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 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

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.

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 1mm or larger and a length of 875mm 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 Ibs.

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 three previously cleared cycles (STANDARD, FLEX, EXPRESS) and the new optional additional DUO 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, and printer paper.

AI/ML Overview

The provided document describes the STERRAD® 100NX® Sterilizer with DUO Cycle, a low-temperature hydrogen peroxide gas plasma sterilization system. The document focuses on the nonclinical validation testing performed to demonstrate its safety and effectiveness for sterilizing medical devices.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Results from Validation Studies)
Dose Response with Biological Model (1 x 875 mm Flexible Endoscope) demonstrates effective sterilization.	Passed
Surface Sterilization demonstrates effective sterilization.	Passed
Mated Surface Sterilization demonstrates effective sterilization.	Passed
1 x 875 mm Flexible Endoscope Validation demonstrates effective sterilization for the specified endoscopes.	Passed
Bacteriostasis Testing in the DUO Cycle demonstrates inhibition of bacterial growth.	Passed
In Use Testing – 1 x 875 mm Flexible Endoscopes and Accessories demonstrates effective sterilization under simulated use conditions.	Passed
Simulated Use Testing demonstrates effective sterilization under various simulated use conditions.	Passed
Toxicity Testing of Materials demonstrates that materials processed do not become toxic.	Passed
Device Functionality and Material Compatibility demonstrates proper system operation and material compatibility.	Passed
Process Reproducibility demonstrates consistent sterilization results across multiple cycles.	Passed

Interpretation of Acceptance Criteria: The acceptance criteria are implicitly performance-based, requiring the sterilizer to effectively sterilize various types of medical devices and demonstrate safety and reliability. The "Passed" result for each study indicates the device met these implicit performance expectations for sterilization. The overarching acceptance criterion is that the STERRAD® 100NX® DUO Cycle is "safe and effective for sterilization of medical devices within the indications for use" and establishes "equivalence...to the predicate devices."

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

The document does not explicitly state numerical sample sizes for each validation study beyond the following:

Validation Load (General): "a validation load consisting of two instrument trays each weighing 10.7 lbs." (for Standard and Flex Scope cycles, excluding the 1x850mm endoscopes).
1 x 850 mm flexible endoscopes (Flex Scope cycle): "validated without any additional load."
EXPRESS Cycle validation load: "a single instrument tray weighing 10.7 Ibs placed on the bottom shelf."
DUO Cycle validation load: "two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs."
1 x 875 mm flexible endoscopes (DUO Cycle): This specific lumen type was used in several validation studies.
Lumen counts: "A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle" and "A maximum of two flexible endoscopes, one per tray per sterilization cycle."

The data provenance is retrospective as the studies were performed specifically for regulatory submission of an existing device (STERRAD 100NX) with a new cycle (DUO Cycle). The country of origin of the data is not specified, but the applicant's address is Irvine, CA, suggesting studies conducted within the US or under US regulatory standards.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the testing (sterilization efficacy using biological indicators) typically relies on laboratory results and microbiological analysis rather than expert human interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method as it relates to human review or consensus for the test set. The validation studies rely on objective criteria (e.g., elimination of G. stearothermophilus spores) for assessing sterilization effectiveness.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices where human interpretation is involved. The STERRAD® 100NX® Sterilizer is a sterilization device, not an AI-assisted diagnostic or interpretive system.

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

This question is not applicable to the STERRAD® 100NX® Sterilizer. The device itself is a standalone sterlization system. Its performance is evaluated directly through its ability to sterilize, not through an algorithm's performance separate from human interaction in an interpretive setting. The "standalone" performance here refers to the sterilizer's ability to achieve sterility without human intervention in the sterilization process, which is the core of its validation.

7. The Type of Ground Truth Used

The primary ground truth used for proving sterilization effectiveness is biological indicator (BI) testing using G. stearothermophilus spores. This is an industry-standard method where the complete elimination of these highly resistant spores indicates successful sterilization. The document refers to this as the "overkill" approach.
Other ground truths include:

Material compatibility: Testing to ensure the sterilization process does not damage the treated devices.
Toxicity testing: Ensuring no toxic residues are left.
Functionality testing: Confirming devices remain functional after sterilization.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a physical medical device (sterilizer) undergoing performance validation, not a machine learning or AI algorithm that requires training data. The devices tested in the validation studies (e.g., flexible endoscopes, instrument trays, lumens) represent the types of items the sterilizer is designed to process, but they are not a "training set" in the computational sense.

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

As there is no "training set" in the context of an AI algorithm, this question is not applicable. The "ground truth" for evaluating the sterilizer's performance was established through the rigorous, standardized microbiological and physical testing methods described (e.g., biological indicator kill, material integrity checks).

Summary

{0}------------------------------------------------

K111377

SEP 1 3 2012

... ... ... ... ..

510(k) Summary

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

Contact Person

Nancy Chu Manager, Regulatory Affairs Tel: (949) 453-6435 Fax: (949) 789-3900

September 10, 2012

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME 1

Classification Name: Common/Usual Name: Product Classification: Classification Number: Proprietary Name:

Sterilizer, Class II Hydrogen Peroxide Gas Plasma Sterilization System Sterilizer, Class II 21 CFR 880.6860 STERRAD® 100NX® Sterilizer with DUO Cycle

2 PREDICATE DEVICES

STERRAD® 100NX® Sterilization System [K071385] STERRAD® 100S Sterilization System [K991999, K023290]

3 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:

{1}------------------------------------------------

a 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

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.

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 1mm or larger and a length of 875mm 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.

{2}------------------------------------------------

ិងក្រុង "

DESCRIPTION OF DEVICE ব

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHARACTERISTICS	SUBJECT DEVICESTERRAD® 100NX®DUO CYCLE	PREDICATE DEVICES
		STERRAD® 100SCYCLE	STERRAD® 100NX® FLEXCYCLE
Base System	STERRAD® 100NX®Sterilizer	STERRAD® 100SSterilizer	STERRAD®100NX® Sterilizer
Hydrogen peroxide, 59%	Yes	Yes	Yes, withconcentrationprocess
Hydrogen peroxidedelivery	STERRAD® 100NX®Cassette and meteredthrough DeliveryModule	STERRAD® 100Scassette	STERRAD®100NX® Cassette
Disposal of hydrogenperoxide after 10 days ofon-board storage	Hydrogen peroxideclearance process,initiated by user	Cassette has to beejected by user	Cassette has to beejected by user
Cycle Time, approximate	60 minutes	54 minutes	42 minutes
Load Type	Two flexibleendoscopes withaccessories; 1x875mmPE/PTFE lumen	No flexibleendoscopes	Two flexibleendoscopes only;1x850mmPE/PTFE lumen
Load Weight, lbs	13.2	Not defined	21.4

5 TABLE 5-1: COMPARISION BETWEEN SUBJECT DEVICE AND . PREDICATES

{3}------------------------------------------------

SUMMARY OF NONCLINICAL TESTS 6

Validation Testing

Testing was performed using the "overkill" approach utilizing G. stearothermophilus spores. Table 6-1 identifies the validation studies performed and the results obtained.

ក្នុង -

STUDY	RESULTS
Dose Response with Biological Model (1 x 875 mmFlexible Endoscope	Passed
Surface Sterilization	Passed
Mated Surface Sterilization	Passed
1 x 875 mm Flexible Endoscope Validation	Passed
Bacteriostasis Testing in the DUO Cycle	Passed
In Use Testing – 1 x 875 mm Flexible Endoscopes andAccessories	Passed
Simulated Use Testing	Passed
Toxicity Testing of Materials	Passed
Device Functionality and Material Compatibility	Passed
Process Reproducibility	Passed

TABLE 6-1: VALIDATION STUDIES

7 OVERALL PERFORMANCE CONCLUSIONS

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

P. 4 of 4

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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, Division of Ethicon, Incorporated 33 Technology Drive Irvine, CA 92618

SEP
13 2012

Re: K111377

Trade/Device Name: STERRAD 100NX™ Sterilizer with DUO Cycle Regulation Number: 21 CFR §880.6860 Regulation Name: Ethylene Gas Sterilizer Regulatory Class: II Product Code: MLR Dated: September 10, 2012 Received: September 12, 2012

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.

{5}------------------------------------------------

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 (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 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 vours.

Wh for

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

{6}------------------------------------------------

X 1113

្រី

Indications for Use

510(k) Number (if known): K111377

STERRAD® 100NX® Sterilizer with DUO 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

{7}------------------------------------------------

រដឹក

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
A 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 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 1mm or larger and a length of 875mm 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 Ibs.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

な

Over-The-Counter Use V (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)

Division Sign-Off) Division Sign-Om)
Division of Anesthesiology, General Hospital ntection Control, Dental Devices

510(k) Number: K 111377

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).