(87 days)
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.
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.
The provided text is a 510(k) summary for a medical device (Sterilucent VH2O2 Chemical Indicator), but it does not describe a study involving an AI/ML-based medical device or comparative effectiveness with human readers. Therefore, many of the requested points, such as MRMC studies, training set details, or expert ground truth adjudication, are not applicable to this type of device (a chemical indicator).
However, I can extract the relevant information regarding the acceptance criteria and performance of this chemical indicator device.
Here's a breakdown of the information available in the provided document, addressing the closest applicable aspects of your request:
Device: Sterilucent VH2O2 Chemical Indicator (a non-AI, non-software device)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Goal) | Reported Device Performance (Result) |
|---|---|---|
| ISO 11140-1 compliance | Demonstrate compliance to ISO 11140-1 pass/fail criteria | Passed |
| Shelf-life | Demonstrate compliance to ISO 11140-1 pass/fail criteria on devices at the stated shelf life | Passed |
| Sterilucent VH2O2 Chemical Indicator Functionality | Demonstrate appropriate color change in applicable sterilizer | Passed |
| Endpoint Color Stability | Demonstrate processed indicator endpoint color stability | Passed |
| Biocompatibility | Demonstrate CI does not release any known toxic substances | Passed |
Color Change Specifics: The device is designed to change color from Red/Pink to Blue upon exposure to the VHP sterilization process. Colors other than blue (e.g., yellow/green) indicate a process failure.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test listed (e.g., how many indicators were tested for ISO compliance, shelf-life, etc.). It only states that "Performance testing was conducted to demonstrate the functionality..." and that the tests "Passed."
- Sample Size: Not explicitly stated for each test.
- Data Provenance: The tests were conducted to demonstrate compliance with the ANSI/AAMI/ISO 11140-1:2014 standard for vaporized hydrogen peroxide sterilization indicators. The testing is non-clinical performance testing of the physical device. Country of origin for testing is not specified, but the applicant is Sterilucent, Inc. in Minneapolis, Minnesota, USA. It is retrospective in the sense that the testing was performed and then summarized for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This concept is not applicable to this type of device. The ground truth for a chemical indicator's performance is established by whether it correctly changes color under specific chemical and physical sterilization conditions according to established international standards (ISO 11140-1). It's a binary chemical reaction/physical property, not an interpretation requiring human experts like in imaging.
4. Adjudication Method for the Test Set
This concept is not applicable. There is no "adjudication" in the sense of resolving disagreements among human readers or expert labelers for this type of device. The pass/fail criteria are based on objective physical/chemical changes and adherence to the ISO standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for AI/ML-based diagnostic devices where human readers' performance with and without AI assistance is being evaluated. This device is a chemical indicator, not an AI/ML diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This concept is not applicable. This is a physical chemical indicator, not an algorithm. Its "standalone performance" refers to its ability to react correctly to sterilization conditions, which is what the non-clinical tests (ISO 11140-1 compliance, functionality, etc.) evaluated.
7. The Type of Ground Truth Used
The ground truth is based on:
- International Consensus Standards: Specifically, ANSI/AAMI/ISO 11140-1:2014, which defines the expected performance and pass/fail criteria for chemical indicators.
- Physical/Chemical Properties: The expected color change reaction when exposed to specific concentrations of hydrogen peroxide vapor and other parameters of the sterilization cycle.
- Absence of Toxicity: Biocompatibility testing to ensure the device does not release known toxic substances.
This is not a ground truth derived from expert consensus, pathology, or outcomes data in the medical imaging or diagnostic sense.
8. The Sample Size for the Training Set
This concept is not applicable. This device is a physical chemical indicator, not an AI/ML model that requires a training set. The device's "training" is its chemical formulation and manufacturing process, which are designed to react consistently.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable for the reason stated in point 8.
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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
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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,
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
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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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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 processindicator that conforms to ANSI/AAMI/ISO 11140-1:2014, and is intendedto 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 HydrogenPeroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization cycles ("Lumen" and "Flexible") which bothutilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety ofreusable medical devices. |
| The Sterilucent VH2O2 Chemical Indicator is provided in two differentformats: Strip and Label. Both formats consist of a polymeric material onwhich indicator ink is deposited. A pressure-sensitive adhesive is providedon the back of the Label, which allows the process indicator to be adhered tovarious substrates including containers, pouches, tamper-proof arrows orlocks, etc. | |
| The Sterilucent VH2O2 Chemical Indicator provides a visual indication that asterilization load has been exposed to the VHP sterilization process. Theindicator works by means of a chemical reaction, which results in arecognizable color change from red to blue. | |
| Indication for Use: | A chemical indicator for monitoring all cycles within the Sterilucent™ HC80TT 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 SterilucentPSD-85 (Lumen & Non-Lumen). The VH2O2 Indicators are intended to beused by health care providers with sterilization wraps, containers, cassettes,or pouches to distinguish between processed and unprocessed units. Colorsother than blue such as yellow/green should be treated as a process failure. |
Technological Characteristics Table:
| ProposedSterilucent VH2O2 ChemicalIndicators | PredicateSPSmedical VH2O2 Indicators(K140566/ K110152) | Comparison | |
|---|---|---|---|
| Manufacturer | Crosstex-SPSmedical | Crosstex-SPSmedical | Same |
| ProposedSterilucent VH2O2 ChemicalIndicators | PredicateSPSmedical 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™ HC80TT 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) andSterilucent PSD-85 (Lumen & Non-Lumen). The VH2O2 Indicators areintended to be used by health careproviders with sterilization wraps,containers, cassettes, or pouches todistinguish between processed andunprocessed units. Colors other thanblue such as yellow/green should betreated as a process failure. | A chemical indicator for monitoringall 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) andSterilucent™ PSD-85 (Lumen & Non-Lumen). The VH2O2 Indicators areintended to be used by health careproviders with sterilization wraps,containers, cassettes, or pouches todistinguish between processed andunprocessed units. Colors other thanblue such as yellow/green should betreated as a process failure. | Similar |
| Device Design | Strip, Label | Strip, Label, Tape | Similar |
| Endpoint Specifications -Color Change UponExposure to H2O2 | Red/Pink changes to Blue | Red/Pink changes to Blue | Same |
| Indicator Agent | TetraethylammoniumBromide(ammonium salt) | TetraethylammoniumBromide(ammonium salt) | Same |
| Indicator InkComponents | 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 Testingunder ISO 11140-1 forVH2O2 Indicators | Comply with Standard | Comply with Standard | Same |
| Full Cycle In-UseValidation Testing of CIwith listed sterilizers | Yes | Yes | Same |
| Shelf Life | Up to 2 years from date of manufacture | Up to 2 years from date ofmanufacture | Same |
| Distributor | Sterilucent & SPSmedical | Sterilucent & SPSmedical | Same |
| Storage Conditions | Dry area, ambient temperature of 15° to30° C, away from alkaline chemicals,acids, and sources of light | Dry area, ambient temperature of 15°to 30° C, away from alkalinechemicals, acids, and sources of light | Same |
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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.
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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 ISO11140-1 pass/fail criteria | Passed |
| Shelf-life | ISO 11140-1 | Demonstrate compliance to ISO11140-1 pass/fail criteria on devicesat the stated shelf life | Passed |
| Sterilucent VH2O2 ChemicalIndicator Functionality | NA | Demonstrate appropriate colorchange in applicable sterilizer | Passed |
| Endpoint Color Stability | NA | Demonstrate processed indicatorendpoint color stability | Passed |
| Biocompatibility | NA | Demonstrate CI does not releaseany 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.
§ 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).