STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137

K052516 · Steritec Products, Inc. · JOJ · Oct 3, 2005 · General Hospital

Device Facts

• Record ID: K052516
• Device Name: STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137
• Applicant: Steritec Products, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Oct 3, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

SteriTec Process Indicator Container Cards, Labels, and DOTS are intended for use by health care providers with steam sterilization wraps, container, cassettes, or pouches to distinguish between processed and unprocessed items. The Cards, Labels, and DOTS can be used in 121° C gravity steam sterilizers or 132° – 134° C pre-vacuum steam sterilizers. Indicators turn to dark gray/black after exposure to steam sterilization processes.

Device Story

Chemical process indicators (cards, labels, dots) used by healthcare providers in steam sterilization environments; function as visual markers to differentiate processed from unprocessed medical items; indicators undergo color change (to dark gray/black) upon exposure to steam sterilization parameters (121°C gravity or 132°–134°C pre-vacuum); provides immediate visual confirmation to staff that items have been subjected to a sterilization cycle; aids in inventory management and infection control workflows.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Chemical process indicators; color-changing ink formulation; form factors include cards, labels, and dots; designed for steam sterilization environments; non-electronic; no software.

Indications for Use

Indicated for use by healthcare providers to distinguish between processed and unprocessed items in steam sterilization (gravity 121°C or pre-vacuum 132°–134°C) for wraps, containers, cassettes, or pouches.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Public Health Service

OCT 3 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Linda Nelson Regulatory Affairs Manager Steritec Products, Incorporated 599 Topeka Way, Suite 400 Castle Rock, Colorado 80109

Re: K052516

Trade/Device Name: STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR Regulation Number: 21 CFR 880.2800 Sterilization process indicator Regulation Name: Regulatory Class: II Product Code: JOJ Dated: August 20, 2005 Received: September 14, 2005

Dear Ms. Nelson:

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.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Nelson

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chris Liu, Ph.D.

Chiu Lin. Ph.D. 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 know): _ K O S a S / 6

Device Names: SteriTec Container Card – Cl 135, SteriTec Process Indicator Labels – Cl 140, and SteriTec Process Indicator DOTS - Cl 137.

## Indications For Use:

inflarone : or or oos.
SteriTec Process Indicator Container Cards, Labels, and DOTS are intended for use by health care providers with steam sterilization wraps, container, cassettes, or pouches to distinguish between processed and unprocessed items. The Cards, Labels, and DOTS can be used in 121° C gravity steam sterilizers or 132° – 134° C pre-vacuum steam sterilizers. Indicators turn to dark gray/black after exposure to steam sterilization processes.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula H. Murphy, MD

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Anesthesionology
Infection Control, Dental Devices

Infection Control

510(k) Number: K652344