The STERRAD 100NX Sterilizer with ALLClear Technology is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterlization 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 Sterilize 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 cvcle:

· 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 1065 mm or shorter**

Note: With the exception of the 1 x 1065 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 1065 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 sterilization process is a multiphase process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. 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 STERRAD 100NX Sterilizer has four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles.

An expansion of existing claims is being applied to the FLEX cycle without affecting the technology, software, or other physical features of the subject device.

The STERRAD 100NX Sterilizer with ALLClear Technology described within this submission expands the indications of the FLEX Cycle of the STERRAD 100NX Sterilizer to include single channel flexible endoscopes with extended dimensions from 850 mm in length to 1065 mm in length, when the inside diameter is ≥1 mm. There are no other changes to the indications for use for the FLEX Cycle. The FLEX Cycle is compatible with single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 1065 mm or shorter.

AI/ML Overview

This document is a 510(k) Premarket Notification for the STERRAD 100NX Sterilizer with ALLClear Technology. The submission focuses on expanding the indications for use of its FLEX cycle. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Expanded FLEX Cycle Claim)	Reported Device Performance (Summary)
Sterilization of single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 1065 mm or shorter.	• Dose Response Study: Demonstrated sterility assurance level (SAL) of 10-6 was reached when processing single channel flexible endoscopes with the expanded claim (≥ 1 mm diameter X ≤ 1065 mm) in STERRAD 100NX FLEX half-cycle conditions.
	• Simulated Use Study: Demonstrated sterilization efficacy of flexible endoscopes with the proposed claims expansion of ≥1 mm diameter x ≤1065 mm in length when processed in the STERRAD 100NX FLEX cycle.

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

The document does not explicitly state a specific "test set" in the context of an AI/algorithm-driven device, as this submission is for a medical device sterilizer. The "testing" refers to performance validation studies for the sterilizer's efficacy.

Dose Response Study: The sample size is not explicitly stated in terms of number of endoscopes or individual tests, but the objective was to demonstrate a Sterility Assurance Level (SAL) of 10-6. This typically involves a statistically significant number of biological indicators and test devices to prove sterilization effectiveness.
Simulated Use Study: The sample size is not explicitly stated. The study aims to demonstrate sterilization efficacy of the specified flexible endoscopes under simulated clinical use.
Data Provenance: The studies were conducted by "Advanced Sterilization Products, Inc." This indicates the data is likely generated by the manufacturer and is prospective, as it's specifically for a claims expansion. No country of origin for the data is specified beyond the company's US address.

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

Not applicable. This is not an AI/algorithm-driven device requiring expert-established ground truth for image or data interpretation. The "ground truth" for a sterilizer's performance is the achievement of sterility, which is measured through microbiological methods (e.g., biological indicators, sterility tests), not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is not an AI/algorithm submission that would involve expert adjudication of results.

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 diagnostic or assistance tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant.

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

Not applicable. This device is a sterilizer and does not operate as an algorithm-only system. Its primary function is to physically sterilize instruments.

7. The Type of Ground Truth Used

The ground truth used for the validation studies is sterility, as determined by standard microbiological methods. For sterilization processes, this involves demonstrating the inactivation of a specified number of highly resistant microorganisms (e.g., bacterial spores) to achieve a desired Sterility Assurance Level (SAL), typically 10-6 (meaning a one in a million chance of a non-sterile unit).

8. The Sample Size for the Training Set

Not applicable. This device is a sterilizer, not an AI/machine learning model that requires a training set. The "training" in the context of a sterilizer involves its design, engineering, and manufacturing to meet performance specifications.

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

Not applicable. As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth to be established in that sense. The product's performance specifications are established through industry standards, regulatory requirements, and internal research and development.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 9, 2021

Advanced Sterilization Products, Inc. Summer Bowman Senior Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618

Re: K212174

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: July 8, 2021 Received: July 12, 2021

Dear Summer Bowman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray III -S

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K212174

Device Name

STERRAD® 100NXTM Sterilizer with ALLClear® Technology

Indications for Use (Describe)