(298 days)
Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The end point is determined by the migration of the steam sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30 minute gravity cycles at 250 degrees F and 3 minute gravity and pre- vacuum cycles at 270 degrees F.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Dana Steam Sterilization Integrator." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain specific information about:
- Acceptance criteria and reported device performance in a table.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for a study.
- Training set sample size or how its ground truth was established.
The document primarily focuses on the regulatory approval process and the indications for use of the device, which are described as:
- Indications for Use: Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The endpoint is determined by the migration of the steam-sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30-minute gravity cycles at 250 degrees F and 3-minute gravity and pre-vacuum cycles at 270 degrees F.
Therefore, I cannot provide the requested table or study details based on the given information. The document is a regulatory approval letter, not a study report.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 7 2002
Mr. Harry Bala President Dana Products, Incorporated 7 Corey Drive South Barington, Illinois 60010
Re: K012195
Trade/Device Name: Dana Steam Sterilization Intergrator Regulation Number: 880.2800 (b) Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: March 30, 2002 Received: April 2, 2002
Dear Mr. Bala:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Bala
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Klichrist
Timothy . 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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K012195 510(k) Number (if known):
Steam Sterilization Integrator Device Name:
Indications For Use:
Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in bealthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The end point is determined by the migration of the steam sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30 minute gravity cycles at 250 degrees F and 3 minute gravity and pre- vacuum cycles at 270 degrees F.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Olin S. Lim
(Division Sign-Off) rvision of Dental, Infection Control, and General Hospital Devices 510(k) Number .
§ 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).