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.

Device Description

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.

AI/ML Overview

The given document is a 510(k) premarket notification for a medical device called "Wire Sterilization Package with Indicators." This document does not describe the acceptance criteria and study for an AI/ML device, but rather for a physical sterilization packaging with chemical indicators. Therefore, many of the requested categories are not applicable.

Here's the relevant information based on the provided text, adapted to the questions where possible:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Performance Requirements)	Reported Device Performance
Sterilization Parameters for Ethylene Oxide (EO) Gas:	EO Indicator Performance:
EO Concentration: 725 mg/L	Color indicator changes from Blue to Cocoa Brown upon completion of the process.
Exposure Temperature: 130°F (55°C)
Exposure Time: 1 hour
Aeration Time: 8 hours

Sterilization Parameters for Steam - Gravity:	Steam Indicator Performance:
Exposure Temperature: 270°F (132°C)	Color indicator changes from Blue to Black/Brownish Black upon completion of the process.
Exposure Time: 15 minutes
Dry Time: 30 minutes

Material Compatibility:
No effect on material or functionality of arch wires after sterilization processes.	Material Compatibility Testing (following ISO 15841:2014) showed sterilization (Steam, Formaldehyde, EO) had no effect on the material or functionality of the arch wires.

Performance Testing (Sterility Assurance Level - SAL):	Processing at half cycle ensures desired Sterility Assurance Level (SAL).
	Performance testing (placing spores in difficult locations, BIs removed after half cycle exposure, incubated) validated that cycles achieve desired SAL.

Residual Testing:
Meet reference guidelines for Ethylene Oxide Sterilization Residuals.	Residual testing (following ISO 10993-7:2008/(R) 2012) met reference guidelines.

Indicator Validation:
Chemical indicators change to appropriate signal color under "Pass Cycle" conditions and meet "Pass Cycle" requirements for Class I process indicators.	Indicator Validation testing (following AAMI/ANSI ISO 11140-1) verified indicators changed to an appropriate signal color and met "Pass Cycle" requirements for Class I process indicators.

Biocompatibility/Leachability (Cytotoxicity - for archwires):	Archwires met USP and ISO 10993-5 requirements; all test samples PASSED.
	Cytotoxicity Testing (after sterilization) following ISO 10993-5 and USP <87> showed that the enclosed archwires met requirements and all test samples PASSED. (The packaging itself does not contact patients).

Biocompatibility (Irritation and Sensitization - for archwires):	All test samples PASSED.
	Biocompatibility testing for archwires (before sterilization) according to ISO 10993-5 and ISO 10993-10 showed all test samples PASSED.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state specific sample sizes for each test in terms of number of units. It refers to "samples" being processed and tested. The data provenance (country of origin, retrospective/prospective) is not specified. It can be inferred that these are prospective bench tests conducted for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI/ML diagnostic tool that requires human expert interpretation for ground truth. The "ground truth" for the indicators is defined by the chemical reaction and color change under specific sterilization parameters, which is a physical and chemical phenomenon, not a human interpretation. The validation was against established standards (e.g., AAMI/ANSI ISO 11140-1) and biological indicators.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human readings. The performance of the chemical indicators is evaluated by observing a color change against defined criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device with an algorithm. The device is a physical product with chemical indicators.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the Wire Sterilization Package with Indicators is based on:

Physical/Chemical Reaction: The color change of the chemical indicators, which is a direct physical and chemical response to specific sterilization conditions (temperature, time, chemical exposure).
Biological Indicators (BIs): Used in performance testing to confirm that the sterilization cycles are effective in achieving the desired Sterility Assurance Level (SAL). BIs contain resistant microorganisms which, if killed, confirm effective sterilization.
Standardized Test Methods: Adherence to established international and national standards such as AAMI/ANSI ISO 11140-1 for chemical indicators, ISO 15841 for dentistry wires, ISO 10993 for biocompatibility, and USP <87> for cytotoxicity.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set or ground truth for training.

Summary

{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)

STERILIZATION PARAMETERS

Ethylene Oxide [100% E.O.] Gas

1. EO Concentration: 725 mg/L
1. Exposure Temperature: 130°F (55°C)
1. Exposure Time: 1 hour
1. 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)
1. Exposure Time: 15 minutes
1. 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)
☑ 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:

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.
1. Exposure Time: 1 hour
1. 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)
1. Exposure Time: 15 minutes
1. 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 Pouchwith Steam and Ethylene OxideProcess Indicators / Safe SecurePackaging Company, Limited	Cross-Checks / SteriTecProducts Mfg. Co., Inc	Wire SterilizationPackaging withIndicators/ AmericanOrthodontics	SubstantialEquivalenceAnalysis
510(k) Number	K112591	K951113	K143117	N/A
ClassificationCode/RegulationNumber	FRG880.6850	JOJ880.2800	FRG/JOJ880.2800/880.6850	N/A
Intended Use	Safe Secure Sterilization Pouch withSteam and Ethylene Oxide ProcessIndicators Models: ABHSP, ABSSP, isintended to be used to encloseanother medical device that is to besterilized by a health provider bygravity steam and ethylene oxide(EtO). The recommended steamsterilization cycle parameters are 30minutes at 121°C (250°F). Therecommended EtO gas sterilizationcycle is 735mg/L of ethylene oxide(EtO) for 1 hour at 55°C (130°F) and50% to 80% RH. The pouch'sexternal chemical ink indicators onthe pouches are intended todemonstrate that the device has beenexposed to steam or EtO sterilizationprocess and to distinguish betweenprocessed and unprocessed devices.The pouch is intended to allowsterilization of the enclosed medicaldevice.	SteriTec CROSS-CHECKSsterilization chemicalmonitoring strips aredesigned to be utilized insteam sterilizer operatingat 132°C to 135°C (270°Fto 276°F). When used asdirected, the SteriTecCross-Checks indicatorstrips give visibleindication that sterilizingconditions were met.During steamsterilization, the checkmark at the end of thestrip changes from whiteto black, becoming asdark or darker inintensity than the blackreference arrow printedon the strip.	Wire Sterilization Packagewith Indicators is intendedto be used to enclose andpackage AmericanOrthodontics' line ofOrthodontic Arch Wires.These packages are shippedunsterile and for single-useonly. This packaging offersthe health provider (traineddental professional and/orOrthodontist) the option ofsterilizing the enclosed archwire using steam orethylene oxide gas. Theindicators will display avisual color change tosignify exposure to steam orethylene oxide gas anddistinguish betweenprocessed and unprocessedwire.	Equivalent
Device Design &Components	Pouch: 2-30" Wx2-30"L, Medical-grade paper or Tyvek, Plastic FilmChemical Indicator:not disclosed; printed on surgicalpaper	Strip: 0.5625"W x 7.66"L, 80 lbs CoverChemical Indicator:White to Dark; printed onpaper strip over laminateof PET	Pouch: 3.5" Wx4.5"L,60g/m² Surgical Paper, BlueFilmChemical Indicator:Steam: Blue to BrownishBlack/Black; EthyleneOxide: Blue to Coco Brown	Equivalent
Indicator Agent	Indicating Ink: Proprietary to SafeSecure, yields a color-change	Indicating Ink: Leadbased agent to yieldcolor-change	Steam Indicating Ink: Leadbased agent to yield color-changeEthylene Oxide IndicatingInk: Water based agent toyield color-change	Equivalent
SterilizationMethods	Steam: 121°C for 30 minutes.Ethylene Oxide gas : 55°C for 1 hour	Steam: 132°C - 134°C for3 minutes	Steam: 132°C for 15minutesEthylene Oxide: 55°C for 1hour	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.

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).