← Product Code [JOJ](/productcode/JOJ) · K150477
# 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization (K150477)
_3M Company · JOJ · Jul 2, 2015 · General Hospital · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K150477
## Device Facts
- **Applicant:** 3M Company
- **Product Code:** [JOJ](/productcode/JOJ.md)
- **Decision Date:** Jul 2, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.2800
- **Device Class:** Class 2
- **Review Panel:** General Hospital
## Indications for Use
The tape is designed to secure packs wrapped with untreated woven (i.e., reusable 100% cotton and cotton/poly blends) and disposable non-woven, paper/plastic, and spunbond polyolefin/plastic wraps. Use the EO indicator tape to demonstrate that packs have been exposed to one of the EO sterilization processes in the table below and to distinguish between processed and unprocessed packs.
## Device Story
3M Comply 1224 Indicator Tape is a pressure-sensitive adhesive tape used to secure sterilization packs. It features yellow indicator stripes that undergo a chemical color change to red-maroon upon exposure to specific EO sterilization parameters (gas concentration, time, temperature, humidity). The device is used in clinical settings by healthcare personnel to distinguish between processed and unprocessed packs. It provides a visual indicator of exposure to sterilization conditions, aiding in the management of sterile supplies. The device is reformulated to reduce environmental impact from manufacturing solvents compared to the predicate.
## Clinical Evidence
No clinical data was included in this submission. Effectiveness was demonstrated via bench testing per ISO 11140-1:2005/R2010, including color change verification in resistometer samples and healthcare facility cycle samples, and endpoint color stability testing.
## Technological Characteristics
Pressure-sensitive adhesive tape with yellow stripes containing phenol red indicator agent. Designed to meet ISO 11140-1 Class 1 EO process indicator requirements. Storage: 15-30°C, <50% relative humidity. Endpoint stability: 6 months.
## Regulatory Identification
Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.
## Predicate Devices
- Indox Ethylene Oxide Indicator Tape
## Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2015
3M Health Care Matt Mortensen, PhD, RAC Regulatory Affairs Lead 3M Center Building 275-5W-06 St. Paul. MN 55144
Re: K150477
Trade/Device Name: 3M Comply™ 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization Regulation Number: 21 CFR 880.2800 Regulation Name: Physical/chemical sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: June 4, 2015 Received: June 5, 2015
Dear Dr. Mortensen:
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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
*Tejashri Purohit-Sheth, M.D.*
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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# Indications for Use
#### 510(k) Number (if known) K150477
#### Device Name
3M Comply 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization
#### Indications for Use (Describe)
The tape is designed to secure packs wrapped with untreated woven (i.e., reusable 100% cotton and cotton/poly blends) and disposable non-woven, paper/plastic, and spunbond polyolefin/plastic wraps.
### United States
Use the EO indicator tape to demonstrate that packs have been exposed to one of the EO sterilization processes in the table below and to distinguish between processed and unprocessed packs.
| EO Gas Concentration | Exposure Time | Temperature | Relative Humidity % |
|----------------------|---------------|-------------|---------------------|
| 736 mg/L | 4.5 hours | 38°C | 40 - 80 % |
| 736 mg/L | 1 hour | 55°C | 40 - 80 % |
| 759 mg/L | 4.5 hours | 38°C | 40 - 80 % |
| 759 mg/L | 1 hour | 55°C | 40 - 80 % |
| 736 mg/L | 1 hour | 54°C | >35% |
| 736 mg/L | 4.5 hours | 38°C | >35% |
| 736 mg/L | 1 hour | 55°C | >35% |
| 736 mg/L | 3 hours | 37°C | >35% |
| 759 mg/L | 1 hour | 55°C | >35% |
| 759 mg/L | 3 hours | 37°C | >35% |
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
> Over-The-Counter Use (21 CFR 801 Subpart C)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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# Premarket Notification (510(k)) Summary
Image /page/4/Picture/1 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The logo is simple and recognizable, and it is often used to represent the company 3M.
## Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact Person: Matt S. Mortensen, Ph.D., RAC Regulatory Affairs Phone Number: (651) 737-2670 FAX Number: (651) 737-5320
# Date of Summary: June 15, 2015
### Device Name and Classification:
Common or Usual Name: EO Process Indicator Tape
Proprietary Name: 3M Comply™ 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization
Classification Name: Indicator, physical/chemical sterilization process (21 CFR § 880.2800)
Device Classification: Class II
Product Code: JOJ
### Predicate Devices:
- . Indox Ethylene Oxide Indicator Tape - pre-amendment
# Description of Device:
The 3M Comply 10 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization is a green, pressure sensitive adhesive tape with yellow stripes that can be used to secure packages for EO sterilization. Post-sterilization the yellow stripes turn to red-maroon.
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# Nonclinical Comparison to the Predicate Device
The 3M Comply™ 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization is similar in design to the previous generation of this product (the predicate) which was sold under the tradename Indox Ethylene Oxide Indicator Tape. In 2012 this previous version was determined by the Agency to meet the definition of a pre-amendment device. The product has been reformulated to lessen the environmental impact of solvents used in the manufacturing process. The new tape has the same intended use as the predicate.
# Summary of Clinical Testing
No clinical data was included in this premarket application submission.
# Indications for Use
The tape is designed to secure packs wrapped with untreated woven (i.e., reusable 100% cotton and cotton/poly blends) and disposable non-woven, paper, paper/plastic, and spunbond polyolefin/plastic wraps.
# United States
Use the EO indicator tape to demonstrate that packs have been exposed to one of the EO sterilization processes in the table below and to distinguish between processed and unprocessed packs.
| EO Gas
Concentration | Exposure
Time | Temperature | Relative
Humidity % |
|-------------------------|------------------|-------------|------------------------|
| 736 mg/L | 4.5 hours | 38°C | 40 - 80 % |
| 736 mg/L | 1 hour | 55°C | 40 - 80 % |
| 759 mg/L | 4.5 hours | 38°C | 40 - 80 % |
| 759 mg/L | 1 hour | 55°C | 40 - 80 % |
| 736 mg/L | 1 hour | 54°C | >35% |
| 736 mg/L | 4.5 hours | 38°C | >35% |
| 736 mg/L | 1 hour | 55°C | >35% |
| 736 mg/L | 3 hours | 37°C | >35% |
| 759 mg/L | 1 hour | 55°C | >35% |
| 759 mg/L | 3 hours | 37°C | >35% |
# Comparison to Predicate Devices
| Feature | Submission Device: 3M Comply 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization | Predicate Device (Pre- |
|---------|----------------------------------------------------------------------------------------|------------------------|
|---------|----------------------------------------------------------------------------------------|------------------------|
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| amendment):
Indox Ethylene
Oxide Indicator
Tape | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------|-------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The tape is designed to secure packs wrapped with untreated
woven (i.e., reusable 100% cotton and cotton/poly blends) and
disposable non-woven, paper, paper/plastic, and spunbond
polyolefin/plastic wraps.
United States
Use the EO indicator tape to demonstrate that packs have been
exposed to one of the EO sterilization processes in the table below
and to distinguish between processed and unprocessed packs. | | | | | Use the EO
indicator tape to
demonstrate that
packs have been
exposed to the
sterilization
process and to
distinguish
between processed
and unprocessed
packs. The tape is
designed to secure
packs wrapped
with treated and
untreated woven,
with treated and
untreated non-
woven, paper,
paper/plastic, and
Tyvek®/plastic
wraps. |
| Indications
for use | EO Gas
Concentration | Exposure
Time | Temperature | Relative
Humidity % | |
| | 736 mg/L | 4.5 hours | 38°C | 40 - 80 % | |
| | 736 mg/L | 1 hour | 55°C | 40 - 80 % | |
| | 759 mg/L | 4.5 hours | 38°C | 40 - 80 % | |
| | 759 mg/L | 1 hour | 55°C | 40 - 80 % | |
| | 736 mg/L | 1 hour | 54°C | >35% | |
| | 736 mg/L | 4.5 hours | 38°C | >35% | |
| | 736 mg/L | 1 hour | 55°C | >35% | |
| | 736 mg/L | 3 hours | 37° | >35% | |
| | 759 mg/L | 1 hour | 55°C | >35% | |
| | 759 mg/L | 3 hours | 37° | >35% | |
| Indicator
Agent | Phenol red | | | | 1,8-
dihydroxyanthroquinone |
| Minimum
exposure to
critical
parameters
for color
change | Designed to meet ISO 11140-1 Class 1 EO process indicator
requirements | | | | Identical |
| Recommended storage | Best stored at normal room temperature conditions, 15-30°C (59-
86°F) and <50% relative humidity. Store away from direct | | | | Identical |
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| | as cleaning/disinfecting agents. Store away from all chemical
sterilants (e.g., hydrogen peroxide). | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------|
| Stability of
the
endpoint
reaction | 6 months | Identical |
| Shelf life | Will be based on results of completed testing at time of marketing. | 18 months |
# Effectiveness
The effectiveness of the 3M ComplyTM 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization is demonstrated by the application of testing described in the Recognized Consensus Standard:
ISO 11140-1:2005/R2010; Sterilization of Health Care Products - Chemical Indicators -Part 1: General Requirements,
- Color Change in Resistometer Samples from 3 different lots were verified to meet the requirements for detectable color change post-exposure to ISO conditions in a resistometer.
- Color Change in Health Care Facility Cycle Samples from 3 different lots were verified to meet the requirements for detectable color change post-exposure in an FDA cleared 3M Steri-Vac 5XL sterilizer cycle.
- End-point Color Stability Samples from 3 different lots were verified to be stable to storage under typical office lighting conditions up to 6 months post-exposure in an FDA cleared 3M Steri-Vac 5XL sterilizer cycle.
# Conclusion
The 3M ComplyTM 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization meets the performance standards of ISO 11140-1 and are substantially equivalent to the predicate device in terms of their intended use, physical properties and technological characteristics. The nonclinical testing demonstrates that the 3M ComplyTM 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization is as safe, as effective, and performs as well as the predicate device, Indox Ethylene Oxide Indicator Tape.
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**Source:** [https://fda-staging.innolitics.com/device/K150477](https://fda-staging.innolitics.com/device/K150477)
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