STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR

K102884 · Advanced Sterilization Products · FRC · Jan 28, 2011 · General Hospital

Device Facts

• Record ID: K102884
• Device Name: STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
• Applicant: Advanced Sterilization Products
• Product Code: FRC · General Hospital
• Decision Date: Jan 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of STERRAD® Sterilizer cycles.

Device Story

Self-contained biological monitor for STERRAD® sterilization process; consists of glass fiber disc with Geobacillus stearothermophilus spores (min 10^8 CFU), nutrient growth medium ampoule, and cap with chemical indicator. Cap features small openings for hydrogen peroxide vapor diffusion. Used by healthcare personnel to verify sterilization cycle efficacy. Device monitors sterilization success; failure to kill spores indicates cycle failure, preventing use of non-sterile instruments. Provides assurance of sterilization process performance.

Clinical Evidence

Bench testing only. No clinical data. Validation studies included evaporation, positive BI color verification, bacteriostasis, minimum incubation time (readout), spore resistance, dose response in STERRAD sterilizers, and growth promotion. All tests passed.

Technological Characteristics

Self-contained biological indicator. Materials: molded polypropylene vial, glass fiber disc, nutrient growth medium, Tyvek® cap liner. Sensing principle: biological spore death (Geobacillus stearothermophilus) and chemical indicator. Dimensions: small vial with restricted diffusion openings. Sterilization method: hydrogen peroxide vapor. No software or electronic components.

Indications for Use

Indicated for routine monitoring of STERRAD® Sterilization cycles in healthcare settings. No specific patient population, age, or gender restrictions apply as this is a sterilization process monitoring device.

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

• STERRAD® CycleSure® Biological Indicator (K071014)

Submission Summary (Full Text)

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# 510(k) SUMMARY

JAN 2 8 2011

1102884

#### Applicant's Name, Address, Telephone, FAX, Contact Person

Advanced Sterilization Products, Division of Ethicon, Inc. A Johnson & Johnson company 33 Technology Drive Irvine, CA 92618

#### Contact Person

Kevin Corrigan, RAC Director. Regulatory Affairs Tel: [phone] Fax: [phone]

Summary Date: September 27, 2010

### 1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

| Classification Name: | Biological Sterilization Process Indicator |
|-------------------------|---------------------------------------------|
| Common/Usual Name: | Biological Indicator |
| Product Classification: | II |
| Proprietary Name: | STERRAD® CYCLESURE® 24 Biological Indicator |

#### 2. PREDICATE DEVICES

STERRAD® CycleSure® Biological Indicator, K071014, May 24, 2007

## 3. INDICATIONS FOR USE

The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of STERRAD® Sterilizer cycles.

### 4. DESCRIPTION OF DEVICE

STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained stand-alone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 108 CFU of Geobacillus stearothermophilus spores, a glass ampoule containing nutrient growth medium, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion.

## 5. SUMMARY OF NONCLINICAL TESTS

The testing conducted demonstrated that our modified STERRAD® CYCLESURE® 24 Biological Indicator device is substantially equivalent to the predicate, unmodified STERRAD® CycleSure® Biological Indicator device. The devices share the same intended

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use, utilize the same technology (hydrogen peroxide as sterilant), exhibit the same performance characteristics and those characteristics have been verified using the same test methods for both devices.

| Validation Study | Results |
|------------------------------------------------------|---------|
| Evaporation | Passed |
| Verification of Positive BI Color | Passed |
| Bacteriostasis | Passed |
| Verification of Minimum Incubation Time (Readout) | Passed |
| Spore Resistance | Passed |
| BI Validation in STERRAD Sterilizers (Dose Response) | Passed |
| Growth Promotion | Passed |

# 6. DESCRIPTION OF CHANGE:

The following is a list of the specific changes to the predicate STERRAD® CycleSure® Biological Indicator:

- a. Outer vial resin material change (remains molded polypropylene, new vendor)
- b. New supplier for silicon coating process for the Tyvek® cap liner
- Reduced maximum incubation/readout time from 7 days to 3 days C.
- d. Name changed from STERRAD® CycleSure® Biological Indicator to STERRAD® CYCLESURE® 24 Biological Indicator

## 7. OVERALL PERFORMANCE CONCLUSIONS

The testing conducted demonstrated that the modified STERRAD® CYCLESURE® 24 Biological Indicator device is substantially equivalent to the predicate, unmodified STERRAD® CycleSure® Biological Indicator device.

TYVEK® is a Registered Trademark of Du Pont

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.

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

Mr. Kevin Corrigan Director, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, California 92618

JAN 28 2011

Re: K102884

Trade/Device Name: STERRAD CYCLESURE 24 Biological Indicator . Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: January 18, 2011 Received: January 19, 2011

Dear Mr. Corrigan:

:

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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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), pleasc 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,

Jams J. Dobbins

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): TBD

Device Name: STERRAD® CYCLESURE® 24 Biological Indicator

Indications for Use:

The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.

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

Over-The-Counter Use _ V (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 H. F.L. Cummins Will

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

510(k) Number: K102884

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