(157 days)
Integron IT12, K191021
No
The device is a chemical indicator that changes color based on chemical reactions to sterilization parameters, not through computational analysis or learning.
No.
The Gas-Chex Indicator is designed to monitor the effectiveness of Ethylene Oxide sterilization cycles, not to directly treat or diagnose a medical condition.
No
Explanation: The device is an integrating indicator used to monitor the critical parameters of Ethylene Oxide sterilization cycles by changing color. It does not diagnose medical conditions in patients.
No
The device description clearly states it is a physical strip with reactive ink, which is a hardware component.
Based on the provided information, the Gas-Chex Indicator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to monitor the critical parameters of Ethylene Oxide sterilization cycles. This is a process monitoring function, not a diagnostic test performed on a biological sample to diagnose a disease or condition.
- Device Description: The device is a chemical indicator that changes color based on exposure to sterilization parameters. It does not interact with biological samples for diagnostic purposes.
- Performance Studies: The performance studies focus on the indicator's ability to accurately reflect the sterilization process parameters and correlate with biological indicators used for sterilization validation. They do not involve evaluating diagnostic accuracy on patient samples.
In summary, the Gas-Chex Indicator is a sterilization process indicator, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Gas-Chex Indicator is an integrating indicator designed to respond to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex Indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
- 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure
- 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure
- 38°C, 736 mg/l EO, 40-80% RH, 4.5 hours exposure
- 38°C, 759 mg/l EO, 40-80% RH, 4.5 hours exposure
- 55°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
- 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure
- 55°C. 600 mg/l EO. 60% RH. 4 hours exposure
The Gas-Chex Indicator for EO sterilization has the following minimum Stated Values determined in a Resistometer:
54℃, 42 min, EO 600 mg/l, RH 60±10%
37℃,75 min. EO 600 mg/l. RH 60±10%
55°C, 36 min, EO 736 mg/l, RH 50±10%
37°C, 75 min, EO 736 mg/l, RH 50±10%
55°C, 35 min, EO 759 mg/l, RH 50±10%
37°C, 75 min, EO 759 mg/l, RH 50±10%
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The Gas-Chex® Indicator is a single use chemical integrating indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a 4" x 9/16" substrate paper strip. It can be also printed on other substrate sizes, for example 8" x 9/16" paper. Gas-Chex® Indicators are sold in boxes of 250 strips.
The indicator responds to all critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During sterilization process the indicator ink chemicals react to EO gas forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from brown-red to green. If the parameters do not achieve the required level, the indicator color will be brown-red, or brown-yellow.
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 Non-Clinical Testing:
- Performance testing in EO BIER vessel:
- Purpose: Demonstrate conformance of Gas-Chex Indicator with the FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003 for integrating indicators.
- Acceptance Criteria: Color changes as specified for various temperature, EO, and RH conditions, including green for successful sterilization and brown, brown-red, or brown-yellow for insufficient conditions.
- Result: Passed.
- Testing in "No EO Gas" cycles:
- Purpose: Confirm that Gas-Chex indicator does not change color in absence of Ethylene Oxide gas.
- Acceptance Criteria: When tested in cycle with temperature 60°C±2°C, RH≥85%, time 90 min±1min, the indicator should not achieve end point color.
- Result: Passed.
- Testing against biological indicator:
- Purpose: Establish correlation between performance of Gas-Chex indicator and EO Biological indicator.
- Acceptance Criteria: The integrator does not achieve end-point color before the biological indicator is inactivated and demonstrates parallel performance to the biological indicator.
- Result: Passed.
- Single parameter variation testing:
- Purpose: Confirm that Gas-Chex indicator is sensitive to critical sterilization parameters.
- Acceptance Criteria: Variation of one parameter while other ones are maintained steady. Gas-Chex Indicator should not reach specified end-point green color.
- Result: Passed.
- Testing in cycles with parameters typical for healthcare:
- Purpose: Demonstrate Gas-Chex indicator achieves specified end color in typical cycles.
- Acceptance Criteria: Color change from brown-red to green.
- Result: Passed.
- Biocompatibility study and ink transfer test:
- Purpose: Demonstrate that the indicator does not create biocompatibility issues to health care professionals and patients.
- Acceptance Criteria: Evaluation of individual components for biocompatibility and review of biocompatibility of indicators with similar formulation with history on the market. Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and EO processed samples.
- Result: Passed.
- End-point stability and shelf- life study:
- Purpose: Confirm that Gas-Chex indicator has acceptable stability after processing when achieved and not achieved end point color ("Pass" and "Fail" conditions). Demonstrate that Gas-Chex indicator maintains its performance when tested using real-time shelf-life exposure method.
- Acceptance Criteria: Gas-Chex indicators processed in Pass and Fail cycles at various time points after production and at the end of shelf life should demonstrate stable color for at least 3 months. Meet specifications after real-time 36 months shelf-life exposure.
- Result: Passed.
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.
Integron IT12, 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.
Propper BI-OK® EO Gas Biological Test Pack, K972747, Terragene ChemDye CD16 EO Multivariable process indicator, K191021
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
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January 20, 2022
Propper Manufacturing Co., Inc. Andrew Sharavara Chief Technical Officer 36-04 Skillman Avenue Long Island City, New York 11101
Re: K212592
Trade/Device Name: Gas-Chex Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: December 20, 2021 Received: December 23, 2021
Dear Andrew Sharavara:
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: K212592
Device Name Gas-Chex Indicator
Indications for Use (Describe)
The Gas-Chex Indicator is an integrating indicator designed to respond to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex Indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
-
- 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure 2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure 3. 38°C, 736 mg/l EO, 40-80% RH, 4.5 hours exposure 4. 38°C, 759 mg/l EO, 40-80% RH, 4.5 hours exposure 5. 55°C, 736 mg/l EO, ≥35% RH, 1 hour exposure 6. 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure 7. 55°C. 600 mg/l EO. 60% RH. 4 hours exposure
The Gas-Chex Indicator for EO sterilization has the following minimum Stated Values determined in a Resistometer:
- 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure 2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure 3. 38°C, 736 mg/l EO, 40-80% RH, 4.5 hours exposure 4. 38°C, 759 mg/l EO, 40-80% RH, 4.5 hours exposure 5. 55°C, 736 mg/l EO, ≥35% RH, 1 hour exposure 6. 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure 7. 55°C. 600 mg/l EO. 60% RH. 4 hours exposure
54℃, 42 min, EO 600 mg/l, RH 60±10% 37℃,75 min. EO 600 mg/l. RH 60±10%
55°C, 36 min, EO 736 mg/l, RH 50±10% 37°C, 75 min, EO 736 mg/l, RH 50±10%
55°C, 35 min, EO 759 mg/l, RH 50±10% 37°C, 75 min, EO 759 mg/l, RH 50±10%
| 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
510(k) Summarv K212592
| Submitted by: | Propper Manufacturing Company, Inc. |
|---|---|
| Address: | 36-04 Skillman Avenue, |
| Long Island City, New York 11101 | |
| Contact Name: | Andrew Sharavara, Ph.D., Chief Technical Officer |
| Telephone: | (800) 832-4300 x149 |
| Fax: | (718) 482-8909 |
| E-mail: | as@proppermfg.com |
| Date Submitted: | August 12, 2021 |
Device information:
| Device Trade Name: | Gas-Chex® Indicator |
|---|---|
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
| Common Name: | Ethylene Oxide Gas Sterilization Indicator |
| Product Code: | JOJ |
| Classification: | Class II (21 C.F.R. 880.2800) |
| 510k number | K212592 |
Description of the Device
The Gas-Chex® Indicator is a single use chemical integrating indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a 4" x 9/16" substrate paper strip. It can be also printed on other substrate sizes, for example 8" x 9/16" paper. Gas-Chex® Indicators are sold in boxes of 250 strips.
The indicator responds to all critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During sterilization process the indicator ink chemicals react to EO gas forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from brown-red to green. If the parameters do not achieve the required level, the indicator color will be brown-red, or brown-yellow.
Indications for Use
The Gas-Chex® Indicator is an integrating indicator designed to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex® Indicator is intended to be placed in each pack, pouch, tray, or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
4
- 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure 2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure 3. 38°C, 736 mg/1 EO, 40-80% RH, 4.5 hours exposure 4. 38°C, 759 mg/1 EO, 40-80% RH, 4.5 hours exposure 5. 55°C. 736 mg/l EO. >35% RH. 1 hour exposure 6. 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure 7. 55°C, 600 mg/l EO, 60% RH, 4 hours exposure
The Gas-Chex® Indicator has the following minimum Stated Values determined in a Resistometer:
54℃, 42 min, EO 600 mg/1, RH 60±10% 37℃,75 min, EO 600 mg/1, RH 60±10% 55℃,36 min, EO 736 mg/1, RH 50±10% 37℃,73 min, EO 736 mg/1, RH 50±10% 55℃, 35 min, EO 759 mg/l, RH 50±10% 37℃, 73 min, EO 759 mg/1, RH 50±10%
Performance
The performance of the Gas-Chex® Indicator complies with FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003 for integrating indicators.
Technological Characteristics Comparison to Legally Marketed Predicate Device
Comparison of the subject device (Gas-Chex Indicator, Propper Manufacturing Co., Inc) to Predicate device (Integron IT12, K191021, by Terragene S.A.).
| Subject device | Predicate device | Comparison | design | indicator ink | |||
|---|---|---|---|---|---|---|---|
| Product name | Gas-Chex Indicator | Integron IT12 integrator, | |||||
| K191021 | Initial color | Brown-red | Purple | Similar | |||
| Product | |||||||
| generic name | A physical/chemical sterilization | ||||||
| process indicator | A physical/chemical | ||||||
| sterilization process indicator | Identical | End point color | Green | Green | Identical | ||
| Product code | JOJ | JOJ | Identical | Indicator category | Integrating indicator | ISO Integrator | Similar. Both indicators are designed to respond to all critical parameters over a specified range. |
| Sterilization | |||||||
| method | Ethylene Oxide gas sterilization | Ethylene Oxide gas | |||||
| sterilization | Identical | Single use | Yes | Yes | Identical | ||
| Intended use | Sterilization process indicator | Sterilization process indicator | Identical | Shelf life | 36 months | 36 months | Identical |
| Sterilization | |||||||
| cycles | 37°C,736 mg/l EO, ≥35% RH, 3hrs | ||||||
| 37°C,759 mg/l EO, ≥35% RH, 3hrs | |||||||
| 38°C,736 mg/l EO, 40-80% RH, 4.5 hrs | |||||||
| 38°C,759 mg/l EO, 40-80% RH, 4.5 hrs | |||||||
| 55°C,736 mg/l EO, ≥35% RH, 1 hr | |||||||
| 55°C,759 mg/l EO, ≥35% RH, 1 hr | |||||||
| 55°C,600 mg/l EO, 60% RH, 4 hrs | 55°C, 600 mg/l EO, 60% RH, | ||||||
| 240min | Identical with | ||||||
| additional cycles for | |||||||
| Gas-Chex Indicator | Indications for use | The Gas-Chex Indicator is designed to respond to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex Indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: | |||||
| 37°C,736 mg/l EO, ≥35% RH, 3hrs | |||||||
| 37°C,759 mg/l EO, ≥35% RH, 3hrs | |||||||
| 38°C,736 mg/l EO, 40-80% RH, 4.5 hrs | |||||||
| 38°C,759 mg/l EO, 40-80% RH, 4.5 hrs | |||||||
| 55°C,736 mg/l EO, ≥35% RH, 1 hr | |||||||
| 55°C,759 mg/l EO, ≥35% RH, 1 hr | |||||||
| 55°C,600 mg/l EO, 60% RH, 4 hrs |
The Gas-Chex Indicator for EO sterilization has the following minimum Stated Values determined in a Resistometer:
54°C, 42 min, EO 600 mg/l, RH 60±10%
37°C, 75 min, EO 600 mg/l, RH 60±10%
55°C, 36 min, EO 736 mg/l, RH 50±10%
37°C, 73 min, EO 736 mg/l, RH 50±10%
55°C, 35 min, EO 759 mg/l, RH 50±10%
37°C, 73 min, EO 759 mg/l, RH 50±10% | The integrator Terragene Integron® IT12 is designed to chemically react over time with the critical parameters of ethylene oxide 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:
55°C for 240 minutes, 600 mg/l, RH 60 %.
SV 37°C/75 min,
SV 54°C/30 min,
SV 55°C/28 min. | Similar. Gas-Chex indicator can be used in several additional cycles.
Stated value at 37°C is identical.
Gas-Chex indicator has longer stated value time in BIER vessel at 54°C which is within typical performance range and conforms to the requirement not to achieve end point before biological indicator spore death. |
| Device | Paper strip printed with indicator ink | Paper strip printed with | Identical | | | | |
5
Propper BI-OK® EO Gas Biological Test Pack, K972747, was used as a reference device for stability and shelf-life review because this reference device includes EO sterilization record card – a paper sheet printed with EO indicator ink very similar to the ink of Gas-Chex Indicator.
Terragene ChemDye CD16 EO Multivariable process indicator, K191021, was used as a reference device for color change comparison.
6
Summary of Non-Clinical Testing
Provided below is the summary of non-clinical testing that was performed to demonstrate that the subject device met the acceptance criteria for each standard or test method.
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Performance | |||
| testing in EO | |||
| BIER vessel | Demonstrate conformance of | ||
| Gas-Chex Indicator with the | |||
| FDA guidance for industry and | |||
| FDA Staff: Pre-market | |||
| notification [510(k)] | |||
| submissions for chemical | |||
| indicators, 2003 for integrating | |||
| indicators. | Color changes: | ||
| 54°C, 42 min, EO 600 mg/l, RH 60%: green | |||
| 49°C, 33.6min, EO 510 mg/l, RH 60%: | |||
| brown, brown-red, brown-yellow | |||
| 37°C, 75 min, EO 600 mg/l, RH 60%: green | |||
| 32°C, 60 min, EO 510 mg/l, RH 60%: | |||
| brown, brown-red, brown-yellow | |||
| 55°C, 36 min, EO 736 mg/l, RH 50%: green | |||
| 50°C, 28.8min, EO 625mg/l, RH 50%: | |||
| brown, brown-red, brown-yellow | |||
| 37°C, 73 min, EO 736 mg/l, RH 50%: green | |||
| 32°C, 58.4min, EO 625mg/l, RH 50%: | |||
| brown, brown-red, brown-yellow | |||
| 55°C, 35 min, EO 759 mg/l, RH 50%: green | |||
| 50°C, 28 min, EO 645 mg/l, RH 50%: | |||
| brown, brown-red, brown-yellow | |||
| 37°C, 73 min, EO 759 mg/l, RH 50%: green | |||
| 32°C, 58.4min, EO 645mg/l, RH 50%: | |||
| brown, brown-red, brown-yellow | Passed | ||
| Testing in "No | |||
| EO Gas" cycles | Confirm that Gas-Chex | ||
| indicator does not change color | |||
| in absence of Ethylene Oxide | |||
| gas | When tested in cycle with temperature | ||
| 60°C±2°C, RH≥85%, time 90 min±1min, the | |||
| indicator should not achieve end point color. | Passed | ||
| Testing against | |||
| biological | |||
| indicator | Establish correlation between | ||
| performance of Gas-Chex | |||
| indicator and EO Biological | |||
| indicator | The integrator does not achieve end-point | ||
| color before the biological indicator is | |||
| inactivated and demonstrates parallel | |||
| performance to the biological indicator. | Passed | ||
| Single parameter | |||
| variation testing | Confirm that Gas-Chex | ||
| indicator is sensitive to critical | |||
| sterilization parameters. | Variation of one parameter while other ones | ||
| are maintained steady. Gas-Chex Indicator | |||
| should not reach specified end-point green | |||
| color. | Passed | ||
| Testing in cycles | |||
| with parameters | |||
| typical for | |||
| healthcare | Demonstrate Gas-Chex | ||
| indicator achieves specified end | |||
| color in typical cycles. | Color change from brown-red to green. | Passed | |
| Biocompatibility | |||
| study and ink | |||
| transfer test | Demonstrate that the indicator | ||
| does not create biocompatibility | |||
| issues to health care | |||
| professionals and patients. | Evaluation of individual components for | ||
| biocompatibility and review of | |||
| biocompatibility of indicators with similar | |||
| formulation with history on the market. |
Testing according to ISO 11140-1:2014.
Requirement: 6.2.2. No ink transfer should be
observed on unprocessed and EO processed
samples. | Passed |
| End-point
stability and
shelf- life study | Confirm that Gas-Chex
indicator has acceptable
stability after processing when
achieved and not achieved end
point color ("Pass" and "Fail"
conditions).
Demonstrate that Gas-Chex
indicator maintains its
performance when tested using
real-time shelf-life exposure
method. | Gas-Chex indicators processed in Pass and
Fail cycles at various time points after
production and at the end of shelf life should
demonstrate stable color for at least 3 months.
Meet specifications after real-time 36 months
shelf-life exposure. | Passed |
7
Conclusion
The conclusion drawn from the nonclinical test demonstrate that the Gas-Chex Indicator is as safe, as effective, and performs as well as or better that the legally marketed predicate device, K191021.