(298 days)
Not Found
No
The device description and performance studies focus on biological and chemical indicators for sterilization, with no mention of AI or ML technologies.
No
The device is a sterilizing indicator, not a therapeutic device. It is used to monitor the effectiveness of steam sterilization processes and does not directly treat or diagnose any medical condition.
No
This device is a sterilization indicator used for monitoring steam sterilization processes, not for diagnosing medical conditions in patients.
No
The device description clearly lists physical components (polycarbonate vial, polypropylene cap, silicone vented cap, vinyl sealant, biological tablet) and describes a biological indicator, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor saturated steam sterilization processes. This is a quality control function for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The components and the biological tablet containing enzymes from Geobacillus stearothermophilus are designed to indicate whether a sterilization cycle was effective, not to analyze a patient sample.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, treatment, or prevention of disease.
Therefore, the True Indicating Instant 20s Indicator is a sterilization process indicator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre- Vacuum), 135°C, 3 minutes (Pre-Vacuum).
Product codes (comma separated list FDA assigned to the subject device)
MTC
Device Description
The True Indicating Instant 20s Indicator consists of a polycarbonate vial, polypropylene cap, a silicone vented cap which serves as a base, a vinyl sealant, and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953.
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)
Summary of Nonclinical Tests:
Per FDA recognized consensus standards and guidance documents, testing was performed for steam sterilization processes using multiple lots of True Indicating Instant 20s Indicator over the range of the shelf life:
- Resistance Characteristic Studies were conducted including D value per ISO 11138-1 Annex D and ISO 11138-3 Annex A z value per ISO 11138-3 Annex B, and Survival/Kill Windows per ISO 11138-1 Annex E.
- Hold Time Assessment was evaluated for a period of 72-hours per Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions Section 7.D. Holding Time Assessment and True Indicating Protocol.
- Simulated Use Full, Half, and Abbreviated Exposure Cycles were tested per Guidance for Industry and FDA Staff Biological Indicator(BI) Premarket Notification [510(k)] Submissions Section 7 and True Indicating Protocols.
- Chemical Indicator Performance per ISO 11140-1:2014 and FDA Staff Chemical Indicator (CI) Premarket Notification [510(k)] Submissions.
- Biocompatibility (in Vitro Cytotoxicity) per ISO 10993-5:2009.
Testing was conducted on the Instant 20s Indicator following the FDA guidance and standards below:
- Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification(510(k)] Submissions, October 4, 2007
- Guidance for Industry and FDA Staff, Premarket Notification [510(k)] Submissions for Chemical indicators, December 19, 2003
- ISO 11138-1:2017 Sterilization of health care products – Biological indicators, Part 1: General requirements
- ISO 11138-3:2017 Sterilization of health care products – Biological indicators, Part 3: Biological indicators for moist heat sterilization processes
- United Sates Pharmacopeia, Biological Indicators Resistance Performance Tests
- ISO 11140-1:2014 Sterilization of healthcare products – Chemical indicators - Part 1: General requirements
- ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
Key Results from Summary of Nonclinical Testing Table:
- D value Based on Enzymatic Activity: PASS (D121 >= 1.7 min, D132 >= 12 s, D135 >= 12 s)
- z value Based on Enzymatic Activity: PASS (>= 13.6)
- Survival Time Based on Enzymatic Activity: PASS (121°C >= 5.1 min, 132°C >= 1.0 min, 135°C >= 40 sec)
- Kill Time Based on Enzymatic Activity: PASS (121°C
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
December 14, 2021
True Indicating LLC Thomas Riha CSO 946 Kane St Toledo, Ohio 43612
Re: K210481
Trade/Device Name: Instant 20s Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: MTC Dated: November 8, 2021 Received: November 8, 2021
Dear Thomas Riha:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 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,
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
2
Indications for Use
510(k) Number (if known) K210481
Device Name Instant 20s Indicator
Indications for Use (Describe)
The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at:
121℃, 30 minutes (Gravity) 132°C, 4 minutes (Pre-Vacuum) 135°C, 3 minutes (Pre-Vacuum)
| 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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3
| Submitter: | True Indicating LLC
946 Kane Street
Suite A
Toledo, OH 43612
P: 419 476 7119
F: 419 470 8899
E: info@trueindicating.com |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts: | Tom Riha
Chief Scientific Officer
P: 248 982 6492
F: 419 470 8899
E: tom.riha@trueindicating.com
Julie Wheeler
President and Chief Operations Officer
P:419 304 6535
F: 419 470 8899
julie.wheeler@trueindicating.com |
| Prepared on: | December 13, 2021 |
| Device Name: | Instant 20s Indicator |
| Classification: | Class II Medical Device, FDA Product Code MTC, General Hospital |
| Predicate Devices:
(Legally Marketed) | Sportrol Rapid Sterility Indicator, K962649 |
| Description of Device: | The True Indicating Instant 20s Indicator consists of a polycarbonate vial,
polypropylene cap, a silicone vented cap which serves as a base, a vinyl sealant,
and a biological tablet produced using cellulose, and enzymes from Geobacillus
stearothermophilus ATCC® 7953. |
| Indications for Use: | The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme
indicator, is used for monitoring saturated steam sterilization processes operating
at: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre- Vacuum), 135°C, 3
minutes (Pre-Vacuum). |
| Operational
Principles: | Place an Instant 20s Indicator in the most difficult area to sterilize in a load.
When the cycle is complete, the Instant 20s Indicator is removed and the base is
detached to gain access to the biological tablet. The Indicator Solution supplied
with the Instant 20s Indicator is applied dropwise onto the biological tablet to
activate.
The activated Instant 20s Indicator should be immediately viewed for a minimum
of 20 seconds to determine the efficacy of the sterilization cycle. Ineffective
cycles are indicated by a color shift of the biological tablet from off-white to a
shade of red. The absence of a red color change indicates the cycle was
effective. After 20 seconds, verify the color of the activated biological tablet and
immediately discard the tablet. |
4
Technological Characteristic Comparison Table
| Feature | Subject Device
Instant 20s Indicator
(K210481) | Predicate
Sportrol Rapid Sterility
Indicator (K962649) | Comparison |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use:
Method of
Sterilization | 121°C, 30 minutes (Gravity)
132°C, 4 minutes (Pre-Vac)
135°C, 3 minutes (Pre-Vac) | 121°C (Gravity) no stated time
132°C (Pre-Vac) no stated time
134°C (Pre-Vac) no stated time | Similar |
| Product Code | MTC | MTC | Same |
| FDA
Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Same |
| Indications for
Use (IFU) | The True Indicating Instant 20s
Indicator, a multiple, interactive,
bacterial enzyme indicator, is
used for monitoring saturated
steam sterilization processes
operating at: 121°C, 30 minutes
(Gravity), 132°C, 4 minutes (Pre-
Vacuum), 135°C, 3 minutes
(Pre-Vacuum) | The RSI Rapid Indicator, a
multiple, interactive, bacterial
enzyme indicator, is used for
monitoring saturated steam
sterilization processes
operating at 121°C gravity,
132°C vacuum assisted, 134°C
vacuum assisted cycles. | Similar |
| Mechanism of
Action | Enzymes, from Geobacillus
stearothermophilus, react with
Indicator Solution which consist
of co-enzymes. The co-enzymes
react with viable enzymes
present in the tablet to produce a
visual color change | Enzymes, from Geobacillus
stearothermophilus, react with
Indicator Solution which consist
of co-enzymes. The co-
enzymes can react with viable
enzymes present in the tablet to
produce a visual color change | Same |
| Modified
Survival Time | 121°C for 5 minutes 132°C for
20 seconds
Calculated = 121°C, ≥ 5.1 min
Calculated = 132°C, ≥ 1.0 min
Calculated = 135°C, ≥ 40 sec | 121°C for 5 minutes
132°C for 20 seconds
Calculated = Not Applicable | Similar |
| Feature | Subject Device
Instant 20s Indicator for Steam
(K210481) | Predicate
Sportrol Rapid Sterility
Indicator (K962649) | Comparison |
| Modified
Kill Time | 121°C for 15 minutes 132°C for
3 minutes
Calculated = 121°C, $ Biological Indicators Resistance Performance Tests ●
- . ISO 11140-1:2014 Sterilization of healthcare products – Chemical indicators - Part 1: General requirements
- . ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
Summary of Nonclinical Testing Table
| Name of Test | Purpose and Guidance
Document/Standard | Acceptance Criteria | Subject Device Result |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| D value
Based on
Enzymatic
Activity | Determine the resistance
of the Instant 20s Indicator
following ISO
11138-1 and 11138-3 | D121 ≥ 1.5 min
D132 ≥ 10 s D135 ≥ 8 s | PASS
D121 ≥ 1.7 min
D132 ≥ 12 s
D135 ≥ 12 s |
| z value
Based on
Enzymatic
Activity | Determine the z-value of
the Instant 20s Indicator
per ISO 11138-1 and
11138-3 | ≥10 | PASS
≥13.6 |
| Survival Time
Based on
Enzymatic
Activity | Determine the exposure
time for all Instant 20s
Indicator to retain viable
spores (Survival Time) per
ISO 11138-1, 11138-3 and
Guidance for Industry and
Staff - Biological Indicator
(BI) Premarket Notification
[510(k)] Submission | Meets the longer of
FDA and ISO 11138-3
requirements | PASS
121°C ≥ 5.1 min
132°C ≥ 1.0 min
135°C ≥ 40 sec |
| Kill Time
Based on
Enzymatic
Activity | Determine the exposure
time for all Instant 20s
Indicator to inactivate all
spores (Kill Time) per ISO
11138-1,11138-3 and
Guidance for Industry and
Staff - Biological Indicator
(BI) Premarket Notification
[510(k)] Submission | Meets the shorter of
FDA and ISO 11138-3
requirements | PASS
121°C ≤ 15.3 min
132°C ≤ 1.8 min
135°C ≤ 1.8 min |
| Hold Time | Determine the length of
time that an exposed
Instant 20s Indicator can
be held before incubation
(Hold Time) per Guidance
for Industry and Staff –
Biological Indicator (BI)
Premarket Notification
[510(k)] Submission | Performance not
affected if used within
72 hours of exposure to
steam sterilization | PASS |
| Growth
Inhibition | Determine if positive result
is achieved when primary
packaging is subject to
worst case steam
exposure per Guidance for
Industry and Staff –
Biological Indicator (BI)
Premarket Notification
[510(k)] Submission | 100% Positive Results | Pass |
| Shelf Life | Resistance and
Survival/Kill must meet
above criteria at each
stability time point per ISO
11138-1, 11138-3 and
Guidance for Industry and
Staff - Biological Indicator
(BI) Premarket Notification
[510(k)] Submission | D value = see above
Survival = see above
Kill = see above | PASS |
| Chemical
Indicator
Performance | Determine the pass/fail
criteria for each critical
cycle parameter and
provide the pass/fail
results to show how the
chemical indicator reacts
to all the critical
parameters in the
sterilization cycle for which
it is intended according to
ANSI/AAMI/ISO
11140-1:2014 Sterilization | Pass result at Stated
Value for each
temperature claimed:
121°C, 30 minutes
(Gravity)
132°C, 3 minutes
(Pre-Vac)
135°C, 3 minutes
(Pre-Vac) | PASS |
| | of health care products -
Chemical indicators - Part
1: General requirements
and Guidance for Industry
and FDA Staff - Premarket
Notification [510(k)]
Submissions for Chemical
Indicators | Fail Result at 15% less
time and -1°C of Stated
Value | PASS |
| Endpoint
Stability of
Positive
Result Color | Determine the endpoint
stability of developed color
due to a positive result
(failure) per Guidance for
Industry and FDA Staff -
Premarket Notification
[510(k)] Submissions for
Chemical Indicators | 7 Days | PASS |
| | | | |
| Endpoint
Stability of
Negative
Result Color | Determine the endpoint
stability of color due to a
negative result (pass) per
Guidance for Industry and
FDA Staff - Premarket
Notification [510(k)]
Submissions for Chemical
Indicators | 30 Minutes | PASS |
| Simulated
Use | Determine the simulated
use of the Instant 20s
Indicator in a sterilizer per
Guidance for Industry and
FDA Staff - Biological
Indicator (BI) Premarket
Notification [510(k)]
Submission | Demonstrates a survival
(positive) result when
exposed to abbreviated
cycle, and all kill
(negative) in full and
half cycles | PASS
Abbreviated cycles -
positive
Half cycles - negative
Full cycles - negative |
7
8
| Name of Test | Purpose | Acceptance Criteria | Subject Device Result |
|---|---|---|---|
| Biocompatibility | |||
| (In Vitro | |||
| Cytotoxicity) | To determine if the | ||
| device is cytotoxic to | |||
| mammalian cells in | |||
| vitro | Under conditions of | ||
| the study, did not | |||
| show potential | |||
| toxicity to L-929 | |||
| cells. | PASS |
Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K210481, Instant 20s Indicator, is as safe, as effective, and performs as well or better than the legally marketed predicate device cleared under K962649.