(91 days)
The STERRAD NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD Sterilization Process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The STERRAD NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD NX Sterilizer STANDARD Cycle:
· Single-channel stainless steel lumens with an inside diameter of 1 mm or larger and a length of 150 mm or shorter. ↑
· Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter. ↑ 7 The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not
exceed the maximum number of lumens validated by this testing.
Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD NX Sterilizer ADVANCED Cycle:
· Single-channel stainless steel lumens with an inside diameter of 1 mm or larger and a length of 500 mm or shorter. ↑
· Single-channel PE/PTFE flexible endoscopes with an inside diameter of 1 mm or larger and a length of 1065 mm or shorter.*
Note: With the exception of the flexible endoscopes, the validation studies were performed using a validation load consisting of devices in one instrument tray weighing 10.7 lbs (4.9 kg). The flexible endoscopes were validated without any additional load. **
f The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing.
- Only one flexible endoscope up to 1065 mm long with or without APTIMAX Instrument Tray Holders can be used per cycle, or only one flexible endoscope up to 850 mm long per cycle with or without a STERRAD Instrument Tray Mat. No additional load. Check the medical device manufacturer's instructions for use prior to processing any scope in the STERRAD NX Sterilizer; and check if Instrument tray mats or only tray holders are validated for use with flexible endoscopes longer than 850 mm.
** The validation testing for flexible endoscopes up to 850 mm long was conducted with one endoscope per cycle using a STERRAD Instrument Tray Mat to help protect the endoscope no additional load. The validation testing for flexible endoscopes longer that 850 mm was conducted with one endoscope per cycle using APTIMAX Instrument Tray Holders to assist with device placement and help protect the endoscope: no additional load.
The STERRAD NX Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas plasma using electrical energy. The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles.
The sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. The hydrogen peroxide is concentrated before into the sterilizer chamber and its concentration is monitored during the cycle. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the specification.
The hardware for the STERRAD NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, printer paper, and an optional movable cart. The STERRAD NX Sterilizer can be placed directly on a table, countertop, or on the movable cart.
An expansion of existing claims is being applied to the ADVANCED Cycle without affecting the technology, software, or other physical features of the subject device.
The STERRAD NX Sterilizer with ALLClear Technology described within this submission expands the indications of the ADVANCED Cycle of the Sterilizer to include single channel flexible endoscopes with extended dimensions of 1065mm in length when the inside diameter is ≥1mm. The previously cleared dimensions of the predicate device are 850mm in length when the inside diameter is ≥1mm. There are no other changes to the indications for use of the ADVANCED Cycle. The ADVANCED Cycle is compatible with single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1mm or larger and length of 1065mm or shorter2
The provided document is a 510(k) summary for the STERRAD® NX Sterilizer with ALLClear™ Technology, specifically for an ADVANCED Cycle Claims Expansion. This device is a sterilizer and the document describes its performance in achieving sterility of medical devices, not an AI/ML-enabled diagnostic or treatment device. Therefore, many of the requested categories in the prompt, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "human readers improve with AI vs without AI assistance," "standalone performance," "training set," and "ground truth for the training set," are not applicable to this type of device and submission.
However, I can extract information related to the acceptance criteria and performance studies for the sterilization function.
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Methodology | Description of Study | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|
| Biocompatibility | The proposed changes to the indications for use do not affect sterilization cycle parameters, sterilant, sterilant injection volume, or types of materials processed in the sterilizer. The previously submitted biocompatibility data for the predicate device (K160818) remains applicable to the subject STERRAD NX Sterilizer with ALLClear Technology. | Process residual levels remaining on/in materials used in the sterilizer shall be non-toxic when evaluated by in vivo toxicity tests. | Pass |
| Dose Response | Study demonstrated sterility assurance level (SAL) of 10^-6 was reached when processing single channel flexible endoscopes with expanded claim (≥ 1 mm diameter X ≤ 1065 mm) in STERRAD NX ADVANCED half-cycle conditions. | ||
| • Study demonstrated a total kill of BIs in the half cycle condition at 1.5 mL of 53% hydrogen peroxide injected. | |||
| • The results demonstrated an increasing number of sterile BIs corresponding to an increasing injection volume of hydrogen peroxide. | |||
| • The positive control demonstrated growth and the negative control demonstrated no growth. | • BI Samples from 1.5mL of 53% hydrogen peroxide in half cycles shall be sterile at the end of the incubation period. | ||
| • A trend of increasing number of sterile BIs corresponding to the increasing injection volume of hydrogen peroxide must be seen. | |||
| • Positive control demonstrates growth and negative control demonstrates no growth. | Pass | ||
| Simulated Use | Study demonstrated sterilization efficacy of flexible endoscopes with proposed claims expansion of ≥1 mm diameter x ≤1065 mm in length when processed in the STERRAD NX ADVANCED cycle. | ||
| • The spore log reduction was greater than 6 for all test devices. | |||
| • The positive controls ranged from 1.6 x 10^6 to 1.8 x 10^6 CFU. | • Spore log reduction must be greater than 6 for test devices. | ||
| • Positive control shall show a combined exhaustive recovery of at least 1 x 10^6 CFU. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each test in terms of the number of endoscopes or biological indicators (BIs) used. However, it indicates:
- Dose Response: "BI Samples from 1.5mL of 53% hydrogen peroxide in half cycles" and "total kill of BIs in the half cycle condition at 1.5 mL of 53% hydrogen peroxide injected." This implies multiple BI samples were used at different hydrogen peroxide injection volumes.
- Simulated Use: "flexible endoscopes with proposed claims expansion of ≥1 mm diameter x ≤1065 mm in length" and "all test devices." This suggests multiple endoscopes were tested.
- Data Provenance: The studies were conducted by Advanced Sterilization Products, Inc. (ASP), located in Irvine, CA. The document does not specify whether the data is retrospective or prospective, but given it's for a claims expansion and performance testing, it would inherently be prospective testing specifically performed to support this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a sterilization device, not a diagnostic device requiring expert interpretation for ground truth. Sterility is determined by microbiological testing (absence of microbial growth).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). Sterilization efficacy is determined objectively through microbiological testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a sterilization device, not an AI-enabled diagnostic or treatment device involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a sterilizer, not an algorithm, and its performance is evaluated based on its ability to sterilize medical instruments.
7. The Type of Ground Truth Used
The ground truth used for these studies is microbiological sterility, defined by:
- Absence of microbial growth in biological indicators (Dose Response and Simulated Use tests).
- A sterility assurance level (SAL) of 10^-6 (Dose Response).
- A spore log reduction greater than 6 (Simulated Use).
- Presence of growth in positive controls to confirm viability of microorganisms (Dose Response and Simulated Use).
8. The Sample Size for the Training Set
Not applicable. This device does not involve a training set as it's not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set for an AI/ML device.
§ 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).