Wire Sterilization Package with Indicators

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000 October 29, 2015 American Orthodontics Ms. Trang Adams Regulatory Affairs Specialist 3524 Washington Avenue Sheboygan, WI 53081 Re: K143117 Trade/Device Name: Wire Sterilization Package with Indicators Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG; JOJ Dated: September 21, 2015 Received: September 29, 2015 Dear Ms. Adams, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {1}------------------------------------------------ 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K143117 Device Name Wire Sterilization Package with Indicators #### Indications for Use (Describe) Wire Sterilization Package with Indicators is intended to be used to enclose and package American Orthodontics' line of Orthodontic Arch Wires. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. The indicators will display a visual color change to steam or ethylene oxide gas and distinguish between processed and unprocessed wire. #### STERILIZATION PARAMETERS Ethylene Oxide [100% E.O.] Gas - 1. EO Concentration: 725 mg/L - 2. Exposure Temperature: 130°F (55°C) - 3. Exposure Time: 1 hour - 4. Aeration Time: 8 hours Upon completion of the process, the EO color indicator will change from Blue to Cocoa Brown. Steam - Gravity - 1. Exposure Temperature: 270°F (132°C) - 2. Exposure Time: 15 minutes - 3. Dry Time: 30 minutes Upon completion of the process, the STEAM color indicator will change from Blue to Black. Please Note: Upon completion of the process, the archwire is to be used immediately. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font on the left, followed by the words "AMERICAN" and "ORTHODONTICS" stacked on top of each other on the right. The letters and words are all in a dark blue color. The logo is simple and modern, and it is likely used to represent the company's brand. www.americanortho.com 1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax Page 5-1 # 510(k) Summary 21CFR807.92 ### Date Prepared: October 23, 2015 #### Company Information: American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 Phone: 920-457-5051 Fax: 920-457-5773 #### Contact Information: Trang Adams / Regulatory Affairs Specialist #### Device Information: Trade Name: Wire Sterilization Package with Indicators Common Name: Wire Sterilization Package with Indicators Classification Name: Sterilization Wrap; Sterilization Process Indicator 510(k) Number: K143117 Classification Code: FRG; JOJ Regulation Number (21CFR): 880.6850; 880.2800 #### Component Device Information: Common Name: Orthodontic Arch Wires Classification Name: Wire, Orthodontic 510(k) Number: Exempt (Class I) Classification Code: DZC Regulation Number (21CFR): 872.5410 American Orthodontics' Models: Stainless Steel Wires, Nickel Titanium (NiTi) Wires, Beta Titanium Wires, Chromium Cobalt (CrCo) Wires, Copper Nickel Titanium (CuNiTi) Wires #### Predicate Devices Information: Primary Predicate: Product/Trade Name: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Manufacturer: Safe Secure Packaging Company, Limited 510(k) #: K112591 Classification Name: Sterilization Wrap Classification Code: FRG Regulation Number (21CFR): 880.6850 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font on the left, followed by the words "AMERICAN" and "ORTHODONTICS" stacked on top of each other on the right. The letters and words are all in a dark blue color. The logo is simple and modern, and it is likely used to represent the company's brand. www.americanortho.com 1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax # Page 5-2 Secondary Predicate: Product/Trade Name: Cross-Checks Indicator Manufacturer: SteriTec Products Mfg. Co., Inc 510(k) #: K951113 Classification Name: Sterilization Process Indicator Classification Code: JOJ Regulation Number (21CFR): 880.2800 American Orthodontics' new device combines a sterilizable pouch (Classification Code: FRG) with sterilization process indicators (Classification Code: JOJ) that contains an Arch Wire (Classification Code: DZC). It was deemed appropriate to choose two predicates containing the classification codes that were suitable to the Wire Sterilization Package with Indicators to demonstrate substantial equivalency. ## Description of the Device: American Orthodontics' Wire Sterilization Package with indicators is manufactured from bleached surgical paper and plastic film with external chemical process indicators. This packaging is a pouch that is enclosed on all four sides and contains a single arch wire. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. Upon completion of the sterilization process, the enclosed arch wire is intended to be used immediately. This packaging is not offered as a stand-alone product, but is strictly used for the packaging of American Orthodontics' Arch Wires (Classification Code: DZC; 510(k) Exempt). The bleached surgical paper conforms to the FDA 21CFR186.1673 and can be sterilized using steam or ethylene oxide gas. The plastic film is sealed to the bleached surgical paper and conforms to 21CFR177.1630 (Polyester), 21CFR175.105 (Adhesive) and 21CFR177.1520 (Polypropylene). The process indicators meet the performance requirements of AAMI/ANSI/ISO 11140-1:2014. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font, followed by the words "AMERICAN ORTHODONTICS" in a smaller, sans-serif font. The color of the logo is a dark blue. The logo is simple and modern, and it is likely used to represent the company's brand. www.americanortho.com 1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax # Page 5-3 ## Indications for Use: Wire Sterilization Package with Indicators is intended to enclose and package American Orthodontics' line of Orthodontic Arch Wires. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. The indicators will display a visual color change to signify exposure to steam or ethylene oxide gas and distinguish between processed and unprocessed wire. ### STERILIZATION PARAMETERS Ethylene Oxide [100% E.O.] Gas - 1. EO Concentration: 725 mg/L - Exposure Temperature: 130°F (55°C) 2. - 3. Exposure Time: 1 hour - 4. Aeration Time: 8 hours Upon completion of the process, the EO color indicator will change from Blue to Cocoa Brown. #### Steam – Gravity - 1. Exposure Temperature: 270°F (132°C) - 2. Exposure Time: 15 minutes - 3. Dry Time: 30 minutes Upon completion of the process, the STEAM color indicator will change from Blue to Black/Brownish Black. Please Note: Upon completion of the process, the archwire is to be used immediately. The Indications for Use statement for American Orthodontics' Wire Sterilization Package with indicators is not identical to the predicates however, the differences do not alter the intended use or safety and effectiveness of the device relative to the predicates. Both devices have the same intended use, to be able to distinguish between processed and unprocessed devices. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font, followed by the words "AMERICAN" and "ORTHODONTICS" stacked on top of each other. The logo is in a dark blue color. The logo is simple and modern, and it is likely used to represent the company's brand. www.americanortho.com 1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax # Page 5-4 ## Device Comparison: For detailed comparisons, please reference Section 12: Substantial Equivalence Discussion. The table below outlines comparisons of the predicates and American Orthodontics' Wire Sterilization Packaging with Indicators to show substantial equivalency. | | Device Name / Manufacturer | | | | |---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Element | Safe Secure Sterilization Pouch<br>with Steam and Ethylene Oxide<br>Process Indicators / Safe Secure<br>Packaging Company, Limited | Cross-Checks / SteriTec<br>Products Mfg. Co., Inc | Wire Sterilization<br>Packaging with<br>Indicators/ American<br>Orthodontics | Substantial<br>Equivalence<br>Analysis | | 510(k) Number | K112591 | K951113 | K143117 | N/A | | Classification<br>Code/Regulation<br>Number | FRG<br>880.6850 | JOJ<br>880.2800 | FRG/JOJ<br>880.2800/880.6850 | N/A | | Intended Use | Safe Secure Sterilization Pouch with<br>Steam and Ethylene Oxide Process<br>Indicators Models: ABHSP, ABSSP, is<br>intended to be used to enclose<br>another medical device that is to be<br>sterilized by a health provider by<br>gravity steam and ethylene oxide<br>(EtO). The recommended steam<br>sterilization cycle parameters are 30<br>minutes at 121°C (250°F). The<br>recommended EtO gas sterilization<br>cycle is 735mg/L of ethylene oxide<br>(EtO) for 1 hour at 55°C (130°F) and<br>50% to 80% RH. The pouch's<br>external chemical ink indicators on<br>the pouches are intended to<br>demonstrate that the device has been<br>exposed to steam or EtO sterilization<br>process and to distinguish between<br>processed and unprocessed devices.<br>The pouch is intended to allow<br>sterilization of the enclosed medical<br>device. | SteriTec CROSS-CHECKS<br>sterilization chemical<br>monitoring strips are<br>designed to be utilized in<br>steam sterilizer operating<br>at 132°C to 135°C (270°F<br>to 276°F). When used as<br>directed, the SteriTec<br>Cross-Checks indicator<br>strips give visible<br>indication that sterilizing<br>conditions were met.<br>During steam<br>sterilization, the check<br>mark at the end of the<br>strip changes from white<br>to black, becoming as<br>dark or darker in<br>intensity than the black<br>reference arrow printed<br>on the strip. | Wire Sterilization Package<br>with Indicators is intended<br>to be used to enclose and<br>package American<br>Orthodontics' line of<br>Orthodontic Arch Wires.<br>These packages are shipped<br>unsterile and for single-use<br>only. This packaging offers<br>the health provider (trained<br>dental professional and/or<br>Orthodontist) the option of<br>sterilizing the enclosed arch<br>wire using steam or<br>ethylene oxide gas. The<br>indicators will display a<br>visual color change to<br>signify exposure to steam or<br>ethylene oxide gas and<br>distinguish between<br>processed and unprocessed<br>wire. | Equivalent | | Device Design &<br>Components | Pouch: 2-30" Wx2-30"L, Medical-<br>grade paper or Tyvek, Plastic Film<br>Chemical Indicator:<br>not disclosed; printed on surgical<br>paper | Strip: 0.5625"W x 7.66"<br>L, 80 lbs Cover<br>Chemical Indicator:<br>White to Dark; printed on<br>paper strip over laminate<br>of PET | Pouch: 3.5" Wx4.5"L,<br>60g/m² Surgical Paper, Blue<br>Film<br>Chemical Indicator:<br>Steam: Blue to Brownish<br>Black/Black; Ethylene<br>Oxide: Blue to Coco Brown | Equivalent | | Indicator Agent | Indicating Ink: Proprietary to Safe<br>Secure, yields a color-change | Indicating Ink: Lead<br>based agent to yield<br>color-change | Steam Indicating Ink: Lead<br>based agent to yield color-<br>change<br>Ethylene Oxide Indicating<br>Ink: Water based agent to<br>yield color-change | Equivalent | | Sterilization<br>Methods | Steam: 121°C for 30 minutes.<br>Ethylene Oxide gas : 55°C for 1 hour | Steam: 132°C - 134°C for<br>3 minutes | Steam: 132°C for 15<br>minutes<br>Ethylene Oxide: 55°C for 1<br>hour | Equivalent | | Standards Met | ISO 11140-1 (Indicators) | ISO 11140-1 (Indicators) | ISO 11140-1 (Indicators) | Equivalent | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font, with the word "AMERICAN" written to the right of the letters. Below the word "AMERICAN" is the word "ORTHODONTICS" in a smaller font. The logo is in a dark blue color. www.americanortho.com 1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax # Page 5-5 ## Performance Data: Please reference Section 15: Biocompatibility and Section 18: Performance Testing - Bench for more details. The following performance data were provided: ## MATERIAL COMPATIBILITY TESTING Material Compatibility Testing for the enclosed arch wires were conducted following ISO 15841:2014 Dentistry – Wires for Use in Orthodontics before and after the sterilization processes. Sterilization of the arch wires using Steam, Formaldehyde and Ethylene Oxide had no effect on the material or functionality of the arch wires. ## PERFORMANCE TESTING Performance Testing was conducted by placing spores in the most difficult to sterilize locations. Samples were processed at half cycle and biological indicators (BI) removed after exposure. Biological indicators were aseptically transferred to culture media and incubated. Performance testing validated that the cycles are able to achieve the desired Sterility Assurance Level (SAL). ## RESIDUAL TESTING Residual testing was conducted following ISO 10993-7:2008/(R) 2012 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. Test samples met reference guidelines. ## INDICATOR VALIDATION Indicator Validation testing was conducted following AAMI/ANSI ISO 11140-1 Sterilization of Health Care Products – Chemical Indicators – Part 1: General Requirements. Results verified that the chemical indicators tested changed to an appropriate signal color when tested under the "Pass Cycle" conditions and met the "Pass Cycle" requirements for Class I process indicators. ## BIOCOMPATIBILITY/LEACHABILITY: CYTOTOXICITY TESTING Cytotoxicity Testing was conducted after sterilization processes following ISO 10993-5: Biological Evaluation of Medical Devices – Part 5: Tests for In-Vitro Cytotoxicity and United States Pharmacopeia/National Foundry, <87> Biological Reactivity Test, In Vitro; Elution Test. American Orthodontics' Wire Sterilization Package with Indicators do not come into contact with patients. The enclosed archwires met the USP and ISO 10993-5 requirements for the test. All test samples PASSED. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font, followed by the words "AMERICAN ORTHODONTICS" in a sans-serif font. The letters and words are all in a dark blue color. The logo is simple and modern, and it is likely used to represent the company's brand. www.americanortho.com 1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax # Page 5-6 # BIOCOMPATIBILITY - (ENCLOSED ARCHWIRES) Archwires were sent to independent labs for biocompatibility testing before sterilization according to ISO 10993-5:2009, Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity and ISO 10993-10, Tests for Irritation and Sensitization - Sensitization Test. All test samples PASSED. Biocompatibility Justification for stainless steel archwires is included in Section 15: Biocompatibility. ## Summary: The Wire Sterilization Package with Indicators is provided as a convenient and purely optional method for the trained dental professional and/or Orthodontist to sterilize American Orthodontics' arch wires. This does not affect the function of the enclosed arch wires, nor does it affect the original purpose of the package – which is to store and ship individual arch wires. ## Conclusion: American Orthodontics' Wire Sterilization Package with Indicators has the following similarities to those legally marketed under 510(k) numbers K112591 (Primary Predicate) and K951113 (Secondary Predicate): - . Same intended use; and - Same technological characteristics through device design, indicator agent, sterilization . method and incorporation of similar materials. Generated testing data in accordance to "ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products – Chemical indicators" demonstrates that the indicators on American Orthodontics' Wire Sterilization Package with Indicators are substantially equivalent to the predicate devices. Any slight differences do not affect the original function or intended purpose of the device. Information contained in this 510(k) does not raise new questions or safety and effectiveness, and, demonstrates it is at least as safe and effective as the listed predicates.