STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR

K122044 · Advanced Sterilization Products · FRC · Oct 4, 2012 · General Hospital

Device Facts

• Record ID: K122044
• Device Name: STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
• Applicant: Advanced Sterilization Products
• Product Code: FRC · General Hospital
• Decision Date: Oct 4, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The STERRAD® CYCLESURE® 24 Biological Indicator (PN 14324) 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® (Standard, Flex, EXPRESS).

Device Story

Self-contained biological monitor for routine verification of STERRAD hydrogen peroxide sterilization cycles. Device consists of glass fiber disc containing Geobacillus stearothermophilus spores, nutrient growth medium in glass ampoule, and cap with chemical indicator. Cap features small circular openings allowing hydrogen peroxide vapor diffusion into vial; openings restrict diffusion rate. Used in clinical settings to confirm sterilization efficacy. Healthcare personnel place indicator in sterilizer; after cycle, vial is activated to release medium; growth or lack thereof indicates sterilization success. Provides objective verification of sterilization process, ensuring patient safety by confirming instrument sterility.

Clinical Evidence

Bench testing only. Studies included evaporation, positive BI color verification, bacteriostasis, dose response validation in STERRAD systems, minimum incubation time verification, growth promotion, and spore resistance testing. All tests passed.

Technological Characteristics

Self-contained biological indicator. Components: glass fiber disc with Geobacillus stearothermophilus spores (min 1x10^6), nutrient growth medium in glass ampoule, outer vial (resin), cap with chemical indicator. Sensing principle: biological spore death/growth. Sterilant: hydrogen peroxide vapor. Diffusion-restricted vial design.

Indications for Use

Indicated for routine monitoring of STERRAD sterilization systems (100S, 50, 200, NX, 100NX) across specified cycles. No specific patient population or contraindications listed.

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® 24 Biological Indicator (K103222)

Submission Summary (Full Text)

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**510(k) Summary**

Applicant's Name, Address, Telephone, FAX, Contact Person Advanced Sterilization Products, Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618

Contact Person Nancy Chu Manager, Regulatory Affairs Tel: [phone]= Fax: [phone]

Summary Date: September 5, 2012

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

Classification Name: Common/Usual Name: Product Classification: Classification Regulation: Proprietary Name:

Biological Sterilization Process Indicator Biological Indicator II 21 CFR 880.2800 · STERRAD® CYCLESURE® 24 Biological indicator

-122044

. Ост

4 2012

# 2. PREDICATE DEVICES

STERRAD® CYCLESURE® 24 Biological Indicator, K103222, 2/25/2011

## 3. INDICATIONS FOR USE

The STERRAD® CYCLESURE® 24 Biological Indicator (PN 14324) 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 |
| STERRAD® NX® | Advanced |
| STERRAD® 100NX® | Standard |
| STERRAD® 100NX® | Flex |
| STERRAD® 100NX® | 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

Both the modified and predicate devices have the same intended use, the same technological characteristics, the same operating principles, and utilize the same sterilant (hydrogen peroxide).

Testing was conducted to confirm that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended when used with the STERRRAD® Sterilization Systems. The following tests were performed:

| Studies Performed | Results |
|------------------------------------------------------------------------|---------|
| Evaporation | Passed |
| Verification of Positive BI Color | Passed |
| Bacteriostasis | Passed |
| BI Validation in the STERRAD® Sterilization Systems<br>(Dose Response) | Passed |
| Verification of Minimum Incubation Time | Passed |
| Growth Promotion | Passed |
| Spore Resistance Testing | Passed |

### 6. DESCRIPTION OF CHANGE

The change of the material grade of the outer vial resin (relative to the predicate device, K103222) is shown in this submission to work as intended with the STERRAD® Sterilization Systems.

#### 7. OVERALL PERFORMANCE CONCLUSIONS

Performance testing demonstrated that the modified STERRAD® CYCLESURE® 24 Biological Indicator is substantially equivalent to the predicate device (K103222) because they have the same intended use, the same technological characteristics, the same operating principles, and are exposed to the same sterilant (hydrogen peroxide).

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is an abstract image of an eagle.

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

OCT
4
2012

Advanced Sterilization Products Ms. Nancy Chu Manager, Regulatory Affairs 33 Technology Drive Irvine, California 92618

Re: K122044

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: September 5, 2012 Received: September 6, 2012

Dear Ms. Chu:

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- Ms. Chu

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 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.

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 K122 0 44

Device Name: STERRAD® CYCLESURE® 24 Biological Indicator

### Indication for Use:

The STERRAD® CYCLESURE® 24 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 _ 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)

Elicheth F. Olamin-Will-

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Anesthesiology, General Hospital
Anesthesiology, General Hospital Control, Dental Devices

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510(k) Number. K122044