(228 days)
The Kimberly-Clark™ Gas Plasma Indicator Strip is a chemical sterilization process indicator as defined in 21 CFR Part 880.2800(b). The indicator strip is intended to be used by a health care provider to accompany products being sterilized via a low temperature (STERRAD) sterilization process. The indicator strip is used to differentiate between product that has been exposed to hydrogen peroxide and product that has not been exposed to hydrogen peroxide. The strip will change color, from blue to green, upon exposure to the low temperature sterilant (hydrogen peroxide).
The Kimberly-Clark Gas Plasma Indicator Strip (KCGPIS) is manufactured from a Tyvek® material or other synthetic substrate. The indicator is approximately 34 " wide by 4 inches long and is flexographically printed with a hydrogen peroxide sensitive ink.
This document describes the validation of the Kimberly-Clark™ Gas Plasma Indicator Strip (KCGPIS).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative thresholds in the provided text, but rather implied by the description of the tests and successful outcomes. The device performance is reported as meeting these implied good manufacturing practice standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Aging Stability: Device function is not compromised by aging. | Aging (30 days @ 40° C/0% RH) did not affect the ability of the product to function as an indicator. Visual color comparisons confirmed no significant difference in color between control and aged samples. |
| Fading Resistance: Device maintains color integrity over time, especially under light exposure. | The KCGPIS exposed to fluorescent light over 12 days showed less fading than the predicate (STERRAD strip). KCGPIS maintained 80% color retention compared to 37.4% for the STERRAD strip. |
| Chemical Resistance (pH Buffer): Device is robust against various pH levels, especially acidic conditions. | While sensitive to alkaline materials (like the predicate), the KCGPIS provided better resistance to acidic materials than the STERRAD strip (7 of 33 color changing exposures for KCGPIS vs. 27 of 32 for STERRAD strip). Both were tested pre and post sterilization. |
| Specificity to EO/Steam Sterilization: Device does not inadvertently change color when exposed to common sterilization methods other than hydrogen peroxide. | Both KCGPIS and STERRAD strips maintained their pre-process colors when tested in EO (Ethylene Oxide) and steam sterilizers, validating the absence of color conversion by these alternative sterilization methods. |
| Indicator Efficacy: Device accurately and completely changes color upon exposure to a full STERRAD sterilization cycle. | Color change from blue to green was total as a result of a completed STERRAD sterilization cycle when contained in pouches and wrapped trays with medical instruments. KCGPIS adequately tracked exposure to hydrogen peroxide sterilant, and the color change was complete in all samples at the end of the diffusion cycle. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Aging Study: Not explicitly stated, but implies a comparison between "control and aged samples."
- Fading Properties: Not explicitly stated, but implies multiple strips were tested to yield percentage retention.
- pH Buffer and Chemical Testing: 33 exposures for KCGPIS, 32 exposures for STERRAD strip.
- EO/Steam Sterilization: Not explicitly stated, but implies multiple strips were tested for each sterilization method.
- Indicator Efficacy: "All samples" showed complete color change when contained in pouches and wrapped trays, but the specific number of samples is not given.
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective in nature, as they involve testing the newly developed Kimberly-Clark™ Gas Plasma Indicator Strip under controlled conditions to demonstrate its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The validation relies on observable color changes and comparisons to a predicate device, which implies a direct assessment without the need for expert consensus on subjective interpretations.
4. Adjudication Method for the Test Set
The document does not mention any formal adjudication method (e.g., 2+1, 3+1). The nature of the device (a chemical indicator with a clear visual color change) suggests that adjudication by multiple independent parties would likely not be necessary. The assessment of color change is typically straightforward.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation plays a significant role, and the AI's impact on human reader performance is being evaluated. The KCGPIS is a simple chemical indicator with a direct visual output, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described is effectively a standalone performance evaluation of the chemical indicator itself. The device's performance is determined purely by its physical and chemical properties (color change in response to sterilant or other conditions), without any human interpretation element that an "algorithm" might typically assist or replace. There is no AI algorithm involved in this device.
7. The Type of Ground Truth Used
The ground truth used is primarily objective physical/chemical reaction.
- For efficacy studies, the ground truth is whether the complete STERRAD sterilization cycle was actually performed (i.e., exposure to hydrogen peroxide sterilant). The indicator is then expected to change color.
- For stability and resistance studies, the ground truth is the controlled environmental condition (e.g., specific temperature, humidity, light exposure, pH, or exposure to other sterilants like EO/steam). The expected behavior (no change or a specific change) is then observed.
8. The Sample Size for the Training Set
This question is not applicable. The KCGPIS is a chemical indicator, not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an AI algorithm.
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510(k) Summary of Safety and Effectiveness
Manufacturer:
Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA 30076
Regulatory Affairs Contact:
Manager Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA 30076 (770) 587-8279
Larry R. Kludt
November 20, 1997 Summary Date:
Product Trade Name: Kimberly-Clark™ Gas Plasma Indicator Strip
| Common Name: | Chemical Indicator |
|---|---|
| Classification: | Indicator, Chemical Indicator Strip |
J & J STERRAD* Chemical Indicator Strip Predicate Device:
The Kimberly-Clark Gas Plasma Indicator Strip (KCGPIS) is Description: manufactured from a Tyvek® material or other synthetic substrate. The indicator is approximately 34 " wide by 4 inches long and is flexographically printed with a hydrogen peroxide sensitive ink.
The KCGPIS is a chemical sterilization process indicator as Intended Use: defined in 21 CFR Part 880.2800(b). The indicator strip is intended to be used by a health care provider to accompany products being sterilized via a low temperature, (STERRAD) sterilization process. The indicator strip is used to differentiate between product that has been exposed to hydrogen peroxide and product that has not been exposed to hydrogen peroxide. The strip will change color, from blue to green, upon exposure to the low temperature sterilant (hydrogen peroxide).
Technological Both the STERRAD Chemical Indicator Strip and the Kimberly-Characteristics: Clark Gas Plasma Indicator Strip have a one year expiration date. Both products can be used to distinguish between products that have been exposed, or not exposed, to hydrogen peroxide sterilant, via a visible color change.
JUL 10 1998
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Summary of Testing
| Test | Result |
|---|---|
| Aging Study | Aging (30 days @ 40° C/0% RH) did not affect theability of the product to function as an indicator.Visual color comparisons confirmed that the controland aged samples had no significant difference incolor. |
| Fading Properties | The KCGPIS exposed to fluorescent light, over12 days of continuous exposure, showed lessfading that the STERRAD strip. The KCGPISmaintained 80% of its color vs 37.4% colorretention for the STERRAD strip. |
| pH Buffer and ChemicalTesting | Both the KCGPIS and the STERRAD stripwere tested pre and post sterilization. Both stripswere sensitive to alkaline based materials but theKCGPIS provided better resistance to acidicmaterials than did the STERRAD strip. TheKCGPIS experienced 7 of 33 color changingexposures while the STERRAD strip experiencedcolor changes in 27 of 32 samples. |
| EO/Steam Sterilization | The purpose of this experiment was to validate theabsence of color conversion of the KCGPIS bysteam and EO sterilization. Both the KCGPIS andthe STERRAD strips were tested in EO and steamsterilizers and both products maintained their pre-process colors. |
| Indicator Efficacy | Color change as a result of a completed STERRADsterilization cycle revealed total colorconversion, from blue to green, when containedin pouches and wrapped trays containingmedical instruments. KCGPIS adequatelytracked exposure to hydrogen peroxide sterilantand the color change (to green) was complete in allsamples at the end of the diffusion cycle. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 1998
Kimberly-Clark Corporation ·C/O Mr. Larry R. Kludt Manager Regulatory Affaris 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re : K974415 Kimberly-Clark™ Gas Plasma Sterilization Trade Name: Indicator Strip Requlatory Class: II. Product Code: JOJ Dated: June 26, 1998 Received: June 29, 1998
Dear Mr. Kludt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Kludt
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on --the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure_______
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Page 1
K974415 5 l 0(k) Number (if known):
Dcvicc Namc: Kimberly-Clark Gas Plasma Indicator Strip
Indications For Usc:
The Kimberly-Clark™ Gas Plasma Indicator Strip is a chemical sterilization process indicator as defined in 21 CFR Part 880.2800(b). The indicator strip is intended to be used by a health care provider to accompany products being sterilized via a low temperature (STERRAD) sterilization process. The indicator strip is used to differentiate between product that has been exposed to hydrogen peroxide and product that has not been exposed to hydrogen peroxide. The strip will change color, from blue to green, upon exposure to the low temperature sterilant (hydrogen peroxide).
(PLEASE DO NOT WIUTE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
Clim S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 974415
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Formal 1-2-96)
§ 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).