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 affect sterilization.

The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted 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.

*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.

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 diffusionrestricted spaces, such as the hinged portion of forceps and scissors
It can sterilize rigid and semi-rigid endoscopes without lumens

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

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® 100NXTM Sterilizer has three different sterilization cycles, the Standard cycle, the Flex cycle, and the new optional additional EXPRESS cycle.

The hardware for the STERRAD® 100NX™ Sterilizer consists of a sterilization chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer system also uses accessories such as a disposable sterilant cassette, reusable instrument trays, printer paper, and an optional movable cart. The STERRAD® 100NXTM Sterilizer can be placed directly on a table, counter top, or on the movable cart.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the STERRAD® 100NX™ Sterilizer with EXPRESS Cycle, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria (e.g., "sterility assurance level of X"). Instead, it describes a "Passed" outcome for various validation studies, implying that the device met pre-defined success metrics for each study. The overarching acceptance criterion is achieving sterilization and demonstrating equivalence to predicate devices.

Study	Acceptance Criteria (Implied)	Reported Device Performance
Dose Response with Anodized Aluminum Surfaces	Demonstrated effective sterilization on anodized aluminum surfaces.	Passed
Surface Sterilization	Achieved effective surface sterilization.	Passed
Mated Surface Sterilization	Achieved effective sterilization of mated surfaces.	Passed
Bacteriostasis Testing in the EXPRESS Cycle	No inhibition of bacterial growth attributed to the process.	Passed
In Use Testing - General Medical Devices	Sterilized general medical devices as intended.	Passed
Simulated Use Testing	Sterilized devices under simulated use conditions.	Passed
Toxicity Testing of Materials	Demonstrated material compatibility and non-toxicity post-process.	Passed
Chemical Indicator Functionality	Chemical indicators accurately reflected sterilization conditions.	Passed
CycleSure Biological Indicator Qualification	Biological indicators performed as expected, confirming sterility.	Passed
Bacteriostasis Testing of CycleSure Biological Indicator	No inhibition of biological indicator growth.	Passed
Device Functionality and Material Compatibility	Maintained device functionality and material integrity.	Passed
Process Reproducibility	Consistently achieved sterilization across multiple cycles.	Passed

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

Sample Size: The document does not explicitly state a total numerical sample size for the "test set" in terms of how many individual items were sterilized across all tests. However, it does provide specific load configurations used for validation studies:
- Standard Cycle Validation Load: Two instrument trays, each weighing 10.7 lbs. (for 0.7 mm x 500 mm lumens). A maximum of ten single-channel stainless steel lumens (five per tray per cycle).
- Flex Scope Cycle Validation Load: Two flexible endoscopes (one per tray per cycle) for 1 mm x 850 mm flexible endoscopes. For other flexible endoscopes, the load was two instrument trays, each weighing 10.7 lbs.
- EXPRESS Cycle Validation Load: A single instrument tray weighing 10.7 lbs placed on the bottom shelf.
Data Provenance: The document does not specify the country of origin of the data. It implies the studies were conducted by Advanced Sterilization Products (division of Ethicon, Inc.), based in Irvine, CA, USA.
Retrospective or Prospective: The studies described ("Validation Testing") are inherently prospective, as they were conducted to validate the performance of the new EXPRESS cycle.

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 document primarily focuses on microbiological "overkill" methods using G. stearothermophilus spores and physical testing, which don't typically involve human expert adjudication for ground truth in the same way as, for example, medical imaging diagnostics.

4. Adjudication Method for the Test Set:

This information is not provided as the ground truth establishment method (microbiological challenge and physical testing) does not involve adjudication by multiple experts. The "ground truth" for sterilization is typically measured by the inactivation of biological indicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved. The STERRAD® 100NX™ Sterilizer is a sterilization device, and its effectiveness is determined by its ability to kill microorganisms, not by human interpretation of images or data.

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

The device itself is a standalone system (the sterilizer). The validation studies presented evaluate the performance of the sterilizer operating on its own; there is no "human-in-the-loop" performance being measured in the context of the device's primary function (sterilization). Therefore, in a sense, the evaluations are entirely of the "algorithm only" (the sterilization process) without human interpretive intervention.

7. The Type of Ground Truth Used:

The primary ground truth used is the inactivation of biological indicators, specifically G. stearothermophilus spores, using an "overkill" approach. This is a well-established and accepted method for demonstrating sterilization efficacy. Additional ground truth elements include:

Physical/Chemical measurements: Ensuring appropriate levels of hydrogen peroxide and plasma are achieved.
Bacteriostasis testing: Confirming that materials or residues do not inhibit microbial growth.
Functionality and material compatibility assessments: Ensuring the devices being sterilized are not damaged and remain functional.

8. The Sample Size for the Training Set:

This document does not refer to a "training set" in the context of an algorithm or AI. The STERRAD® 100NX™ Sterilizer is a physical device with a defined process, not a machine learning model that undergoes a training phase. The validation studies demonstrate the performance of the finalized device.

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

As there is no "training set" in the machine learning sense, this question is not applicable. The device's design and parameters would have been developed based on scientific principles of sterilization and iterative testing, not by training an algorithm on a dataset with pre-established ground truth.

Summary

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K092622
510(k) Notification

510(k) Summary

MAR - 4 2011

Applicant's Name, Address, Telephone, FAX, Contact Person Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618

Contact Person

Nancy Chu Regulatory Affairs Manager Tel: (949) 453-6435 Fax: (949) 789-3900 Email: nchu@its.jnj.com

April 15, 2010

1.0 CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME Classification Name: Sterilizer, Class II Common/Usual Name: Hydrogen Peroxide Gas Plasma Sterilization System Product Classification: Sterilizer, Class II Proprietary Name: STERRAD® 100NX™ Sterilizer with EXPRESS Cycle

2.0 PREDICATE DEVICES

STERRAD® 100NX™ Sterilization System [K071385] STERRAD® 200 Sterilization System [K030429]

3.0 INDICATIONS FOR USE

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 affect sterilization.

The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.

Medical devices with the following materials and dimensions can be processed in the STERRAD® 100NXTM 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*

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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 l x 850 mm flexible endoscopes were validated without any additional load.

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,

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 Ibs placed on the bottom shelf.

4.0 DESCRIPTION OF DEVICE

SUMMARY OF NONCLINICAL TESTS 5.0

5.1 Validation Testing

Testing was performed using the "overkill" approach utilizing G. stearothermophilus spores. Table 8-1 on the following page identifies the validation studies performed and the results obtained.

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Table 8-1: Validation Studies

Study	Results
Dose Response with Anodized Aluminum Surfaces	Passed
Surface Sterilization	Passed
Mated Surface Sterilization	Passed
Bacteriostasis Testing in the EXPRESS Cycle	Passed
In Use Testing - General Medical Devices	Passed
Simulated Use Testing	Passed
Toxicity Testing of Materials	Passed
Chemical Indicator Functionality	Passed
CycleSure Biological Indicator Qualification	Passed
Bacteriostasis Testing of CycleSure Biological Indicator	Passed
Device Functionality and Material Compatibility	Passed
Process Reproducibility	Passed

OVERALL PERFORMANCE CONCLUSIONS 6.0

The nonclinical studies demonstrate that the STERRAD® 100NX™ EXPRESS Cycle is safe and effective for surface sterilization of medical devices within the indications for use for the sterilizer and establish equivalence of the STERRAD® 100NX™ EXPRESS Cycle to the predicate devices, the STERRAD® 100NX™ Sterilizer, and the STERRAD® 200 Sterilizer.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Ms. Nancy Chu Manager, Regulatory Affairs Advanced Sterilization Products 330 Technology Drive Irvine, California 92618

MAR - 4 2011

Re: K092622

Trade/Device Name: STERRAD® 100NX™ Sterilizer with EXPRESS Cycle Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR . Dated: March 1, 2011 Received: March 2, 2011

Dear Ms. Chu:

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.

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Page 2- Ms. Chu

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 (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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known): K092622

STERRAD® 100NX™ Sterilizer with EXPRESS Cycle Device Name:

Indications for Use:

The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted 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.

*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.

Page 1 of 2

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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 diffusionrestricted spaces, such as the hinged portion of forceps and scissors
It can sterilize rigid and semi-rigid endoscopes without lumens

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizth. B. Clain-Wall

Jivision Sign-Off) ·············································································································································································· Tection Control, Dental Devices

10(k) Number: K092622

Page 2 of 2

Regulation Number and Section

§ 880.6860 Ethylene oxide gas sterilizer.

(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).