(351 days)
Sterilox is a high level disinfectant system intended for processing heat-sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 25°C. Sterilox is a single use product generated on site for use at its MRC of 650-675 ppm (AFC). Sterilox is intended for use with manual or automatic endoscope reprocessing protocols.
Sterilox High Level Disinfectant system is intended for use by qualified health care personnel trained in its use.
The Sterilox Liquid Chemical High Level Disinfectant System is an apparatus that produces a single use High Level Disinfectant by on-site electrochemical activation (electrolysis) of a dilute aqueous solution of sodium chloride (NaCI). The germicide is then circulated through and about reusable heat-sensitive medical devices either in a manual system or within a typical washer-disinfector used in hospitals, clinics and various other health care settings. It is a device intended for use by qualified healthcare personnel trained in its use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) Summary.
Acceptance Criteria and Device Performance for Sterilox Liquid Chemical High Level Disinfectant System
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the efficacy tests performed and the results reported as "Meets (efficacy) requirements" or "Solution is..." (e.g., fungicidal, bactericidal, virucidal, tuberculocidal). For "High Level Disinfectant", the primary criteria relate to the destruction of specific microorganisms within a defined time and temperature.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Microbiological Efficacy: | |
| Spore inactivation (Bacillus subtilis, Clostridium sporogenes) | Meets liquid chemical sterilant efficacy requirements (via AOAC Official Method 966.04) |
| Fungicidal activity (Trichophyton mentagrophytes) | Solution is fungicidal |
| Bactericidal activity (Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa) | Solution is bactericidal |
| Virucidal activity (Herpes Simplex I, Poliovirus II, HIV Type I) | Solution is virucidal |
| Tuberculocidal activity (Mycobacterium bovis) | Solution is tuberculocidal |
| Simulated Use Efficacy (Bacillus subtilis, Clostridium sporogenes) | Meets efficacy requirements (Flexible fiber optic endoscopes contaminated with >10⁶ cfu spores) |
| Simulated Use Efficacy (Mycobacterium terrae) | Meets efficacy requirements (Flexible fiber optic endoscopes contaminated with >10⁶ cfu) |
| Clinical In-Use Efficacy (flexible endoscopes) | No surviving microorganisms on any of the endoscopes tested |
| Residue Data: | |
| Effective removal from complex devices | Effectively removed from a complex device like a flexible endoscope by the rinse cycle after disinfection, posing no additional risk |
| Toxicological Evaluation: | |
| Non-irritating (Skin, Eye) | Non-irritating (Rabbits for Skin, Primary Eye) |
| Non-sensitizing (Skin) | Non-sensitizing (Guinea Pig) |
| Acceptable Dermal Toxicity (LD50) | Dermal LD50 > 2 g/kg body weight (Rabbits) |
| Acceptable Oral Toxicity (LD50) | Dermal LD50 > 5 g/kg body weight (Rats) |
| Non-mutagenic | Non-mutagenic (Bacterial Mutation Assay) |
| Minimal patient/user health risks | Minimal health risks to patient and operator. Unlikely to pose a significant risk. |
| Materials Compatibility: | |
| No corrosion or visible damage to most endoscope components | Does not produce corrosion or visible damage in majority of endoscope components. (Note: Color changes/tack of coating on some, corrosion on anodized aluminum) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a single comprehensive "test set" sample size in terms of the number of unique devices or the overall quantity of tests performed for all criteria. Instead, it lists various studies, each with its own sample considerations, but the exact number of replicates or individual samples within each test is not provided in this summary.
Data Provenance: The document does not specify the country of origin for the data. The studies are described as lab-based efficacy tests (e.g., AOAC methods) and simulated-use/clinical in-use tests. It can be inferred that these are prospective studies conducted specifically for this 510(k) submission, rather than retrospective analyses of pre-existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. For microbiological efficacy studies, the "ground truth" is typically established by the laboratory performing the tests and adhering to standardized methodologies (e.g., AOAC, EPA). The interpretation of results against pass/fail criteria is inherent in these methods. There's no mention of a separate panel of experts establishing ground truth for individual test outcomes beyond the standard practices of the testing labs.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the context of multiple readers or reviewers for the test results. The efficacy tests are primarily quantitative (e.g., log reduction, survival/non-survival) and are typically evaluated against pre-defined acceptance criteria specified by the test method (e.g., AOAC, EPA guidelines).
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study (MRMC for human readers improving with AI) is relevant for diagnostic imaging AI devices where human interpretation is assisted by AI. The Sterilox Liquid Chemical High Level Disinfectant System is a physical disinfectant system, not a diagnostic AI tool, so an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the primary efficacy testing represents "standalone" performance in the sense that the disinfectant solution's performance was evaluated inherently. While a human initiates the process and follows instructions, the efficacy (microbial kill, toxicological safety, etc.) is an intrinsic property of the chemical system itself when used as directed, independent of ongoing human-in-the-loop decisions during its operation for a specific disinfection cycle. The "Microbiological Efficacy" and "Residue Data" sections specifically detail these standalone performance evaluations.
7. The Type of Ground Truth Used
The ground truth used for the efficacy studies can be categorized as follows:
- Microbiological Culture Results: For all microbial efficacy tests (sporicidal, fungicidal, bactericidal, virucidal, tuberculocidal, simulated use, clinical in-use), the "ground truth" is determined by established laboratory methods that quantify or qualitatively assess the survival or death of target microorganisms. This involves culturing residual organisms after exposure to the disinfectant.
- Analytical Chemistry/Toxicology Assays: For residue data and toxicological assessments, the "ground truth" is derived from quantitative analytical tests for chemical residues and standardized biocompatibility/toxicology assays (e.g., skin irritation, mutation assays).
8. The Sample Size for the Training Set
This device does not utilize a "training set" in the context of machine learning or AI. Therefore, this question is not applicable. The development of chemical disinfectants relies on chemical formulation, microbiology, and toxicology, not statistical models trained on data.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for this type of device, the concept of establishing ground truth for it is not applicable.
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510(k) Summary 1
| 1.1 | Date of Summary Preparation: | Wednesday, September 18, 2002 |
|---|---|---|
| 1.2 | Manufacturers Contact Person: | Howard MannVP U.S. Operations, QA/RATEL (610)-341-1899FAX (610)-341-0503Sterilox Technologies Inc320 King of Prussia Road, Suite 200Radnor, PA 19087 |
| 1.3 | Trade Name: | Sterilox Liquid Chemical High LevelDisinfectant System |
1.4 Classification Name, Product Code, Class, Classification Reference:
| Classification Name | Product Code | Class | 21CFR § |
|---|---|---|---|
| High Level Disinfectant | MED | II | 880.6885 |
1.5 Special Controls:
Guidance on the Content and Format of Pre-market Notification [510(k)] Submissions for Liquid Chemical Sterilant/ High Level Disinfectants; user information and training.
1.6 Indications for Use:
Sterilox is a high level disinfectant system intended for processing heat-sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 25°C. Sterilox is a single use product generated on site for use at its MRC of 650-675 ppm (AFC). Sterilox is intended for use with manual or automatic endoscope reprocessing protocols.
Sterilox High Level Disinfectant system is intended for use by qualified health care personnel trained in its use.
1.7 Device Description:
The Sterilox Liquid Chemical High Level Disinfectant System is an apparatus that produces a single use High Level Disinfectant by on-site electrochemical activation (electrolysis) of a dilute aqueous solution of sodium chloride (NaCI). The germicide is then circulated through and about reusable heat-sensitive medical devices either in a manual system or within a typical washer-disinfector used in hospitals, clinics and various other health care settings. It is a device intended for use by qualified healthcare personnel trained in its use.
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The Sterilox device is similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution.
Substantially Equivalent Commercially Available Devices: 1.8
The Sterilox Liguid Chemical High Level Disinfectant System is substantially equivalent to the products described herein with respect to indications for use, device design, materials, and method of manufacture. Section 4 and Appendix A contains all relevant and available information for the following commercially available predicate devices:
Cidex liquid chemical sterilants/disinfectants ~ (K923744, K924334, K924434) Endo-Spor Plus/Hyprocide Liquid Chemical Sterilants ~ (K972708) Steris 20™ Sterilant/Steris System 1™ Processor ~ (K875280)
These predicate devices are commercially available and marketed Unclassified and Class II devices indicated for use as liquid chemical sterilants/high level disinfectants.
1.9 Substantial Equivalence Comparison:
The Sterilox Liquid Chemical High Level Disinfectant System is similar to commercially available devices with respect to intended use, material, design and operational principles as follows:
1.9.1 General:
| Sterilox LiquidChemical High LevelDisinfectant System(System and Germicide) | Steris(System and Germicide) | Endo-SporPlus/Hyprocide(Germicide) | Cidex(Germicide) | |
|---|---|---|---|---|
| Labeling | High Level Disinfectant | Liquid Chemical sterilant | Liquid ChemicalSterilant/High LevelDisinfectant | Liquid ChemicalSterilant/High LevelDisinfectant |
| Intended Use | Disinfect reusable heat-sensitive medical deviceswhich contact normallysterile areas of the bodyIntended for use byqualified healthcarepersonnel trained in itsuse. | Disinfect reusable heat-sensitive medical deviceswhich contact normallysterile areas of the bodyIntended for use byqualified healthcarepersonnel trained in itsuse. | Disinfect reusableheat-sensitivemedical deviceswhich contactnormally sterileareas of the bodyIntended for use byqualified healthcarepersonnel trained inits use. | Disinfect reusableheat-sensitivemedical deviceswhich contactnormally sterileareas of the bodyIntended for use byqualified healthcarepersonnel trained inits use. |
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| Sterilox LiquidChemical High LevelDisinfectant System(System and Germicide) | Steris(System and Germicide) | Endo-SporPlus/Hyprocide(Germicide) | Cidex(Germicide) | |
|---|---|---|---|---|
| HumanFactors | Dispensed ready to use | Dispensed ready to use | Dispensed ready touse | Needsactivation |
| Design,Construction,Components | Aqueous solutionUsed in a standalonecontainer orWasher/Disinfector | Aqueous solutionMust be used in adedicated sterileprocessing system | Aqueous solutionUsed in astandalonecontainer orWasher/Disinfector | Aqueous solutionUsed in astandalonecontainer orWasher/Disinfector |
| ProcessMonitors | Pre-programmedcolorimeter for direct-reading of chlorineconcentration | Chemical reaction onindicator pad to producecolor change | None | Chemical IndicatorChemical reactionon indicator pad toproduce colorchange |
| Reuse | Single use | Single use | 14 days | 14 days |
| SoftwareControls | Yes | Yes | N/A | N/A |
| Process Parameters | ||||
| LiquidChemicalSterilant | N/A | 12 min at 50-56°C | 180 min at 20°C | 10 hr at 25°C |
| High LevelDisinfectant | 10 min at 25°C | N/A | 15 min at 20°C | 45 min at 25°C |
1.9.2 Operational Principles:
The basic operational principles of the Sterilox Liquid Chemical High Level Disinfectant System and the predicate devices are similar in that they result in high level disinfection of reusable medical equipment that is heat sensitive by putting their germicides in contact with the devices for a specified period of time and temperature, in either static or dynamic conditions. The operating principles are compared as follows:
| Sterilox LiquidChemical High LevelDisinfectant System(System and Germicide) | Steris(System and Germicide) | Endo-SporPlus/Hyprocide(Germicide) | Cidex(Germicide) | |
|---|---|---|---|---|
| Form | Inputs of water &germicide | Inputs of water &germicide | germicide | germicide |
| Control | Software controlled | Software controlled | N/A | N/A |
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| Sterilox LiquidChemical High LevelDisinfectant System(System and Germicide) | Steris(System and Germicide) | Endo-SporPlus/Hyprocide(Germicide) | Cidex(Germicide) | |
|---|---|---|---|---|
| Contact | Liquid contact | Liquid contact | Liquid contact | Liquid contact |
| Purpose | To achieve high leveldisinfection bydestroying viableforms of microbial life,when used accordingto labeling | To achieve liquidchemical sterilizationby destroying viableforms of microbial life,when used accordingto labeling | To achieve liquidchemicalsterilization orhigh leveldisinfection bydestroying viableforms of microbiallife, when usedaccording tolabeling | To achieve liquidchemicalsterilization orhigh leveldisinfection bydestroying viableforms of microbiallife, when usedaccording tolabeling |
| Mode ofAction | Sterilox exerts itsgermicidal effect byattacking the surfaceand plasmamembrane proteins,impairing transport ofsolutes and the saltbalance of bacterialcells (Pieterson et al,Water SA (1996)22(1); 43-48) | It is believed thatperacetic acid exertsits germicidal effect byoxidizing sulfhydryland sulfur bonds inproteins andenzymes, particularlyin the cell walls(Block, 1991) | It is believed thathydrogenperoxide andperacetic acidexert theirgermicidal effectby oxidizingsulfhydryl andsulfur bonds inproteins andenzymes,particularly in thecell walls (Block,1991) | Strong interactionwith outer celllayers; crosslinking of aminogroups in proteinsand inhibition oftransportprocesses intocell (McDonell,Clin. Microbiol.Rev., 1999 147-179) |
The parameters that are measured and displayed are generally the same as those for the predicate devices
Indications and Contraindications: 1.10
Relative indications and contraindications for the Sterilox Liquid Chemical High Level Disinfectant System and commercially available devices for similar intended uses are the same.
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Microbiological Efficacy: 1.11
The Sterilox germicide is a single use solution and all efficacy testing was conducted at the MRC of 650 ppm AFC.
| Test Method | Test Organisms | Results |
|---|---|---|
| Sporicidal Activity ofDisinfectants; AOAC OfficialMethod 966.04 | Bacillus subtilisClostridium sporogenes | Meets liquid chemicalSterilant efficacyrequirements3 |
| Confirmatory SporicidalActivity of Disinfectants; AOACOfficial Method 966.04 | Bacillus subtilisClostridium sporogenes | Meets liquid chemicalSterilant efficacyrequirements3 |
| Fungicidal Activity ofDisinfectants (AOAC6.3.02:1995, Official Method955.17) | Trichophyton mentagrophytes | Solution is fungicidal |
| Use-Dilution Method (AOAC6.2.01:1995, Official Methods955.14, 955.15, 964.02) | Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosa | Solution is bactericidal |
| EPA Virucidal Testing(DIS/TSS-7, Nov. 1981) | Herpes Simplex IPoliovirus IIHuman ImmunodeficiencyVirusType I | Solution is virucidal |
| Quantitative TuberculocidalTest | Mycbacterium bovis | Solution is tuberculocidal |
| Simulated Use Test | Bacillus subtilis1Clostridium sporogenes1Mycobacterium terrae2 | Meets efficacyrequirements |
| Clinical In-Use | Organisms remaining on flexibleendoscopes after clinical use | No survivingmicroorganisms on any ofthe endoscopes tested. |
'Simulated use testing was conducted using actual used flexible fiber optic endoscopes whose external surfaces and internal channels were contaminated with >10 cfu Bacillus subtilis and Clostridium sporogenes spores. The inoculated scopes were processed in Sterilox manually for 30 minutes at 23° C. 2Simulated use testing was conducted using actual used flexible fiberoptic endoscopes whose external
surfaces and internal channels were contaminated with >10°cfu Mycobacterium terrae. The inoculated scopes were processed in Sterilox manually for 10 minutes at 28 C
"This testing was conducted in accordance with AOAC Offficial Method 966.04, except that polyester loops (instead of silk loops) were used as a carrier.
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Residue Data: 1.12
Residue testing was performed to quantify any residuals remaining after disinfection with Sterilox above MRC and rinsing according to the label claims. The endoscope was then extracted and the eluates analyzed for residual Sterilox components. The results showed that Sterilox germicide well above its maximum use concentration is effectively removed from a complex device such as a flexible endoscope by the rinse cycle after disinfection and therefore poses no additional risk to the patient or user of the device.
1.13 Toxicological Evaluation of Sterilox:
Testing was performed to determine the potential toxicological effects of exposure to Sterilox liquid chemical High Level Disinfectant. The results are summarized as follows:
| Skin Irritation (Rabbits) | Non-irritating |
|---|---|
| Skin Sensitization (Guinea Pig) | Non-sensitizing |
| Acute Dermal Toxicity (Rabbits) | Dermal LD50 > 2 g/kg body weight |
| Acute Oral Toxicity (Rats) | Dermal LD50 > 5 g/kg body weight |
| Primary Eye Irritation (Rabbits) | Non-irritating |
| Bacterial Mutation Assay | Non-mutagenic |
In section III.I.3 'Evaluation of toxicity' of the guidance for industry and FDA reviewers indicates the tests that should be considered when evaluation the biocompatibility of the germicidal product or the individual ingredients.
1.14 Patient toxicity:
Skin irritation and skin sensitization maximization test have been conducted on the product, Sterilox germicide. The test reports indicate that the studies were conducted properly. There were no indications of irritation or sensitization. Although positive results of studies on cytotoxicity and on haemocompatibility might be predicted from knowledge of the effects of hypotonic aqueous solutions generally, these results would also be expected of any suitably disinfected water used to rinse equipment.
As the toxicity of the product is essentially similar to that of chlorine based disinfectants, it is unlikely that any useful information will be obtained from further studies and it is therefore undesirable on the grounds of animal welfare to conduct these studies.
1.15 User toxicity:
An acute oral toxicity test (by the OECD 'fixed dose' procedure), a primary eve irritancy study and a bacterial mutagenicity study in Salmonella typhimurium (the 'Ames' test) have been conducted on the product, Sterilox germicide. The test reports indicate that the studies were conducted properly. The results of these tests indicated that Sterilox germicide is non-mutagenic and non-irritating to the eye.
As, for toxicological purposes, the product is essentially equivalent to chlorine disinfectant, the conclusion reached by the International Program on Chemical Safety in Environmental Health Criteria 216 (2000) concerning the toxic effects of these disinfectants in drinking water that:
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"Evidence from animal and human studies suggests that exposure to chlorine, chlorite solutions, chloramine and chlorine dioxide themselves probably do not contribute to the development of cancer or any toxic effects".
This also applies to the Sterilox germicide solution, thus undertaking additional testing is scientifically unnecessary and, on animal welfare grounds the studies should be omitted.
Toxicological Conclusion: 1.16
For all practical purposes the health risks to patient and to operator arising from exposure to Sterilox germicide and diluted Sterilox germicide are minimal. The principal potential effect of the chemicals present in Sterilox would be irritation, but Sterilox does not exhibit this effect in tests. Sterilox is unlikely to pose a significant risk to either patient or user.
1.17 -Materials Compatibility:
The material compatibility of the Sterilox germicide was evaluated by subjecting a variety of metallic, plastic, adhesive and rubber endoscope components to continuous immersion in Sterilox. The samples were inspected for. visible change, visible evidence of damage or any other change in appearance. Sterilox germicide does not produce any corrosion or other visible damage in the majority of endoscope components. Color chanqes and the "tack" of the coating of the outer endoscope sheaths were noted on some endoscopes. Corrosion was noted on anodized aluminum. Refer to User Manual for materials compatibility information.
Assessment of non-clinical performance data for equivalence: 1.18
Currently there are no FDA standards for this device. However, the Sterilox Liquid Chemical High Level Disinfectant System complies with:
The Essential Requirements of Annex I of the Medical Device Directive 93/42/EEC and is manufactured under a Quality System approved by LRQA (Notified Body No. 0088) complying with Annex VII & V of the Directive.
The Sterilox Liquid Chemical High Level Disinfectant System intends to comply with the FDA guidance document "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants," dated January 3, 2000, where applicable.
1.19 Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Sterilox Technologies concludes that the new device, the Sterilox Liquid Chemical High Level Disinfectant System, is safe, effective and substantially equivalent to the predicate device as described herein.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of an eagle's head with three wavy lines extending from the back of the head, resembling feathers or streams.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2002
Sterilox Technologies, Incorporated C/O Mr. Robert Mosenkis Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K013280
Trade/Device Name: Sterilox Liquid Chemical High Level Disinfectant System Regulation Number: 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: II Product Code: MED Dated: September 5, 2002 Received: September 6, 2002
Dear Mr. Mosenkis:
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.
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.
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Page 2 - Mr. Mosenkis
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
Timothy A. Ulatowski 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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Page 1 of 1
510(k) Number:
Device Name : Sterilox Liquid High Level Disinfectant System
Indications for Use:
Sterilox is a high level disinfectant system intended for processing heat-sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 25°C. Sterilox is a single use product generated on site for use at its MRC of 650-675 ppm (AFC). Sterilox is intended for use with manual or automatic endoscope reprocessing protocols.
This device is intended for use by qualified healthcare personnel trained in its use.
R. Culleton A.
Division Sign-Of ivision of Anesthesidlogy, General Hospital, Infection Control. Denta 510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.