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 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 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-
. An inside diameter of 2 mm or larger and a length of 400 mm or shorter 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 shorter1 ● Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with

An inside diameter of 1 mm or larger and length of 850 mm or shorter2 ●

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 a 59% aqueous hydrogen peroxide solution into the vaporizer subassembly where the solution is then concentrated and is vaporized at relatively low temperatures through a process that utilizes a combination of heating and sub-ambient pressures created by an on-board vacuum pump. The vaporized hydrogen peroxide is then introduced into the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and, facilitating hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is repeated an additional time to complete a full STERRAD NX Sterilization cycle (i.e., the full sterilization cycle is composed of two identical half-cycles). The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles, both of which follow the general process described here.

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. Other major components of the system are constructed from passivated stainless steel. Viton (a copolymer of vinylidene fluoride and hexafluoropropylene), Ultem (polyetherimide), and structural foam. 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, counter top, or on the movable STERRAD NX cart.

The STERRAD NX Sterilizer uses a disposable sterilant cassette that contains a 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. As previously described, the hydrogen peroxide is concentrated before introduction 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 pre-defined minimum concentration specification.

The modified STERRAD NX Sterilizer, which is the subject of this submission, incorporates a new vacuum pump and associated mounting components to improve the pump's durability. The new vacuum pump utilizes an oil warming element to maintain an optimum operating temperature range for the vacuum pump's oil during the periods of pump inactivation in-between reprocessing cycles. This modification will be implemented through hardware changes with no impact on the system software.

The technological characteristics associated with the sterilization process for the modified STERRAD NX Sterilizer are identical to those of the previously cleared STERRAD NX Sterilizer. In addition, the hardware changes associated with the described modification do not affect the cleared sterilization cycles or the manner by which the STERRAD NX Sterilizer is operated by the customer.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: the STERRAD NX® Sterilizer with a new vacuum pump. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not for proving effectiveness of a new technology (like an AI algorithm) through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI models is largely not applicable to this document.

The document describes a modification to an existing sterilizer (changing the vacuum pump) and focuses on demonstrating that this change does not negatively impact the device's existing performance or safety.

However, I can extract the closest analogous information from the document to answer your prompt, focusing on the verification testing conducted for the sterilizer's modification.

Summary of Device Performance and Acceptance Criteria (as applicable to a non-AI device modification):

This document describes a design modification (new vacuum pump) to an existing medical device, the STERRAD NX Sterilizer. The "acceptance criteria" here relate to demonstrating that the new component does not compromise the sterilizer's function or safety, and maintains the established efficacy of sterilization. Since this is not an AI device, concepts like "sensitivity," "specificity," or specific performance metrics for model predictions are not relevant. Instead, the acceptance criteria relate to functional performance and sterility assurance.

The studies conducted are primarily non-clinical design verification tests. There were no clinical studies submitted for this specific 510(k) notification.

Here's the breakdown of the information requested, adapting it to the content of the document:

A table of acceptance criteria and the reported device performance:

Acceptance Criterion (Design Input Verified)	Reported Device Performance (Verification Testing Outcome)
Vacuum Pump Performance:
* Time to warm up across different power settings	Pass
* Pump startup across different power settings	Pass
* Pump current draw	Pass
* Environmental specifications	Pass
* Noise generation	Pass
* Time to pump an enclosed space to a defined pressure	Pass
* Fitment	Pass
* Weight (impact on total device weight, mentioned in comparison table)	Modified device weighs 10 lb more, deemed acceptable
* Qualitative verification of features (e.g., drain valve, liftable feature)	Pass
Sterilization Efficacy (for STANDARD and ADVANCED Cycles with new pump):
* Sterility Assurance Level (SAL) of 10⁻⁶ for Geobacillus stearothermophilus (Biological Indicators - BIs) with no growth observed. This demonstrates no impact to efficacy.	Pass (No growth observed on test BIs)
Safety and Compatibility:
* Biocompatibility (continued applicability of predicate data)	Applicable
* Electromagnetic compatibility (EMC) (continued applicability of predicate data)	Applicable (no anticipated impact from notified body)
* Electrical Safety (conformance to specific standards: CAN/CSA-C22.2 No. 61010-1, CAN/CSA-C22.2 No. 61010-2-040, UL 61010-1, IEC/EN 61010-1, IEC/EN 61010-2-40)	Conforms to applicable standards
* Software Verification and Validation (continued applicability of predicate data - no software changes)	Applicable

Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of units or test runs for the vacuum pump verification tests. For the sterilization efficacy testing, it mentions "test BIs" (Biological Indicators) but doesn't quantify the number used. For lumen validation, specifies "a maximum of 10 lumens per load" and "only one flexible endoscope per sterilization cycle."
- Data Provenance: The data is generated from non-clinical design verification testing performed by the manufacturer, Advanced Sterilization Products. The location or specific date of data generation isn't explicitly stated beyond the submission date (February 16, 2017). It is prospective with respect to the design modification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes engineering and sterility validation, not AI algorithm performance requiring expert human interpretation as ground truth. The "ground truth" for sterilization efficacy is the sterility assurance level (SAL) demonstrated by no growth of highly resistant biological indicators.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None applicable. This is not a human-in-the-loop diagnostic study requiring expert adjudication. The "adjudication" is based on objective measurements and established sterilization standards.
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:
- No MRMC study was done. This is not an AI-assisted diagnostic device, but a sterilizer. The document explicitly states: "No clinical data is being submitted in support of this Premarket Notification."
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is a physical sterilizer, not an algorithm. The "standalone" performance relates to the sterilizer's ability to achieve sterility on its own, which was tested.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for sterilization efficacy is established by objective microbial biological indicator testing. Specifically, the absence of growth of Geobacillus stearothermophilus to demonstrate a Sterility Assurance Level (SAL) of 10⁻⁶. This is a universally accepted method for validating sterilization processes. Other "ground truths" were successful mechanical and electrical performance according to engineering specifications and safety standards.
The sample size for the training set:
- Not applicable. This is not an AI device that uses a "training set." The device's operational parameters and design are based on engineering principles and previous validation, not machine learning.
How the ground truth for the training set was established:
- Not applicable. As above, no training set was used.

Summary

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

February 16, 2017

Advanced Sterilization Products Nazanin Yacobi Senior Regulatory Affairs Program Lead 33 Technology Dr. Irvine, California 92618

Re: K162007

Trade/Device Name: Sterrad Nx Sterilizer Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: July 18, 2016 Received: July 20, 2016

Dear Nazanin Yacobi:

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.

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

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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)

Device Name STERRAD NX® Sterilizer

Indications for Use (Describe)

The STERRAD NX Sterilizer is designed for sterilization of both metal 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*
· An inside diameter of 2 mm or larger and a length of 400 mm or shorter*

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 polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope 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, validation studies were performed using a validation load consisting of one instrument tray weighing 10.7 lbs. The 1 x 850 mm flexible endoscope was validated without any additional load.

The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. * Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load.

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.

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510(k) Summary

Advanced Sterilization Products STERRAD NX® Sterilizer with New Vacuum Pump

General Information

Submitter Name:	Advanced Sterilization ProductsDivision of Ethicon, Inc., a Johnson & Johnson company
Address:	33 Technology DriveIrvine, CA 92618
Contact Person:	Nazanin YacobiSenior Regulatory Affairs Program LeadTel: (949) 789-8672Fax: (949) 798-3900Email: nyacobi@its.jnj.com

Date Prepared: February 16, 2017

Device Name

Proprietary Name:	STERRAD NX® Sterilizer
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 originally cleared under K042116.

Description

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peroxide is then introduced into the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and, facilitating hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is repeated an additional time to complete a full STERRAD NX Sterilization cycle (i.e., the full sterilization cycle is composed of two identical half-cycles). The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles, both of which follow the general process described here.

Intended Use/Indications For Use

The intended use of the STERRAD NX Sterilizer, as described in the labeling, has not changed as a result of the modification nor are there any differences between the predicate STERRAD NX and modified STERRAD NX indications for use.

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sterilization. The STERRAD NX 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 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-
. An inside diameter of 2 mm or larger and a length of 400 mm or shorter 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 shorter1 ● Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with

An inside diameter of 1 mm or larger and length of 850 mm or shorter2 ●
With the exception of the 1 x 850 mm flexible endoscopes, validation studies were Note: performed using a validation load consisting of one instrument tray weighing 10.7 lbs. The 1 x 850 mm flexible endoscope was validated without any additional load.

Non-Clinical Data

Design verification testing was conducted to test the modified STERRAD NX Sterilizer ● (with new vacuum pump) design against applicable design inputs; all testing yielded passing results. This testing is summarized in the following table.

Verification Testing	Description	Pass/Fail
Verification of the newVacuum Pump in theSTERRAD NX System	This study conducted design verification to demonstrate that the newvacuum pump is able to meet applicable design inputs.Testing includes design input factors such as time to warm up acrossdifferent power settings, pump startup across different power settings,pump current draw, environmental specifications, noise generation, timeto pump an enclosed space to a defined pressure, fitment, weight andqualitative verification of the presence of certain features such as adrain valve, a feature by which the pump can be lifted.	Pass

	Table 1: Summary of performance testing

1 The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

2 Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load.

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Verification Testing	Description	Pass/ Fail
Verification of theSTERRAD NXSTANDARD andADVANCED Cyclesusing STERRAD NXSterilizers Built with theNew Vacuum Pumps	This study conducted efficacy testing of the STANDARD and ADVANCED cycles in the modified STERRAD NX Sterilizer to verify that there is no impact to efficacy introduced by the use of the new vacuum pump. No growth was observed on the test BIs with a sterility assurance level (SAL) of 10-6 of Geobacillus stearothermophilus demonstrating no impact to efficacy.	Pass

. Biocompatibility testing data submitted in the predicate device 510(k) continues to be applicable to the modified STERRAD NX Sterilizer as no changes have been made to the sterilization process/cycle parameters or the sterilant (hydrogen peroxide) materials.
Electromagnetic compatibility (EMC) testing data submitted in the predicate device 510(k) continues to be applicable to the modified STERRAD NX Sterilizer. Upon review of the device modification TÜV SÜD America, Inc., the notified body that conducts EMC testing on the STERRAD NX Sterilizer, has concluded that there is no anticipated impact to the results of the previous EMC testing.
. Electrical Safety testing was conducted to demonstrate that the modified STERRAD NX is electrically and mechanically safe when operated and maintained in accordance with the User's Guide and the Service Guide. Based upon this testing, the modified STERRAD NX Sterilizer conforms to the applicable sections of the following standards:
- CAN/CSA-C22.2 No. 61010-1:2004 + Update 1:2008 R: 2009 Safety Requirements O for Electrical Equipment for Measurement, Control, and Laboratory Use
- CAN/CSA-C22.2 No. 61010-2-040:2007-12 Safety requirements for electrical o equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
- UL 61010-1/R:2008-10 Standard for Safety for Electrical Equipment for Laboratory o Use
- IEC/EN 61010-1:2001 Safety Requirements for Electrical Equipment for o Measurement, Control, and Laboratory Use
- IEC/EN 61010-2-40:2005 Particular Requirements for Sterilizers and Washer- O disinfectors used to Treat Medical Materials, First Edition
Software verification and validation testing data submitted in the predicate device's 510(k) ● continues to be applicable to the modified STERRAD NX Sterilizer as there are no modifications being made to the software of the system. Software verification and validation testing was previously conducted in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005.

Clinical Data

No clinical data is being submitted in support of this Premarket Notification.

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Summary

The modified STERRAD NX Sterilizer and its predicate device, the previously cleared STERRAD NX Sterilizer, have the same intended use and indications for use. Further, the modified STERRAD NX Sterilizer utilizes the same technology, performance characteristics, sterilant, and cycles as the predicate device to sterilize medical devices. As the only difference between the modified STERRAD NX and the predicate device is the vacuum pump and associated mounting components, no new questions of safety or efficacy are raised.

Comparison of Device Characteristics
Characteristic	PredicateSTERRAD NX SterilizerK042116, K142454 and K151725	ModifiedSTERRAD NX Sterilizer
Intended Use	Designed for sterilization of both metal andnonmetal medical devices at low temperatures.Because the cycle operates within a dryenvironment and at low temperatures, it isespecially suitable for instruments sensitive toheat and moisture.	Same
Sterilization Process	Hydrogen peroxide gas plasma	Same
Principle of operation	Combined use of hydrogen peroxide vapor andplasma safely and rapidly sterilizes mostmedical instruments and materials withoutleaving toxic residues.	Same
Sterilization Cycles	STANDARD and ADVANCED	Same
Recommended Materials	Common materials found in reusable medicaldevices. All medical devices should beprocessed in accordance with the medicaldevice manufacturer's recommendations.	Same
Approximate Total CycleTime
Standard Cycle:	28 minutes	Same
Advanced Cycle:	38 minutes	Same
Approximate SterilizerWeight	325 lb.	335 lb. (new pump weighs10 lb. more)
Sterilizer ExternalDimensions	22.0" W x 33" H x 32" D(558.8 mm x 838.2 mm x 812.8 mm)	Same
Sterilizer InternalDimensions	12.6" W x 23.6" H x 6.2" L(320 mm x 600 mm x 157 mm)	Same
Shelves
Shelf Dimensions	Upper & Lower: 23.6" L X 12.3" W (600 mm x312 mm)	Same
Shelf Weight Capacity	24.3 lb (11 kg)	Same
Distance Between Shelves	3.4" (86 mm)	Same
Comparison of Device Characteristics
Characteristic	PredicateSTERRAD NX SterilizerK042116, K142454 and K151725	ModifiedSTERRAD NX Sterilizer
Chamber Volume	Usable: 30 liters (1.1 ft3)Total: 51.3 liters (1.8 ft3)	Same
Major Component Materials
Chamber Components	Aluminum	Same
Shelves	Passivated stainless steel	Same
Chamber Door O-Ring	Viton(copolymer of vinylidene fluoride &hexafluoropropylene)	Same
Injector and Vaporizer	Aluminum, Ultem (Polyetherimide), Stainlesssteel, Viton	Same
Exterior Panels	Structural Foam	Same
Operator Interface
Flat Panel Display	6.4" touch screenTFT (thin-film transistor) LCD	Same
Graphical User Interface	Geode SC2200 266 MHz	Same
Hydrogen Peroxide Monitor	Cancels sterilization cycle if the areas under theconcentration-time curve or rate constant do notmeet predetermined specifications	Same
Temperature Sensors	Chamber, chamber door andvaporizer/condenser thermistors	Same
Pressure Sensors	Chamber pressure transducersChamber atmospheric pressure switchVaporizer/condenser pressure transducer	Same
Door Sensors	Lock sensorClosed sensor	Same
Connectivity	DTI (Digital Transfer interface)Network connectivity software allows thehospital IT department to connect the sterilizerto a hospital local area network.	Same
Accessories	STERRAD NX CassetteTest PackCycleSure® Biological IndicatorSTERRAD Chemical Indicator StripSTERRAD SealSure™ Chemical IndicatorTapeTyvek® PouchesInstrument Trays	Same

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Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device of this special 510(k) is substantially equivalent to the predicate device cleared under K042116, K142454 and K151725.

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).