The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue.

The STERRAD 100NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Medical devices with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer STANDARD cycle:

· Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter* Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer FLEX Scope cycle:

· Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 850 mm or shorter**

Note: With the exception of the 1 x 850 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs. The 1 x 850 mm flexible endoscopes were validated without any additional load.

The STERRAD 100NX EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures.

• It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors

· It can sterilize rigid and semi-rigid endoscopes without lumens

Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 lbs placed on the bottom shelf.

The STERRAD 100NX DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions:

· Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter

· Accessory devices that are normally connected to a flexible endoscope during use
Flexible endoscopes without lumens

Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs.

A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.

** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.

Device Description

The STERRAD 100NX Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas plasma using electrical energy. The STERRAD 100NX Sterilizer has four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles.

For the STANDARD and FLEX cycles, hydrogen peroxide (HoO2) vapor is generated by injecting aqueous hydrogen peroxide into an on-board vaporizer where the solution is heated and vaporized, thereby concentrating 59% H2O2 to 90% nominal H2O2. The H2O2 vapor is then introduced into the sterilization chamber under sub-ambient pressure and transformed into a gas-plasma using electrical energy. The sterilization process is a multiphase process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization.

For the EXPRESS cycle, the onboard concentration process utilized for STANDARD and FLEX cycles is not used: the subsystem receives hydrogen peroxide solution from the delivery system. vaporizes the liquid and delivers it to the chamber.

For the DUO Cycle, hydrogen peroxide from the STERRAD 100NX Cassette follows a different flow path through the delivery module. The hydrogen peroxide, when withdrawn from the cassette, is temporarily held in the accumulators of the delivery module, and a smaller quantity (1.55 mL, nominal value) of hydrogen peroxide is dispensed or metered into the vaporizer during each of the two half-cycles of the DUO cycle. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, and printer paper.

The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. Other major components of the system are constructed from passivated stainless steel, Viton (a copolymer of vinylidene fluoride and hexafluoropropylene), Ultem (polyetherimide), injection molding, and structural foam. The sterilizer also uses accessories such as reusable instrument trays, and printer paper.

The STERRAD 100NX Sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the pre-defined minimum concentration specification.

The modified STERRAD 100NX Sterilizer with ALLClear Technology described within this submission incorporates enhancements and new features to improve reliability and usability. as briefly described following:

Load Conditioning Feature: Available for use with the STANDARD, FLEX, and . EXPRESS cycles. Reduces canceled cycles by performing load and system checks and executing a load conditioning step prior to starting a sterilization cycle.
. Enhanced Graphical User Interface (GUI): Added information to the error messages enabling users to take actions related to that error message. GUI enhancement also provides more intuitive navigation.
Improved cassette insertion.
New Touchscreen Display: Larger, higher resolution, and wider viewing angle.
New External Panels: Enhance aesthetic appearance and accommodate the larger display.
Capability for future "ecosystem" connectivity: Will allow communication and integration . with future ASP biological indicator reader(s), as well as other potential future communication features.

The technological characteristics associated with the sterilization process for the modified STERRAD 100NX Sterilizer ALLClear Technology are identical to those of the previously cleared STERRAD 100NX Sterilizer; the software and hardware changes associated with the described enhancements and new features do not modify the existing sterilization cycles.

AI/ML Overview

This document describes the STERRAD® 100NX Sterilizer with ALLClear™ Technology, a low-temperature sterilization system using hydrogen peroxide gas plasma. The submission (K160903) concerns enhancements to reliability and usability of the previously cleared device, not changes to the core sterilization process.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative predefined "acceptance criteria" for the changes, but rather "Pass/Fail" results for various verification tests demonstrating compliance and functionality. The overall acceptance is implied by all tests yielding "Pass".

Verification Testing Category	Description	Reported Performance (Pass/Fail)
Load Conditioning Feature
Load Check Design Verification	Device detects load out-gassing causing cycle cancellations.	Pass
Load Conditioning Design Verification	Load conditioning feature reduces load out-gassing.	Pass
Titer Enumeration of STERRAD CYCLESURE 24 BI	Load conditioning has no significant impact on BI.	Pass
Chemical Indicator Functionality Testing	Verified functionality of various CIs (Strip, Tape, Disc, pouches) following exposure to load conditioning.	Pass
Load Temperature Verification	Device with load conditioning does not exceed load temperature limits.	Pass
Final Process Qualification - STANDARD Cycle	Sterilizer performs consistently within process specifications with load conditioning.	Pass
Final Process Qualification - FLEX Cycle	Sterilizer performs within process specifications with load conditioning.	Pass
Final Process Qualification - EXPRESS Cycle	Sterilizer performs within process specifications with load conditioning.	Pass
Hardware Modifications
H2O2 Delivery System Design Verification	Cassette insertion modifications allow easier insertion and detect alignment.	Pass
Panel Subsystem Design Verification	New panels provide appropriate protection, access, and accommodate modifications.	Pass
Panel Subsystem Design Verification (Int. Temp)	Internal air temperature during operation at max ambient temperature is within allowed limits.	Pass
Panel Materials Testing	Effects of 70% isopropyl alcohol (IPA) and hydrogen peroxide on new panel material are within acceptable range.	Pass
Display Assembly Subsystem Design Verification	Characteristics of new display assembly and compatibility with modified system confirmed.	Pass
System & Compliance
System Verification	Verified new and related system requirements impacted by modifications.	Pass
System Tests (Environmental)	Modified device operates reliably and effectively at ambient conditions.	Pass
Summative Usability Testing	Assessed user interaction with the modified device.	Pass
Biocompatibility testing	Mean residual hydrogen peroxide level statistically significantly less than acceptable threshold on worst case materials after load conditioning and sterilization.	Pass
Electromagnetic compatibility (EMC) testing	Complies with IEC/EN 60601-1-2:2014 and EN 55011 Group I Class A limits.	Pass
Electrical Safety testing	Conforms to applicable sections of CAN/CSA-C22.2 No. 61010-1, CAN/CSA-C22.2 No. 61010-2-040, UL 61010-1/R:2008-10, IEC/EN 61010-1:2001, and IEC/EN 61010-2-40:2005.	Pass
Software Verification and Validation	Unit, Integration, and System level testing successfully completed per Guidance for Premarket Submissions for Software Contained in Medical Devices.	Pass

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each verification test. It generally refers to "studies" or "testing" without detailing the number of units or cycles tested.
The data provenance is internal to Advanced Sterilization Products, as these are non-clinical verification tests conducted for regulatory submission. No information on country of origin of the data is provided beyond the submitting company's location (Irvine, CA, USA). The tests are prospective in nature, as they are specifically conducted to verify the changes in the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests seem to be objective engineering and scientific evaluations rather than expert-driven ground truth establishment. For example, sterilizer performance is evaluated against defined physical and biological parameters, and usability testing is conducted with users, but the "ground truth" for the device's function is its validated performance.

4. Adjudication Method for the Test Set

Not applicable. The tests are presented as objective measurements and verifications, not requiring an adjudication panel.

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 device is a sterilizer, not an AI-powered diagnostic system that involves human readers or interpretation of medical images.

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

Not applicable. This device is a physical sterilizer and does not involve AI algorithms in the context of diagnostic interpretation. Its performance is inherent to its mechanical, chemical, and software components operating in a standalone fashion.

7. The Type of Ground Truth Used

The ground truth for the performance of the sterilizer is based on established scientific principles of sterilization (e.g., microbial inactivation, hydrogen peroxide concentration, temperature, pressure), material compatibility, electrical safety standards, and software validation. For biological efficacy, this typically involves testing with biological indicators. For the improvements in this submission, the "ground truth" for the new features (e.g., load conditioning, new display) are that they perform their intended function (e.g., reduce out-gassing, display correctly) and do not compromise existing validated sterilization processes.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI models that require a "training set" in the conventional sense. The "training" for the device's operation is its design, engineering tolerances, and validated parameters.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the AI sense for this device. The design and performance parameters are established through engineering specifications, regulatory standards, and scientific principles related to sterilization and medical device manufacturing.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2016

Advanced Sterilization Products Jamie Byun Senior Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92617

Re: K160903

Trade/Device Name: STERRAD® 100NX Sterilizer with ALLClear™ Technology Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: August 25, 2016 Received: August 29, 2016

Dear Jamie Byun,

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Michael J. Ryan -S

for Tina Kiang

Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160903

Device Name

STERRAD® 100NX Sterilizer with ALLClear™ Technology

Indications for Use (Describe)