(175 days)
CIDEXR Activated Dialdehyde Solution.
Not Found
No
The device is a liquid chemical sterilant and disinfectant, and the summary describes its chemical composition and microbiological efficacy testing. There is no mention of any computational or algorithmic components that would suggest the use of AI or ML.
No
This device is a sterilizing and disinfecting solution used for reprocessing medical and surgical instruments, not for directly treating a medical condition in a patient.
No
The described device, Sporicidin® Sterilizing and Disinfecting Solution (SSDS), is a liquid chemical sterilant and high-level disinfectant. It is intended for reprocessing medical and surgical instruments. While it mentions the use of "Sporicidin Test Strips" to verify chemical levels, the SSDS itself is not performing a diagnostic function; it is actively sterilizing/disinfecting.
No
The device is a liquid chemical sterilant and high level disinfectant, which is a physical substance, not software.
Based on the provided information, the Sporicidin® Sterilizing and Disinfecting Solution (SSDS) itself is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use of SSDS is for the sterilization or high-level disinfection of medical and surgical instruments. This is a process applied to medical devices to render them safe for reuse, not a test performed on a biological sample from a patient to diagnose a condition or provide information about a patient's health.
- Device Description: SSDS is described as a liquid chemical sterilant and high-level disinfectant. Its function is to kill microorganisms on surfaces.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. SSDS does not interact with or analyze such samples.
However, the Sporicidin Indicator Strips mentioned in the description are likely considered an IVD.
Here's why:
- Intended Use: The indicator strips are intended for "verifying the MRC of glutaraldehyde and phenol in SSDS during use." This is a test performed on the SSDS solution itself to determine if it is still effective for its intended purpose. While not a test on a human sample, it is a test performed in vitro (outside the body) to assess the performance of a medical product (the disinfectant solution).
- Function: The strips provide a result (indicating whether the chemical levels are above or below the MRC) that is used to make a decision about the usability of the SSDS. This aligns with the function of many IVD devices which provide information used in a decision-making process related to healthcare.
In summary:
- Sporicidin® Sterilizing and Disinfecting Solution (SSDS): NOT an IVD. It's a disinfectant/sterilant for medical devices.
- Sporicidin Indicator Strips: LIKELY an IVD. They are a test used to assess the efficacy of the SSDS solution.
N/A
Intended Use / Indications for Use
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 Level Disinfection | 20 minutes | 25 degrees C | 0.6% | 1.3% |
Product codes (comma separated list FDA assigned to the subject device)
80 MED
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Efficacy Testing:
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 |
|---|---|
| SPORES Bacillus subtilis Clostridium sporogenes | Freshly activated and reused solution were effective at 12 hours at 25° C. |
| VEGETATIVE ORGANISMS Pseudomonas aeruginosa Salmonella cholerasuis Staphylococcus aureus | Freshly activated and reused solutions were effective within 10 minutes at 20° C. |
| Mycobacterium bovis Mycobacterium terrae | Freshly activated and reused solutions were effective within 20 minutes at 25° C. |
| FUNGI Trichophyton mentagrophytes | Freshly activated and reused solutions were effective within 10 minutes at 20° C. |
| NON-LIPID SMALL VIRUS Poliovirus 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 VIRUS Herpes simplex Type I Herpes 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 VIRUS Vaccinia | Reused solutions were effective within 10 minutes at 20-25° C. |
| Cytomegalovirus | Reused solutions were effective within 2 minutes at 20° C. |
Simulated In-Use Testing:
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 10^6 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:
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.
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.
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 devices listed when used according to the instructions for use.
Materials tested include: 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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CIDEXR Activated Dialdehyde Solution.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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 Level | ||||
| Disinfection | 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.
2
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 |
|---|---|
| SPORES | |
| Bacillus subtilis | |
| Clostridium sporogenes | Freshly activated and reused solution were effective at 12 hours at |
| 25° C. | |
| VEGETATIVE ORGANISMS | |
| Pseudomonas aeruginosa | |
| Salmonella cholerasuis | |
| Staphylococcus aureus | Freshly activated and reused solutions were effective within 10 |
| minutes at 20° C. | |
| Mycobacterium bovis | |
| Mycobacterium terrae | Freshly activated and reused solutions were effective within 20 |
| minutes at 25° C. | |
| FUNGI | |
| Trichophyton mentagrophytes | Freshly activated and reused solutions were effective within 10 |
| minutes at 20° C. | |
| NON-LIPID SMALL VIRUS | |
| Poliovirus 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 VIRUS | |
| Herpes simplex Type I | |
| Herpes 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 VIRUS | |
| Vaccinia | 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
3
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
8
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 Level | ||
| Disinfection | 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
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