STERRAD 100NX STERILIZER EXPRESS CYCLE

K092622 · Advanced Sterilization Products · MLR · Mar 4, 2011 · General Hospital

Device Facts

• Record ID: K092622
• Device Name: STERRAD 100NX STERILIZER EXPRESS CYCLE
• Applicant: Advanced Sterilization Products
• Product Code: MLR · General Hospital
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

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 affect sterilization. The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted 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* 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 850 mm or shorter** 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. * 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, 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 Ibs placed on the bottom shelf.

Device Story

STERRAD 100NX Sterilizer is a self-contained, stand-alone system for low-temperature sterilization of medical instruments. It utilizes a multiphase process: aqueous hydrogen peroxide injection into a vaporizer; introduction of vapor into a chamber under sub-ambient pressure; transformation into gas-plasma via electrical energy. The system includes a sterilization chamber, disposable sterilant cassettes, reusable instrument trays, and optional cart. It offers three cycles: Standard, Flex, and the EXPRESS cycle. The EXPRESS cycle is designed for surface sterilization of metal/nonmetal devices, including those with diffusion-restricted spaces and rigid/semi-rigid endoscopes without lumens. The device is operated in clinical settings to ensure instrument sterility, reducing infection risk. Healthcare providers load instruments into trays, select the appropriate cycle, and the system automates the sterilization process. Output is a sterilized instrument ready for clinical use.

Clinical Evidence

No clinical data. Bench testing only. Validation performed using an 'overkill' approach with G. stearothermophilus spores. Studies included dose response with anodized aluminum, surface and mated surface sterilization, bacteriostasis testing, in-use testing for general medical devices, simulated use testing, toxicity testing, chemical indicator functionality, and process reproducibility. All tests passed.

Technological Characteristics

Hydrogen peroxide gas plasma sterilization system. Operates via sub-ambient pressure vapor injection and electrical energy plasma transformation. Components include sterilization chamber, disposable sterilant cassette, and reusable instrument trays. Stand-alone system; can be placed on table or cart. Software-controlled cycles (Standard, Flex, EXPRESS).

Indications for Use

Indicated for low-temperature sterilization of metal and nonmetal medical devices, including instruments with diffusion-restricted spaces (e.g., hinged forceps/scissors), rigid/semi-rigid endoscopes without lumens, and specific stainless steel or polyethylene/Teflon flexible endoscopes.

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™ Sterilization System (K071385)
• STERRAD® 200 Sterilization System (K030429)

Submission Summary (Full Text)

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K092622
510(k) Notification

# 510(k) Summary

MAR - 4 2011

Applicant's Name, Address, Telephone, FAX, Contact Person Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618

## Contact Person

Nancy Chu Regulatory Affairs Manager Tel: [phone] Fax: [phone] Email: [e-mail]

April 15, 2010

1.0 CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME Classification Name: Sterilizer, Class II Common/Usual Name: Hydrogen Peroxide Gas Plasma Sterilization System Product Classification: Sterilizer, Class II Proprietary Name: STERRAD® 100NX™ Sterilizer with EXPRESS Cycle

### 2.0 PREDICATE DEVICES

STERRAD® 100NX™ Sterilization System [K071385] STERRAD® 200 Sterilization System [K030429]

### 3.0 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 affect sterilization.

The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.

Medical devices with the following materials and dimensions can be processed in the STERRAD® 100NXTM 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*

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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 850 mm or shorter**
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 l x 850 mm flexible endoscopes were validated without any additional load.

* 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,

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 Ibs placed on the bottom shelf.

#### 4.0 DESCRIPTION OF DEVICE

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 STERRAD® 100NXTM Sterilizer has three different sterilization cycles, the Standard cycle, the Flex cycle, and the new optional additional EXPRESS cycle.

The hardware for the STERRAD® 100NX™ Sterilizer consists of a sterilization chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer system also uses accessories such as a disposable sterilant cassette, reusable instrument trays, printer paper, and an optional movable cart. The STERRAD® 100NXTM Sterilizer can be placed directly on a table, counter top, or on the movable cart.

### SUMMARY OF NONCLINICAL TESTS 5.0

### 5.1 Validation Testing

Testing was performed using the "overkill" approach utilizing G. stearothermophilus spores. Table 8-1 on the following page identifies the validation studies performed and the results obtained.

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# Table 8-1: Validation Studies

| Study | Results |
|----------------------------------------------------------|---------|
| Dose Response with Anodized Aluminum Surfaces | Passed |
| Surface Sterilization | Passed |
| Mated Surface Sterilization | Passed |
| Bacteriostasis Testing in the EXPRESS Cycle | Passed |
| In Use Testing - General Medical Devices | Passed |
| Simulated Use Testing | Passed |
| Toxicity Testing of Materials | Passed |
| Chemical Indicator Functionality | Passed |
| CycleSure Biological Indicator Qualification | Passed |
| Bacteriostasis Testing of CycleSure Biological Indicator | Passed |
| Device Functionality and Material Compatibility | Passed |
| Process Reproducibility | Passed |

### OVERALL PERFORMANCE CONCLUSIONS 6.0

The nonclinical studies demonstrate that the STERRAD® 100NX™ EXPRESS Cycle is safe and effective for surface sterilization of medical devices within the indications for use for the sterilizer and establish equivalence of the STERRAD® 100NX™ EXPRESS Cycle to the predicate devices, the STERRAD® 100NX™ Sterilizer, and the STERRAD® 200 Sterilizer.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Nancy Chu Manager, Regulatory Affairs Advanced Sterilization Products 330 Technology Drive Irvine, California 92618

MAR - 4 2011

Re: K092622

Trade/Device Name: STERRAD® 100NX™ Sterilizer with EXPRESS Cycle Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR . Dated: March 1, 2011 Received: March 2, 2011

Dear Ms. Chu:

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. 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.

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Page 2- Ms. Chu

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## 510(k) Number (if known): K092622

### STERRAD® 100NX™ Sterilizer with EXPRESS Cycle Device Name:

### 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 affect sterilization.

The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted 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*
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 850 mm or shorter**
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.

*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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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 diffusionrestricted spaces, such as the hinged portion of forceps and scissors
- > It can sterilize rigid and semi-rigid endoscopes without lumens

The validation studies for EXPRESS Cycle were performed using a validation load Note: consisting of a single instrument tray weighing 10.7 Ibs placed on the bottom shelf.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizth. B. Clain-Wall

Jivision Sign-Off) ·············································································································································································· Tection Control, Dental Devices

10(k) Number: K092622

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