(105 days)
Not Found
Not Found
No
The device is a chemical indicator strip that changes color based on exposure to sterilization processes, with no mention of AI or ML in the description or intended use.
No
The device is a chemical indicator strip used to confirm exposure to a sterilization process, not to treat a condition or disease.
No
This device is a sterilization process indicator, meaning it confirms exposure to a sterilization process, not that it diagnoses a condition or disease in a patient.
No
The device description clearly states it is a "chemical indicator strip," which is a physical, hardware component, not software.
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 exposed to a sterilization process (steam or chemical vapor). This is a quality control measure for the sterilization process itself, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device is a chemical indicator strip that changes color based on exposure to sterilization conditions. It does not interact with or analyze biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing a disease or condition, or providing information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
SteriTec CROSS-CHECKS Sterilization Process Indicators are a white to black chemical indicator strip that change color during steam or chemical vapor sterilization process. They are designed to be placed in each pack or package to be steam or chemical vapor sterilized, to indicate an item has been exposed to a steam or vapor process.
Product codes (comma separated list FDA assigned to the subject device)
80JOJ
Device Description
SteriTec CROSS-CHECKS Sterilization Process Indicators are a white to black chemical indicator strip that change color during steam or chemical vapor sterilization process. They are designed to be placed in each pack or package to be steam or chemical vapor sterilized, to indicate an item has been exposed to a steam or vapor process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ATI Division of PyMah Corporation Sterilometer Steam Strip® chemical indicator strip for steam.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K955426 crinkle
MAR 1 2 1996
SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Process Indicator FDA 510(k) Application November 15, 1995 PAGE - 17
510(k) SUMMARY
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 _ November 20, 1995
. TOM ROLL Printed name of person required to submit 510(k)
Signature of person signing under penalty of perjury under section 512(c)
Signature of person required to submit 510(k)
- PRESIDENT Title of person submitting 510(k)
Proprietary Name: CROSS-CHECKS
Common/Usual Name: Steam Sterilization Process Indicator
Classification Name: Sterilization
Classification:
FDA has classified Physical/Chemical Sterilization Indicators in Class II under Classification Number 80JOJ, Regulation Number 880.2800.
Identification of Predicate devices:
1
Mr. Tim Ulatowski, Acting Director Office of Device Evaluation - FDA Response Letter to FDA 510(k) letter of January 24, 1996 RE: 510(k) Notification Number K955426 for the SteriTec Cross-Checks Steam/Vapor Process Indicator Cl 105
MODIFIED PAGE 2 OF 510(K) SUMMARY
The SteriTec product is similar in design, composition and function to the ATI Division of PyMah Corporation Sterilometer Steam Strip® chemical indicator strip for steam.
This predicate product was marketed prior to May 28, 1976.
Description of 510(k) submission device:
Intended use:
SteriTec CROSS-CHECKS Sterilization Process Indicators are a white to black chemical indicator strip that change color during steam or chemical vapor sterilization process. They are designed to be placed in each pack or package to be steam or chemical vapor sterilized, to indicate an item has been exposed to a steam or vapor process.
Comparison to Predicate device:
The basic formula and concept of chemical steam process indicators has not changed dramatically since they were invented in 1932.
Ink Composition Certification:
SteriTec certifies that the composition of this ink is basically the same as the ink formulation discribed in patent number 2,118,144 issued to Berman and Chaney on May 24, 1938 for a led sulfide reaction. This reaction and the indicator strip described in the patent has been produced and marketed since the 1930's by the company they founded, Aseptic Thermo Indicator (ATI). ATI, now a division of the PyMah Corporation, uses this same formulation in the production of their Sterilometer Steam Strip® chemical indicator strip for steam. The only changes in the formula are variations in solvents to allow for the silk screen printing process used by SteriTec, Inc. versus Rotogravure printing process used by ATI Corporation. Please note: the solvents used in the formulation of the ink evaporate out during the manufacturing process.
Conclusion:
The SteriTec CROSS-CHECKS CI 105 is a white to black process indicator and it is essentially equivalent in construction and operation to the predicate device. Since the SteriTec Cross-Checks indicator is essentially equivalent in construction to the predicate device, it will perform in the same safe and effective manner, equivalent to the predicate device.