STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)

K234082 · Advanced Sterilization Products · MLR · Jul 5, 2024 · General Hospital

Device Facts

• Record ID: K234082
• Device Name: STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)
• Applicant: Advanced Sterilization Products
• Product Code: MLR · General Hospital
• Decision Date: Jul 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The STERRAD 100NX Sterilizer with ALLClear Technology is 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. The APTIMAX Tray for ULTRA GI Cycle is designed to encase surgical instruments for sterilization in STERRAD 100NX Sterilization System with ALLCLEAR Technology.

Device Story

STERRAD 100NX Sterilizer is a self-contained system using hydrogen peroxide gas plasma to sterilize heat/moisture-sensitive medical instruments. Process involves injecting aqueous hydrogen peroxide, vaporizing it under sub-ambient pressure, and converting to gas plasma via electrical energy. System includes sterilizer chamber, reusable instrument trays (APTIMAX), and sterilant cassettes. Operated by healthcare staff in clinical settings. New ULTRA GI cycle specifically processes flexible multi-channel duodenoscopes. ALLClear technology integrates load check, system check, and load conditioning. Output is a sterilized device ready for clinical use; benefits include safe, residue-free sterilization of complex, diffusion-restricted instruments like hinged forceps and multi-channel endoscopes.

Clinical Evidence

Bench testing only. No clinical data generated. Performance testing included sterilization verification (SAL 10^-6), growth inhibition, in-use testing, biocompatibility, simulated use, and device functionality/material compatibility post-processing. All tests passed.

Technological Characteristics

Hydrogen peroxide gas plasma sterilization. Materials: 5052 Aluminum (tray/lid), 304 Stainless Steel (latch). Chamber volume: 152L. H2O2 concentration: 59-94%. Features: ALLClear technology (load check, system check, load conditioning). Standalone system. Software-controlled cycles.

Indications for Use

Indicated for sterilization of metal and nonmetal medical devices, including flexible endoscopes, rigid/semi-rigid endoscopes, and duodenoscopes. Compatible with hydrogen peroxide-compatible flexible multi-channel duodenoscopes (up to 4 channels, ID ≥1mm x ≤1500mm or ≥2mm ID x ≤1630mm). Not for use with non-compatible materials.

Regulatory Classification

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.

Predicate Devices

• STERRAD 100NX Sterilizer with ALLClear Technology (K212174)
• APTIMAX Instrument Tray (K013003)

Reference Devices

• EOGas 4 Ethylene Oxide Gas Sterilizer (K192978)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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."

{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<br>Irvine, CA 92618 |
| Contact Person: | Ayse Erkan<br>Senior Regulatory Affairs Program Lead<br>Telephone: [phone]<br>Email: [e-mail] |

Date Prepared: July 1, 2024

#### Devices Names

| Proprietary Name: | STERRAD™ 100NX<br>Sterilizer with ALLClear™<br>Technology and ULTRA<br>GI™ Cycle (10104) | APTIMAX™ Instrument<br>Tray for ULTRA GI Cycle<br>(011077) |
|----------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Device Common Name: | Hydrogen Peroxide Gas<br>Plasma Sterilization System | Sterilizable Instrument Tray<br>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<br>ALLClear Technology with ULTRA<br>GI Cycle Subject Device | STERRAD 100NX Sterilizer with<br>ALLClear Technology<br>K212174 Predicate Device | Comparison |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Intended Use | Designed for sterilization of both metal<br>and nonmetal medical devices at low<br>temperatures. Because the cycle operates<br>within a dry environment and at low<br>temperatures, it is especially suitable for<br>instruments sensitive to heat and<br>moisture. | Designed for sterilization of both metal<br>and nonmetal medical devices at low<br>temperatures. Because the cycle operates<br>within a dry environment and at low<br>temperatures, it is especially suitable for<br>instruments sensitive to heat and<br>moisture. | Identical |
| Indications<br>for Use | The STERRAD 100NX Sterilizer with<br>ALLClear Technology is designed for<br>sterilization of both metal and nonmetal<br>medical devices at low temperatures. The<br>STERRAD sterilization process is a<br>multiphase sterilization process that<br>utilizes a combination of exposure to<br>hydrogen peroxide vapor and plasma to<br>safely sterilize medical instruments and<br>materials without leaving toxic residue.<br>The STERRAD 100NX Sterilizer can<br>sterilize instruments which have diffusion-<br>restricted spaces, such as the hinged<br>portion of forceps and scissors.<br>Medical devices with the following<br>materials and dimensions can be<br>processed in the STERRAD 100NX<br>Sterilizer STANDARD cycle:<br>Single channel stainless steel<br>lumens with an inside diameter of<br>0.7 mm or larger and a length of 500<br>mm or shorter. A maximum of ten<br>single channel stainless steel lumens,<br>five per tray per sterilization cycle.Medical devices, including most flexible<br>endoscopes, with the following materials<br>and dimensions can be processed in the<br>STERRAD 100NX Sterilizer FLEX Scope<br>cycle:<br>Single channel polyethylene and<br>Teflon (polytetrafluoroethylene) | The STERRAD 100NX Sterilizer with<br>ALLClear Technology is designed for<br>sterilization of both metal and nonmetal<br>medical devices at low temperatures. The<br>STERRAD sterilization process is a<br>multiphase sterilization process that<br>utilizes a combination of exposure to<br>hydrogen peroxide vapor and plasma to<br>safely sterilize medical instruments and<br>materials without leaving toxic residue.<br>The STERRAD 100NX Sterilizer can<br>sterilize instruments which have diffusion-<br>restricted spaces, such as the hinged<br>portion of forceps and scissors.<br>Medical devices with the following<br>materials and dimensions can be<br>processed in the STERRAD 100NX<br>Sterilizer STANDARD cycle:<br>Single channel stainless steel<br>lumens with an inside diameter of<br>0.7 mm or larger and a length of 500<br>mm or shorter. A maximum of ten<br>single channel stainless steel lumens,<br>five per tray per sterilization cycle.Medical devices, including most flexible<br>endoscopes, with the following materials<br>and dimensions can be processed in the<br>STERRAD 100NX Sterilizer FLEX Scope<br>cycle:<br>Single channel polyethylene and<br>Teflon (polytetrafluoroethylene) | Similar,<br>includes<br>additional<br>indications for<br>Use for ULTRA<br>GI cycle. |
| | flexible endoscopes with an inside<br>diameter of 1 mm or larger and<br>length of 1065 mm or shorter. A<br>maximum of two flexible<br>endoscopes, one per tray per<br>sterilization cycle. No additional load.<br>Note: With the exception of the 1 x 1065<br>mm flexible endoscopes, the validation<br>studies were performed using a validation<br>load consisting of two instrument trays<br>each weighing 10.7 lbs. The 1 x 1065 mm | flexible endoscopes with an inside<br>diameter of 1 mm or larger and<br>length of 1065 mm or shorter. A<br>maximum of two flexible<br>endoscopes, one per tray per<br>sterilization cycle. No additional load.<br>Note: With the exception of the 1 x 1065<br>mm flexible endoscopes, the validation<br>studies were performed using a validation<br>load consisting of two instrument trays<br>each weighing 10.7 lbs. The 1 x 1065 mm | |
| Feature | STERRAD 100NX Sterilizer with<br>ALLClear Technology with ULTRA<br>GI Cycle Subject Device | STERRAD 100NX Sterilizer with<br>ALLClear Technology<br>K212174 Predicate Device | Comparison |
| | flexible endoscopes were validated<br>without any additional load. | flexible endoscopes were validated<br>without any additional load. | |
| | The STERRAD 100NX EXPRESS Cycle is<br>an additional optional cycle designed<br>for surface sterilization of both metal<br>and nonmetal medical devices at low<br>temperatures. | The STERRAD 100NX EXPRESS Cycle is<br>an additional optional cycle designed<br>for surface sterilization of both metal<br>and nonmetal medical devices at low<br>temperatures. | |
| | It can sterilize instrument surfaces<br>and instruments having diffusion-<br>restricted spaces, such as the hinged<br>portion of forceps and scissors It can sterilize rigid and semi-rigid<br>endoscopes without lumens. Note: The validation studies for<br>EXPRESS Cycle were performed using<br>a validation load consisting of a single<br>instrument tray weighing 10.7 lbs<br>placed on the bottom shelf. | It can sterilize instrument surfaces<br>and instruments having diffusion-<br>restricted spaces, such as the hinged<br>portion of forceps and scissors It can sterilize rigid and semi-rigid<br>endoscopes without lumens. Note: The validation studies for<br>EXPRESS Cycle were performed using<br>a validation load consisting of a single<br>instrument tray weighing 10.7 lbs<br>placed on the bottom shelf. | |
| | The STERRAD 100NX DUO Cycle is an<br>additional optional cycle designed for<br>sterilization of medical devices<br>including most flexible endoscopes,<br>with the following materials and<br>dimensions: | The STERRAD 100NX DUO Cycle is an<br>additional optional cycle designed for<br>sterilization of medical devices<br>including most flexible endoscopes,<br>with the following materials and<br>dimensions: | |
| | Single channel polyethylene and<br>Teflon (polytetrafluoroethylene)<br>flexible endoscopes with an inside<br>diameter of 1 mm or larger and a<br>length of 875 mm or shorter Accessory devices that are<br>normally connected to a flexible<br>endoscope during use Flexible endoscopes without<br>lumens Note: The validation studies for DUO<br>Cycle were performed using a<br>validation load consisting of two<br>flexible endoscopes with their<br>accessory devices weighing a total of<br>13.2 lbs. | Single channel polyethylene and<br>Teflon (polytetrafluoroethylene)<br>flexible endoscopes with an inside<br>diameter of 1 mm or larger and a<br>length of 875 mm or shorter Accessory devices that are<br>normally connected to a flexible<br>endoscope during use Flexible endoscopes without<br>lumens Note: The validation studies for DUO<br>Cycle were performed using a<br>validation load consisting of two<br>flexible endoscopes with their<br>accessory devices weighing a total of<br>13.2 lbs. | |
| | The STERRAD 100NX Sterilizer ULTRA<br>GI Cycle is designed for sterilization of<br>the following: | | |
| | Hydrogen peroxide compatible<br>flexible multi-channel<br>duodenoscopes, with no more<br>than 4 channels, with lumen<br>dimensions having an inside<br>diameter (ID) of ≥1mm x<br>≤1500mm in length, or<br>≥2mm ID x ≤1630mm in<br>length. | | |
| Feature | STERRAD 100NX Sterilizer with<br>ALLClear Technology with ULTRA<br>GI Cycle Subject Device | STERRAD 100NX Sterilizer with<br>ALLClear Technology<br>K212174 Predicate Device | Comparison |
| | One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle | | |
| | Note 1: The STERRAD 100NX Sterilizer<br>ULTRA GI Cycle was validated using a<br>load weight of 15.4 lbs (2 x 7.7 lbs),<br>one endoscope per shelf.<br>Note<br>2: Only duodenoscopes that have been<br>cleared as compatible with vaporized<br>hydrogen peroxide are<br>acceptable. Check STERRAD Sterilizer<br>Cycle Selection table for ULTRA GI<br>Cycle compatible duodenoscopes | | |
| Sterilization<br>Cycles | ULTRA GI<br>STANDARD<br>FLEX<br>EXPRESS<br>DUO | STANDARD<br>FLEX<br>EXPRESS<br>DUO | Identical |
| Dimensions | One Door:<br>30.5" W x 70.9" H x 41.5" D<br>(775 mm x 1800 mm x 1055<br>mm)<br>Two Door:<br>30.5" W x 70.9" H x 43.1" D<br>(775 mm x 1800 mm x 1095<br>mm) | One Door:<br>30.5" W x 70.9" H x 41.5" D<br>(775 mm x 1800 mm x 1055<br>mm)<br>Two Door:<br>30.5" W x 70.9" H x 43.1" D<br>(775 mm x 1800 mm x 1095<br>mm) | Identical |
| H2O2<br>Concentration<br>by Weight | 59-94%<br>Depending on Cycle | 59-94%<br>Depending on Cycle | Identical |
| Number Of<br>Half Cycles | 2 | 2 | Identical |
| Chamber<br>Volume | 152L | 152L | Identical |
| Key Critical<br>Process<br>Parameters | Pressure, temperature & H2O2<br>concentration, H2O2 Dose &<br>Exposure Time | Pressure, temperature & H2O2<br>concentration, H2O2 Dose &<br>Exposure Time | Identical |
| Use of Pre-<br>Conditioning<br>Step | Yes | Yes | Identical |
| Use of<br>Secondary<br>Step to<br>Remove<br>Residual H2O2<br>(technology) | Yes (plasma) | Yes(plasma) | Identical |

# Table 1. Comparison between the subject device and predicate devices

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

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

### Table 2. APTIMAX ULTRA GI Instrument Tray Predicate Device Comparison

| Feature | APTIMAX ULTRA GI<br>Instrument Tray<br>Subject Device | APTIMAX Instrument Tray<br>K013003 Predicate Device | Comparison |
|------------------------|--------------------------------------------------------|-----------------------------------------------------|------------|
| Indications for<br>Use | Designed to encase<br>instruments for<br>sterilization | Designed to encase instruments<br>for sterilization | Identical |

{10}------------------------------------------------

| Feature | APTIMAX ULTRA GI<br>Instrument Tray<br>Subject Device | APTIMAX Instrument Tray<br>K013003 Predicate Device | Comparison |
|------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Reusable/Single<br>Use | Reusable | Reusable | Identical |
| Classification<br>Name…