STERILOX LIQUID CHEMICAL STERILANT SYSTEM

{0}------------------------------------------------ K 063154 #### 1.0 510(k) Summary | 1.1 | Date of Summary Preparation: | March 30, 2007 | |-----|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1.2 | Manufacturers Contact Person: | Howard Mann<br>Regulatory Affairs<br>TEL (610)-341-1899 ext 2703<br>FAX (610)-341-0503<br>PuriCore Inc<br>508 Lapp Road<br>Malvern, PA 19355<br>APR - 2 2007 | | 1.3 | Trade Name: | Sterilox Liquid Chemical High | 1.4 Level Disinfectant System | Classification Name | Product Code | Class | Classification<br>Reference | |-------------------------|--------------|-------|-----------------------------| | 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 Image /page/0/Picture/13 description: The image shows the word "sterilux" in a bold, sans-serif font. The letters are black, and the background is white. The word is written in lowercase letters, and the "u" in "sterilux" has a small, curved line above it. {1}------------------------------------------------ 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: Image /page/1/Picture/8 description: The image shows the word "sterilox" in black font. The letters are all lowercase, and the "o" is represented by a circle with a textured fill. The word is centered and the background is white. {2}------------------------------------------------ # Ko63159 p 3 J 8 ## 1.9.1 General: | | Sterilox Liquid Chemical<br>High Level Disinfectant<br>System<br>(System and HLD) | Predicate Device<br>Sterilox Liquid Chemical<br>High Level Disinfectant<br>System<br>(System and HLD)<br>(K013280) | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Labeling | High Level Disinfectant | High Level Disinfectant | | Intended Use | Disinfect reusable heat-<br>sensitive medical devices<br>which contact normally<br>sterile areas of the body | Disinfect reusable heat-<br>sensitive medical devices<br>which contact normally sterile<br>areas of the body | | | Intended for use by qualified<br>healthcare personnel trained<br>in its use. | Intended for use by qualified<br>healthcare personnel trained<br>in its use. | | Human Factors | Dispensed ready to use<br>by trained personnel | Dispensed ready to use<br>By trained personnel | | Design,<br>Construction,<br>Components | Aqueous solution<br>Used in a stand alone<br>Washer/Disinfector | Aqueous solution<br>Used in a stand alone<br>Washer/Disinfector | | Process Monitors | Pre-programmed colorimeter<br>for direct-reading of chlorine<br>concentration | Pre-programmed colorimeter<br>for direct-reading of chlorine<br>concentration | | Reuse | Single use | Single use | | Software<br>Controls | Yes | Yes | | High level<br>disinfectant | 10 min at 30°C at 400-450<br>ppm AFC | 10 min at 25°C at 650-675<br>ppm AFC | | | Sterilox Liquid Chemical<br>High Level Disinfectant<br>System<br>(System and Germicide) | Sterilox Liquid Chemical<br>High Level Disinfectant<br>System<br>(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 level<br>disinfection by destroying<br>viable forms of microbial<br>life, when used according to<br>labeling | To achieve high level<br>disinfection by destroying<br>viable forms of microbial life,<br>when used according to<br>labeling | | Mode of Action | Sterilox exerts its germicidal<br>effect by attacking the<br>surface and plasma<br>membrane proteins,<br>impairing transport of<br>solutes and the salt balance<br>of bacterial cells (Pieterson<br>et al, Water SA (1996)<br>22(1): 43-48) | Sterilox exerts its disinfection<br>effect by attacking the surface<br>and plasma membrane<br>proteins, impairing transport<br>of solutes and the salt<br>balance of bacterial cells<br>(Pieterson et al, Water SA<br>(1996) 22(1); 43-48) | Image /page/2/Picture/3 description: The image shows the word "sterilux" in black font. The "u" in "sterilux" is stylized with a dotted pattern, giving it a unique visual appearance. Below the word, there is a faint, dotted line that spans the length of the word above it. {3}------------------------------------------------ ## 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. Image /page/3/Picture/7 description: The image shows the word "sterilux" in a bold, sans-serif font. The letters are black, and the background is white. The word is all lowercase, and the letters are evenly spaced. The "u" in "sterilux" is slightly different from the other letters, as it appears to be made up of small dots. {4}------------------------------------------------ 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 of<br>Disinfectants; AOAC<br>Official Method 966.04¹ | Bacillus subtilis<br>Clostridium sporogenes | Meets liquid chemical<br>High level disinfectant<br>efficacy requirements | | Confirmatory Sporicidal<br>Activity of Disinfectants;<br>AOAC Official Method<br>966.04¹ | Bacillus subtilis<br>Clostridium sporogenes | Meets liquid chemical<br>High level disinfectant<br>efficacy requirements | | Fungicidal Activity of<br>Disinfectants (AOAC<br>6.3.02:1995, Official<br>Method 955.17) | Trichophyton<br>mentagrophytes | Solution is fungicidal | | Use-Dilution Method<br>(AOAC 6.2.01:1995,<br>Official Methods 955.14,<br>955.15, 964.02) | Salmonella choleraesuis<br>Staphylococcus aureus<br>Pseudomonas aeruginosa | Solution is bactericidal | | EPA Virucidal Testing<br>(DIS/TSS-7, Nov. 1981) | Poliovirus II | Solution is virucidal | | Quantitative Tuberculocidal<br>Test | Mycobacterium bovis | Solution is<br>tuberculocidal | | Simulated Use Test | Mycobacterium terrae² | Meets efficacy<br>requirements | | Clinical In-Use | Organisms remaining on<br>flexible endoscopes after<br>clinical use | No surviving<br>microorganisms on any<br>of the endoscopes<br>tested | 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. Image /page/4/Picture/6 description: The image shows the word "sterilux" in bold, black letters. The letters are evenly spaced and the word is centered. The font is sans-serif and the letters are all lowercase. There is some faint text below the word, but it is not legible. {5}------------------------------------------------ #### 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 Image /page/5/Picture/11 description: The image shows the word "sterilux" in a bold, sans-serif font. The letters are black, and the word is slightly angled upwards from left to right. The "u" in "sterilux" is stylized with a dotted line forming a semicircle above it. K063159 1.648 {6}------------------------------------------------ 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. Image /page/6/Picture/11 description: The image shows the word "sterilux" in black font. The letters are all lowercase except for the "X" at the end, which is uppercase. There is a faint, dotted circle above the "U" in "sterilux". The word is likely a brand name or product name. K063159 {7}------------------------------------------------ K063159 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. Image /page/7/Picture/4 description: The image shows the word "sterilux" in black font. The letters are lowercase, and the "u" has a dotted design. The word is centered in the image and is easy to read. {8}------------------------------------------------ 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. {9}------------------------------------------------ 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 {10}------------------------------------------------ # 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