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

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

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

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

Device Description

The STERRAD® NX® and 100NX® Sterilizers are self-contained stand-alone systems of hardware and software designed to sterilize medical instruments and devices using a hydrogen peroxide 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 and transforming the vapor into a gas plasma using electrical energy. The STERRAD® NX® and 100NX® are controlled by software running on an onboard microprocessor. The software is designed to control the sterilizer and provide an interface for user interaction with the sterilizer.

The network connectivity software revision that is the basis for this 510(k) premarket notification allows the Hospital IT Department to connect the STERRAD® NX® or STERRAD® 100NX® to a Hospital Local Area Network (LAN) for transfer of cycle parameters to a server and then, if desired, to an Instrument Tracking System. The software has been designed for ease of configuration using Dynamic Host Configuration Protocol (DHCP). The cycle information will be available in Portable Document Format (PDF) and Comma Separated Values (CSV) formats and transmitted using Transmission Control Protocol/Internet Protocol (TCP/IP). The network digital information will be identical to the existing cycle information printed out by the devices after each cycle (PDF file) and the existing electronic delimited data (CSV file) that can be downloaded through the USB port.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

It's important to note that this document is a 510(k) summary for a medical device (sterilizer), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against new, specific clinical acceptance criteria. The "acceptance criteria" here are primarily based on established standards for safety, electromagnetic compatibility, and software validation, aligning with regulatory requirements for demonstrating equivalence for a modification to an existing device.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria/Standard	Reported Device Performance
I. Biocompatibility	Not required (due to changes not affecting design or materials)	Not applicable
II. Electrical Safety & Electromagnetic Compatibility (EMC)	Radiated Emissions:
	- CISPR 11:2009 (Amended by A1:2010) Class A	Pass
	- EN 60601-1-2:2007 Class A	Pass
	Conducted Emissions:
	- CISPR 11:2009 (Amended by A1:2010) Class A	Pass
	- EN 60601-1-2:2007 Class A	Pass
	Safety Standards:
	- CAN/CSA-C22.2 No.:61010-1/R: 2009	Evaluated (standardized level of assurance achieved)
	- UL 61010-1/R: 2008-10	Evaluated (standardized level of assurance achieved)
	- IEC/EN 61010-1: 2001	Evaluated (standardized level of assurance achieved)
	- IEC/EN 61010-2-240 First Ed., 2005	Evaluated (standardized level of assurance achieved)
	- IEC/EN 60601-1-2: 2007 CLASS A	Evaluated (standardized level of assurance achieved)
	- EN 55011, Group I Class A limits (subset of EN 60601-1-2)	Evaluated (standardized level of assurance achieved)
III. Software Verification and Validation	Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Software considered "moderate" level of concern, meaning a failure could result in Minor Injury).	Software verification and validation testing conducted, and documentation provided. Devices perform as intended under specified use conditions.
IV. Mechanical and Acoustic	No additional testing required (due to changes limited to CPU, controller board, and software).	Not applicable
V. Animal Study	Not required	Not applicable
VI. Clinical Studies	Not required	Not applicable

Study Details:

Given the nature of this 510(k) submission, the "study" primarily consists of engineering and software testing to demonstrate that the modifications (software revision, upgraded CPU, and controller board) to the existing STERRAD® sterilizers do not negatively impact their performance and that the modified devices remain substantially equivalent to their predicates. This is not a typical clinical performance study of a diagnostic AI device.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated in terms of typical clinical "samples" (e.g., patients or images). For the electrical and EMC testing, entire STERRAD® NX® and 100NX® Sterilizer units with the upgraded CPU and controller board were tested. For software, the "test set" would refer to software validation test cases, which are not quantified here.
Data Provenance: The testing was conducted by the manufacturer (Advanced Sterilization Products) or their designated testing facilities. This is internal testing, not external patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this submission. "Ground truth" in a clinical sense (e.g., expert labels on medical images or pathology reports) is not relevant for electrical, EMC, and software validation of a sterilizer. The "ground truth" for these tests are the specifications and requirements of the referenced standards.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth from expert opinions. Here, the "truth" is determined by meeting objective engineering and software standards.

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 MRMC or comparative effectiveness study was performed. This device is a sterilizer, not a diagnostic AI tool that assists human readers. The changes are to its internal computing and networking capabilities.

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

Not directly applicable in the terms of a diagnostic algorithm. However, the electrical, EMC, and software validation tests are essentially "standalone" in that they evaluate the device's adherence to technical standards without human intervention in its primary operation during these tests. The software itself is a standalone component within the sterilizer, and its functionality (like network connectivity) was validated independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For electrical safety and EMC, the ground truth is defined by the requirements of the referenced international and national standards (e.g., CISPR 11, EN 60601-1-2, UL 61010-1).
For software validation, the ground truth is adherence to the software requirements specification and meeting safety and functionality expectations outlined in the FDA's guidance document for medical device software.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI algorithm in the context of diagnostic imaging that requires a "training set" of data. The software is deterministic control software.

9. How the ground truth for the training set was established:

Not applicable, as there is no "training set."

Summary

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

Public Health Service

April 3, 2015

Advanced Sterilization Products Sun Choi Regulatory Affairs Specialist 33 Technology Dr. Irvine, California 92618

Re: K142454 Trade/Device Name: STERRAD® NX® Sterilizer, STERRAD® 100NX® Sterilizer Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR Dated: March 4, 2015 Received: March 6, 2015

Dear Ms. Choi,

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.

Image /page/0/Picture/8 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the most prominent.

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

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 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 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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

Indications for Use

510(k) Number (if known) K142454

Device Name STERRAD® NX® Sterilizer

Indications for Use (Describe)

Page 1 of 3

The STERRAD® NX® Sterilizer is designed for sterilization of both metal 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 Sterilizer can sterilize instruments which have diffusion-restracted 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*

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.

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

Indications for Use

510(k) Number (if known) K142454

Device Name STERRAD® 100NX® Sterilizer

Indications for Use (Describe)

Page 2 of 3

The STERRAD® 100NX® Sterilizer is designed for sterilization of both metal 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® 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® Sterlizer 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 bs. 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

Indications for Use

510(k) Number (if known) K142454

Device Name STERRAD® 100NX® Sterilizer

Indications for Use (Describe)

Page 3 of 3

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 sterlize 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 sterlization of medical devices including most flexible endoscopes, with the following materials and dimensions:

· Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside dameter 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 of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

510(k) Summary

SUBMITTER I.

Advanced Sterilization Products 33 Technology Drive Irvine, CA 92618

Contact Person: Sun Choi Regulatory Affairs Specialist IV Tel: (949) 453-6378 Fax: (949) 798-3900

Date Prepared: March 27, 2015

II. DEVICE

Name of Device:	STERRAD® NX® and STERRAD® 100NX® Sterilizers
Common or Usual Name:	Hydrogen Peroxide Gas Plasma Sterilization System
Classification Name:	Ethylene Oxide Gas Sterilizer (21 CFR 880.6860)
Regulatory Class:	II
Product Code:	MLR

III. PREDICATE DEVICE

STERRAD® NX® Sterilization System withSTANDARD and ADVANCED Cycles	K042116
STERRAD® 100NX® Sterilization System withSTANDARD and FLEX CyclesEXPRESS CycleDUO Cycle	K071385 K092622 K111377

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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

introducing the vapor into the chamber and transforming the vapor into a gas plasma using electrical energy. The STERRAD® NX® and 100NX® are controlled by software running on an onboard microprocessor. The software is designed to control the sterilizer and provide an interface for user interaction with the sterilizer.

The software revision has the following performance features:

It can be configured automatically or manually ●
. It will be activated only upon the request of the User
Once it is activated, the User can turn it off and back on
It will have diagnostic tools for network troubleshooting ●
. It will notify the User of an unsuccessful transmission

The associated accessories include:

Network cable

INDICATIONS FOR USE V.

STERRAD® NX® Sterilizer

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

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

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*
TThe 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.

STERRAD® 100NX® Sterilizer

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.

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.

{8}------------------------------------------------

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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the predicate devices (STERRAD® NX® and STERRAD® 100NX®) are identical to the devices that are the subject of this 510(k) with the exception of the differences in the software revision for network connectivity and an upgraded CPU with controller board. Design, materials, and functions of the sterilizers have not changed. Refer to Table 1 and Table 2 for comparison between modified and predicate devices for the STERRAD® NX® and STERRAD® 100NX®, respectively.

	Modified Device:STERRAD® NX® Sterilizer	Predicate Device:STERRAD® NX® Sterilizer(K042116)	Comparison
Intended Use	The STERRAD® Sterilizers are designedfor sterilization of both metal andnonmetal medical devices at lowtemperatures. Because the cycle operateswithin a dry environment and at lowtemperatures, it is especially suitable for	The STERRAD® Sterilizers are designedfor sterilization of both metal andnonmetal medical devices at lowtemperatures. Because the cycle operateswithin a dry environment and at lowtemperatures, it is especially suitable for	Same

		Table 1: STERRAD® NX® - Comparison Table for Modified Devices vs. Predicate
Devices

{9}------------------------------------------------

	Modified Device:STERRAD® NX® Sterilizer	Predicate Device:STERRAD® NX® Sterilizer(K042116)	Comparison
	instruments sensitive to heat andmoisture.	instruments sensitive to heat andmoisture.
Indications forUse	Refer to Section V, Indications for Useof this 510(k) Summary.	Refer to Section V, Indications for Useof this 510(k) Summary.	Same
TechnologicalCharacteristics	The STERRAD® NX® is a hydrogenperoxide gas plasma sterilizer designedto sterilize medical instruments anddevices using a hydrogen peroxideprocess. Hydrogen peroxide vapor isgenerated by injecting aqueoushydrogen peroxide into the vaporizerwhere the solution is heated andvaporized, introducing the vapor intothe chamber and transforming thevapor into a gas plasma usingelectrical energy.The network connectivity softwareallows the hospital IT department toconnect the sterilizer to a hospital localarea network for transfer of cycleparameters to a server and then, ifdesired, to an instrument trackingsystem. The software has been revisedfor ease of configuration usingDynamic Host Configuration Protocol(DHCP) for network connectivity andan upgraded CPU with controllerboard.	The STERRAD® NX® is a hydrogenperoxide gas plasma sterilizer designedto sterilize medical instruments anddevices using a hydrogen peroxideprocess. Hydrogen peroxide vapor isgenerated by injecting aqueoushydrogen peroxide into the vaporizerwhere the solution is heated andvaporized, introducing the vapor intothe chamber and transforming thevapor into a gas plasma usingelectrical energy.The network connectivity softwareallows the hospital IT department toconnect the sterilizer to a hospital localarea network for transfer of cycleparameters to a server and then, ifdesired, to an instrument trackingsystem.	Same withthedifferencesshown inbold font.
Materials	The chamber and door are constructedwith aluminum.The cassette contains the 59% nominalhydrogen peroxide solution in the plasticcell pack and cassette shells.	The chamber and door are constructedwith aluminum.The cassette contains the 59% nominalhydrogen peroxide solution in the plasticcell pack and cassette shells.	Same
Design Features	The sterilizer concentrates the hydrogenperoxide. The hydrogen peroxideconcentration is monitored during thecycle and the sterilizer cancels the cycleif the hydrogen peroxide monitor datadoes not meet the specification.	The sterilizer concentrates the hydrogenperoxide. The hydrogen peroxideconcentration is monitored during thecycle and the sterilizer cancels the cycleif the hydrogen peroxide monitor datadoes not meet the specification.	Same
SterilizerFunctions	Logout is used when the current operatoris finished using the sterilizer. WhenLogout is selected, login is requiredbefore using the sterilizer.System Summary displays the SystemSummary file and allows operator toprint a copy.Cycle History displays the Select CycleHistory screen. This screen allowsoperator to select a cycle history file andview or print it.	Logout is used when the current operatoris finished using the sterilizer. WhenLogout is selected, login is requiredbefore using the sterilizer.System Summary displays the SystemSummary file and allows operator toprint a copy.Cycle History displays the Select CycleHistory screen. This screen allowsoperator to select a cycle history file andview or print it.	Same
Modified Device:STERRAD® NX® Sterilizer	Predicate Device:STERRAD® NX® Sterilizer(K042116)	Comparison
Additional Utilities is available only tooperators with Supervisor-level access. Itdisplays the Additional Utilities Menu.	Additional Utilities is available only tooperators with Supervisor-level access. Itdisplays the Additional Utilities Menu.

{10}------------------------------------------------

Table 2: STERRAD® 100NX® - Comparison Table for Modified Devices vs. Predicate Devices

Table 2: STERRAD® 100NX® - Comparison Table for Modified Devices vs. Predicate Devices
	Modified Device:STERRAD® 100NX® Sterilizer	Predicate Devices:STERRAD® 100NX® Sterilizer(K071385 for STANDARD and FlexCycles, K092622 for EXPRESS Cycle,K111377 for DUO Cycle)	Comparison
Intended Use	The STERRAD® Sterilizers are designedfor sterilization of both metal andnonmetal medical devices at lowtemperatures. Because the cycle operateswithin a dry environment and at lowtemperatures, it is especially suitable forinstruments sensitive to heat andmoisture.	The STERRAD® Sterilizers are designedfor sterilization of both metal andnonmetal medical devices at lowtemperatures. Because the cycle operateswithin a dry environment and at lowtemperatures, it is especially suitable forinstruments sensitive to heat andmoisture.	Same
Indications forUse	Refer to Section V, Indications for Useof this 510(k) Summary.	Refer to Section V, Indications for Useof this 510(k) Summary.	Same
TechnologicalCharacteristics	The STERRAD® 100NX® is ahydrogen peroxide gas plasmasterilizer designed to sterilize medicalinstruments and devices using ahydrogen peroxide process. Hydrogenperoxide vapor is generated byinjecting aqueous hydrogen peroxideinto the vaporizer where the solution isheated and vaporized, introducing thevapor into the chamber andtransforming the vapor into a gasplasma using electrical energy.The network connectivity softwareallows the hospital IT department toconnect the sterilizer to a hospital localarea network for transfer of cycleparameters to a server and then, ifdesired, to an instrument trackingsystem. The software has been revisedfor ease of configuration usingDynamic Host Configuration Protocol(DHCP) for network connectivity andan upgraded CPU with controllerboard.	The STERRAD® 100NX® is ahydrogen peroxide gas plasmasterilizer designed to sterilize medicalinstruments and devices using ahydrogen peroxide process. Hydrogenperoxide vapor is generated byinjecting aqueous hydrogen peroxideinto the vaporizer where the solution isheated and vaporized, introducing thevapor into the chamber andtransforming the vapor into a gasplasma using electrical energy.The network connectivity softwareallows the hospital IT department toconnect the sterilizer to a hospital localarea network for transfer of cycleparameters to a server and then, ifdesired, to an instrument trackingsystem.	Same withthedifferencesshown inbold font.
Materials	The chamber and door are constructedwith aluminum.The cassette contains the 59% nominalhydrogen peroxide solution in the plastic	The chamber and door are constructedwith aluminum.The cassette contains the 59% nominalhydrogen peroxide solution in the plastic	Same
	cell pack and cassette shells.	cell pack and cassette shells.
	Modified Device:STERRAD® 100NX® Sterilizer	Predicate Devices:STERRAD® 100NX® Sterilizer(K071385 for STANDARD and FlexCycles, K092622 for EXPRESS Cycle,K111377 for DUO Cycle)	Comparison
Design Features	The sterilizer concentrates the hydrogenperoxide for Standard and Flex Cycles.The hydrogen peroxide concentration ismonitored during the cycle and thesterilizer cancels the cycle if thehydrogen peroxide monitor data does notmeet the specification.	The sterilizer concentrates the hydrogenperoxide for Standard and Flex Cycles.The hydrogen peroxide concentration ismonitored during the cycle and thesterilizer cancels the cycle if thehydrogen peroxide monitor data does notmeet the specification.	Same
SterilizerFunctions	Logout is used when the current operatoris finished using the sterilizer and theoption is enabled. When Logout isselected, the operator must re-login touse the sterilizer.Cycle History displays the Select CycleHistory screen. This screen allows theoperator to select a cycle history file andview or print it.	Logout is used when the current operatoris finished using the sterilizer and theoption is enabled. When Logout isselected, the operator must re-login touse the sterilizer.Cycle History displays the Select CycleHistory screen. This screen allows theoperator to select a cycle history file andview or print it.	Same
	Utilities are available only to operatorswith Supervisor-level access. It displaysthe Additional Utilities Menu.Door Open opens the active door.	Utilities are available only to operatorswith Supervisor-level access. It displaysthe Additional Utilities Menu.Door Open opens the active door.
	Door Close closes the active door.	Door Close closes the active door.

{11}------------------------------------------------

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Since the cited changes to the predicate devices do not affect the design or materials of the devices, biocompatibility testing was not required.

Electrical safety and electromagnetic compatibility (EMC)

The STERRAD® NX® and 100NX® Sterilizers with the upgraded CPU and controller board were tested for Radiated and Conducted Emissions according to the Standards shown in the table below. All test results passed the requirements of the Standards (Table 3).

{12}------------------------------------------------

Test Description	Standard	Pass/Fail
Radiated Emissions	CISPR 11:2009(Amended by A1:2010)Class A	Pass
Radiated Emissions	EN 60601-1-2:2007 Class A	Pass
Conducted Emissions	CISPR 11:2009(Amended by A1:2010)Class A	Pass
Conducted Emissions	EN 60601-1-2:2007 Class A	Pass

Table 3: Testing of STERRAD® NX® and 100NX® Sterilizers for Radiated and Conducted Emissions

The STERRAD® NX® and 100NX® Sterilizers were evaluated for safety under the standards listed below. The testing, conducted to the set of standards, provided a standardized level of assurance that the system is electrically and mechanically safe when operated and maintained in accordance with the STERRAD® User Guide.

CAN/CSA-C22.2 No.:61010-1/R: 2009; Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use.
UL 61010-1/R: 2008-10; Standard for Safety for Electrical Equipment for Laboratory Use. ●
IEC/EN 61010-1: 2001; Safety Requirements for Electrical ● Equipment for Measurement, Control, and Laboratory Use.
IEC/EN 61010-2-240 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials, First Ed., 2005
IEC/EN 60601-1-2: 2007 CLASS A; Medical Electrical Equipment, Part 1: ● General Requirements for Safety, Section 2: Collateral Standard: Electromagnetic Compatibility
EN 55011, Group I Class A limits, based on CISPR 11:2009, Group I Class A limits (subset of EN 60601-1-2)

{13}------------------------------------------------

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate " level of concern since prior to mitigation of hazards a failure of the software could result in Minor Injury, either to a patient or to a user of the device.

Mechanical and acoustic testing

No additional mechanical testing was performed since the only change in the predicate devices was the upgraded CPU with controller board and the software upgrade.

Animal Study

No animal studies were conducted.

Clinical Studies

No clinical studies were conducted.

VIII. CONCLUSIONS

The changes to the predicate devices were a software revision and the use of a newer version of the CPU with the associated control board. Software verification and validation performed with these changes demonstrated that the modified devices will perform as intended under the specified use conditions. Therefore Advanced Sterilization Products considers the STERRAD® NX® and STERRAD® 100NX® with revised software, CPU and controller board to be substantially equivalent to their predicates.

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).