(637 days)
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Not Found
No
The device is a simple chemical indicator label that changes color based on temperature and time, with no mention of AI or ML in the description or performance studies.
No
The device is a dry heat indicator label used to verify sterilization, not to provide therapy or treatment to a patient.
No.
The device, SteriTec Dry Heat Indicator Labels, is described as a process indicator that changes color to show if an item has been processed in a dry heat sterilizer. It does not diagnose any medical condition or disease in a patient.
No
The device is a physical label that changes color, indicating it is a hardware-based device, 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 whether items have been processed in a dry heat sterilizer. This is a quality control or process monitoring function, not a diagnostic test performed on biological samples to diagnose a disease or condition.
- Device Description: The device is a chemical indicator that changes color based on exposure to heat. It does not analyze biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological specimens (blood, urine, tissue, etc.), diagnosing a disease, 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 description.
N/A
Intended Use / Indications for Use
SteriTec Dry Heat Indicator Labels are designed to be utilized in dry heat (hot air) sterilizers operating at 160 C. The label provides clear identification of processed versus unprocessed items.
Product codes
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Device Description
SteriTec Dry Heat Indicator Labels are process indicators that turn color from green to dark brown/black during dry heat processing at 160 C. The labels will usually complete their color change in less than 10 minutes at this temperature.
Mentions image processing
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Mentions AI, DNN, or ML
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests substantiated that the Steritec Dry Heat Indicator Label performed safely and effectively as described and is equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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
APR - 2 1997
K95-3122
SteriTec Products Mfg. Co., Inc. SteriTec Dry Heat Indicator Label
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 ● -
Original Date Summary was Prepared __May 15, 1995 Date of this submission February 12, 1997
-
TOM ROLL Printed name of person required to submit 510(k)
1500 Signature of person required to submit 510(k)
- PRESIDENT Title of person submitting 510(k)
- Proprietary Name: SteriTec Dry Heat Indicator Label
- Dry Heat Sterilization Process Indicator Common/Usual Name:
- Classification Name: Process Indicator
Classification:
C
FDA has classified Physical/Chemical Sterilization Indicators in Class II under Classification Number 80JOJ, Regulation Number 880.2800.
1
SteriTec Products Mfg. Co., Inc. SteriTec Dry Heat Indicator Label
510(k) Summary - continued
Identification of Predicate device:
The SteriTec Dry Heat Indicator Label is a sterilization process indicator label product and is similar in design, composition and function to the:
ATI Dry Heat Indicator Labels ATI Division of PyMah Corporation 89 Rt. 206, P.O. Box 1114 Somerville, NJ 08876 (800) 526-3538
Description of Steritec Dry Heat Indicator Label:
SteriTec Dry Heat Indicator Labels are process indicators that turn color from green to dark brown/black during dry heat processing at 160 C. The labels will usually complete their color change in less than 10 minutes at this temperature.
Intended use:
SteriTec Dry Heat Indicator Labels are designed to be utilized in dry heat (hot air) sterilizers operating at 160 C. The label provides clear identification of processed versus unprocessed items.
Comparison to Predicate devices:
Tests substantiated that the Steritec Dry Heat Indicator Label performed safely and effectively as described and is equivalent to the predicate device.