Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a sterilization device with hardware and software controls for a chemical and plasma process. While it mentions software verification and validation, and features like load conditioning and an enhanced GUI, there is no mention of AI or ML algorithms being used for decision-making, process control, or data analysis beyond standard programming. The focus is on the physical and chemical sterilization process and user interface improvements.

Therapeutic

No.
The device is a sterilizer for medical instruments, not a device used to treat patients or restore health.

Diagnostic

No

The device is described as a sterilizer designed to sterilize medical instruments. Its intended use is to prepare devices for use, not to diagnose medical conditions or provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the STERRAD 100NX Sterilizer is a "self-contained stand-alone system of hardware and software" and details various hardware components like the chamber, instruments, components housed in a frame, and accessories. The performance studies also include verification testing related to hardware aspects like panel subsystems, display assembly, and electrical safety.

IVD (In Vitro Diagnostic)

Based on the provided text, the STERRAD 100NX Sterilizer is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is designed for the sterilization of medical devices. This is a process performed on instruments before they are used on or with a patient, not a test performed on a sample taken from a patient to diagnose a condition.
Device Description: The description details a system for generating hydrogen peroxide vapor and plasma to sterilize instruments. It does not describe any components or processes related to analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
- Reagents or test kits

The STERRAD 100NX Sterilizer is a device used in the healthcare setting to prepare medical instruments for use, ensuring they are free from harmful microorganisms. This falls under the category of a sterilization device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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**

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.

The STERRAD 100NX EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures.

• It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors

· It can sterilize rigid and semi-rigid endoscopes without lumens

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

The STERRAD 100NX DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions:

· Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter

· Accessory devices that are normally connected to a flexible endoscope during use
Flexible endoscopes without lumens

Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs.

A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.

** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.

Product codes (comma separated list FDA assigned to the subject device)

MLR

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 four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles.

For the STANDARD and FLEX cycles, hydrogen peroxide (HoO2) vapor is generated by injecting aqueous hydrogen peroxide into an on-board vaporizer where the solution is heated and vaporized, thereby concentrating 59% H2O2 to 90% nominal H2O2. The H2O2 vapor is then introduced into the sterilization chamber under sub-ambient pressure and transformed into a gas-plasma using electrical energy. The sterilization process is a multiphase process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization.

For the EXPRESS cycle, the onboard concentration process utilized for STANDARD and FLEX cycles is not used: the subsystem receives hydrogen peroxide solution from the delivery system. vaporizes the liquid and delivers it to the chamber.

For the DUO Cycle, hydrogen peroxide from the STERRAD 100NX Cassette follows a different flow path through the delivery module. The hydrogen peroxide, when withdrawn from the cassette, is temporarily held in the accumulators of the delivery module, and a smaller quantity (1.55 mL, nominal value) of hydrogen peroxide is dispensed or metered into the vaporizer during each of the two half-cycles of the DUO cycle. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, and printer paper.

The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. Other major components of the system are constructed from passivated stainless steel, Viton (a copolymer of vinylidene fluoride and hexafluoropropylene), Ultem (polyetherimide), injection molding, and structural foam. The sterilizer also uses accessories such as reusable instrument trays, and printer paper.

The STERRAD 100NX Sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the pre-defined minimum concentration specification.

The modified STERRAD 100NX Sterilizer with ALLClear Technology described within this submission incorporates enhancements and new features to improve reliability and usability. as briefly described following:

Load Conditioning Feature: Available for use with the STANDARD, FLEX, and . EXPRESS cycles. Reduces canceled cycles by performing load and system checks and executing a load conditioning step prior to starting a sterilization cycle.
. Enhanced Graphical User Interface (GUI): Added information to the error messages enabling users to take actions related to that error message. GUI enhancement also provides more intuitive navigation.
Improved cassette insertion.
New Touchscreen Display: Larger, higher resolution, and wider viewing angle.
New External Panels: Enhance aesthetic appearance and accommodate the larger display.
Capability for future "ecosystem" connectivity: Will allow communication and integration . with future ASP biological indicator reader(s), as well as other potential future communication features.

The technological characteristics associated with the sterilization process for the modified STERRAD 100NX Sterilizer ALLClear Technology are identical to those of the previously cleared STERRAD 100NX Sterilizer; the software and hardware changes associated with the described enhancements and new features do not modify the existing sterilization cycles.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Data:

Verification testing was conducted in support of the enhancements to the STERRAD 100NX Sterilizer that is the subject of this submission; all testing yielded passing results. This testing is summarized in the following table.

| Verification Testing | Description | Pass/
Fail |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Load Check Design Verification | Study demonstrated that the modified device, with
load conditioning feature enabled, is able to detect
load out-gassing that causes cycle cancellations. | Pass |
| Load Conditioning Design
Verification | Study demonstrated that the modified device with
load conditioning feature enabled is effective in
reducing load out-gassing. | Pass |
| Titer Enumeration of STERRAD
CYCLESURE® 24 BI With and
Without Load Conditioning
Feature | Study verified that the load conditioning has no
significant impact on the CYCLESURE 24 BI | Pass |
| Chemical Indicator Functionality
Testing | Study verified the functionality of the STERRAD
Chemical Indicator (CI) Strip, SEALSURE®
Chemical Indicator Tape, Chemical Indicator Disc on
the CYCLESURE BI, and Tyvek® self-seal and heat-
seal pouches with STERRAD Chemical Indicator
following exposure to the load conditioning feature. | Pass |
| Load Temperature Verification | Study demonstrated that the modified STERRAD
100NX system, with load conditioning feature
enabled, does not exceed the load temperature limit. | Pass |
| Final Process Qualification -
STANDARD Cycle | Testing demonstrated that the sterilizer performs
consistently within its process specifications with the
load conditioning feature enabled. | Pass |
| Final Process Qualification -
FLEX Cycle | Testing demonstrated that the sterilizer performs
within its process specifications with the load
conditioning feature enabled. | Pass |
| Final Process Qualification -
EXPRESS Cycle | Testing demonstrated that the sterilizer performs
within its process specifications with the load
conditioning feature enabled. | Pass |
| H2O2 Delivery System Design
Verification | Study demonstrated that the cassette insertion
modifications allow easier insertion and also detect
cassette alignment. | Pass |
| Panel Subsystem Design
Verification | Study verified that the new panels provide appropriate
protection, provide appropriate access to the users,
and accommodate the other modifications. | Pass |
| Panel Subsystem Design
Verification for Internal
Enclosure Air Temperature | Study verified that internal air temperature during
operation at maximum ambient temperature is within
the temperature allowed for sterilizer operation. | Pass |
| Panel Materials Testing | Study verified that the effects of 70% isopropyl
alcohol (IPA) and hydrogen peroxide on the new
panel material are within the acceptable range. | Pass |
| Display Assembly Subsystem
Design Verification | Study verified that the characteristics of the new
display assembly and confirmed compatibility with
the modified STERRAD 100NX system. | Pass |
| System Verification | Study verified new and related system requirements
which were impacted by the modifications. | Pass |
| System Tests (Environmental) | Study verified that the modified device operates
reliably and effectively at ambient conditions. | Pass |
| Summative Usability Testing | Usability testing assessed user interaction with the
modified device. | Pass |

Biocompatibility testing: An additional study was performed to assess residual hydrogen peroxide on worst case medical device materials (known to absorb hydrogen peroxide) following load conditioning in conjunction with an STANDARD sterilization cycle. This study demonstrated that mean residual hydrogen peroxide level was statistically significantly less than the acceptable threshold level.

Electromagnetic compatibility (EMC) testing was conducted to demonstrate that the modified STERRAD 100NX complies with the requirements for radiated and conducted emissions in accordance with the following standards: IEC/EN 60601-1-2:2014, EN 55011 Group I Class A limits.

Electrical Safety testing was undertaken to demonstrate that the modified STERRAD 100NX is electrically and mechanically safe when operated and maintained in accordance with the User's Guide. Conforms to applicable sections of: CAN/CSA-C22.2 No. 61010-1:2004 + Update 1:2008 R: 2009, CAN/CSA-C22.2 No. 61010-2-040:2007-12 R:2013, UL 61010-1/R:2008-10, IEC/EN 61010-1:2001, IEC/EN 61010-2-40:2005.

Software verification and validation testing was conducted and documentation was provided within the submission as recommended by Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. Unit, Integration, and System level testing were successfully completed.

Clinical Data: No clinical data was submitted in support of this Premarket Notification.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K071385, K092622, K111377, K142454

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or clothing. The profiles are stacked on top of each other, creating a sense of unity and collaboration.

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

September 26, 2016

Advanced Sterilization Products Jamie Byun Senior Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92617

Re: K160903

Trade/Device Name: STERRAD® 100NX Sterilizer with ALLClear™ Technology Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: August 25, 2016 Received: August 29, 2016

Dear Jamie Byun,

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.

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

1

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 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,

Michael J. Ryan -S

for Tina Kiang

Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K160903

Device Name

STERRAD® 100NX Sterilizer with ALLClear™ Technology

Indications for Use (Describe)

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: