CHALLENGE TEST PACK

K983451 · North American Science Assoc., Inc. · JOJ · Apr 23, 1999 · General Hospital

Device Facts

• Record ID: K983451
• Device Name: CHALLENGE TEST PACK
• Applicant: North American Science Assoc., Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Apr 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

RSI Process Challenge Device is intended to be used in conjunction with RSI Rapid Indicators for Monitoring Steam Sterilization to monitor the effectiveness of wrapped loads at 132°C/134°C vacuum assisted steam sterilization cycles.

Device Story

RSI Process Challenge Device (PCD) functions as a test pack for monitoring steam sterilization efficacy. Used in conjunction with RSI Rapid Indicators, the device simulates the challenge of a wrapped load during 132°C/134°C vacuum-assisted steam sterilization cycles. The PCD is placed within the sterilizer load; it provides a standardized challenge to the sterilization process. Healthcare personnel use the device to verify that sterilization parameters are met, ensuring the sterility of wrapped instruments. The output is a visual or rapid indicator result that informs the operator whether the sterilization cycle was effective, directly impacting the decision to release sterilized items for clinical use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a process challenge device designed for vacuum-assisted steam sterilization at 132°C/134°C. It functions as a physical test pack to simulate wrapped loads. No specific materials, software, or electronic components are described.

Indications for Use

Indicated for monitoring the effectiveness of vacuum-assisted steam sterilization cycles at 132°C/134°C for wrapped loads.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1999

Mr. Matthew G. Sliva Manager, Quality Assurance North American Science Associates, Incorporated 2261 Tracy Road Northwood, Ohio 43619-1397

Re : ку83451 Trade Name: RSI® Process Challenge Device for Monitoring Steam Sterilization Process Regulatory Class: II Product Code: JOJ Dated: February 9, 1999 Received: February 11, 1999

Dear Mr. Sliva:

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 regulation may result in regulatory action. Won end Son, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your device in premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Sliva

This letter will allow you to begin marketing your device as This letter will allow your results notification. The FDA described in your 510(K) prematic norresonevice to a legally
finding of substantial equivalence of your sizes in for your marketed predicate device results in a classification for your marketed predicate device results in a crabbillability. The market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 Crk Parc bor anase contact the Office of
vitro diagnostic devices), please contact the for questi vitro diagnostic devices), prease consuly, for questions on Compliance at (3017 394-4022. Addresses of your device, please contact the office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to the regulation encitied, "Missianisms ») . Other general
premarket notification" (21 CFR 807.97). "Other general information on your responsibilities under the Act may be information on your responsibilities ander one order assistance obtained from the Division of Smart Manara [phone] or at
at its toll-free number [phone] or (300) . at its toll-free number [phone] 02 1902) 180 11.
its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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Image /page/2/Picture/0 description: The image is a logo for NAMSA, which stands for North American Science Associates. The logo is in black and white and features the company's name in a bold, sans-serif font. Below the name is the tagline "World Leader in Testing Services for the Medical Device Industry.". The TM symbol is located to the right of the last letter of the company name.

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: RSI® Process Challenge Device for Steam Sterilization (132°C/134°C Vacuum Assisted)

Indications for Use:

RSI Process Challenge Device is intended to be used in conjunction with RSI Rapid Indicators for Monitoring Steam Sterilization to monitor the effectiveness of wrapped loads at 132°C/134°C vacuum assisted steam sterilization cycles.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clum S. Lin
(Division Sign-Off)

Division of Dental, Infection Control. and General Hospit 510(k) Number

Prescription Use 99~ (Per 21 CFR 801.109)

OR

Over-The-Counter Use 99~ X

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