SPORTROL RAPID STERILITY INDICATOR

K962649 · North American Science Assoc., Inc. · MTC · Sep 26, 1997 · General Hospital

Device Facts

• Record ID: K962649
• Device Name: SPORTROL RAPID STERILITY INDICATOR
• Applicant: North American Science Assoc., Inc.
• Product Code: MTC · General Hospital
• Decision Date: Sep 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Indications for Use

RSI Rapid Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at 121°C gravity, 132°C vacuum assisted 134°C vacuum assisted cycles.

Device Story

RSI Rapid Indicator is a biological indicator used to monitor the efficacy of saturated steam sterilization cycles. It utilizes a multiple, interactive, bacterial enzyme system to detect sterilization failure. The device is intended for use in healthcare facilities to verify that sterilization parameters (time, temperature, steam saturation) have been met. The indicator provides a visual result to the operator, allowing for immediate assessment of the sterilization process. By confirming the inactivation of the bacterial enzyme system, the device helps ensure that medical instruments are properly sterilized, thereby reducing the risk of infection transmission to patients.

Clinical Evidence

Bench testing only.

Technological Characteristics

Biological indicator utilizing a multiple, interactive, bacterial enzyme system. Designed for saturated steam sterilization cycles at 121°C, 132°C, and 134°C. Standalone, non-electronic device.

Indications for Use

Indicated for monitoring saturated steam sterilization processes at 121°C gravity, 132°C vacuum assisted, and 134°C vacuum assisted 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

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

SEP 26 1997

Re: K962649
Trade Name: RSI™ Rapid Indicator for Monitoring Steam Sterilization
Regulatory Class: II
Product Code: MTC
Dated: July 21, 1997
Received: July 22, 1997

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 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 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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

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Page 2 - Mr. Sliva

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.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic 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 the regulation entitled, "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] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
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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510(k) Number (if known): K962649

Device Name: RSI, Rapid Indicator

Indications for Use:

RSI Rapid Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at 121°C gravity, 132°C vacuum assisted 134°C vacuum assisted cycles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑
(Optional Format 1-2-96)