(451 days)
Surgicot 20 1:0 Gas Indicator
Not Found
No
The device is a chemical indicator strip that changes color based on exposure to ethylene oxide. There is no mention of any computational or learning-based technology.
No
This device is a chemical indicator strip used to monitor the ethylene oxide sterilization process, not to treat or diagnose a disease or condition.
No
Explanation: The device is an Ethylene Oxide process indicator, used to confirm that items have been processed in EO, not to diagnose a medical condition.
No
The device description clearly states it is a "chemical indicator strip," which is a physical, hardware component. It does not describe any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to indicate that an item has been processed in Ethylene Oxide. This is a process monitoring function, not a diagnostic test performed on a biological sample to determine the state of health or disease.
- Device Description: The device is a chemical indicator strip that changes color based on exposure to EO gas. This is a chemical reaction, not a diagnostic test.
- Lack of Biological Sample: IVD devices are designed to test biological samples (blood, urine, tissue, etc.). This device interacts with EO gas, not a biological sample.
- Performance Studies: The performance studies focus on verifying the indicator's function in the EO process, not on diagnostic accuracy metrics like sensitivity, specificity, etc.
This device is a sterilization process indicator, used to confirm that a sterilization process has occurred. It does not provide any diagnostic information about a patient or a biological sample.
N/A
Intended Use / Indications for Use
SteriTec CROSS-CHECKS EO gas process indicator monitoring strips are a yellow to brown chemical indicator strip that changes color during Ethylenc Oxide (EO) processing. They indicate that the item has been processed in Ethylene Oxide.
Product codes
80JOJ
Device Description
SteriTec CROSS-CHECKS EO process indicators are a pale yellow to brown chemical indicator strip that changes color during ethylene oxide processing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Laboratory tests were performed to substantiate und verify that the performance of the submitted SteriTcc product performed safely and effectively as described and is equivalent to the prodicate competitive product. These tests were performed by an independent testing laboratory.
Key Metrics
Not Found
Predicate Device(s)
Surgicot 20 1:0 Gas Indicator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
SteriTec Products Mfg. Co., Inc. CROSS-CHECKS EO Chemical Process Indicator FDA 510(k) Application May 27, 1996 Page 18
510(k) SUMMARY
SUBMITTER:
- STERITEC PRODUCTS MFG. CO., INC. 680 Atchison Way - Suite 600 Castle Rock, CO 80104 (303) 660-4201 (303) 660-4213 Fax
- Establishment Registration Number: 2028456
- Date Summary Summary was Prepared _May 27, 1996 ●
- TOM ROLL Printed name of person required to submit 510(k)
tous
Signature of person required to submit $10(k)
- PRESIDENT Title of person submitting 510(k)
- Proprietary Name: CROSS-CHECKS EO
- Common/Usual Name: EO Process Indicator
Classification Name: Process indicator
Classification:
●
FDA has classified Physical/Chemical Sterilization Indicators in Class II under Classification Number 80JOJ, Regulation Number 880.2800.
1
SteriTec Products Mfg. Co., Inc. CROSS-CHECKS FO Chemical Process Indicator FDA 510(k) Application May 27, 1996 Page I
510(k) Summary - continued
Identification of Predicate device:
The SteriTec CROSS CHECKS EO gas process indication suip product is summar in design, composition and function to the:
Surgicot 20 1:0 Gas Indicator, chemical indicator strip, which was marketed prior to May 28. 1976.
Description of 510(k) submission device:
Product Description:
SteriTec CROSS-CHECKS EO process indicators are a pale yellow to brown chemical indicator strip that changes color during ethylene oxide processing.
Intended use:
Sterilier CROSS-CHECKS EO gas process indicator monitoring strips are a yellow to brown chemical indicator strip that changes color during Ethylenc Oxide (EO) processing. They indicate that the item has been processed in Ethylene Oxide.
Comparison to Predicate devices:
The basic formula and concept of chemical Ethylene Oxide process indicators has not changed dramatically since they were invented in the fifties and sixties.
Laboratory testing
Laboratory tests were performed to substantiate und verify that the performance of the submitted SteriTcc product performed safely and effectively as described and is equivalent to the prodicate competitive product. These tests were performed by an independent testing laboratory.
Conclusion:
Results of performance testing indicate that the submitted product, SteriTec CROSS CHECKS EO, performed in a safe and effective manner equivalently to the Surgicot 20 predicato device.