(205 days)
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.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter dated April 23, 1999, for the "RSI® Process Challenge Device for Monitoring Steam Sterilization Process" does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.
The letter primarily:
- Acknowledges receipt and review of the 510(k) submission.
- States that the device is substantially equivalent to pre-amendment devices.
- Informs the manufacturer that they can market the device, subject to general controls and good manufacturing practices.
- Provides contact information for further inquiries.
- Includes an "Indications for Use Statement" for the device.
It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Details on experts used for ground truth or adjudication methods.
- Information about MRMC or standalone studies.
- The type of ground truth used.
- Sample size for a training set or how its ground truth was established.
To obtain this information, one would typically need to refer to the full 510(k) submission document itself, which would contain the detailed testing protocols and results that the FDA reviewed to make its substantial equivalence determination. The letter provided is simply the FDA's decision communication.
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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 (301) 594-4639. 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 (301) 443-6597 or at
at its toll-free number (800) 638-2041 or (300) . at its toll-free number (800) 638-2041 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
DOCUMENTUSSUE\AD\MISC\FORMS\A471FU-00
§ 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).