(445 days)
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.
RSI, Rapid Indicator
The provided document is a 510(k) clearance letter from the FDA for the "RSI™ Rapid Indicator for Monitoring Steam Sterilization." This type of document does not contain the detailed study information or acceptance criteria requested.
A 510(k) clearance primarily establishes substantial equivalence to a predicate device already on the market. It confirms that the new device is as safe and effective as a legally marketed device and does not typically delve into the specifics of performance studies in the way you've outlined for AI or diagnostic devices.
Therefore, I cannot provide the requested information from this document. The document confirms the device name, its use for monitoring steam sterilization processes, and its substantial equivalence determination, but no detailed performance metrics, study designs, sample sizes, or ground truth establishment methods are present.
To obtain such information, one would typically need to refer to the original 510(k) submission document itself (which is usually much more extensive than the clearance letter) or published studies related to the device.
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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". The caduceus is depicted with a modern, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 26 1997
Mr. Matthew G. Sliva Manager, Quality Assurance North American Science Associates, Incorporated 2261 Tracy Road Northwood, Ohio 43619
K962649 Re : RSI™ Rapid Indicator for Monitoring Steam Trade Name: 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, Druq, 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, labelinq, and prohibitions aqainst 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 Requlations, 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 requlation (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 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
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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 requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Chilatrust
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
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)
Olin S. him
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital D 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).