(228 days)
JOJ
Not Found
No
The device is a chemical indicator strip that changes color based on exposure to hydrogen peroxide, a purely chemical reaction. There is no mention of AI or ML in the description, intended use, or performance studies.
No
The device is a chemical sterilization process indicator used to determine if products have been exposed to hydrogen peroxide during a sterilization process, not to treat a condition or disease.
No
This device is a chemical sterilization process indicator, used to determine if products have been exposed to hydrogen peroxide during sterilization, not to diagnose a medical condition in a patient.
No
The device is a physical indicator strip made of Tyvek® material with hydrogen peroxide sensitive ink, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to indicate exposure to a sterilization process (hydrogen peroxide) for medical products. This is a quality control/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 strip that changes color based on exposure to a chemical sterilant. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing a disease, or providing information about a patient's health status.
The device is clearly defined as a "chemical sterilization process indicator" under 21 CFR Part 880.2800(b), which falls under the category of general hospital and personal use devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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).
Product codes
JOJ
Device Description
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.
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
health care provider
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
Aging Study: Aging (30 days @ 40° C/0% RH) did not affect the ability of the product to function as an indicator. Visual color comparisons confirmed that the control and aged samples had no significant difference in color.
Fading Properties: The KCGPIS exposed to fluorescent light, over 12 days of continuous exposure, showed less fading that the STERRAD strip. The KCGPIS maintained 80% of its color vs 37.4% color retention for the STERRAD strip.
pH Buffer and Chemical Testing: Both the KCGPIS and the STERRAD strip were tested pre and post sterilization. Both strips were sensitive to alkaline based materials but the KCGPIS provided better resistance to acidic materials than did the STERRAD strip. The KCGPIS experienced 7 of 33 color changing exposures while the STERRAD strip experienced color changes in 27 of 32 samples.
EO/Steam Sterilization: The purpose of this experiment was to validate the absence of color conversion of the KCGPIS by steam and EO sterilization. Both the KCGPIS and the STERRAD strips were tested in EO and steam sterilizers and both products maintained their pre-process colors.
Indicator Efficacy: Color change as a result of a completed STERRAD sterilization cycle revealed total color conversion, from blue to green, when contained in pouches and wrapped trays containing medical instruments. KCGPIS adequately tracked exposure to hydrogen peroxide sterilant and the color change (to green) was complete in all samples at the end of the diffusion cycle.
Key Metrics
Not Found
Predicate Device(s)
J & J STERRAD* Chemical Indicator Strip
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
Summary of Testing
| Test | Result |
|---|---|
| Aging Study | Aging (30 days @ 40° C/0% RH) did not affect the |
| ability of the product to function as an indicator. | |
| Visual color comparisons confirmed that the control | |
| and aged samples had no significant difference in | |
| color. | |
| Fading Properties | The KCGPIS exposed to fluorescent light, over |
| 12 days of continuous exposure, showed less | |
| fading that the STERRAD strip. The KCGPIS | |
| maintained 80% of its color vs 37.4% color | |
| retention for the STERRAD strip. | |
| pH Buffer and Chemical | |
| Testing | Both the KCGPIS and the STERRAD strip |
| were tested pre and post sterilization. Both strips | |
| were sensitive to alkaline based materials but the | |
| KCGPIS provided better resistance to acidic | |
| materials than did the STERRAD strip. The | |
| KCGPIS experienced 7 of 33 color changing | |
| exposures while the STERRAD strip experienced | |
| color changes in 27 of 32 samples. | |
| EO/Steam Sterilization | The purpose of this experiment was to validate the |
| absence of color conversion of the KCGPIS by | |
| steam and EO sterilization. Both the KCGPIS and | |
| the STERRAD strips were tested in EO and steam | |
| sterilizers and both products maintained their pre- | |
| process colors. | |
| Indicator Efficacy | Color change as a result of a completed STERRAD |
| sterilization cycle revealed total color | |
| conversion, from blue to green, when contained | |
| in pouches and wrapped trays containing | |
| medical instruments. KCGPIS adequately | |
| tracked exposure to hydrogen peroxide sterilant | |
| and the color change (to green) was complete in all | |
| samples at the end of the diffusion cycle. |
.
:
2
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
3
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_______
4
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)