(175 days)
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion. SSDS is intended for reprocessing only heat-sensitive medical devices.
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) should be used under the following contact conditions:
| Time | Temperature | |
|---|---|---|
| Sterilization | 12 hours | 25 degrees C |
| High LevelDisinfection | 20 minutes | 25 degrees C |
SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its Minimum Recommended Concentration (MRC). The glutaraldehyde MRC is 0.6%; the phenol MRC is 1.3%.
Sporicidin Indicator Strips are intended for verifying the MRC of glutaraldehyde and phenol in SSDS during use. Sporicidin Indicator strips should be used before each use of SSDS.
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is a liquid chemical sterilant and high level disinfectant. The product contains two solutions: a buffer containing 1.7% phenol/phenate, and an activator containing 25% glutaraldehyde. When the two solutions are mixed, or activated, SSDS contains 0.95 % glutaraldehyde and 1.64% phenol/phenate. The solutions are combined at the user level, resulting in the activated germicide.
SSDS is a liquid chemical sterilant and a high level disinfectant when used or reused according to the DIRECTIONS FOR USE included in the package insert. SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its Minimum Recommended Concentration (MRC). The MRC for glutaraldehyde is 0.6%, and 1.3% for phenol/phenate.
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) must be used with Sporicidin Indicator Strips, used to verify that the MRC of active ingredients is present. It is recommended that SSDS be tested with Sporicidin Indicator Strips prior to each use.
The provided documentation describes the efficacy testing and acceptance criteria for Sporicidin® Sterilizing and Disinfecting Solution (SSDS).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for SSDS are based on its ability to act as a liquid chemical sterilant and high-level disinfectant. The performance is assessed against various microorganisms under specified conditions. The Minimum Recommended Concentration (MRC) levels for glutaraldehyde (0.6%) and phenol (1.3%) are also key acceptance criteria, along with specific contact times and temperatures.
| Acceptance Criteria (Intended Use Conditions) | Target Microorganism Type | Reported Device Performance |
|---|---|---|
| Sterilization: 12 hours immersion at 25°C with MRC levels (0.6% glutaraldehyde, 1.3% phenol) | Spores (Bacillus subtilis, Clostridium sporogenes) | Effective at 12 hours at 25°C (freshly activated and reused solution) |
| High-Level Disinfection: 20 minutes immersion at 25°C with MRC levels (0.6% glutaraldehyde, 1.3% phenol) | High-Level Disinfection (Mycobacterium bovis, Mycobacterium terrae) | Effective within 20 minutes at 25°C (freshly activated and reused solutions) |
| Vegetative Organisms (Pseudomonas aeruginosa, Salmonella cholerasuis, Staphylococcus aureus) | Effective within 10 minutes at 20°C (freshly activated and reused solutions) | |
| Fungi (Trichophyton mentagrophytes) | Effective within 10 minutes at 20°C (freshly activated and reused solutions) | |
| Non-Lipid Small Virus (Poliovirus Type II, Coxsackie, Rotavirus) | Effective within 3 minutes at 23°C (Poliovirus Type II)Effective within 2 minutes at 23°C (Coxsackie)Effective within 2 minutes at 20°C (Rotavirus) (reused solutions) | |
| Lipid Medium Virus (Herpes simplex Type I, Herpes simplex Type II, HIV-1, Influenza Type A2) | Effective within 3 minutes at 25°C (Herpes simplex Type I & II)Effective within 1 minute at 23°C (HIV-1 (HTLV-IIIRF) strain)Effective within 10 minutes at 20-25°C (Influenza Type A2) (reused solutions) | |
| Lipid Large Virus (Vaccinia, Cytomegalovirus) | Effective within 10 minutes at 20-25°C (Vaccinia)Effective within 2 minutes at 20°C (Cytomegalovirus) (reused solutions) | |
| Simulated In-Use Testing: Effective in reducing Mycobacterium terrae by 10^6 on endoscopes within 15 minutes at 25°C with active ingredient levels near or below MRC. | Mycobacterium terrae (on endoscopes) | Solutions with active ingredient levels near or below MRC were effective in reducing Mycobacterium terrae by 10^6 on endoscopes in 15 minutes at 25°C. |
| Residue Testing: No detectable glutaraldehyde, phenol levels < 24 ppm. | Glutaraldehyde and Phenol Residues | No detectable glutaraldehyde, phenol < 24 ppm (0.0024%) after 12-hour soak. |
| Material Compatibility: Compatible with a wide range of materials and endoscopes. | Various Materials (Plastics, Synthetic Rubber, Glass, Alumite, Stainless Steel, Adhesive, Sealing material) | Compatible with the materials and devices listed in the document. |
| Shelf Life/Stability: 2 years | Retention of Efficacy | Supported by real-time stability studies and accelerated aging. |
| Test Strips: Verify MRC of glutaraldehyde (0.6%) and phenol (1.3%) | Glutaraldehyde and Phenol MRC | Sporicidin Indicator Strips should be used prior to each use to verify MRC. |
2. Sample size used for the test set and the data provenance
- Microbiological Testing: The document does not specify a precise sample size in terms of number of organisms tested per run, but it states that testing was conducted under "worst case conditions with solution batches that were at the end of, or beyond, their two year expiration dates."
- Simulated In-Use Testing (Endoscopes):
- Sample Size: Mentions "Flexible fiber endoscopes made of a variety of material types were used." No specific number provided.
- Data Provenance: Retrospective (implied, as the tests were conducted for market submission). The country of origin is not specified, but the submission is to the FDA in the USA.
- Clinical (In-Use) Testing (Endoscopes):
- Sample Size: Refers to "Lower GI endoscopes used in patient care." No specific number provided.
- Data Provenance: Prospective (implied, "under actual use conditions" of patient care). The country of origin is not specified.
- Residue Testing:
- Sample Size: "devices were soaked". No specific number provided.
- Data Provenance: Retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document describes laboratory efficacy testing rather than studies requiring expert adjudication for ground truth (e.g., image interpretation). Therefore, no information is provided on the number or qualifications of experts for establishing ground truth as it would be understood in a diagnostic accuracy study. The "ground truth" for the microbiological efficacy studies would be the established methods for determining microbial kill and reduction.
4. Adjudication method for the test set
Not applicable, as the studies are primarily laboratory efficacy tests and chemical residue analysis, not requiring expert adjudication in the manner of diagnostic accuracy studies.
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 sterilant/disinfectant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a chemical product, not an algorithm. The product itself, when used according to instructions, is "standalone."
7. The type of ground truth used
The ground truth used for efficacy testing is based on microbiological assay results (e.g., reduction in microbial count, complete kill) following standardized testing procedures. For residue testing, the ground truth is established by chemical analysis (e.g., HPLC, spectroscopy) to detect and quantify residues.
8. The sample size for the training set
Not applicable. This is a chemical sterilant/disinfectant, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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3/5/99
198 3194 INFORMATION REQUIRED BY THE SMDA OF 1990 C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Sporiciding Sterilizing and Disinfecting Solution (SSDS)
Sporicidin® International 5901 Montrose Road Rockville, MD 20852
Telephone: (301) 231-7700 FAX: (301) 231-8165
Official Contact: Dr. Harold E. Plank Technical Director
August 20, 1998 DATE SUMMARY PREPARED:
Sporiciding Sterilizing and Disinfecting Solution is a Liquid chemical sterilant and high level disinfectant. These products have been assigned the product code Sterilant 80 MED by the FDA and proposed for classification into Class II by the General Hospital and Personal Use Devices Panel on July 18, 1995.
1. DEVICE DESCRIPTION
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is a liquid chemical sterilant and high level disinfectant. The product contains two solutions: a buffer containing 1.7% phenol/phenate, and an activator containing 25% glutaraldehyde. When the two solutions are mixed, or activated, SSDS contains 0.95 % glutaraldehyde and 1.64% phenol/phenate. The solutions are combined at the user level, resulting in the activated germicide.
SSDS is a liquid chemical sterilant and a high level disinfectant when used or reused according to the DIRECTIONS FOR USE included in the package insert. SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its MRC. The MRC for glutaraldehyde is 0.6%, and 1.3% for phenol/phenate.
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) must be used with Sporicidin Indicator Strips, used to verify that the MRC of active ingredients is present. It is recommended that SSDS be tested with Sporicidin Indicator Strips prior to each use.
000007
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INTENDED USE OF DEVICE: 2.
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion.
Sporicidin® Sterilizing and Disinfecting Solution (SSDS) should be used with medical devices that are not compatible with other sterilization or high level disinfection processes that can be biologically monitored.
SSDS can be reused for a maximum of 7 days or until Sporicidin Indicator Strips indicate that either the glutaraldehyde or phenol level falls below its MRC.
Sporiciding Sterilizing and Disinfecting Solution (SSDS) should be used under the following contact conditions:
| Time | Temperature | MRC levels | ||
|---|---|---|---|---|
| Glutaraldehyde | Phenol | |||
| Sterilization | 12 hours | 25 degrees C | 0.6% | 1.3% |
| High LevelDisinfection | 20 minutes | 25 degrees C | 0.6% | 1.3% |
3. COMPARISON TO PREDICATE DEVICE (STATEMENT OF SUBSTANTIAL EQUIVALENCE)
Sporicidink Sterilizing and Disinfecting Solution (SSDS) is substantially equivalent to other liquid sterilants currently on the market, including CIDEXR Activated Dialdehyde Solution. CIDEX® is 2.4 % Glutaraldehyde solution while activated Sporicidin® Sterilizing and Disinfecting Solution contains as active ingredients 0.95 % glutaraldehyde and 1.64% total phenol/phenate.
Both CIDEX and Sporiciding Sterilizing and Disinfecting Solution are similar in intended uses.
The safety and effectiveness of CIDEX and SSDS are comparable as they are sporicidal, virucidal, fungicidal, tuberculocidal, bactericidal and pseudomonacidal.
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EFFICACY TESTING 4.
All performance testing was conducted on formulations where the nominal concentration of glutaraldehyde was at levels less than in the current formulation (0.95%). The nominal level of phenol in all formulations tested was equivalent to that in the current formulation (1.64%).
MICROBIOLOGICAL TESTING showed SSDS to be sporicidal, tuberculocidal, virucidal, fungicidal, and bactericidal. Testing was conducted under worst case conditions with solution batches that were at the end of, or beyond, their two year expiration dates. SSDS was tested for sporicidal, bactericidal, fungicidal, tuberculocidal, and virucidal activity. The test battery included use-re-use manual stressing related to the product label directions for reuse. Results for SSDS are shown below:
| Tests Performed | Results |
|---|---|
| SPORESBacillus subtilisClostridium sporogenes | Freshly activated and reused solution were effective at 12 hours at25° C. |
| VEGETATIVE ORGANISMSPseudomonas aeruginosaSalmonella cholerasuisStaphylococcus aureus | Freshly activated and reused solutions were effective within 10minutes at 20° C. |
| Mycobacterium bovisMycobacterium terrae | Freshly activated and reused solutions were effective within 20minutes at 25° C. |
| FUNGITrichophyton mentagrophytes | Freshly activated and reused solutions were effective within 10minutes at 20° C. |
| NON-LIPID SMALL VIRUSPoliovirus Type II | Reused solutions were effective within 3 minutes at 23° C. |
| Coxsackie | Reused solutions were effective within 2 minutes at 23° C. |
| Rotavirus | Reused solutions were effective within 2 minutes at 20° C. |
| LIPID MEDIUM VIRUSHerpes simplex Type IHerpes simplex Type II | Reused solutions were effective within 3 minutes at 25° C. |
| HIV-1 (HTLV-IIIRF)strain | Reused solutions were effective within 1 minute at 23° C. |
| Influenza Type A2 | Reused solutions were effective within 10 minutes at 20-25° C. |
| LIPID LARGE VIRUSVaccinia | Reused solutions were effective within 10 minutes at 20-25° C. |
| Cytomegalovirus | Reused solutions were effective within 2 minutes at 20° C. |
Summary of Microbiological Test Data
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SIMULATED IN-USE TESTING WITH ENDOSCOPES was also conducted. The test organism used was Mycobacterium terrae. Flexible fiber endoscopes made of a variety of material types were used. Solutions with active ingredient levels near or below the MRC were effective in reducing the level of Mycobacterium terrae by 106 on endoscopes in 15 minutes at 25° C.The testing demonstrated the effectiveness of SSDS as a high level disinfectant under simulated use conditions.
CLINICAL (IN-USE) TESTING of used endoscopes further supports the efficacy of SSDS as a sterilant and high level disinfectant under actual use conditions. Freshly prepared, unstressed, activated solution was used under labeled conditions for use as a high level disinfectant. Lower GI endoscopes used in patient care were immersed for 20 minutes at room temperature. Results of the study showed SSDS effectively disinfected endoscopes used in patient care.
5. RESIDUE AND TOXICITY DATA
A residue test in which devices were soaked for 12 hours in a solution of SSDS (containing 0.5% glutaraldehyde and 1.64% phenol) demonstrated that no detectable glutaraldehyde was present in either rinse water or wipings of the external surface of the devices. SSDS treated devices do not raise safety concerns related to glutaraldehyde residues.
Phenol was present in the rinsings and wipings at less than 24 ppm, or 0.0024%. The phenol level is acceptable and does not represent a hazard to those treated with devices disinfected with SSDS according to label directions. Phenol's demonstrated safety in other Sporicidin® International products at similar levels, as well as in mouth wash, supports that SSDS is safe for its intended use as a sterilant and high level disinfectant.
Glutaraldehyde is not detectable and phenol residues do not represent exposures greater than those which may result from use of other products with FDA clearance. Glutaraldehyde and phenol are well characterized chemicals. The toxicological and safety literature were reviewed.
6. MATERIAL COMPATIBILITY
Material compatibility testing demonstrated that SSDS can be used with a wide range of materials and endoscopes. SSDS is compatible with the materials and
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| devices listed when used according to the instructions for use. | ||||||||
|---|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | ----------------------------------------------------------------- | -- | -- |
| Plastics | Teflon |
|---|---|
| Polyacetal | |
| Polysulfone | |
| Polyetherimide | |
| Polycarbonate | |
| Vinyl chloride | |
| Polybutylene terephthalate (PBT) | |
| Polyurethane* | |
| Synthetic Rubber | Silicone rubber |
| Acrylonitrile-butadiens rubber (NBR) | |
| Neoprene | |
| Nitrile rubber | |
| Fluoro rubber | |
| Glass | Optical Glass |
| Alumite | Anodized aluminum |
| Stainless Steel | |
| Adhesive | Epoxy adhesive |
| Sealing material | Silicone sealing compound |
-
- Polyurethane and other materials not listed should be tested for compatibility prior to use.
Refer to the reusable device labeling for additional material compatibility information.
- Polyurethane and other materials not listed should be tested for compatibility prior to use.
7. STABILITY
SSDS has a shelf life of two years. Real time stability studies, together with accelerated aging and other testing, support a two year expiration date.
8. TEST STRIPS
.
Sporicidin Indicator Strips should be used prior to each use of SSDS. Sporicidin Indicator Strips indicate if the glutaraldehyde or phenol level falls below its MRC.
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9. SUMMARY OF SUBSTANTIAL EQUIVALENCE
Results of the performance, simulated in-use, in-use, and residue and toxicity data have demonstrated that Sporicidin® Sterilizing and Disinfecting Solution (SSDS), when used in accordance with its labeling, is as safe, as effective, and performs as well as or better than the predicate device, CIDEX.
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Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The text is in all capital letters and is evenly spaced around the curve.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1999
Dr. Harold E. Plank Technical Director Sporicidin,® International 5901 Montrose Road Rockville, Maryland 20852
Re: K983194 Sporicidin Sterilizing and Disinfecting Trade Name: Solution (SSDS) Unclassified Requlatory Class: Product Code: MED December 29, 1998 Dated: December 29, 1998 Received:
Dear Dr. Plank
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 through 542 of
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Page 2 - Dr. Plank
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-20:41 or (301) 443-6597 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:
Device Name; Sporicidin® Sterilizing and Disinfecting Solution (SSDS)
Intended Use:
1
Sporicidin® Sterilizing and Disiafecting Solution (SSDS) is intended for sterilization Cook of high level disinfection of medical and surgical instruments that require submersion. SSDS is intended for reprocessing only heat-sensitive medical devices,
Sporiciding Sterilizing and Disinfecting Solution (SSDS) should be used under the following contact conditions:
| Time | Temperature | |
|---|---|---|
| Sterilization | 12 hours | 25 degrees C |
| High LevelDisinfection | 20 minutes | 25 degrees C |
SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its Minimum Recommended Concentration (MRC). The glutaraldehyde MRC is 0.6%; the phenol MRC is 1.3%.
Sporicidin Indicator Strips are intended for verifying the MRC of glutaraldehyde and phenol in SSDS during use. Sporicidin Indicator strips should be used before each use of SSDS.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Chin S. Kim
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices
Over-the-Counter Use (Optional Format 1-2-96)
510(k) Number K98 3194
GOOO14
§ 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.