A chemical indicator for monitoring all cycles within the STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

Device Description

The Crosstex VH2O2 Chemical Indicators are intended for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX, and Sterilucent™ PSD-85 sterilization processes. The Crosstex VH2O2Chemical Indicators are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Chemical indicators change to a color of blue after exposure to vaporized hydrogen peroxide. Colors other than blue such as yellow/green should be treated as a process failure.

AI/ML Overview

This document describes the Crosstex VH2O2 Chemical Indicators, a device designed to monitor vaporized hydrogen peroxide sterilization cycles. The information provided outlines the device's acceptance criteria and the studies conducted to prove its performance.

Acceptance Criteria and Reported Device Performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ANSI/AAMI/ISO 11140-1:2014 testing for Type 1 Process Indicator	To demonstrate compliance to requirements specified in ISO 11140-1:2014	Device functions and transitions to blue when processed in a STERRAD® 100NX™ DUO sterilization cycle.	Pass
Testing Color Change	To demonstrate the color change of the device when used in the STERRAD® 100NX™ DUO sterilization cycle.	Color change to blue without ink bleeding	Pass
End Point Color Stability	To demonstrate the post sterilization color stability of the device after use in the STERRAD® 100NX™ DUO sterilization cycle	No significant color change after exposure to fluorescent light for a minimum of six (6) months.	Pass
Biocompatibility and ink transfer test.	To demonstrate device and materials of construction are biocompatible with end-users and Healthcare Professionals.	Tested per ISO 11140-2:2014. Materials of construction is the same as currently cleared device. Device does not release any toxic substance in sufficient quantities to cause a health hazard. No ink migration or transfer observed with unprocessed and processed devices.	Pass.

Detailed Study Information:

Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" sample size in terms of number of indicators. The testing involves subjecting the indicators to specific sterilization cycles (e.g., STERRAD® 100NX™ DUO) and then evaluating their performance, color change, and stability. The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted by Crosstex International, Inc., a U.S. company. The studies appear to be prospective, laboratory-based tests designed to evaluate the physical and chemical properties of the indicators under controlled conditions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This type of device (chemical indicator) does not typically involve human expert interpretation for "ground truth" establishment in the way an AI diagnostic algorithm would. The "ground truth" for these tests is based on objective, measurable changes in the indicator's color and stability following exposure to defined sterilization conditions, and compliance with established international standards (ISO 11140-1:2014). The assessment would likely be performed by trained laboratory personnel or quality control specialists rather than medical experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The assessment criteria are objective (e.g., "Color change to blue," "No significant color change"). There is no mention of a subjective evaluation process requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a chemical indicator, not an AI-assisted diagnostic tool for human readers. Its function is to provide a direct visual indication of sterilization processing, not to interpret complex medical images or data.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This device is not an algorithm. Its performance is observed directly by human users (healthcare providers) who visually assess the color change of the indicator. The "standalone" performance here refers to the intrinsic chemical and physical response of the indicator itself, which is what the non-clinical tests evaluate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth is based on the objective physical and chemical reaction of the indicator when exposed to vaporized hydrogen peroxide under specific, controlled sterilization conditions, as defined by international standards (ANSI/AAMI/ISO 11140-1:2014) and verified by direct observation in laboratory settings.
The sample size for the training set:
Not applicable. This device is a physical chemical indicator, not a machine learning or AI algorithm that requires a training set.
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 15, 2021

Crosstex International, Inc. (A Cantel Medical Company) Pablo Martinez Sr. Manager, Regulatory Affairs 10 Ranick Road Hauppauge, New York 11788

Re: K200096

Trade/Device Name: Crosstex VH2O2 Chemical Indicators Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: June 21, 2021 Received: June 24, 2021

Dear Pablo Martinez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200096

Device Name

Crosstex International VH2O2 Chemical Indicators

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Crosstex logo. The word "CROSSTEX" is written in large, blue, bold letters. Below the word "CROSSTEX" is the phrase "A CANTEL MEDICAL COMPANY" in smaller, blue letters.

Crosstex International, Inc. 6789 West Henrietta Road Rush, NY 14543 Tel: (800) 722-1529

510(k) Summary for K200096 Crosstex VH2O2 Chemical Indicators

Manufacturer:	Crosstex International, Inc.
Address:	6789 West Henrietta RoadRush, NY 14543(800) 722-1529
Official Contact:	Pablo MartinezSr. Manager, Regulatory Affairs
Address:	Crosstex International, Inc.10 Ranick RoadHauppauge, NY 11788PabloM@Crosstex.com(631) 257-1046
Date:	July 14, 2021

1. Device Name and Classification:

Trade Name:	Crosstex VH2O2 Chemical Indicators
Common Name:	Chemical Indicator
Regulation No:	21CFR 880.2800 (b)
Classification Name:	Indicator, physical/chemical sterilization indicator
Product Code:	JOJ
Device Class:	II

2. Predicate Device:

510(K) Number:	K140566
Trade Name:	Crosstex/SPSmedical VH2O2 Chemical Indicator
Submitter/holder:	Crosstex International Inc.6789 West Henrietta RoadRush, NY 14543 U.S.A.

3. Device Description

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Image /page/4/Picture/0 description: The image shows the Crosstex logo in blue. The text "CROSSTEX" is in large, bold letters. Below the main text, in smaller letters, it says "A CANTEL MEDICAL COMPANY". The logo is simple and professional.

Crosstex International, Inc. 6789 West Henrietta Road Rush, NY 14543 Tel: (800) 722-1529

4. Intended Use

5. Technological Characteristics Comparison

Element	Proposed Device (K200096)	Predicate Device (K140566)	Comparison
Intended Use	The Crosstex VH2O2 Chemical Indicatorsare intended for use as process indicators forall vaporized hydrogen peroxide cycles inthe STERRAD® 100S, 200, 100NX(Standard, Duo, Flex & Express), NX(Standard & Advanced), STERIS® V-PRO®1, V-PRO® 1 Plus, V-PRO® maX, andSterilucent™ PSD-85 sterilization processes.The Crosstex VH2O2 Chemical Indicatorsare intended to be used by health careproviders with articles such as sterilizationwraps, containers, cassettes, or pouches todistinguishbetween processedandunprocessed units. Chemical indicatorschange to a color of blue after exposure tovaporized hydrogen peroxide. Colors otherthan blue such as yellow/green should betreated as a process failure.	The SPSmedical VH2O2 Indicators areintended for use as process indicators forall vaporized hydrogen peroxide cycles inthe STERRAD® 100S, 200, 100NX, NX,STERIS® V-PRO 1, V-PRO 1 Plus, V-PROmaX and Sterilucent PSD-85 sterilizationprocesses. They are intended to be usedby health care providers with articles suchas sterilization wraps, containers,cassettes, or pouches to distinguishbetween processed and unprocessed items.Indicators change to a signal color of Blueafter exposure to vapor hydrogenperoxide.	Similar
Indications forUse	A chemical indicator for monitoring allcycles within the STERRAD® 100S(Standard & Long), 200, 100NX (Standard,Duo, Flex & Express), NX (Standard &Advanced), STERIS® V-PRO® 1, V-PRO®1 Plus (Lumen & Non-lumen), V-PRO®maX (Flexible, Lumen & Non-lumen) andSterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intendedto be used by health care providers withsterilization wraps, containers, cassettes, orpouches to distinguish between processedand unprocessed units. Colors other thanblue such as yellow/green should be treatedas a process failure.	A chemical indicator for monitoring allcycles within the STERRAD® 100S(Standard & Long), 200, 100NX(Standard, Flex & Express), NX(Standard & Advanced), STERIS® V-PROTM 1, V-PROTM 1 Plus (Lumen &Non-lumen), V-PRO® maX (Flexible,Lumen & Non-lumen) and SterilucentTMPSD-85 (Lumen & Non-lumen). TheVH2O2 Indicators are intended to be usedby health care providers with sterilizationwraps, containers, cassettes, or pouches todistinguish between processed andunprocessed units. Colors other than bluesuch as yellow/green should be treated asa process failure.	Similar
Device Design	Label, Card, Strip, Tape	Strip, Label, Tape, Card	Same
Endpoint Color	Signal Color of Blue	Signal Color of Blue	Same

Table 1 - Technological Characteristics Comparison

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Image /page/5/Picture/0 description: The image shows the logo for "CROSSTEX A CANTEL MEDICAL COMPANY". The text is in a sans-serif font and is blue. The word "CROSSTEX" is in a larger font than the words "A CANTEL MEDICAL COMPANY". The logo is simple and modern.

Table 1 - Technological Characteristics Comparison - continued
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Element	Proposed Device (K200096)	Predicate Device (K140566)	Comparison
Indicator Agent	H2O2 Indicator Ink	H2O2 Indicator Ink	Same
SterilizationMethod	Vaporized HydrogenPeroxide	Vaporized HydrogenPeroxide	Same
Device Materials	Synthetic Substrate	Synthetic Substrate	Same
Performance underISO 11140-1Complete reactioncycle	Passed	Passed	Same
Biocompatibility	Complies	Complies	Same
Performance underISO 11140-1Incomplete reactioncycle	Passed	Passed	Same
Shelf-life	Up to 2 years	Up to 2 years	Same
Non-ClinicalPerformance -STERRAD®100NX® DUOCycle sterilizationcycle	Complete cycle turns blue withyellow/green intermediate.	Complete cycle turns blue withyellow/green intermediate.	Same

Summary of Non-Clinical Testing 6.

Nonclinical testing and biocompatibility testing was performed to demonstrate that the subject device conforms to the standards and testing mentioned below:

Test Methodology	Purpose	Acceptance Criteria	Results
ANSI/AAMI/ISO11140-1:2014 testingfor Type 1 ProcessIndicator	To demonstrate compliance torequirements specified in ISO11140-1:2014	Device functions andtransitions to blue whenprocessed in a STERRAD®100NXTM DUO sterilizationcycle.	Pass
Testing Color Change	To demonstrate the colorchange of the device when usedin the STERRAD® 100NXTMDUO sterilization cycle.	Color change to bluewithout ink bleeding	Pass
End Point ColorStability	To demonstrate the poststerilization colorstability of the deviceafter use in theSTERRAD® 100NXTMDUO sterilization cycle	No significant color changeafter exposure tofluorescent light for aminimum of six (6) months.	Pass

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Crosstex International, Inc. 6789 West Henrietta Road Rush, NY 14543 Tel: (800) 722-1529

Image /page/6/Picture/1 description: The image shows the Crosstex logo. The word "CROSSTEX" is written in large, blue, sans-serif letters. Below the word "CROSSTEX" is the phrase "A CANTEL MEDICAL COMPANY" in smaller, blue, sans-serif letters. The logo is simple and professional.

Test Methodology	Purpose	Acceptance Criteria	Results
Biocompatibility andink transfer test.	To demonstrate device andmaterials of construction arebiocompatible with end-usersand Healthcare Professionals.	Tested per ISO 11140-2:2014.Materials of construction isthe same as currently cleareddevice.	Pass.
		Device does not release anytoxic substance in sufficientquantities to cause a healthhazard,
		No ink migration or transferobserved with unprocessedand processed devices.

7. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device

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).