(31 days)
Not Found
No.
The document describes a medical device for sterilization and mentions "hardware and software" but does not provide any details that suggest the presence of an AI model, such as machine learning, deep learning, or neural networks. The software appears to control the sterilization processes based on predefined parameters.
No
The device is a sterilizer for medical instruments, not a device used for treating a patient's condition or disease directly.
No.
The device is a sterilizer for medical devices, not a diagnostic device. Its purpose is to clean and disinfect instruments, not to diagnose medical conditions.
No
The device is a physical sterilizer with hardware components (sterilizer chamber, instruments, frame, accessories like trays and cassettes) that performs a physical and chemical sterilization process using hydrogen peroxide vapor and plasma. While it mentions "hardware and software," the primary function and description clearly indicate it is not a software-only device. The software likely controls the hardware and sterilization cycles.
No.
The device is a sterilizer for medical instruments, not a device used to provide information for diagnosis, prevention, monitoring, treatment, or alleviation of disease. It does not perform tests on biological samples.
N/A
Intended Use / Indications for Use
The STERRAD 100NX Sterilizer with ALLClear Technology is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue.
The STERRAD 100NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer STANDARD cycle:
- Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter. 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 a 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 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 on the bottom shelf.
The STERRAD 100NX DUO Cycle is 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 1: 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.
- One Dual channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter.
Note 2: The validation studies for DUO Cycle was performed using a validation load consisting of 1 dual channel endoscope with 1 mm diameter x 885 mm long and ≥2.2 mm diameter x ≤845 mm long PTFE/PE lumens and 1 dual channel endoscope with ≥1 mm diameter x ≤670 mm long and ≥2.2 mm diameter x ≤845 mm long PTFE/PE lumens
The STERRAD 100NX Sterilizer ULTRA GI Cycle is designed for sterilization of the following:
- Medical devices, including multi-channel endoscopes (including duodenoscopes), with no more than 4 channels, with lumen dimensions of ≥1mm x ≤1500mm in length, and ≥2mm x ≤1630mm in length.
- One flexible endoscope per tray, and no more than two flexible endoscopes per cycle
Note1: 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 compatible duodenoscopes.
Product codes
MLR
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 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, chemical indicator products and sterilant cassettes.
The STERRAD 100NX Sterilizer has five cleared sterilization cycles: STANDARD, FLEX, EXPRESS, DUO and ULTRA GI Cycles.
The STERRAD 100NX Sterilizer with ALLClear Technology described within this submission expands the indications of the DUO Cycle of the STERRAD 100NX Sterilizer to include one dual-channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter and with the weight of 3.4 kg (7.4 lbs). There are no other changes to the indications for use for the DUO cycle.
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
The following performance testing was conducted to verify the DUO Cycle device functionality.
Test: Sterilization Verification
Acceptance Criteria: SAL of 10⁻⁶ shall be demonstrated.
Results: Pass
Test: Surface Sterilization
Acceptance Criteria: All test samples show no growth.
Results: Pass
Test: Mated Surface Sterilization
Acceptance Criteria: All test samples show no growth.
Results: Pass
Test: Growth Inhibition
Acceptance Criteria: No growth inhibition shall be indicated for processed samples.
Results: Pass
Test: Biocompatibility
Acceptance Criteria: The biological safety of materials shall be demonstrated following exposure to the sterilant agent.
Results: Pass
Test: Simulated Use Test
Acceptance Criteria: Microbial performance should be demonstrated under simulated conditions.
Results: Pass
Test: Device Functionality and Material Compatibility
Acceptance Criteria: Dual channel flexible endoscopes shall remain within established functional specifications post processing.
Results: Pass
No clinical data was generated in support of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
STERRAD 100NX Sterilizer with ALLClear Technology K234082
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).
FDA 510(k) Clearance Letter - STERRAD® 100NX Sterilizer with ALLClear™ Technology
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 14, 2025
Advanced Sterilization Products Inc.
Ayse Erkan
Sr. Regulatory Affairs Program Lead
33 Technology Drive
Irvine, California 92618
Re: K250802
Trade/Device Name: STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
Regulation Number: 21 CFR 880.6860
Regulation Name: Ethylene Oxide Gas Sterilizer
Regulatory Class: Class II
Product Code: MLR
Dated: March 14, 2025
Received: March 14, 2025
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.
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"
Page 2
K250802 - Ayse Erkan Page 2
(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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K250802 - Ayse Erkan Page 3
Sincerely,
Stephen A. Anisko -S
Digitally signed by Stephen A. Anisko -S
Date: 2025.04.14 14:44:09 -04'00'
for: Christopher K. Dugard
Division Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K250802
Device Name
STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
Indications for Use (Describe)
The STERRAD 100NX Sterilizer with ALLClear Technology is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue.
The STERRAD 100NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer STANDARD cycle:
- Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter. 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 a 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 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 on the bottom shelf.
The STERRAD 100NX DUO Cycle is 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 1: 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.
- One Dual channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter.
Note 2: The validation studies for DUO Cycle was performed using a validation load consisting of 1 dual channel endoscope with 1 mm diameter x 885 mm long and ≥2.2 mm diameter x ≤845 mm long PTFE/PE lumens and 1 dual channel endoscope with ≥1 mm diameter x ≤670 mm long and ≥2.2 mm diameter x ≤845 mm long PTFE/PE lumens
The STERRAD 100NX Sterilizer ULTRA GI Cycle is designed for sterilization of the following:
- Medical devices, including multi-channel endoscopes (including duodenoscopes), with no more than 4 channels, with lumen dimensions of ≥1mm x ≤1500mm in length, and ≥2mm x ≤1630mm in length.
- One flexible endoscope per tray, and no more than two flexible endoscopes per cycle
Note1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs),
FORM FDA 3881 (8/23) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF
Page 5
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 compatible duodenoscopes.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
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FORM FDA 3881 (8/23) Page 2 of 2 PSC Publishing Services (301) 443-6740 EF
Page 6
510(k) Summary for K250802
Advanced Sterilization Products, Inc.
STERRAD™ 100NX 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, Inc.
Address: 33 Technology Drive
Irvine, CA 92618
Contact Person: Ayse Erkan
Senior Regulatory Affairs Program Lead
Telephone: (714)580-2880
Email: ayse.erkan@asp.com
Date Prepared: April 10, 2025
Devices Names
| Proprietary Name: | STERRAD™ 100NX Sterilizer with ALLClear™ Technology (10104) |
|---|---|
| Device Common Name: | Hydrogen Peroxide Gas Plasma Sterilization System |
| Classification Name: | Ethylene Oxide Gas Sterilizer |
| Product Code: | MLR |
| Device Class: | Class II |
| CFR Section: | 21 CFR 880.6860 |
Predicate Devices
STERRAD 100NX Sterilizer with ALLClear Technology K234082 cleared July 5, 2024.
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 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, chemical indicator products and sterilant cassettes.
Page 7
The STERRAD 100NX Sterilizer has five cleared sterilization cycles: STANDARD, FLEX, EXPRESS, DUO and ULTRA GI Cycles.
The STERRAD 100NX Sterilizer with ALLClear Technology described within this submission expands the indications of the DUO Cycle of the STERRAD 100NX Sterilizer to include one dual-channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter and with the weight of 3.4 kg (7.4 lbs). There are no other changes to the indications for use for the DUO cycle.
Intended Use/Indications for Use
The intended use of the subject STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI has not changed as a result of expanded indications for DUO Cycle. Refer to Table 1 below for a comparison of intended use and indications for use of the predicate and proposed devices.
Technological Characteristics
The technological characteristics associated with the sterilization process for the proposed STERRAD 100NX Sterilizer with ALLClear Technology with expanded indications for the Duo Cycle are equivalent to those of the previously cleared STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI cycle; there are no modifications being introduced to alter existing sterilization cycles and other physical features of the subject device.
The predicate device continues to have the same technological characteristics, sterilization performance, and physical traits as the predicate device, STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI cycle.
Table 1. Comparison between the subject device and predicate devices
| Feature | STERRAD 100NX Sterilizer with ALLClear Technology DUO cycle claims expansion Subject Device | STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle K234082 Predicate Device | Comparison |
|---|---|---|---|
| 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. | Identical |
| Indications for Use | The STERRAD 100NX Sterilizer with ALLClear Technology is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue. The STERRAD 100NX Sterilizer can sterilize instruments which have diffusion- | The STERRAD 100NX Sterilizer with ALLClear Technology is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue. The STERRAD 100NX Sterilizer can sterilize instruments which have diffusion- | Similar, includes expanded claims for DUO cycle |
Page 8
| Feature | STERRAD 100NX Sterilizer with ALLClear Technology DUO cycle claims expansion Subject Device | STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle K234082 Predicate Device | Comparison |
|---|---|---|---|
| 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 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 designed for sterilization of medical devices including most flexible | 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, |
Page 9
| Feature | STERRAD 100NX Sterilizer with ALLClear Technology DUO cycle claims expansion Subject Device | STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle K234082 Predicate Device | Comparison |
|---|---|---|---|
| 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 o Accessory devices that are normally connected to a flexible endoscope during use o Flexible endoscopes without lumens Note 1: 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. • One Dual channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter. Note 2: The validation studies for DUO Cycle was performed using a validation load consisting of 1 dual channel endoscope with 1 mm diameter x 885 mm long and 2.2 mm diameter x 835 mm long PTFE/PE lumens, and 1 dual channel endoscope with 1 mm diameter x 670 mm long and 2.2 mm diameter x 845 mm long PTFE/PE lumens. 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. | 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 |
Page 10
| Feature | STERRAD 100NX Sterilizer with ALLClear Technology DUO cycle claims expansion Subject Device | STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle K234082 Predicate Device | Comparison |
|---|---|---|---|
| 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 o Accessory devices that are normally connected to a flexible endoscope during use o Flexible endoscopes without lumens Note 1: 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. • One Dual channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter. Note 2: The validation studies for DUO Cycle was performed using a validation load consisting of 1 dual channel endoscope with 1 mm diameter x 885 mm long and 2.2 mm diameter x 835 mm long PTFE/PE lumens, and 1 dual channel endoscope with 1 mm diameter x 670 mm long and 2.2 mm diameter x 845 mm long PTFE/PE lumens. 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. | 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 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 | ||
| Sterilization Cycles | ULTRA GI STANDARD FLEX EXPRESS DUO | ULTRA GI STANDARD FLEX EXPRESS DUO | Identical |
| Dimensions | One Door: 30.5" W x 70.9" H x 41.5" D (775 mm x 1800 mm x 1055 mm) Two Door: 30.5" W x 70.9" H x 43.1" D (775 mm x 1800 mm x 1095 mm) | One Door: 30.5" W x 70.9" H x 41.5" D (775 mm x 1800 mm x 1055 mm) Two Door: 30.5" W x 70.9" H x 43.1" D (775 mm x 1800 mm x 1095 mm) | Identical |
| H2O2 Concentration by Weight | 59-94% Depending on Cycle | 59-94% Depending on Cycle | Identical |
| Number Of Half Cycles | 2 | 2 | Identical |
| Chamber Volume | 152L | 152L | Identical |
| Key Critical Process Parameters | Pressure, temperature & H2O2 concentration, H2O2 Dose & Exposure Time | Pressure, temperature & H2O2 concentration, H2O2 Dose & Exposure Time | Identical |
| Use of Pre-Conditioning Step | Yes | Yes | Identical |
| Use of Secondary Step to Remove Residual H2O2 (technology) | Yes (plasma) | Yes(plasma) | Identical |
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| Feature | STERRAD 100NX Sterilizer with ALLClear Technology DUO cycle claims expansion Subject Device | STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle K234082 Predicate Device | Comparison |
|---|---|---|---|
| • 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 User Guide "STERRAD Sterilizer Cycle Selection table" for ULTRA GI compatible duodenoscopes | 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 |
Cycle Summary of Non-Clinical Testing
The following performance testing was conducted to verify the DUO Cycle device functionality.
Table 2. Performance Test Results – STERRAD 100NX Sterilizer
| 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 |
| 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 | Dual channel flexible endoscopes shall remain within established functional specifications post processing. | Pass |
Cycle Clinical Testing
No clinical data was generated in support of this submission.
Summary
The subject device, STERRAD 100NX Sterilizer with ALLClear Technology with DUO cycle claims expansion, 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 DUO Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject STERRAD 100NX Sterilizer with ALLClear Technology with DUO cycle claims expansion, to be as safe and effective as the predicate device and reference devices.
Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data; the subject device, STERRAD 100NX with ALLClear Technology with DUO Cycle claims expansion is as safe, as effective, and performs as well as the legally marketed predicate device cleared via K234082.