DANA REUSABLE BI TEST PACK

K130135 · Dana Products, Inc. · JOJ · Nov 25, 2013 · General Hospital

Device Facts

• Record ID: K130135
• Device Name: DANA REUSABLE BI TEST PACK
• Applicant: Dana Products, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Nov 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with SGM Biotech's Self-Contained Biological Indicator Smart-Read EZTest - Steam along with or without SteriScan Integrators.

Device Story

Dana Reusable Test Pack serves as a challenge device for steam sterilization processes. It functions as a housing for biological indicators (SGM Biotech Smart-Read EZTest) and chemical integrators (SteriScan) to monitor pre-vacuum steam sterilization cycles. Used in healthcare facilities by sterilization technicians to verify cycle efficacy. The pack provides a standardized challenge to the sterilization process, ensuring that the biological/chemical indicators are subjected to conditions representative of the load. By confirming the sterilization cycle meets parameters, it assists clinicians in ensuring instruments are sterile for patient use, reducing infection risk.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Reusable test pack designed for 4 minute 270°F pre-vacuum steam sterilization cycles. Acts as a physical challenge device to hold biological indicators and chemical integrators. Standalone device; no software or electronic components.

Indications for Use

Indicated for routine monitoring of pre-vacuum steam sterilization cycles in healthcare facilities using 4 minute 270°F cycles. Used in conjunction with SGM Biotech's Self-Contained Biological Indicator Smart-Read EZTest - Steam, with or without SteriScan Integrators.

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.

Reference Devices

• SGM Biotech's Self-Contained Biological Indicator Smart-Read EZTest - Steam
• SteriScan Integrators

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 25. 2013

Dana Products, Incorporated Mr. Harry Bala President 7 Corey Drive SOUTH BARINGTON IL 60010

Rc: K130135

Trade/Device Name: Dana Reusable Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ . Dated: October 23, 12013 Received: October 24, 2013

Dear Mr. Bala:

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 docs not evaluate information related to contract liability warrantics. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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 - Mr. Bala

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), 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/dcfault.hum 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

Sincercly yours.

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.

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Erin Keith M.S. Acting Division 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: December 31, 2013 See PRA Statement on last page.

### 510(k) Number (if known) K130132

#### Device Name Dana Reusable Test Pack

Indications for Use (Describe)

Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with SGM Biotech's Self-Contained Biological Indicator Smart-Read EZTest - Steam along with or without SteriScan Integrators.

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 FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR :::::: . : . . . : -

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

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FORM FDA 3881 (9/13)

PSC Publishing Services [phone] F