The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX 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 (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 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle, the subject of this submission, can sterilize:

Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:
- single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
- triple channeled devices with stainless steel lumens that are either
  - ≥ 1.2 mm ID and ≤ 310 mm in length
    or
  - ≥2.8 mm ID and ≤ 317 mm in length
The validation studies were 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 and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, cleared under K083097, K102394, and K111810, can sterilize:
Non-lumened instruments including non-lumened rigid, semi-rigid and flexible 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, cleared under K102330 and K112760, 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.
  The flexible endoscopes may contain either:
a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
or two lumens with:
- one lumen that is ≥ 1 mm ID and ≤ 998 mm in length
- and the other lumen that is > 1 mm ID and < 850 mm in length
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 that is > 1 mm ID and < 1050 mm in length
or two lumens with:
- one lumen that is ≥ 1 mm ID and ≤ 998 mm in length
- and the other lumen that is > 1 mm and < 850 mm in length
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 Sterilization Systems are vaporized hydrogen peroxide sterilizers. The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed V-PRO 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.

AI/ML Overview

The provided document is a 510(k) Summary for the Amsco® V-PRO® 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems. The submission's primary purpose is to modify the V-PRO Lumen Cycle's stainless steel lumen claims. The acceptance criteria and supporting studies are detailed for this specific modification.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for each test. However, the "Conclusion" column for each test serves as the acceptance criteria being met (i.e., "PASS"). The reported device performance is integrated within the "Result" column.

Test Title	Acceptance Criteria (Implied)	Reported Device Performance
1/2 Cycle Modified Total Kill Endpoint Verification	Modified total kill endpoint analysis is demonstrated.	The standard injection weight of 2.1 g and a lower injection weight of 1.457 g resulted in all sterile results for the Lumen Cycle modified stainless steel lumen claims. All survival results were shown at the lowest weight evaluated (0.121 g). Partial positives results were seen at the intermediate injection weights.
1/2 Cycle Sterilization Verification of Lumen Claims	V-PRO Lumen Cycle reproducibly sterilizes lumen claims.	The V-PRO Lumen Cycle reproducibly sterilizes the modified stainless steel lumen claims under worst case conditions in a V-PRO Lumen 1/2 Cycle.
1/2 Cycle Sterilization Verification of Double Pouched Lumens	V-PRO Lumen Cycle reproducibly sterilizes double pouched lumens.	The V-PRO Lumen Cycle reproducibly sterilizes the modified stainless steel lumen claims under worst case conditions in a V-PRO Lumen 1/2 Cycle in a double pouched configuration.
Simulated Use Test	V-PRO Lumen Cycle sterilizes lumen claims under simulated use.	Simulated use testing verified the ability of the V-PRO Lumen Cycle to sterilize the modified stainless steel lumen claims under worst case processing conditions.
In Use Test	V-PRO Lumen Cycle sterilizes clinically cleaned instruments.	The in use investigation demonstrated the ability of the V-PRO Lumen Cycle to sterilize clinically cleaned, patient-soiled medical instruments representative of the modified stainless steel lumen claims.
Biocompatibility	Biocompatibility is demonstrated.	Residue analysis evaluation has demonstrated biocompatibility after processing in the V-PRO Lumen Cycle.
Validation of Accessories (V-PRO Sterilization Trays)	Modified lumen claims are sterilized in trays.	The modified stainless lumens claims were successfully sterilized in the V-PRO Sterilization Trays under Lumen ½ cycle worst case conditions.
Validation of Accessories (Vis-U-All Tyvek Pouches)	Modified lumen claims are sterilized in pouches.	The modified stainless lumens claims were successfully sterilized in the Vis-U-All Tyvek Pouches under ½ cycle worst case conditions.

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

The document details the lumen configurations tested, which infer the "sample" being tested:

Single channeled devices: Stainless lumen ≥ 0.77 mm ID and ≤ 500 mm in length.
Dual channeled devices: Stainless steel lumens ≥ 0.77 mm ID and ≤ 527 mm in length.
Triple channeled devices: Stainless steel lumens either ≥ 1.2 mm ID and ≤ 310 mm in length OR ≥ 2.8 mm ID and ≤ 317 mm in length.

The validation studies were conducted using a maximum of twenty (20) lumens per load.

The validation load consisted of two instrument trays and two pouches for a total weight of 19.65 lbs. for the Lumen Cycle (and Non Lumen Cycle). For the Flexible Cycle (which is not the primary focus of this submission, though mentioned for context), different configurations of flexible endoscopes and additional instruments were used.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for sterility claims, these would be prospective, laboratory-based validation studies conducted under controlled conditions to demonstrate effective sterilization. The "In Use Test" indicates some testing with "clinically cleaned, patient-soiled medical instruments," suggesting a component of real-world or simulated clinical conditions, but still likely a prospective study.

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

The document does not provide information about the number of experts or their qualifications for establishing the ground truth. For sterilization studies, the "ground truth" is typically defined by the complete eradication of specified biological indicators (e.g., bacterial spores) under rigorous testing parameters, observed by trained microbiology and sterilization validation specialists according to recognized standards.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method with multiple reviewers (e.g., 2+1, 3+1). For sterilization efficacy testing, the outcome is generally a definitive "sterile" or "non-sterile" based on microbiological culturing, which doesn't typically involve human opinion-based adjudication in the same way, for example, a radiology study might.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a sterilization system, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC comparative effectiveness study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a sterilization system; it is not an algorithm for diagnosis or image interpretation. The device's performance is inherently "standalone" in its function as a sterilizer, meaning its efficacy is measured directly, not through human-in-the-loop performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for sterilization efficacy is the complete kill of microbial organisms, typically using highly resistant biological indicators (e.g., bacterial spores). The tests refer to "Total Kill Endpoint Verification," "Sterilization Verification," and "Simulated Use Test," all of which fundamentally rely on demonstrating the absence of viable microorganisms after processing. The "In Use Test" further corroborates this with "clinically cleaned, patient-soiled medical instruments."

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable in the context of this device and study. This is a validation of a physical sterilization process using specific parameters and loads, not an AI or machine learning model that requires training data.

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

As there is no "training set" in the context of an AI/ML model, this question is not applicable. For the validation studies, the efficacy (ground truth) was established through scientifically accepted microbiological testing methods to confirm sterility.

Summary

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K120632/S001 STERIS Response to 5/10/12 Request for Additional Information Amsco® V-PRO 1 Plus and V-PRO max Low Temperature Sterilization Systems

Image /page/0/Picture/10 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in all capital letters, with a registered trademark symbol to the right of the S. Below the word STERIS is a graphic of several horizontal wavy lines stacked on top of each other.

JUN 2 6 2012

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

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

Contact: Bill Brodbeck Senior Manager, Regulatory Affairs

Telephone: (440) 392-7690 Fax No: (440) 357-9198

Summary Date: June 5, 2012

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® 1, V-PRO 1 Plus and V-PROmaX Low Temperature Sterilization Systems
Common/usual Name:	Vapor Phase Hydrogen Peroxide Sterilizer
Classification Name:	Sterilizer, Ethylene Oxide Gas21-CFR 880.6860Product Code MLR

2. Predicate Devices

Amsco® V-PRO® 1 Low Temperature Sterilization System (K062297, K102394, and K111810) Amsco V-PRO ®1 Plus Low Temperature Sterilization System (K083097, K102394, and K111810) Amsco® V-PRO® maX Low Temperature Sterilization System (K102330, K112760)

3. Description of Device

. The three V-PRO Sterilizers share common cycles as outlined in Table 5-1.

Cycle	V-PRO 1	V-PRO 1 Plus	V-PRO maX
Lumen Cycle	X	X	X
Non Lumen Cycle	*	X	X
Flexible Cycle			X

Table 5-1: V-PRO Cvcles Provided in the V-PRO Family of Sterilizers

Shaded cell indicates that the V-PRO Sterilizer does not include the identified cycle.

All three sterilizers contain the Lumen Cycle. The purpose of this submission is to modify the V-PRO Lumen Cycle stainless steel lumen claims. No modifications were made to the Sterilizers' hardware or software for the proposed modification to the Lumen Cycle stainless steel lumen claims.

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The accessories that have been validated for use in the three V-PRO Cvcles and the Premarket Notification submission references under which the accessories were cleared for the cycles are listed in Table 5-2.

Accessory	Submission Reference
	V-PRO Lumen Cycle	V-PRO Non Lumen Cycle	V-PRO Flexible Cycle
Verify V24 SCBIs	K073244,K090514	K083097	K102330
Verify VaporizedVH2O2 ProcessIndicators	K091174	K091174	K102330
V-PROSterilization Trays	K070769,K103226	K083097,K103226	K102330,K103226
Vis-U-All TyvekPouches	K070765 K071087 K090371	K083097 K090371	K102330

Table 5-2. Accessories Validated for Use in the V-PRO Sterilizers

4. Intended Use

The purpose of this submission is to modify the V-PRO Lumen Cycle stainless steel lumen claims. No modifications are being made to the V-PRO Sterilizers' intended use with respect to the Non Lumen and Flexible Cycles.

The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX 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 (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 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle, the subject of this submission, can sterilize:2

Lumened and non-lumened instruments with diffusion-restricted spaces . such as the hinged portion of forceps and scissors
. Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: 4
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
- dual channeled devices with stainless steel lumens that are ≥ 0.77 O mm ID and ≤ 527 mm in length

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K120632/S001 STERIS Response to 5/10/12 Request for Additional Information Amsco® V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems

triple channeled devices with stainless steel lumens that are either o ■ > 1.2 mm ID and < 310 mm in length
or
≥ 2.8 mm ID and ≤ 317 mm in length
a The validation studies were 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 and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, cleared under K083097, K102394 and K111810, can sterilize:b

Non-lumened instruments including non-lumened rigid, semi-rigid and flexible 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 Ibs.
The Amsco V-PRO maX Low Temperature Sterilization System's Flexible Cycle, cleared under K102330 and K112760, 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:
l . 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 that is > 1 mm ID and < 1050 mm in length
· or two lumens with:
- o one lumen that is > 1 mm ID and < 998 mm in length
- o and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
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 that is ≥ 1 mm ID and ≤ 1050 mm in length
or two lumens with:

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o one lumen that is ≥ 1 mm ID and ≤ 998 mm in length o and the other lumen that is > 1 mm and < 850 mm in length
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 Ibs.

5. Summary of Nonclinical Tests

The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems have the same or similar intended use and the same technological characteristics as compared to the predicate devices. Performance testing to assess and demonstrate substantial equivalence to the predicates is summarized below.

Test	Result	Conclusion
1/2 Cycle ModifiedTotal Kill EndpointVerification	Modified total kill end point analysis wasdemonstrated. The standard injection weight of 2.1g and a lower injection weight of 1.457 g resultedin all sterile results for the Lumen Cycle modifiedstainless steel lumen claims. All survival resultswere shown at the lowest weight evaluated(0.121 g). Partial positives results were seen at theintermediate injection weights.	PASS
1/2 Cycle SterilizationVerification ofLumen Claims	The V-PRO Lumen Cycle reproducibly sterilizesthe modified stainless steel lumen claims underworst case conditions in a V-PRO Lumen 1/2 Cycle.	PASS
1/2 Cycle SterilizationVerification ofDouble PouchedLumens	The V-PRO Lumen Cycle reproducibly sterilizesthe modified stainless steel lumen claims underworst case conditions in a V-PRO Lumen 1/2 Cyclein a double pouched configuration.	PASS
Simulated Use Test	Simulated use testing verified the ability of theV-PRO Lumen Cycle to sterilize the modifiedstainless steel lumen claims under worst caseprocessing conditions.	PASS
In Use Test	The in use investigation demonstrated the ability ofthe V-PRO Lumen Cycle to sterilize clinicallycleaned, patient-soiled medical instrumentsrepresentative of the modified stainless steel lumenclaims.	PASS

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K120632/S001 STERIS Response to 5/10/12 Request for Additional Information Amsco V-PRO 1 Plus and V-PRO max Low Temperature Sterilization Systems

Test	Result	Conclusion
Biocompatibility	Residue analysis evaluation has demonstratedbiocompatibility after processing in the V-PROLumen Cycle.	PASS
Validation of Accessories for use with the V-PRO Lumen Cycle Modified LumenClaims
V-PRO SterilizationTrays	The modified stainless lumens claims weresuccessfully sterilized in the V-PRO SterilizationTrays under Lumen ½ cycle worst case conditions.	PASS
Vis-U-All TyvekPouches	The modified stainless lumens claims weresuccessfully sterilized in the Vis-U-All TyvekPouches under ½ cycle worst case conditions.	PASS

The Amsco V-PRO Low Temperature Sterilization Systems have been tested for conformity and are certified to the following standards:

. EN 61010-1:2001 Safety requirements for electrical equipment for measurement, control and laboratory use. General requirements; Part 1: General Requirements
EN 60601-1-2:2002 Medical electrical equipment. General requirements for safety. Collateral standard. Electromagnetic compatibility. Requirements and tests. . .

6. Conclusion

The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems have been validated to meet the established performance criteria. The results of the Amsco V-PRO Low Temperature Sterilization System verification studies demonstrate that the Lumen Cycle performs as intended and the proposed device is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's three main goals: health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

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

Bill Brodbeck, Ph.D. Senior Manager, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

JUN 2 6 2012

Re: K120632

Trade/Device Name: Amsco® V-PRO® 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR Dated: June 5, 2012 Received: June 6, 2012

Dear Dr. Brodbeck:

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 - Dr. Brodbeck

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,

For

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): K120632

Device Name:

Amsco® V-PRO® 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems

Indications For Use:

The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle, the subject of this submission, can sterilize:4

Lumened and non-lumened instruments with diffusion-restricted spaces . such as the hinged portion of forceps and scissors
Medical devices, including single, dual and triple channeled rigid and . semi-rigid endoscopes, with the following configurations: 4
- single channeled devices with a stainless lumen that is ≥ 0.77 mm 0 internal diameter (ID) and ≤ 500 mm in length
- dual channeled devices with stainless steel lumens that are ≥ 0.77 0 mm ID and ≤ 527 mm in length
- triple channeled devices with stainless steel lumens that are either o
  - ≥ 1.2 mm ID and ≤ 310 mm in length

≥2.8 mm ID and ≤ 317 mm in length
a The validation studies were 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.

Page 1 of 3

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The Amsco V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, cleared under K083097, K102394, and K111810, can sterilize: 8

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, cleared under K102330 and K112760, 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 that is ≥ 1 mm ID and ≤ 1050 mm in length
or two lumens with: .
- . one lumen that is ≥ 1 mm ID and ≤ 998 mm in length
- and the other lumen that is > 1 mm ID and < 850 mm in length .
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. 9

The flexible endoscope can contain either:

a single lumen that is > 1 mm ID and < 1050 mm in length .
. or two lumens with:
- one lumen that is ≥ 1 mm ID and ≤ 998 mm in length .
- and the other lumen that is > 1 mm and < 850 mm in length .
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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K120632/S001 STERIS Response to 5/10/12 Request for Additional Information Amsco® 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 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)

La ocw

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

. .

510(k) Number: K120632

Page 3 of 3

. .

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).