The Amsco® V-PRO™ maX Low Temperature Sterilization System, with VAPROXTM 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 maX Low Temperature Sterilization System is a new sterilizer model to be added to the Amsco V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1 and Amsco V-PRO 1 Plus Sterilizers.

The V-PRO maX Sterilizer has three pre-programmed cycles: the Lumen Cycle (K062297), the Non Lumen Cycle (K083097) and the Flexible Cycle (K102330). The V-PRO maX Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.

The V-PRO maX Sterilizer uses VAPROX HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed cycles all utilize a conditioning phase, a sterilization phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle; no cool down or aeration period is required.

The Flexible Cycle has been designed to sterilize surgical flexible endoscopes (such as those used in ENT, Urology and Surgical care) and bronchoscopes. The flexible endoscopes can be single or dual channeled and they may be processed in a flexible endoscope-only load or in combination with non-lumened medical instruments. The cycle is approximately 35 minutes long.

The Verify V24 SCBI (K073244 and K09051), Verify VH2O2 Process Indicator (K091174), V-PRO Sterilization Trays (K070769), and Vis-U-All Tyvek pouches (K070765, K071087, and K090371) have been validated for use in the V-PRO maX Sterilizer.

AI/ML Overview

The provided 510(k) summary (K112760) describes a modification to the Amsco V-PRO maX Low Temperature Sterilization System, involving minor software changes to enhance usability. The study submitted for this modification is a Software Validation.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device Modification	Testing	Acceptance Criteria	Results
Software Modifications	Software Validation	Software shall be appropriately verified and validated.	PASS

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

The document does not explicitly state the sample size used for the software validation test set (e.g., number of test cases run, or specific inputs). It only indicates that "Software Validation" was performed.

Regarding data provenance, the document does not specify country of origin for the validation data. The nature of the study (software validation) suggests it would be conducted in a controlled environment, likely by the manufacturer (STERIS Corporation, based in Mentor, Ohio, USA). The study is retrospective in the sense that the software was already developed and then validated.

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

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the software validation. For a software validation, ground truth would typically be defined by the software requirements and specifications, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the software validation. For software validation, discrepancies (bugs) are typically identified and fixed, not adjudicated by independent parties.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or other data. The Amsco V-PRO maX is a sterilizer, and its effectiveness is determined by its ability to reliably sterilize medical devices, not by human interpretation of its output in a clinical setting. Therefore, an MRMC study with human readers and AI assistance is not applicable to this device.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Yes, a standalone study was performed. The "Software Validation" is an assessment of the algorithm (software)'s performance against its specifications and intended function without human intervention in its operation other than initiating the process and evaluating the outcome of the software's execution.

7. Type of Ground Truth Used

For the "Software Validation," the ground truth would be defined by the software requirements and specifications. The software's performance is validated against these pre-defined functional and non-functional requirements to ensure it operates as intended.

8. Sample Size for the Training Set

The document does not mention a "training set" because this is a software validation for a sterilizer. The software for a sterilizer is typically developed based on engineering principles and verified through testing against specifications, rather than being "trained" on a dataset like a machine learning algorithm.

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

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.

Summary

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K112760

STERIS®

NOV 222 2011

510(k) Summary For Amsco® V-PRO™ maX 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:

September 21, 2011

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

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1. Device Name

Trade Name:	Amsco V-PRO maX Low 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 maX Low Temperature Sterilization System (K102330)

3. Description of Device

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4. Intended Use

The Amsco V-PRO maX Low Temperature Sterilization System, with VAPROXTM 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

. 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
a 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: 0

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.

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:
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:

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STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification of K102330 V-PRO maX Low Temperature Sterilization System

· 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
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).
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
ರ್ 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.

Description of Safety and Substantial Equivalence ક.

The Amsco V-PRO maX Low Temperature Sterilization System is the same as the predicate devices (K102330). Minor modifications are proposed to the device software that addresses customer requests and enhance device usability. The following performance testing has been completed to ensure substantial equivalence.

DeviceModification	Testing	AcceptanceCriteria	Results
SoftwareModifications	Software Validation	Software shall be appropriately verified andvalidated.	PASS

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is written in a bold, sans-serif font. The words are arranged on a single line and centered horizontally. The text is black against a white background.

Public Health Service

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

NOV 222 2011

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

Re: K112760

Trade/Device Name: Amsco® V-PRO™ maX Low Temperature Sterilization System . Regulation Number: 21 CFR 880.6860 Regulation Name: Etylene Oxide Gas Sterilzer Regulatory Class: II Product Code: MLR Dated: October 24, 2011 Received: October 25, 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 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/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 O. waton

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-PROTM 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 0 shorter
- an inside diameter of 3 mm or larger and a length of 400 mm or o shorter
a 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: 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
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
d 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 K102330 V-PRO maX Low Temperature Sterilization System

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 _ 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)

Page 3 of 3

Elizabeth F. Clavie-Williams

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

510(k) Number: K112760

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).