2.65% for Wavicide 01, 3,4% for Cidex Plus, and 2.8% for MetriCide), and overlapping pH ranges. Banicide Advanced has demonstrated comparable sterilizing and disinfecting capabilities to the predicates. All three products are labeled with a 30-day or 28-day reuse period and require a chemical test strip to verify that the active ingredient remains at an effective concentration throughout the reuse period.

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Indications for Use: Banicide Advanced is intended for use as a liquid chemical sterilant and/or a high level disinfectant to sterilize and disinfect medical devices and instruments in healthcare facilities when used according to the directions for use in the package insert.

Sterilant: Banicide Advanced is a sterilant when used in accordance with its directions for use for a maximum of 30 days at 25°C with an immersion time of at least 10 hours at its minimum effective concentration (MEC) of 1.8% glutaraldehyde.

High Level Disinfectant: Banicide Advanced is a high level disinfectant when used according to its directions for use for a maximum of 30 days at 25°C with an immersion time of at least 45 minutes at its minimum effective concentration (MEC) of 1.8% glutaraldehyde.

Reuse: Banicide Advanced can be reused for a period not to exceed 30 days provided the required conditions of glutaraldehyde concentration and temperature exist. The number of days in use should not be solely relied upon for assuring efficacy during its reuse period. A chemical indicator test strip is available for assuring that the glutaraldehyde concentration is at or above the MEC, 1.8%.

Material Compatibility: Glutaraldehyde solutions have a long history of compatible use with medical instruments made from a variety of materials without corrosive or other apparent damaging effects. The 510(k) includes documentation of this. A supplemental study was conducted and submitted showing that Banicide® Advanced is compatible with endoscopes under actual conditions of use.

Performance Testing: Banicide Advanced was evaluated in several efficacy tests after 30 days of manual stressing to simulate worst-case conditions encountered during its reuse. Banicide Advanced was tested for sporicidal, bactericidal, fungicidal, tuberculocidal, and virucidal activity, and the results are summarized below.

Sporicidal Tests a.

Banicide Advanced passed the AOAC Sporicidal Test against B. subtillis spores and C. sporogenes spores carried on silk suture loops and porcelain penicylinders in 10 hours at 22°C.

In a sporicidal test involving an end-point analysis of porcelain penicylinder carriers inoculated with C. sporogenes, Banicide Advanced was found to be sporicidal at 22°C and exposure times ranging from 8 hours to 11 hours.

In a spore rate-of-kill (D-value) test, Banicide Advanced was found to have a D-value of approximately one hour for B. subtillis,

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Banicide Advanced will be re-tested prior to marketing to confirm that it passes a fullscale AOAC sporicidal test at 25°C and a glutaraldehyde concentration at or below the 1.8% MEC.

AOAC Use Dilution Test b.

S. aureus, P. aeruginosa, and S. cholerasuis dried onto steel penicylinder carriers were exposed to 30-day stressed Banicide Advanced in test tubes for 45 minutes at 22°C. No growth was observed on the carriers following exposure to Banicide Advanced.

AOAC Tuberculocidal Test C.

When tested under the quantitative tuberculocidal test protocol, stressed Banicide Advanced was found to achieve a six log reduction in Mycobacterium bovis in 45 minutes at 25°C.

AOAC Fungicidal Test d.

When tested under the AOAC Fungicidal test protocol, stressed Banicide Advanced was found to kill Trichophyton mentagrophytes within 45 minutes at 22°C.

Simulated In-Use Test e.

In a test designed to simulate the actual use of stressed Banicide Advanced on medical devices, Banicide Advanced effectively disinfected flexible fiber optic endoscopes with no microorganisms recovered from the instruments after 45 minutes of exposure at 22°C.

f. Virucidal Efficacy Tests

Stressed Banicide Advanced was shown to be effective against the following viruses: Cytomegalovirus, Coxsackievirus B-6, Hepatitis A, Influenza A2, Poliovirus Type II, Rhinovirus Type 14, Rotavirus Type WA, Respiratory Syncytial Virus, Herpes Simplex Types I and II, Duck Hepatitis B, Human Immunodeficiency Virus (HIV), and Adenovirus Type S in 45 minutes at 25°C.

In-Use Test 8-

Banicide Advanced was shown to be an effective high level disinfectant when tested on a variety of endoscopes taken from an actual clinical setting.

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Safety

Studies conducted by Union Carbide on the safety of glutaraldehyde are summarized and cited. It is demonstrated through exhaustive extraction testing that residues of glutaraldehyde on treated instruments will not present a safety risk to patients or health care workers who come into contact with the instruments.

Exposure to glutaraldehyde may produce toxic, inflammatory and allergic responses. Warnings and precautions in labeling can adequately inform users of these hazards. The personnel handling Banicide Advanced will be medical professionals, or healthcare personnel trained to handle glutaraldehyde products. Although the concentrations being handled are not highly toxic, they may be initating. Warning and precaution statements must be read and followed. In sum, Banicide Advanced is a safe and highly effective product when used in accordance with its labeled directions for use and precautionary information.

Testing of the Indicator Strip

Pascal has confirmed through testing that the 3M Cold Sterilog" 2.1% test strip is compatible with Banicide Advanced. A sample of Banicide Advanced solution was stressed by the addition of fetal boyine serum and diluted with hard water. Sets of 60 test strips were tested at each of 6 different concentrations, 2.4%, 2.2%, 2.0%, 1.8%, and 1.7% glutaraldehyde. Test strip readings were taken at 4, 5, 8, and 9 minutes. No positive readings were obtained at the MEC of 1.8% or at 1.7% glutaraldehydc. Further analysis of the results was provided to FDA.

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Product Comparison

A comparison of key features of Banicide Advanced with the predicates, Wavicide, Cidex Plus, and MetriCide is presented in the table below. The information regarding Wavicide, MetriCide, and Cidex Plus is taken from publicly available 510(k) summaries and labeling.

Features	Banicide Adv.	Wavicide 01	MetriCide	Cidex Plus
target glutaraldehydeconcentration of usedilution	3.5%	2.65%	2.5%	3.4%
claimed minimumeffective concentration	1.8%	1.7%	1.8%	2.1%
reuse period	30 days	30 days	28 days	28 days
exposure conditions forsterilization	10 hours25°C	10 hours22°C	10 hours25°C	10 hours20-25°C
exposure conditions forhigh level disinfection	45 minutes at25°C	45 minutes at22°C	90 minutes25°C	20 minutes25°C
dilution required	no	no	no	no
activation required	no	no	yes	yes
test strip available	yes	yes	yes	yes

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 2003

Pascal Company, Incorporated C/O Mr. David Joy Keller and Heckman LLP 1001 G Street, N.W., Suite 500 West Washington, DC 20001

Re: K012889

Trade/Device Name: Banicide® Advanced Regulation Number: 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: II Product Code: MEB Dated: February 27, 2003 Received: February 27, 2003

Dear Mr. Joy:

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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) 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). please contact the Office of Compliance at (301) 594-4618. 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 Division 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/dsma/dsmamain.html

Sincerely yours,

Susan Hanson

Susan Runner, DDS, MA Interim 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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510(k) Number (if known):	K012889
Device Name:	Banicide Advanced

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109) OR

Over-The-Counter Use √

(Optional Format 1-2-96)

Page

Rina Lim

Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division Control, Dental Devices

510(k) Number: K012559

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.