The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems, with VAPROX HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization 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 Cycle, which is identical to the V-PRO 1 Plus Lumen Cycle, was cleared under K062297 and 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 was cleared under K083097 and 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 and V-PRO 1 Plus Low Temperature Sterilizers are selfcontained stand-alone devices using vaporized hydrogen peroxide. These devices are intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizers operate at low pressure and low temperature and are therefore suitable for processing medical devices sensitive to heat and moisture.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the STERIS® Amsco® V-PRO™ 1 and V-PRO™ 1 Plus Low Temperature Sterilization Systems:

1. Table of Acceptance Criteria and Reported Device Performance

Device Modification	Acceptance Criteria	Reported Device Performance
Odor Filter	Oil smell shall not be present in devices using the proposed filter before that observed for devices using the current filter.	PASS
Vacuum pump oil	For devices using the proposed oil, oil smell shall not be detected before or at higher levels than that observed for devices using the current oil. No alarms or failures shall be observed during testing.	PASS
ARS Filter	The proposed ARS filters perform equally to or better than the current ARS filters.	PASS
Gas Ballast Filter	The proposed filters perform equally to or better than the current filters.	PASS
Software Modifications	Software shall be appropriately verified and validated.	PASS

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

Odor Filter: Implied sample size based on "running continuous Non-Lumen cycles." No specific number of cycles or devices is given.
Vacuum pump oil: Testing was performed "concurrently with the ARS Filter testing." No specific number of devices or cycles is given.
ARS Filter: "Nine filters of each variety were run either until an oil smell was detected or 750 cycles were reached."
Gas Ballast Filter: "The proposed filters (a total of 5) was tested by running until a failure was detected."
Software Modifications: No specific sample size mentioned, just "Software Validation."

Data Provenance: The document does not specify the country of origin for the data. The studies appear to be prospective, as they involve testing proposed modifications against existing versions to determine equivalency or improvement.

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

The document does not mention the use of experts to establish ground truth for this set of performance tests. The acceptance criteria are objective and measurable (e.g., presence of oil smell, performance comparison, software validation).

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing involves objective measurement against pre-defined criteria rather than expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not done. These tests are focused on the hardware and software performance of a sterilization system, not on human interpretation or diagnostic efficacy.

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

This concept is not applicable here. The device is a sterilization system, not an algorithm, and its performance is inherently standalone in its function (sterilizing medical devices). The tests described evaluate the device's components and software in isolation from human intervention in the sterilization process itself.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on objective performance metrics and pre-defined standards comparing the modified components/software against the existing, predicate device components/software. For example:

Absence/presence of oil smell
Equal or better performance of filters
Appropriate verification and validation of software

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to the performance testing of a physical sterilization device and its components/software. These tests are evaluations, not machine learning model training.

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

As there is no training set in the context of this device's performance evaluation, this question is not applicable.

Summary

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STERIS®

KIII810

, "

SEP - 2 2011

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

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Robert Sullivan Senior Director, FDA Regulatory Affairs Tel: 440-392-7695 Fax: 440-357-9198

Submission Date:

June 24, 2011

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

| 出

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SEP - 2 2011

1. Device Name

Trade Name:	Amsco V-PRO 1 Low Temperature SterilizationSystem and Amsco V-PRO 1 Plus LowTemperature Sterilization System
Common/usual Name:	Vapor Phase Hydrogen Peroxide Sterilizer
Classification Name:	Sterilizer, Ethylene Oxide Gas
Classification Number:	21 CFR 880.6860
Product Code:	MLR

Predicate Device 2.

Amsco® V-PROTM 1 Low Temperature Sterilization System (K062297)

Amsco® V-PROTM 1 Plus Low Temperature Sterilization System (K083097)

3. Description of Device

4. Intended Use

The V-PRO 1 Cycle, which is identical to the V-PRO 1 Plus Lumen Cycle, was cleared under K062297 and can sterilize: *

. Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors

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STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification of K062297 and K083097 V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems

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 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 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.

The Amsco V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle was cleared under K083097 and can sterilize: **

Non-lumened instruments including non-lumened instruments 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.

5. Description of Safety and Substantial Equivalence

The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems are the same as the predicate devices (K062297 and K083097). Minor modifications are proposed to the device software and hardware that collectively address customer requests and enhance device usability. The following performance testing has been completed to ensure substantial equivalence.

DeviceModification	Testing	AcceptanceCriteria	Results
Odor Filter	Filters were testedrunning continuousNon-Lumen cycles.	Oil smell shall not be present in devicesusing the proposed filter before that observedfor devices using the current filter.	PASS
Vacuum pump oil	Testing was performedconcurrently with theARS Filter testing.	For devices using the proposed oil, oil smellshall not be detected before or at higherlevels that that observed for devices using thecurrent oil. No alarms or failures shall beobserved during testing.	PASS
ARS Filter	Nine filters of eachvariety of were runeither until an oil smellwas detected or 750cycles were reached.	The proposed ARS filters perform equally toor better than the current ARS filters.	PASS
Gas Ballast Filter	The proposed filters (atotal of 5) was tested byrunning until a failurewas detected.	The proposed filters perform equally to orbetter than the current filters.	PASS
SoftwareModifications	Software Validation	Software shall be appropriately verified andvalidated.	PASS

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

Mr. Robert Sullivan Senior Director, FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

SEP - 2 2011

Re: K111810

Trade/Device Name: Amsco® V-PRO™ I Low Temperature Sterilization System 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 Code: MLR

Dated: August 5, 2011

Received: August 8, 2011

Dear Mr. Sullivan:

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.

ff 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. Sullivan

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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part.803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Cintron V. O'Brien

Anthony B. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Amsco® V-PRO™ 1 Low Temperature Sterilization System Amsco® V-PROTM 1 Plus Low Temperature Sterilization System

Indications For Use:

The Amsco V-PRO 1 Cycle, which is identical to the V-PRO 1 Plus Lumen Cycle, was cleared under K062297 and 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 was cleared under K083097 and 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.
Prescription Use ____________ AND/OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K111 810
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June 24, 2011	Page 7-1

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).