(187 days)
Not Found
No
The document describes a sterilization device with hardware and software controls for a chemical and plasma process. While it mentions "Load Conditioning Feature" and "Enhanced Graphical User Interface," these features are described in terms of system checks, error message improvements, and navigation, not AI/ML algorithms for decision-making or pattern recognition. The performance studies focus on the effectiveness of the sterilization process and the new features, without mentioning any AI/ML-specific metrics or methodologies.
No.
The STERRAD NX Sterilizer is explicitly designed for the sterilization of medical devices, not for therapeutic purposes on patients. Its function is to prepare instruments for use, preventing contamination rather than treating a medical condition.
No.
The device is a sterilizer designed to clean medical instruments, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states that the STERRAD NX Sterilizer is a "self-contained stand-alone system of hardware and software" and details numerous hardware components like the sterilizer chamber, vacuum pump, and various materials used in its construction.
Based on the provided text, the STERRAD NX Sterilizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "sterilization of both metal and nonmetal medical devices at low temperatures." This is a process applied to medical devices themselves, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a system for sterilizing medical instruments using hydrogen peroxide gas plasma. This process is for decontamination, not for analyzing biological specimens.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases
- Reagents or assays for detecting analytes
- Measurement of biological parameters
The STERRAD NX 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 sterilization equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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-
- Note: With the exception of the 1 x 850 mm flexible endoscopes, 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.
1 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.
Product codes (comma separated list FDA assigned to the subject device)
MLR
Device Description
The STERRAD NX Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting a 59% aqueous hydrogen peroxide into the vaporizer subassembly where the solution is heated and vaporized and relatively low temperatures through a process that utilizes a combination of heating and sub-ambient pressures created by an on-board vacuum pump. The vaporized hydrogen peroxide is then introduced into the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and facilitate hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is repeated an additional time to complete a full STERRAD NX Sterilization cycle (i.e., the full sterilization cycle is composed of two identical half-cvcles). The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles, both of which follow the general process described here.
The hardware for the STERRAD NX 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, printer paper, and an optional movable cart. The STERRAD NX Sterilizer can be placed directly on a table, counter top, or on the movable STERRAD NX cart.
The STERRAD NX Sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. As previously described, the hydrogen peroxide is concentrated before introduction into the sterilizer chamber and its concentration is monitored during the cycle. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the pre-defined minimum concentration specification.
The STERRAD NX Sterilizer with ALLClear Technology incorporates enhancements and new features to improve reliability and usability, as briefly described following:
- . Load Conditioning Feature: 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.
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 NX Sterilizer that is the subject of this submission; all testing yielded passing results. This testing is summarized in the following table.
Summary of Performance Testing
| 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 from moisture that has been absorbed into the load materials. | Pass |
| Load Conditioning Design Verification | Study demonstrated that the modified device with load conditioning feature enabled is effective in correcting 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 NX 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 - ADVANCED 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 consist of all the parts to enclose the sterilizer functional subsystems and control user-access to only appropriate areas. | 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 NX system. | Pass |
| System Verification | Study verified new and related system requirements which were not tested at the subsystem level. | 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
In addition to the biocompatibility data submitted in the predicate device 510(k)s, 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 ADVANCED 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 NX complies with the requirements for radiated and conducted emissions in accordance with the following standards:
- IEC/EN 60601-1-2:2014 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 11:2010, Group I Class A o limits (subset of EN 60601-1-2)
-
. Electrical Safety testing was undertaken to demonstrate that the modified STERRAD NX is electrically and mechanically safe when operated and maintained in accordance with the User's Guide. Based upon this testing, the modified STERRAD NX Sterilizer conforms to the applicable sections of the standards listed following:
- CAN/CSA-C22.2 No. 61010-1:2004 + Update 1:2008 R: 2009 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
- CAN/CSA-C22.2 No. 61010-2-040:2007-12 R:2013 Safety requirements for o electrical equipment for measurement, control and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
- UL 61010-1/R:2008-10 Standard for Safety for Electrical Equipment for o Laboratory Use
- 0 IEC/EN 61010-1:2001 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
- IEC/EN 61010-2-40:2005 Particular Requirements for Sterilizers and Washer o disinfectors used to Treat Medical Materials, First Edition
-
. 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.
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms, possibly representing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2016
Advanced Sterilization Products (ASP) Ms. Jamie Byun Senior Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92617
Re: K160818
Trade/Device Name: STERRAD NX® 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
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D.
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) K160818
Device Name
STERRAD NX® Sterilizer with ALLClear(TM) Technology
Indications for Use (Describe)
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 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*
Note: With the exception of the 1 x 850 mm flexible endoscopes, validation studies were performed using a validation load consisting of one instrument tray weighing 10.7 bs. The 1 x 850 mm flexible endoscope was validated without any additional load.
- 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized font. The letters are white and are set against a light blue background. The logo is enclosed in a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo.
510(k) Summary
Advanced Sterilization Products STERRAD NX® Sterilizer with ALLClear™ Technology
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | Advanced Sterilization Products
Division of Ethicon, Inc., a Johnson & Johnson company |
|-----------------|------------------------------------------------------------------------------------------------------------------------------|
| Address: | 33 Technology Drive
Irvine, CA 92618 |
| Contact Person: | Jamie Byun
Senior Regulatory Affairs Specialist
Tel: (949) 788-2067
Fax: (949) 798-3900
Email: jbyun@its.jnj.com |
| Date Prepared: | September 21, 2016 |
| 510(k) Number: | K160818 |
Device Name
| Proprietary Name: | STERRAD NX® Sterilizer with ALLClear™ Technology |
|---|---|
| Common Name: | Hydrogen Peroxide Gas Plasma Sterilization System |
| Classification Name: | Ethylene oxide gas sterilizer |
| Device Class: | Class II |
| Product Code: | MLR |
| CFR Section: | 21 CFR 880.6860 |
Predicate Device
STERRAD NX Sterilizer cleared under K042116 and K142454
Device Description
The STERRAD NX Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting a 59% aqueous hydrogen peroxide into the vaporizer subassembly where the solution is heated and
5
Image /page/5/Picture/0 description: The image shows a logo with the letters "ASP" in white against a light blue background. The "A" is represented by a triangle, and the letters are stylized with rounded edges. A small registered trademark symbol is visible in the upper right corner of the logo.
vaporized and relatively low temperatures through a process that utilizes a combination of heating and sub-ambient pressures created by an on-board vacuum pump. The vaporized hydrogen peroxide is then introduced into the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and facilitate hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is repeated an additional time to complete a full STERRAD NX Sterilization cycle (i.e., the full sterilization cycle is composed of two identical half-cvcles). The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles, both of which follow the general process described here.
The hardware for the STERRAD NX 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, printer paper, and an optional movable cart. The STERRAD NX Sterilizer can be placed directly on a table, counter top, or on the movable STERRAD NX cart.
The STERRAD NX Sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. As previously described, the hydrogen peroxide is concentrated before introduction into the sterilizer chamber and its concentration is monitored during the cycle. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the pre-defined minimum concentration specification.
The STERRAD NX Sterilizer with ALLClear Technology incorporates enhancements and new features to improve reliability and usability, as briefly described following:
- . Load Conditioning Feature: 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.
6
Image /page/6/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a blue-green rounded rectangle. There is a registered trademark symbol in the upper right corner of the rectangle. The logo is simple and modern.
The technological characteristics associated with the sterilization process for the STERRAD NX Sterilizer with ALLClear Technology are identical to those of the previously cleared STERRAD NX Sterilizer; the software and hardware changes associated with the described enhancements and new features do not modify the existing sterilization cycles.
The intended use of the STERRAD NX Sterilizer, as described in the labeling, has not changed as a result of the modifications nor are there any differences between the predicate STERRAD NX and STERRAD NX with ALLClear Technology indications for use.
Intended Use/Indications For Use
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-●
-
Note: With the exception of the 1 x 850 mm flexible endoscopes, 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.
1 The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
- Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load.
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Image /page/7/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized font. The letters are white and are set against a blue-green background. The logo is enclosed in a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo.
Non-Clinical Data
- . Verification testing was conducted in support of the enhancements to the STERRAD NX Sterilizer that is the subject of this submission; all testing yielded passing results. This testing is summarized in the following table.
Summary of Performance Testing
| 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 from moisture that has been absorbed into the load
materials. | Pass |
| Load Conditioning Design
Verification | Study demonstrated that the modified device with load
conditioning feature enabled is effective in correcting 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 NX 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 -
ADVANCED 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 consist of all the parts to
enclose the sterilizer functional subsystems and control user-
access to only appropriate areas. | 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 NX system. | Pass |
| System Verification | Study verified new and related system requirements which
were not tested at the subsystem level. | Pass |
| | | Pass/ |
| Verification Testing | Description | Fail |
| 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 |
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Image /page/8/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a light blue background. The logo is enclosed in a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo.
Biocompatibility testing ●
In addition to the biocompatibility data submitted in the predicate device 510(k)s, 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 ADVANCED 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 NX complies with the requirements for radiated and conducted emissions in accordance with the following standards:
- IEC/EN 60601-1-2:2014 Medical Electrical Equipment, Part 1: General о Requirements for Safety, Section 2: Collateral Standard: Electromagnetic Compatibility
- EN 55011 Group I Class A limits, based on CISPR 11:2010, Group I Class A o limits (subset of EN 60601-1-2)
- . Electrical Safety testing was undertaken to demonstrate that the modified STERRAD NX is electrically and mechanically safe when operated and maintained in accordance with the User's Guide. Based upon this testing, the modified STERRAD NX Sterilizer conforms to the applicable sections of the standards listed following:
- CAN/CSA-C22.2 No. 61010-1:2004 + Update 1:2008 R: 2009 Safety O Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
- CAN/CSA-C22.2 No. 61010-2-040:2007-12 R:2013 Safety requirements for o electrical equipment for measurement, control and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
- UL 61010-1/R:2008-10 Standard for Safety for Electrical Equipment for o Laboratory Use
- 0 IEC/EN 61010-1:2001 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
- IEC/EN 61010-2-40:2005 Particular Requirements for Sterilizers and Washer o disinfectors used to Treat Medical Materials, First Edition
9
Image /page/9/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a light blue rounded rectangle. There is a registered trademark symbol in the upper right corner of the logo.
- . 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.
Summary
The STERRAD NX Sterilizer with ALLClear Technology and its predicate device, the originally cleared STERRAD NX Sterilizer, have the same intended use and indications for use. Further, the STERRAD NX Sterilizer with ALLClear Technology utilizes the same technology, sterilant, and cycles to sterilize medical devices as does its predicate device. Refer to the following tables for comparisons between the modified and predicate device characteristics and sterilization cycles.
| Comparison of Device Characteristics | |||
|---|---|---|---|
| Characteristic | Predicate | ||
| STERRAD NX Sterilizer | |||
| K042116 and K142454 | STERRAD NX Sterilizer | ||
| with ALLClear Technology | |||
| Intended Use | 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 | ||
| Sterilization Process | Hydrogen peroxide gas plasma | Same | |
| Principle of operation | Combined use of hydrogen peroxide vapor and | ||
| plasma safely and rapidly sterilizes most | |||
| medical instruments and materials without | |||
| leaving toxic residues. | Same | ||
| Sterilization Cycles | STANDARD and ADVANCED | Same | |
| Recommended Materials | Common materials found in reusable medical | ||
| devices. All medical devices should be | |||
| processed in accordance with the medical | |||
| device manufacturer's recommendations. | Same | ||
| Load Conditioning Feature | N/A | Yes | |
| Sterilizer Approx. Weight | 325 lb. | Same | |
| Sterilizer External Dimensions | 22.0" W x 33" H x 32" D | ||
| (558.8 mm x 838.2 mm x 812.8 mm) | 22.3" W x 35.7" H x 31.2" D | ||
| (565 mm x 906 mm x 792 mm) | |||
| Sterilizer Internal Dimensions | 12.6" W x 23.6" H x 6.2" L | ||
| (320 mm x 600 mm x 157 mm) | Same | ||
| Comparison of Device Characteristics | |||
| Characteristic | Predicate | ||
| STERRAD NX Sterilizer | |||
| K042116 and K142454 | STERRAD NX Sterilizer | ||
| with ALLClear Technology | |||
| Shelves | |||
| Shelf Dimensions | Upper & Lower: 23.6" L x 12.3" W | ||
| (600 mm x 312 mm) | Same | ||
| Shelf Weight Capacity | 24.3 lb (11 kg) | Same | |
| Distance Between Shelves | 3.4" (86 mm) | Same | |
| Chamber Volume | Usable: 30 liters (1.1 ft³) | ||
| Total: 51.3 liters (1.8 ft³) | Same | ||
| Major Component Materials | |||
| Chamber Components | Aluminum | Same | |
| Shelves | Passivated stainless steel | Same | |
| Chamber Door O-Ring | Viton | ||
| (copolymer of vinylidene fluoride & | |||
| hexafluoropropylene) | Same | ||
| Injector and Vaporizer | Aluminum, Ultem (Polyetherimide), Stainless | ||
| steel, Viton | Same | ||
| Exterior Panels | Structural Foam | Injection molding and | |
| Structural Foam | |||
| Operator Interface | |||
| Flat Panel Display | 6.4" touch screen | ||
| TFT (thin-film transistor) LCD | 8.4" touch screen | ||
| IPS (In Plane Switching) LCD | |||
| Graphical User Interface | Geode SC2200 266 MHz. | AMD Geode family CPU | |
| Hydrogen Peroxide Monitor | Cancels sterilization cycle if the areas under the | ||
| concentration-time curve or rate constant do not | |||
| meet predetermined specifications. | Same | ||
| Temperature | Chamber, chamber door and | ||
| vaporizer/condenser thermistors | Same | ||
| Pressure | Chamber pressure transducers | ||
| Chamber atmospheric pressure switch | |||
| Vaporizer/condenser pressure transducer | Same | ||
| Door sensors | Lock sensor | ||
| Closed sensor | Same | ||
| Connectivity | DTI (Digital Transfer interface) | ||
| Network connectivity software allows the | |||
| hospital IT department to connect the sterilizer | |||
| to a hospital local area network | Same | ||
| Comparison of Device Characteristics | |||
| Characteristic | Predicate | ||
| STERRAD NX Sterilizer | |||
| K042116 and K142454 | STERRAD NX Sterilizer | ||
| with ALLClear Technology | |||
| Accessories | STERRAD NX Cassette | ||
| Test Pack | |||
| CycleSure® Biological Indicator | |||
| STERRAD Chemical Indicator (CI) Strip | |||
| STERRAD SealSure™ CI Tape | |||
| Tyvek® Pouches | |||
| Instrument Trays | Same |
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Image /page/10/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a light blue background. The logo is enclosed in a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo.
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Image /page/11/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized font. The letters are white and are set against a light blue background. The logo is enclosed in a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo.
| Comparison of Sterilization Cycles | ||
|---|---|---|
| Phase | Predicate | |
| STERRAD NX Sterilizer | ||
| K042116 and K142454 | STERRAD NX Sterilizer | |
| with ALLClear Technology | ||
| Exposure 1 | ||
| Delivery | The hydrogen peroxide is transferred from the | |
| cassette into the vaporizer. | Same | |
| Vaporization Pumpdown | The pressure within the chamber and vaporizer/ | |
| condenser is reduced. Water is removed from the | ||
| hydrogen peroxide solution, leaving behind a | ||
| concentrated hydrogen peroxide solution in the | ||
| condenser. | Same | |
| Chamber Pumpdown | The chamber is isolated from the | |
| vaporizer/condenser. The chamber pressure is | ||
| reduced to remove air from the lumens. | Same | |
| Transfer | The concentrated hydrogen peroxide solution is | |
| transferred to the chamber where it penetrates | ||
| throughout the load. | Same | |
| Diffusion | Chamber pressure is increased in order to drive | |
| hydrogen peroxide is through the load packaging | ||
| onto the surfaces of the devices and into the | ||
| lumens of the load. | Same | |
| Plasma Pumpdown/Plasma | Plasma power is applied to the electrode screen | |
| and the plasma is lit. | Same | |
| Vent | The chamber is vented to atmospheric pressure. | Same |
| Exposure 2 | Identical to Exposure 1 | Same |
| Final Vent | The chamber is vented to atmospheric pressure. | Same |
| Total Cycle Time | ||
| STANDARD | 28 minutes | Same |
| ADVANCED | 38 minutes | Same |
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Image /page/12/Picture/0 description: The image shows a logo with the letters "ASP" in white against a light blue rounded rectangle. The "A" is represented by a triangle without a horizontal line. A small circled "R" symbol is located in the upper right corner of the rectangle, indicating a registered trademark.
Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the STERRAD NX Sterilizer with ALLClear Technology that is the subject of 510(k) K160818 is substantially equivalent to the predicate devices cleared under K042116 and K142454.