(59 days)
Not Found
No
The device is a chemical indicator tape that changes color based on exposure to a sterilization process, which is a purely chemical reaction and does not involve any computational or learning processes.
No
The device is a sterilization process indicator tape used to differentiate processed from unprocessed items, not to treat a disease or condition.
No
This device is an indicator tape used to differentiate processed from unprocessed items during sterilization. It does not diagnose any condition or disease.
No
The device is a physical indicator tape with chemical stripes that change color, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to secure packs and act as an external process indicator for sterilization. This is related to monitoring a sterilization process, not diagnosing a condition or analyzing a biological sample from a human body.
- Device Description: The device is a tape with a chemical indicator that changes color based on exposure to a sterilization agent. This is a physical/chemical indicator, not a diagnostic test.
- No mention of biological samples: There is no indication that this device is used to test or analyze any biological samples (blood, urine, tissue, etc.).
- Focus on sterilization process: The performance studies and description clearly focus on the device's ability to indicate successful exposure to the sterilization process.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The 3M™ Comply™ 1228 Gas Plasma Indicator Tape is indicated for use to secure packs and as an external pack process indicator to differentiate processed from unprocessed items when exposed to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterillization processes.
Product codes
JOJ
Device Description
The 3M Comply™ 1228 Gas Plasma Indicator Tape is a sterilization process indicator and is comprised of non-cellulosic plastic backing material with a pressure sensitive adhesive on one side and indicator stripes on the other side. A color match is printed in the Comply 1228 Technical Information Sheet. The chemical indicator stripes turn from blue to pink after exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and the STERRAD® 50 Sterilization processes.
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
Testing Summary:
Cycle Conditions Required for Color Change in a STERRAD 100 Sterilizer: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 100 Sterilization cycle and the minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.
Cycle Conditions Required for Color Change Using the STERRAD 100S Cycle: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 100S Sterilization cycle and the minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.
Cycle Conditions Required for Color Change in a STERRAD 50 Sterilizer: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 50 Sterilization cycle and the minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.
Eighteen-Month Color Change Stability Study: Six-month interim results verified that all indicator tape turned from blue to pink when exposed to the complete STERRAD 100S Sterilization cycles, thereby confirming the continued stability of the 3M ComplyTM 1228 Gas Plasma Chemical Indicator to date. Eighteen-Month color change stability testing is ongoing.
Eighteen-Month Adhesive Stability Study: Six-month interim results have found no initial trends in the peel force over time for both unprocessed tape and processed tape when removed from Kimberly-Clark Spungard One-Step wrap. Six-month interim results have verified wrap security. Eighteen-Month adhesive stability testing is ongoing.
Light Stability Testing: Testing verified that the colors of the processed and unprocessed 3M Comply™ 1228 Gas Plasma Indicator Tape samples did not change significantly after four (4) weeks of exposure to fluorescent light.
Performance After Exposure to Light: Testing verified that all indicator tape samples continued to meet the color match when exposed to both the complete STERRAD 100S Sterilization cycles, thereby confirming the stability of the 3M Comply™ 1228 Gas Plasma Indicator Tape samples following four (4) weeks of exposure to fluorescent light.
Effect of the Absence of Hydrogen Peroxide on the Color Change: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples did not exhibit any color change following exposure to a cycle containing deionized water instead of hydrogen peroxide.
Effects of Steam and Ethylene Oxide Sterilization: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples were found to be unaffected by the steam or ethylene oxide sterilization process. The Instructions For Use includes a Precaution not to use the indicator tape to monitor steam or ethylene oxide sterilization cycles.
Effects of Acid and Base: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples were not sensitive to the presence of an acidic or basic (alkaline) environment. The unprocessed color of the 3M Comply 1228 Gas Plasma Indicator Tape samples was found to be sensitive to the presence of an acidic and basic (alkaline) environment, but does not change to pink, the processed color. The Instructions For Use includes a Precaution to store the indicator tape away from hydrogen peroxide and alkaline chemicals.
Key Metrics
Not Found
Predicate Device(s)
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
3M™ Comply™ 1228 Gas Plasma Indicator Tape 510(k) Notification
K020589
Page 92
APPENDIX G: Premarket Notification (510 (k)) Summary
Manufacturer:
3M Company 3M Medical Division 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Regulatory Affairs Contact:
Joann L. Huehn Advanced Regulatory Affairs Associate 3M Company Tel: 651-733-9209 FAX: 651-737-5320
Date
February 21, 2002
Summary Prepared:
| Device Trade Name: | 3MTM ComplyTM 1228 Gas Plasma Indicator Tape |
|---|---|
| Common or Usual | |
| Name: | Chemical Indicator Tape |
Classification: Physical/Chemical Sterilization Process Indicator [21CFR 880.2800(b)]
Device Description:
The 3M Comply™ 1228 Gas Plasma Indicator Tape is a sterilization process indicator and is comprised of non-cellulosic plastic backing material with a pressure sensitive adhesive on one side and indicator stripes on the other side. A color match is printed in the Comply 1228 Technical Information Sheet. The chemical indicator stripes turn from blue to pink after exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and the STERRAD® 50 Sterilization processes.
Intended Use: The 3M Comply™ 1228 Gas Plasma Indicator Tape is indicated for use to secure packs and as an external pack process indicator to differentiate processed from unprocessed items when exposed to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterillization processes.
1
Substantial Equivalence: The 3M Comply™ 1228 Gas Plasma. Indicator Tape is comparable in performance to the Advanced Sterilization Products (ASP) STERRAD® Gas Plasma Indicator Tape (K945190). The 3M Comply 1228 Gas Plasma Indicator Tape and the predicate device share the same intended use to secure packs and as external pack indicators to differentiate processed from unprocessed items when exposed to vapor hydrogen peroxide in the STERRAD 100, STERRAD 100S, and the STERRAD 50 sterilization processes. In addition, the 3M Comply™ 1228 Gas Plasma Indicator Tape and the predicate device share similar design and appearance.
Testing Summary:
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Cycle Conditions Required for Color Change in a STERRAD 100 Sterilizer
Cycle Conditions Required for Color Change Using the STERRAD 100S Cycle
Cycle Conditions Required for Color Change in a STERRAD 50 Sterilizer
Eighteen-Month Color Change Stability Study
Eighteen-Month Adhesive Stability Study
Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 100 Sterilization cycle and the minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.
Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 100S Sterilization cycle and the minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.
Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 50 Sterilization cycle and the minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.
Six-month interim results verified that all indicator tape turned from blue to pink when exposed to the complete STERRAD 100S Sterilization cycles, thereby confirming the continued stability of the 3M ComplyTM 1228 Gas Plasma Chemical Indicator to date. Eighteen-Month color change stability testing is ongoing.
Six-month interim results have found no initial trends in the peel force over time for both unprocessed tape and processed tape when removed from Kimberly-Clark Spungard One-Step wrap. Six-month interim results have verified wrap security. Eighteen-Month adhesive stability testing is ongoing.
2
Testing verified that the colors of the processed and Light Stability unprocessed 3M Comply™ 1228 Gas Plasma Indicator Tape Testing samples did not change significantly after four (4) weeks of exposure to fluorescent light.
Testing verified that all indicator tape samples continued to Performance After meet the color match when exposed to both the complete Exposure to Light STERRAD 100S Sterilization cycles, thereby confirming the stability of the 3M Comply™ 1228 Gas Plasma Indicator Tape samples following four (4) weeks of exposure to fluorescent light.
Effect of the Absence of Hydrogen Peroxide on the Color Change
Effects of Steam and Ethylene Oxide Sterilization
Effects of Acid and Base
Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples did not exhibit any color change following exposure to a cycle containing deionized water instead of hydrogen peroxide.
Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples were found to be unaffected by the steam or ethylene oxide sterilization process. The Instructions For Use includes a Precaution not to use the indicator tape to monitor steam or ethylene oxide sterilization cycles.
Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples were not sensitive to the presence of an acidic or basic (alkaline) environment. The unprocessed color of the 3M Comply 1228 Gas Plasma Indicator Tape samples was found to be sensitive to the presence of an acidic and basic (alkaline) environment, but does not change to pink, the processed color. The Instructions For Use includes a Precaution to store the indicator tape away from hydrogen peroxide and alkaline chemicals.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PR 2 2 2002
Ms. Joann L. Huehn 3M Company Medical Division 3M Center, Building 275-5W-06 Saint Paul, Minnesota 55144-1000
Re: K020589
Trade/Device Name: 3M™ ComplyTM 1228 Gas Plasma Indicator Tape Regulation Number: 880.2800 (b) Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: February 21, 2002 Received: February 22, 2002
Dear Ms. Huehn:
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. 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 (PMA), it may be subject to such 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.
4
You must comply with all the Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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
5
APPENDIX C: INDICATIONS FOR USE STATEMENT
510(k) Number:
. TBD
Device Name:
Indications For Use:
The 3M™ Comply™ 1228 Gas Plasma Indicator Tape is indicated for use to secure packs and as an external pack indicator to differentiate processed from unprocessed items when exposure to vapor hydrogen peroxide in the STERRAD® sterilization processes (100, 100S, 50). The 3M Comply 1228 is suitable for use on non-woven disposable wraps and peel pouches. The diagonal stripes of chemical indicator ink turn from blue to pink after exposure to vapor hydrogen peroxide in
3M™ Comply™ 1228 Gas Plasma Indicator Tape
Chin S. Lim
these sterilization processes.
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number