STERITITE PROCESS INDICATOR ACCESSORIES

K982151 · Case Medical, Inc. · JOJ · Feb 9, 1999 · General Hospital

Device Facts

• Record ID: K982151
• Device Name: STERITITE PROCESS INDICATOR ACCESSORIES
• Applicant: Case Medical, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

Process indicators are intended for the use with individual units, to demonstrate that the unit has been exposed to a process at stated conditions and distinguish between processed and unprocessed units at stated conditions.

Device Story

Steritite Process Indicator Accessories are used in clinical or hospital settings to verify that individual units have been exposed to a sterilization process. The device functions as a visual indicator to distinguish between processed and unprocessed items. It is used by healthcare personnel during sterilization workflows to ensure quality control and confirm that items have undergone the required process conditions.

Clinical Evidence

bench testing only

Technological Characteristics

Process indicator accessory; visual indicator for sterilization process verification. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use with individual units to verify exposure to a sterilization process at stated conditions and distinguish between processed and unprocessed units.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marcia Frieze Vice President Case Medical, Incorporated® 65 Railroad Avenue Ridgefield, New Jersey 07657-0402

Re : K982151 Steritite Process Indicator Accessories Trade Name: Requlatory Class: II Product Code: JOJ November 16, 1998 Dated: Received: November 17, 1998

Dear Ms. Frieze:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially 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 reclassified in accordance 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 devices, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Frieze

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 findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note ene office or compiland, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone]g or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Directd Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name:__________________________________________________________________________________________________________________________________________________________________

## Indications For Use:

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Concurrence of CDIVH, Office of Device Evaluation (ODE)

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Division of Dental, Infection Control, Division of Septital Devices

510(k) Number

Prescription Use (Pcr 21 CFR 801.109) ાર

Over-The-Counter Use_/

(Optional Form:

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

510(k) Number _