K Number

Device Name

AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

Manufacturer

STERIS Corporation

Date Cleared

2013-07-16

(85 days)

Product Code

MLR

Regulation Number

880.6860

Intended 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: - 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). - 2. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K062297, K102394, K111810, K120632, K083097, K102330, K112760

Reference Devices

K083097, K102394, K111810, K102330, K112760

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a sterilization system with pre-programmed cycles and does not mention any AI or ML capabilities.

Therapeutic

No
This device is a sterilizer for medical devices, not a therapeutic device used in patient treatment.

Diagnostic

This device is a sterilizer intended for the terminal sterilization of reusable medical devices, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a "vaporized hydrogen peroxide sterilizer," which is a physical piece of equipment, not software. The summary details hardware components and physical processes.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device 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." This describes a device used to sterilize medical instruments, not a device used to perform tests on biological samples to diagnose conditions.
Device Description: The device description reinforces this by stating it "use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP)." This is a sterilization process, not an in vitro diagnostic test.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.

Therefore, the Amsco V-PRO Low Temperature Sterilization Systems are medical devices used for sterilization, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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
    or
= ≥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.

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 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.

Product codes

MLR

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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: ½ Cycle Modified Total Kill Endpoint Verification
Result: Modified total kill end point 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.
Conclusion: PASS

Test: ½ Cycle Sterilization Verification of Lumen Claims
Result: The V-PRO Lumen Cycle reproducibly sterilizes the modified stainless steel lumen claims under worst case conditions in a V-PRO Lumen ½ Cycle.
Conclusion: PASS

Test: ½ Cycle Sterilization Verification of Double Pouched Lumens
Result: 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.
Conclusion: PASS

Test: Simulated Use Test
Result: 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.
Conclusion: PASS

Test: In Use Test
Result: 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.
Conclusion: PASS

Test: Biocompatibility
Result: Residue analysis evaluation has demonstrated biocompatibility after processing in the V-PRO Lumen Cycle.
Conclusion: PASS

Test: Validation of Accessories for use with the V-PRO Lumen Cycle Modified Lumen Claims, V-PRO Sterilization Trays
Result: The modified stainless lumens claims were successfully sterilized in the V-PRO Sterilization Trays under Lumen ½ cycle worst case conditions.
Conclusion: PASS

Test: Validation of Accessories for use with the V-PRO Lumen Cycle Modified Lumen Claims, Vis-U-All Tyvek Pouches
Result: The modified stainless lumens claims were successfully sterilized in the Vis-U-All Tyvek Pouches under ½ cycle worst case conditions.
Conclusion: PASS

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K062297, K102394, K111810, K120632, K083097, K102330, K112760

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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

1. Device Name

| Trade Name: | Amsco® V-PRO® 1, V-PRO 1 Plus and V-PRO
maX Low Temperature Sterilization Systems |
|----------------------|--------------------------------------------------------------------------------------|
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas
21 CFR 880.6860
Product 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.

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 Vaporized
VH2O2 Process
Indicators	K091174	K091174	K102330
V-PRO
Sterilization Trays	K070769,
K103226	K083097,
K103226	K102330,
K103226
Vis-U-All Tyvek
Pouches	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

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."

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 1 mm ID and 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

STERIS Traditional 510(k) PREMARKET NOTIFICATION

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

| Sterilization
Cycle | Sterilant
injection
(g) | # of
Injections | Sterilant
Exposure
Time (min) | Chamber
Pressure
Prior to
Injection
(Torr) | Chamber/
Vaporizer
Temperature
(°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

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