K Number
K242860
Device Name
Type 5 Integrating Indicator for Steam (CSPN-15)
Date Cleared
2025-01-17

(119 days)

Product Code
Regulation Number
880.2800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes. 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. Minimum Stated Values as determined in a resistometer: SV121°C/16.5 min., SV132°C/2.0min. SV134°C/1.4 min. SV135°C/1.2 min.
Device Description
The True Indicating Chemical Indicator for Steam CSPN-15 consists of a white polyester substrate with acrylic adhesive married to a paper substrate. The paper substrate (with acrylic adhesive) has True Indicating water-based steam indicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed. After printing, the top layer of the Type 5 Integrating Indicator strip is covered with a clear colorless polyester laminate with acrylic adhesive. The Integrating Indicators have been designed for Steam sterilization processes, ensuring the effectiveness of sterilization by monitoring all critical process variables (time, temperature and steam). The pink indicating ink was developed to turn to dark and conceal the word "NOT" when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of a 105 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer).
More Information

Not Found

No
The device is a chemical indicator that changes color based on physical parameters (time, temperature, steam). There is no mention of computational analysis, learning, or data processing that would indicate AI/ML.

No

Explanation: This device is a chemical indicator used to monitor the effectiveness of sterilization cycles in hospitals. It is not applied to a patient for diagnosis, treatment, or prevention of disease.

No

Explanation: This device is an integrating indicator used to monitor the effectiveness of steam sterilization cycles by reacting to critical parameters like time, temperature, and steam. It is not intended for diagnosing medical conditions in patients.

No

The device is a physical chemical indicator strip designed to react to steam sterilization parameters. It is not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic). Here's why:

  • Intended Use: The intended use clearly states that the device is designed to monitor the critical parameters of a steam sterilization cycle. It is placed within packs, pouches, containers, etc., to indicate whether the sterilization process has been successful. This is a quality control measure for sterilization, not a diagnostic test performed on a biological sample to diagnose a disease or condition.
  • Device Description: The description details a chemical indicator that changes color based on exposure to steam, time, and temperature. This mechanism is related to monitoring a physical process (sterilization), not analyzing a biological sample.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Providing information for the diagnosis, treatment, or prevention of disease
    • Using reagents or assays to detect specific analytes in a sample

The device is a chemical indicator used to verify the effectiveness of a sterilization process, which is a critical step in healthcare settings to prevent the spread of infection. While important for patient safety, this function falls outside the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes. 135° C for 10 minutes;

Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes.

Minimum Stated Values as determined in a resistometer:
SV121°C/16.5 min., SV132°C/2.0min. SV134°C/1.4 min. SV135°C/1.2 min.

Product codes (comma separated list FDA assigned to the subject device)

JOJ

Device Description

The True Indicating Chemical Indicator for Steam CSPN-15 consists of a white polyester substrate with acrylic adhesive married to a paper substrate. The paper substrate (with acrylic adhesive) has True Indicating water-based steam indicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed. After printing, the top layer of the Type 5 Integrating Indicator strip is covered with a clear colorless polyester laminate with acrylic adhesive. The Integrating Indicators have been designed for Steam sterilization processes, ensuring the effectiveness of sterilization by monitoring all critical process variables (time, temperature and steam). The pink indicating ink was developed to turn to dark and conceal the word "NOT" when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of a 105 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer).

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 Chemical Indicator for Steam CSPN-15 over the range of the shelf-life:

  • Performance Exposure Studies were conducted per ISO 11140-1:2014 for a Type 5 Integrator for Steam, and Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff.
  • End Point Stability of the achieved signal color was evaluated for a period of months 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 side-by-side with a biological indicator utilizing various loads per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification and True Indicating Protocols
  • Shelf-life of product code CSPN-15 per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification and True Indicating Protocols

Summary of Nonclinical Testing - Type 5 Integrating Indicator for Steam CSPN-15
Testing was conducted on the Type 5 Integrating Indicator for Steam CSPN-15 following the FDA quidance 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 (Type 5 Integrator for Steam)

Nonclinical testing results:

  • Steam Resistometer Testing: PASS. Acceptance criteria: Pass result (end signal color achieved for all product codes) at the value for each temperature claimed: 121°C for 16.5 minutes, 132°C for 2.0 minutes, 134°C for 1.4 minutes, 135°C for 1.2 minutes; Fail result (end signal color not achieved) at the value for each temperature claimed: 120°C for 14.025 minutes, 131°C for 1.7 minutes, 133°C for 1.19 minutes, 134°C for 1.02 minutes. Integrator temperature coefficient 10 - 27 °C, Correlation coefficient >= 0.9.
  • Hospital Steam Sterilizer Testing: PASS. 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 Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes.
  • Dry Heat Testing: PASS. Acceptance criteria: Fail result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C).
  • End Point Stability: PASS. Acceptance criteria: 6 Months.
  • Side-by-Side Testing with a Biological Indicator: PASS. Acceptance criteria: Chemical Integrator does not reach endpoint before BIs are inactivated.
  • Offset/Transference: PASS. 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.

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.

Terragene Integron® IT26-1YS (K191021)

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.

January 17, 2025

True Indicating, LLC Thomas Riha Chief Scientific Officer 946 Kane St Suite A Toledo, Ohio 43612

Re: K242860

Trade/Device Name: Type 5 Integrating Indicator for Steam (CSPN-15) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 20, 2024 Received: September 20, 2024

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 (the 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 available 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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

2

assistance/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,

Image /page/2/Picture/3 description: The image shows the name "Stephen A. Anisko -S" on the left side of the image. On the right side of the image, it says "Digitally signed by Stephen A. Anisko" followed by the date "2025.01.17 14 -05'00'". The image appears to be a digital signature.

Stephen A. Anisko -S Date: 2025.01.17 14:10:30

for: Christopher K. Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

Submission Number (if known)

K242860

Device Name

Type 5 Integrating Indicator for Steam (CSPN-15)

Indications for Use (Describe)

The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes. 135° C for 10 minutes;

Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes.

Minimum Stated Values as determined in a resistometer:

SV121°C/16.5 min., SV132°C/2.0min. SV134°C/1.4 min. SV135°C/1.2 min.

Type of Use (Select one or both, as applicable)

scription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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4

| 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 |
| Prepared on: | January 14, 2025 |
| Device Name: | Type 5 Integrating Indicator for Steam (CSPN-15) |
| Classification: | Class II Medical Device, FDA Product Code JOJ, General Hospital |
| Predicate Devices:
(Legally Marketed) | Terragene Integron® IT26-1YS (K191021) |
| Device Description: | The True Indicating Chemical Indicator for Steam CSPN-15 consists of a white
polyester substrate with acrylic adhesive married to a paper substrate. The
paper substrate (with acrylic adhesive) has True Indicating water-based steam
indicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed.
After printing, the top layer of the Type 5 Integrating Indicator strip is covered
with a clear colorless polyester laminate with acrylic adhesive. The Integrating
Indicators have been designed for Steam sterilization processes, ensuring the
effectiveness of sterilization by monitoring all critical process variables (time,
temperature and steam). The pink indicating ink was developed to turn to dark
and conceal the word "NOT" when a theoretical spore population reaches its kill
time, indicating integration condition has been reached. This condition is
calibrated with the kill time of a 105 Geobacillus stearothermophilus spore
population, calculated in BIER (Biological Indicator Evaluator Resistometer). |
| Indications for Use: | The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed
to chemically react over time with the critical parameters of steam sterilization
cycle within a specified tolerance. The integrating indicator strip is intended to be
placed in each pack, pouch, container, tray or other containment device to
function as an independent monitor of critical parameters for the following
sterilization cycles: |
| | Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for
25 minutes, 132° C for 3 minutes, 135° C for 10 minutes; |
| | Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3
minutes. |
| | Minimum Stated Values as determined in a resistometer:
SV121°C/16.5 min., SV132°C/2.0min, SV134°C/1.4 min. SV135°C/1.2 min |

5

Operational The Type 5 Integrating Indicator for Steam CSPN-15 is intended for use Principles: with individual units, (e.g. packs, pouches, containers, trays, or containment devices) to demonstrate that the goods have been exposed to the critical parameters of a steam sterilization process.

The Type 5 Integrating Indicator for Steam CSPN-15 will transition from an initial color of pink (product code CSPN-15) to a dark brown/black signal color and conceal the word "NOT" when exposed to high temperature steam at various time and temperature intervals.

| Feature | Subject Device
True Indicating Type 5 Integrating
Indicator for Steam CSPN-15 | Predicate Device
Terragene Integron® IT26-1YS
(K191021) | Comparison |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Integrating indicator for steam
sterilization | Integrating indicator for steam
sterilization | Identical |
| Product Code | JOJ | JOJ | Identical |
| FDA
Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 | Identical |
| Indications for
Use (IFU) | The True Indicating Type 5 Integrating
Indicator for Steam CSPN-15 is
designed to chemically
react over time with the critical
parameters of steam sterilization cycle
within a specified tolerance. The
integrating indicator strip is intended to
be placed in each pack, pouch,
container, tray or other
containment device to function as an
independent monitor of critical
parameters for the following
sterilization cycles:
Gravity Displacement: 121° C for 30
minutes, 132° C for 15 minutes, 132°
C for 25 minutes, 132° C for 3
minutes, 132° C for 10 minutes;
Dynamic Air Removal (Vacuum
Assist): 132° C for 4 minutes, 135° C
for 3 minutes.
Minimum Stated Values as determined
in a resistometer:
SV121°C/16.5 min., SV132°C/2.0min,
SV134°C/1.4 min. SV135°C/1.2 min. | The integrator Terragene Integron®
IT26-1YS is designed to chemically
react over time with the critical
parameters of steam sterilization cycle
within a specified tolerance. The
integrating indicator strip is intended to
be placed in each pack, pouch,
container, tray or other containment
device to function as an independent
monitor of critical parameters for the
following sterilization cycles:
Gravity Displacement: 121° C for 30
minutes, 132° C for 15 minutes, 132° C
for 25 minutes, 135° C for 10 minutes;
Dynamic Air Removal (Vacuum Assist):
132° C for 4 minutes, 135° C for 3
minutes.
SV121° C/16.5 min. SV132° C/2.0 min,
SV135° C/1.2 min. | Similar |
| Device Design | Paper Strip printed with pink
chemical indicator ink with polyester
overlaminate applied over the top of
the indicating ink strip | Paper strip printed with yellow
chemical indicator ink with polyester
overlaminate applied over the top of
the indicating ink strip | Similar |
| Indicator
Agent | Sulfide based chemical to yield
color transition | Sulfide based chemical to yield
color transition | Similar |
| Endpoint
Specification | Dark brown/black color change | Dark brown/black color change | Identical |
| End Point
Stability | 6 Month | 6 Months | Identical |
| Shelf Life | 48 Months | 60 Months | Similar |

Technological Characteristic Comparison Table

6

Summarv of Nonclinical Tests: Per FDA recognized consensus standards and guidance documents, testing was performed for steam sterilization processes using multiple lots of True Indicating Chemical Indicator for Steam CSPN-15 over the range of the shelf

  • life: ● Performance Exposure Studies were conducted per ISO 11140-1:2014 for a Type 5 Integrator for Steam, and Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff
    • . End Point Stability of the achieved signal color was evaluated for a period of months 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 side-by-side with a biological indicator utilizing various loads per Guidance for Industry and FDA Staff Chemical Indicator (CI) Premarket Notification and True Indicating Protocols
    • Shelf-life of product code CSPN-15 per Guidance for Industry and FDA ● Staff Chemical Indicator (CI) Premarket Notification and True Indicating Protocols

Summary of Nonclinical Testing - Type 5 Integrating Indicator for Steam CSPN-15

Testing was conducted on the Type 5 Integrating Indicator for Steam CSPN-15 following the FDA quidance 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 (Type 5 Integrator for Steam)

7

Summary of Nonclinical Testing Table

| Name of Test | Purpose | Acceptance Criteria | Subject
Device
Result |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Steam
Resistometer
Testing | To identify and test the
pass/fail criteria for each
critical parameter and
provide the pass/fail results
to show how the Type 5
Integrating 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. Integrator
temperature coefficient and
correlation coefficient are
calculated to confirm
alignment to biological
indicator performance. | Pass result (end signal color
achieved for all product
codes) at the value for each
temperature claimed:
121°C for 16.5 minutes
132°C for 2.0 minutes
134°C for 1.4 minutes
135°C for 1.2 minutes
Fail result (end signal color
not achieved) at the value
for each temperature
claimed:
120°C for 14.025 minutes
131°C for 1.7 minutes
133°C for 1.19 minutes
134°C for 1.02 minutes
Integrator temperature
coefficient | PASS |
| | | 10 - 27 °C
Correlation coefficient
$\geq$ 0.9 | PASS |
| Hospital Steam
Sterilizer Testing | Determine if the Type 5
Integrating indicator 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 Displacement: 121° C for
30 minutes, 132° C for 15
minutes, 132° C for 25 minutes,
132° C for 3 minutes, 135° C for
10 minutes;
Dynamic Air Removal (Vacuum
Assist): 132° C for 4 minutes,
135° C for 3 minutes. | PASS |
| 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 | 6 Months | PASS |
| Side-by-Side Testing
with a Biological
Indicator | Confirm Integrators are
parallel (or more robust) in
performance to biological
indicators (BI). | Chemical Integrator does not
reach endpoint before Bls are
inactivated | 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 |

8

K242860 - 510(k) Summary

Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject device, the True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Terragene Integron® IT26-1YS (K191021), Class II (21 CFR 880.2800), product code JOJ.