(213 days)
No reference devices were used in this submission.
No
The document describes a sterilization system controlled by software on a microprocessor, primarily focused on network connectivity for data transfer. There is no mention of AI, ML, or any learning or adaptive capabilities.
No.
This device is designed for sterilization of medical devices, not for therapeutic use on patients.
No
Explanation: The device is described as a sterilizer for medical instruments and devices, using hydrogen peroxide vapor and plasma. Its intended use is sterilization, not diagnosis.
No
The device description explicitly states that the STERRAD® NX® and 100NX® Sterilizers are "self-contained stand-alone systems of hardware and software". The 510(k) is for a software revision that adds network connectivity to existing hardware systems.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The primary function of the STERRAD® NX® and 100NX® Sterilizers is to sterilize 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 or monitor health.
- Device Description: The description details a system for generating hydrogen peroxide vapor and plasma to sterilize instruments. It also mentions network connectivity for transferring cycle parameters, which is related to the operation and tracking of the sterilization process, not diagnostic testing.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for the reprocessing of medical instruments to make them safe for reuse, which falls under the category of sterilization equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MLR
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.
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
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
Hospital IT Department
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)
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).
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
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)
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.
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.
K042116, K071385, K092622, K111377
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.
No reference devices were used in this submission.
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
§ 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).
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 with
| STANDARD and ADVANCED Cycles | K042116 |
|---|---|
| STERRAD® 100NX® Sterilization System with | |
| STANDARD and FLEX Cycles | |
| EXPRESS Cycle | |
| DUO Cycle | K071385 |
| K092622 | |
| K111377 |
No reference devices were used in this submission.
IV. 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,
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 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.
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
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
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.
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 endoscope was validated without any additional load.
STERRAD® 100NX® Sterilizer
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.
- 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 designed
for sterilization of both metal and
nonmetal medical devices at low
temperatures. Because the cycle operates
within a dry environment and at low
temperatures, it is especially suitable for | The STERRAD® Sterilizers are designed
for sterilization of both metal and
nonmetal medical devices at low
temperatures. Because the cycle operates
within a dry environment and at low
temperatures, 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 and
moisture. | instruments sensitive to heat and
moisture. | |
| Indications for
Use | Refer to Section V, Indications for Use
of this 510(k) Summary. | Refer to Section V, Indications for Use
of this 510(k) Summary. | Same |
| Technological
Characteristics | The STERRAD® NX® is a hydrogen
peroxide gas plasma sterilizer 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 network connectivity software
allows the hospital IT department to
connect the sterilizer to a hospital local
area network for transfer of cycle
parameters to a server and then, if
desired, to an instrument tracking
system. The software has been revised
for ease of configuration using
Dynamic Host Configuration Protocol
(DHCP) for network connectivity and
an upgraded CPU with controller
board. | The STERRAD® NX® is a hydrogen
peroxide gas plasma sterilizer 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 network connectivity software
allows the hospital IT department to
connect the sterilizer to a hospital local
area network for transfer of cycle
parameters to a server and then, if
desired, to an instrument tracking
system. | Same with
the
differences
shown in
bold font. |
| Materials | The chamber and door are constructed
with aluminum.
The cassette contains the 59% nominal
hydrogen peroxide solution in the plastic
cell pack and cassette shells. | The chamber and door are constructed
with aluminum.
The cassette contains the 59% nominal
hydrogen peroxide solution in the plastic
cell pack and cassette shells. | Same |
| Design Features | The sterilizer concentrates the hydrogen
peroxide. The hydrogen peroxide
concentration is monitored during the
cycle and the sterilizer cancels the cycle
if the hydrogen peroxide monitor data
does not meet the specification. | The sterilizer concentrates the hydrogen
peroxide. The hydrogen peroxide
concentration is monitored during the
cycle and the sterilizer cancels the cycle
if the hydrogen peroxide monitor data
does not meet the specification. | Same |
| Sterilizer
Functions | Logout is used when the current operator
is finished using the sterilizer. When
Logout is selected, login is required
before using the sterilizer.
System Summary displays the System
Summary file and allows operator to
print a copy.
Cycle History displays the Select Cycle
History screen. This screen allows
operator to select a cycle history file and
view or print it. | Logout is used when the current operator
is finished using the sterilizer. When
Logout is selected, login is required
before using the sterilizer.
System Summary displays the System
Summary file and allows operator to
print a copy.
Cycle History displays the Select Cycle
History screen. This screen allows
operator to select a cycle history file and
view or print it. | Same |
| Modified Device:
STERRAD® NX® Sterilizer | Predicate Device:
STERRAD® NX® Sterilizer
(K042116) | Comparison | |
| Additional Utilities is available only to
operators with Supervisor-level access. It
displays the Additional Utilities Menu. | Additional Utilities is available only to
operators with Supervisor-level access. It
displays 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 Flex | |||
| Cycles, K092622 for EXPRESS Cycle, | |||
| K111377 for DUO Cycle) | Comparison | ||
| Intended Use | The STERRAD® Sterilizers are designed | ||
| for sterilization of both metal and | |||
| nonmetal medical devices at low | |||
| temperatures. Because the cycle operates | |||
| within a dry environment and at low | |||
| temperatures, it is especially suitable for | |||
| instruments sensitive to heat and | |||
| moisture. | The STERRAD® Sterilizers are designed | ||
| for sterilization of both metal and | |||
| nonmetal medical devices at low | |||
| temperatures. Because the cycle operates | |||
| within a dry environment and at low | |||
| temperatures, it is especially suitable for | |||
| instruments sensitive to heat and | |||
| moisture. | Same | ||
| Indications for | |||
| Use | Refer to Section V, Indications for Use | ||
| of this 510(k) Summary. | Refer to Section V, Indications for Use | ||
| of this 510(k) Summary. | Same | ||
| Technological | |||
| Characteristics | The STERRAD® 100NX® is a | ||
| hydrogen peroxide gas plasma | |||
| sterilizer 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 network connectivity software | |||
| allows the hospital IT department to | |||
| connect the sterilizer to a hospital local | |||
| area network for transfer of cycle | |||
| parameters to a server and then, if | |||
| desired, to an instrument tracking | |||
| system. The software has been revised | |||
| for ease of configuration using | |||
| Dynamic Host Configuration Protocol | |||
| (DHCP) for network connectivity and | |||
| an upgraded CPU with controller | |||
| board. | The STERRAD® 100NX® is a | ||
| hydrogen peroxide gas plasma | |||
| sterilizer 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 network connectivity software | |||
| allows the hospital IT department to | |||
| connect the sterilizer to a hospital local | |||
| area network for transfer of cycle | |||
| parameters to a server and then, if | |||
| desired, to an instrument tracking | |||
| system. | Same with | ||
| the | |||
| differences | |||
| shown in | |||
| bold font. | |||
| Materials | The chamber and door are constructed | ||
| with aluminum. | |||
| The cassette contains the 59% nominal | |||
| hydrogen peroxide solution in the plastic | The chamber and door are constructed | ||
| with aluminum. | |||
| The cassette contains the 59% nominal | |||
| hydrogen 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 Flex | |||
| Cycles, K092622 for EXPRESS Cycle, | |||
| K111377 for DUO Cycle) | Comparison | ||
| Design Features | The sterilizer concentrates the hydrogen | ||
| peroxide for Standard and Flex Cycles. | |||
| The hydrogen peroxide concentration is | |||
| monitored during the cycle and the | |||
| sterilizer cancels the cycle if the | |||
| hydrogen peroxide monitor data does not | |||
| meet the specification. | The sterilizer concentrates the hydrogen | ||
| peroxide for Standard and Flex Cycles. | |||
| The hydrogen peroxide concentration is | |||
| monitored during the cycle and the | |||
| sterilizer cancels the cycle if the | |||
| hydrogen peroxide monitor data does not | |||
| meet the specification. | Same | ||
| Sterilizer | |||
| Functions | Logout is used when the current operator | ||
| is finished using the sterilizer and the | |||
| option is enabled. When Logout is | |||
| selected, the operator must re-login to | |||
| use the sterilizer. | |||
| Cycle History displays the Select Cycle | |||
| History screen. This screen allows the | |||
| operator to select a cycle history file and | |||
| view or print it. | Logout is used when the current operator | ||
| is finished using the sterilizer and the | |||
| option is enabled. When Logout is | |||
| selected, the operator must re-login to | |||
| use the sterilizer. | |||
| Cycle History displays the Select Cycle | |||
| History screen. This screen allows the | |||
| operator to select a cycle history file and | |||
| view or print it. | Same | ||
| Utilities are available only to operators | |||
| with Supervisor-level access. It displays | |||
| the Additional Utilities Menu. | |||
| Door Open opens the active door. | Utilities are available only to operators | ||
| with Supervisor-level access. It displays | |||
| the 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.