(482 days)
No
The document describes a physical chemical indicator pack for steam sterilization, with no mention of software, algorithms, or data processing that would suggest AI/ML.
No
The device is designed to monitor sterilization cycles in steam sterilizers, not to provide therapy or treatment to a patient.
No
The device is designed to monitor sterilization cycles in steam sterilizers, ensuring the effectiveness of the sterilization process. It does not diagnose medical conditions in patients.
No
The device description clearly states it consists of a chemical integrator test sheet placed inside a package of porous and non porous material, indicating it is a physical device, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is used to monitor the performance of steam sterilizers, which are used to sterilize medical devices and other items. It does not analyze biological samples (like blood, urine, or tissue) to provide information about a patient's health or condition.
- Device Description: The device consists of a chemical integrator within a pack designed to challenge steam penetration. This is a test for the sterilization process itself, not a test on a biological sample.
- Anatomical Site/Patient Age Range: These are not applicable to the device's function, further indicating it's not used directly on or for a patient in a diagnostic capacity.
- Intended User/Care Setting: The intended user is the operator of steam sterilizers, typically in a healthcare or laboratory setting, but their role is to ensure the sterilization equipment is functioning correctly, not to perform a diagnostic test on a patient.
IVDs 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
The SteriTec Chemical Integrator Challenge Pack-Steam is designed specifically for the testing of 132 ℃. (270 °F) pre-vacuum steam sterilizers. The SteriTec Chemical Integrator Challenge Pack-Steam is used to supplement testing with biological packs. It gives the operator assurance of sterilizer performance between biological tests or while waiting for biological test results during the incubation period.
The SteriTec Chemical Integrator Challenge Pack-Steam is designed to be used to monitor sterilization cycles in pre-vacuum steam sterilizers operating at 132 "C. for 3 minutes or longer. It is to be used as a supplementary test to biological pack testing, not as a substitute.
Product codes
80JOJ
Device Description
The SteriTec Chemical Integrator Challenge Pack-Steam consists of a chemical integrator test sheet placed inside a package of porous and non porous material. This pack provides resistance to the penetration of steam during the sterilization cycle.
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
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Summary of Performance Studies
The laboratory test data showed that the performance of the Steritec Chemical Integrator Challenge Pack-Steam is equivalent to the predicate. In addition, laboratory test data show that the chemical integrator sheet inside the test pack did not change color completely when the SteriTec Chemical Integrator Challenge Pack-Steam was exposed for 1, 2, and 3 minutes at 132 ℃. but did change color completely (PASS) between 3 and 4 minutes. At 130 ℃. it did not change when exposed for 1, 2, 3, or 4 minutes but did change between 4 and 5 minutes. At 128 °C. it did not change when exposed for 1, 2, 3, 4, and 5 minutes but did change between 5 and 6 minutes.
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).
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Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 6, 5, 2, 1, and 2. The characters are written in a dark ink, and they appear to be on a white background.
COSIVE
86 August 200
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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 was Revised_ April 14, 1998
- 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)
- SteriTec Chemical Integrator Challenge Pack-Steam Proprietary Name:
Chemical Integrator Pack for Steam Sterilizers Common/Usual Name:
Chemical Integrator Pack Classification Name:
- "Indicator, Chemical Integrator Sterilization Process" in Class II Classification: under Classification Number 80JOJ, Regulation Number 880.2800.
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510(k) Summary - continued
Identification of Predicate device:
The predicate device is ATI Disposable Test Pack for Steam K952408
Description of 510(k) submission device:
The SteriTec Chemical Integrator Challenge Pack-Steam is designed specifically for load testing of steam sterilizers. The SteriTec Chemical Integrator Challenge Pack-Steam consists of a chemical integrator test sheet placed inside a package of porous and non porous material. This pack provides resistance to the penetration of steam during the sterilization cycle.
Intended use:
The SteriTec Chemical Integrator Challenge Pack-Steam is designed specifically for the testing of 132 ℃. (270 °F) pre-vacuum steam sterilizers. The SteriTec Chemical Integrator Challenge Pack-Steam is used to supplement testing with biological packs. It gives the operator assurance of sterilizer performance between biological tests or while waiting for biological test results during the incubation period.
Performance Testing:
The laboratory test data showed that the performance of the Steritec Chemical Integrator Challenge Pack-Steam is equivalent to the predicate. In addition, laboratory test data show that the chemical integrator sheet inside the test pack did not change color completely when the SteriTec Chemical Integrator Challenge Pack-Steam was exposed for 1, 2, and 3 minutes at 132 ℃. but did change color completely (PASS) between 3 and 4 minutes. At 130 ℃. it did not change when exposed for 1, 2, 3, or 4 minutes but did change between 4 and 5 minutes. At 128 °C. it did not change when exposed for 1, 2, 3, 4, and 5 minutes but did change between 5 and 6 minutes.
Conclusion:
Results of performance testing indicate that the SteriTec Chemical Integrator Challenge Pack-Steam, provides a sufficient load challenge to monitor steam sterilization cycles at 132 ℃ for 3 minutes or longer.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the eagle in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 1998
Mr. Tom Roll ·President SteriTec Products Mfg. Co., Inc. 680 Atchison Way - Suite 600 Castle Rock, Colorado 80104
K965212 Re : SteriTec Chemical Integrator Challenge Pack-Trade Name: Steam Requlatory Class: II Product Code: JOJ Dated: January 28, 1998 Received: January 29, 1998
Dear Mr. Roll: --
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Earts 800 to 895 ... A ... ...... substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Roll
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaygov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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Page _
510(k) Number (if known):_
Device Name:__________________________________________________________________________________________________________________________________________________________________
ﻬﺎ، ﻣ
Indications For Use:
The SteriTec Chemical Integrator Challenge Pack-Steam is designed to be used to monitor sterilization cycles in pre-vacuum steam sterilizers operating at 132 "C. for 3 minutes or longer. It is to be used as a supplementary test to biological pack testing, not as a substitute. --------------
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Concurrence of CDRH, Office of Device Evaluation (01)[1)
Qlin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) ાર
Over The-Counter Use. X
(Optional Formal 1-2-96)
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