(100 days)
Not Found
No
The device description and performance studies focus on traditional biological and chemical indicators and reader incubators, with no mention of AI or ML technologies.
No
This device is a biological and chemical indicator used to monitor the efficacy of sterilization processes, not to treat or diagnose patients.
No
The devices described (biological and chemical indicators) are used to monitor the efficacy of sterilization processes, not to diagnose a disease or condition in a patient.
No
The device description clearly outlines physical components such as polypropylene tubes, spore carriers, glass ampoules, plastic strips, and adhesive tape, which are hardware. The device is not solely software.
Based on the provided text, these devices are not In Vitro Diagnostics (IVDs).
Here's why:
- Intended Use: The intended use of these devices is to monitor the efficacy of sterilization processes for medical devices. They are used to confirm that the sterilization equipment is functioning correctly and that items have been adequately exposed to the sterilizing agent.
- Mechanism of Action:
- The biological indicator (BT96) uses bacterial spores to assess if the sterilization process killed the spores.
- The chemical indicators (CD42 and CT40) use a chemical reaction (color change) to indicate exposure to the sterilizing agent.
- IVD Definition: An In Vitro Diagnostic (IVD) is a medical device that is intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes.
These devices do not examine specimens from the human body. They are used to assess the performance of a sterilization process, which is a critical step in preparing medical devices for use on patients, but they are not used to diagnose or monitor a patient's health condition.
N/A
Intended Use / Indications for Use
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.
Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.
Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
The self-contained biological indicator and chemical processing indicators are intended for use with the STERLINK™ FPS-15s Plus when operating in chamber mode.
Product codes (comma separated list FDA assigned to the subject device)
FRC, JOJ
Device Description
Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FR, IC10/20FRLCD or MiniBio Auto-Readers Incubators.
Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are single-use chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.
Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are single-use chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic.
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)
Non-clinical tests were performed using the following standards for Self-Contained Biological Indicator (BT96):
- Viable spore population assay (ANSI/AAMI/ISO 11138-1:2017) - Pass
- Resistance characteristics study (ANSI/AAMI/ISO 11138-1:2017) - Pass
- Carrier and primary packaging materials evaluation (ANSI/AAMI/ISO 11138-1:2017) - Pass
- Holding time assessment (Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions) - Pass
- Reduced incubation time validation test (Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions) - Pass
- Recovery protocols: Recovery medium test (ANSI/AAMI/ISO 11138-1:2017) - Pass
- Visual readout stability: Visual inspection test (ANSI/AAMI/ISO 11138-1:2017) - Pass
- Shelf life study (ANSI/AAMI/ISO 11138-1:2017) - 2 years
- Resistance Validation for Biological Indicator (ISO 11138-1:2017) - Pass
- BI & Test Pack Validation (Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions) - Pass
Non-clinical tests were performed using the following standards for Chemical Indicator (CD42, CT40):
- Performance characteristics obtained from resistometer (Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators ANSI/AAMI/ISO 11140-1:2014) - Pass
- Biocompatibility (Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators ANSI/AAMI/ISO 11140-1:2014) - Pass
- Endpoint stability (ANSI/AAMI/ISO 11140-1:2014) - Pass
- Shelf life study (Premarket Notification [510(k)] Submissions for Chemical Indicators) - 5 years
- Chemical Indicator Validation (ANSI/AAMI/ISO 11140-1:2014) - Pass
The conclusions drawn from the non-clinical tests demonstrate that the device in 510(k) submission K212193 is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K191021.
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
October 22, 2021
Plasmapp Co., Ltd. % Candace Cederman Consultant CardioMed Device Consultants LLC 1783 Forest Drive. Suite 254 Annapolis, Maryland 21401
Re: K212193
Trade/Device Name: Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC, JOJ Dated: September 20, 2021 Received: September 21, 2021
Dear Candace Cederman:
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.
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 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,
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
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Indications for Use
510(k) Number (if known) K212193
Device Name
Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42), Terragene Cintape® (CT40)
Indications for Use (Describe)
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10% Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.
Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met.
Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
The self-contained biological indicator and chemical processing indicators are intended for use with the STERLINK™ FPS-15s Plus when operating in chamber mode.
| 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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1. General Information
| Applicant/Submitter: | Plasmapp Co., Ltd.
BVC-111, 125, Gwahak-ro,
Yuseong-gu, Daejeon, 34141,
Rep. of Korea (South Korea)
Tel: +82 (0)42 716 2115 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Candace Cederman |
| Address: | CardioMed Device Consultants LLC
3168 Braverton Street
Suite 200
Edgewater, MD 21037
Tel: +1 410 674 2060 |
| Preparation Date: | October 7, 2021 |
2. Device Name and Code
| Device Trade Name: | Terragene Bionova® SCBI (BT96); Terragene Bionova® Reader
Incubators (IC10/20FRLCD, Mini-Bio); Terragene Chemdye®
(CD42); Terragene Cintape® (CT40) |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Self-Contained Biological Indicator, Self-Contained Biological
Indicator Incubator, Chemical Indicator |
| Classification Name: | Sterilization Process Indicator |
| Product Code: | FRC, JOJ |
| Regulation Number: | 21 CFR 880.2800 |
| Classification: | Class II |
| Review Panel: | General Hospital |
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3. Device Description
Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FR, IC10/20FRLCD or MiniBio Auto-Readers Incubators.
Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.
Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic.
4. Indications for Use / Intended Use
The revised indications for use are as follows:
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.
Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
5
Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.
Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
The self-contained biological indicator and chemical processing indicators are intended for use with the STERLINK™ FPS-15s Plus when operating in chamber mode.
5. Technical Characteristics in Comparison to Predicate Devices
The subject device uses identical technology as the cited predicate devices and has the same intended uses. Based upon the overall performance characteristics for the sterilization process indicators used with the STERLINK" sterilizer, Plasmapp Co., Ltd. believes that there are no significant differences in usage for the underlying technological principles between the subject devices and predicate devices.
| Subject Device | Predicate Device | |
|---|---|---|
| Sponsor | Plasmapp Co., Ltd. | Terragene® S.A. |
| Device Name | Terragene Bionova® SCBI (BT96); | |
| Terragene Bionova® Reader Incubators | ||
| (IC10/20FRLCD, Mini-Bio); | ||
| Terragene Chemdye® (CD42); | ||
| Terragene Cintape® (CT40) | Same | |
| 510(k) Number | K212193 | K191021 |
| Manufacturer | Terragene® S.A. | Same |
| Device Classification | ||
| Name | Sterilization Process Indicator | Same |
| Classification Product | ||
| Code | FRC (biological indicators) | |
| JOJ (chemical indicators) | Same | |
| Regulation Number | 21 CFR 880.2800 | Same |
| Subject Device | Predicate Device | |
| Sponsor | Plasmapp Co., Ltd. | Terragene® S.A. |
| Indications for Use | Terragene Bionova® SCBI (BT96) is a self- | |
| contained biological indicator inoculated | ||
| with viable 106 Geobacillus | ||
| stearothermophilus bacterial spores and is | ||
| intended for monitoring the efficacy of | ||
| vaporized hydrogen peroxide sterilization | ||
| processes. BT96 has Super Rapid readout at | ||
| 30 minutes at 60°C. | ||
| Terragene Bionova® Reader Incubators | ||
| (IC10/20FRLCD, Mini-Bio) incubate at | ||
| 60°C and 37°C and read the Terragene | ||
| Bionova® SCBI for fluorescent results at the | ||
| times prescribed in the User Manuals. | ||
| Terragene Chemdye® (CD42) is a chemical | ||
| process indicator intended for monitoring | ||
| the efficacy of vaporized hydrogen peroxide | ||
| sterilization processes. The chemical | ||
| indicator changes from red to yellow for | ||
| CD42 to indicate that the conditions of the | ||
| cycle have been met. | ||
| Terragene Cintape® CT40 is a chemical | ||
| process indicator tape intended for monitoring | ||
| Excerpted from K191021: | ||
| Terragene Bionova® SCBI (BT96) is a self- | ||
| contained biological indicator inoculated with | ||
| viable 106 Geobacillus stearothermophilus | ||
| bacterial spores and is intended for monitoring | ||
| the efficacy of vaporized hydrogen peroxide | ||
| sterilization processes. BT96 has Super Rapid | ||
| readout at 30 minutes at 60°C. | ||
| Terragene | ||
| Bionova® Reader | ||
| Incubators | ||
| (IC10/20FRLCD, Mini-Bio) incubate at 60°C | ||
| and 37°C and read the Terragene Bionova® | ||
| SCBI for fluorescent results at the times | ||
| prescribed in the User Manuals. | ||
| Terragene Chemdye® (CD40, CD42) is a | ||
| chemical process indicator intended for | ||
| monitoring the efficacy of vaporized hydrogen | ||
| peroxide sterilization processes. The chemical | ||
| indicator changes from purple to green for | ||
| CD40 and red to yellow for CD42 to indicate | ||
| that the conditions of the cycle have been met. | ||
| Terragene Cintape® CT40 is a chemical | ||
| process indicator tape intended for monitoring | ||
| the efficacy of Vaporized Hydrogen Peroxide | ||
| sterilization processes. The indicating tape | ||
| changes from purple to green when exposure | ||
| to vaporized hydrogen peroxide. | ||
| Intended Use: Cycles | ||
| Terragene Bionova® SCBI (BT96) | Vaporized Hydrogen Peroxide | |
| Models | ||
| Cycle | ||
| BT96, CD42, | ||
| STERLINK™ FPS-15s | ||
| CT40 | ||
| Plus - Chamber mode | Vaporized Hydrogen Peroxide | |
| Models | ||
| Cycles | ||
| BT96, CD42, | ||
| STERRAD 100S (54 | ||
| CT40 | ||
| minutes) | ||
| STERRAD Standard and | ||
| Express Cycles | ||
| V-Pro Max and Sterizone | ||
| VP4 | ||
| Type of Biological | ||
| Indicator | Self-Contained | Same |
| Organism Spore, | ||
| Species, Strain | Geobacillus stearothermophilus ATCC 7953 | |
| spores inoculated on a strip (spore carrier) | Same | |
| Viable Spore | ||
| Population | ≥ 106 | Same |
| Resistance | ||
| characteristics | D-value | |
| Survival time/Kill window | Same | |
| Subject Device | Predicate Device | |
| Sponsor | Plasmapp Co., Ltd. | Terragene® S.A. |
| Intended Sterilization | ||
| Cycles | STERLINK™ FPS-15s Plus - Chamber mode | |
| (overall cycle: 36 minutes) | STERRAD® 100S (54-minute Short cycle, 72- | |
| minute Long cycle), STERRAD® 100NX | ||
| (Standard Cycle - 47 minutes, Express Cycle |
- 24 minutes), V-Pro® maX (Non Lumen Cycle
- 28 minutes, Flexible Cycle - 35 minutes,
Lumen Cycle - 55 minutes), Sterizone® VP4
(Cycle 1) |
| Shelf Life | 2 years | Same |
| | Terragene Chemdye® (CD42), Terragene Chemdye® (CT40) | |
| Intended Sterilization
Cycles | STERLINK™ FPS-15s Plus - Chamber mode
(overall cycle: 36 minutes) | STERRAD® 100S sterilization cycles:
• 54-minute Short cycle for most surgical
instruments
• 72-minute Long cycle for flexible
endoscopes and instruments with longer
lumen
STERRAD® 100NX® sterilization cycles:
• 24-minute express cycle for fast turnaround
endoscopes and many other instruments
• 47-minute standard cycle for most surgical
instruments
AMSCO® V-PRO maX cycles:
• 28-minute non-lumen cycle for most
surgical instruments
• 35-minute flexible cycle for single or dual
channel flexible endoscopes and any non-
lumen devices
• 55-minute lumen cycle for stainless steel
lumen instruments with a single, dual or
triple channel.
Sterizone VP4 cycle. |
| Device design | Strip, Tape | Same |
| Color Change upon
Exposure to H2O2 | CD42: red to yellow
CT40: purple to green | Same |
| Recommended Storage
Conditions | Dry place, away from sunlight, at temperature
between 10-30°C, 30-80% relative humidity.
Do not wet. Do not store close to sterilizing
agents. | Same |
| Shelf Life | 5 years | Same |
| The subject and predicate devices are identical with respect to the organism, accessories, spore population, resistance
characteristics, culture conditions, carrier materials, packaging, storage conditions and claimed shelf life. The only
difference between the subject and predicate devices are the proposed indications for use, to label the indicators for use
with the STERLINK™ FPS-15s Plus when operating in chamber mode. | | |
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510(k) Summary - K212193
6. Performance Data
Non-clinical tests were performed using following standards:
| Item | Test | Standard/Guidance Document | Result |
|---|---|---|---|
| Self- | |||
| Contained | |||
| Biological | |||
| Indicator | |||
| (BT96) | Viable spore population assay | ANSI/AAMI/ISO 11138-1:2017 | Pass |
| Resistance characteristics study | ANSI/AAMI/ISO 11138-1:2017 | Pass | |
| Carrier and primary packaging | |||
| materials evaluation | ANSI/AAMI/ISO 11138-1:2017 | Pass | |
| Holding time assessment | Guidance for Industry and FDA Staff - | ||
| Biological Indicator (BI) Premarket | |||
| Notification [510(k)] Submissions | Pass | ||
| Reduced incubation time validation | |||
| test | Guidance for Industry and FDA Staff - | ||
| Biological Indicator (BI) Premarket | |||
| Notification [510(k)] Submissions | Pass | ||
| Recovery protocols: Recovery | |||
| medium test | ANSI/AAMI/ISO 11138-1:2017 | Pass | |
| Visual readout stability: Visual | |||
| inspection test | ANSI/AAMI/ISO 11138-1:2017 | Pass | |
| Shelf life study | ANSI/AAMI/ISO 11138-1:2017 | 2 years | |
| Resistance Validation for Biological | |||
| Indicator | ISO 11138-1:2017 | Pass | |
| BI & Test Pack Validation | Guidance for Industry and FDA Staff- | ||
| Biological Indicator (BI) Premarket | |||
| Notification [510(k)] Submissions | Pass | ||
| Chemical | |||
| Indicator | |||
| (CD42, | |||
| CT40) | Performance characteristics obtained | ||
| from resistometer | Guidance for Industry and FDA Staff - | ||
| Premarket Notification [510(k)] | |||
| Submissions for Chemical Indicators | |||
| ANSI/AAMI/ISO 11140-1:2014 | Pass | ||
| Biocompatibility | Guidance for Industry and FDA Staff - | ||
| Premarket Notification [510(k)] | |||
| Submissions for Chemical Indicators | |||
| ANSI/AAMI/ISO 11140-1:2014 | Pass | ||
| Endpoint stability | ANSI/AAMI/ISO 11140-1:2014 | Pass | |
| Shelf life study | Premarket Notification [510(k)] | ||
| Submissions for Chemical Indicators | 5 years | ||
| Chemical Indicator Validation | ANSI/AAMI/ISO 11140-1:2014 | Pass |
7. Conclusions
The conclusions drawn from the non-clinical tests demonstrates that the device in 510(k) submission K212193, Terragene Bionova® SCBI (BT96); Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene Chemdye® (CD42); Terragene Cintape® (CT40) are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K191021.