The Amsco V-PRO I, V-PRO I 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 ≤ 275 mm in length
  - ≥ 1.8 mm ID and ≤ 310 mm in length
  - or
  - ≥ 2.8 mm ID and ≤ 317 mm in length
The validation studies for all channel/lumen configurations 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:
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:
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 Ibs.

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 text describes the 510(k) summary for the Amsco V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems. It focuses on updating the indications for use statement for the Lumen Cycle.

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

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the successful demonstration of sterilization capability under various test conditions for the device's Lumen Cycle, especially for the modified stainless steel lumen claims. The "Conclusion" column in the table below explicitly states "PASS" for all tests, indicating that these criteria were met.

Test	Acceptance Criteria (Implied)	Reported Device Performance
½ Cycle Modified Total Kill Endpoint Verification	Demonstrate a modified total kill endpoint analysis, showing all sterile results for specified Lumen Cycle claims at standard and lower injection weights, and survival at the lowest weight.	Modified total kill endpoint analysis was 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.
½ Cycle Sterilization Verification of Lumen Claims	Reproducibly sterilize the modified stainless steel lumen claims under worst-case conditions in a V-PRO Lumen ½ Cycle.	The V-PRO Lumen Cycle reproducibly sterilizes the modified stainless steel lumen claims under worst case conditions in a V-PRO Lumen ½ Cycle.
½ Cycle Sterilization Verification of Double Pouched Lumens	Reproducibly sterilize the modified stainless steel lumen claims under worst-case conditions in a V-PRO Lumen ½ Cycle in a double pouched configuration.	The V-PRO Lumen Cycle reproducibly sterilizes the modified stainless steel lumen claims under worst case conditions in a V-PRO Lumen ½ Cycle in a double pouched configuration.
Simulated Use Test	Verify the ability of the V-PRO Lumen Cycle to sterilize the modified stainless steel lumen claims under worst-case processing conditions.	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	Demonstrate the ability of the V-PRO Lumen Cycle to sterilize clinically cleaned, patient-soiled medical instruments representative of the modified stainless steel lumen claims.	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	Demonstrate biocompatibility after processing in the V-PRO Lumen Cycle through residue analysis.	Residue analysis evaluation has demonstrated biocompatibility after processing in the V-PRO Lumen Cycle.
Validation of Accessories for use with the V-PRO Lumen Cycle Modified Lumen Claims (V-PRO Sterilization Trays)	Successfully sterilize the modified stainless lumens claims in V-PRO Sterilization Trays under Lumen ½ cycle worst-case conditions.	The modified stainless lumens claims were successfully sterilized in the V-PRO Sterilization Trays under Lumen ½ cycle worst case conditions.
Validation of Accessories for use with the V-PRO Lumen Cycle Modified Lumen Claims (Vis-U-All Tyvek Pouches)	Successfully sterilize the modified stainless lumens claims in Vis-U-All Tyvek Pouches under ½ cycle worst-case conditions.	The modified stainless lumens claims were successfully sterilized in the Vis-U-All Tyvek Pouches under ½ cycle worst case conditions.

Study Details

Based on the provided text, the document describes nonclinical tests primarily focused on verifying the sterilization efficacy of the device.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The exact number of individual devices or lumens tested for each specific test is not explicitly stated in numerical form. However, for the "Lumen Cycle," the validation studies for all channel/lumen configurations 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.
- Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the US FDA, implying the studies were conducted to meet US regulatory requirements. The studies appear to be prospective validation studies conducted by the manufacturer, STERIS Corporation, for the purpose of demonstrating the device's efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts or their qualifications for establishing the ground truth. Sterilization efficacy studies like these typically rely on microbiological testing (e.g., spore-kill assays) to establish an objective "ground truth" of sterility, rather than expert human interpretation.
Adjudication method for the test set:
- Adjudication methods (like 2+1, 3+1) are typically used in studies involving human readers or subjective assessments. This document describes objective performance testing (sterilization efficacy), so such adjudication methods are not applicable and therefore not mentioned.
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:
- No. This is a study on a sterilization device, not an AI-assisted diagnostic device that would involve human readers. Therefore, an MRMC study and related effect sizes are not relevant or described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The tests described are "standalone" performance evaluations of the sterilization system's ability to achieve sterility without direct human intervention during the sterilization cycle itself. The device is an automated sterilizer, so its performance is inherently "algorithm-only" in its operation. However, no "algorithm" in the typical AI sense is discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth in these sterilization studies is microbiological sterility. The "½ Cycle Modified Total Kill Endpoint Verification" and "½ Cycle Sterilization Verification" tests indicate the use of biological indicators (spores) to definitively determine if sterilization was achieved (total kill/survival results). The "In Use Test" also mentions sterilization of "patient-soiled medical instruments," implying a microbiological assessment of sterility. Biocompatibility is assessed by "residue analysis."
The sample size for the training set:
- This document describes validation and verification studies for a physical sterilization device, not a machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable and not mentioned.
How the ground truth for the training set was established:
- As there is no training set for an AI algorithm, this information is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the word "STERIS" in all capital letters. To the right of the word is the registered trademark symbol. Below the word is a graphic of several horizontal wavy lines stacked on top of each other.

JUL 1 6 2013

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 Director, Regulatory Affairs

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

April 19, 2013 Summary Date:

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, K111810 and K120632) Amsco V-PRO ® 1 Plus Low Temperature Sterilization System (K083097, K102394, K111810 and K120632) Amsco® V-PRO® maX Low Temperature Sterilization System (K102330, K112760 · and K120632)

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 Cycles 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 update the indications for use statement cleared under K120632. 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 Cycles and the Premarket Notification submission references under which the accessories were cleared for the cycles are listed in Table 5-2.

	Submission Reference
Accessory	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

Intended Use 4.

The purpose of this submission is to update the indications for use statement cleared under K120632. 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: 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
- o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length

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dual channeled devices with stainless steel lumens that are ≥ 0.77 o mm ID and ≤ 527 mm in length
triple channeled devices with stainless steel lumens that are either o
- ≥ }.2 mm ID and ≤ 275 mm in length
- ≥ 1.8 mm ID and ≤ 310 mm in length
  - or
- 2.8 mm ID and ≤ 317 mm in length
a The validation studies for all channel/lumen configurations 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:

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:
- 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."

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The flexible endoscope can 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 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.

Summary of Nonclinical Tests న్.

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
½ 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
½ Cycle SterilizationVerification ofLumen Claims	The V-PRO Lumen Cycle reproducibly sterilizesthe modified stainless steel lumen claims underworst case conditions in a V-PRO Lumen ½ Cycle.	PASS
½ Cycle SterilizationVerification ofDouble PouchedLumens	The V-PRO Lumen Cycle reproducibly sterilizesthe modified stainless steel lumen claims underworst case conditions in a V-PRO Lumen ½ 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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STERIS Traditional 510(k) PREMARKET NOTIFICATION TERIO Traditional UTO(n) + REMARRE + 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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Image /page/6/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 16, 2013

STERIS Corporation Mr. Bill Brodbeck Director, Regulatory Affairs 5960 Heisley Road MENTOR OH 44060

Re: K131120

Trade/Device Name: Amsco® V-PRO® 1, V-PRO 1 Plus and V-PROmaX Low Temperature Sterilization Systems Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR Dated: April 19, 2013 Received: April 22, 2013

Dear Mr. Brodbeck:

We have reviewed your Scetion 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 mav be subject to additional controls. Existing major regulations affecting your device can be finav oc sabyer to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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,

Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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): K13 | 120

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 I, V-PRO I 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-luments 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: 9
- single channeled devices with a stainless lumen that is ≥ 0.77 mm o 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
- triple channeled devices with stainless steel lumens that are o
  - = ≥ 1.2 mm ID and ≤ 275 mm in length
  - = ≥ 1.8 mm ID and ≤ 310 mm in length

= ≥2.8 mm ID and ≤ 317 mm in length
0 The validation studies for all channel/lumen configurations 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 I 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:"

Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-luments 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 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:
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 .
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-luments including instruments with mile and acestricted 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 > I mm and ≤ 850 mm in length v
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 Traditional 510(k) PREMARKET NOTIFICATION

Amsco® V-PRO® 1, V-PRO 1 Pius 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 2) 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)

Elizabeth F Claverie
2013.07.16 15:06:54 -04'00'

Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K131120
----------------	---------

Page 3 of 3

April 19, 2013

Page 4-3

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).