(237 days)
Not Found
No
The device is a chemical sterilization indicator that changes color based on temperature and time, with no mention of AI or ML in the description or performance studies.
No.
This device is an indicator used to monitor steam sterilization processes, not to diagnose, treat, or prevent disease in a patient.
No
The device is a chemical sterilization indicator, not a diagnostic device. It monitors the efficacy of a sterilization process, it does not diagnose a patient's condition.
No
The device is a chemical sterilization indicator, which is a physical product that changes color. The description explicitly states it is a "chemical sterilization indicator" and describes its physical properties and color change mechanism. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Emu-Chex™ Sterilization Indicator's Purpose: The Emu-Chex™ Sterilization Indicator is used to monitor the effectiveness of steam sterilization processes for medical devices and instruments. It does not interact with or analyze human specimens.
- Intended Use: The intended use clearly states it's for monitoring steam sterilization processes, not for diagnostic purposes related to a patient's health.
- Device Description: The description confirms it's a chemical sterilization indicator.
Therefore, based on the provided information, the Emu-Chex™ Sterilization Indicator falls under the category of a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Emu-Chex™ Sterilization Indicator is an emulating indicator intended to be used by a health care provider to monitor steam sterilization processes. Emu-Chex™ Sterilization Indicator comes in three varieties: for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in pre-vacuum steam sterilization processes operating at 132° C for 4 minutes and 135° C for 3 minutes.
The Emu-Chex™ Sterilization Indicators can be placed together with items to be steam sterilized. The indicator changes color from blue-green to brown when the sterilization cycle is complete. The performance of the Emu-Chex™ Sterilization Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating indicators.
Product codes
JOJ
Device Description
The Emu-Chex™ Sterilization Indicator is a chemical sterilization indicator for steam sterilizers that complies with ANSI/AAMI/ISO 11140-1:2005, Sterilization of health care products - Chemical indicators - Part 1 : General requirements, emulating indicators. The variety of Emu-Chex sterilization indicators includes those for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in prevacuum steam sterilization process operating at 132° C for 4 minutes and 135° C for 3 minutes. No lead or heavy metals or their compounds are added in the production of the indicator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
MAY 25 2011
Submitted by Propper Manufacturing Company, Inc. Address: 36-04 Skillman Avenue, Long Island City, New York 11101 Telephone: (800) 832-4300 or (718) 392-6650 Facsimile: (718) 482-8909 Contact Name: Andrew Sharavara
Date Submitted: September 27, 2010
| Trade Name: | Emu-Chex TM Sterilization Indicator |
|---|---|
| Common Name: | Chemical Sterilization Process Indicator |
Product Code / Regulation: JOJ / 21 C.F.R. 880.2800
- Description: The Emu-Chex™ Sterilization Indicator is a chemical sterilization indicator for steam sterilizers that complies with ANSI/AAMI/ISO 11140-1:2005, Sterilization of health care products - Chemical indicators - Part 1 : General requirements, emulating indicators. The variety of Emu-Chex sterilization indicators includes those for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in prevacuum steam sterilization process operating at 132° C for 4 minutes and 135° C for 3 minutes. No lead or heavy metals or their compounds are added in the production of the indicator.
Intended Use: The Emu-Chex™ Stcrilization Indicator is an emulating indicator intended to be used by a health care provider to monitor steam sterilization processes. Emu-Chex™ Sterilization Indicator comes in three varieties: for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in pre-vacuum steam sterilization processes operating at 132° C for 4 minutes and 135° C for 3 minutes.
The Emu-Chex™ Sterilization Indicators can be placed together with items to be steam sterilized. The indicator changes color from blue-green to brown when the sterilization cycle is complete. The performance of the Emu-Chex™ Sterilization Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating indicators.
The Emu-Chex™ Sterilization Indicator is similar in Substantial Equivalence: intended use and operating characteristics to the following indicators:
1
Emu-Chex Predicate device 510k number varsion 121°C - 20 min Propper Vapor Line indicator K895910 1320C -- 4 min Steris Verify indicator K071895 135°C - 3 min Steris Verify indicator K070461
Substantial equivalence to the predicate device was evaluated according to the FDA guidance document "Premarket Notification [510(k)] Submissions for Chemical Indicators," issued on December 19, 2003 and technological parameters have been tested according to the FDA recognized consensus standard ANSI/AAMI/ISO 11140-1:2005, Sterilization of health care products -- Chemical indicators -- Part 1 : General requirements.
The proposed and predicate devices are single use chemical indicators for monitoring steam sterilization cycles. The Emu-Chex "M Sterilization Indicator is similar with respect to indications for use and operating characteristics to the predicate devices in terms of 510(k) substantial equivalency. The differences between the new device and predicate devices are limited to differences in design, materials, and colors of unprocessed indicators and end-point reaction and those differences do not raise any new issues of safety and efficacy.
- Conclusion: Test results demonstrate that Emu-Chex " Sterilization indicator is equivalent to the predicate devices and therefore should be allowed for market in the United States.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Andrew Sharavara Chief Technical Officer and R&D Director Propper Manufacturing Company, Incorporated 36-04 Skillman Avenue Long Island City, New York 11101
MAY 25 2011
Re: K102894
Trade/Device Name: EmuTM-Chex Sterilization Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: April 26, 2011 Received: May 2, 2011
Dear Dr. Sharavara:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2- Dr. Sharavara
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Cinthong D. Watson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K102894
Device Name: Emu-Chex™ Sterilization Indicator
Intended Use:
The Emu-Chex™ Sterilization Indicator is an cmulating indicator intended to be used by a health care provider to monitor steam sterilization processes. Ennu-Chex" Sterilization Indicator comes in three varieties; for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in pro-vacuum steam sterilization processes operating at 132°C for 4 minutes and 135°C for 3 minutes.
The Emu-Chex™ Sterilization Indicators can be placed together with items to be steam sterifized. The indicator changes color from blue-green to brown when the sterilization cycle is complete. The performance of the Enni-Chex" Sterilization Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating indicators.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elliott F. Clavin- Wills
Division Sign-Off) >>ivision of Anesthesiology, General Hospital infection Control. Dental Devices
:10(k) Number: K162894