(88 days)
The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack.
The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures.
Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.
The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilization process indicator that conforms to ANSI/AAMI/ISO 11138-1, and is intended for use only with 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 SCBI is to be used in a test pack configuration, with a different test pack (Process Challenge Device) used for each sterilization cycle. Each Process Challenge Device (PCD) is designed to have greater resistance than the worst-case sterilization load, allowing for survival beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.
The Sterilucent SCBI provides information on whether necessary conditions were met to kill a specified number of microorganisms upon exposure to either cycle of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer.
The document describes the acceptance criteria and study results for the Sterilucent Self-Contained Biological Indicator (SCBI) and Process Challenge Device (PCD).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SCBI Resistance Evaluation (D-Value & Survival/Kill Window) | Meaningful value | Passed |
| SCBI Holding Time Assessment (24 hours) | Meaningful value | Passed |
| SCBI Reduced Incubation Time (24 hours) | Value less than seven (7) days based on FDA RIT protocol | Passed |
| SCBI Growth Inhibition (none allowed) | Spore growth | Passed |
| SCBI Population Stability & 12-month Shelf Life | Spore population remains between 1.0-4.0 x 10^6 throughout | Passed |
| SCBI Integrated Chemical Indicator Verification | ISO 11140-1 Section 8.7, Table 6 | Passed |
| PCD Resistance Characterization | Greater resistance as demonstrated by fractional kill | Passed |
| PCD Functionality | Fractional kill at half-cycle; all kill at full cycle | Passed |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test. The provenance of the data is not explicitly stated in terms of country of origin, but the submission is for the U.S. Food and Drug Administration (FDA), implying the testing was conducted to meet U.S. regulatory standards. The testing appears to be prospective as it was conducted to demonstrate the functionality of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a biological indicator and process challenge device for sterilization. Its performance is evaluated through biological and physical tests based on established standards, not through expert interpretation of data like in diagnostic imaging.
4. Adjudication method for the test set
This information is not applicable for this type of device and testing. The evaluation relies on quantitative measurements and adherence to predefined performance metrics rather than expert consensus on subjective outcomes.
5. 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
This information is not applicable. This device is a sterilization indicator, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device itself is non-algorithmic and does not involve AI or human-in-the-loop performance in the conventional sense of software-as-a-medical-device. Its performance is inherent to its design and material properties.
7. The type of ground truth used
The ground truth for the SCBI and PCD testing is established by recognized international standards and methodologies for sterilization indicators. This includes:
- Biological inactivation: The absence or presence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
- Physical/chemical parameters: Measurements of D-value, survival/kill windows, spore population counts, pH changes, and color changes in chemical indicators.
- Compliance with standards: Adherence to ANSI/AAMI/ISO 11138-1, ANSI/AAMI/ISO 11140-1, and FDA Guidance documents.
8. The sample size for the training set
This information is not applicable. The Sterilucent SCBI and PCD are not AI/ML-based devices; therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable as the device does not utilize a training set in the AI/ML sense.
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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 & Human Services logo. To the right of that is the FDA logo, which 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 22, 2019
Sterilucent, Inc. Peter Kalkbrenner Director of Engineering 1400 Marshall St. NE Minneapolis, Minnesota 55413
Re: K192001
Trade/Device Name: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC 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.
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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 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 (QS) 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 medical devices and radiation-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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192001
Device Name
Sterilucent Self-Contained Biological Indicator Sterilucent Lumen Cycle Process Challenge Device Sterilucent Flexible Cycle Process Challenge Device
Indications for Use (Describe)
The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack.
The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures.
Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.
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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510(k) Summary for the Sterilucent Self-Contained Biological Indicator and Test Pack (K192001)
| Submitted by: | Sterilucent, Inc.1400 Marshall Street NEMinneapolis, MN 55413USA |
|---|---|
| Contact Person: | Peter R. KalkbrennerDirector of Engineeringpeter.kalkbrenner@sterilucent.comPhone: 612-767-3253Fax: 612-767-3261 |
| Date of Summary: | 22 October 2019 |
| Device Trade Name: | Sterilucent Self-Contained Biological IndicatorSterilucent Lumen Cycle Process Challenge DeviceSterilucent Flexible Cycle Process Challenge Device |
| Common or UsualName: | Biological Indicator (Test Pack) |
| Classification Name:Classification: | Biological Sterilization Process Indicator21 CFR 880.2800(a) |
| Class: | II |
| Product Code: | FRC |
| Predicate Device(s): | STERRAD® CYCLESURE® 24 Plus BI (K140589)Sterilucent Process Challenge Device (K141312) |
| Device Description: | The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilizationprocess indicator that conforms to ANSI/AAMI/ISO 11138-1, and is intendedfor use only with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. TheHC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilizationcycles ("Lumen" and “Flexible") which both utilize vaporized hydrogenperoxide (VHP) to rapidly sterilize a variety of reusable medical devices.The Sterilucent SCBI is to be used in a test pack configuration, with adifferent test pack (Process Challenge Device) used for each sterilizationcycle. Each Process Challenge Device (PCD) is designed to have greaterresistance than the worst-case sterilization load, allowing for survival beyondthe sterilization half-cycle, but complete inactivation upon exposure to the fullcycle.The Sterilucent SCBI provides information on whether necessary conditionswere met to kill a specified number of microorganisms upon exposure toeither cycle of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. |
| Indication for Use: | The Sterilucent SCBI is intended to be used as a standard method for frequentmonitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporatedinto a test pack.The Sterilucent Process Challenge Device (PCD) test pack is used for routinemonitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles.The Sterilucent PCD may also be used for performance qualification of theSterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial |
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installation, after relocation, major repairs or malfunctions, or after sterilization process failures.
Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.
| ProposedSterilucent SCBI(K192001) | PredicateSTERRAD CYCLESURE 24 PlusBI (K140589) | Comparison | |
|---|---|---|---|
| Intended Use | Single use sterilization processindicator | Single use sterilization processindicator | Same |
| Indications for Use | The STERRAD® CYCLESURE® 24PLUS Biological Indicator is intendedto be used as a standard method forfrequent monitoring of STERRAD ®Sterilizer Cycles. | The Sterilucent SCBI is intended to beused as a standard method for frequentmonitoring of the Sterilucent HC80TT Sterilizer Cycles, whenincorporated into a test pack. | Similar |
| Organism | Geobacillus stearothermophilusATCC 7953 | Geobacillus stearothermophilusATCC 7953 | Same |
| Viable Spore Population | Equal or greater than 1.0 x106 | Equal or greater than 1.0 x106 | Same |
| Sterilization Agent | Hydrogen Peroxide Vapor | Hydrogen Peroxide Vapor | Same |
| Culture Conditions | Crushable glass ampoule containingmodified Tryptic Soy Broth with a pHindicator | Crushable glass ampoule containingmodified Tryptic Soy Broth with a pHindicator | Same |
| Carrier Material | Quartz Fiber Disc | Quartz Fiber Disc | Same |
| Primary Packaging | Polypropylene vial with a whitepolypropylene cap. The cap filter isTyvek non-woven polyethylene | Polypropylene vial with a whitepolypropylene cap. The cap filter isTyvek non-woven polyethylene | Same |
| D-Value | 5.7 - 9.1 sec. | 1.93 - 2.28 sec. | Similar |
| Survival/Kill Window | 25.0 sec. (All survive)140 sec. (All kill) | Not calculated or determined | Different |
| Shelf Life | 12 months from date of manufacture | 12 months from date of manufacture | Same |
| Storage Conditions | 2-25°C (35-77°F) under dry conditions | 2-25°C (35-77°F) under dryconditions | Same |
| Manufacturer | MESA Laboratories, Inc. | MESA Laboratories, Inc. | Same |
SCBI Technological Characteristics Table
PCD Test Pack Technological Characteristics Table
| ProposedSterilucent HC 80TT PCD(K192001) | PredicateSterilucent PSD-85 PCD (K141312) | Comparison | |
|---|---|---|---|
| Intended Use | Single use sterilization processindicator | Single use sterilization processindicator | Same |
| Indications for use | The Sterilucent Process ChallengeDevice is used for performancequalification of the Sterilucent PSD-85sterilizer Lumen and Non-LumenCycles during initial installation, afterrelocation, major repairs ormalfunctions, or after sterilizationprocess failures. The Sterilucent | The Sterilucent Process ChallengeDevice (PCD) test pack is used forroutine monitoring of the SterilucentHC 80TT Sterilizer Lumen andFlexible Cycles.The Sterilucent PCD may also be usedfor performance qualification of theSterilucent HC 80TT sterilizer Lumen | Similar |
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| ProposedSterilucent HC 80TT PCD(K192001) | PredicateSterilucent PSD-85 PCD (K141312) | Comparison | |
|---|---|---|---|
| Process Challenge Device may also beused for routine monitoring of the PSD-85 sterilizer Lumen and Non-LumenCycles. | and Flexible Cycles during initialinstallation, after relocation, majorrepairs or malfunctions, or aftersterilization process failures.Both the Sterilucent Lumen CyclePCD and the Sterilucent FlexibleCycle PCD are intended to havegreater resistance than the stand aloneSCBI. Both devices are designed tohave increased resistance beyond thesterilization half-cycle, but completeinactivation upon exposure to the fullcycle. | ||
| SCBI | Sterilucent HC 80TT SCBI, quartzfiber carrier inoculated with > 106Geobacillus sterathermophilus sporesper disc, K192001 (current submission) | Sterilucent PSD-85 SCBI, stainlesssteel carrier inoculated with > 106Geobacillus sterathermophilus sporesper disc, K141238 | Similar |
| Packaging | Clear polymer vial with polymer capsand a challenge tube on one end. | Clear polymer vial with polymer capsand a challenge tube on one end. | Same |
| Diffusion Restrictor | Tube of various inner diameter andlengths tailored to individualsterilization cycle | Tube of various inner diameter andlengths tailored to individualsterilization cycle | Same |
| Integrated ProcessIndicator | SPSmedical VH2O2 Chemical Indicatorplaced on the outside of the vial | SPSmedical VH2O2 ChemicalIndicator placed on the outside of thevial | Same |
| Relative Resistance | Greater than stand-alone SCBI; greaterthan most difficult to sterilize device ineach respective cycle; all kill at fullcycle | Greater than stand-alone SCBI;greater than most difficult to sterilizedevice in each respective cycle; all killat half cycle | Similar |
| D-Value | 28.69 sec. (PCD-F) | 18.18 sec. (PCD-NL) | Different |
| Manufacturer | Sterilucent, Inc. | Sterilucent, Inc. | Same |
The Sterilucent SCBI is similar to the STERRAD CYCLESURE 24 Plus Biological Indicator (K140589), manufactured by MESA Laboratories (Bozeman. MT). The Sterilucent SCBI and predicate device are both single-use sterilization process indicators intended to monitor exposure to sterilization cycles utilizing VHP as a sterilant. Both devices have the same intended use, materials, specifications, and mode-of-action, and are manufactured using the exact same production methods.
The Sterilucent HC 80TT PCD (Lumen and Flexible) is similar to the Sterilucent PSD-85 PCD (Lumen and Non-Lumen), which is intended for use in routine monitoring of the Sterilycent PSD-85 sterilization cycles (K141312). Both devices are designed to increase resistance beyond that measured with a SCBI and to represent a challenge to the sterilization process that is equal to or greater than the routinely processed item that is most difficult to sterilize in each respective cycle (ref. AAMI TIR31:2008).
Performance testing was conducted to demonstrate the functionality of the Summary of Non-Clinical Testing (Bench): Sterilucent SCBI either alone or when incorporated into a PCD. Testing was completed in accordance with FDA Guidance ("Biological Indicator (BI) Premarket Notification [510(k)] Submissions" dated October 2007), ANSI/AAMI/ISO 11138-1, and/or ANSI/AAMI/ISO 11140-1. Resistance characterization of the SCBI was performed using a resistometer compliant with the requirements of ANSI/AAMI/ISO 18472. A summary of nonclinical
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tests performed to demonstrate the safety and effectiveness of both the Sterilucent SCBI and PCD are as follows:
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| SCBI Resistance Evaluation(D-Value & Survival/KillWindow) | Determination of resistancecharacteristics under conditionsrepresentative of the subjectintended sterilizer | Meaningful value | Passed |
| SCBI Holding TimeAssessment (24 hours) | Determination of time periodexposed SCBI can be heldbefore incubation. | Meaningful value | Passed |
| SCBI Reduced IncubationTime (24 hours) | Determination of reducedincubation time | Value less than seven (7)days based on FDA RITprotocol | Passed |
| SCBI Growth Inhibition(none allowed) | Demonstrate sterilant absorptiondoes not inhibit spore growth | Spore growth | Passed |
| SCBI Population Stability &12-month Shelf Life | Demonstrate spore population ismaintained throughout thelabeled shelf life | Spore population remainsbetween 1.0-4.0 x 106throughout | Passed |
| SCBI Integrated ChemicalIndicator Verification | Demonstrate compliance to ISO11140-1 pass/fail criteria | ISO 11140-1 Section 8.7,Table 6 | Passed |
| PCD ResistanceCharacterization | Demonstrate test packs are moredifficult to sterilize than theSCBI | Greater resistance asdemonstrated by fractionalkill | Passed |
| PCD Functionality | Demonstrate challenge to thesterilization process is equal toor greater than the most difficultitem routinely processed | Fractional kill at half-cycle;all kill at full cycle | Passed |
| Summary of ClinicalTesting: | Clinical evaluations were not required and therefore are not submitted withthis 510(k). | ||
| Conclusions: | The conclusions drawn from the non-clinical tests demonstrate that thesubject device is as safe, as effective and performs as well as or better thanthe legally marketed predicate device. |
§ 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).