Crosstex VH2O2 Chemical Indicators

K200096 · Crosstex International, Inc. (A Cantel Medical Company) · JOJ · Jul 15, 2021 · General Hospital

Device Facts

• Record ID: K200096
• Device Name: Crosstex VH2O2 Chemical Indicators
• Applicant: Crosstex International, Inc. (A Cantel Medical Company)
• Product Code: JOJ · General Hospital
• Decision Date: Jul 15, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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.

Device Story

Crosstex VH2O2 Chemical Indicators are process indicators used in vaporized hydrogen peroxide sterilization cycles. The device consists of a synthetic substrate treated with H2O2-sensitive indicator ink, available in label, card, strip, or tape formats. Healthcare providers place the indicator with sterilization wraps, containers, cassettes, or pouches before processing. Upon exposure to vaporized hydrogen peroxide, the indicator ink undergoes a chemical reaction, changing color from yellow/green to blue. This visual change allows providers to distinguish between processed and unprocessed units. If the indicator does not turn blue, it indicates a process failure. The device is used in clinical settings to ensure that items have been subjected to the sterilization process, aiding in the management of sterile supplies.

Clinical Evidence

Bench testing only. Performance was evaluated per ANSI/AAMI/ISO 11140-1:2014 standards. Testing confirmed the device transitions to blue in STERRAD 100NX DUO cycles without ink bleeding. Biocompatibility testing per ISO 11140-2:2014 confirmed no toxic substance release or ink migration. Post-sterilization color stability was verified after 6 months of fluorescent light exposure.

Technological Characteristics

Synthetic substrate with H2O2-sensitive indicator ink. Form factors include label, card, strip, and tape. Operates via chemical reaction to vaporized hydrogen peroxide. Complies with ISO 11140-1:2014 (Type 1 Process Indicator) and ISO 11140-2:2014. Shelf-life is 2 years.

Indications for Use

Indicated for monitoring all vaporized hydrogen peroxide sterilization cycles in STERRAD 100S, 200, 100NX, NX, STERIS V-PRO 1, V-PRO 1 Plus, V-PRO maX, and Sterilucent PSD-85 systems. Used by healthcare providers with sterilization wraps, containers, cassettes, or pouches to distinguish processed from unprocessed units.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• Crosstex/SPSmedical VH2O2 Chemical Indicator (K140566)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| | 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: [phone]

# 510(k) Summary for K200096 Crosstex VH2O2 Chemical Indicators

| Manufacturer: | Crosstex International, Inc. |
|-------------------|----------------------------------------------------------------------------------------------------------------|
| Address: | 6789 West Henrietta Road<br>Rush, NY 14543<br>[phone] |
| Official Contact: | Pablo Martinez<br>Sr. Manager, Regulatory Affairs |
| Address: | Crosstex International, Inc.<br>10 Ranick Road<br>Hauppauge, NY 11788<br>[e-mail]<br>[phone] |
| 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.<br>6789 West Henrietta Road<br>Rush, NY 14543 U.S.A. |

### 3. 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.

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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: [phone]

### 4. Intended Use

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.

## 5. Technological Characteristics Comparison

| Element | Proposed Device (K200096) | Predicate Device (K140566) | Comparison |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The Crosstex VH2O2 Chemical Indicators<br>are intended for use as process indicators for<br>all vaporized hydrogen peroxide cycles in<br>the STERRAD® 100S, 200, 100NX<br>(Standard, Duo, Flex & Express), NX<br>(Standard & Advanced), STERIS® V-PRO®<br>1, V-PRO® 1 Plus, V-PRO® maX, and<br>Sterilucent™ PSD-85 sterilization processes.<br>The Crosstex VH2O2 Chemical Indicators<br>are intended to be used by health care<br>providers with articles such as sterilization<br>wraps, containers, cassettes, or pouches to<br>distinguish<br>between processed<br>and<br>unprocessed units. Chemical indicators<br>change to a color of blue after exposure to<br>vaporized hydrogen peroxide. Colors other<br>than blue such as yellow/green should be<br>treated as a process failure. | The SPSmedical VH2O2 Indicators are<br>intended for use as process indicators for<br>all vaporized hydrogen peroxide cycles in<br>the STERRAD® 100S, 200, 100NX, NX,<br>STERIS® V-PRO 1, V-PRO 1 Plus, V-PRO<br>maX and Sterilucent PSD-85 sterilization<br>processes. They are intended to be used<br>by health care providers with articles such<br>as sterilization wraps, containers,<br>cassettes, or pouches to distinguish<br>between processed and unprocessed items.<br>Indicators change to a signal color of Blue<br>after exposure to vapor hydrogen<br>peroxide. | Similar |
| Indications for<br>Use | A chemical indicator for monitoring all<br>cycles within the STERRAD® 100S<br>(Standard & Long), 200, 100NX (Standard,<br>Duo, Flex & Express), NX (Standard &<br>Advanced), STERIS® V-PRO® 1, V-PRO®<br>1 Plus (Lumen & Non-lumen), V-PRO®<br>maX (Flexible, Lumen & Non-lumen) and<br>Sterilucent™ PSD-85 (Lumen & Non-<br>lumen). The VH2O2 Indicators are intended<br>to be used by health care providers with<br>sterilization wraps, containers, cassettes, or<br>pouches to distinguish between processed<br>and unprocessed units. Colors other than<br>blue such as yellow/green should be treated<br>as a process failure. | A chemical indicator for monitoring all<br>cycles within the STERRAD® 100S<br>(Standard & Long), 200, 100NX<br>(Standard, Flex & Express), NX<br>(Standard & Advanced), STERIS® V-<br>PROTM 1, V-PROTM 1 Plus (Lumen &<br>Non-lumen), V-PRO® maX (Flexible,<br>Lumen & Non-lumen) and SterilucentTM<br>PSD-85 (Lumen & Non-lumen). The<br>VH2O2 Indicators are intended to be used<br>by health care providers with sterilization<br>wraps, containers, cassettes, or pouches to<br>distinguish between processed and<br>unprocessed units. Colors other than blue<br>such as yellow/green should be treated as<br>a 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 | | | | | | | | | | | | | |
|----------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|
|----------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|

| Element | Proposed Device (K200096) | Predicate Device (K140566) | Comparison |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|------------|
| Indicator Agent | H2O2 Indicator Ink | H2O2 Indicator Ink | Same |
| Sterilization<br>Method | Vaporized Hydrogen<br>Peroxide | Vaporized Hydrogen<br>Peroxide | Same |
| Device Materials | Synthetic Substrate | Synthetic Substrate | Same |
| Performance under<br>ISO 11140-1<br>Complete reaction<br>cycle | Passed | Passed | Same |
| Biocompatibility | Complies | Complies | Same |
| Performance under<br>ISO 11140-1<br>Incomplete reaction<br>cycle | Passed | Passed | Same |
| Shelf-life | Up to 2 years | Up to 2 years | Same |
| Non-Clinical<br>Performance -<br>STERRAD®<br>100NX® DUO<br>Cycle sterilization<br>cycle | Complete cycle turns blue with<br>yellow/green intermediate. | Complete cycle turns blue with<br>yellow/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/ISO<br>11140-1:2014 testing<br>for Type 1 Process<br>Indicator | To demonstrate compliance to<br>requirements specified in ISO<br>11140-1:2014 | Device functions and<br>transitions to blue when<br>processed in a STERRAD®<br>100NXTM DUO sterilization<br>cycle. | Pass |
| Testing Color Change | To demonstrate the color<br>change of the device when used<br>in the STERRAD® 100NXTM<br>DUO sterilization cycle. | Color change to blue<br>without ink bleeding | Pass |
| End Point Color<br>Stability | To demonstrate the post<br>sterilization color<br>stability of the device<br>after use in the<br>STERRAD® 100NXTM<br>DUO sterilization cycle | No significant color change<br>after exposure to<br>fluorescent light for a<br>minimum of six (6) months. | Pass |

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Crosstex International, Inc. 6789 West Henrietta Road Rush, NY 14543 Tel: [phone]

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 and<br>ink transfer test. | To demonstrate device and<br>materials of construction are<br>biocompatible with end-users<br>and Healthcare Professionals. | Tested per ISO 11140-<br>2:2014.<br><br>Materials of construction is<br>the same as currently cleared<br>device. | Pass. |
| | | Device does not release any<br>toxic substance in sufficient<br>quantities to cause a health<br>hazard, | |
| | | No ink migration or transfer<br>observed with unprocessed<br>and 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