The Amsco® V-PRO™ MAX 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 three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO MAX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize:

Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
Medical devices, including rigid endoscopes, with a single stainless steel lumen with:
- an inside diameter of 1 mm or larger and a length of 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 lbs.

The Amsco V-PRO MAX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize:
Non-lumened instruments including non-lumened rigid endoscopes and 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.
The Amsco V-PRO MAX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations:

Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either:
a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
or two lumens with:
- one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.

The flexible endoscope can contain either:

a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
or two lumens with:
- one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

Device Description

The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilizers are self-contained 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

The document is a 510(k) premarket notification for the Amsco V-PRO Low Temperature Sterilization Systems, specifically concerning modifications to the VAPROX® HC Sterilant cartridge. The study described focuses on demonstrating substantial equivalence of the modified product to previously cleared predicate devices.

Here's the breakdown of the acceptance criteria and the study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device Modification	Testing	Acceptance Criteria	Results
Sterilant cartridge materials change	Testing at time 0 and 3 months to demonstrate no difference between resins used in construction of the cartridge or current or the current and proposed cartridge design.	No difference in the following characteristics at the 0 time point and following 3 months of storage:• Package Appearance• Sterilant Color• Clarity• Hydrogen Peroxide Concentration• Sterilant pH	PASSTesting demonstrates that cups meet 0 time point and stability specifications at 3 months.
Sterilant cartridge design change	(No specific testing or acceptance criteria for design change are detailed in the provided table, but the document implies that the "Sterilant cartridge materials change" testing addresses both aspects.)	(Not explicitly stated for design change alone in the table.)	(Not explicitly stated for design change alone in the table.)

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

Sample Size for Test Set: The document does not explicitly state the sample size for the test set in terms of the number of cartridges tested. It mentions "Testing at time 0 and 3 months," suggesting a stability study over time.
Data Provenance: The document does not specify the country of origin of the data. The study is prospective in nature, as it involves testing the modified product at specific time points (0 and 3 months) to evaluate its characteristics.

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

This type of information is not applicable to this study. The study focuses on the physical and chemical characteristics of a sterilant cartridge, not on diagnostic accuracy requiring expert interpretation (e.g., radiologists interpreting images). The "ground truth" here is the chemical and physical properties of the sterilant itself.

4. Adjudication Method for the Test Set

This information is not applicable to this study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments where consensus is needed to establish ground truth, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical devices that involve human readers (e.g., CAD systems for image analysis), which is not the function of a sterilant cartridge.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI system was not done. This study concerns the physical and chemical characteristics of a sterilant cartridge and its substantial equivalence to predicate devices, not an independent algorithm's performance.

7. The Type of Ground Truth Used

The ground truth used in this study relates to the chemical and physical specifications of the sterilant. Specifically, the acceptance criteria for "Package Appearance," "Sterilant Color," "Clarity," "Hydrogen Peroxide Concentration," and "Sterilant pH" serve as the ground truth against which the modified sterilant cartridge is evaluated at different time points. These are objective measurements against established specifications.

8. The Sample Size for the Training Set

This study does not involve a "training set" in the context of machine learning or AI. The study is a direct performance and stability test of a medical device component.

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

Since there is no "training set" in this context, this question is not applicable. The "ground truth" for the performance evaluation (chemical and physical specifications) would have been established through a combination of engineering design specifications, industry standards, and regulatory requirements for sterilants.

Summary

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K112813/S001 STERIS Response to 10/26/11 Request for Additional Information Modification of K062297, K083097 and K102330 V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems

STER

510(k) Summary For Amsco® V-PRO™ 1, V-PROTM 1 Plus and V-PROTM maX 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:

November 3, 2011

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

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Device Name 1.

Trade Name:	Amsco V-PRO 1 Low Temperature SterilizationSystem and Amsco V-PRO 1 Plus LowTemperature Sterilization System and V-PRO maXLow Temperature 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)

Amsco® V-PROT maX Low Temperature Sterilization System (K102330)

Description of Device 3.

4. Intended Use

The Amsco V-PRO MAX 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 three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO MAX Low Temperature Sterilizer System's Lumen Cycle, cleared under K062297, can sterilize:4

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Instruments with diffusion-restricted spaces such as the hinged portion . of forcens and scissors
Medical devices, including rigid endoscopes, with a single stainless . steel lumen with:
- an inside diameter of 1 mm or larger and a length of 125 mm or o shorter
- an insider diameter of 2 mm or larger and a length of 250 mm or o shorter
- an inside diameter of 3 mm or larger and a length of 400 mm or o shorter
The validation testing for all lumen sizes was conducted using a maximum of a 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 MAX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize:'

Non-lumened instruments including non-lumened rigid endoscopes and 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 D two instrument trays and two pouches for a total weight of 19.65 ibs.
The Amsco V-PRO MAX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical care) and bronchoscopes in either of two load configurations:
1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.6
  The flexible endoscopes may contain either:
· a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
or two lumens with: .
- · one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
- · and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
The validation studies were conducted with two flexible ပ endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

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1. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. "
  The flexible endoscope can contain either:
· a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
or two lumens with: .
- · one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

5. Description of Safety and Substantial Equivalence

The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are the same as the predicate devices (K062297, K083097 and K102330). Modifications are proposed to the VAPROX® HC Sterilant cartridge/cup, specifically to the design and the material of the cartridge.

The following performance testing has been completed, verifying that the modified product is substantially equivalent to the predicates. The proposed modifications described have introduced no new concerns of safety or effectiveness compared to the predicates.

DeviceModification	Testing	AcceptanceCriteria	Results
Sterilantcartridgematerials change	Testing at time 0 and 3 months to demonstrate no difference between resins used in construction of the cartridge or current or the current and proposed cartridge design.	No difference in the following characteristics at the 0 time point and following 3 months of storage:• Package Appearance• Sterilant Color• Clarity• Hydrogen Peroxide Concentration• Sterilant pH	PASSTesting demonstrates that cups meet 0 time point and stability specifications at 3 months.
Sterilantcartridge designchange

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and is a common symbol associated with healthcare and medicine.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

DEC - 1 2011

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

Re: K112813

Trade/Device Name: Amsco® V-PRO™ 1 Low Temperature Sterilization System Amsco® V-PRO™ 1 Plus Low Temperature Sterilization Systems Amsco® V-PRO™ maX Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR

Dated: November 3, 2011

Received: November 4, 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.

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. 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 clectronic 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/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.

Chas Velaz

Anthony D. 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 Amsco® V-PRO™ maX Low Temperature Sterilization System

Indications For Use:

The Amsco V-PRO MAX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize:4

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

The Amsco V-PRO MAX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize. 9

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

Page 1 of 3

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b 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.
The Amsco V-PRO MAX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations:
Two flexible endoscopes with a light cord (if not integral to 1 . endoscope) and mat with no additional load.6
The flexible endoscopes may contain either:
a single lumen with an inside diameter of 1 mm or larger and a . length of 1050 mm or shorter
t or two lumens with:
- one lumen having an inside diameter of 1 mm or larger and a . length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
C The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
One flexible endoscope with a light cord (if not integral to endoscope) 2. and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. "

The flexible endoscope can contain either:

a single lumen with an inside diameter of 1 mm or larger and a . length of 1050 mm or shorter
or two lumens with:

one lumen having an inside diameter of 1 mm or larger and a . length of 998 mm or shorter
and the other lumen having-an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

Page 2 of 3

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STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification of K062297, K083097 and K102330 V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems

SterilizationCycle	Sterilantinjection(g)	# ofInjections	SterilantExposureTime (min)	ChamberPressurePrior toInjection(Torr)	Chamber/VaporizerTemperature(°C)
Lumen	2.1	4	32	0.4	50/60
Non Lumen	2.1	4	12	1	50/60
Flexible	2.1	4	12	0.4	50/60

The parameters for the three V-PRO Cycles are as follows:

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

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)

Page 3 of 3

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113813

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).