STERRAD BI TEST PACK

K993775 · Advanced Sterilization Products · FRC · Jun 1, 2000 · General Hospital

Device Facts

• Record ID: K993775
• Device Name: STERRAD BI TEST PACK
• Applicant: Advanced Sterilization Products
• Product Code: FRC · General Hospital
• Decision Date: Jun 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.

Device Story

The STERRAD® BI Test Pack is a monitoring device for STERRAD® sterilization cycles. It consists of a plastic tray containing a Bacillus subtilis var. niger spore strip (10^6 spores), a chemical indicator strip, and latex tubing. The tubing and tray design create a diffusion-restrictive environment to challenge the sterilization process. During a cycle, the chemical indicator changes color from red to yellow, providing immediate visual feedback. The biological indicator is used to verify the lethality of the sterilization process. The device is used by healthcare personnel in clinical settings to ensure sterilizer performance. This modification specifically validates the test pack's performance characteristics for use in STERRAD 50 and STERRAD 100S sterilizer models.

Clinical Evidence

Bench testing only. Survival and Kill performance data were generated for the STERRAD 50 and STERRAD 100S sterilizers using three manufacturing lots of the BI Test Pack to confirm accuracy and reproducibility.

Technological Characteristics

Plastic tray, Tyvek/Mylar peel pouch, latex tubing, Bacillus subtilis var. niger spores (10^6). Chemical indicator strip (Class A per EN867-1) changes color from red to yellow upon exposure to STERRAD cycle. Diffusion-restrictive design.

Indications for Use

Indicated for frequent monitoring of STERRAD® Sterilizer cycles using a biological indicator and chemical process indicator. No specific patient population or contraindications described.

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® BI Test Pack (K921909, K991675)

Submission Summary (Full Text)

{0}------------------------------------------------

Advanced Sterilization Products

### ADVANCED STERILIZATION PRODUCTS®

a Johnson Johnson company REGULATORY AFFAIRS DEPARTMENT

993775
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

Kevin Corrigan, R.A.C. Director of Regulatory Affairs Tel: [phone] Fax: [phone]

#### Submission Date

November 5, 1999

#### Trade Name

STERRAD® BI Test Pack

#### Common Name

Biological Indicator (Challenge Pack)

Classification Name Class II

### Legally Marketed Equivalent Device Name(s)

STERRAD® BI Test Pack, K921909, October 1, 1993 as modified in K991675, June 15, 1999.

DIVISION OF ETHICON, INC. + 33 TECHNOLOGY DRIVE · IRVINE, CA 92618 · [phone] FAX [phone]

{1}------------------------------------------------

# Description of Device

The STERRAD® BI Test Pack (BI Test Pack) consists of a plastic tray with a clear top which contains a STERRAD® Biological Indicator paper strip containing 10° Bacillus subtilis var. niger spores, a STERRAD® BI Test Pack Indicator Strip and a length of latex tubing. The BI spore strip is packaged in a Tyvek/Mylar peel pouch to protect the spore strip during handling.

The narrow opening and channels leading to the BI Test Pack and the absorptive properties of the latex tubing provide a diffusion restrictive environment which contributes to the effective resistance of the indicator organism. Included with the BI Test Pack are individual BI spore strips in Tyvek/Mylar peel pouches to serve as positive controls in the microbiological testing.

The STERRAD® BI Test Pack Chemical Indicator Strip included in the Test Pack serves as a chemical process indicator (Class A per EN867-1) for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator strip to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.

# Statement of Intended Use

The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.

# Description of Modification

The modification to the STERRAD® BI Test Pack involves labeling only.

With the continued evolution of the STERRAD Sterilization System, new models of the sterilizer have been developed. The STERRAD BI Test Pack was originally cleared for use in the STERRAD 100 Sterilizer. In January of 1999, ASP received marketing clearance (K981625) for the STERRAD 50 Sterilizer and ASP currently has a 510(k) notification pending for another new sterilizer model, the STERRAD 100S Sterilizer. These two new sterilizers utilize a modification of the original STERRAD process. Consequently, new performance data (Survival and Kill characteristics) were needed for the STERRAD BI Test Pack in these new sterilizers.

This premarket notification modifies the Performance Certification of the STERRAD BI Test Pack to add the performance characteristics of the test pack in the STERRAD 50 and STERRAD 100S Sterilizers.

{2}------------------------------------------------

# Summary of Nonclinical Tests

Testing was conducted to show that the Survival and Kill Performance Data generated for the STERRAD 50 and STERRAD 100S Sterilizers was accurate and reproducible using three different manufacturing lots of STERRAD BI Test Packs.

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an abstract bird or a series of flowing lines, possibly representing movement or progress. The logo is presented in black and white.

JUN - 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kevin Corrigan, R.A.C. Director, Regulatory Affairs Advanced Sterilization Products Division of Ethicon, Incorporated 33 Technology Drive Irvine, California 92618

K993775 Re : STERRAD® BI Test Pack Trade Name: Regulatory Class: II FRC Product Code: Dated: March 10, 2000 Received: March 13, 2000

Dear Mr. Corrigan:

We have reviewed your Section 510(k) notification of intent to we have reviewed freferenced above and we have determined the market the device ially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been Medical Device imendance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of Intras, 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 (Premarket Approval), it may be subject to such additional controls. Existing major be subject to back us your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with SubbeanClarly Squaring Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (UP) / regarions, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP vertif bac. abbamasy action. In addition. In addition, FDA regaration may ther announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any premazion you might have under sections 531 through 542 of

{4}------------------------------------------------

Page 2 - Mr. Corrigan

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your 510 m, providence of your device to a legally rinding of bubbandedice results in a classification for your marketed predication wour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regaradiagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on Jourision of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

> Sincerely yours, Suzar unner

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

#### ED STERILIZATION PRODUCTS® ADVANC

1031400111001 como REGULATORY AFFAIRS DEPARTMENT

Indications for Use

To Be Assigned 510(k) Number:

STERRAD®BI Test Pack Device Name

Indications For Use:

The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-the-Counter Use

(Optional Format 1-2-96)

DIVISION OF ETHICON, INC. . 33 TECHNOLOGY DRIVE . IRVINE, CA 92618 . [phone] FAX [phone]

Lain S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev

510(k) Number K993275