(279 days)
Not Found
No
The device is a chemical process indicator strip that changes color based on exposure to hydrogen peroxide. There is no mention of any computational or algorithmic processing, let alone AI/ML. The performance studies describe a simple color change based on exposure time.
No
The device is a chemical process indicator strip used to confirm exposure to hydrogen peroxide in a sterilizer, not to treat a medical condition or patient.
No
Explanation: This device is a chemical process indicator used to confirm exposure to hydrogen peroxide during a sterilization cycle, not to diagnose a medical condition in a patient.
No
The device is a physical indicator strip with ink printed on plastic, designed to change color when exposed to hydrogen peroxide. It is not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to indicate exposure to hydrogen peroxide during a sterilization cycle (Sterrad cycle). This is a process indicator for sterilization, not a test performed on biological samples (in vitro).
- Device Description: It's a chemical indicator strip that changes color based on exposure to a chemical (hydrogen peroxide).
- Lack of Biological Sample Testing: There is no mention of the device being used to test blood, urine, tissue, or any other biological sample.
IVDs are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition. It's a quality control tool for a sterilization process.
N/A
Intended Use / Indications for Use
Cross-Checks P chemical process indicator strips are designed to be used in the Sterrad sterilizer. Cross-Checks P Process Indicator Strips will exhibit a hite to red color change when exposed to hydrogen peroxide during the diffusion phase of the Sierral - cycle. When used as directed, the Cross-Checks P strips give visible confirmation that the item has been expossed to hydrogen peroxide during the Sterrad cycle.
Product codes
JOJ
Device Description
SteriTec Cross-Checks P strips are 4" x 5/8" process indicators with indicator ink printed onto Tyvek plastic.
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
Tests substantiated that the Sterited Cross Checks P Indicators performed effectively as described and is equivalent to the claims of the predicate device. Specifically, 200 strips were run in a Sterrad cycle for each of four different exposure timings ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . minutes, 15 minutes, 25 minutes and 30 minutes The indicator completed its color change between 25 and 30 minutes of diffusion phase exposure.
Key Metrics
| EXPOSURE TIME | RESULTS |
|---|---|
| 10 MINUTES | 200/200 INCOMPLETE COLOR CIIANGE |
| 15 MINUTES | 200/200 INCOMPLETE COLOR CHANGE |
| 25 MINUTES | 200/200 POSSIBLE PASS |
| 30 MINUTES | 200/200 COMPLETE COLOR CIIANGE |
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).
0
CROSS-CHECKS P 510(k) Premarket Notification SteriTec Products Mfg. Co., Inc.
MAR 2 5 1998
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 of Original Submission _June 20_1997 Date Additonal Information provided December 17, 1997 Date Additional information submitted March , 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 Cross-Checks P process indicator strips Proprietary Name:
Common/Usual Name: Sterrad sterilizer process indicator strips
Classification Name: Process Chemical Indicator
Classification:
- FDA has classified Physical/Chemical Sterilization Indicators in Class II under Classification Number 80JOJ, Regulation Number 880 2800.
1
CROSS-CHECKS P 510(k) Premarket Notification SteriTec Products Mig. Co. Inc.
Page D-1
510(k) Summary - continued
Identification of Predicate device:
The Steriter Cross-Checks P Process Indicator Strips are similar in design, and function to the:
Johnson & Johnson Sterrad Chemical Indicator Strips Ref 14100 510(k) K921910
Description of Steritec Cross-Checks P process indicator strips.
SteriTec Cross-Checks P strips are 4" x 5/8" process indicators with indicator ink printed onto Tyvek plastic.
Intended use:
Cross-Checks P chemical process indicator strips an designed to be used in the Sterrad Sterilizer. Cross-Checks P Process Indicator Strips will exhibit a blue to red color change when exposed to hydrogen peroxide during the dillusion phase of the Sterrad cycle. When used as directed, the Cross Checks P strips give visible confirmation that the item has been exposed to hydrogen peroxide during the Sterrad Cycle.
Comparison to Predicate devices
Tests substantiated that the Sterited Cross Checks P Indicators performed effectively as described and is equivalent to the claims of the predicate device. Specifically, 200 strips were run in a Sterrad cycle for each of four different exposure timings ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . minutes, 15 minutes, 25 minutes and 30 minutes The indicator completed its color change between 25 and 30 minutes of diffusion phase exposure.
| EXPOSURE TIME | RESULTS |
|---|---|
| 10 MINUTES | 200/200 INCOMPLETE COLOR CIIANGE |
| 15 MINUTES | 200/200 INCOMPLETE COLOR CHANGE |
| 25 MINUTES | 200/200 POSSIBLE PASS |
| 30 MINUTES | 200/200 COMPLETE COLOR CIIANGE |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 1998
Mr. Tom Roll ·President Steritec Products Mfg. Co. Incorporated 680 Atchison Way, Suite 600 Castle Rock, Colorado 80104
Re : K972300 Cross-Checks P Trade Name: Regulatory Class: II Product Code: دم م Dated: December 19, 1997 Received: December 29, 1997
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 regulations affecting your device can be found in the Code of Federal Requlations, 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
3
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 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) 638-20#1 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Timothy A. Ulatow Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page_ 1 of_1
510(k) Number (if known):
Device Name: SteriTec CROSS CHECKS P Chemical Process Indicators
Indications For Use:
Cross-Checks P chemical process indicator strips are designed to be used in the Sterrad sterilizer. Cross-Checks P Process Indicator Strips will exhibit a hite to red color change when exposed to hydrogen peroxide during the diffusion phase of the Sierral - cycle. When used as directed, the Cross-Checks P strips give visible confirmation that the item has been expossed to hydrogen peroxide during the Sterrad cycle.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODL) |
|---|
| (Division Sign-Off) |
| Division of Dental, Infection Control, and General Hospital Devices |
| 510(k) Number | K972300 |
|---|---|
| --------------- | --------- |
| Prescription Use Use
| (Per 21 CFR 801.109) | OR | Over The-Counter | X |
|---|---|---|---|
| ---------------------------------------------- | ---- | ------------------ | --- |
(Optional Format 1 2 96)