VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK

K070895 · STERIS Corporation · JOJ · Sep 5, 2007 · General Hospital

Device Facts

• Record ID: K070895
• Device Name: VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Sep 5, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Verify® Challenge Packs are chemical indicator test packs intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The indicator sheet within the challenge pack changes color from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle. The performance of the Verify® Challenge Packs meets the requirements of ANSI/AAMI / ISO 11140-1-2005 for emulating [Class 6] steam indicators.

Device Story

Verify® Challenge Packs are single-use chemical indicators used by healthcare providers to monitor steam sterilization efficacy. Each pack contains an emulating indicator (Class 6) enclosed within a steam penetration barrier. During a sterilization cycle, the indicator ink undergoes a color change from yellow to blue/purple upon exposure to specific time and temperature parameters. The device provides a visual confirmation of cycle completion, allowing clinicians to verify that sterilized products have been subjected to the required sterilization conditions. This process helps ensure the sterility of medical instruments, thereby reducing the risk of infection for patients.

Clinical Evidence

Bench testing only. Performance verified against ANSI/AAMI ISO 11140-1:2005 requirements for Class 6 emulating indicators using a prototype resistometer per ANSI/AAMI ISO 18472. Barrier material efficacy demonstrated using AAMI 16 Towel Packs with biological indicators as references.

Technological Characteristics

Single-use chemical indicator pack; emulating indicator (Class 6) per ANSI/AAMI/ISO 11140-1:2005; steam penetration barrier material; color-changing ink (yellow to blue/purple); passive sensing based on thermal and steam exposure.

Indications for Use

Indicated for use by healthcare providers to monitor steam sterilization cycles. Models include Verify® 270°F 4 for 4-minute 270°F/132°C Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum cycles, and Verify® 275°F 3 for 3-minute 275°F/135°C pre-vacuum 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

• STERIS Integrator Challenge Pack (Model LCC003) (K002741)

Submission Summary (Full Text)

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# 510(k) Summary For Verify® Steam Indicators

SEP - 5 2007

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

| Contact: | Richard Bancroft<br>Development and Technical Service Director |
|----------|----------------------------------------------------------------|
| | Telephone: [phone]<br>Fax No: 011 44 116 2768639 |

Date Prepared: July 23, 2007

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

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#### 1. Device Name

| Challenge Packs Models: | Verify® 270°F 4 Challenge Pack<br>Verify® 275°F 3 Challenge Pack |
|-------------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Chemical Indicator |
| Classification Name: | Physical/chemical sterilization process indicator (21 CFR 880.2800 (b), Product Code JOJ). |

#### 2. Predicate Devices

- STERIS Integrator Challenge Pack (Model LCC003) -K002741 .
#### Device Description 3.

The proposed Verify® Challenge Packs consist of an emulating indicator surrounded by a steam penetration barrier. The indicator ink inside the proposed Verify® Challenge Packs changes from yellow to blue/purple color when the steam sterilization cycle is complete.

- The Verify® 270°F 4 Challenge Pack can be used to monitor a 4 minute . 270°F/132°C Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle.
- The Verify® 275°F 3 Challenge Pack can be used to monitor a 3 minute ● 275°F/135°C pre-vacuum steam sterilization cycle.

#### 4. Intended Use

The Verify® Challenge Packs are chemical indicator test packs intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The indicator sheet within the challenge pack changes color from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle. The performance of the Verify® Challenge Packs meets the requirements of ANSI/AAMI / ISO 11140-1-2005 for emulating [Class 6] steam indicators.

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

The proposed and predicate devices are all single use indicator packs for use in steam sterilization cycles. The differences between the proposed bundled Verify® Challenge Packs and predicate device 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.

#### 6. Performance Testing

Performance testing was conducted to verify that the proposed indicators within the challenge packs meet the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a prototype resistometer to ANSI/AAMI ISO 18472.

Further testing was conducted to demonstrate the efficacy of the barrier material using an AAMI 16 Towel Pack with biological indicators as references. Predicate test packs were included in this testing.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2007

Mr. John Scoville Fellow, Regulatory Affairs Steris, Corporation 5960 Heisley Road Mentor, Ohio 44060-1834

Re: K070895

Trade/Device Name: Verify" Challenge Packs Models Verify 270F 4 and Verify 275F 3 Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 23, 2007 Received: August 24, 2007

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 such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.

Chiv Lin, Ph.D.

Chiu Lin, Ph.D. 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

K070895 510(k) Number (if known):

Device Name:

Verify® Challenge Packs

Indications For Use:

The Verify® Challenge Packs are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are:

| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|----------------|---------------|--------------------------------------------------|-----------|
| Verify® 270F 4 | 270°F (132°C) | Pre-vacuum, Steam Flush<br>Pressure Pulse (SFPP) | 4 minutes |
| Verify® 275F 3 | 275°F (135°C) | Pre-vacuum | 3 minutes |

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __X__ (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule H Murphy MD

Fision Sign-Off) Livision of Anesthesiology, General Hospital, Infection Control, Dental Davices

510(k) Number. N 020

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