The Amsco V-PRO 1 Plus Low Temperature Sterilization System, with VAPROX HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles; the Lumen and the Non Lumen Cycles operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO 1 Plus Low Temperature Sterilizer System's (Lumen Cycle) was cleared under (K062297) 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
- an insider diameter of 2 mm or larger and a length of 250 mm or shorter
- an inside diameter of 3 mm or larger and a length of 400 mm or shorter
- 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.

The Amsco V-PRO 1 Plus Low Temperature Sterilization System's (Non Lumen Cycle) the subject of this (K083097) can sterilize**:
Non-lumened instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.

** The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

Device Description

The Amsco V-PRO 1 Plus Low Temperature Sterilizer is a self-contained standalone device using vaporized hydrogen peroxide. This device is intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizer operates at low pressure and low temperature and is therefore suitable for processing medical devices sensitive to heat and moisture.

AI/ML Overview

The provided document is a 510(k) Summary for the Amsco V-PRO 1 Plus Low Temperature Sterilization System, focusing on the addition of a Non Lumen Cycle. It describes the device's validation against established criteria for sterilization effectiveness and safety.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Effectiveness (Sterilization)	Complete kill of biological indicators.	Demonstrated by complete kill of biological indicators.
Sterility Assurance Level (SAL)	At least 10⁻⁶ probability of survival.	Verified an appropriate safety factor or sterility assurance level (SAL) of at least 10⁻⁶ probability of survival.
Validation Standards	Meet requirements of FDA Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, 1993, and Addendum to the Sterilizer guidance document, 1995.	The Amsco V-PRO 1 Plus Low Temperature Sterilization System has been validated to meet these requirements.
Safety (Electrical)	Compliance with Underwriters Laboratory (UL) Electrical Safety Code 61010-1.	Certified by Intertek Testing Services (ITS).
Safety (Canadian Electrical)	Compliance with Canadian Standards Association (CSA) Standard C22.2 No. 1010-1.	Certified by Intertek Testing Services.
Safety (Pressure Vessels)	Compliance with American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels.	Complies with this requirement.
Intended Use - Non Lumen Cycle	Sterilize non-lumened instruments, including non-lumens with stainless steel diffusion-restricted areas (e.g., hinged portion of forceps or scissors).	"The Amsco V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle can sterilize**: Non-lumened instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors."
Validation Load Capacity - Non Lumen Cycle	Not explicitly stated as a criterion, but a validation load was specified for the studies.	The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

Study Information:

The document describes "Performance Testing - Bench" and "Effectiveness" studies.

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

Test Set Sample Size: The document does not explicitly state a numerical sample size for the test set in terms of number of instruments or specific configurations beyond the validation load. For the Non Lumen Cycle, it states: "The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs." This load represents the challenge in the sterility effectiveness tests. The number of biological indicators (BIs) used is not specified.
Data Provenance: The studies are described as "Performance Testing - Bench" and "verification studies." There is no mention of country of origin of the data or whether the studies were retrospective or prospective, but given the nature of a 510(k) submission for a sterilizer, these would typically be prospective, controlled bench studies and laboratory tests conducted by the manufacturer (STERIS Corporation, USA).

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. For sterilization efficacy, ground truth is typically established by laboratory methods demonstrating the complete kill of highly resistant biological indicators, rather than human expert interpretation of device performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging diagnostics) where there might be disagreement among readers. For sterilization efficacy, the outcome (kill/no kill of BIs) is objectively measured in a laboratory setting, not subject to human adjudication in the same way.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is not relevant for a sterilizer's performance evaluation. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) is affected by AI assistance, which is not applicable here as the device is a sterilization system, not a diagnostic tool that involves human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, effectively. The performance testing described (complete kill of biological indicators, verifying SAL, meeting FDA guidance) evaluates the sterilizer system's ability to achieve sterility on its own without human intervention influencing the sterilization outcome. While human operators load the device and select cycles, the performance of the sterilization process itself is measured as a standalone function of the device.

7. The Type of Ground Truth Used

The primary ground truth for sterilization effectiveness is the complete kill of biological indicators (BIs) which are highly resistant microorganisms (spores) placed in challenging locations. This is an objective, laboratory-based physical/biological measure, designed to demonstrate a high Sterility Assurance Level (SAL) (at least 10⁻⁶). This is a direct measure of microbial inactivation.

8. The Sample Size for the Training Set

Not applicable. The Amsco V-PRO 1 Plus Low Temperature Sterilization System is a physical sterilization device, not an AI software/algorithm that requires a "training set" in the machine learning sense. Its design and operation are based on validated physical and chemical principles, not learned patterns from data.

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

Not applicable. As explained above, there is no "training set" for this type of medical device. The device's performance is established through rigorous validation studies based on scientific and regulatory standards.

Summary

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AUG 0 3 2009

STERIS®

510(k) Summary For

Amsco V-PRO 1 Plus Low Temperature Sterilization System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

John Robert (Jack) Scoville Jr. Fellow, Regulatory Affairs Telephone: (440) 392-7330 Fax No: (440) 357-9198

Summary Date:

July 31, 2009

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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STERIS Response w 7/30/09 Request for Additional Information 51 Line Noo 100 100 100 Reguest for Auditional mionnation

K083097 / S003 Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System

1. Device Name

Trade Name:	Amsco V-PRO 1 Plus Low TemperatureSterilization System
Common/usual Name:	Vapor Phase Hydrogen Peroxide Sterilizer
Classification Name:	Sterilizer, Ethylene Oxide Gas
FDA classification number:	21 CFR 880.6860
Product Code:	80 MLR.

2... Predicate Device

Amsco V-PRO 1 Low Temperature Sterilization System: K062297. ●

క్ష Overview

The purpose of this 510(k) is to obtain premarket clearance for the Amsco V-PRO 1 Plus Low Temperature Sterilization System. The V-PRO 1 Plus has an added preprogrammed Non Lumen Cycle as compared to the Amsco V-PRO 1 Low Temperature Sterilization System. This cycle is intended for sterilization of non lumened surgical instruments.

4. Description of Device

5. Intended Use

The Amsco V-PRO 1 Plus Low Temperature Sterilization System, with VAPROX HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles, the Lumen and the Non Lumen Cycles, operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

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The Amsco V-PRO 1 Plus Low Temperature Sterilizer System's Lumen Cycle was cleared under K062297. The Lumen Cycle 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:

o an inside diameter of 1 mm or larger and a length of a 125 mm or shorter o an insider 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

- 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.
  The Amsco V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle can sterilize**:

Non-lumened instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.

** The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 Ibs.

Description of Safety and Substantial Equivalence 6.

The proposed and predicate devices have the same intended use. The difference between the proposed and predicate device is limited to the addition of a Non Lumen sterilization cycle. The difference does not raise any new issues of safety and efficacy.

7. Performance Testing Summary

Performance Testing - Bench

Effectiveness

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 106 probability of survival. STERIS 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).

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The Amsco V-PRO 1 Plus Low Temperature Sterilization System has been validated to meet the requirements of FDA Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities, 1993 and Addendum to the Sterilizer guidance document, 1995.

The results of the Amsco V-PRO 1 Plus Low Temperature Sterilization System verification studies demonstrate that the sterilizer performs as intended. The results are summarized as follows:

Safety

STERIS sterilizers including the Amsco V-PRO 1 Plus Low Temperature Sterilization System have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Amsco V-PRO 1 Plus Low Temperature Sterilization System complies with the following requirements:

· Underwriters Laboratory (UL) Electrical Safety Code 61010-1 certified by Intertek Testing Services (ITS).
· Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 as certified by Intertek Testing Services.
· American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels.

Hazards – Failure of Performance

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 and dried, 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,

8. Conclusion

The Amsco V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle has been validated to meet the established performance criteria. The results of the Amsco V-PRO 1 Plus Low Temperature Sterilization System verification studies demonstrate that the Non Lumen Cycle performs as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in uppercase letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John R. Scoville Fellow, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834

AUG 0 3 2009

Re: K083097

Trade/Device Name: Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System Regulation Number: 21 CFR 880. 6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Codc: MLR Dated: July 22, 2009 Received: July 23, 2009

Dear Mr. Scoville:

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 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. Scoville

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 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Min for

Susan Runner, D.D.S., M.A. Acting Division 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): K083097

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

Indications for Use:

The Amsco V-PRO 1 Plus Low Temperature Sterilizer System's (Lumen Cycle) was cleared under (K062297) 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:
- o an inside diameter of 1 mm or larger and a length of a 125 mm or shorter o an insider 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
- - 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.

The Amsco V-PRO 1 Plus Low Temperature Sterilization System's (Non Lumen Cycle) the subject of this (K083097) can sterilize**:

Non-lumened instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.

** The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
Page 1 of 2

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STERIS Response to 7/30/09 Request for Additional Information

K083097 / S003 Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula H. Murphy MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K083097 510(k) Number:

Page 2 of 2

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).