The Fort Defiance Industries, Inc. Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments.

Device Description

The Fort Defiance Industries, Inc. model P2131 sterilizer is an automated steam sterilizer designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments.

The P2131 is a pre-vacuum and post-vacuum sterilizer that has a conditioning stage with vacuum air removal before the start of the exposure stage, as well as a post-exposure drying stage that is based on the combined operation of heat plus vacuum. The sterilization agent is steam that is electrically-generated in a jacketed boiler.

The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer, (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS). The WRS reclaims hot condensate and exhaust steam for re-use by the sterilizer. The WRS also includes a water eductor, which provides the vacuum capability for the pre and post-vac phases of sterilization. The Sterilizer Water Softener (SWS) filters and de-mineralizes the incoming water to prevent scale build-up.

The P2131 is an automated, microprocessor-controlled, prevacuum autoclave. It has a fully-jacketed, horizontal-type pressure vessel. The P2131 is of welded aluminum alloy construction to minimize weight. The chamber assembly, with internal dimensions of 16" diameter x 36" long, is supported in a combination frame and endcap assembly to provide rigidity and protection. These endcaps, when closed, completely enclose and protect the sterilizer and its heat source providing the capability to serve as a shipping container. When the endcaps are opened they provide an integral stand, placing the sterilizing chamber and operating controls at a convenient working height.

AI/ML Overview

The provided text describes the Fort Defiance Industries, Inc. Automated Field Steam Sterilizer Model P2131. Here's a breakdown of the acceptance criteria and study information:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria for the sterilizer's effectiveness are based on achieving a sterility assurance level (SAL) of at least 10^-6, meaning a 1 in a million chance of a non-sterile item. The device's performance is reported as meeting these criteria through validation studies.

Acceptance Criteria	Reported Device Performance
Complete kill of biological indicators	Demonstrated
Sterility Assurance Level (SAL) of at least 10^-6 probability of survival	Verified
Compliance with ANSI/AAMI ST8:2013, Hospital Steam Sterilizers	Validated to meet requirements
Compliance with UL 61010-1 2nd Edition (Safety Requirements for Electrical Equipment)	Designed, constructed, and tested to meet
Compliance with IEC 61010-2-040 1st Edition (Safety requirements for electrical equipment for sterilizers)	Designed, constructed, and tested to meet
Compliance with ASME Boiler and Pressure Vessel Code, Section VIII, Division I, 2013 Edition (Rules for Construction of Pressure Vessels)	Designed, constructed, and tested to meet

The specific performance for each cycle is also relevant to the acceptance criteria for those cycles:

Cycle	Recommended Use	Maximum Load	Exposure Temperature (°F/°C)	Exposure Time (minutes)	Dry Time (minutes)	Performance Status
Immediate Use (IUSS)	Unwrapped nonporous (e.g., instruments) and porous items in mixed loads	36 lbs.	270/132	4	0	Validated
Textiles	Textile packs	3 textile packs*	270/132	4	5**	Validated
Wrapped Instruments	Wrapped instruments/utensils	36 lbs.	270/132	4	20**	Validated
Wrapped Instruments	Wrapped instruments/utensils	36 lbs.	270/132	10	20**	Validated
Bowie-Dick Test	Test	NA	273/134	3.5	0	Validated
Vacuum Leak Test	Test	NA	NA	Test time: 20	0	Validated

AAMI standard 16-towel pack (9"x9"x6")
** Dry times default to established standard conditions, but can be manually increased.

2. Sample size used for the test set and the data provenance

The document indicates that validation studies were performed, specifically mentioning "complete kill of biological indicators" and "verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10^-6". However, the exact sample size for the test set (e.g., number of sterilization cycles, number of biological indicators) is not explicitly stated. The data provenance is also not explicitly stated beyond stating that "Fort Defiance validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI)." This implies the testing was conducted prospectively according to established guidelines for sterilizer validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For sterilizer validation studies, the "ground truth" (i.e., whether sterilization was achieved) is typically established by laboratory testing of biological indicators and physiochemical measurements, not by expert consensus or interpretation of an image/result.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This concept is not applicable to the type of device and study described. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., medical imaging reads) to resolve discrepancies among experts. Sterilizer efficacy relies on objective measurement of biological and physical parameters.

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

This is not applicable as the device is an automated steam sterilizer, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was mentioned or would be relevant for this type of device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was conducted. The document states that "Effectiveness of sterilizer function and exposure time recommendations was demonstrated by complete kill of biological indicators and by verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10^-6 probability of survival." This refers to testing the sterilizer's ability to achieve sterility on its own, based on its automated cycles. The phrase "algorithm only" or "AI" is not used as this is a physical device, but the validation is of its automated, pre-programmed processes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the effectiveness of the sterilizer was established by:

Complete kill of biological indicators: This refers to the absence of microbial growth on biological indicators after exposure to the sterilization cycle. This is a direct, objective measure of sterilization efficacy.
Verification of a Sterility Assurance Level (SAL) of at least 10^-6: This is a statistical measure derived from testing, ensuring a very low probability of non-sterility.
Compliance with ANSI/AAMI ST8:2013: This standard outlines specific physical and biological test requirements to demonstrate effective sterilization.

8. The sample size for the training set

This information is not applicable as the device is a steam sterilizer, not an AI/machine learning algorithm that requires a "training set" of data. The device's operation is based on physical and chemical principles and pre-programmed parameters, not learned data.

9. How the ground truth for the training set was established

This is not applicable for the same reason as #8. There is no training set for this device.

Summary

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

December 16, 2014

Fort Defiance Industries, Inc. Mr. Chris Yerger President 155 B Natalie Boulevard Loudon, TN 37774

Re: K141009

Trade/Device Name: Fort Defiance Automated Steam Sterilizer Model P2131 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: November 18, 2014 Received: November 18, 2014

Dear Mr. Yerger:

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 - Mr. Yerger

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K141009

Device Name

Automated Field Steam Sterilizer Model P2131

Indications for Use (Describe)

Cycle	RecommendedUse	MaximumLoad	ExposureTemperature(°F/°C)	ExposureTime (minutes)	Dry Time(minutes)
ImmediateUse(IUSS)	Unwrappednonporous(e.g., instruments)and porous items inmixed loads	36 lbs.	270/132	4	0
Textiles	Textile packs	3 textile packs*	270/132	4	5**
WrappedInstruments	Wrappedinstruments/utensils	36 lbs.	270/132	4	20**
WrappedInstruments	Wrappedinstruments/utensils	36 lbs.	270/132	10	20**
Bowie-DickTest	Test	NA	273/134	3.5	0
Vacuum LeakTest	Test	NA	NA	Test time: 20	0

Notes:

AAMI standard 16-towel pack (9"x9"x6")

** Dry times default to established standard conditions, but can be manually increased.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary (K141009) For Automated Field Steam Sterilizer Model P2131

Fort Defiance Industries, Inc. 155 B Natalie Blvd Loudon, TN 37774 Phone: (865) 408-0100 Fax No: (865) 408-0960

Chris Yerger President Fort Defiance Industries, Inc. Phone: 865-408-0100 Fax: 865-408-0960

Submission Date: April 15, 2014

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Device Name 1.

Trade Name:	Automated Field Steam Sterilizer
Model Name:	P2131
Common/usual Name:	Steam Sterilizer
Classification Name:	Steam Sterilizer (21 CFR 880.6880)Product Code FLE

2. Predicate Device

K030789, Amsco Century Steam Sterilizer, product code [FLE] cleared March 26, 2003

3. Description of Device

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4. Intended Use

The Fort Defiance Automated Field Steam Sterilizer is equipped with the following factoryvalidated preprogrammed sterilization cycles:

Cycle	Recommended Use	MaxLoad	ExposureTemperature(°F/°C)	ExposureTime(minutes)	DryTime(minutes)
ImmediateUse(IUSS)	Unwrapped nonporous(e.g., instruments) andporous items in mixedloads	36 lbs.	270/132	4	0
Textiles	Textile packs	3 textilepacks1	270/132	4	52
WrappedInstruments	Wrappedinstruments/utensils	36 lbs.	270/132	4	202
WrappedInstruments	Wrappedinstruments/utensils	36 lbs.	270/132	10	202
Bowie-DickTest	Test	NA	273/134	3.5	0
Vacuum LeakTest	Test	NA	NA	Test time20	0

1 AAMI standard 16-towel pack (9"x9"x6").

2 Dry times default to established standard conditions, but can be manually increased.

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న. Substantial Equivalence

The previously cleared device and the P2131 Sterilizer are both traditional pre-vacuum steam sterilizers of similar chamber size using 4 and 10 minute 270°F cycles with the same Intended Use. Both sterilizers use electric heaters to generate steam, water eductors for vacuum, and electronic controllers with touch screens for cycle control. The main difference between the devices is that the P2131 is a transportable device so it uses lightweight aluminum for the frame, jacket and chamber instead of stainless steel for the chamber and carbon steel for the boiler. This provides some new technological differences from the predicate, but the differences do not affect the safety or effectiveness of the device. The table below provides a summary of the proposed new device and predicate device technological characteristics.

TechnologicalCharacteristic	New DeviceFort Defiance IndustriesAutomated Field Steam Sterilizer	Predicate DeviceSTERISAMSCO Century Steam Sterilizer
Intended Use	A steam sterilizer designed forsterilization of porous and non-porous,heat- and moisture-stable materials(e.g., surgical instruments and textiles)in healthcare facilities. The P2131sterilizer is a transportable devicedesigned for field use in a variety ofaustere environments.	A steam sterilizer designed forsterilization of non-porous and porous,heat- and moisture-stable materials inhealthcare facilities.
OperatingPrinciple	Steam is the sterilization agent.Traditional.	Steam is the sterilization agent.Traditional.
SterilizationCycles	Factory Pre-ProgrammedPrevac 4/0 @ 270°FPrevac 4/5 @ 270°FPrevac 4/20 @ 270°FPrevac 10/20 @ 270°FBowie-Dick & Vacuum Leak tests	Factory Pre-ProgrammedPrevac 3/1 @ 270°FPrevac 10/1 @ 270°FPrevac 4/3 @ 270°FPrevac 4/20 @ 270°FPrevac 3/16 @ 275°F4 Gravity cyclesBowie-Dick & Vacuum Leak tests
Chamber Size& Volume	16" dia. x 36" lg.4.2 cf. (118.6 L)	16" x 16" x 26"3.9 cf. (108.7 L)
Design	Steam-jacketed	Steam-jacketed
Chamber	ASME Section VIII, Div. I certifiedAluminum chamber, door,trays, frame and boiler(Aluminum for lighter weight)	ASME Section VIII, Div. I certifiedStainless steel chamber, door, traysand frame. Carbon steel boiler.
Steam Source	Integrated steam boiler.	Integrated steam boiler oroptional house steam.

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TechnologicalCharacteristic	New DeviceFort Defiance IndustriesAutomated Field Steam Sterilizer	Predicate DeviceSTERISAMSCO Century Steam Sterilizer
SteamGeneration	Electric heaters	Electric heaters
Vacuum System	Water eductor	Water eductor
ControlTechnology	Electronic controller	Electronic controller
	Touch Screen	Touch Screen
ProcessMonitors	Chamber pressure transmitter.	Chamber pressure transmitter.
	Dual element chamber drain	Dual element chamber drain
	temperature sensor.	temperature sensor.
Safety PressureRelief Valves	ASME approved	ASME approved
Electrical(Controls)	120V, 1Ø, 50/60 Hz	120V, 1Ø, 50/60 Hz
Electrical(Boiler)	208V, 3Ø, 50/60Hz, 30A	208V, 3Ø, 50/60Hz, 83A
		240V, 3Ø, 50/60Hz, 72A
		480V, 3Ø, 50/60Hz, 37A

Effectiveness 6.

Effectiveness of sterilizer function and exposure time recommendations was demonstrated by complete kill of biological indicators and by verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10 6 probability of survival. Fort Defiance validates its sterilization cycles using recommended practices, standards and guidelines developed by independent organizations such as the Association for the Advancement of Medical Instrumentation (AAMI). The Fort Defiance Automated Field Steam Sterilizer has been validated to meet the requirements of ANSI/AAMI ST8:2013, Hospital Steam Sterilizers.

7. Safety

The Fort Defiance Automated Field Steam Sterilizer Model P2131 has been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Model P2131 sterilizer will comply with the following requirements:

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UL 61010-1 2nd Edition, "Safety Requirements for Electrical Equipment for ● Measurement, Control and Laboratory Use - Part 1 General Requirements".
IEC 61010-2-040 1st Edition, "Safety requirements for electrical equipment for . measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials"
ASME Boiler and Pressure Vessel Code, Section VIII, Division I, 2013 Edition, . Rules for Construction of Pressure Vessels

Hazards – Failure of Performance 8.

Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident.

To avoid failure, the user must ensure that the materials, instruments and devices to be sterilized are thoroughly cleaned, the manufacturer's instructions for use are followed, the cycle to be used for each type of sterilizer load has been validated, the sterilizer has been maintained in accordance with the sterilizer manufacturer's recommended maintenance schedule and is operating properly, and each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.

The technology designed into the Fort Defiance Automated Field Steam Sterilizer provides control safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.

9. Conclusion

The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 has been validated to meet the requirements of ANSI/AAMI ST8:2013. The results of the Automated Field Steam Sterilizer validation studies demonstrate that the sterilizer performs as intended. Based on the information provided in this premarket notification, it can be concluded that the Automated Field Steam Sterilizer Model P2131 is substantially equivalent to the predicate device and is as safe and as effective when used as intended.

Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).