(79 days)
K800029, K800029A
Not Found
No
The device is described as a chemical integrator and the performance studies focus on its chemical response to sterilization parameters, not on any computational or learning capabilities.
No
The device is a chemical integrator used to monitor the effectiveness of EO gas sterilization in hospital sterilizers, not to directly treat patients.
No
This device is an integrator designed to verify the effectiveness of sterilization processes, not to diagnose medical conditions in patients. While it "surpassed the performance of the biologicals," this refers to indicators of sterilization efficacy, not biological markers for patient diagnosis.
No
The device description explicitly states it is a "chemical integrator," which is a physical device, not software. The performance studies also describe testing of a physical product.
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 EO gas sterilization in hospital sterilizers. This is a quality control or monitoring device for a sterilization process, not a test performed on a biological sample from a patient to diagnose or monitor a medical condition.
- Device Description: It is described as a "chemical integrator," which is consistent with a sterilization monitoring device.
- Lack of Biological Sample Testing: There is no mention of the device being used to test blood, urine, tissue, or any other biological sample.
- Focus on Sterilization Parameters: The performance studies focus on the device's response to parameters of the EO sterilization process (gas concentration, temperature, humidity, exposure time) and comparison to biological indicators used for sterilization validation.
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 the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers.Color change occurs between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.
Product codes
JOJ
Device Description
The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator is a chemical integrator equivalent in construction and performance to the 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
hospital sterilizers
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)
The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator performance was determined in parallel tests against several biological indicators, (EZTEST, ATTEST, and STS Spore Strips) and in a separate test against the predicate device as well as the Sterigage EO Integrator. The Cross-Checks EO Integrators surpassed the performance of the biologicals for each of the four parameters used in the ethylene oxide sterilization process. In addition, the Cross-Checks EO Integrators surpassed the performance of the Surgicot 2 EO Integrator (the predicate) as well as the Sterigage EO indicator when tested on a side by side basis by an independent laboratory. In both tests , each parameter for EO gas sterilzation was varied while holding the balance of parameters constant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K800029, K800029A
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
OCT 8 1998
CROSS-CHECKS EO Gas Sterilization Integrator 510(k) Premarket Notification K982547 SteriTec Products Mfg. Co., Inc.
510(k) PREMARKET NOTIFICATION
SUMMARY
SUBMITTER:
Image /page/0/Picture/5 description: The image shows a handwritten string of characters and numbers. The string begins with the letter 'K', followed by the number '98'. After '98', the numbers '2547' are written. A line is drawn underneath the numbers, possibly indicating a signature or underlining.
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
November 19, 1996 Date Summary was Prepared Date of First Revison February 7, 1997 November 5, 1997 Date of Second Revision Date of Third Revision July 15, 1998
TOM ROLL
Printed name of person required to submit 510(k)
Tom Selleck
Signature of person required to submit 510(k)
PRESIDENT
Title of person submitting 510(k)
| Proprietary Name: | SteriTec CROSS-CHECKS EO Gas Sterilization Integrator |
|---|---|
| Common/ Usual Name: | Ethylene Oxide Gas Sterilization Process Integrator |
| Classification Name: | Sterilization Chemical Integrator |
| Classification: | FDA has classified Physical/Chemical Indicators in Class II |
| under Classification Number 80JOJ, Regulation 880.2800 |
1
CROSS-CHECKS EO Gas Sterilization Integrator 510(k) Premarket Notification-K982547 SteriTec Products Mfg. Co., Inc.
510(k) Summary - continued
Identification of Predicate device:
The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator is a chemical integrator equivalent in construction and performance to the predicate device. Since it is equivalent in construction and performance to the SURGICOT 2 EO Gas Indicator Strip, (FDA 510(k) # K800029 and K800029A) manufactured by SURGICOT of Research Triangle Park, North Carolina (Predicate device), it will perform in the same safe and effective manner as the predicate device as demonstrated in performance tests.
Description of 510(k) submission device:
Intended Use:
The Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers.Color change occurs between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.
Comparison to Predicate Device:
Compared to the predicate device our performance data shows the Cross-Checks EO to be substantially equivalent.
Performance Testing:
The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator performance was determined in parallel tests against several biological indicators, (EZTEST, ATTEST, and STS Spore Strips) and in a separate test against the predicate device as well as the Sterigage EO Integrator. The Cross-Checks EO Integrators surpassed the performance of the biologicals for each of the four parameters used in the ethylene oxide sterilization process. In addition, the Cross-Checks EO Integrators surpassed the performance of the Surgicot 2 EO Integrator (the predicate) as well as the Sterigage EO indicator when tested on a side by side basis by an independent laboratory. In both tests , each parameter for EO gas sterilzation was varied while holding the balance of parameters constant.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure, with "DEPARTMENT OF HEALTH & HUMAN" on the left side and "SERVICES - USA" on the right side.
OCT 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Roll ·President SteriTec Products Mfg., Co., Incorporated 680 Atchison Way - Suite 600 Castle Rock, Colorado 80104
Re : K982547 Trade Name: SteriTec CROSS-CHECKS EO Gas Sterilization Inteqrator Regulatory Class: II Product Code: JOJ Dated: July 16, 1998 Received: July 21, 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 qeneral controls provisions of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,
3
Page 2 - Mr. Roll
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.fda.gov/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
Enclosure
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Page _ 1 of _ 1 _ _ 1 _ _
510(k) Number (if known):_____K982547
Device Name:___Cross-Checks EO Integrator
Indications For Use:
Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers. Color change to brown is complete between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Use (Per 21 CFR 801.109)
OR
Over-The-Counter X
(Optional Format 1-2-96)
Clins S. Cin
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .