(87 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to vaporized hydrogen peroxide, relying on a chemical reaction, not AI/ML. The text explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is a chemical indicator used to monitor sterilization processes, not to treat or diagnose patients.
No
This device is a chemical indicator used to monitor sterilization cycles by distinguishing between processed and unprocessed units; it does not diagnose medical conditions in patients.
No
The device is a chemical indicator, which is a physical product that changes color based on exposure to a chemical process. 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 in hydrogen peroxide sterilizers. It's used to distinguish between processed and unprocessed units of medical devices. This is a quality control measure for sterilization, not a diagnostic test performed on biological samples.
- Device Description: The device is a chemical indicator that changes color based on exposure to vaporized hydrogen peroxide. It's a physical indicator used in a sterilization process.
- Lack of Biological Sample Analysis: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological samples.
- Focus on Sterilization Process: The entire description revolves around monitoring the effectiveness of a sterilization process for medical devices.
Therefore, this device falls under the category of a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A chemical indicator for monitoring all cycles within the Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer (Lumen & Flexible), STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® VPRO™ 1, V-PRO™ 1 Plus (Lumen & Non-Lumen). VPRO® 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 units. Colors other than blue such as yellow/green should be treated as a process failure.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The Sterilucent VH2O2 Chemical Indicator is a Class 1/Type 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1:2014, and is intended to be used with currently cleared hydrogen peroxide sterilizers (STERRAD® 100S, 200, 100NX, NX, STERIS® VPRO™ 1, V-PRO™ 1 Plus, VPRO® maX and the Sterilucent PSD-85) and the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization cycles ("Lumen" and "Flexible") which both utilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety of reusable medical devices.
The Sterilucent VH2O2 Chemical Indicator is provided in two different formats: Strip and Label. Both formats consist of a polymeric material on which indicator ink is deposited. A pressure-sensitive adhesive is provided on the back of the Label, which allows the process indicator to be adhered to various substrates including containers, pouches, tamper-proof arrows or locks, etc.
The Sterilucent VH2O2 Chemical Indicator provides a visual indication that a sterilization load has been exposed to the VHP sterilization process. The indicator works by means of a chemical reaction, which results in a recognizable color change from red to blue.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to demonstrate the functionality of the Sterilucent VH2O2 Chemical Indicator and general conformance with the requirements for Class 1/Type 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2014.
Study type: ISO 11140-1 compliance
Goal: Demonstrate compliance to ISO 11140-1 pass/fail criteria
Result: Passed
Study type: Shelf-life
Goal: Demonstrate compliance to ISO 11140-1 pass/fail criteria on devices at the stated shelf life
Result: Passed
Study type: Sterilucent VH2O2 Chemical Indicator Functionality
Goal: Demonstrate appropriate color change in applicable sterilizer
Result: Passed
Study type: Endpoint Color Stability
Goal: Demonstrate processed indicator endpoint color stability
Result: Passed
Study type: Biocompatibility
Goal: Demonstrate CI does not release any know toxic substances
Result: Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SPSmedical VH2O2 Indicators (K140566/ K110152)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 21, 2019
Sterilucent, Inc. Peter Kalkbrenner Director of Engineering 1400 Marshall St. NE Minneapolis, Minnesota 55413
Re: K191999
Trade/Device Name: Sterilucent VH2O2 Chemical Indicators Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: July 25, 2019 Received: July 26, 2019
Dear Peter Kalkbrenner:
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,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K191999
Device Name Sterilucent VH2O2 Chemical Indicator
Indications for Use (Describe)
A chemical indicator for monitoring all cycles within the Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer (Lumen & Flexible), STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® VPRO™ 1, V-PRO™ 1 Plus (Lumen & Non-Lumen). VPRO® 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 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)
× | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary for the Sterilucent VH2O2 Chemical Indicator
| Submitted by: | Sterilucent, Inc. |
|---|---|
| Contact Person: | Peter R. Kalkbrenner |
| Director of Engineering | |
| peter.kalkbrenner@sterilucent.com | |
| Phone: 612-767-3253 | |
| Fax: 612-767-3261 | |
| Date of Summary: | 21 October 2019 |
| Device Trade Name: | Sterilucent VH2O2 Chemical Indicator |
| Common or Usual Name: | Chemical sterilization process indicator |
| Classification: | 21 CFR 880.2800(b) |
| Class: | II |
| Product Code: | JOJ |
| Predicate Device(s): | SPSmedical VH2O2 Indicators (K140566/ K110152) |
| Device Description: | The Sterilucent VH2O2 Chemical Indicator is a Class 1/Type 1 process |
| indicator that conforms to ANSI/AAMI/ISO 11140-1:2014, and is intended | |
| to be used with currently cleared hydrogen peroxide sterilizers (STERRAD® | |
| 100S, 200, 100NX, NX, STERIS® VPRO™ 1, V-PRO™ 1 Plus, VPRO® | |
| maX and the Sterilucent PSD-85) and the Sterilucent HC 80TT Hydrogen | |
| Peroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre- | |
| programmed sterilization cycles ("Lumen" and "Flexible") which both | |
| utilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety of | |
| reusable medical devices. | |
| The Sterilucent VH2O2 Chemical Indicator is provided in two different | |
| formats: Strip and Label. Both formats consist of a polymeric material on | |
| which indicator ink is deposited. A pressure-sensitive adhesive is provided | |
| on the back of the Label, which allows the process indicator to be adhered to | |
| various substrates including containers, pouches, tamper-proof arrows or | |
| locks, etc. | |
| The Sterilucent VH2O2 Chemical Indicator provides a visual indication that a | |
| sterilization load has been exposed to the VHP sterilization process. The | |
| indicator works by means of a chemical reaction, which results in a | |
| recognizable color change from red to blue. | |
| Indication for Use: | A chemical indicator for monitoring all cycles within the Sterilucent™ HC |
| 80TT Hydrogen Peroxide Sterilizer (Lumen & Flexible), STERRAD® 100S | |
| (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard | |
| & Advanced), STERIS® VPRO™ 1, V-PRO™ 1 Plus (Lumen & Non- | |
| Lumen), VPRO® 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. |
Technological Characteristics Table:
| | Proposed
Sterilucent VH2O2 Chemical
Indicators | Predicate
SPSmedical VH2O2 Indicators
(K140566/ K110152) | Comparison |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Crosstex-SPSmedical | Crosstex-SPSmedical | Same |
| Proposed
Sterilucent VH2O2 Chemical
Indicators | | Predicate
SPSmedical VH2O2 Indicators
(K140566/ K110152) | Comparison |
| Intended Use | Single use sterilization process indicator | Single use sterilization process indicator | Same |
| Indications for Use | A chemical indicator for monitoring all cycles within the Sterilucent™ HC
80TT Hydrogen Peroxide Sterilizer
(Lumen & Flexible), STERRAD®
100S (Standard & Long), 200, 100NX
(Standard, Flex & Express), NX
(Standard & Advanced), STERIS®
VPRO™ 1, V-PRO™ 1 Plus (Lumen
& Non-Lumen), VPRO® 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®
VPRO™ 1, V-PRO™ 1 Plus (Lumen
& Non-Lumen), VPRO® 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. | Similar |
| Device Design | Strip, Label | Strip, Label, Tape | Similar |
| Endpoint Specifications -
Color Change Upon
Exposure to H2O2 | Red/Pink changes to Blue | Red/Pink changes to Blue | Same |
| Indicator Agent | Tetraethylammonium
Bromide(ammonium salt) | Tetraethylammonium
Bromide(ammonium salt) | Same |
| Indicator Ink
Components | Water-based Carrier; Activator,
Indicator Agent, & Modulator | Water-based Carrier; Activator,
Indicator Agent, & Modulator | Same |
| Substrate | Polymer (Tyvek, Polypropylene,
polystyrene) | Polymer (Tyvek, Polypropylene,
polystyrene) | Same |
| Conformance Testing
under ISO 11140-1 for
VH2O2 Indicators | Comply with Standard | Comply with Standard | Same |
| Full Cycle In-Use
Validation Testing of CI
with listed sterilizers | Yes | Yes | Same |
| Shelf Life | Up to 2 years from date of manufacture | Up to 2 years from date of
manufacture | Same |
| Distributor | Sterilucent & SPSmedical | Sterilucent & SPSmedical | Same |
| Storage Conditions | Dry area, ambient temperature of 15° to
30° C, away from alkaline chemicals,
acids, and sources of light | Dry area, ambient temperature of 15°
to 30° C, away from alkaline
chemicals, acids, and sources of light | Same |
4
The Sterilucent VH2O2 Chemical Indicator and predicate device are both single-use process indicators intended to monitor exposure to sterilization cycles utilizing vaporized hydrogen peroxide as a sterilant. Both devices have the same intended use, design, materials, specifications, and modeof-action, and are manufactured using the exact same production methods.
5
Summary of Non-Clinical Testing:
Performance testing was conducted to demonstrate the functionality of the Sterilucent VH2O2 Chemical Indicator and general conformance with the requirements for Class 1/Type 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2014. A summary of nonclinical tests performed follows:
| Test | Standard Used | Goal | Result |
|---|---|---|---|
| ISO 11140-1 compliance | ISO 11140-1 | Demonstrate compliance to ISO | |
| 11140-1 pass/fail criteria | Passed | ||
| Shelf-life | ISO 11140-1 | Demonstrate compliance to ISO | |
| 11140-1 pass/fail criteria on devices | |||
| at the stated shelf life | Passed | ||
| Sterilucent VH2O2 Chemical | |||
| Indicator Functionality | NA | Demonstrate appropriate color | |
| change in applicable sterilizer | Passed | ||
| Endpoint Color Stability | NA | Demonstrate processed indicator | |
| endpoint color stability | Passed | ||
| Biocompatibility | NA | Demonstrate CI does not release | |
| any know toxic substances | Passed |
Summary of Clinical Clinical evaluations were not required and therefore are not submitted with this Testing: 510(k).
Overall Performance Based on the nonclinical tests performed, the subject device, the Sterilucent Conclusion: VH2O2 Chemical Indicator, is as safe, as effective and performs as well as or better than the legally marketed predicate device, the SPSmedical VH2O2 Indicators.