(200 days)
SteriTec Integraph Flash is a steam sterilization integrator for use in either a pre-vacuum or gravity displacement steam sterilization process of 3 minutes or longer at 132° C (270° F), or a flash steam sterilization process for a 3 Minute cycle or 10 Minute cycle in gravity displacement sterilizers. When exposed to steam sterilization conditions the Integraph Flash strips give an integrated response and visible indication that sterilization conditions were met by changing from a purple to a green color. The stated value in a laboratory test sterilizer for the 3-Minute indicator spot is 5 minutes at 132° C, and for the 10-Minute indicator spot is 11.5 minutes at 132° C.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, or MRMC studies. The document is a 510(k) clearance letter from the FDA for a device called "SteriTec Integraph Flash," which is a sterilization process indicator.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and mentions its indications for use. However, it does not describe the data or studies that led to this determination.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 2002
Ms. Linda Nelson RA/QA Manager SteriTec Products, Incorporated 599 Topeka Way, Suite 700 Castle Rock, Colorado 80104
Re: K012732
Trade/Device Name: SteriTec Integraph Flash, Model CI 110 Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: January 15, 2002 Received: January 17, 2002
Dear Ms. Nelson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater or see 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 Interstate conmisered proct to may as, as a reclassified in accordance with the provisions of Alliendinents, of to devroos and Cosmetic Act (Act) that do not require approval of a premarket the redelar Food, Drug, and Common , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provincies of an 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 (I MA), it may of subject to back adde of Federal Regulations, Title 21, Parts 800 to 898. In your device can or found in the be announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements modifine act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Ms. Nelson ·
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,
:
Timoth 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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Indications for Use
510(k) Number: K012732
Device Name: SteriTec Integraph Flash, Model No(s). Cl 110
Indications For Use:
SteriTec Integraph Flash is a steam sterilization integrator for use in either a pre-Olch Foo finalism Process of 3 minutes or longer at 132° C (270° F), or vaoually flash steam sterilization process for a 3 Minute cycle or 10 Minute cycle in gravity natin exposed to steam sterilization conditions the Integraph Flash strips give an integrated response and visible indication that sterilization conditions were met by changing from a purple to a green color. The stated value in a laboratory test sterilizer for the 3-Minute indicator spot is 5 minutes at 132° C, and for the 10-Minute indicator spot is 11.5 minutes at 132° C.
Clim S. him
(Division Sign-Off) Division of Dental, Infection Control, and Ceneral Hospital Devices 2127 510(k) Number --
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE) :
§ 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).