STERRAD CYCLESURE BIOLOGICAL INDICATOR

K103222 · Advanced Sterilization Products · FRC · Feb 25, 2011 · General Hospital

Device Facts

• Record ID: K103222
• Device Name: STERRAD CYCLESURE BIOLOGICAL INDICATOR
• Applicant: Advanced Sterilization Products
• Product Code: FRC · General Hospital
• Decision Date: Feb 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The STERRAD® CYCLESURE® Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles: STERRAD® 100S (Standard), STERRAD® 50 (Standard), STERRAD® 200 (Standard), STERRAD® NX™ (Standard, Advanced), STERRAD® 100NX™ (Flex, EXPRESS).

Device Story

STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained, standalone monitor for STERRAD® hydrogen peroxide sterilization processes. Device consists of glass fiber disc containing Geobacillus stearothermophilus spores, nutrient growth medium in glass ampoule, cap with diffusion-restricting openings, and chemical indicator. Used in clinical settings to monitor sterilization cycles. Hydrogen peroxide vapor diffuses into vial during sterilization; if sterilization fails, spores grow in medium, indicating cycle failure. Provides readout within 3 days. Enables healthcare providers to verify sterilization efficacy, ensuring patient safety by confirming instruments are sterile before use.

Clinical Evidence

Bench testing only. Studies included evaporation testing, verification of positive BI color, bacteriostasis, and BI validation (dose-response) in the STERRAD® 100NX™ Express Cycle. All tests passed.

Technological Characteristics

Self-contained biological indicator. Materials: molded polypropylene vial, glass fiber disc with Geobacillus stearothermophilus spores, glass ampoule with nutrient growth medium, Tyvek® cap liner. Sensing principle: biological spore growth following exposure to hydrogen peroxide vapor. Connectivity: standalone. Sterilization: intended for use in STERRAD® hydrogen peroxide systems.

Indications for Use

Indicated for routine monitoring of STERRAD® sterilization systems and cycles (100S, 50, 200, NX, 100NX) to verify sterilization efficacy.

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

# K103222 FEB 2 5 2011

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

Advanced Sterilization Products, Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618

#### Contact Person

Ms. Yogi Shah Project Manager, Regulatory Affairs Tel: [phone] Fax: [phone]

Summary Date: October 28, 2010

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

Classification Name: Biological Sterilization Process Indicator Common/Usual Name: Biological Indicator Product Classification: II Classification Regulation: 21CFR880.2200 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® Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:

| MODEL | CYCLE |
|----------------|----------|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| | Advanced |
| STERRAD®100NX™ | Flex |
| | EXPRESS |

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### 4. DESCRIPTION OF DEVICE

The STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained standalone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 1x10° 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

Testing was previously submitted in support of the substantial equivalence of the modified STERRAD® CYCLESURE® 24 Biological Indicator to the predicate STERRAD® CycleSure® Biological Indicator device. Both devices have same intended use, same technological characteristics, same operating principles, and utilize the same sterilant (hydrogen peroxide).

Additional testing was conducted to confirm that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended when used with the STERRAD® 100NX" Express Cycle.

| Study Performed | Results |
|-------------------------------------------------------------------|---------|
| Evaporation | Passed |
| Verification of positive BI color | Passed |
| Bacteriostasis | Passed |
| BI validation in STERRAD® 100NX™ Express Cycle (Dose<br>Response) | Passed |

# 6. DESCRIPTION OF CHANGE:

The following changes (relative to the predicate device, K071014) were reported in K102884 and incorporated into the STERRAD® CycleSure® 24 Biological Indicator that is shown in this submission to work as intended with the STERRAD® 100NX™ Express Cycle:

- a. Outer vial resin material changed (remains molded polypropylene from the same vendor)
- b. New supplier (and new process) for the silicon coating process for the Tyvek® cap liner
- c. Maximum readout time reduced from 7 days to 3 days
- d. Name changed from STERRAD® CycleSure® Biological Indicator to STERRAD® CYCLESURE® 24 Biological Indicator
- e. Additional changes to the Instructions for Use for clarity

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In addition, Intended Use statement revised adding sterilizer models and their related cycles for clarity for this submission.

# 7. OVERALL PERFORMANCE CONCLUSIONS

Performance testing demonstrated that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended in a newly developed STERRAD® 100NX™ Express Cycle.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

Ms. Yogi Shah Project Manager, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, California 92618

FEB 2 5 2011

Re: K103222

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: February 10, 2011 Received: February 14, 2011

Dear Ms. Shah:

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 that developmation 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- Ms. Shah

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 Fequirement 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 53) -542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), a
please go to 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, (2) CER D . . 007 CE) . . 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 tollulu free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Jums J. Rabadad
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): K103222

Device Name: STERRAD® CYCLESURE® 24 Biological Indicator

Indication for Use:

The STERRAD® CYCLESURE® Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:

| MODEL | CYCLE |
|----------------|----------|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| | Advanced |
| STERRAD®100NX™ | Flex |
| | EXPRESS |

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)
Elishath to. Willian

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

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510(k) Number: K103222