(196 days)
No
The summary describes a sterilization system based on hydrogen peroxide vapor and plasma, with different cycles for various medical devices. There is no mention of AI or ML in the intended use, device description, or performance studies. The "ALLClear Technology" is mentioned as integrating features like Load Check, System Check, and Load Conditioning, but these are not described in a way that suggests AI/ML is used.
No.
This device is designed for sterilization of medical instruments, not for direct therapeutic treatment of patients.
No
This device is a sterilizer, designed to clean medical instruments using hydrogen peroxide vapor and plasma, not to diagnose medical conditions.
No
The device description explicitly states it is a "self-contained stand-alone system of hardware and software" and details various hardware components like a sterilizer chamber, instruments, and accessories.
Based on the provided text, the STERRAD 100NX Sterilizer with ALLClear Technology is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed for the sterilization of medical devices. This is a process performed on instruments before they are used on or with a patient, or on samples taken from a patient.
- Device Description: The description details a system that uses hydrogen peroxide vapor and plasma to sterilize medical instruments and materials. This is a physical/chemical process for disinfection/sterilization, not a test performed on biological samples.
- 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.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays for testing
The STERRAD 100NX Sterilizer is a device used in the healthcare setting to prepare medical instruments for use, ensuring they are free from harmful microorganisms. This falls under the category of a sterilizer, which is a type of medical device, but not an IVD.
N/A
Intended Use / Indications for Use
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 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 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
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MLR, FRG
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing was conducted to verify the ULTRA GI 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: Not specified, but implied from the row context.
Results: All test samples show no growth. Pass
Test: Growth Inhibition
Acceptance Criteria: No growth inhibition shall be indicated for processed samples.
Results: Pass
Test: In Use Test
Acceptance Criteria: Cycle performance shall be validated using scopes under in-use conditions.
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: GI Endoscopes shall remain within the manufacturer's functional specifications post processing.
Results: Pass
Test: Final Process Qualification
Acceptance Criteria: The critical process parameter values shall conform to the specifications for the STERRAD® 100NX™ Sterilizer Titan Cycle.
Results: Pass
Test: Usability
Acceptance Criteria: 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.
Results: Pass
Tray Life Test: Pre-determined target cycle number was set for testing and shall be achieved post completion. Results: Pass
Tray Design Verification: The proposed design must meet the specifications for: 1. Stress/pressure testing 2. Temperature 3. Material 4. Weight. Results: Pass
Manual Cleaning of Tray: Cleaning efficacy results of material shall be below the pre-established limit. Results: Pass
No clinical data was generated in support of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/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.
1
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
2
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
3
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
4
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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5
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 Drive |
| Irvine, CA 92618 | |
| Contact Person: | Ayse Erkan |
| Senior Regulatory Affairs Program Lead | |
| Telephone: (714)580-2880 | |
| Email: ayse.erkan@asp.com |
Date Prepared: July 1, 2024
Devices Names
| Proprietary Name: | STERRAD™ 100NX
Sterilizer with ALLClear™
Technology and ULTRA
GI™ Cycle (10104) | APTIMAX™ Instrument
Tray for ULTRA GI Cycle
(011077) |
|----------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Device Common Name: | Hydrogen Peroxide Gas
Plasma Sterilization System | Sterilizable Instrument Tray
and 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
6
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.
7
| Feature | STERRAD 100NX Sterilizer with
ALLClear Technology with ULTRA
GI Cycle Subject Device | STERRAD 100NX Sterilizer with
ALLClear Technology
K212174 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-
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) | 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) | Similar,
includes
additional
indications for
Use for ULTRA
GI cycle. |
| | 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 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 | |
| Feature | STERRAD 100NX Sterilizer with
ALLClear Technology with ULTRA
GI Cycle Subject Device | STERRAD 100NX Sterilizer with
ALLClear Technology
K212174 Predicate Device | Comparison |
| | flexible endoscopes were validated
without any additional load. | 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. | 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. | 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: | 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. | 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. | | |
| Feature | STERRAD 100NX Sterilizer with
ALLClear Technology with ULTRA
GI Cycle Subject Device | STERRAD 100NX Sterilizer with
ALLClear Technology
K212174 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 Sterilizer
Cycle Selection table for ULTRA GI
Cycle compatible duodenoscopes | | |
| Sterilization
Cycles | ULTRA GI
STANDARD
FLEX
EXPRESS
DUO | 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 |
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 GI
Instrument Tray
Subject Device | APTIMAX Instrument Tray
K013003 Predicate Device | Comparison |
|------------------------|--------------------------------------------------------|-----------------------------------------------------|------------|
| Indications for
Use | Designed to encase
instruments for
sterilization | Designed to encase instruments
for sterilization | Identical |
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| Feature | APTIMAX ULTRA GI
Instrument Tray
Subject Device | APTIMAX Instrument Tray
K013003 Predicate Device | Comparison |
|------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Reusable/Single
Use | Reusable | Reusable | Identical |
| Classification
Name | Sterilization Wrap | Sterilization Wrap | Identical |
| Classification
Regulation | 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 of
Sterilization | For use in only the
STERRAD 100NX ULTRA
GI Cycle | For use in STERRAD System,
steam and Ethylene Oxide
sterilization cycles | Similar, subject device is designed
to be used with ULTRA GI cycle |
| Materials of
Construction | Tray & Lid:
5052 Aluminum
Latch:
304 Stainless Steel | Hoechst Celanese's Vectral A130
Liquid Crystal Polymer | Similar, both were manufactured
from medical grade materials |
| STERRAD 100NX
Sterilization
Cycles | Only to be used for the
STERRAD 100NX ULTRA
GI Cycle | STANDARD, FLEX, EXPRESS and
DUO | Similar, subject device is designed
to 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 be
used 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 | |
|---|---|---|---|
| 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. |
| 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 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 |
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.