(89 days)
Not Found
No
The document describes a sterilization device and its cycles, focusing on the physical process and validated parameters for different types of medical devices. There is no mention of AI or ML in the description of the technology, software, or performance studies.
No
The device is a sterilizer for medical instruments, not a device used to treat or cure a disease or condition in a patient.
No
The device is a sterilizer designed to sterilize medical instruments. It does not diagnose medical conditions.
No
The device description explicitly states that the STERRAD 100NX Sterilizer is a "self-contained stand-alone system of hardware and software" and details various hardware components like a sterilizer chamber, instruments, and a covered frame.
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 is clearly stated as the "sterilization of both metal and nonmetal medical devices at low temperatures." This is a process applied to medical devices themselves, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a system for sterilizing medical instruments using a hydrogen peroxide gas plasma process. This aligns with a sterilization device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays for testing
The device is designed to make medical instruments safe for use on patients by sterilizing them, which is a crucial step in preventing the spread of infection, but it does not perform a diagnostic test.
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 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 cvcle:
· Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter*
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**
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.
- A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.
** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.
Product codes
MLR
Device Description
The STERRAD 100NX Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas plasma using electrical energy. The sterilization process is a multiphase process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, and printer paper. The STERRAD 100NX Sterilizer has four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles.
An expansion of existing claims is being applied to the FLEX cycle without affecting the technology, software, or other physical features of the subject device.
The STERRAD 100NX Sterilizer with ALLClear Technology described within this submission expands the indications of the FLEX Cycle of the STERRAD 100NX Sterilizer to include single channel flexible endoscopes with extended dimensions from 850 mm in length to 1065 mm in length, when the inside diameter is ≥1 mm. There are no other changes to the indications for use for the FLEX Cycle. The FLEX Cycle is compatible with single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 1065 mm or shorter
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to verify that single channel flexible endoscopes with the expanded lumen claim of ≥ 1 mm diameter x ≤ 1065 mm length can be successfully sterilized in the FLEX cycle of the STERRAD 100NX Sterilizer with AllClear Technology.
Verification Testing Description: Study demonstrated sterility assurance level of (SAL) of 10-6 was reached when processing single channel flexible endoscopes with expanded claim (≥ 1 mm diameter X ≤ 1065 mm) in STERRAD 100NX FLEX half-cycle conditions. Pass/Fail: Pass
Verification Testing Description: Study demonstrated sterilization efficacy of flexible endoscopes with proposed claims expansion of ≥1 mm diameter x ≤1065 mm in length when processed in the STERRAD 100NX FLEX cycle. Pass/Fail: Pass
The results of the performance testing demonstrate that single channel flexible endoscopes with lumen dimensions of ≥ 1mm x ≤ 1065mm can be sterilized in the FLEX cycle of the STERRAD 100NX Sterilizer.
No clinical data was generated in support of this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).
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October 9, 2021
Advanced Sterilization Products, Inc. Summer Bowman Senior Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618
Re: K212174
Trade/Device Name: STERRAD 100NX Sterilizer with ALLClear Technology Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene oxide gas sterilizer Regulatory Class: Class II Product Code: MLR Dated: July 8, 2021 Received: July 12, 2021
Dear Summer Bowman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III -S
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212174
Device Name
STERRAD® 100NXTM Sterilizer with ALLClear® Technology
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 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 cvcle:
· Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter*
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**
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.
- A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.
** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.
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Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K212174 510(k) Summary
Advanced Sterilization Products, Inc. STERRAD® 100NX Sterilizer with ALLClear® Technology FLEX Cycle Claims Expansion
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
General Information
- Submitter Name: Advanced Sterilization Products, Inc.
- Address: 33 Technology Drive Irvine, CA 92618
- Contact Person: Summer Bowman Senior Regulatory Affairs Specialist Tel: (949) 561-9540 Email: summer.bowman@asp.com
- July 08, 2021 Date Prepared:
Device Name
| Proprietary Name: | STERRAD® 100NX Sterilizer with ALLClear® Technology |
|---|---|
| Common Name: | Hydrogen Peroxide Gas Plasma Sterilization System |
| Classification Name: | Ethylene oxide gas sterilizer |
| Device Class: | Class II |
| Product Code: | MLR |
| CFR Section: | 21 CFR 880.6860 |
Predicate Device
STERRAD® 100NX Sterilizer with ALLClear® Technology cleared under 510(k) K160903 on September 26, 2016.
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Device Description
The STERRAD 100NX Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas plasma using electrical energy. The sterilization process is a multiphase process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, and printer paper. The STERRAD 100NX Sterilizer has four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles.
An expansion of existing claims is being applied to the FLEX cycle without affecting the technology, software, or other physical features of the subject device.
The STERRAD 100NX Sterilizer with ALLClear Technology described within this submission expands the indications of the FLEX Cycle of the STERRAD 100NX Sterilizer to include single channel flexible endoscopes with extended dimensions from 850 mm in length to 1065 mm in length, when the inside diameter is ≥1 mm. There are no other changes to the indications for use for the FLEX Cycle. The FLEX Cycle is compatible with single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 1065 mm or shorter1 **
Technological Characteristics
The technological characteristics associated with the sterilization process for the proposed STERRAD 100NX Sterilizer with ALLClear Technology with expanded indications for the Flex Cycle are equivalent to those of the previously cleared STERRAD 100NX Sterilizer with ALLClear Technology; there are no modifications being introduced to alter existing sterilization cycles.
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.
Intended Use/Indications For Use
The intended use of the subject STERRAD 100NX Sterilizer with ALLClear Technology has not changed as a result of expanded indications for use of the FLEX Cycle. Refer to Table 5.1 to see
1 A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.
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a comparison of intended use of the predicate and proposed devices. Table 5.1 also exhibits a comparison of the Indications for Use.
| Predicate | Proposed | |
|---|---|---|
| STERRAD 100NX Sterilizer with | ||
| ALLClear Technology K160903 | STERRAD 100NX Sterilizer with | |
| ALLClear Technology | ||
| Intended Use | Designed for sterilization of both | |
| metal and nonmetal medical devices | ||
| at low temperatures. Because the | ||
| cycle operates within a dry | ||
| environment and at low | ||
| temperatures, it is especially suitable | ||
| for instruments sensitive to heat and | ||
| moisture. | Same | |
| Indications for Use | The STERRAD 100NX Sterilizer is | |
| designed for sterilization of both | ||
| metal and nonmetal medical devices | ||
| at low temperatures. The STERRAD | ||
| sterilization process is a multiphase | ||
| sterilization process that utilizes a | ||
| combination of exposure to hydrogen | ||
| peroxide vapor and plasma to 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. | Same | |
| 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. | FSame | |
| Medical devices, including most | ||
| flexible endoscopes, with the | ||
| following materials and dimensions | ||
| can be processed in the STERRAD | Medical devices, including most | |
| flexible endoscopes, with the | ||
| following materials and dimensions | ||
| can be processed in the STERRAD | ||
| Predicate | Proposed | |
| STERRAD 100NX Sterilizer with | ||
| ALLClear Technology K160903 | STERRAD 100NX Sterilizer with | |
| ALLClear Technology | ||
| • Single channel polyethylene and | ||
| Teflon (polytetrafluoroethylene) | ||
| flexible endoscopes with an inside | ||
| diameter of 1 mm or larger and length | ||
| of 850 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 | ||
| 850 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 850 mm flexible | ||
| endoscopes were validated without | ||
| any additional load. | • 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 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. | Same |
Table 5.1 Intended Use/Indications for Use Comparison
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Biocompatibility
The proposed changes to the indications for use do not affect sterilization cycle parameters, sterilant, sterilant injection volume, or types of materials processed in the sterilizer. The previously submitted biocompatibility data for the predicate device (K160903) remains applicable to the subject STERRAD 100NX Sterilizer with ALLClear Technology.
Summary of Non-Clinical Testing
No clinical data was generated in support of this Premarket Notification.
Performance testing was conducted to verify that single channel flexible endoscopes with the expanded lumen claim of ≥ 1 mm diameter x ≤ 1065 mm length can be successfully sterilized in the FLEX cycle of the STERRAD 100NX Sterilizer with AllClear Technology.
| Verification Testing | Description | Pass/Fail |
|---|---|---|
| Dose Response | Study demonstrated sterility assurance level of (SAL) of 10-6 | |
| was reached when processing single channel flexible | ||
| endoscopes with expanded claim (≥ 1 mm diameter X ≤ | ||
| 1065 mm) in STERRAD 100NX FLEX half-cycle conditions. | Pass | |
| Simulated Use | Study demonstrated sterilization efficacy of flexible | |
| endoscopes with proposed claims expansion of ≥1 mm | ||
| diameter x ≤1065 mm in length when processed in the | ||
| STERRAD 100NX FLEX cycle. | Pass |
Table 5.2 Performance Testing Results
The results of the performance testing demonstrate that single channel flexible endoscopes with lumen dimensions of ≥ 1mm x ≤ 1065mm can be sterilized in the FLEX cycle of the STERRAD 100NX Sterilizer.
Summary
The proposed STERRAD 100NX Sterilizer with ALLClear Technology with expanded indications and its predicate device utilize the same technology, sterilization validation validation methods to sterilize medical devices. Based on the results of the performance testing, the indications of the FLEX Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject STERRAD 100NX Sterilizer with ALClear Technology, with expanded Flex Cycle indications, to be as safe and as effective as the predicate device.
Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the proposed device, STERRAD 100NX with ALLClear Technology with FLEX Cycle indications expansion, is as safe, as effective, and performs as well as or better than the legally marketed device STERRAD 100NX with ALLClear Technology, cleared under K160903.