STERILOX LIQUID CHEMICAL STERILANT SYSTEM

K013280 · Sterilox Technologies, Inc. · MED · Sep 18, 2002 · General Hospital

Device Facts

• Record ID: K013280
• Device Name: STERILOX LIQUID CHEMICAL STERILANT SYSTEM
• Applicant: Sterilox Technologies, Inc.
• Product Code: MED · General Hospital
• Decision Date: Sep 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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.

Device Story

System produces high-level disinfectant on-site via electrochemical activation (electrolysis) of dilute aqueous sodium chloride solution; germicide circulated through/around reusable heat-sensitive medical devices (e.g., endoscopes) in manual or automatic washer-disinfector systems. Operated by trained healthcare personnel in hospitals/clinics. System includes pre-programmed colorimeter for monitoring chlorine concentration. Output is single-use germicide; healthcare providers use output to achieve high-level disinfection of equipment, reducing risk of microbial transmission to patients. Benefits include effective disinfection of heat-sensitive devices without requiring long-term storage of hazardous chemicals.

Clinical Evidence

Bench testing only. Efficacy validated via AOAC Official Methods (966.04, 955.17, 955.14, 955.15, 964.02) against B. subtilis, C. sporogenes, T. mentagrophytes, S. choleraesuis, S. aureus, P. aeruginosa, M. bovis, and viruses (Herpes Simplex I, Poliovirus II, HIV-1). Simulated use testing on flexible endoscopes confirmed efficacy against spores and M. terrae. Clinical in-use testing showed no surviving microorganisms on endoscopes post-processing. Residue testing confirmed effective removal of germicide. Toxicological studies (skin/eye irritation, sensitization, acute toxicity, mutagenicity) showed no adverse effects.

Technological Characteristics

Electrochemical activation (electrolysis) of aqueous NaCl. Produces germicide with 650-675 ppm available free chlorine (AFC). System includes software-controlled processing and integrated colorimeter for concentration monitoring. Compatible with manual or automatic washer-disinfector systems. Materials: various metallic, plastic, adhesive, and rubber endoscope components. Sterilization: N/A (High-level disinfection).

Indications for Use

Indicated for high-level disinfection of reusable heat-sensitive medical devices, including endoscopes, in healthcare settings. Intended for use by qualified, trained healthcare personnel.

Regulatory Classification

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.

Special Controls

*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.

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)

Submission Summary (Full Text)

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### 510(k) Summary 1

| 1.1 | Date of Summary Preparation: | Wednesday, September 18, 2002 |
|-----|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.2 | Manufacturers Contact Person: | Howard Mann<br>VP U.S. Operations, QA/RA<br>TEL [phone]<br>FAX [phone]<br>Sterilox Technologies Inc<br>320 King of Prussia Road, Suite 200<br>Radnor, PA 19087 |
| 1.3 | Trade Name: | Sterilox Liquid Chemical High Level<br>Disinfectant 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 Liquid<br>Chemical High Level<br>Disinfectant System<br>(System and Germicide) | Steris<br>(System and Germicide) | Endo-Spor<br>Plus/Hyprocide<br>(Germicide) | Cidex<br>(Germicide) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Labeling | High Level Disinfectant | Liquid Chemical sterilant | Liquid Chemical<br>Sterilant/High Level<br>Disinfectant | Liquid Chemical<br>Sterilant/High Level<br>Disinfectant |
| Intended Use | Disinfect reusable heat-<br>sensitive medical devices<br>which contact normally<br>sterile areas of the body<br><br>Intended for use by<br>qualified healthcare<br>personnel trained in its<br>use. | Disinfect reusable heat-<br>sensitive medical devices<br>which contact normally<br>sterile areas of the body<br><br>Intended for use by<br>qualified healthcare<br>personnel trained in its<br>use. | Disinfect reusable<br>heat-sensitive<br>medical devices<br>which contact<br>normally sterile<br>areas of the body<br><br>Intended for use by<br>qualified healthcare<br>personnel trained in<br>its use. | Disinfect reusable<br>heat-sensitive<br>medical devices<br>which contact<br>normally sterile<br>areas of the body<br><br>Intended for use by<br>qualified healthcare<br>personnel trained in<br>its use. |
| | | | | |

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| | Sterilox Liquid<br>Chemical High Level<br>Disinfectant System<br>(System and Germicide) | Steris<br>(System and Germicide) | Endo-Spor<br>Plus/Hyprocide<br>(Germicide) | Cidex<br>(Germicide) |
|----------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Human<br>Factors | Dispensed ready to use | Dispensed ready to use | Dispensed ready to<br>use | Needs<br>activation |
| Design,<br>Construction,<br>Components | Aqueous solution<br>Used in a standalone<br>container or<br>Washer/Disinfector | Aqueous solution<br>Must be used in a<br>dedicated sterile<br>processing system | Aqueous solution<br>Used in a<br>standalone<br>container or<br>Washer/Disinfector | Aqueous solution<br>Used in a<br>standalone<br>container or<br>Washer/Disinfector |
| Process<br>Monitors | Pre-programmed<br>colorimeter for direct-<br>reading of chlorine<br>concentration | Chemical reaction on<br>indicator pad to produce<br>color change | None | Chemical Indicator<br>Chemical reaction<br>on indicator pad to<br>produce color<br>change |
| Reuse | Single use | Single use | 14 days | 14 days |
| Software<br>Controls | Yes | Yes | N/A | N/A |
| Process Parameters | | | | |
| Liquid<br>Chemical<br>Sterilant | N/A | 12 min at 50-56°C | 180 min at 20°C | 10 hr at 25°C |
| High Level<br>Disinfectant | 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 Liquid<br>Chemical High Level<br>Disinfectant System<br>(System and Germicide) | Steris<br>(System and Germicide) | Endo-Spor<br>Plus/Hyprocide<br>(Germicide) | Cidex<br>(Germicide) |
|---------|-----------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------|----------------------|
| Form | Inputs of water &<br>germicide | Inputs of water &<br>germicide | germicide | germicide |
| Control | Software controlled | Software controlled | N/A | N/A |

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| | Sterilox Liquid<br>Chemical High Level<br>Disinfectant System<br>(System and Germicide) | Steris<br>(System and Germicide) | Endo-Spor<br>Plus/Hyprocide<br>(Germicide) | Cidex<br>(Germicide) |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Liquid contact | Liquid contact | Liquid contact | Liquid contact |
| Purpose | To achieve high level<br>disinfection by<br>destroying viable<br>forms of microbial life,<br>when used according<br>to labeling | To achieve liquid<br>chemical sterilization<br>by destroying viable<br>forms of microbial life,<br>when used according<br>to labeling | To achieve liquid<br>chemical<br>sterilization or<br>high level<br>disinfection by<br>destroying viable<br>forms of microbial<br>life, when used<br>according to<br>labeling | To achieve liquid<br>chemical<br>sterilization or<br>high level<br>disinfection by<br>destroying viable<br>forms of microbial<br>life, when used<br>according to<br>labeling |
| Mode of<br>Action | Sterilox exerts its<br>germicidal effect by<br>attacking the surface<br>and plasma<br>membrane proteins,<br>impairing transport of<br>solutes and the salt<br>balance of bacterial<br>cells (Pieterson et al,<br>Water SA (1996)<br>22(1); 43-48) | It is believed that<br>peracetic acid exerts<br>its germicidal effect by<br>oxidizing sulfhydryl<br>and sulfur bonds in<br>proteins and<br>enzymes, particularly<br>in the cell walls<br>(Block, 1991) | It is believed that<br>hydrogen<br>peroxide and<br>peracetic acid<br>exert their<br>germicidal effect<br>by oxidizing<br>sulfhydryl and<br>sulfur bonds in<br>proteins and<br>enzymes,<br>particularly in the<br>cell walls (Block,<br>1991) | Strong interaction<br>with outer cell<br>layers; cross<br>linking of amino<br>groups in proteins<br>and inhibition of<br>transport<br>processes into<br>cell (McDonell,<br>Clin. Microbiol.<br>Rev., 1999 147-<br>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 of<br>Disinfectants; AOAC Official<br>Method 966.04 | Bacillus subtilis<br>Clostridium sporogenes | Meets liquid chemical<br>Sterilant efficacy<br>requirements3 |
| Confirmatory Sporicidal<br>Activity of Disinfectants; AOAC<br>Official Method 966.04 | Bacillus subtilis<br>Clostridium sporogenes | Meets liquid chemical<br>Sterilant efficacy<br>requirements3 |
| Fungicidal Activity of<br>Disinfectants (AOAC<br>6.3.02:1995, Official Method<br>955.17) | Trichophyton mentagrophytes | Solution is fungicidal |
| Use-Dilution Method (AOAC<br>6.2.01:1995, Official Methods<br>955.14, 955.15, 964.02) | Salmonella choleraesuis<br>Staphylococcus aureus<br>Pseudomonas aeruginosa | Solution is bactericidal |
| EPA Virucidal Testing<br>(DIS/TSS-7, Nov. 1981) | Herpes Simplex I<br>Poliovirus II<br>Human Immunodeficiency<br>Virus<br>Type I | Solution is virucidal |
| Quantitative Tuberculocidal<br>Test | Mycbacterium bovis | Solution is tuberculocidal |
| Simulated Use Test | Bacillus subtilis1<br>Clostridium sporogenes1<br>Mycobacterium terrae2 | Meets efficacy<br>requirements |
| Clinical In-Use | Organisms remaining on flexible<br>endoscopes after clinical use | No surviving<br>microorganisms on any of<br>the 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)