The V-PRO 1 Low Temperature Sterilization System and Vaprox® HC Hydrogen Peroxide Sterilant (59%) are intended for use in terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities.

The V-PRO 1 Low Temperature Sterilization System can sterilize*:

Instruments with diffusion-restricted spaces such as the hinged portion of . forceps and scissors.
Medical devices with a single stainless steel lumen with: .
- an inside diameter of 1 mm or larger and a length of 125 mm or shorter o
- an inside diameter of 2 mm or larger and a length of 250 mm or shorter o
- an inside diameter of 3 mm or larger and a length of 400 mm or shorter o

The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs,

Device Description

The STERIS Amsco V-PRO Low Temperature Sterilizer is a self contained standalone device, using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusshle metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suits ator processing medical devices sensitive to heat and moisture. The hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into a vaporization chamber where the solution is heated and converted to a vapor, and then introduced into the sterilizer chamber under negative pressure.

The equipment (hardware) for the V-PRO 1 Sterilizer is similar to that of the predicate device (Sterrad 100S Sterilizer System). The hardware consists of a welded frame onto which is mounted the sterilization chamber along with a variety of instruments and components, controls, piping, vacuum pump, housed in a covered frame of stainless steel panels. The V-PRO 1 Sterilizer also uses accessories such as disposable multiple use sterilant cartridge, reusable instrument trays, printer paper and ink cartridges.

AI/ML Overview

Acceptance Criteria and Device Performance for Amsco® V-PRO™ 1 Low Temperature Sterilization System

This document describes the acceptance criteria and the study used to demonstrate that the Amsco® V-PRO™ 1 Low Temperature Sterilization System meets these criteria, as derived from the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Amsco® V-PRO™ 1 Low Temperature Sterilization System is sterility, defined as a Sterility Assurance Level (SAL) of 10⁻⁶. This means that the probability of a single viable microorganism remaining on an item after sterilization is one in a million.

The studies presented extensively use "sterility" of all tested items as the performance metric, indicating that no viable microorganisms (specifically Geobacillus stearothermophilus spores) were recovered after processing.

Acceptance Criterion	Reported Device Performance
Sterility (SAL of 10⁻⁶)	All tested items across various scenarios (surface, mated, lumen, pouched, simulated use, in-use) were sterile. An "all kill endpoint" was demonstrated for 2, 3, and 4 pulse cycles, establishing an SAL of 10⁻⁶.
Effective for Surface Sterilization	All coupons tested in ½ cycles were sterile, demonstrating efficacy on various medical device materials.
Effective for Mated Surfaces	All coupons (metallic and polymer carriers) tested in ½ cycles were sterile, demonstrating efficacy on closely-opposed surfaces.
Effective for Lumen Sterilization	All lumens of various sizes (1x125mm, 2x250mm, 3x400mm) were sterile after ½ cycle.
Effective for Tyvek/Mylar Pouched Devices	All lumens of various sizes in pouches were sterile after ½ cycle.
Effective under Reduced Peroxide (Worst-Case Lumen)	All 3x400mm lumens were sterile at standard (2.1g) and reduced (1.457g) hydrogen peroxide injection weights.
No Toxic Sterilant Residuals	Cytotoxicity and in vivo biocompatibility testing showed no toxic sterilant residuals.
Sterility in Simulated Use Conditions	All 114 device sites across 16 devices were sterile after full cycle with and without cleaning.
Sterility in In-Use Clinical Conditions	All 42 device sites across 12 devices were sterile after full cycle with clinical soiling and cleaning.
Software Validation	Software validation complied with FDA's "moderate level of concern" recommendations.
Risk Management	Software and equipment risk management plans and analyses (FMECA, FTA) were performed.
Compliance with Standards	Met UL 61010-1, CSA 22.2 No. 1010.1, MDD 93/42/EEC, EN61010-1, EN60601-1-2.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly use the term "test set" in the context of machine learning. Instead, it describes various validation studies for the sterilizer's performance. The sample sizes for these studies are:

Surface Sterilization of Medical Device Materials: "a wide variety of medical device materials" (specific number not given, but refers to multiple coupons).
Mated Surfaces: "metallic and polymer carriers" (specific number not given, but includes stainless steel, Ultem, Radel, Delrin, Noryl).
Lumen Sterilization - Worst Case Lumen Size: Three lumen sizes (1x125mm, 2x250mm, 3x400mm stainless steel) were tested to determine the worst case.
Half Cycle Verification at Multiple Peroxide Injection Weights Worse Case Lumen Size: The 3x400mm lumen was tested at five injection weights. "All lumens" were sterile at two specific weights. The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load.
Half Cycle Verification of Lumen Claims: Three lumen sizes (1x125mm, 2x250mm, 3x400mm) were tested. "All lumens of each size" were sterile.
Tyvek/Mylar Pouched Device Sterilization: Test articles of lumen sizes of 1x125mm, 2x250mm, and 3x400mm stainless steel were used. "All lumens of each size" were sterile.
AOAC Sporicidal carrier testing: "None of the carriers" demonstrated growth.
Modified Total Kill Endpoint Bracket Testing: Cycles consisting of 1, 3, and 4 pulses were evaluated. Two-pulse cycles were evaluated in a prior study.
Simulated Use Testing: A total of 16 devices with 19 inoculated sites (multiple sites per device, lumens and surface sites) were tested in each cycle, with three replicate cycles performed with and without cleaning conditions. This equates to a total of 114 device sites tested.
In-Use Sterility Testing: A total of 12 devices were tested with 14 inoculated sites evaluated. This equates to a total of 42 device sites tested across three trials.

Data Provenance: The data appears to be prospective and internal to STERIS Corporation, generated purely for the purpose of validating the device. The "In-Use" testing mentions devices used in "routine surgeries at a local hospital," indicating some practical application for that specific test, but the overall testing is laboratory-controlled. Country of origin is not explicitly stated but implied to be the US given the submission to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device validation (sterilizer) typically relies on microbiological testing rather than expert human interpretation of images or observations. Therefore, the concept of "experts" establish ground truth in the way it applies to diagnostic AI is not directly applicable here.

The "ground truth" for sterility is established through:

Presence or absence of growth of Geobacillus stearothermophilus: This is a direct biological measure.
AOAC Sporicidal carrier testing: This adheres to specific guidelines and methods established by a scientific association.

While trained microbiologists would conduct and interpret these tests, the decision of "sterile" or "not sterile" is based on observable biological outcomes (e.g., bacterial growth) and validated test protocols, not subjective expert consensus in the same vein as a physician reading an image.

4. Adjudication Method for the Test Set

Given the nature of microbiological testing, an "adjudication method" involving multiple experts resolving discrepancies is generally not applicable. The endpoints (growth/no growth) are typically objective.

The "overkill" method for validation implies a rigorous approach where the device is tested under conditions that are more challenging than typical use, ensuring a wide margin of safety. If any growth were observed, it would typically lead to a failure of that test condition, requiring re-evaluation or modification of the process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in interpreting medical data (e.g., radiologists reading images). The Amsco® V-PRO™ 1 Low Temperature Sterilization System is a standalone sterilization device and does not involve human interpretation in its primary function.

6. Standalone (Algorithm Only Without Human-In-The-Loop Performance) Study

Yes, the entire series of physical validation studies constitutes a standalone performance evaluation of the sterilization device. The device's ability to achieve sterility is tested directly, without human intervention in the sterilization process itself or in the primary assessment of sterility (which is microbiologically determined).

7. The Type of Ground Truth Used

The primary ground truth used is microbiological evidence of sterility, specifically the absence of viable Geobacillus stearothermophilus spores.

This is achieved by inoculating samples with a known resistant microorganism, subjecting them to the sterilization process, and then culturing them to detect any surviving organisms.
Secondary ground truths include toxicity testing (cytotoxicity, in vivo biocompatibility) to ensure no harmful residuals.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. The Amsco® V-PRO™ 1 Low Temperature Sterilization System is a physical sterilization device, not a machine learning algorithm that requires training data. The validation studies described are testing the physical device's performance, not "training" it.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of this device, this question is not applicable.

Summary

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510(k) Summary For Amsco® V-PRO™ 1 Low Temperature Sterilization System

1. Submitter Information

2007 OCT 4

Contact:	Patrick J. McCullagh, Ph.D.Vice PresidentGlobal Quality Systems Engineering & Regulatory Affairs
Address:	STERIS Corporation5960 Heisley Rd.Mentor, Ohio 44060
Telephone:Fax No:	(440) 392-7601(440) 392-8963
Submission Date:	August 4, 2006

2. Device Name

Trade Name:	Amsco® V-PRO™ Low Temperature SterilizationSystem
Common/usual Name:	Vapor Phase Hydrogen Peroxide Sterilizer
Classification Name:	Sterilizer, Ethylene Oxide Gas

3. Predicate Device

Sterrad 100S Sterilization System

4. Description of Device

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5. Statement of Intended Use

The V-PRO 1 Low Temperature Sterilization System can sterilize*:

Instruments with diffusion-restricted spaces such as the hinged portion of . forceps and scissors.
. Medical devices with a single stainless steel lumen with:
- an inside diameter of 1 mm or larger and a length of a 125 mm or shorter o
- an inside diameter of 2 mm or larger and a length of 250 mm or shorter o
- an inside diameter of 3 mm or larger and a length of 400 mm or shorter o

The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 Ibs.

6. Effectiveness

Validation Testing

Testing was performed using the "overkill" method.

Pre-validation Testing

. Test Organism: Geobacillus stearothermophilus
Process Variables and Parameters: Testing was conducted to characterize . the effect of the process parameters on lethality. The four critical process parameters that may affect process lethality are chamber wall temperature, vaporizer temperature, injection pressure and injection weight. The level tested for each parameter was selected to provide a worst case situation for the test series and to be outside the abort levels or settings for the sterilizer. The study showed that process lethality was unaffected over the range of process parameters tested.

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V-PRO 1 Sterilization System Process Validation

. Surface Sterilization of Medical Device Materials:
The purpose of this study was to demonstrate the effectiveness of the V-PRO 1 Sterilizer using EOSL sterilant under ½ cycle parameters with Geobacillus stearothermophilus spores inoculated on a wide variety of medical device materials. Coupons made from these materials were cleaned, then inoculated with >10° Geobacillus stearothermophilus spores. the Most Resistant Organism (MRO), and dried for 1 hour.

All of the coupons tested in the V-PRO 1 Sterilizer 1/2 cvcles were sterile indicating sterile efficacy of all representative device materials using End of Shelf Life (EOSL) sterilant dose at 1/2 cycle conditions.

Mated Surfaces: .

This study was designed to demonstrate the ability of the V-PRO 1 Sterilizer using EOSL sterilant to effectively sterilize mated or closelyopposed surfaces, a study was performed with metallic and polymer carriers and tested under half cycle conditions in the V-PRO 1 sterilization process. The materials used were stainless steel, Ultem, Radel, Delrin, and Noryl. These polymers were chosen because they are the most commonly used in nonmetallic reusable devices with mated surfaces.

All of the coupons tested in the V-PRO 1 Sterilizer 1/2 cycles were sterile indicating sterile efficacy of all representative device materials using EOSL sterilant dose.

Lumen Sterilization - Worst Case Lumen Size: .

Microbial efficacy testing was performed to determine the most difficult of the V-PRO 1 System's lumen claims to sterilize. The iumen sizes tested were 1 x 125 mm, 2 x 250 mm, and 3 x 400 mm stainless steel.

Worst case lumen testing was performed in the V-PRO 1 Sterilizer at ½ cycle operation parameters using a reduced hydrogen peroxide injection weight of the EOSL sterilant; that is at < the standard 2.1g hydrogen peroxide injection weight.

Results indicate that the 3 x 400 mm is the worst case, i.e. most difficult to sterilize, of the lumens size claims for the V-PRO 1 Sterilizer.

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Half Cycle Verification at Multiple Peroxide Injection Weights Worse Case . Lumen Size:
Five injection weights, 0.121, 0.607, 1.214, 1.457, and 2.1g, were used to test the worst case lumen size, 3 x 400 mm, at 1/2 cycle parameters and EOSL sterilant to demonstrate the microbial efficacy of the V-PRO 1 Sterilizer.

At the standard hydrogen peroxide injection weight of 2.1g and the reduced injection weight of 1.457g, all lumens were sterile.

Half Cycle Verification of Lumen Claims: ●
The testing was performed to demonstrate the microbial efficacy of the V-PRO 1 Sterilizer under ½ cycle parameters and EOSL sterilant using 1 x 125 mm, 2 x 250, and 3 x 400 mm stainless steel lumens.

All lumens of each size were sterile after the V-PRO 1 ½ cycle using EOSL sterilant.

Tyvek/Mylar Pouched Device Sterilization: .

The purpose of this validation study was to demonstrate efficacy of the V-PRO 1 Sterilizer using EOSL sterilant at ½ cycle parameters using an alternative device/instrument packaging method, individual placement in Tyvek/Mylar pouches rather than arranged in a wrapped sterilization tray. Test articles of lumen sizes of 1 x 125 mm, 2 x 250 mm, and 3 x 400 mm stainless steel were used.

All lumens of each size were sterile after the V-PRO 1 ½ cycle using EOSL sterilant.

. Supporting Microbiological Testing:

AOAC Sporicidal carrier testing was performed in the V-PRO 1 Sterilizer per the guidelines provided in the Official Methods of Analysis of the AOAC International Association of Official Chemists, 17th Edition, 2000, AOAC Official Method 966.04 "Sporicidal Activity of Disinfectant". None of the carriers demonstrated growth.

. Modified Total Kill Endpoint Bracket Testing:

Total Kill Endpoint Bracketing is testing that evaluates the sterilant exposure time from 14 to 34 of the total full cycle exposure with all sterile results expected after ½ of the cycle. The V-PRO 1 Sterilizer full cycle consists of four fixed time pulses using 2.1g peroxide injected per pulse.

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For this testing, the V-PRO 1 Sterilizer was modified to perform cycles consisting of 1. 3. and 4 pulses to evaluate the total kill endpoint. Two pulse cycles were evaluated in the Half Cycle Verification at Multiple Peroxide Injection Weights study using the worst case lumen size of 3 x 400 mm.

An all kill endpoint was demonstrated with sterile results at the 2, 3 and 4 pulse cycles in the V-PRO 1 Sterilizer. These results demonstrate a SAL of 10-6 for the complete V-PRO 1 sterilization process.

. Toxicity Testing of Processed Materials:

Cytotoxicity and in vivo biocompatibility testing of materials processed in the V-PRO 1 Sterilizer showed that the sterilization process leaves no toxic sterilant residuals on the materials.

Simulated Use Testing: .

Testing was performed to confirm sterility of medical device outer surface sites and lumens after processing in VPRO 1 Low Temperature Sterilization System at full cvcle parameters using EOSL sterilant. Devices representative of surface features and lumen claims for the V-PRO 1 Low Temperature Sterilization System were selected for the Simulated Use testing.

A total of 16 devices with 19 inoculated sites (multiple sites per device, lumens and surface sites) were tested in each cvcle with three replicate cycles performed with and without cleaning conditions. This equates to a total of 114 device sites tested for sterile efficacy with results showing all sites sterile for a full cycle in the V-PRO 1 Low Temperature Sterilization System. The simulated use device load was similar in device make up and weight as the validation load.

. In-Use Sterility Testing:

Testing was performed to confirm sterility of targeted medical device outer surface sites and lumens that were clinically soiled, manually cleaned, dried, packaged, and processed in the V-PRO 1 Low Temperature Sterilization System. Devices tested in this study were used in routine surgeries at a local hospital and included stainless steel devices with open surfaces, mated or hinged surfaces and stainless steel lumened devices with dimensions that were approximate to the V-PRO 1 Low Temperature Sterilization System's claims. The in use device load was similar in device make up as the validation load.

The recoverable bioburden levels before and after cleaning ranged from 0 to 64 CFU. These recoverable bioburden levels are within the published recovery range for critical medical devices. All sites for all three trials were

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sterile after processing the pre-cleaned devices together in the V-PRO 1 Low Temperature Sterilization System.

A total of 12 devices were tested in this study with 14 inoculated sites evaluated. This equates to a total of 42 device sites tested for sterile efficacy with results showing all sites sterile for a full cycle in the V-PRO 1 Low Temperature Sterilization System.

Software Validation: .

The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices".

7. Overall Performance Conclusions

The non-clinical studies demonstrate that the V-PRO 1 Low Temperature Sterilization System is safe and effective for sterilization of heat and moisture sensitive medical devices within the indications for use for the sterilizer and established equivalence of the V-PRO 1 Low Temperature Sterilization System to the predicate device, the Sterrad 100S Sterilization System.

8. Safety

Software Risk Management Plan and Risk Analysis including Failure Mode . Effects and Critical Analysis (FMECA) has been performed.
. Equipment Risk Management Plan and Risk Analysis including Fault Tree Analysis (FTA) and Failure Mode Effects and Critical Analysis (FMECA) has been performed.
The V-PRO 1 Low Temperature Sterilization System meets the applicable . requirement for the following standards as certified by UL:
- o Underwriters Laboratories (UL) Standard 61010-1 Second Edition
- Canadian Standard Association (CSA) Can/CSA 22.2 No. 1010.1o 92, Second Edition
Governing Directive for the Affixing of the CD mark: .
- Medical Device Directive (MDD) 93/42/EEC o
Standards applied to demonstrate conformity to the directives: .
- o EN61010-1
- EN60601-1-2 o

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User Information

Operator Manual .
Service Manual
Installation Instructions .
Technical Data Sheet .

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Patrick J. McCullagh Vice President STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

OCT A 2007

Re: K062297

Trade/Device Name: Amsco® V-PRO™ 1 Low Temperature Sterilization System Regulation Number: 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR Dated: July 31, 2007 Received: August 1, 2007

Dear Dr. McCullagh:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 -Dr. McCullagh

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clive
Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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

K062297 510(k) Number (if known):

Device Name: Amsco® V-PRO™ 1 Low Temperature Sterilization System

Indications For Use:

The V-PRO 1 Low Temperature Sterilization System can sterilize*:

Instruments with diffusion-restricted spaces such as the hinged portion of . forceps and scissors.
Medical devices with a single stainless steel lumen with: .
- an inside diameter of 1 mm or larger and a length of 125 mm or shorter o
- an inside diameter of 2 mm or larger and a length of 250 mm or shorter o
- an inside diameter of 3 mm or larger and a length of 400 mm or shorter o

The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs,

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X ** (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)

Shale A. Murphy, MD

Bion Sign-Off Vision of Anesthesiology, General Hospital Infection Control, Dental Devices

510(K) Number: K012297

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).