AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

K102330 · STERIS Corporation · MLR · Aug 12, 2011 · General Hospital

Device Facts

• Record ID: K102330
• Device Name: AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
• Applicant: STERIS Corporation
• Product Code: MLR · General Hospital
• Decision Date: Aug 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The Amsco V-PRO MAX Low Temperature Sterilization System, with VAPROX™ HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

Device Story

Vaporized hydrogen peroxide (VHP) sterilizer for heat/moisture-sensitive reusable medical instruments. Uses VAPROX HC Sterilant; operates via three pre-programmed cycles (Lumen, Non-Lumen, Flexible). Input: cleaned, rinsed, dried, packaged instruments. Process: conditioning, sterilization, and aeration phases at low pressure/temperature. Output: terminally sterilized devices ready for immediate use. Used in healthcare facilities; operated by trained staff. Benefits: rapid turnaround (approx. 35-minute Flexible Cycle), no aeration/cool-down required, material compatibility with various surgical instruments.

Clinical Evidence

Bench testing only. Efficacy validated via AOAC sporicidal tests, D-value determination, and 1/2 cycle modified total kill endpoint verification. Simulated use and in-use testing confirmed sterilization of patient-soiled instruments and flexible endoscopes under worst-case conditions. Biocompatibility (cytotoxicity/residue) and material compatibility confirmed for 23 materials. All performance criteria met.

Technological Characteristics

Vaporized hydrogen peroxide (VHP) sterilization system. Materials: 23 validated construction materials. Energy: electrical (EN 61010-1, EN 60601-1-2). Form factor: chamber-based sterilizer. Connectivity: standalone. Sterilization: VAPROX HC Sterilant. Software: pre-programmed cycles (Lumen, Non-Lumen, Flexible) with automated parameter control (pressure, temperature, injection weight).

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices in healthcare facilities. Includes rigid endoscopes, hinged instruments (forceps/scissors), and flexible endoscopes/bronchoscopes (single or dual lumen). Contraindicated for devices not compatible with vaporized hydrogen peroxide or heat/moisture sensitivity beyond system specifications.

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)
• Amsco V-PRO 1 Plus Low Temperature Sterilization System (K083097)
• STERRAD NX Sterilizer (K042116)
• TSO3 STERIZONE 125L Sterilizer (K090636)

Reference Devices

• Verify V24 SCBI (K073244 and K09051)
• Verify VH2O2 Process Indicator (K091174)
• V-PRO Sterilization Trays (K070769)
• Vis-U-All Tyvek pouches (K070765, K071087, and K090371)

Submission Summary (Full Text)

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K102330/S002 STERIS Response to 3/3/11 Request for Additional Information Amsco V-PRO Max Low Temperature Sterilization System

-------------

AUG 1 2 2011 ر

# 510(k) Summary For Amsco® V-PROTM MAX Low Temperature Sterilization System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Robert Sullivan Contact: Senior Director, Regulatory Affairs

Telephone: [phone] Fax No: [phone]

Summary Date: July 27, 2011

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

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#### 1. Device Name

| Trade Name: | Amsco®-V-PRO™-MAX-Low Temperature<br>Sterilization System |
|----------------------|-----------------------------------------------------------------------|
| Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer |
| Classification Name: | Sterilizer, Ethylene Oxide Gas<br>21 CFR 880.6860<br>Product Code MLR |

### Predicate Devices 2.

Amsco® V-PROTM 1 Low Temperature Sterilization System (K062297) Amsco® V-PROTM 1 Plus Low Temperature Sterilization System (K083097) STERRAD® NX Sterilizer (K042116) TSO3 STERIZONE® 125L Sterilizer (K090636)

### Description of Device 3.

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

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

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

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

The Verify V24 SCBI (K073244 and K09051), Verify VH2O2 Process Indicator (K091174), V-PRO Sterilization Trays (K070769), and Vis-U-All Tyvek pouches

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(K070765, K071087, and K090371) have been validated for use in the V-PRO MAX Sterilizer.

### Intended Use 4-

The Amsco V-PRO MAX Low Temperature Sterilization System, with VAPROX™ HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO MAX Low Temperature Sterilizer System's Lumen Cycle, cleared under K062297, can sterilize:4

- Instruments with diffusion-restricted spaces such as the hinged portion . of forceps and scissors
- Medical devices, including rigid endoscopes, with a single stainless . steel lumen with:
- an inside diameter of 1 mm or larger and a length of 125 mm or o shorter
- an insider diameter of 2 mm or larger and a length of 250 mm or 0 shorter
- an inside diameter of 3 mm or larger and a length of 400 mm or o shorter
- a The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

The Amsco V-PRO MAX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize: 6

Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.

- b The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
The Amsco V-PRO MAX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical care) and bronchoscopes in either of two load configurations:

- 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.6

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The flexible endoscopes may contain either:

- · a single lumen with an inside diameter of 1 mm or larger and a
- ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
- · or two lumens with:
- · one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
- The validation studies were conducted with two flexible ﮟ 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 with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
- · or two lumens with:
- · one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
- d The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

#### 5. Summary of Nonclinical Tests

The Amsco V-PRO MAX Low Temperature Sterilization System has 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.

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## K102330/S002 STERIS Response to 3/3/11 Request for Additional Information Amsco V-PRO Max Low Temperature Sterilization System

| Test | Result | Conclusion |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| AOAC Sporicidal<br>Test | All 720 carriers processed using 3 lots of EOSL<br>sterilant were sterile. | PASS |
| Determination of D-<br>value and Total Kill<br>Endpoint | Greater than a 12 log reduction of the most resistant<br>organism is achieved within the Flexible Cycle<br>sterilant exposure time. | PASS |
| 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 both validation loads. All<br>survival results were shown at the lowest weight<br>evaluated, 0.121 g. Partial positives results were<br>seen at the intermediate injection weights. | PASS |
| 1/2 Cycle Sterilization<br>Verification of<br>Lumen Claims | The V-PRO Flexible Cycle reproducibly sterilizes 1<br>x 1050 mm lumens under worst case conditions in a<br>V-PRO Flexible ½ Cycle | PASS |
| 1/2 Cycle Verification<br>of Mated Surfaces | Sterile efficacy was demonstrated for mated<br>surfaces packaged in a double-wrapped tray or in a<br>double-pouch configuration under worst case<br>conditions in a V-PRO Flexible ½ Cycle | PASS |
| ½ Cycle Verification<br>of Non Mated<br>Surfaces | Sterile efficacy was demonstrated for non mated<br>surfaces packaged in a double-wrapped tray under<br>worst case conditions in a V-PRO Flexible ½ Cycle | PASS |
| Simulated Use Test | Simulated use testing verified the ability of the<br>V-PRO Flexible Cycle to sterilize flexible<br>endoscopes and non lumened medical devices<br>under worst case processing conditions. | PASS |
| In Use Test | The in use investigation demonstrated the ability of<br>the V-PRO Flexible Cycle to sterilize<br>clinically-cleaned, patient-soiled medical<br>instruments. | PASS |
| Biocompatibility | Cytotoxicity and residue analysis of 23 materials<br>have demonstrated biocompatibility after<br>processing in the V-PRO MAX Sterilizer. | PASS |
| Medical Device<br>Material<br>Compatibility | Evaluation of medical devices after multiple cycles<br>in the V-PRO MAX Sterilizer has demonstrated<br>compatibility with 23 materials of construction. | PASS |
| Flexible Cycle Final<br>Process<br>Qualification | The V-PRO Flexible Cycle final process<br>qualification was successful. All three lots of CI<br>exhibited complete color change. All three SCBI<br>PIs exhibited a passing color change and all SCBIs<br>were negative for growth. Manual inspection of the<br>process parameter data confirmed that all cycle<br>specifications were met. | PASS |
| Test | Result | Conclusion |
| Validation of Accessories for use in the V-PRO Flexible Cycle | | |
| Verify V24 SCBIs | Three lots of Verify V24 SCBIs were sterile (no growth) after processing in the V-PRO Flexible ½ Cycle. | PASS |
| Verify Vaporized<br>VH2O2 Process<br>Indicators | Three lots of Verify Vaporized <span style="border: 1px solid black">VH2O2</span> Process Indicator exhibited a complete color change under worst case simulated use. | PASS |
| V-PRO Sterilization<br>Trays | 1 x 1050 mm lumens were successfully sterilized in the V-PRO Sterilization Trays under ½ cycle worst case conditions. | PASS |
| Vis-U-All Tyvek<br>Pouches | Mated and non mated surfaces were successfully sterilized in the Vis-U-All Tyvek Pouches under ½ cycle worst case conditions | PASS |

·

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K102330/S002 STERIS Response to 3/3/11 Request for Additional Information Amsco V-PRO Max Low Temperature Sterilization System

The V-PRO Accessories (Verify V24 SCBIs, Verify Vaporized VH2O2) Process Indicators. V-PRO Sterilization Trays and Vis-U-All Tyvek Pouches) are qualified for the Lumen. Non Lumen and Flexible V-PRO Sterilization Cycles.

The Amsco V-PRO MAX Low Temperature Sterilization System has been tested for conformity and is 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 MAX Low Temperature Sterilization System's Flexible Cycle has been validated to meet the established performance criteria. The results of the Amsco V-PRO MAX Low Temperature Sterilization System verification studies demonstrate that the Flexible Cycle performs as intended and the proposed device is substantially equivalent to the predicate devices.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol with three angled lines above a wavy line, all in black. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WQ66-G609 Silver Spring, MD 20993-0002

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

AUG 1 2 2011

Re: K102330

Trade/Device Name: Amsco® V-PRO ™ MAX Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: MLR Dated: July 27, 2011 Received: July 28, 2011

Dear Mr. Sullivan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Sullivan

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-live number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ronthing U. and Anthony D. Watson. B.S., M.S.. M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devi Office of Device Evaluation Center of Devices and Radiological Health

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## Indications for Use

K102330 510(k) Number (if known):

Device Name:

### Amsco® V-PROTM MAX Low Temperature Sterilization System

Indications For Use:

The Amsco V-PROTM MAX Low Temperature Sterilization System, with VAPROX™ HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO MAX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize:4

- Instruments with diffusion-restricted spaces such as the hinged portion . of forceps and scissors
- Medical devices, including rigid endoscopes, with a single stainless . steel lumen with:
- an inside diameter of 1 mm or larger and a length of 125 mm or o shorter
- an insider diameter of 2 mm or larger and a length of 250 mm or o shorter
- an inside diameter of 3 mm or larger and a length of 400 mm or o shorter
- a The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 Ibs.

The Amsco V-PRO MAX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize: 6

Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.

Page 1 of 3

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### K102330/S002 STERIS Response to 3/3/11 Request for Additional Information Amsco V-PRO MAX Low Temperature Sterilization System

- b The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The Amsco V-PRO MAX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations:

- Two flexible endoscopes with a light cord (if not integral to 1. endoscope) and mat with no additional load.
The flexible endoscopes may contain either:

- a single lumen with an inside diameter of 1 mm or larger and a : length of 1050 mm or shorter
- or two lumens with: .
- one lumen having an inside diameter of 1 mm or larger and a . length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
- C The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
- One flexible endoscope with a light cord (if not integral to endoscope) 2. and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. 4

The flexible endoscope can contain either:

- a single lumen with an inside diameter of 1 mm or larger and a . length of 1050 mm or shorter
- or two lumens with: .
- one lumen having an inside diameter of 1 mm or larger and a . length of 998 mm or shorter
- and the other lumen having an inside diameter of 1 mm or . larger and a length of 850 mm or shorter
- d The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

Page 2 of 3

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K102330/S002 STERIS Response to 3/3/11 Request for Additional Information Amsco V-PRO MAX Low Temperature Sterilization System

| 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 _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 3 of 3

Elizabeth P. Clausing-Wells

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

510(k) Number: K102330