(546 days)
No
The device is a chemical indicator that changes color based on exposure to vaporized hydrogen peroxide. There is no mention of any computational processing, learning, or data analysis, which are characteristic of AI/ML.
No
The device is a chemical indicator used to monitor sterilization cycles and distinguish between processed and unprocessed units, not to treat a disease or condition in a patient.
No
Explanation: The device is a chemical indicator used to monitor sterilization cycles by distinguishing between processed and unprocessed units based on a color change. It indicates a process failure but does not diagnose a medical condition in a patient.
No
The device is a chemical indicator, which is a physical product that changes color. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor sterilization cycles and distinguish between processed and unprocessed units. This is a quality control function for a sterilization process, not a diagnostic test performed on a biological sample to diagnose a disease or condition.
- Device Description: The device is a chemical indicator that changes color based on exposure to vaporized hydrogen peroxide. It does not interact with or analyze biological samples.
- Lack of Biological Sample Interaction: IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not use or analyze such samples.
- Performance Studies: The performance studies focus on the chemical indicator's ability to change color correctly and its biocompatibility, not on diagnostic accuracy metrics like sensitivity, specificity, etc., which are typical for IVDs.
In summary, this device is a process indicator used to verify the effectiveness of a sterilization cycle, which is a quality control measure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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.
Product codes
JOJ
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.
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
health care providers
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
Nonclinical testing and biocompatibility testing was performed to demonstrate that the subject device conforms to the standards and testing mentioned below:
- Test Methodology: ANSI/AAMI/ISO 11140-1:2014 testing for Type 1 Process Indicator; Purpose: To demonstrate compliance to requirements specified in ISO 11140-1:2014; Acceptance Criteria: Device functions and transitions to blue when processed in a STERRAD® 100NXTM DUO sterilization cycle.; Results: Pass
- Test Methodology: Testing Color Change; Purpose: To demonstrate the color change of the device when used in the STERRAD® 100NXTM DUO sterilization cycle.; Acceptance Criteria: Color change to blue without ink bleeding; Results: Pass
- Test Methodology: End Point Color Stability; Purpose: To demonstrate the post sterilization color stability of the device after use in the STERRAD® 100NXTM DUO sterilization cycle; Acceptance Criteria: No significant color change after exposure to fluorescent light for a minimum of six (6) months.; Results: Pass
- Test Methodology: Biocompatibility and ink transfer test.; Purpose: To demonstrate device and materials of construction are biocompatible with end-users and Healthcare Professionals.; Acceptance Criteria: 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.; Results: Pass.
Key Metrics
Not Found
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
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
1
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
2
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: (800) 722-1529
510(k) Summary for K200096 Crosstex VH2O2 Chemical Indicators
| Manufacturer: | Crosstex International, Inc. |
|---|---|
| Address: | 6789 West Henrietta Road |
| Rush, NY 14543 | |
| (800) 722-1529 | |
| Official Contact: | Pablo Martinez |
| Sr. Manager, Regulatory Affairs | |
| Address: | Crosstex International, Inc. |
| 10 Ranick Road | |
| Hauppauge, NY 11788 | |
| PabloM@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 Road | |
| 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.
4
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
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 | ||
| 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 VH2O2 Chemical 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. | The SPSmedical VH2O2 Indicators are | ||
| intended for use as process indicators for | |||
| all vaporized hydrogen peroxide cycles in | |||
| the STERRAD® 100S, 200, 100NX, NX, | |||
| STERIS® V-PRO 1, V-PRO 1 Plus, V-PRO | |||
| maX and Sterilucent PSD-85 sterilization | |||
| processes. They 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 items. | |||
| Indicators change to a signal color of Blue | |||
| after exposure to vapor hydrogen | |||
| peroxide. | Similar | ||
| Indications for | |||
| Use | 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, 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, containers, 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. | A chemical indicator for monitoring all | ||
| cycles 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 SterilucentTM | |||
| PSD-85 (Lumen & Non-lumen). The | |||
| VH2O2 Indicators are intended to be used | |||
| by health care providers with sterilization | |||
| wraps, containers, 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. | 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 | |||
| Method | Vaporized Hydrogen | ||
| Peroxide | Vaporized Hydrogen | ||
| Peroxide | Same | ||
| Device Materials | Synthetic Substrate | Synthetic Substrate | Same |
| Performance under | |||
| ISO 11140-1 | |||
| Complete reaction | |||
| cycle | Passed | Passed | Same |
| Biocompatibility | Complies | Complies | Same |
| Performance under | |||
| ISO 11140-1 | |||
| Incomplete reaction | |||
| cycle | Passed | Passed | Same |
| Shelf-life | Up to 2 years | Up to 2 years | Same |
| Non-Clinical | |||
| Performance - | |||
| STERRAD® | |||
| 100NX® DUO | |||
| Cycle sterilization | |||
| cycle | Complete cycle turns blue with | ||
| yellow/green intermediate. | Complete cycle turns blue with | ||
| 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 | |||
| 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® | |||
| 100NXTM DUO sterilization | |||
| cycle. | Pass | ||
| Testing Color Change | To demonstrate the color | ||
| change of the device when used | |||
| in the STERRAD® 100NXTM | |||
| 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® 100NXTM | |||
| DUO sterilization cycle | No significant color change | ||
| after exposure to | |||
| fluorescent light for a | |||
| minimum of six (6) months. | Pass |
6
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 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. | Pass. |
| | | 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. | |
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