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

K120632 · STERIS Corporation · MLR · Jun 26, 2012 · General Hospital

Device Facts

• Record ID: K120632
• Device Name: AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM
• Applicant: STERIS Corporation
• Product Code: MLR · General Hospital
• Decision Date: Jun 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

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.

Device Story

Vaporized hydrogen peroxide (VHP) sterilizer; uses VAPROX HC Sterilant to process heat/moisture-sensitive medical devices. Operates via pre-programmed cycles (Lumen, Non Lumen, Flexible) involving conditioning, sterilization, and aeration phases. Used in healthcare facilities; operated by trained personnel. Input: cleaned, rinsed, dried medical instruments in validated trays/pouches. Output: terminally sterilized devices ready for immediate use. No cool-down required. Clinical benefit: enables safe, rapid sterilization of complex, heat-sensitive surgical instruments, including endoscopes and hinged tools, without damaging materials.

Clinical Evidence

No clinical data. Evidence consists of bench testing: 1/2 cycle modified total kill endpoint verification, sterilization verification of lumen claims, double-pouch configuration testing, simulated use testing, and in-use testing with patient-soiled instruments. Biocompatibility residue analysis performed. All tests passed.

Technological Characteristics

Vaporized hydrogen peroxide sterilizer; low pressure/temperature operation. Materials: stainless steel lumen compatibility. Connectivity: standalone. Standards: EN 61010-1 (safety), EN 60601-1-2 (EMC). Sterilization: VAPROX HC Sterilant. Software: pre-programmed cycles (Lumen, Non Lumen, Flexible).

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices in healthcare facilities. Includes lumened/non-lumened instruments, hinged instruments (forceps/scissors), and rigid/semi-rigid/flexible endoscopes (single, dual, triple channeled) with specific lumen ID/length configurations. Contraindicated for devices not cleaned, rinsed, or dried, or those exceeding validated lumen dimensions or load weights.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] Fax No: [phone]

Contact: Bill Brodbeck Senior Manager, Regulatory Affairs

Telephone: [phone] Fax No: [phone]

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-PRO<br>maX Low Temperature Sterilization Systems |
|----------------------|--------------------------------------------------------------------------------------|
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas<br>21-CFR 880.6860<br>Product 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 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.

. 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,<br>K090514 | K083097 | K102330 |
| Verify Vaporized<br>VH2O2 Process<br>Indicators | K091174 | K091174 | K102330 |
| V-PRO<br>Sterilization Trays | K070769,<br>K103226 | K083097,<br>K103226 | K102330,<br>K103226 |
| Vis-U-All Tyvek<br>Pouches | K070765<br>K071087<br>K090371 | K083097<br>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).
- 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:

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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 Modified<br>Total Kill Endpoint<br>Verification | Modified total kill end point analysis was<br>demonstrated. The standard injection weight of 2.1<br>g and a lower injection weight of 1.457 g resulted<br>in all sterile results for the Lumen Cycle modified<br>stainless steel lumen claims. All survival results<br>were shown at the lowest weight evaluated<br>(0.121 g). Partial positives results were seen at the<br>intermediate injection weights. | PASS |
| 1/2 Cycle Sterilization<br>Verification of<br>Lumen Claims | The V-PRO Lumen Cycle reproducibly sterilizes<br>the modified stainless steel lumen claims under<br>worst case conditions in a V-PRO Lumen 1/2 Cycle. | PASS |
| 1/2 Cycle Sterilization<br>Verification of<br>Double Pouched<br>Lumens | The V-PRO Lumen Cycle reproducibly sterilizes<br>the modified stainless steel lumen claims under<br>worst case conditions in a V-PRO Lumen 1/2 Cycle<br>in a double pouched configuration. | PASS |
| Simulated Use Test | Simulated use testing verified the ability of the<br>V-PRO Lumen Cycle to sterilize the modified<br>stainless steel lumen claims under worst case<br>processing conditions. | PASS |
| In Use Test | The in use investigation demonstrated the ability of<br>the V-PRO Lumen Cycle to sterilize clinically<br>cleaned, patient-soiled medical instruments<br>representative of the modified stainless steel lumen<br>claims. | 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 demonstrated<br>biocompatibility after processing in the V-PRO<br>Lumen Cycle. | PASS |
| Validation of Accessories for use with the V-PRO Lumen Cycle Modified Lumen<br>Claims | | |
| V-PRO Sterilization<br>Trays | The modified stainless lumens claims were<br>successfully sterilized in the V-PRO Sterilization<br>Trays under Lumen ½ cycle worst case conditions. | PASS |
| Vis-U-All Tyvek<br>Pouches | The modified stainless lumens claims were<br>successfully sterilized in the Vis-U-All Tyvek<br>Pouches 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 [phone] or [phone] 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, 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
- 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

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 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

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.

- 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).
- 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. 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

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

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