VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL

K140515 · STERIS Corporation · JOJ · Jul 17, 2014 · General Hospital

Device Facts

• Record ID: K140515
• Device Name: VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Jul 17, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The VERIFY® HPU Chemical Indicator is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System. The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non-Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.

Device Story

Single-use chemical process indicator; monitors vaporized hydrogen peroxide (VH2O2) sterilization cycles. Two formats: HPU indicator (placed inside packs) and adhesive label (affixed to packs). Contains proprietary chemical indicator ink on spun-bonded polyolefin substrate. Upon exposure to defined sterilization cycle conditions (temperature, sterilant), ink undergoes irreversible color change from magenta to yellow. Used in clinical settings by healthcare personnel to verify that packs have been subjected to a V-PRO sterilization process. Provides visual confirmation to distinguish processed from unprocessed items; does not provide information on sterility assurance level. Supports quality control workflows in sterile processing departments.

Clinical Evidence

Bench testing only. Performance verified against ANSI/AAMI/ISO 11140-1:2005 requirements for Class 1 indicators. Simulated-use testing conducted in V-PRO 60 and V-PRO maX systems across Lumen, Non-Lumen, and Flexible cycles. All 6 lots tested met 100% acceptance criteria (≥90% pass rate).

Technological Characteristics

Class 1 chemical process indicator per ISO 11140-1:2005. Materials: Proprietary indicator ink on spun-bonded polyolefin substrate. Mechanism: Chemical reaction causing color change (magenta to yellow) upon exposure to VH2O2. Single-use. No electronic components, software, or connectivity.

Indications for Use

Indicated for use as a Class 1 process indicator to distinguish between processed and unprocessed units in V-PRO Low Temperature Sterilization Systems (Lumen, Non-Lumen, or Flexible cycles).

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Predicate Devices

• Verify® V-PRO Chemical Indicator - Version 1A and 2A (K091174)

Submission Summary (Full Text)

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STERIS®

JUL 1 7 2014

# 510(k) Summary For VERIFY® V-PRO Chemical Indicator

## Sponsor Facility

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

## Manufacturing Facility

Albert Browne Ltd., a subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

Contact:

Bill Brodbeck Director, Regulatory Affairs

Telephone: [phone] Fax No: [phone] William [e-mail]

Submission Date:

July 16, 2014

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

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#### 1. Device Name

| Trade Name: | VERIFY® HPU Chemical Indicator and<br>VERIFY® Vaporized VH2O2 Process Indicator Adhesive<br>Label |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models: | Version 1B: VERIFY® HPU Chemical Indicator<br>Version 2B: VERIFY® Vaporized VH2O2 Process Indicator<br>Adhesive Label<br>(Collectively referenced as the VERIFY® V-PRO Chemical<br>Indicator) |
| Common Name: | Chemical Indicator |
| Class: | II |
| Classification Name: | Physical/chemical sterilization process indicator (21 CFR<br>880.2800, Product Code JOJ) |

### 2. Predicate Device

Verify® V-PRO Chemical Indicator - Version 1A and 2A (K091174)

### 3. Device Description

The VERIFY® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to a Lumen. Non-Lumen or Flexible Cycle in a V-PRO 1, V-PRO 1 Plus, V-PRO maX, or V-PRO 60 Low Temperature Sterilizer. When exposed to the defined processing conditions, the indicator exhibits a visible color change from magenta to yellow.

The VERIFY® V-PRO Chemical Indicator is provided as two formats:

- Version 1B: VERIFY® HPU Chemical Indicator .
- Version 2B: VERIFY® Vaporized VH2O2 Process Indicator Adhesive . Label

The Version 1B: VERIFY® HPU Chemical Indicator is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate.

The Version 2B: VERIFY® Vaporized | VH2O2 Process Indicator Adhesive Label is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of

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## K140515 STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® V-PRO CHEMICAL INDICATOR

the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.

### 4. Indications for Use:

The VERIFY® HPU Chemical Indicator is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to be sterilized to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.

The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.

### ડ. Description of Safety and Substantial Equivalence

The proposed and predicate devices are single use process indicators for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The differences between the proposed V-PRO Chemical Indicator - Versions 1B and 2B and the predicate VERIFY® V-PRO Chemical Indicator - Version 1A and 2A device are limited to minor physical differences as well as expanding the indications for use statement to include use in the V-PRO 60 Low Temperature Sterilization System. Testing included in this submission demonstrates that the proposed device performs as intended and is substantially equivalent to the predicate device.

### 6. Technological Characteristics

The proposed and predicate devices are Class 1 single use process indicators in accordance with ISO 11140-1:2005 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The ink, mechanism of action, and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to yellow.

Table 5-1 contains a comparison of technological characteristics and specifications of the proposed VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label to the predicate Verify® V-PRO Chemical Indicator - Version 1A and 2A.

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# K140515 STERIS ABBREVIATED 510(K) PREMARKET NOTIFICATION
VERIFY® V-PRO CHEMICAL INDICATOR

| Feature | Proposed<br>VERIFY® V-PRO Chemical<br>Indicator - V1B, V2B | K091174<br>Verify® V-PRO Chemical<br>Indicator - V1A, V2A | Comparison |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The VERIFY® HPU Chemical<br>Indicator is a Class 1<br>vaporized hydrogen peroxide<br>sterilization process indicator.<br>It is designed to distinguish<br>between processed and<br>unprocessed units when placed<br>within packs to be sterilized to<br>indicate, through a visible<br>change from magenta to<br>yellow, when the device has<br>been exposed to the Lumen,<br>Non Lumen or Flexible<br>sterilization cycle of a V-<br>PRO® Low Temperature<br>Sterilization System.<br><br>The VERIFY® Vaporized<br>VH2O2 Process Indicator<br>Adhesive Label is a Class 1<br>vaporized hydrogen peroxide<br>sterilization process indicator.<br>It is designed to distinguish<br>between processed and<br>unprocessed units, when<br>affixed to packs to be<br>sterilized, through a visible<br>color change from magenta to<br>yellow, when the pack has<br>been exposed to the Lumen,<br>Non Lumen or Flexible<br>sterilization cycle of a V-<br>PRO® Low Temperature<br>Sterilization System. | The Verify® V-PRO<br>Chemical Indicator (Version<br>1A) and the Verify® V-PRO<br>Chemical Indicator Adhesive<br>Label (Version 2A) are Class<br>1 vaporized hydrogen<br>peroxide sterilization process<br>indicators that conform to<br>ANSI/AAMI/ISO 11140-1:<br>2005. They are designed to<br>distinguish between processed<br>and unprocessed units when<br>placed within (Version 1A) or<br>affixed to (Version 2A)<br>sterilization wraps, trays or<br>pouches to indicate, through a<br>visible change from magenta<br>to yellow, when the device<br>(Version 1A) or pack (Version<br>2A) has been exposed to a V-<br>PRO 1 Low Temperature<br>sterilization process (Lumen<br>Cycle) or V-PRO 1 Plus Low<br>Temperature sterilization<br>process (Lumen or Non-<br>Lumen cycle). This product is<br>designed for use exclusively in<br>the Amsco V-PRO 1 Low<br>Temperature Sterilization<br>System and Amsco V-PRO 1<br>Plus Low Temperature<br>Sterilization System at 50 °C<br>using Vaprox™ HC Sterilant.<br>The Verify® V-PRO<br>Chemical Indicator (Version<br>1A) and the Verify® V-PRO<br>Chemical Indicator Adhesive<br>Label (Version 2A) intended<br>for use in vaporized hydrogen<br>peroxide sterilization<br>processes. The Verify® V-<br>PRO Chemical Indicator<br>(Version 1A) and the Verify®<br>V-PRO Chemical Indicator<br>Adhesive Label (Version 2A)<br>change color from magenta to<br>yellow when exposed to the<br>appropriate cycle conditions of<br>temperature, sterilant | The intended use<br>statement has been<br>rearranged for<br>simplicity for the<br>proposed device but<br>conveys a similar<br>intended use. The<br>proposed device is<br>intended to monitor<br>Lumen, Non Lumen<br>and Flexible Cycles<br>of V-PRO 1, 1 Plus<br>and maX Low<br>Temperature<br>Sterilization<br>Systems as with the<br>predicate device<br>with the addition of<br>adding the claim of<br>use in the V-PRO 60<br>Low Temperature<br>Sterilization System. |
| Feature | Proposed<br>VERIFY® V-PRO Chemical<br>Indicator - V1B, V2B | K091174<br>Verify® V-PRO Chemical<br>Indicator - V1A, V2A | Comparison |
| Device<br>design -<br>components | Indicator Ink printed onto spun-<br>bonded polyolefin (Versions 1B<br>and 2B) | Indicator Ink printed onto<br>Polypropylene (Version 1A) or<br>spun-bonded polyolefin<br>(Version 2A) | The proposed device<br>contains the same<br>components for<br>versions 2A and 2B<br>as version IB of the<br>predicate device. |
| Indicator<br>agent | Proprietary formulation | Proprietary formulation | The indicator agent<br>is identical to the<br>predicate. |
| Sterilization<br>method and<br>cycles | Vaporized Hydrogen Peroxide<br>in the V-PRO 1, V-PRO 1<br>Plus, V-PRO maX and V-PRO<br>60 Low Temperature<br>Sterilizers | Vaporized Hydrogen Peroxide<br>in the Amsco V-PRO 1 and<br>Amsco V-PRO 1 Plus Low<br>Temperature Sterilizers | The sterilization<br>cycles for the V-<br>PRO maX and V-<br>PRO 60 are being<br>added for the<br>proposed device. |
| Mechanism<br>of action | Proprietary | Proprietary | Mechanism of<br>action is identical to<br>predicate |
| Endpoint<br>specifications | No Endpoint Specifications<br>(Class 1 Process Indicator) | No Endpoint Specifications<br>(Class 1 Process Indicator) | Same |
| Side by side<br>testing with<br>biological<br>indicators? | No | No | Same |
| Specification | Conforms to<br>ANSI/AAMI/ISO 11140-<br>1:2005 requirements for a<br>Class I Hydrogen Peroxide<br>Chemical Indicator | Conforms to<br>ANSI/AAMI/ISO 11140-<br>1:2005 requirements for a<br>Class I Hydrogen Peroxide<br>Chemical Indicator | Same |

## Table 5-1. Device Comparison Table

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## K140515 STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® V-PRO CHEMICAL INDICATOR

### 7. Performance Testing

Performance testing was conducted to verify that the proposed VERIFY® V-PRO Chemical Indicator meets the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2005. Additional testing was completed to simulate typical in-use applications.

Table 5-2 summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the proposed VERIFY® V-PRO Chemical Indicator - Version 1B and Version 2B is safe and effective. These studies confirm that the proposed device's performance meets the requirements of its pre-defined acceptance criteria and intended uses, and qualify the proposed device for use in the V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems.

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## K140515 STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® V-PRO CHEMICAL INDICATOR

| Test of 6 Lots | Acceptance Criteria | | Study |
|----------------------------------------------------------------------------------|---------------------|--------------|--------|
| | FAIL | PASS | Result |
| Class 1<br>Performance Testing | 100% | $\u2265$ 90% | Pass |
| V-PRO 60 Simulated Use<br>Testing in Lumen, Non<br>Lumen and Flexible Cycles | 100% | $\u2265$ 90% | Pass |
| V-PRO maX Simulated<br>Use Testing in Lumen,<br>Non-Lumen and Flexible<br>Cycles | 100% | $\u2265$ 90% | Pass |

Table 5-2. Verification Results Summary

The results of the VERIFY® V-PRO Chemical Indicator performance testing demonstrate that both formats of the device, VERIFY® HPU Chemical Indicator and VERIFY® Vaporized | VH2O2 Process Indicator Adhesive Label, perform as intended and the proposed device is substantially equivalent to the predicate device.

### 8. Conclusion

The proposed device contains the same indicator agent on the same substrate with the minor addition of the adhesive on the VERIFY® Vaporized (VH2O2) Process Indicator Adhesive Label. The indications for use vary only in the addition of claims for a new sterilizer. Testing included in this submission demonstrates that the VERIFY® V-PRO Chemical Indicator performance testing demonstrate that both formats of the device, VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label, perform as intended and the proposed device is substantially equivalent to the predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

July 17, 2014

STERIS Corporation Bill Brodbeck, Ph.D. Director, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060

Re: K140515

Trade/Device Name: VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label Regulation Number: 21 CFR 880.2800 Regulation Name: Process Indicators Regulatory Class: II Product Code: JOJ Dated: June 19, 2014 Received: June 20, 2014

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 (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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): K140515

VERIFY® HPU Chemical Indicator and Device Name: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label

Indications For Use:

The VERIFY® HPU Chemical Indicator is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.

The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non-Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.

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)

Elizabeth F. Claverie -

Digitally signed by Elizabeth F. Claverie -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA. ou=People, 0.9.2342.19200300.100.1.1=1300055864, cn=Elizabeth F. Claverie -S Date: 2014.07.15 19:14:13 -04'00'

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