(128 days)
Indox Ethylene Oxide Indicator Tape
Not Applicable
No
The device is a chemical indicator tape that changes color based on exposure to EO sterilization conditions, with no mention of AI/ML in the description or performance studies.
No
The device is an indicator tape used to confirm exposure to ethylene oxide sterilization processes, not to treat a condition or disease.
No
The device is an indicator tape used to confirm exposure to sterilization processes, not to diagnose a medical condition in a patient.
No
The device is a physical tape with a chemical indicator, 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 secure sterilization packs and indicate exposure to ethylene oxide (EO) sterilization processes. This is a process indicator for sterilization, not a diagnostic test performed on biological samples.
- Device Description: The device is a tape with a color-changing indicator. It does not interact with or analyze biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays to detect specific substances
The device's function is solely to provide a visual confirmation that a sterilization process has occurred. This falls under the category of a sterilization process indicator, not an in vitro diagnostic device.
N/A
Intended Use / 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.
| 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% |
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The 3M ComplyTM 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.
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)
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.
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.
Indox Ethylene Oxide Indicator Tape
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.
Not Found
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).
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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.
5
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- |
|---|---|---|
| --------- | ---------------------------------------------------------------------------------------- | ------------------------ |
6
| 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 |