(462 days)
ATT Steam Close
Not Found
No
The device is a chemical indicator/integrator, which relies on a chemical reaction (color change) to indicate sterilization conditions, not AI/ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is a chemical indicator used to monitor steam sterilization, not a device used for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
This device is a chemical indicator/integrator used to verify proper steam sterilization conditions, not to diagnose a medical condition in a patient.
No
The device description explicitly states it is a "chemical indicator/integrator" and is equivalent in construction and operation to a predicate device which is also a chemical indicator. The performance studies describe testing of physical strips and their color change, indicating a physical, non-software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide an integrated response to steam sterilization. This is a process control for sterilization equipment, not a diagnostic test performed on biological samples to diagnose a disease or condition.
- Device Description: It's described as a chemical indicator/integrator. These devices are used to monitor the effectiveness of sterilization processes, not to analyze biological specimens.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing conditions, or providing information about a patient's health status.
Therefore, the Steritec Integraph is a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Steritec Integraph is designed to provide an integrated response to steam sterilization at 132 C for sterilizers operating for 3 1/2 minutes or longer.
Product codes
80JOJ
Device Description
The Steritec Integraph CI 101 is a chemical indicator/integrator equivalent in construction and operation to the ATT Steam Close (predicate device).
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
Not Found
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
To demonstrate the performance of the SteriTec Integraph the product was tested: - At multiple sterilization temperatures and times against biological (1) indicators . - For stability after storage in high temperature conditions. (2) - For stability after storage in high humidity conditions. (3) - For stability after storage for two and one half years years. (4) - For stability after being sterilized and then stored for two years. (R)
No false "PASS" Indications: In all cases they indicated properly whether the sterifization conditions had been met or not in the sterilizer chamber as verified by biological spore strips. There were NO instances in which the SteriTec strips indicated that sterilization conditions were met when they were not (NO FAI SI PASS RESULTS).
Margin of Safety: Test results show the SteriTce strips provide a "murgin of safely". During these tests, No SteriTec strip tested provided a "PASS" test result in tests when there were any biological spore survivors.
Stability Testing: Independent laboratory testing showed the SteriTec Integraph is stable after being subjected to extremes of heat and high humidity. In addition, under room temperarture storage of both exposed and unexposed strips for 2 years the strips also performed satisfactorily. All strips maintained their purple color after storage testing. After exposure to sterilization conditions, the indicators properly changed color from purple to green.
Key Metrics
Not Found
Predicate Device(s)
ATT Steam Close
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
SteriTec Products Mfg. Co,, Inc. Steritec Integraph Integrators FDA 510(k) Application-K960441 Original Submission-January 24, 1996 Current Date-May 2, 1997
510(k) SUMMARY
,
MAY - 8 1997
510(k) PREMARKET NOTIFICATION SUMMARY
510(k) Premarket Notification Summary
SUBMITTER:
- STERITEC PRODUCTS MFG. CO,, INC. ● 680 Atchison Way - Suite 600 Castle Rock, CO 80104 (303) 660-4201 Establishment Registration Number: 2028456 ● Date _ May 2, 1997 ● C TOM ROLL Printed name of person required to submit 510(k) Signature of person required to submit 510(k) PRESIDENT ● Title of person submitting 510(k) Proprietary Name: Integraph Common/Usual Name: Steam Sterilization Indicator/Integrator Classification Name: Sterilization Indicator
Classification:
FDA has classified Physical/Chemical Sterilization Indicators in Class II under Classification Number 80JOJ, Regulation Number 880.2800.
1
PB2
SteriTec Products Mfg. Co., Inc. Steritec Integraph Integrators FDA 510(k) Application-K960441 Original Submission-January 24, 1996 Current Date-May 2, 1997
510(k) SUMMARY
Identification of Predicate devices
The Steritec Integraph CI 101 is a chemical indicator/integrator equivalent in construction and operation to the ATT Steam Close (predicate device). Since the Steritec Integraph is equivalent in construction (o the predicate device, it will perform equivalently .
Description of 510(k) submission device:
Intended use:
The Steritec Integraph is designed to provide an integrated response to steam sterilization at 132 C for sterilizers operating for 3 1/2 minutes or longer.
Comparison to Predicate device:
Compared to the predicate device our performance data shows the Integraph Integrator to he substantially coulvalem
Performance Testing:
To demonstrate the performance of the SteriTec Integraph the product was tested:
- At multiple sterilization temperatures and times against biological (1) indicators .
- For stability after storage in high temperature conditions. (2)
- For stability after storage in high humidity conditions. (3)
- For stability after storage for two and one half years years. (4)
- For stability after being sterilized and then stored for two years. (ર)
No false "PASS" Indications
In all cases they indicated properly whether the sterifization conditions had been met or not in the sterilizer chamber as verified by biological spore strips. There were NO instances in which the SteriTec strips indicated that sterilization conditions were met when they were not (NO FAI SI PASS RESULTS).
Margin of Safety
Test results show the SteriTce strips provide a "murgin of safely". During these tests, No SteriTec strip tested provided a "PASS" test result in tests when there were any biological spore survivors.
2
SteriTec Products Mfg. Co., Inc. Steritec Integraph Integrators FDA 510(k) Application-K960441 Original Submission-January 24, 1996 Current Date-May 2, 1997
510(k) SUMMARY
18
were any biological spore survivors.
Stability Testing:
Independent laboratory testing showed the SteriTec Integraph is stable after being subjected to extremes of heat and high humidity. In addition, under room temperarture storage of both exposed and unexposed strips for 2 years the strips also performed satisfactorily. All strips maintained their purple color after storage testing. After exposure to sterilization conditions, the indicators properly changed color from purple to green.