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 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.

Device Description

SteriTec Cross-Checks P strips are 4" x 5/8" process indicators with indicator ink printed onto Tyvek plastic.

AI/ML Overview

The SteriTec Cross-Checks P process indicator strips are designed to change color from blue to red when exposed to hydrogen peroxide during the diffusion phase of the Sterrad sterilizer cycle.

Acceptance Criteria and Device Performance:

Exposure Time to Hydrogen Peroxide	Acceptance Criteria (Expected Outcome)	Reported Device Performance (Number of strips meeting criteria)
Less than 25 minutes	Incomplete color change	200/200 incomplete color change (at 10 and 15 minutes)
25 minutes	Possible pass (indicating some color change, but not necessarily complete)	200/200 possible pass
30 minutes	Complete color change	200/200 complete color change

Study Details:

Sample Size and Data Provenance:
- Test Set Sample Size: 200 strips were used for each of the four different exposure timings (10 minutes, 15 minutes, 25 minutes, and 30 minutes), totaling 800 strips.
- Data Provenance: The study was conducted using a Sterrad sterilizer, implying a controlled laboratory environment rather than a retrospective analysis of field data. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S. company.
Number of Experts and Qualifications: Not applicable. The assessment of color change for process indicators is typically objective and determined visually, often against a reference color chart, rather than through expert interpretation.
Adjudication Method: Not applicable. The color change is a direct physical observation.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed. This type of study is relevant for diagnostic devices requiring human interpretation.
Standalone Performance: Yes, a standalone performance study was conducted. The device's color change response was evaluated directly under controlled exposure times without human intervention influencing the outcome.
Type of Ground Truth: The ground truth was established by defining the expected color change (or lack thereof) at specific exposure durations to hydrogen peroxide within the Sterrad cycle. This is a direct measure of the device's functional response to the sterilizing agent.
Training Set Sample Size: The document does not specify a separate training set. The study appears to be a validation study of the final product with the reported 800 strips.
Ground Truth for Training Set: Not applicable, as a separate training set is not described. The performance criteria against which the device was evaluated are inherent to the intended function of a chemical process indicator.

Summary

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K972300

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.

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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

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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

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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 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

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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
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Prescription Use Use(Per 21 CFR 801.109)	OR	Over The-Counter	X
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(Optional Format 1 2 96)

Regulation Number and Section

§ 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).