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.

Device Description

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

AI/ML Overview

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

May 16, 2022

Advanced Sterilization Products, Inc. Katy Nennig Senior Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618

Re: K220404

Trade/Device Name: STERRAD® NX Sterilizer with ALLClear™ Technology Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: February 6, 2022 Received: February 14, 2022

Dear Katy Nennig:

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, PhD 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}------------------------------------------------

Indications for Use

510(k) Number (if known) K220404

Device Name

STERRAD® NX™ Sterilizer with ALLClear Technology™

Indications for Use (Describe)

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 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. ↑

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.*

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo consists of the letters "ASP" in a stylized, connected font, with the words "Advanced Sterilization Products" written to the right of the letters. The letters and words are in a dark blue color. The logo is simple and professional, and it is likely used to represent the company's brand.

510(k) Summary Advanced Sterilization Products, Inc. STERRAD® NX Sterilizer with ALLClear™ Technology ADVANCED Cycle Claims Expansion

This summary of 510(k) information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

Submitter Name:	Advanced Sterilization Products, Inc.
Address:	33 Technology DriveIrvine, CA 92618
Contact Person:	Katy NennigSenior Regulatory Affairs SpecialistTel: (920)254-6370Email: Katelyn.nennig@asp.com
Date Prepared:	May 11th, 2022

Device Name

Proprietary Name:	STERRAD® NX Sterilizer with ALLClearTM 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® NX Sterilizer with ALLClear® Technology cleared via 510(k) K160818 on September 27, 2016.

Device Description

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo is in a dark blue color. The letters "ASP" are in a bold, sans-serif font, with the "S" being larger than the "A" and "P". To the right of the letters, the words "Advanced Sterilization Products" are written in a smaller, sans-serif font.

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.

Intended Use/Indications For Use

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.t
. Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter.t

†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.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo consists of the letters "ASP" in a stylized, bold, dark blue font. To the right of the letters, the words "Advanced Sterilization Products" are written in a smaller, lighter font. The logo is simple and professional, conveying a sense of trust and reliability.

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. *

†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.

Technological Characteristics Comparison

The following table provides a comparison of the technological characteristics associated with the sterilization process of the proposed STERRAD NX Sterilizer with ALLClear Technology with expanded indications for the ADVANCED Cycle as compared to those of the previously cleared STERRAD NX with ALLClear Technology.

Device & Predicate Device(s):	K160818	K220404
Intended Use	Designed for sterilization of bothmetal and nonmetal medicaldevices at low temperatures.Because the cycle operates within adry environment and at lowtemperatures, it is especiallysuitable for instruments sensitiveto heat and moisture.	Designed for sterilization of bothmetal and nonmetal medicaldevices at low temperatures.Because the cycle operates within adry environment and at lowtemperatures, it is especiallysuitable for instruments sensitiveto heat and moisture.

	Table 5.1 Technological Characteristics Comparison

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo consists of the letters "ASP" in a stylized, connected font, with the words "Advanced Sterilization Products" to the right of the letters. The letters are in a dark purple color, while the words are in a lighter gray color. The logo is simple and modern, and it effectively communicates the company's focus on sterilization products.

Device & Predicate Device(s):	K160818	K220404
Sterilization Process	Hydrogen peroxide gas plasma	Hydrogen peroxide gas plasma
Principle of Operation	Combined use of hydrogenperoxide vapor and plasma safelyand rapidly sterilizes most medicalinstruments and materials withleaving toxic residues.	Combined use of hydrogenperoxide vapor and plasma safelyand rapidly sterilizes most medicalinstruments and materials withleaving toxic residues.
Pre-Programmed SterilizationCycles	Two Cycles:STANDARD and ADVANCED	Two Cycles:STANDARD and ADVANCED
Material Compatibility(Recommended Materials)	Common materials found inreusable medical devices. Allmedical devices should beprocessed in accordance with themedical device manufacturer'srecommendations.	Common materials found inreusable medical devices. Allmedical devices should beprocessed in accordance with themedical device manufacturer'srecommendations.
Approximate Cycle Time	STANDARD Cycle: 28 MinutesADVANCED Cycle: 38 Minutes	STANDARD Cycle: 28 MinutesADVANCED Cycle: 38 Minutes
Hydrogen Peroxide Monitor	Cancels sterilization cycle if theareas under the concentration-timecurve or rate constant do not meetpredetermined specifications.	Cancels sterilization cycle if theareas under the concentration-timecurve or rate constant do not meetpredetermined specifications.
Temperature	Chamber, Chamber door andvaporizer/condenser thermistors	Chamber, Chamber door andvaporizer/condenser thermistors
Pressure	Chamber pressure transducersChamber atmospheric pressureswitch Vaporizer/condenserpressure transducer	Chamber pressure transducersChamber atmospheric pressureswitch Vaporizer/condenserpressure transducer

Summary of Non-Clinical Testing

Performance testing was conducted to verify that single channel flexible endoscopes with the expanded lumen claim of ≥ 1mm diameter x ≤ 1065mm length can be successfully sterilized by the ADVANCED Cycle of the STERRAD NX Sterilizer with ALLClear Technology. No clinical data was generated in support of this submission.

TestingMethodology	Description	Acceptance Criteria	Results(Pass/Fail)
Biocompatibility	The proposed changes to the indications for usedo not affect sterilization cycle parameters,sterilant, sterilant injection volume, or types ofmaterials processed in the sterilizer. Thepreviously submitted biocompatibility data forthe predicate device (K160818) remainsapplicable to the subject STERRAD NX Sterilizerwith ALLClear Technology.	Process residual levels remainingon/in materials used in thesterilizer shall be non-toxic whenevaluated by in vivo toxicity tests.	Pass

Table 5.2 Performance Testing Results

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo consists of the letters "ASP" in a stylized, bold, sans-serif font, with the letters connected. To the right of the letters, the words "Advanced Sterilization Products" are stacked vertically in a smaller, sans-serif font. The color of the logo is a dark blue or purple.

TestingMethodology	Description	Acceptance Criteria	Results(Pass/Fail)
Dose Response	Study demonstrated sterility assurance level of(SAL) of 10-6 was reached when processingsingle channel flexible endoscopes withexpanded claim (≥ 1 mm diameter X ≤ 1065mm) in STERRAD NX ADVANCED half-cycleconditions.• Study demonstrated a total kill of BIs in thehalf cycle condition at 1.5 mL of 53% hydrogenperoxide injected.• The results demonstrated an increasingnumber of sterile BIs corresponding to anincreasing injection volume of hydrogenperoxide.• The positive control demonstrated growth andthe negative control demonstrated no growth.	• BI Samples from 1.5mL of 53%hydrogen peroxide in half cyclesshall be sterile at the end of theincubation period• A trend of increasing number ofsterile BIs corresponding to theincreasing injection volume ofhydrogen peroxide must be seen.• Positive control demonstratesgrowth and negative controldemonstrates no growth	Pass
Simulated Use	Study demonstrated sterilization efficacy offlexible endoscopes with proposed claimsexpansion of ≥1 mm diameter x ≤1065 mm inlength when processed in the STERRAD NXADVANCED cycle.• The spore log reduction was greater than 6for all test devices.• The positive controls ranged from 1.6 x 106 to1.8 x 106 CFU	• Spore log reduction must begreater than 6 for test devices.• Positive control shall show acombined exhaustive recovery ofat least 1 x 106 CFU	Pass

The results of performance testing demonstrates that single channel flexible endoscopes with lumen dimensions of ≥ 1mm x ≤ 1065mm can be sterilized by the ADVANCED Cycle of the STERRAD NX Sterilizer.

Summary

The subject device, STERRAD NX Sterilizer with ALLClear Technology with expanded indications, and its predicate device utilize the same technology, sterilization cycles, and sterilization methods to sterilize medical devices. Based on the results of the performance testing, the indications of the ADVANCED Cycle does not raise any new questions of safety or effectiveness.

Conclusion

The conclusions drawn from the non-clinical performance data demonstrate that the subject device, STERRAD NX with ALLClear Technology including the ADVANCED Cycle indications expansion, is as safe,

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for Advanced Sterilization Products (ASP). The logo consists of the letters "ASP" in a bold, sans-serif font, with the words "Advanced Sterilization Products" to the right of the letters. The letters are in a dark blue color, and the words are in a smaller, lighter font.

as effective, and performs as well or better than the legally marketed predicate device cleared via K160818.

Regulation Number and Section

§ 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).