(174 days)
Not Found
No
The device description and performance studies focus on traditional biological and physical principles (spore growth, color change, temperature monitoring) and do not mention any AI or ML components.
No.
The device is a biological indicator and monitoring system intended for monitoring the efficacy of a sterilization process, not for directly treating a disease or condition in a patient.
No
The device, a biological indicator system, monitors the efficacy of hydrogen peroxide sterilization processes, not a medical condition or disease in a patient.
No
The device description clearly outlines physical components: a self-contained biological indicator (vial, spores, carrier, ampoule, media) and a biological indicator incubator (a physical device with incubation cavities and LEDs). This is not a software-only device.
Based on the provided information, the Sterilucent Self-Contained Biological Indicator and the Sterilucent Biological Indicator Monitoring System are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The primary purpose of the biological indicator is to monitor the efficacy of a sterilization process. This involves testing a sample (the biological indicator with spores) in vitro (outside of a living organism) to determine if the sterilization process was successful in killing microorganisms.
- Device Description: The biological indicator contains bacterial spores and a culture medium. The process involves incubating the indicator and observing a color change in the medium, which is a chemical reaction indicating bacterial growth or lack thereof. This is a classic in vitro diagnostic method.
- Monitoring System: The incubator is designed to facilitate the in vitro growth and monitoring of the biological indicator. It provides the necessary environment (temperature) and a mechanism to observe the result (LED indicating color change).
While the device is used in the context of sterilizing medical devices, the biological indicator itself is performing a diagnostic test on the sterilization process, not on a patient or a biological sample from a patient. However, the definition of an IVD includes devices used to examine specimens derived from the human body or to provide information concerning a physiological state, a state of health or disease, or a congenital abnormality. In this case, the "specimen" is the biological indicator, and the "information" provided is about the efficacy of the sterilization process, which is crucial for ensuring the safety of medical devices used on patients.
Furthermore, the predicate devices listed (STERRAD® CycleSure® 24 Biological Indicator and Smart-Well Model 1710 EZTest Incubator) are also biological indicators and incubators used for sterilization monitoring, and these types of devices are typically regulated as IVDs by regulatory bodies like the FDA.
N/A
Intended Use / Indications for Use
The Sterilucent Self-Contained Biological Indicator is for monitoring the efficacy of the hydrogen peroxide sterilization process in the Sterilizer Lumen and Non-Lumen cycles. It is intended for use solely in a test pack.
The Sterilucent Biological Indicator Monitoring System is intended for incubating and monitoring of the Sterilucent Self-Contained Biological Indicator.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The Sterilucent Self-Contained Biological Indicator is a self-contained biological indicator (SCBI) designed for use in monitoring the efficacy of the Sterilucent PSD-85 Sterilizer Lumen and Non-Lumen cycles. The SCBI consists of Geobacillus stearothermophilus bacterial spores, inoculated on a stainless steel carrier, and placed into a thermoplastic vial that serves as a culture tube. A small glass ampoule containing sterile culture medium (soybean casein digest formulation) and pH color indicator (Bromocresol Purple) is also contained in the vial.
The user places the Sterilucent SCBI into the Sterilucent PSD-85 sterilizer load and initiates a sterilization cycle appropriate for the particular type of load. After cycle completion, the SCBI is retrieved and activated by breaking the glass ampoule which contains a growth media. The activated SCBI is then incubated at 60°C ± 2°C for 18 hours and monitored for any color change. The appearance of a yellow color in the media indicates bacterial growth (a failing result); no color change indicates conditions for sterilization were achieved (a passing result).
The Sterilucent Biological Indicator Monitoring System is a biological indicator incubator which monitors for the presence and condition (growth [as indicated by a yellow color in the growth media] or no-growth [as indicated by purple growth media]) of Sterilucent SCBI. When an activated Sterilucent SCBI is placed into one of the incubation cavities, the LED in front of the cavity will illuminate amber. The incubator maintains the operating temperature specifications under all potential loading conditions over the recommended incubation time. It can incubate and monitor up to ten (10) Sterilucent SCBI plus one control unit.
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
Not Found
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)
Following the recommendations and guidelines in the Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions (October 4, 2007), the Sterilucent SCBI was evaluated for spore population, resistance characteristics, carrier and primary packaging materials evaluation (Growth Inhibition Studies), holding time assessment, incubation time validation (Reduced Incubation Time). The results of all studies met the established acceptance criteria when applicable.
Spore population and stability was demonstrated by regularly scheduled population assays on multiple lots throughout the 24 month claimed shelf life period.
Resistance characteristics were demonstrated by regularly scheduled D-value determinations in accordance with ANSI/AAMI/ISO 11138-1 on multiple lots throughout the 24 month claimed shelf life period.
The growth inhibition studies demonstrated that, following a worst case vaporized hydrogen peroxide exposure in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer, all exposed carriers and packaging components were not bacteriostatic.
The holding time assessment study demonstrated, through a series of sub-lethal exposures and population assays, that the resistance characteristics of the Sterilucent SCBI are not altered significantly over a 29 hour hold time prior to incubation.
The RIT validation was conducted in accordance with the Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions. The data generated supports an incubation time of 18 hours.
Additionally, performance characterization in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer identified, through dose response exposures, cycle exposure conditions that result in BI growth (BI fail conditions). This testing also demonstrated no growth pass conditions at both the half cycle and full cycle.
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.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 3, 2014
Sterilucent. Inc. % Peter Kalkbrenner Director of Engineering 1400 Marshall Street NE Minneapolis, Minnesota 55413
Re: K141238
Trade/Device Name: Sterilucent Self-Contained Biological Indicator Sterilucent Biological Indicator Monitoring System Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator/Biological Sterilization Process Indicator (21 CFR 880.2800) Regulatory Class: Class II Product Code: FRC Dated: September 25, 2014 Received: October 3, 2014
Dear Mr. 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. 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.
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141238
Device Name
Sterilucent Self-Contained Biological Indicator Sterilucent Biological Indicator Monitoring System
Indications for Use (Describe)
The Sterilucent Self-Contained Biological Indicator is for monitoring the efficacy of the hydrogen peroxide sterilization process in the Sterilizer Lumen and Non-Lumen cycles. It is intended for use solely in a test pack.
The Sterilucent Biological Indicator Monitoring System is intended for incubating and monitoring of the Sterilucent Self-Contained Biological Indicator.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Sterilucent. The logo consists of a blue icon on the left, followed by the word "sterilucent" in blue, stylized font. Below the word "sterilucent" is the phrase "scientific sterilization solutions" in a smaller, blue font.
510(k) Summary for the Sterilucent Self-Contained Biological Indicator K141238
| Owner: | Sterilucent, Inc. |
|---|---|
| Address: | 1400 Marshall St. NE |
| Minneapolis, MN 55413 | |
| Contact: | Peter R. Kalkbrenner |
| Director of Engineering | |
| Telephone: | 612-767-3253 |
| Fax: | 612-767-3261 |
| Summary Date: | 30 October, 2014 |
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1. Device Name and Classification
| Trade Name: | Sterilucent Self-Contained Biological Indicator
Sterilucent Biological Indicator Monitoring System | |
|----------------------|-------------------------------------------------------------------------------------------------------|--|
| Common/Usual Name: | Self-Contained Biological Indicator | |
| Classification Name: | Sterilization Process Indicator | |
| Device Class: | Class II | |
| Product Code: | FRC (21 CFR 880.2800) | |
2. Predicate Device
STERRAD® CycleSure® 24 Biological Indicator (K102884) Smart-Well Model 1710 EZTest Incubator (K122362)
3. Device Description
The Sterilucent Self-Contained Biological Indicator is a self-contained biological indicator (SCBI) designed for use in monitoring the efficacy of the Sterilucent PSD-85 Sterilizer Lumen and Non-Lumen cycles. The SCBI consists of Geobacillus stearothermophilus bacterial spores, inoculated on a stainless steel carrier, and placed into a thermoplastic vial that serves as a culture tube. A small glass ampoule containing sterile culture medium (soybean casein digest formulation) and pH color indicator (Bromocresol Purple) is also contained in the vial.
The user places the Sterilucent SCBI into the Sterilucent PSD-85 sterilizer load and initiates a sterilization cycle appropriate for the particular type of load. After cycle completion, the SCBI is retrieved and activated by breaking the glass ampoule which contains a growth media. The activated SCBI is then incubated at 60°C ± 2°C for 18 hours and monitored for any color change. The appearance of a yellow color in the media indicates bacterial growth (a failing result); no color change indicates conditions for sterilization were achieved (a passing result).
The Sterilucent Biological Indicator Monitoring System is a biological indicator incubator which monitors for the presence and condition (growth [as indicated by a yellow color in the growth media] or no-growth [as indicated by purple growth media]) of Sterilucent SCBI. When an activated Sterilucent SCBI is placed into one of the incubation cavities, the LED in front of the cavity will illuminate amber. The incubator maintains the operating temperature specifications under all potential loading conditions over the recommended incubation time. It can incubate and monitor up to ten (10) Sterilucent SCBI plus one control unit.
5
4. Statement of Intended Use
The Sterilucent Self-Contained Biological Indicator is for monitoring the efficacy of the sterilization process in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen cycles. It is intended for use solely in a test pack.
The Sterilucent Biological Indicator Monitoring System is intended for incubating and monitoring of the Sterilucent Self-Contained Biological Indicator.
5. Technological Characteristics Summary Comparison
The Sterilucent SCBI technological characteristics are substantially equivalent to the predicate device as summarized in the table below. Both are used to monitor vaporized H2O2 (VHP) sterilization cycles. Each include at least 106 spores of Geobacillus sterathermophilus (the most resistant organism for vaporized hydrogen peroxide sterilization), a chemical process indicator appropriate for VHP sterilization to indicate exposure, and a glass ampoule containing soybean casein digest broth with Bromocresol Purple as the color change indicator. The carrier and culture media for both devices are packaged in a polypropylene culture tube with a polypropylene cap.
| Predicate Device | ||
|---|---|---|
| Characteristic | New Device | |
| Sterilucent Self-Contained Biological | ||
| Indicator | Predicate Device | |
| CycleSure® 24 Biological | ||
| Indicator | ||
| Device Design | Disc containing indicator organism, glass ampoule containing nutrient growth medium, vial containing the disc and vial, cap and liner closing the vial, and a chemical indicator in the cap. | Same |
| Materials of Construction | Glass (ampoule) and polypropylene (vial and cap) | Same |
| Indicator Organism | Geobacillus sterathermophilus | Same |
| Population | ≥1.0 x 106 | Same |
| Sterilization Modality | Vaporized Hydrogen Peroxide (VHP) | Same |
| Indications for Use | The Sterilucent Self-Contained Biological Indicator is for monitoring the efficacy of the sterilization process in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen cycles. | The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of STERRAD® Sterilization cycles. |
Summary of Technological Characteristics of the Device Compared to the
6. Summary of Non-Clinical Performance Data
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Following the recommendations and guidelines in the Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions (October 4, 2007), the Sterilucent SCBI was evaluated for spore population, resistance characteristics, carrier and primary packaging materials evaluation (Growth Inhibition Studies), holding time assessment, incubation time validation (Reduced Incubation Time). The results of all studies met the established acceptance criteria when applicable.
Spore population and stability was demonstrated by regularly scheduled population assays on multiple lots throughout the 24 month claimed shelf life period.
Resistance characteristics were demonstrated by regularly scheduled D-value determinations in accordance with ANSI/AAMI/ISO 11138-1 on multiple lots throughout the 24 month claimed shelf life period.
The growth inhibition studies demonstrated that, following a worst case vaporized hydrogen peroxide exposure in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer, all exposed carriers and packaging components were not bacteriostatic.
The holding time assessment study demonstrated, through a series of sub-lethal exposures and population assays, that the resistance characteristics of the Sterilucent SCBI are not altered significantly over a 29 hour hold time prior to incubation.
The RIT validation was conducted in accordance with the Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions. The data generated supports an incubation time of 18 hours.
Additionally, performance characterization in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer identified, through dose response exposures, cycle exposure conditions that result in BI growth (BI fail conditions). This testing also demonstrated no growth pass conditions at both the half cycle and full cycle.
7. Summary of Clinical Performance Data
N/A - No clinical tests were conducted for this submission
8. Overall Performance Conclusion Statement
The results of the testing demonstrate that the Sterilucent SCBI is appropriate for monitoring the efficacy of the sterilization process in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen cycles. The proposed device and the predicate device utilize the same test organism which is appropriate for VHP sterilization processes. The proposed device and the predicate device are comprised of a similar design and materials. The proposed device and the predicate device have similar performance characteristics. The proposed device is substantially equivalent to the predicate device.