(86 days)
SteriTec Emu-Graph 4 is a steam sterilization emulator for use in a pre-vacuum steam sterilization process operating at 132°C (270° F) or 135° C (275° F). When exposed to steam sterilization conditions the indicator bar will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met.
Critical Parameters in a standard hospital pre-vacuum steam sterilizer
| Temperature | Time |
|---|---|
| 132°C (270°F) | 4 minutes |
| 135°C (275°F) | 3 minutes |
Not Found
The provided text is an FDA 510(k) clearance letter for a medical device called the "Emu-Graph 4 Emulator, Model No .: CI 144." This document describes the device, its intended use, and indicates that it has been found substantially equivalent to a predicate device.
Crucially, this document is a regulatory clearance letter, not a study report. It states the intended use and performance requirements (acceptance criteria in this context), but it does not contain the details of the study that proves the device meets those criteria.
Therefore, I cannot provide the requested information regarding the study design, sample sizes, ground truth establishment, or expert qualifications because this information is not present in the provided text.
However, I can extract the acceptance criteria and the reported device performance as stated in the "Indications for Use" section.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Parameter | Acceptance Criteria | Reported Device Performance Statement |
|---|---|---|
| Device Type | Steam sterilization emulator | SteriTec Emu-Graph 4 is a steam sterilization emulator. |
| Process Type | Pre-vacuum steam sterilization | For use in a pre-vacuum steam sterilization process. |
| Temperature | 132°C (270° F) or 135° C (275° F) | Operating at 132°C (270° F) or 135° C (275° F). |
| Response | Integrated response and visible indication | Indicator bar will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met. |
| Time at 132°C (270°F) | 4 minutes | Critical Parameters in a standard hospital pre-vacuum steam sterilizer: 132°C (270°F) for 4 minutes |
| Time at 135°C (275°F) | 3 minutes | Critical Parameters in a standard hospital pre-vacuum steam sterilizer: 135°C (275°F) for 3 minutes |
| Color Change | From purple to green (indicating sterilization met) | Indicator bar will turn from purple to green. |
The following information cannot be provided from the given document as it describes a regulatory decision, not the underlying study report:
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done. (This device is a chemical indicator, not an AI algorithm).
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping, curved shapes that resemble a stylized human figure.
Public Health Service
Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850
5 2009 MAR
Ms. Linda Nelson Regulatory Affairs Manager SteriTec Products, Incorporated 599 Topeka Way, Suite 400 Castle Rock, Colorado 80109
Re: K083650
Trade/Device Name: Emu-Graph 4 Emulator, Model No.: CI 144 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: January 31, 2009 Received: February 4, 2009
Dear Ms. Nelson:
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.
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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. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony D. arater for
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K083650
Device Name: Emu-Graph 4 Emulator, Model No .: CI 144
Indications for Use:
SteriTec Emu-Graph 4 is a steam sterilization emulator for use in a pre-vacuum steam sterilization process operating at 132°C (270° F) or 135° C (275° F). When exposed to steam sterilization conditions the indicator bar will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met.
Critical Parameters in a standard hospital pre-vacuum steam sterilizer
| Temperature | Time |
|---|---|
| 132°C (270°F) | 4 minutes |
| 135°C (275°F) | 3 minutes |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shaila A. Murphey, JD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
510(k) Number: K083650
§ 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).