(196 days)
The STERRAD 100NX Sterilizer with ALLClear Technology 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 Sterilize 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. A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.
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 1065 mm or shorter. A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.
Note: With the exception of the 1 x 1065 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 1065 mm flexible endoscopes were validated without any additional load.
The STERRAD 100NX EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures.
• It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors
· It can sterilize rigid and semi-rigid endoscopes without lumens.
Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 lbs placed on the bottom shelf.
The STERRAD 100NX DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions:
• Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter
· Accessory devices that are normally connected to a flexible endoscope during use
• Flexible endoscopes without lumens
Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs.
The STERRAD 100NX Sterilizer ULTRA GI Cycle is designed for sterilization of the following:
• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions having an inside diameter (ID) of ≥1mm x ≤1500mm in length, or ≥2mm ID x ≤1630mm in length.
· One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle
Notel : The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf. Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD User Guide "STERRAD Sterilizer Cycle Selection table" for ULTRA GI Cycle compatible duodenoscopes.
The APTIMAX™ Tray for ULTRA GI™ Cycle is designed to encase surgical instruments for sterilization in STERRAD™ 100NX Sterilization System with ALLCLEAR™ Technology:
• ULTRA GI™ Cycle
The STERRAD 100NX Sterilization System with ALLClear Technology 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 sterilization process is a multiphase process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to achieve sterilization. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, biological indicator products and sterilant cassettes. The STERRAD 100NX Sterilizer has four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles.
The STERRAD 100NX Sterilizer described within this submission introduces the new ULTRA GI Cycle along with the new APTIMAX Instrument Tray for ULTRA GI Cycle.
The STERRAD 100NX Sterilizer ULTRA GI Cycle is an additional cycle designed for sterilization of the following:
- Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more ● than 4 channels, with lumen dimensions having an inside diameter (ID) of ≥1mm x ≤1500mm in length, or ≥2mm ID x ≤1630mm in length.
- . One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle
Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.
Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes.
The APTIMAX Instrument Tray for ULTRA GI Cycle is designed to encase surgical instruments for sterilization in STERRAD 100NX Sterilization System with ALLClear Technology:
- ULTRA GI Cycle .
This cycle is designed to run on STERRAD 100NX System with ALLClear Technology with the DUO Module enabled. ALLClear Technology features of Load Check, System Check, and Load Conditioning are integrated into the ULTRA GI cycle.
The provided text describes the acceptance criteria and study results for the STERRAD™ 100NX Sterilizer with ALLClear™ Technology, specifically for the new ULTRA GI™ Cycle, and the APTIMAX™ Instrument Tray for ULTRA GI Cycle.
Here's an breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides two tables: Table 3 for the STERRAD 100NX Sterilizer and Table 4 for the APTIMAX Instrument Tray.
Table 3. Performance Test Results - STERRAD 100NX Sterilizer (ULTRA GI Cycle)
| Test | Acceptance Criteria | Results |
|---|---|---|
| Sterilization Verification | SAL of 10-6 shall be demonstrated. | Pass |
| Surface Sterilization | All test samples show no growth. | Pass |
| Mated Surface Sterilization | All test samples show no growth. | Pass |
| Growth Inhibition | No growth inhibition shall be indicated for processed samples. | Pass |
| In Use Test | Cycle performance shall be validated using scopes under in-use conditions. | Pass |
| Biocompatibility | The biological safety of materials shall be demonstrated following exposure to the sterilant agent. | Pass |
| Simulated Use Test | Microbial performance should be demonstrated under simulated conditions. | Pass |
| Device Functionality and Material Compatibility | GI Endoscopes shall remain within the manufacturer's functional specifications post processing. | Pass |
| Final Process Qualification | The critical process parameter values shall conform to the specifications for the STERRAD® 100NX™ Sterilizer Titan Cycle. | Pass |
| Usability | System must demonstrate it can be used safely and effectively by the intended users, under the expected conditions, without producing hazardous situations or unacceptable use errors. | Pass |
Table 4. Performance Test Results - APTIMAX Instrument Tray for ULTRA GI Cycle
| Test | Acceptance Criteria | Results |
|---|---|---|
| Tray Life Test | Pre-determined target cycle number was set for testing and shall be achieved post completion | Pass |
| Tray Design Verification | The proposed design must meet the specifications for: 1. Stress/pressure testing 2. Temperature 3. Material 4. Weight | Pass |
| Manual Cleaning of Tray | Cleaning efficacy results of material shall be below the pre-established limit | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the numerical sample size for the test sets. However, it mentions procedures like "validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs" for existing cycles and similar descriptions for the ULTRA GI cycle (e.g., "validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf"). These refer to the type and weight of the sterilization load, not the statistical sample size for performance validation.
The data provenance is from non-clinical testing conducted by Advanced Sterilization Products, Inc., likely within the United States (given it's an FDA submission for a US company). These are prospective tests performed specifically for this submission to demonstrate the device's efficacy and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described is for a sterilization device, which typically relies on laboratory microbiologists and engineers to establish ground truth through direct measurement of sterilization efficacy (e.g., elimination of spores, microbial growth inhibition) and material compatibility, rather than clinical experts like radiologists interpreting images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. Adjudication methods like '2+1' or '3+1' are typical for studies involving human interpretation of medical images or data where expert consensus is needed. For a sterilization device, the "ground truth" (e.g., sterility, material integrity) is established through objective, quantifiable laboratory performance tests, not through expert consensus or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a sterilizer, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical sterilizer system with hardware and software controlling the sterilization process. Its performance is inherent to the system itself, not an algorithm that performs a standalone task in isolation from human input or a physical process, in the way a diagnostic algorithm would. The tests aim to demonstrate the sterilizer's ability to achieve sterility without human intervention in the sterilization process, only the loading and unloading of instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the sterilization efficacy tests is microbiological validation (e.g., demonstration of a Sterility Assurance Level (SAL) of 10-6, absence of microbial growth). For material compatibility, the ground truth is the maintenance of manufacturer's functional specifications for the processed endoscopes and the biological safety of materials post-sterilization. For the tray, it's the mechanical and physical integrity and cleaning efficacy. These are objective, empirically measured outcomes.
8. The sample size for the training set:
This is not applicable. The document describes a physical medical device (sterilizer) and its accessory tray. It's not an AI/ML device that requires a training set of data. The "training" for such a device occurs during its design and development, through engineering principles, material science, and iterative testing, not through a data-driven training set in the AI sense.
9. How the ground truth for the training set was established:
This is not applicable, as it's not an AI/ML device requiring a training set. The "ground truth" for the device's design and functionality would be established through established engineering standards, sterilization guidelines (e.g., AAMI standards), and internal R&D validation processes.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 5, 2024
Advanced Sterilization Products Ayse Erkan Sr. Regulatory Affairs Program Lead 33 Technology Dr. Irvine, California 92618
Re: K234082
Trade/Device Name: STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104); APTIMAX™ Instrument Tray for ULTRA GITM Cycle (011077) Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene oxide gas sterilizer Regulatory Class: Class II Product Code: MLR, FRG Dated: December 22, 2023 Received: June 7, 2024
Dear Ayse Erkan:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Christopher K. Dugard -S
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control
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and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K234082
Device Name
STERRAD™ 100NX Sterilizer with ALLClear™ Technology and ULTRA GIT™ Cycle (10104) APTIMAX™ Instrument Tray for ULTRA GI Cycle (011077)
Indications for Use (Describe)
The STERRAD 100NX Sterilizer with ALLClear Technology 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 Sterilize 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. A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.
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 1065 mm or shorter. A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.
Note: With the exception of the 1 x 1065 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 1065 mm flexible endoscopes were validated without any additional load.
The STERRAD 100NX EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures.
• It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors
· It can sterilize rigid and semi-rigid endoscopes without lumens.
Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 lbs placed on the bottom shelf.
The STERRAD 100NX DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions:
• Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter
· Accessory devices that are normally connected to a flexible endoscope during use
• Flexible endoscopes without lumens
Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs.
The STERRAD 100NX Sterilizer ULTRA GI Cycle is designed for sterilization of the following:
• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen
dimensions having an inside diameter (ID) of ≥1mm x ≤1500mm in length, or ≥2mm ID x ≤1630mm in length.
· One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle
Notel : The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf. Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD User Guide "STERRAD Sterilizer Cycle Selection table" for ULTRA GI Cycle compatible duodenoscopes.
The APTIMAX™ Tray for ULTRA GI™ Cycle is designed to encase surgical instruments for sterilization in
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STERRAD™ 100NX Sterilization System with ALLCLEAR™ Technology:
• ULTRA GI™ Cycle
Type of Use (Select one or both, as applicable)
7 Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for K234082 Advanced Sterilization Products, Inc. STERRAD™ 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle APTIMAX™ Instrument Tray for ULTRA GI Cycle
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, Inc. |
|---|---|
| Address: | 33 Technology DriveIrvine, CA 92618 |
| Contact Person: | Ayse ErkanSenior Regulatory Affairs Program LeadTelephone: (714)580-2880Email: ayse.erkan@asp.com |
Date Prepared: July 1, 2024
Devices Names
| Proprietary Name: | STERRAD™ 100NXSterilizer with ALLClear™Technology and ULTRAGI™ Cycle (10104) | APTIMAX™ InstrumentTray for ULTRA GI Cycle(011077) |
|---|---|---|
| Device Common Name: | Hydrogen Peroxide GasPlasma Sterilization System | Sterilizable Instrument Trayand Accessories |
| Classification Name: | Ethylene Oxide Gas Sterilizer | Wrap, sterilization |
| Product Code: | MLR | FRG |
| Device Class: | Class II | Class II |
| CFR Section: | 21 CFR 880.6860 | 21 CFR 880.6850 |
Predicate Devices
STERRAD 100NX Sterilizer with ALLClear Technology K212174 cleared October 9, 2021 APTIMAX Instrument Tray K013003 cleared August 28, 2002.
Reference Device
EOGas 4 Ethylene Oxide Gas Sterilizer K192978 cleared November 12, 2020.
Device Description
The STERRAD 100NX Sterilization System with ALLClear Technology 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 sterilization process is a multiphase process that utilizes a combination of
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exposure to hydrogen peroxide vapor and plasma to achieve sterilization. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, biological indicator products and sterilant cassettes. The STERRAD 100NX Sterilizer has four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles.
The STERRAD 100NX Sterilizer described within this submission introduces the new ULTRA GI Cycle along with the new APTIMAX Instrument Tray for ULTRA GI Cycle.
The STERRAD 100NX Sterilizer ULTRA GI Cycle is an additional cycle designed for sterilization of the following:
- Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more ● than 4 channels, with lumen dimensions having an inside diameter (ID) of ≥1mm x ≤1500mm in length, or ≥2mm ID x ≤1630mm in length.
- . One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle
Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.
Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes.
The APTIMAX Instrument Tray for ULTRA GI Cycle is designed to encase surgical instruments for sterilization in STERRAD 100NX Sterilization System with ALLClear Technology:
- ULTRA GI Cycle .
This cycle is designed to run on STERRAD 100NX System with ALLClear Technology with the DUO Module enabled. ALLClear Technology features of Load Check, System Check, and Load Conditioning are integrated into the ULTRA GI cycle.
Intended Use/Indications for Use
The intended use of the subject STERRAD 100NX Sterilizer with ALClear Technology has not changed with the proposed expanded indications for use in the ULTRA GI Cycle. The APTIMAX Tray for ULTRA GI Cycle is designed to encase surgical instruments for sterilization in STERRAD 100NX Sterilization System with ALLCLEAR Technology. Refer to Table 1, Comparison between the subject device and predicate devices and Table 2, APTIMAX ULTRA GI Instrument Tray Predicate Device Comparison for of Intended Use & Indications for Use Comparison.
Technological Characteristics
The technological characteristics associated with the sterilization process of the proposed STERRAD 100NX Sterilizer with ALLClear Technology with expanded indications for the ULTRA GI Cycle in combination with the APTIMAX Tray for ULTRA GI Cycle is designed to run on STERRAD 100NX System with ALLClear Technology with the DUO Module enabled. ALLClear Technology features of Load Check, System Check, and Load Conditioning are integrated into the ULTRA GI cycle.
The subject devices continue to have the same technological characteristics, sterilization, performance, and physical traits as the predicate devices, STERRAD 100NX Sterilizer with ALL Clear Technology and the APTIMAX Instrument Tray.
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| Feature | STERRAD 100NX Sterilizer withALLClear Technology with ULTRAGI Cycle Subject Device | STERRAD 100NX Sterilizer withALLClear TechnologyK212174 Predicate Device | Comparison |
|---|---|---|---|
| Intended Use | Designed for sterilization of both metaland nonmetal medical devices at lowtemperatures. Because the cycle operateswithin a dry environment and at lowtemperatures, it is especially suitable forinstruments sensitive to heat andmoisture. | Designed for sterilization of both metaland nonmetal medical devices at lowtemperatures. Because the cycle operateswithin a dry environment and at lowtemperatures, it is especially suitable forinstruments sensitive to heat andmoisture. | Identical |
| Indicationsfor Use | The STERRAD 100NX Sterilizer withALLClear Technology is designed forsterilization of both metal and nonmetalmedical devices at low temperatures. TheSTERRAD sterilization process is amultiphase sterilization process thatutilizes a combination of exposure tohydrogen peroxide vapor and plasma tosafely sterilize medical instruments andmaterials without leaving toxic residue.The STERRAD 100NX Sterilizer cansterilize instruments which have diffusion-restricted spaces, such as the hingedportion of forceps and scissors.Medical devices with the followingmaterials and dimensions can beprocessed in the STERRAD 100NXSterilizer STANDARD cycle:Single channel stainless steellumens with an inside diameter of0.7 mm or larger and a length of 500mm or shorter. A maximum of tensingle channel stainless steel lumens,five per tray per sterilization cycle.Medical devices, including most flexibleendoscopes, with the following materialsand dimensions can be processed in theSTERRAD 100NX Sterilizer FLEX Scopecycle:Single channel polyethylene andTeflon (polytetrafluoroethylene) | The STERRAD 100NX Sterilizer withALLClear Technology is designed forsterilization of both metal and nonmetalmedical devices at low temperatures. TheSTERRAD sterilization process is amultiphase sterilization process thatutilizes a combination of exposure tohydrogen peroxide vapor and plasma tosafely sterilize medical instruments andmaterials without leaving toxic residue.The STERRAD 100NX Sterilizer cansterilize instruments which have diffusion-restricted spaces, such as the hingedportion of forceps and scissors.Medical devices with the followingmaterials and dimensions can beprocessed in the STERRAD 100NXSterilizer STANDARD cycle:Single channel stainless steellumens with an inside diameter of0.7 mm or larger and a length of 500mm or shorter. A maximum of tensingle channel stainless steel lumens,five per tray per sterilization cycle.Medical devices, including most flexibleendoscopes, with the following materialsand dimensions can be processed in theSTERRAD 100NX Sterilizer FLEX Scopecycle:Single channel polyethylene andTeflon (polytetrafluoroethylene) | Similar,includesadditionalindications forUse for ULTRAGI cycle. |
| flexible endoscopes with an insidediameter of 1 mm or larger andlength of 1065 mm or shorter. Amaximum of two flexibleendoscopes, one per tray persterilization cycle. No additional load.Note: With the exception of the 1 x 1065mm flexible endoscopes, the validationstudies were performed using a validationload consisting of two instrument trayseach weighing 10.7 lbs. The 1 x 1065 mm | flexible endoscopes with an insidediameter of 1 mm or larger andlength of 1065 mm or shorter. Amaximum of two flexibleendoscopes, one per tray persterilization cycle. No additional load.Note: With the exception of the 1 x 1065mm flexible endoscopes, the validationstudies were performed using a validationload consisting of two instrument trayseach weighing 10.7 lbs. The 1 x 1065 mm | ||
| Feature | STERRAD 100NX Sterilizer withALLClear Technology with ULTRAGI Cycle Subject Device | STERRAD 100NX Sterilizer withALLClear TechnologyK212174 Predicate Device | Comparison |
| flexible endoscopes were validatedwithout any additional load. | flexible endoscopes were validatedwithout any additional load. | ||
| The STERRAD 100NX EXPRESS Cycle isan additional optional cycle designedfor surface sterilization of both metaland nonmetal medical devices at lowtemperatures. | The STERRAD 100NX EXPRESS Cycle isan additional optional cycle designedfor surface sterilization of both metaland nonmetal medical devices at lowtemperatures. | ||
| It can sterilize instrument surfacesand instruments having diffusion-restricted spaces, such as the hingedportion of forceps and scissors It can sterilize rigid and semi-rigidendoscopes without lumens. Note: The validation studies forEXPRESS Cycle were performed usinga validation load consisting of a singleinstrument tray weighing 10.7 lbsplaced on the bottom shelf. | It can sterilize instrument surfacesand instruments having diffusion-restricted spaces, such as the hingedportion of forceps and scissors It can sterilize rigid and semi-rigidendoscopes without lumens. Note: The validation studies forEXPRESS Cycle were performed usinga validation load consisting of a singleinstrument tray weighing 10.7 lbsplaced on the bottom shelf. | ||
| The STERRAD 100NX DUO Cycle is anadditional optional cycle designed forsterilization of medical devicesincluding most flexible endoscopes,with the following materials anddimensions: | The STERRAD 100NX DUO Cycle is anadditional optional cycle designed forsterilization of medical devicesincluding most flexible endoscopes,with the following materials anddimensions: | ||
| Single channel polyethylene andTeflon (polytetrafluoroethylene)flexible endoscopes with an insidediameter of 1 mm or larger and alength of 875 mm or shorter Accessory devices that arenormally connected to a flexibleendoscope during use Flexible endoscopes withoutlumens Note: The validation studies for DUOCycle were performed using avalidation load consisting of twoflexible endoscopes with theiraccessory devices weighing a total of13.2 lbs. | Single channel polyethylene andTeflon (polytetrafluoroethylene)flexible endoscopes with an insidediameter of 1 mm or larger and alength of 875 mm or shorter Accessory devices that arenormally connected to a flexibleendoscope during use Flexible endoscopes withoutlumens Note: The validation studies for DUOCycle were performed using avalidation load consisting of twoflexible endoscopes with theiraccessory devices weighing a total of13.2 lbs. | ||
| The STERRAD 100NX Sterilizer ULTRAGI Cycle is designed for sterilization ofthe following: | |||
| Hydrogen peroxide compatibleflexible multi-channelduodenoscopes, with no morethan 4 channels, with lumendimensions having an insidediameter (ID) of ≥1mm x≤1500mm in length, or≥2mm ID x ≤1630mm inlength. | |||
| Feature | STERRAD 100NX Sterilizer withALLClear Technology with ULTRAGI Cycle Subject Device | STERRAD 100NX Sterilizer withALLClear TechnologyK212174 Predicate Device | Comparison |
| One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle | |||
| Note 1: The STERRAD 100NX SterilizerULTRA GI Cycle was validated using aload weight of 15.4 lbs (2 x 7.7 lbs),one endoscope per shelf.Note2: Only duodenoscopes that have beencleared as compatible with vaporizedhydrogen peroxide areacceptable. Check STERRAD SterilizerCycle Selection table for ULTRA GICycle compatible duodenoscopes | |||
| SterilizationCycles | ULTRA GISTANDARDFLEXEXPRESSDUO | STANDARDFLEXEXPRESSDUO | Identical |
| Dimensions | One Door:30.5" W x 70.9" H x 41.5" D(775 mm x 1800 mm x 1055mm)Two Door:30.5" W x 70.9" H x 43.1" D(775 mm x 1800 mm x 1095mm) | One Door:30.5" W x 70.9" H x 41.5" D(775 mm x 1800 mm x 1055mm)Two Door:30.5" W x 70.9" H x 43.1" D(775 mm x 1800 mm x 1095mm) | Identical |
| H2O2Concentrationby Weight | 59-94%Depending on Cycle | 59-94%Depending on Cycle | Identical |
| Number OfHalf Cycles | 2 | 2 | Identical |
| ChamberVolume | 152L | 152L | Identical |
| Key CriticalProcessParameters | Pressure, temperature & H2O2concentration, H2O2 Dose &Exposure Time | Pressure, temperature & H2O2concentration, H2O2 Dose &Exposure Time | Identical |
| Use of Pre-ConditioningStep | Yes | Yes | Identical |
| Use ofSecondaryStep toRemoveResidual H2O2(technology) | Yes (plasma) | Yes(plasma) | Identical |
Table 1. Comparison between the subject device and predicate devices
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Table 2. APTIMAX ULTRA GI Instrument Tray Predicate Device Comparison
| Feature | APTIMAX ULTRA GIInstrument TraySubject Device | APTIMAX Instrument TrayK013003 Predicate Device | Comparison |
|---|---|---|---|
| Indications forUse | Designed to encaseinstruments forsterilization | Designed to encase instrumentsfor sterilization | Identical |
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| Feature | APTIMAX ULTRA GIInstrument TraySubject Device | APTIMAX Instrument TrayK013003 Predicate Device | Comparison |
|---|---|---|---|
| Reusable/SingleUse | Reusable | Reusable | Identical |
| ClassificationName | Sterilization Wrap | Sterilization Wrap | Identical |
| ClassificationRegulation | 21 CFR 880.6850 | 21 CFR 880.6850 | Identical |
| Product Code | FRG | FRG | Identical |
| Class | II | II | Identical |
| Panel | General Hospital | General Hospital | Identical |
| Method ofSterilization | For use in only theSTERRAD 100NX ULTRAGI Cycle | For use in STERRAD System,steam and Ethylene Oxidesterilization cycles | Similar, subject device is designedto be used with ULTRA GI cycle |
| Materials ofConstruction | Tray & Lid:5052 AluminumLatch:304 Stainless Steel | Hoechst Celanese's Vectral A130Liquid Crystal Polymer | Similar, both were manufacturedfrom medical grade materials |
| STERRAD 100NXSterilizationCycles | Only to be used for theSTERRAD 100NX ULTRAGI Cycle | STANDARD, FLEX, EXPRESS andDUO | Similar, subject device is designedto be used with ULTRA GI cycle |
| Dimensions | 12.6" W x 19.4" L x 4.3" H | 3-10" W x 7-23.6" L x 1-2" H | Similar, dimensions designed to beused for ULTRA GI cycle |
Cycle/Tray Summary of Non-Clinical Testing
The following performance testing was conducted to verify the ULTRA GI Cycle device functionality.
| Test | Acceptance Criteria | Results | |
|---|---|---|---|
| SterilizationVerification | SAL of 10-6 shall be demonstrated. | Pass | |
| SurfaceSterilization | All test samples show no growth. | Pass | |
| Mated SurfaceSterilization | All test samples show no growth. | Pass | |
| GrowthInhibition | No growth inhibition shall be indicated for processed samples. | Pass | |
| In Use Test | Cycle performance shall be validated using scopes under in-use conditions. | Pass | |
| Biocompatibility | The biological safety of materials shall be demonstratedfollowing exposure to the sterilant agent. | Pass | |
| Simulated UseTest | Microbial performance should be demonstrated undersimulated conditions. | Pass | |
| DeviceFunctionalityand MaterialCompatibility | GI Endoscopes shall remain within the manufacturer'sfunctional specifications post processing. | Pass | |
| Final ProcessQualification | The critical process parameter values shall conform to thespecifications for the STERRAD® 100NX™ Sterilizer Titan Cycle. | Pass | |
| Usability | System must demonstrate it can be used safely and effectivelyby the intended users, under the expected conditions, withoutproducing hazardous situations or unacceptable use errors. |
| Table 3. Performance Test Results - STERRAD 100NX Sterilizer | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | --------------------------------------------------------------- |
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| Test | Acceptance Criteria | Results |
|---|---|---|
| Tray Life Test | Pre-determined target cycle number was set for testing andshall be achieved post completion | Pass |
| Tray DesignVerification | The proposed design must meet the specifications for: 1.Stress/pressure testing 2. Temperature 3. Material 4. Weight | Pass |
| Manual Cleaning ofTray | Cleaning efficacy results of material shall be below the pre-established limit | Pass |
Table 4. Performance Test Results - APTIMAX Instrument Tray for
Cycle/Tray Clinical Testing
No clinical data was generated in support of this submission.
Summary
The subject device, STERRAD 100NX Sterilizer with ALLClear Technology with expanded indications, and its predicate device utilize the same technology, sterilization cycles, and sterilization validation methods to sterilize medical devices. Based on the results of the performance testing, the change to the indications of the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject STERRAD 100NX Sterilizer with ALLClear Technology, with expanded ULTRA GI Cycle indications, to be as safe and effective as the predicate device. Further, the APTIMAX ULTRA GI Instrument Tray verification testing demonstrates that the device meets the intended use to encase surgical instruments for sterilization in the STERRAD 100NX ULTRA GI Cycle. ASP believes the subject STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle along with the APTIMAX ULTRA GI Instrument Tray to be as safe and effective as their predicate and reference devices.
Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data; the subject device, STERRAD 100NX with ALLClear Technology including the ULTRA GI Cycle indications expansion along with APTIMAX ULTRA GI Instrument Tray, is as safe, as effective, and performs as well as the legally marketed predicate device cleared via K212174 and the APTIMAX Instrument Tray, cleared under K013003.
§ 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).