VERIFY 275F GRAVITY INDICATORS

K083643 · STERIS Corporation · JOJ · Aug 7, 2009 · General Hospital

Device Facts

• Record ID: K083643
• Device Name: VERIFY 275F GRAVITY INDICATORS
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Aug 7, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Verify® 275F Gravity Indicators are chemical indicators intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The indicators change color from yellow to blue/purple when exposed to saturated steam at 275°F for the specified period of time. The performance of the Verify® 275F Gravity Indicators meet the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] chemical steam indicators.

Device Story

Verify® 275F Gravity Indicators are single-use chemical indicators used by healthcare providers to monitor steam sterilization efficacy. The device consists of a polypropylene strip (22 mm x 143 mm) featuring chemical indicator ink spots. Upon exposure to saturated steam at 275°F (135°C) for a specific duration, the ink undergoes a visual color change from yellow to blue/purple. This color change is compared against an adjacent reference block to confirm cycle completion. The device provides a qualitative visual output that informs the healthcare provider whether the sterilization parameters were met, thereby ensuring the sterility of the processed products.

Clinical Evidence

Bench testing only. Performance verified against ANSI/AAMI/ISO 11140-1:2005 requirements for Class 6 chemical indicators using a resistometer per ANSI/AAMI/ISO 18472.

Technological Characteristics

Polypropylene strip (22 mm x 143 mm) with chemical indicator ink spots. Sensing principle: chemical color change (yellow to blue/purple) in response to saturated steam at 275°F (135°C). Emulates Class 6 chemical indicators per ANSI/AAMI/ISO 11140-1:2005. Single-use, non-electronic.

Indications for Use

Indicated for use by healthcare providers to monitor steam sterilization cycles. Models include Verify 275F 3-10 for 3 and 10-minute 275°F (135°C) gravity flash steam cycles, and Verify 275F 10 for 10-minute 275°F (135°C) gravity steam 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

• DANA SteriScan Indicators (K012195)
• SteriTec Integraph [Cardinal Steam Integrators (K960441)]
• STERIS Verify Integrators (K002937)

Submission Summary (Full Text)

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AUG 0 7 2009

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# 510(k) Summary For Verify® 275F Gravity Indicators

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

Contact:

Robert F. Sullivan. Senior Director, FDA Regulatory Affairs

Telephone: [phone] Fax No: 440 357 9198

Summary Date:

August 5, 2009

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

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#### 1. Device Name

Verify® 275F 3-10 Indicator. Verify® 275F 10 Indicator.

Chemical Indicators. Common Name:

Classification Name:

Physical/chemical sterilization process indicators (21 CFR 880.2800 (b), Product Code JOJ).

#### Predicate Devices 2.

- DANA SteriScan Indicators (K012195)
- SteriTec Integraph [Cardinal Steam Integrators (K960441)] ●
- STERIS Verify Integrators (K002937) ●

#### 3. Device Description

The proposed Verify® 275F Gravity Indicators consist of:

- A 22 mm x 143 mm polypropylene strip with two 12 mm chemical indicator . ink spots (for Verify® 275F 3-10 Indicator).
- A 22 mm x 143 mm polypropylene strip with one 12 mm chemical indicator . ink spots (for Verify® 275F 10 Indicator).

The indicator ink spots are located on each end of the strip (or one end if it is just one ink spot), adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify® 275F Gravity Indicators changes from yellow to blue/purple color when the steam sterilization cycle is complete.

The Verify® 275F Gravity Indicators can be used to monitor 275ºF (135ºC) sterilization cycles as follows:

- The Verify® 275F 3-10 Indicator can be used to monitor a 3 and 10 minute . 275°F (135°C) gravity flash steam sterilization cycle.
- The Verify® 275F 10 Indicator can be used to monitor a 10 minute 2759F . (135℃) gravity steam sterilization cycle.

¹ Cardinal is a private label brand produced by Steritec under K960441.

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### Intended Use 4.

The Verify® 275F Gravity Indicators are chemical indicators intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The indicators change color from yellow to blue/purple when exposed to saturated steam at 275°F for the specified period of time. The performance of the Verify® 275F Gravity Indicators meet the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] chemical steam indicators.

#### Description of Safety and Substantial Equivalence న్.

The proposed and predicate devices are all single use indicators for use in steam sterilization cycles. The differences between the proposed Verify® 275F Gravity Indicators and predicate devices are limited to differences in design, material, and parameters of the sterilization cycles these indicators are designed to monitor. These differences do not raise any new issues of safety and efficacy.

#### Performance Testing 6.

Performance testing was conducted to verify that the proposed Verify® 275F Gravity Indicators meet the requirements for emulating [Class 6] chemical indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI ISO 18472.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the figure.

AUG 0 7 2009

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

Mr. John R. Scoville Senior Director of FDA Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834

Re: K083643

Trade/Device Name: Verify® 275F Gravity Indicators Regulation Number: 21 CFR 880. 2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: July 9, 2009 Received: July 14, 2009

Dear Mr. Scoville:

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.

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. Scoville

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours,

for

Susan Runner, D.D.S., M.A. Acting Division 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): K083643

Device Name:

Verify® 275F Gravity Indicators

Indications for Use:

The Verify® 275F Gravity Indicators are chemical integrators which meet ANSVAAMI 1140-1:2005 for emulating indicators intended for use in steam sterilization. The Verify® 275F Gravity Indicators change color from yellow to blue/purple when exposed to 275°F (135°C) and to the appropriate cycle type and duration. The Verify® 275F Indicators models and their cycle types and times are:

| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|------------------|---------------|---------------------|------------------|
| Verify 275F 3-10 | 275°F (135°C) | Gravity flash steam | 3 and 10 minutes |
| Verify 275F 10 | 275°F (135°C) | Gravity steam | 10 minutes |

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)

Stink R. Murphy, Ke

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

510(k) Number: K083643

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