STERRAD 50/100S/200 TEST PACK

K130263 · Advanced Sterilization Products · FRC · Mar 28, 2014 · General Hospital

Device Facts

• Record ID: K130263
• Device Name: STERRAD 50/100S/200 TEST PACK
• Applicant: Advanced Sterilization Products
• Product Code: FRC · General Hospital
• Decision Date: Mar 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The STERRAD® 50/100S/200 Test Pack is used for routine monitoring of the STERRAD® 50, STERRAD® 100S and STERRAD® 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads containing devices that do not exceed claims of the cycle. The STERRAD® 50/100S/200 Test Pack consists of the following components: STERRAD® CYCLESURE® 24 Biological Indicator (REF 14324) . Test Pack vial with "STERRAD" 50/100S/200" marking and a corresponding cap . STERRAD® Instrument Mats (REF 99205) . Tyvek® Pouch with STERRAD® Chemical Indicator (REF 12340) .

Device Story

Test pack for monitoring hydrogen peroxide gas plasma sterilization cycles (STERRAD 50, 100S, 200). Device consists of a Tyvek pouch containing a biological indicator (CYCLESURE 24), a high-density polyethylene (HDPE) vial with defined orifices, and silicon instrument mats. Used by hospital staff to verify sterilizer performance. The test pack acts as a challenge to the sterilization process; resistance is compared against a biological model via survival curves and fraction negative data. If the biological indicator is successfully sterilized, the process is deemed effective. Provides assurance of sterilization efficacy for hospital-defined loads.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated via survival curves and fraction negative data using three lots of CYCLESURE 24 Biological Indicators exposed to hydrogen peroxide in STERRAD 50, 100S, and 200 cycles. Results confirmed the test pack configuration is at least as resistant as the biological model. Chemical indicator functionality also verified.

Technological Characteristics

Components: HDPE vial (17mm x 52mm) with 1.40-1.55mm orifice, Tyvek pouch, silicon instrument mats. Sterilant: Hydrogen peroxide gas plasma. Principle: Biological challenge test using Geobacillus stearothermophilus (CYCLESURE 24).

Indications for Use

Indicated for routine monitoring and periodic testing of STERRAD 50, 100S, and 200 sterilizers using hospital-defined loads that do not exceed cycle claims.

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® Test Pack (K051643)
• STERRAD® 100NX® Test Pack (K071537)

Submission Summary (Full Text)

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# MAR 2 8 2014

K130263

## 510(k) Summary

#### 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

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

#### SUMMARY DATE

February 26, 2014

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

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

Biological Sterilization Process Indicator Biological Indicator (Test Pack) Class II FRC General Hospital 21 CFR 880.2800 STERRAD® 50/100S/200 Test Pack

#### 2. PREDICATE DEVICES

- STERRAD® CycleSure® Test Pack (K051643, cleared August 19, 2005) .
- STERRAD® 100NX® Test Pack (K071537, cleared December 18, 2007) .

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### 3. INDICATIONS FOR USE

The STERRAD® 50/100S/200 Test Pack is used for routine monitoring of the STERRAD® 50, STERRAD® 100S and STERRAD® 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads containing devices that do not exceed claims of the cycle.

The STERRAD® 50/100S/200 Test Pack consists of the following components:

- STERRAD® CYCLESURE® 24 Biological Indicator (REF 14324) .
- Test Pack vial with "STERRAD" 50/100S/200" marking and a corresponding cap .
- STERRAD® Instrument Mats (REF 99205) .
- Tyvek® Pouch with STERRAD® Chemical Indicator (REF 12340) .

## 4. DESCRIPTION OF DEVICE

The STERRAD® 50/100S/200 Test Pack consists of a pouch which holds a closed vial containing a STERRAD® CYCLESURE® 24 Biological Indicator (BI) and silicon mats. The vial and its corresponding cap have defined orifices.

## 5. SUMMARY OF NONCLINICAL TESTS

The STERRAD® 50/100S/200 Test Pack has been evaluated for its resistance to the STERRAD® 100S, 50, and 200 Sterilizers.

A comparison of the STERRAD® 50/100S/200 Test Pack to the biological model developed for their respective cycles indicates that the Test Pack is at least as resistant to the sterilization process as the biological model. This is based on both survival curves and fraction negative data as a function of dose.

STERRAD® 50/100S/200 Test Packs assembled from three lots of CYCLESURE® 24 Biological Indicator (BI) were exposed to several doses of hydrogen peroxide in STERRAD® 100S, STERRAD®50, or STERRAD® 200 Cycles. These survivor curves were compared to the survivor curves for the biological model developed for the respective cycles. The test data showed that the Test Pack configuration was at least as resistant as the biological model.

Additionally, fraction negative data were collected using Test Packs assembled from three lots of CYCLESURE® 24 BI and exposed to increasing volumes of hydrogen peroxide in

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STERRAD® 100S, STERRAD®50, or STERRAD® 200 Cycles. The results indicated that the Test Pack configuration was at least as resistant as the biological model.

Indicative functionality of the chemical indicator in a STERRAD® 50/100S/200 Test Pack configuration was evaluated using half-cycle parameters of the STERRAD® 100S, STERRAD®50, and STERRAD® 200 Cycles and was determined to be appropriate for a chemical indicator.

The subject device and its predicate device have the same intended use which is for routine monitoring of the STERRAD® 100S, STERRAD®50, or STERRAD® 200 Cycles. Additionally, they have the same technological characteristics, the same operating principles and are subjected to the same sterilant (hydrogen peroxide) and therefore, the subject device is substantially equivalent to the predicate. A comparison of similarities and differences of design features and materials of construction and Indications for Use of both the subject and two predicate devices are shown in Table 1 and Table 2, respectively.

| Table 1: Comparison of Similarities and Differences between Devices | | | |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device<br>(K051643) | Predicate Device<br>(K071537) |
| Name | STERRAD®<br>50/100S/200 Test Pack | STERRAD® CycleSure®<br>Test Pack | STERRAD® 100NX®<br>Test Pack |
| Cycle | For use in STERRAD®<br>50, STERRAD® 100S or<br>STERRAD® 200 cycle | For use in STERRAD®<br>50, STERRAD® 100S or<br>STERRAD® 200 cycle | For use in STERRAD®<br>100NX® Standard or<br>Flex cycle |
| Biological<br>Indicator | STERRAD®<br>CYCLESURE® 24<br>Biological Indicator | STERRAD®<br>CYCLESURE® 24<br>Biological Indicator | STERRAD®<br>CYCLESURE® 24<br>Biological Indicator |
| Tyvek Pouch | Tyvek Pouch, 8"x16" | • Tyvek Pouch, 3" x 8"<br>• Tyvek Pouch, 6" x 12.5" | Tyvek Pouch, 6" x 12.5" |
| Test Pack Vial | • Test Pack Vial with<br>an opening (1.40 to<br>1.55 mm) in the<br>center of the bottom;<br>17 mm x 52 mm<br>• High density<br>polyethylene<br>(HDPE) | • Test Vial has an<br>opening (1.3 ± 0.20<br>mm diameter) in the<br>center of the bottom;<br>27 mm x 61 mm<br>• High density<br>polyethylene<br>(HDPE) | • Test Pack Vial, with<br>no opening in the<br>bottom; 17 mm x 52<br>mm<br>• High density<br>polyethylene<br>(HDPE) |

Table 1: Comparison of Similarities and Differences hetween Devices

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| | Subject Device | Predicate Device<br>(K051643) | Predicate Device<br>(K071537) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Test Vial Cap | • Test Vial Cap with<br>an opening (1.40 to<br>1.55 mm) in its<br>center; diameter of<br>18 mm<br>• High density<br>polyethylene<br>(HDPE) | • Cap has an opening<br>( $1.3 ± 0.20$ mm<br>diameter) in the<br>center; diameter of<br>22 mm<br>• High density<br>polyethylene<br>(HDPE) | • Test Vial Cap with<br>an opening (1.40 to<br>1.55 mm) in its<br>center; diameter of<br>18 mm<br>• High density<br>polyethylene<br>(HDPE) |
| STERRAD®<br>Sterilization<br>Mat | Four mats, 2.5" x 6.5" | Two mats, 2.5" x 6.5" | Four mats, 2.5" x 6.5" |

# Table 2: Comparison of Indications for Use between Devices

| Device | Name | Indications for Use Statement |
|----------------------------------|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | STERRAD®<br>50/100S/200<br>Test Pack | The STERRAD® 50/100S/200 Test Pack is used for<br>routine monitoring of the STERRAD® 50, STERRAD®<br>100S and STERRAD® 200 Sterilizers and is also used<br>for the periodic testing of these sterilizers using<br>hospital-defined loads containing devices that do not<br>exceed claims of the cycle.<br>The STERRAD® 50/100S/200 Test Pack consists of the<br>following components:<br>• STERRAD® CYCLESURE® 24 Biological<br>Indicator (REF 14324)<br>• Test Pack vial with "STERRAD® 50/100S/200"<br>marking and a corresponding cap<br>• STERRAD® Instrument Mats (REF 99205)<br>• Tyvek® Pouch with STERRAD® Chemical<br>Indicator (REF 12340) |
| Predicate<br>Device<br>(K051643) | STERRAD®<br>CycleSure® Test<br>Pack | The STERRAD® Sterilizer CycleSure® Test Pack is<br>used for routine monitoring of the STERRAD® 50,<br>STERRAD® 100S and STERRAD® 200 Sterilizers and<br>is also used for the periodic testing of these sterilizers<br>using hospital-defined loads. |

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| Device | Name | Indications for Use Statement |
|----------------------------------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate<br>Device<br>(K071537) | STERRAD®<br>100NX® Test<br>Pack | The STERRAD® 100NX® Test Pack is used for routine<br>monitoring of the STERRAD® 100NX® sterilization<br>cycle and is also used for the periodic testing of a<br>STERRAD® 100NX® system using hospital-defined<br>loads. |

Table 3 below lists the tests performed to demonstrate that the STERRAD® 50/100S/200 Test Pack functions as intended in the STERRAD® 100S, STERRAD®50, or STERRAD® 200 Cycle.

Table 3: Testing Summary

| Studies Performed | Results |
|-------------------------------------------------------------------------------------------------------------------|---------|
| Design Evaluation and Performance Qualification of STERRAD® 50/100S/200 Test Pack in the STERRAD® 50 Sterilizer | Passed |
| Design Evaluation and Performance Qualification of STERRAD® 50/100S/200 Test Pack in the STERRAD® 100S Sterilizer | Passed |
| Design Evaluation and Performance Qualification of STERRAD® 50/100S/200 Test Pack in the STERRAD® 200 Sterilizer | Passed |
| Functionality Study of the Chemical Indicator Disc of CYCLESURE® 24 BI in Test Pack | Passed |
| Functional Compatibility Testing of STERRAD® Test Pack Reusable Components | Passed |

## 6. OVERALL PERFORMANCE CONCLUSIONS

The performance data shows that the STERRAD® 50/100S/200 Test Pack has the necessary resistance relative to the biological model to be an appropriate challenge for testing the STERRAD® 100S, STERRAD® 50 and STERRAD® 200 Sterilizer, and it is substantially equivalent to the predicate devices.

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

March 28, 2014

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

Re: K130263

Trade/Device Name: STERRAD® 50/100s/200 Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Indicator (Test Pack) Regulatory Class: II Product Code: FRC Dated: February 26, 2014 Received: February 27, 2014

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known) K130263

Device Name STERRAD® 50/100S/200 Test Pack

Indications for Use (Describe)

The STERRAD® 50/100S/200 Test Pack is used for routine monitoring of the STERRAD® 100S and STERRAD® 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined based that do not exceed claims of the cycle.

The STERRAD® 50/100S/200 Test Pack consists of the following components:

- · STERRAD® CYCLESURE® 24 Biological Indicator (REF 14324)
- · Test Pack vial with "STERRAD® 50/100S/200" marking and a corresponding cap
- · STERRAD® Instrument Mats (REF 99205)
- · Tyvek® Pouch with STERRAD® Chemical Indicator (REF 12340)

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

[X] Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

2014. ." ( )( )"