(167 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 30°C. Sterilox is a single use product generated on site by the Maxigen II (E200) generator for use at its MRC of 400-450 ppm (AFC). The Sterilox high level disinfectant is intended for processing only in an automated endoscope reprocessor or washer disinfector with FDA-cleared capability to maintain the solution temperature at 30°C.
The device 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 (NaCl). The disinfectant is then circulated on the internal and external surfaces of re-usable heat-sensitive medical devices within a washer-disinfector AER with FDA-cleared capability to maintain the solution temperature at 30°C 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 provided text regarding the Sterilox™ High Level Disinfectant System, structured to answer your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Method) | Reported Device Performance |
|---|---|
| Sporicidal Activity of Disinfectants; AOAC Official Method 966.04 | Meets liquid chemical High level disinfectant efficacy requirements |
| Confirmatory Sporicidal Activity of Disinfectants; AOAC Official Method 966.04 | Meets liquid chemical High level disinfectant efficacy requirements |
| Fungicidal Activity of Disinfectants (AOAC 6.3.02:1995, Official Method 955.17) | Solution is fungicidal |
| Use-Dilution Method (AOAC 6.2.01:1995, Official Methods 955.14, 955.15, 964.02) | Solution is bactericidal |
| EPA Virucidal Testing (DIS/TSS-7, Nov. 1981) | Solution is virucidal |
| Quantitative Tuberculocidal Test | Solution is tuberculocidal |
| Simulated Use Test | Meets efficacy requirements |
| Clinical In-Use (Organisms remaining on flexible endoscopes after clinical use) | No surviving microorganisms on any of the endoscopes tested |
| Residue Testing (after disinfection and rinsing) | Sterilox components effectively removed, no additional risk to patient/user |
| 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 |
| Cytotoxicity | Non-cytotoxic |
| Materials Compatibility (corrosion, damage, appearance) | No corrosion or visible damage in majority of endoscope components; some color changes/tack on sheaths; corrosion on anodized aluminum. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes for each microbiological or toxicity test test set, other than:
- "Clinical In-Use": "No surviving microorganisms on any of the endoscopes tested" implies a sample size of multiple endoscopes, but the exact number isn't given.
- "Simulated Use Test": "inoculated scopes were processed in Sterilox and AER for 10 minutes at 30° C." implies multiple scopes, but quantity not specified.
- General Microbiological Tests (AOAC, EPA methods): These methods typically have defined sample sizes, but the report summarizes the results rather than detailing the experimental setup for each test performed on this specific device.
Data Provenance: The information provided generally describes laboratory testing (e.g., AOAC methods for efficacy, animal studies for toxicity). There is no explicit mention of data origin (e.g., country) for these studies. The "Clinical In-Use" implies real-world usage, making it prospective in nature for that specific part of the study. The remaining tests are laboratory studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information in the provided text about the use of "experts" to establish ground truth in the way one might for diagnostic AI. The ground truth for the microbiological efficacy tests and toxicological tests is established by standardized laboratory methods (e.g., AOAC, EPA protocols) which inherently define what constitutes a positive or negative result. For instance, for sporicidal activity, the ground truth is whether spores are killed as per the method's criteria, not an expert's interpretation of an image.
4. Adjudication Method for the Test Set
Not applicable. This device is a high-level disinfectant, not an AI or diagnostic tool where expert adjudication of results would typically be employed. The tests are laboratory-based and use objective endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a chemical disinfectant, not a diagnostic imaging device or AI algorithm for human interpretation enhancement. Therefore, an MRMC study is not relevant or included in this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in the sense that all efficacy and safety studies were conducted on the device itself (the Sterilox Liquid Chemical High Level Disinfectant System and its germicide solution), demonstrating its performance independently without a human interpretation component that would require "human-in-the-loop" considerations.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily:
- Laboratory outcomes/direct measurements: For microbiological efficacy, it's the destruction or inactivation of specific microorganisms (e.g., spores, bacteria, fungi, viruses, mycobacteria) under specified conditions, measured by standard laboratory culture techniques.
- Physiological/toxicological responses: For toxicity, the ground truth is the observable response (or lack thereof) in animal models (e.g., irritation, sensitization, LD50 values, mutagenicity) against established biological endpoints.
- Chemical analysis: For residue data, the ground truth is the quantifiable level of Sterilox components remaining after rinsing.
- Physical observation: For material compatibility, the ground truth is visible changes, damage, or corrosion.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of supervised learning. The testing described is empirical validation against pre-defined performance standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
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K 063154
1.0 510(k) Summary
| 1.1 | Date of Summary Preparation: | March 30, 2007 |
|---|---|---|
| 1.2 | Manufacturers Contact Person: | Howard MannRegulatory AffairsTEL (610)-341-1899 ext 2703FAX (610)-341-0503PuriCore Inc508 Lapp RoadMalvern, PA 19355APR - 2 2007 |
| 1.3 | Trade Name: | Sterilox Liquid Chemical High |
1.4
Level Disinfectant System
| Classification Name | Product Code | Class | ClassificationReference |
|---|---|---|---|
| Classification Name | Product Code | Class | 21CFR § |
| High Level Disinfectant | MED | II | 880.6885 |
1.5 Special Controls:
Content and Format of Pre-Market Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants, dated January 3, 2000.
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 30°C. Sterilox is a single use product generated on site by the Maxigen II (E200) generator for use at its MRC of 400-450 ppm (AFC). The Sterilox high level disinfectant is intended for processing only in an automated endoscope reprocessor or washer disinfector with FDA-cleared capability to maintain the solution temperature at 30°C.
The device is intended for use by qualified health care personnel trained in its use.
Device Description: 1.7
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 (NaCl). The disinfectant is then circulated on the internal and external surfaces of re-usable heat-sensitive medical devices within a washer-disinfector AER with FDA-cleared
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capability to maintain the solution temperature at 30°C 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.
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 Liquid Chemical High Level Disinfectant System is substantially equivalent with respect to indications for use, device design, materials, and method of manufacture to the following commercially available predicate device:
Sterilox High Level Disinfectant System ~ (K013280)
Sterilox is also equivalent to other commercially available and marketed Unclassified and Class II devices indicated for use as liquid chemical sterilants/high level disinfectants.
Substantial Equivalence Comparison: 1.9
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:
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Ko63159 p 3 J 8
1.9.1 General:
| Sterilox Liquid ChemicalHigh Level DisinfectantSystem(System and HLD) | Predicate DeviceSterilox Liquid ChemicalHigh Level DisinfectantSystem(System and HLD)(K013280) | |
|---|---|---|
| Labeling | High Level Disinfectant | High Level Disinfectant |
| Intended Use | Disinfect reusable heat-sensitive medical deviceswhich contact normallysterile areas of the body | Disinfect reusable heat-sensitive medical deviceswhich contact normally sterileareas of the body |
| Intended for use by qualifiedhealthcare personnel trainedin its use. | Intended for use by qualifiedhealthcare personnel trainedin its use. | |
| Human Factors | Dispensed ready to useby trained personnel | Dispensed ready to useBy trained personnel |
| Design,Construction,Components | Aqueous solutionUsed in a stand aloneWasher/Disinfector | Aqueous solutionUsed in a stand aloneWasher/Disinfector |
| Process Monitors | Pre-programmed colorimeterfor direct-reading of chlorineconcentration | Pre-programmed colorimeterfor direct-reading of chlorineconcentration |
| Reuse | Single use | Single use |
| SoftwareControls | Yes | Yes |
| High leveldisinfectant | 10 min at 30°C at 400-450ppm AFC | 10 min at 25°C at 650-675ppm AFC |
| Sterilox Liquid ChemicalHigh Level DisinfectantSystem(System and Germicide) | Sterilox Liquid ChemicalHigh Level DisinfectantSystem(System and HLD) | |
| Form | Inputs of water & germicide | Inputs of water & disinfectant |
| Control | Software controlled | Software controlled |
| Contact | Liquid contact | Liquid contact |
| Purpose | To achieve high leveldisinfection by destroyingviable forms of microbiallife, when used according tolabeling | To achieve high leveldisinfection by destroyingviable forms of microbial life,when used according tolabeling |
| Mode of Action | Sterilox exerts its germicidaleffect by attacking thesurface and plasmamembrane proteins,impairing transport ofsolutes and the salt balanceof bacterial cells (Pietersonet al, Water SA (1996)22(1): 43-48) | Sterilox exerts its disinfectioneffect by attacking the surfaceand plasma membraneproteins, impairing transportof solutes and the saltbalance of bacterial cells(Pieterson et al, Water SA(1996) 22(1); 43-48) |
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1.9.2 Operational Principles:
The basic operational principles of the Sterilox Liquid Chemical High Level Disinfectant System and the predicate device are similar in that they result in high level disinfection of reusable medical equipment that is heat sensitive by putting their disinfectant in contact with the devices for a specified period of time and temperature, in dynamic conditions. The operating principles are compared as follows:
The parameters that are measured and displayed are generally the same as those for the predicate device.
1.10 Indications and Contraindications:
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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K063159
p.5.18
1.11 Microbiological Efficacy:
The Sterilox germicide is a single use solution and all efficacy testing was conducted at or below the MRC of 400 ppm AFC.
| Test Method | Test Organisms | Results |
|---|---|---|
| Sporicidal Activity ofDisinfectants; AOACOfficial Method 966.04¹ | Bacillus subtilisClostridium sporogenes | Meets liquid chemicalHigh level disinfectantefficacy requirements |
| Confirmatory SporicidalActivity of Disinfectants;AOAC Official Method966.04¹ | Bacillus subtilisClostridium sporogenes | Meets liquid chemicalHigh level disinfectantefficacy requirements |
| Fungicidal Activity ofDisinfectants (AOAC6.3.02:1995, OfficialMethod 955.17) | Trichophytonmentagrophytes | Solution is fungicidal |
| Use-Dilution Method(AOAC 6.2.01:1995,Official Methods 955.14,955.15, 964.02) | Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosa | Solution is bactericidal |
| EPA Virucidal Testing(DIS/TSS-7, Nov. 1981) | Poliovirus II | Solution is virucidal |
| Quantitative TuberculocidalTest | Mycobacterium bovis | Solution istuberculocidal |
| Simulated Use Test | Mycobacterium terrae² | Meets efficacyrequirements |
| Clinical In-Use | Organisms remaining onflexible endoscopes afterclinical use | No survivingmicroorganisms on anyof the endoscopestested |
4This testing was conducted in accordance with AOAC Official Method 966.04, except that polyester loops (instead of silk loops) were used as a carrier.
2 Simulated use testing was conducted using actual used flexible endoscopes whose external surfaces and internal channels were contaminated with >106 cfu Mycobacterium terrae. The inoculated scopes were processed in Sterilox and AER for 10 minutes at 30° C.
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1.12 Residue Data:
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 |
| Cytotoxicity | Non-cytotoxic |
In section III.I.3 'Evaluation of toxicity' of the quidance 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 eye
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1.648
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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 qermicide 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:
"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.
1.16 Toxicological Conclusion:
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 changes and the "tack" of the coating of the outer endoscope sheaths were noted on some endoscopes. Corrosion was noted on anodized aluminum.
1.18 Assessment of non-clinical performance data for equivalence:
The Sterilox 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.
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p. 8588
The Sterilox Liquid Chemical High Level Disinfectant System intends to comply with the FDA quidance document "Content and Format of Pre-market Notification [510(k)] Submissions for Liquid Chemical High level disinfectants/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, PuriCore concludes that the 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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Image /page/8/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Howard K. Mann Director Regulatory Affairs & Official Correspondent PuriCore, Incorporated 320 King of Prussia Road, Suite 200 Radnor, Pennsylvania 19087
APR - 2 2007
Re: K063159
Trade/Device Name: Sterilox™ High Level Disinfectant System Regulation Number: 880.6885 Regulation Name: Liquid Chemical Sterilants High Level Disinfectants Regulatory Class: II Product Code: MED Dated: March 23, 2007 Received: March 26, 2007
Dear Mr. Mann:
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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Page 2 - Mr. Mann
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 (OS) 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the 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/industry/support/index.html.
Sincerely yours,
Suette G. Michael DMD
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K063159
Device Name: Sterilox™ 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 30°C. Sterilox is a single use product generated on site by the Maxigen II (E200) generator for use at its MRC of 400-450 pm (AFC). The Sterilox high level disinfectant is intended for processing only in an automated endoscope reprocessor or washer disinfector with FDAcleared capability to maintain the solution temperature at 30°C.
The device is intended for use by qualified health care personnel trained in its use.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule H Murphy, MD
Anasthesiology, General Hospital uon Control, Dental
3(k) Number: K063159
§ 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.