The STERRAD® NX 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® NX 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® NX Sterilizer Standard cycle:

Single channel stainless steel lumens with

An inside diameter of 1 mm or larger and a length of 150 mm or shorter
An inside diameter of 2 mm or larger and a length of 400 mm or shorter

Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® NX Sterilizer Advanced cycle:

Single channel stainless steel lumens with

An inside diameter of 1 mm or larger and a length of 500 mm or shorter
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with
An inside diameter of 1 mm or larger and length of 850 mm or shorter

Device Description

The STERRAD® NX 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® NX Sterilizer has two different sterilization cycles, the Standard cycle and the Advanced cycle.

The hardware for the STERRAD® NX 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 system and an optional movable cart. The STERRAD® NX Sterilizer can be placed directly on a table, counter top, or on the movable cart.

AI/ML Overview

The document describes the validation testing for the STERRAD® NX Sterilizer. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each study type are implied as "Passed," meaning the sterilization process successfully rendered the tested items sterile. The document does not provide specific quantitative thresholds for passing (e.g., spore kill percentages), but "Passed" indicates the criteria were met.

Study Type	Acceptance Criteria (Implied)	Reported Device Performance
Dose Response with 1 x 500mm Stainless Steel Lumens	Sterile	Passed
Surface Sterilization	Sterile	Passed
Mated Surface Sterilization	Sterile	Passed
1 x 500mm Stainless Steel Lumen Validation	Sterile	Passed
1 x 150 Stainless Steel Lumen Validation	Sterile	Passed
2 x 400mm Stainless Steel Lumen Validation	Sterile	Passed
1 x 850mm Flexible Endoscope Validation	Sterile	Passed
Pouched 1 x 500mm Stainless Steel Lumen Validation	Sterile	Passed
Bacteriostasis Testing in Standard and Advanced Cycles	No bacterial growth	Passed
Sporicidal Testing	Kill spores	Passed
In Use Testing	Sterile	Passed
Bacteriostasis/Fungistasis Testing	No microbial growth	Passed
Simulated Use Testing	Sterile	Passed
Toxicity Testing of Materials	Non-toxic	Passed
Chemical Indicator Functionality	Proper indication	Passed
Biological Indicator Functionality	Proper indication	Passed
Bacteriostasis Testing of CycleSure Biological Indicator	No bacterial growth	Passed
Device Functionality and Material Compatibility	Functional, Compatible	Passed
Process Reproducibility	Consistent sterilization	Passed

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

Sample Size: The document does not explicitly state a total number of samples for the entire test set. However, it provides details for specific validations:
- 1 x 850mm flexible endoscope validation: Tested with only one flexible endoscope per sterilization cycle.
- 1 mm diameter or larger and 500 mm or shorter lumens: Maximum of 10 lumens per load.
- Other validations: The "Note" implies that with the exception of the 1 x 850mm flexible endoscopes, the validation studies were performed using a "validation load consisting of one instrument tray weighing 10.7 lbs." This suggests that for many tests, the sample size per cycle was consistent with a single instrument tray load.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission for a medical device cleared in the U.S. in 2005, it is highly likely that these were prospective validation studies conducted in a controlled laboratory environment to demonstrate the sterilizer's efficacy.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for sterilization efficacy studies is typically determined empirically through microbiological testing (e.g., culturing biological indicators or test organisms) rather than expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established objectively through microbiological methods, not through expert review and adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a sterilizer, and its performance is evaluated in terms of its ability to kill microorganisms, not by human reader interpretation of images or other data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study

While "standalone" is often used in the context of AI algorithms, this refers to the performance of the sterilizer itself. The document comprehensively details numerous validation studies performed to demonstrate the sterilizer's standalone efficacy in achieving sterilization. The entire "SUMMARY OF NONCLINICAL TESTS" section (5.0) describes the standalone performance without human intervention during the sterilization cycle.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for these sterilization validation studies is primarily microbiological/biological evidence. Specifically, the "overkill" approach utilizes G. stearothermophilus spores, which are highly resistant biological indicators. The "Passed" result for each study indicates the complete inactivation of these spores and other tested microorganisms, demonstrating sterility.

8. Sample Size for the Training Set

Not applicable. This device is a physical sterilizer and not an AI or software device that relies on a "training set" in the machine learning sense. The validation studies demonstrate the sterilizer's inherent physical and chemical process efficacy.

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

Not applicable, as no training set (in the machine learning context) was used.

Summary

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K 042116

APR 2 2 2005

510(k) Summary

Applicant's Name, Address, Telephone, FAX, Contact Person

Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618

Contact Person

Natalie Bennington Regulatory Affairs Project Manager Tel: (949) 453-6482 Fax: (949) 789-3900

April 1, 2005

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME 1.0

Classification Name: Sterilizer, Class II Common/Usual Name: Hydrogen Peroxide Gas Plasma Sterilization System Product Classification: Sterilizer, Class II Proprietary Name: STERRAD® NX Sterilizer

PREDICATE DEVICES 2.0

STERRAD® 50, 100S and 200 Sterilization Systems

INDICATIONS FOR USE 3.0

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

Single channel stainless steel lumens with

· An inside diameter of 1 mm or larger and a length of 150 mm or shorter1
· An inside diameter of 2 mm or larger and a length of 400 mm or shorter1

Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® NX Sterilizer Advanced cycle:

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Single channel stainless steel lumens with

An inside diameter of 1 mm or larger and a length of 500 mm or shorter*
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with
· An inside diameter of 1 mm or larger and length of 850 mm or shorter*
Note: With the exception of the 1 x 850mm flexible endoscopes, the validation studies were performed using a validation load consisting of one instrument tray weighing 10.7 lbs. The 1 x 850mm flexible endoscope was validated without any additional load.

DESCRIPTION OF DEVICE 4.0

* The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

*Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load.

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SUMMARY OF NONCLINICAL TESTS 5.0

Validation Testing 5.1

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.

Table 8-1: Validation Studies	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Study	Results
Dose Response with 1 x 500mm Stainless Steel Lumens	Passed
Surface Sterilization	Passed
Mated Surface Sterilization	Passed
1 x 500mm Stainless Steel Lumen Validation	Passed
1 x 150 Stainless Steel Lumen Validation	Passed
2 x 400mm Stainless Steel Lumen Validation	Passed
1 x 850mm Flexible Endoscope Validation	Passed
Pouched 1 x 500mm Stainless Steel Lumen Validation	Passed
Bacteriostasis Testing in Standard and Advanced Cycles	Passed
Sporicidal Testing	Passed
In Use Testing	Passed
Bacteriostasis/Fungistasis Testing	Passed
Simulated Use Testing	Passed
Toxicity Testing of Materials	Passed
Chemical Indicator Functionality	Passed
Biological Indicator Functionality	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® NX Sterilizer is safe and effective for sterilization of medical devices within the indications for use for the sterilizer and establish equivalence of the STERRAD® NX Sterilizer to the predicate devices, the STERRAD® 50, 100S and 200 Sterilizers.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is in all capital letters and is arranged in a circular fashion to match the shape of the logo.

APR 2 2 2005

ﮯ

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Sterilization Products Ms. Natalie Bennington Regulatory Affairs Project Manager ETHICON, Incorporated 33 Technology Drive Irvine, California 92618

Re: K042116

K042110
Trade/Device Name: STERRAD® NX Sterilizer Regulation Number: 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR Dated: April 1, 2005 Received: April 4, 2005

Dear Ms. Bennington:

We have reviewed your Section 510(k) premarket notification of intent to market the device We liave reviewed your Section of the device is substantially equivalent (for the referenced above and have determined to tegally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate collinered proct to may 20, 1978, as a sectance with the provisions of Amendinens, of to devices that here obct (Act) that do not require approval of a premarket the Federal Pood, Drug, und Communey, therefore, market the device, subject to the general approval application (1 Mill). 1 over al controls provisions of the Act include confors provisions of the rea. "The girling of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see ass 10) into controls. Existing major regulations affecting (PMA), if may be subject to such adatin for a Regulations, Title 21, Parts 800 to 898. In your device can be found in the South no nouncements concerning your device in the Federal Register.

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Page 2 - Ms. Bennington

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled of a baseauxines with other requirements mean that FDA nas made a decommans in the many of ther Federal agencies. of the Act of any rederal statues and reguirements, including, but not limited to: registration You must comply with an the Act 5 requirements and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gDD manufacturing practice and ifiling (21 CFR Part 607), laceling (21 cess (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter whi anow you to begin mational equivalence of your device to a premarket notification. The PDA midning of bassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific auvree for your do at (240) 276-0115. Also, please note the regulation please contact the Office or Comphanes ar (210) = 11 = 1 = 1 = 1 may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on the mational and Consumer Assistance at its toll-free Division of Binasa 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Quitte y. Michau Ond.

Chiu Lin, Ph.D. 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): K042116

STERRAD® NX Sterilizer Device Name:

Indications-For-Use:

Indieations-For-Use:
The STERRAD® NX Sterilizer is designed for sterilization process that utilizes a combination of The STERRAD® NX Sterilization process is a miliphas sterlization process that utilizes a combination of emperatures. The STERRAD stor and plasma o affect sterilization process and U.S. STERRAD® NY Sterlizer can sterilize exposure to hydrogen peroxide vapor and plasma to arrest stormation of forceps and scissors.
instruments which have diffusion-restricted spaces, such as the hinged portion of

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

Single channel stainless steel lumens with

. . An inside diameter of 1 mm or larger and a length of 150 mm or shorter"
· An inside diameter of 2 mm or larger and a length of 400 mm or shorter]

Medical devices, including most flexible endoscopes, with the following matcrials and dimensions can be processed Medical devices, molading with Sterilizer Advanced cycle:

Single channel stainless steel lumcns with

An inside diameter of I mm or larger and a length of 500 mm or shorter] .
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with

An inside diameter of 1 mm or larger and length of 850 mm or shorter* .

The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads and I he validation testing for this famon bize of lumens validated by this testing.

should not exceed the maximum number of lumens vanuated by the testing.
*Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. load.

Note: With the exception of the 1 x 850mm flexible endoscopes, the validation studies were performed using a Note: With the exception of the 1 X 850mm fiexible chooseopes, the valuation comments of the readoscope was validated without any additional load.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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)

Shula F. Murphy KB

on Sian-Off) ision of Anesthesiology, General Hospital, maction Control, Dental Devices

Number: K042116

Page 1 of

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).