(91 days)
No
The summary describes a sterilization device based on hydrogen peroxide gas plasma technology and its performance testing. There is no mention of AI or ML in the device description, intended use, or performance studies. The "ALLClear Technology" is mentioned in the predicate device, but the description focuses on expanding lumen claims and does not indicate AI/ML functionality.
No.
The STERRAD NX Sterilizer is a device designed for the sterilization of medical devices, not for treating diseases or conditions directly in patients. Its function is to prepare other medical devices for safe use.
No.
This device, the STERRAD NX Sterilizer, is designed for the sterilization of medical devices, not for diagnosing medical conditions. Its purpose is to kill microorganisms on other medical instruments using hydrogen peroxide vapor and plasma.
No
The device description explicitly states that the STERRAD NX Sterilizer is a "self-contained stand-alone system of hardware and software" and details various hardware components like a sterilizer chamber, instruments, components, and accessories.
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 instruments using hydrogen peroxide vapor and plasma. This aligns with a sterilization process, not an in vitro diagnostic test.
- 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.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Using reagents or assays to detect analytes
The STERRAD NX Sterilizer is a device used to prepare other medical devices for use, ensuring they are free from viable microorganisms. This falls under the category of a sterilizer, which is a type of medical device, but not an IVD.
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.†
- . Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter.†
†The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing.
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 PE/PTFE flexible endoscopes with an inside diameter of 1 mm or larger and a length of 1065 mm or shorter. *
Note: With the exception of the flexible endoscopes, the validation studies were performed using a validation load consisting of devices in one instrument tray weighing 10.7 lbs (4.9 kg). The flexible endoscopes were validated without any additional load.**
†The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing.
- Only one flexible endoscope up to 1065 mm long with or without APTIMAX Instrument Tray Holders can be used per cycle, or only one flexible endoscope up to 850 mm long per cycle with or without a STERRAD Instrument Tray Mat. No additional load. Check the medical device manufacturer's instructions for use prior to processing any scope in the STERRAD NX Sterilizer; and check if Instrument tray mats or only tray holders are validated for use with flexible endoscopes longer than 850 mm.
**The validation testing for flexible endoscopes up to 850 mm long was conducted with one endoscope per cycle using a STERRAD Instrument Tray Mat to help protect the endoscope no additional load. The validation testing for flexible endoscopes longer that 850 mm was conducted with one endoscope per cycle using APTIMAX Instrument Tray Holders to assist with device placement and help protect the endoscope: no additional load.
Product codes
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 aqueous hydrogen peroxide into the vaporizer where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas plasma using electrical energy. The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles.
The sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. The hydrogen peroxide is concentrated before 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 specification.
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. 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, countertop, or on the movable cart.
An expansion of existing claims is being applied to the ADVANCED Cycle without affecting the technology, software, or other physical features of the subject device.
The STERRAD NX Sterilizer with ALLClear Technology described within this submission expands the indications of the ADVANCED Cycle of the Sterilizer to include single channel flexible endoscopes with extended dimensions of 1065mm in length when the inside diameter is ≥1mm. The previously cleared dimensions of the predicate device are 850mm in length when the inside diameter is ≥1mm. There are no other changes to the indications for use of the ADVANCED Cycle. The ADVANCED Cycle is compatible with single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1mm or larger and length of 1065mm or shorter2
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
Performance testing was conducted to verify that single channel flexible endoscopes with the expanded lumen claim of ≥ 1mm diameter x ≤ 1065mm length can be successfully sterilized by the ADVANCED Cycle of the STERRAD NX Sterilizer with ALLClear Technology. No clinical data was generated in support of this submission.
Biocompatibility Study:
- Description: The proposed changes to the indications for use do not affect sterilization cycle parameters, sterilant, sterilant injection volume, or types of materials processed in the sterilizer. The previously submitted biocompatibility data for the predicate device (K160818) remains applicable to the subject STERRAD NX Sterilizer with ALLClear Technology.
- Acceptance Criteria: Process residual levels remaining on/in materials used in the sterilizer shall be non-toxic when evaluated by in vivo toxicity tests.
- Results: Pass
Dose Response Study:
- Description: Study demonstrated sterility assurance level of (SAL) of 10-6 was reached when processing single channel flexible endoscopes with expanded claim (≥ 1 mm diameter X ≤ 1065 mm) in STERRAD NX ADVANCED half-cycle conditions.
- Study demonstrated a total kill of BIs in the half cycle condition at 1.5 mL of 53% hydrogen peroxide injected.
- The results demonstrated an increasing number of sterile BIs corresponding to an increasing injection volume of hydrogen peroxide.
- The positive control demonstrated growth and the negative control demonstrated no growth.
- Acceptance Criteria:
- BI Samples from 1.5mL of 53% hydrogen peroxide in half cycles shall be sterile at the end of the incubation period.
- A trend of increasing number of sterile BIs corresponding to the increasing injection volume of hydrogen peroxide must be seen.
- Positive control demonstrates growth and negative control demonstrates no growth.
- Results: Pass
Simulated Use Study:
- Description: Study demonstrated sterilization efficacy of flexible endoscopes with proposed claims expansion of ≥1 mm diameter x ≤1065 mm in length when processed in the STERRAD NX ADVANCED cycle.
- The spore log reduction was greater than 6 for all test devices.
- The positive controls ranged from 1.6 x 106 to 1.8 x 106 CFU
- Acceptance Criteria:
- Spore log reduction must be greater than 6 for test devices.
- Positive control shall show a combined exhaustive recovery of at least 1 x 106 CFU.
- Results: Pass
Key Metrics
- Sterility Assurance Level (SAL) of 10^-6
- Spore log reduction greater than 6 for test devices
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 16, 2022
Advanced Sterilization Products, Inc. Katy Nennig Senior Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618
Re: K220404
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: February 6, 2022 Received: February 14, 2022
Dear Katy Nennig:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220404
Device Name
STERRAD® NX™ Sterilizer with ALLClear 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. ↑
· Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter. ↑ 7 The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not
exceed the maximum number of lumens validated by this testing.
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 PE/PTFE flexible endoscopes with an inside diameter of 1 mm or larger and a length of 1065 mm or shorter.*
Note: With the exception of the flexible endoscopes, the validation studies were performed using a validation load consisting of devices in one instrument tray weighing 10.7 lbs (4.9 kg). The flexible endoscopes were validated without any additional load. **
f The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing.
- Only one flexible endoscope up to 1065 mm long with or without APTIMAX Instrument Tray Holders can be used per cycle, or only one flexible endoscope up to 850 mm long per cycle with or without a STERRAD Instrument Tray Mat. No additional load. Check the medical device manufacturer's instructions for use prior to processing any scope in the STERRAD NX Sterilizer; and check if Instrument tray mats or only tray holders are validated for use with flexible endoscopes longer than 850 mm.
** The validation testing for flexible endoscopes up to 850 mm long was conducted with one endoscope per cycle using a STERRAD Instrument Tray Mat to help protect the endoscope no additional load. The validation testing for flexible endoscopes longer that 850 mm was conducted with one endoscope per cycle using APTIMAX Instrument Tray Holders to assist with device placement and help protect the endoscope: 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
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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 the logo for Advanced Sterilization Products (ASP). The logo consists of the letters "ASP" in a stylized, connected font, with the words "Advanced Sterilization Products" written to the right of the letters. The letters and words are in a dark blue color. The logo is simple and professional, and it is likely used to represent the company's brand.
510(k) Summary Advanced Sterilization Products, Inc. STERRAD® NX Sterilizer with ALLClear™ Technology ADVANCED Cycle Claims Expansion
This summary of 510(k) information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | Advanced Sterilization Products, Inc. |
|---|---|
| Address: | 33 Technology Drive |
| Irvine, CA 92618 | |
| Contact Person: | Katy Nennig |
| Senior Regulatory Affairs Specialist | |
| Tel: (920)254-6370 | |
| Email: Katelyn.nennig@asp.com | |
| Date Prepared: | May 11th, 2022 |
Device Name
| Proprietary Name: | STERRAD® NX Sterilizer with ALLClearTM 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 with ALLClear® Technology cleared via 510(k) K160818 on September 27, 2016.
Device Description
The STERRAD NX Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas plasma using electrical energy. The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles.
5
Image /page/5/Picture/1 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo is in a dark blue color. The letters "ASP" are in a bold, sans-serif font, with the "S" being larger than the "A" and "P". To the right of the letters, the words "Advanced Sterilization Products" are written in a smaller, sans-serif font.
The sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. The hydrogen peroxide is concentrated before 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 specification.
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. 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, countertop, or on the movable cart.
An expansion of existing claims is being applied to the ADVANCED Cycle without affecting the technology, software, or other physical features of the subject device.
The STERRAD NX Sterilizer with ALLClear Technology described within this submission expands the indications of the ADVANCED Cycle of the Sterilizer to include single channel flexible endoscopes with extended dimensions of 1065mm in length when the inside diameter is ≥1mm. The previously cleared dimensions of the predicate device are 850mm in length when the inside diameter is ≥1mm. There are no other changes to the indications for use of the ADVANCED Cycle. The ADVANCED Cycle is compatible with single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1mm or larger and length of 1065mm or shorter2
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.t
- . Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter.t
†The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing.
6
Image /page/6/Picture/1 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo consists of the letters "ASP" in a stylized, bold, dark blue font. To the right of the letters, the words "Advanced Sterilization Products" are written in a smaller, lighter font. The logo is simple and professional, conveying a sense of trust and reliability.
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 PE/PTFE flexible endoscopes with an inside diameter of 1 mm or larger and a length of 1065 mm or shorter. *
Note: With the exception of the flexible endoscopes, the validation studies were performed using a validation load consisting of devices in one instrument tray weighing 10.7 lbs (4.9 kg). The flexible endoscopes were validated without any additional load.**
†The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing.
- Only one flexible endoscope up to 1065 mm long with or without APTIMAX Instrument Tray Holders can be used per cycle, or only one flexible endoscope up to 850 mm long per cycle with or without a STERRAD Instrument Tray Mat. No additional load. Check the medical device manufacturer's instructions for use prior to processing any scope in the STERRAD NX Sterilizer; and check if Instrument tray mats or only tray holders are validated for use with flexible endoscopes longer than 850 mm.
**The validation testing for flexible endoscopes up to 850 mm long was conducted with one endoscope per cycle using a STERRAD Instrument Tray Mat to help protect the endoscope no additional load. The validation testing for flexible endoscopes longer that 850 mm was conducted with one endoscope per cycle using APTIMAX Instrument Tray Holders to assist with device placement and help protect the endoscope: no additional load.
Technological Characteristics Comparison
The following table provides a comparison of the technological characteristics associated with the sterilization process of the proposed STERRAD NX Sterilizer with ALLClear Technology with expanded indications for the ADVANCED Cycle as compared to those of the previously cleared STERRAD NX with ALLClear Technology.
| Device & Predicate Device(s): | K160818 | K220404 |
|---|---|---|
| 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. | 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. |
| Table 5.1 Technological Characteristics Comparison | ||
|---|---|---|
7
Image /page/7/Picture/1 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo consists of the letters "ASP" in a stylized, connected font, with the words "Advanced Sterilization Products" to the right of the letters. The letters are in a dark purple color, while the words are in a lighter gray color. The logo is simple and modern, and it effectively communicates the company's focus on sterilization products.
| Device & Predicate Device(s): | K160818 | K220404 |
|---|---|---|
| Sterilization Process | Hydrogen peroxide gas plasma | Hydrogen peroxide gas plasma |
| Principle of Operation | Combined use of hydrogen | |
| peroxide vapor and plasma safely | ||
| and rapidly sterilizes most medical | ||
| instruments and materials with | ||
| leaving toxic residues. | Combined use of hydrogen | |
| peroxide vapor and plasma safely | ||
| and rapidly sterilizes most medical | ||
| instruments and materials with | ||
| leaving toxic residues. | ||
| Pre-Programmed Sterilization | ||
| Cycles | Two Cycles: | |
| STANDARD and ADVANCED | Two Cycles: | |
| STANDARD and ADVANCED | ||
| Material Compatibility | ||
| (Recommended Materials) | Common materials found in | |
| reusable medical devices. All | ||
| medical devices should be | ||
| processed in accordance with the | ||
| medical device manufacturer's | ||
| recommendations. | Common materials found in | |
| reusable medical devices. All | ||
| medical devices should be | ||
| processed in accordance with the | ||
| medical device manufacturer's | ||
| recommendations. | ||
| Approximate Cycle Time | STANDARD Cycle: 28 Minutes | |
| ADVANCED Cycle: 38 Minutes | STANDARD Cycle: 28 Minutes | |
| ADVANCED Cycle: 38 Minutes | ||
| Hydrogen Peroxide Monitor | Cancels sterilization cycle if the | |
| areas under the concentration-time | ||
| curve or rate constant do not meet | ||
| predetermined specifications. | Cancels sterilization cycle if the | |
| areas under the concentration-time | ||
| curve or rate constant do not meet | ||
| predetermined specifications. | ||
| Temperature | Chamber, Chamber door and | |
| vaporizer/condenser thermistors | Chamber, Chamber door and | |
| vaporizer/condenser thermistors | ||
| Pressure | Chamber pressure transducers | |
| Chamber atmospheric pressure | ||
| switch Vaporizer/condenser | ||
| pressure transducer | Chamber pressure transducers | |
| Chamber atmospheric pressure | ||
| switch Vaporizer/condenser | ||
| pressure transducer |
Summary of Non-Clinical Testing
Performance testing was conducted to verify that single channel flexible endoscopes with the expanded lumen claim of ≥ 1mm diameter x ≤ 1065mm length can be successfully sterilized by the ADVANCED Cycle of the STERRAD NX Sterilizer with ALLClear Technology. No clinical data was generated in support of this submission.
| Testing
Methodology | Description | Acceptance Criteria | Results
(Pass/Fail) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Biocompatibility | The proposed changes to the indications for use
do not affect sterilization cycle parameters,
sterilant, sterilant injection volume, or types of
materials processed in the sterilizer. The
previously submitted biocompatibility data for
the predicate device (K160818) remains
applicable to the subject STERRAD NX Sterilizer
with ALLClear Technology. | Process residual levels remaining
on/in materials used in the
sterilizer shall be non-toxic when
evaluated by in vivo toxicity tests. | Pass |
Table 5.2 Performance Testing Results
8
Image /page/8/Picture/1 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo consists of the letters "ASP" in a stylized, bold, sans-serif font, with the letters connected. To the right of the letters, the words "Advanced Sterilization Products" are stacked vertically in a smaller, sans-serif font. The color of the logo is a dark blue or purple.
| Testing
Methodology | Description | Acceptance Criteria | Results
(Pass/Fail) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Dose Response | Study demonstrated sterility assurance level of
(SAL) of 10-6 was reached when processing
single channel flexible endoscopes with
expanded claim (≥ 1 mm diameter X ≤ 1065
mm) in STERRAD NX ADVANCED half-cycle
conditions.
• Study demonstrated a total kill of BIs in the
half cycle condition at 1.5 mL of 53% hydrogen
peroxide injected.
• The results demonstrated an increasing
number of sterile BIs corresponding to an
increasing injection volume of hydrogen
peroxide.
• The positive control demonstrated growth and
the negative control demonstrated no growth. | • BI Samples from 1.5mL of 53%
hydrogen peroxide in half cycles
shall be sterile at the end of the
incubation period
• A trend of increasing number of
sterile BIs corresponding to the
increasing injection volume of
hydrogen peroxide must be seen.
• Positive control demonstrates
growth and negative control
demonstrates no growth | Pass |
| Simulated Use | Study demonstrated sterilization efficacy of
flexible endoscopes with proposed claims
expansion of ≥1 mm diameter x ≤1065 mm in
length when processed in the STERRAD NX
ADVANCED cycle.
• The spore log reduction was greater than 6
for all test devices.
• The positive controls ranged from 1.6 x 106 to
1.8 x 106 CFU | • Spore log reduction must be
greater than 6 for test devices.
• Positive control shall show a
combined exhaustive recovery of
at least 1 x 106 CFU | Pass |
The results of performance testing demonstrates that single channel flexible endoscopes with lumen dimensions of ≥ 1mm x ≤ 1065mm can be sterilized by the ADVANCED Cycle of the STERRAD NX Sterilizer.
Summary
The subject device, STERRAD NX Sterilizer with ALLClear Technology with expanded indications, and its predicate device utilize the same technology, sterilization cycles, and sterilization methods to sterilize medical devices. Based on the results of the performance testing, the indications of the ADVANCED Cycle does not raise any new questions of safety or effectiveness.
Conclusion
The conclusions drawn from the non-clinical performance data demonstrate that the subject device, STERRAD NX with ALLClear Technology including the ADVANCED Cycle indications expansion, is as safe,
9
Image /page/9/Picture/1 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo consists of the letters "ASP" in a bold, sans-serif font, with the words "Advanced Sterilization Products" to the right of the letters. The letters are in a dark blue color, and the words are in a smaller, lighter font.
as effective, and performs as well or better than the legally marketed predicate device cleared via K160818.