DANA REUSABLE TEST PACK

K133267 · Dana Products, Inc. · FRC · Feb 11, 2014 · General Hospital

Device Facts

• Record ID: K133267
• Device Name: DANA REUSABLE TEST PACK
• Applicant: Dana Products, Inc.
• Product Code: FRC · General Hospital
• Decision Date: Feb 11, 2014
• 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 a 3M TM Attest ™ Super Rapid Readout Biological Indicator 1492V along with or without SteriScan Integrators.

Device Story

Dana Reusable Test Pack serves as a process challenge device (PCD) for steam sterilization. Used in healthcare facilities to monitor pre-vacuum steam sterilization cycles. Device houses a 3M Attest Super Rapid Readout Biological Indicator (1492V) and optionally SteriScan Integrators. During sterilization, the pack simulates a challenge to the steam penetration; the biological indicator and/or chemical integrator inside provide evidence of sterilization efficacy. Healthcare personnel retrieve the indicator post-cycle to verify sterilization parameters. Output informs clinical staff whether instruments processed in the same cycle are safe for use, ensuring patient safety by preventing the use of improperly sterilized equipment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Reusable process challenge device designed for pre-vacuum steam sterilization. Compatible with 4 minute 270°F cycles. Functions as a housing/test pack for biological indicators and chemical integrators. No electronic components, software, or energy source.

Indications for Use

Indicated for routine monitoring of pre-vacuum steam sterilization cycles in healthcare facilities using 4 minute 270°F cycles.

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

• 3M Attest Super Rapid Readout Biological Indicator 1492V
• SteriScan Integrators

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Public Health Service

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

February 11, 2014

Dana Products, Incorporated Mr. Harry Bala President 7 Corey Drive South Barrington, IL 60010

Re: K133267

Trade/Device Name: Dana Reusable Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Process Challenge Device Regulatory Class: II Product Code: FRC Dated: January 13, 2014 Received: January 14, 2014

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 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 - 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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Image /page/1/Picture/8 description: The image shows a logo with the letters "IDA" in a stylized font. The text "Tejashri Purohit-Sheth, M.D." is written above "Clinical Deputy Director" and "IDAGRID". The word "FOR" is at the bottom right of the image.

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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## Indications for Use

510(k) Number (if known): K133267 Device Name: Dana Reusable Test Pack

Indications For 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 a 3M TM Attest ™ Super Rapid Readout Biological Indicator 1492V along with or without SteriScan Integrators.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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)

Elizabeth 2014.02

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