(260 days)
Not Found
No
The device is a simple chemical indicator that changes color based on exposure to steam, with no mention of computational analysis or learning algorithms.
No.
This device is a chemical indicator used to demonstrate that materials have been exposed to a steam sterilization process, distinguishing between processed goods; it is not used to treat a disease or condition.
No
This device is a chemical indicator used to confirm that materials have been exposed to a steam sterilization process. It indicates whether goods have been processed, not for diagnosing any medical conditions in a patient.
No
The device description clearly states it is a "Paper Strip printed with Bismuth based chemical indicator ink with polyester overlaminate". This is a physical, chemical-based indicator, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to demonstrate that materials have been exposed to a steam sterilization process to distinguish between processed goods. This is a quality control measure for sterilization, not a diagnostic test performed on biological samples.
- Device Description: The device is a paper strip with chemical indicator ink that changes color based on exposure to steam. This is a physical/chemical indicator, not a device designed to analyze biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition.
- Using reagents or assays to detect specific analytes.
- Testing and Standards: The testing and standards referenced (ISO 11140-1, FDA guidance for Chemical Indicators) are specific to sterilization indicators, not IVDs.
- Predicate Device: The predicate device (K181788) is also described as "Lead-free Chemical Indicators for Steam Sterilization," further confirming its classification outside of IVDs.
In summary, this device is a sterilization process indicator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed goods.
The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators:
Gravity: 121°C/250 F - 30 minutes (wrapped/porous)
Pre-vacuum: 132°C/270 F - 3 minutes (unwrapped/nonporous)
Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous)
Pre-vacuum: 134°C/273 F - 4 minutes (wrapped/porous)
Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The True Indicating Lead-Free Chemical Indicator for Steam product codes CSYN-US (yellow to dark), CSPN-US (pink to dark), and CSBN-US (blue to dark), all turn a permanent dark brown/black color when exposed to high temperature steam.
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 usinq multiple lots of True Indicating Chemical Indicator for Steam over the range of the shelf life:
- Performance Exposure Studies were conducted per ISO 11140-1
- . End Point Stability of the achieved signal color was evaluated for a period of days per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification [510(k)] Submissions.
- Offset-Transference testing was conducted per ISO 11140-1 ●
- . Simulated Use (Healthcare Steam Cycles) - Steam Exposure cycles were tested utilizing various loads per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification and True Indicating Protocols
Summary of Nonclinical Testing – Chemical Indicator for Steam
Testing was conducted on the Chemical Indicator for Steam following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Chemical Indicator (CI) Premarket Notification [510(k)] ● Submissions,
- . ISO 11140-1:2014 Sterilization of health care products – Chemical indicators, Part 1: General requirements
Tests performed:
-
Steam Resistometer Testing:
- Purpose: To test the pass/fail criteria for each critical cycle parameter and provide the pass/fail results to show how the chemical indicator reacts to the critical parameters in the sterilization cycle for which it is intended according to ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements and Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff.
- Acceptance Criteria: Pass result (signal color achieved for all product codes) at the value for each temperature claimed: 121°C for 10 minutes, 134°C for 2 minutes, 135°C for 2 minutes. Fail result (signal color not achieved for all product codes) at the value for each temperature claimed: 121°C for 2 minutes, 134°C for 0.3 minutes, 135°C for 0.3 minutes.
- Result: PASS
-
Hospital Steam Sterilizer Testing:
- Purpose: Determine if the chemical indicators reach specified endpoint color of dark brown/black when combined with a sterilization load and exposed to the sterilization cycle for which it is intended according to Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff.
- Acceptance Criteria: Pass result (signal color achieved for all product codes) at the value for each temperature claimed in combination of a sterilization load: Gravity: 121°C/250 F - 30 minutes (wrapped/porous); Vacuum assisted (prevacuum): 132°C/270 F - 3 minutes (unwrapped/nonporous); Vacuum assisted (prevacuum): 132°C/270 F - 4 minutes (wrapped/porous); Vacuum assisted (prevacuum): 134°C/273 F - 4 minutes (wrapped/porous); Vacuum assisted (prevacuum): 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load).
- Result: PASS
-
Dry Heat Testing:
- Purpose: Demonstrate that the Chemical Indicator for Steam does not change color following a dry heat cycle according to ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements and Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff.
- Acceptance Criteria: Fail result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C).
- Result: PASS
-
End Point Stability:
- Purpose: Determine the length of time that an exposed Chemical Indicator for Steam retains its post-exposure signal color per Guidance for Industry and Staff - Chemical Indicator (CI) Premarket Notification [510(k)] Submission.
- Acceptance Criteria: 1 Month.
- Result: PASS
-
Offset/Transference:
- Purpose: Demonstrate the chemical indicators do not bleed or offset to substrate which it's applied according to ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements.
- Acceptance Criteria: The chemical indicators shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed.
- Result: PASS
Conclusion: The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K220778, the Chemical Indicator for Steam, is as safe, as effective, and performs as well or better than the legally marketed predicate device cleared under K181788.
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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 2, 2022
True Indicating LLC Thomas Riha Chief Scientific Officer 946 Kane St Toledo, Ohio 43612
Re: K220778
Trade/Device Name: Chemical Indicator for Steam Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: May 12, 2022 Received: November 1, 2022
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Christopher K. Dugard -S
for 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) K220778
Device Name Chemical Indicator for Steam
Indications for Use (Describe)
The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed goods.
The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators:
Gravity: 121°C/250 F - 30 minutes (wrapped/porous)
Pre-vacuum: 132℃/270 F - 3 minutes (unwrapped/nonporous)
Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous)
Pre-vacuum: 134℃/273 F - 4 minutes (wrapped/porous)
Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)
| 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
P:419 304 6535
F: 419 470 8899
julie.wheeler@trueindicating.com |
| Prepared on: | November 28, 2022 |
| Device Name: | Chemical Indicator for Steam |
| Classification: | Class II Medical Device, FDA Product Code JOJ, General Hospital |
| Predicate Devices:
(Legally Marketed) | Lead-free Chemical Indicators for Steam Sterilization (K181788) |
| Description of Device: | The True Indicating Lead-Free Chemical Indicator for Steam product codes
CSYN-US (yellow to dark), CSPN-US (pink to dark), and CSBN-US (blue to
dark), all turn a permanent dark brown/black color when exposed to high
temperature steam. |
| Indications for Use: | The Chemical Indicator for Steam is intended for use with individual materials
(i.e. pouches, packs, trays) to demonstrate the material has been exposed to a
steam sterilization process to distinguish between processed and unprocessed
goods.
The Chemical Indicator for Steam can transition from an initial color of yellow and
turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark
brown/black color for Product Code: CSPN-US, and blue to a dark brown/black
color for Product Code: CSBN-US when exposed to high temperature steam at
the following time and temperature intervals as process indicators:
Gravity: 121°C/250 F - 30 minutes (wrapped/porous)
Pre-vacuum: 132°C/270 F - 3 minutes (unwrapped/nonporous)
Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous)
Pre-vacuum: 134°C/273 F - 4 minutes (wrapped/porous)
Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load) |
| Operational
Principles: | The Chemical Indicator for Steam is intended for use with individual units, (e.g.
packs, containers) to demonstrate that the goods have been exposed to a steam
sterilization process and to distinguish between processed and unprocessed
goods |
4
Technological Characteristic Comparison Table
| Feature | Subject Device
(K220778) | Predicate Device
(K181788) | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Process indicator for steam
sterilization | Process indicator for steam
sterilization | Same |
| Product Code | JOJ | JOJ | Same |
| Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Same |
| Indications for
Use (IFU) | The Chemical Indicator for
Steam is intended for use with
individual materials (i.e.
pouches, packs, trays) to
demonstrate the material has
been exposed to a steam
sterilization process to
distinguish between processed
and unprocessed goods.
The Chemical Indicator for
Steam can transition from an
initial color of yellow and turn to
a dark brown/black color for
Product Code: CSYN-US, pink
to a dark brown/black color for
Product Code: CSPN-US, and
blue to a dark brown/black color
for Product Code: CSBN-US
when exposed to high
temperature steam at the
following time and temperature
intervals as process indicators:
Gravity: 121°C/250 F - 30
minutes (wrapped/porous)
Pre-vacuum: 132°C/270 F -
3 minutes (unwrapped/nonporous)
Prevacuum: 132°C/270 F -
4 minutes (wrapped/porous)
Prevacuum: 134°C/273 F -
4 minutes (wrapped/porous)
Prevacuum: 135°C/275 F -
3 minutes (wrapped/porous and
unwrapped/nonporous, mixed
load) | The Kem Medical Lead-free
Chemical Indicators for Steam
Sterilization are designed for use
by a health care provider to
demonstrate that the unit or load
has been exposed to a steam
sterilization process, and to
distinguish between processed
and unprocessed units or loads.
Use the Kem Medical Lead-free
Chemical Indicators for Steam
Sterilization in the validated
steam sterilization processes
described below:
Gravity: 121°C/250 F - 30 minutes
(wrapped/porous)
Gravity: 132°C/270 F - 3 minutes
(unwrapped/nonporous)
Gravity: 132°C/270 F - 15 minutes
(wrapped/porous)
Gravity: 135°C/275 F - 3 minutes
(unwrapped/nonporous)
Gravity: 135°C/275 F - 10 minutes
(wrapped/porous or
unwrapped/nonporous, mixed
load) Vacuum assisted
(prevacuum): 132°C/270 F - 3
minutes (unwrapped/nonporous)
Vacuum assisted (prevacuum):
132°C/270 F - 4 minutes
(wrapped/porous)
Vacuum assisted (prevacuum):
134°C/273 F - 4 minutes
(wrapped/porous)
Vacuum assisted (prevacuum):
135°C/275 F - 3 minutes
(wrapped/porous or
unwrapped/nonporous, mixed
load) | Similar |
| Device Design | Paper Strip printed with
Bismuth based chemical
indicator ink with polyester
overlaminate applied over
the entire indicating ink strip | Paper dot/strip/card printed
with bismuth sulfide based
chemical indicator ink | Similar |
| Feature | Subject Device
(K220778) | Predicate Device
(K181788) | Comparison |
| Indicator
Agent | Bismuth based chemical to yield
color transition | Bismuth based chemical to yield
color transition | Same |
| Endpoint
Specification | Dark brown/black color change | Dark brown/black color change | Same |
| End Point
Stability | 1 Month | 6 Months | Similar |
| Shelf Life | 30 Months | 12 Months | Similar |
5
Summary of Nonclinical Tests:
Per FDA recognized consensus standards and guidance documents, testing was performed for steam sterilization processes usinq multiple lots of True Indicating Chemical Indicator for Steam over the range of the shelf life:
- Performance Exposure Studies were conducted per ISO 11140-1
- . End Point Stability of the achieved signal color was evaluated for a period of days per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification [510(k)] Submissions.
- Offset-Transference testing was conducted per ISO 11140-1 ●
- . Simulated Use (Healthcare Steam Cycles) - Steam Exposure cycles were tested utilizing various loads per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification and True Indicating Protocols
6
Summary of Nonclinical Testing – Chemical Indicator for Steam
Testing was conducted on the Chemical Indicator for Steam following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Chemical Indicator (CI) Premarket Notification [510(k)] ● Submissions,
- . ISO 11140-1:2014 Sterilization of health care products – Chemical indicators, Part 1: General requirements
| Name of Test | Purpose | Acceptance Criteria | Subject
Device
Result |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Steam
Resistometer
Testing | To test the pass/fail
criteria for each critical
cycle parameter and
provide the pass/fail
results to show how the
chemical indicator reacts
to the critical parameters
in the sterilization cycle for
which it is intended
according to
ANSI/AAMI/ISO 11140-
1:2014 Sterilization of
health care products -
Chemical indicators - Part
1: General requirements
and Premarket Notification
[510(k)] Submissions for
Chemical Indicators -
Guidance for Industry and
FDA Staff. | Pass result (signal color
achieved for all product codes)
at the value for each
temperature claimed:
121°C for 10 minutes
134°C for 2 minutes
135°C for 2 minutes
Fail result (signal color not
achieved for all product codes)
at the value for each
temperature claimed:
121°C for 2 minutes
134°C for 0.3 minutes
135°C for 0.3 minutes | PASS |
| Hospital
Steam
Sterilizer
Testing | Determine if the chemical
indicators reach specified
endpoint color of dark
brown/black when
combined with a
sterilization load and
exposed to the sterilization
cycle for which it is
intended according to
Premarket Notification
[510(k)] Submissions for
Chemical Indicators -
Guidance for Industry and
FDA Staff. | Pass result (signal color achieved for
all product codes) at the value for
each temperature claimed in
combination of a sterilization load:
• Gravity: 121°C/250 F - 30 minutes
(wrapped/porous)
• Vacuum assisted
(prevacuum): 132°C/270 F -
3 minutes
(unwrapped/nonporous)
• Vacuum assisted
(prevacuum): 132°C/270 F -
4 minutes (wrapped/porous)
• Vacuum assisted (prevacuum):
134°C/273 F - 4 minutes
(wrapped/porous)
• Vacuum assisted (prevacuum):
135°C/275 F - 3 minutes
(wrapped/porous and | PASS |
| Name of Test | Purpose | Acceptance Criteria | Subject
Device
Result |
| Dry Heat Testing | Demonstrate that the
Chemical Indicator for
Steam does not change
color following a dry
heat cycle according to
ANSI/AAMI/ISO 11140-
1:2014 Sterilization of
health care products -
Chemical indicators -
Part 1: General
requirements and
Premarket Notification
[510(k)] Submissions
for Chemical Indicators -
Guidance for Industry
and FDA Staff | Fail result when exposed to
dry heat alone for 30 minutes
(±1 minute) at 140°C (±2°C) | PASS |
| End Point Stability | Determine the length of
time that an exposed
Chemical Indicator for
Steam retains its post-
exposure signal color
per Guidance for
Industry and Staff -
Chemical Indicator (CI)
Premarket Notification
[510(k)] Submission | 1 Month | PASS |
| Offset/Transference | Demonstrate the
chemical indicators do
not bleed or offset to
substrate which it's
applied according to
ANSI/AAMI/ISO 11140-
1:2014 Sterilization of
health care products -
Chemical indicators -
Part 1: General
requirements. | The chemical indicators shall
not offset or bleed, penetrate
the substrate to which it is
applied, or materials in which it
is in contact before, during or
after the sterilization cycles for
which it is designed | PASS |
Summary of Nonclinical Testing Table
7
Conclusion: The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K220778, the Chemical Indicator for Steam, is as safe, as effective, and performs as well or better than the legally marketed predicate device cleared under K181788.