(128 days)
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% |
The 3M Comply™ 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.
This document describes the 3M Comply™ 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization, a chemical indicator designed to confirm exposure to EO sterilization processes.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Derived from ISO 11140-1 Class 1 EO process indicator requirements) | Reported Device Performance (3M Comply™ 1224 Indicator Tape) |
|---|---|
| Color Change in Resistometer Samples: Must demonstrate detectable color change post-exposure to ISO specified EO conditions. | 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: Must demonstrate detectable color change post-exposure in a healthcare facility sterilizer 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: Must maintain stable color for a specified duration under typical storage conditions post-exposure. | 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. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "Samples from 3 different lots" were used for each of the effectiveness tests (Color Change in Resistometer, Color Change in Health Care Facility Cycle, End-point Color Stability). The exact number of individual tapes within each lot tested is not specified.
- Data Provenance: The document does not explicitly state the country of origin of the data, but the company (3M Health Care) is based in St. Paul, MN, USA, and the testing involved an "FDA cleared 3M Steri-Vac 5XL sterilizer cycle," suggesting the testing was conducted within the United States. The study is retrospective in the context of the device's development to demonstrate substantial equivalence to a pre-amendment device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. For a physical/chemical indicator like this, "ground truth" is typically established by physical/chemical measurement and observation of the color change against predefined specifications, rather than expert interpretation. The "detectable color change" implies objective observation, though the document doesn't specify if this was an automated or human-observed process, or if any specific experts were involved in judging the change.
4. Adjudication Method for the Test Set:
- This information is not applicable and not provided. The testing involves observing a physical color change against a standard, not a subjective interpretation that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical data was included in this premarket application submission." This type of study is for comparing human performance with and without AI assistance, which is not relevant for this physical/chemical indicator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, a standalone performance evaluation was conducted. Although not an "algorithm" in the conventional AI sense, the device (the indicator tape) is designed to independently produce a visual output (color change) based on exposure to sterilization conditions. Its performance was tested inherently as a standalone product; there's no human "in the loop" required for the tape to change color. The "effectiveness" section details the tape's performance in controlled and real-world sterilization cycles.
7. The Type of Ground Truth Used:
- The ground truth is based on physical/chemical parameters and observable color change as defined by the ISO 11140-1:2005/R2010 consensus standard.
- For "Color Change in Resistometer Samples," the ground truth is whether the tape successfully changed color after exposure to the specific EO gas concentration, exposure time, temperature, and relative humidity defined by ISO standards.
- For "Color Change in Health Care Facility Cycle Samples," the ground truth is whether the tape changed color after being subjected to an actual, validated FDA-cleared sterilization cycle.
- For "End-point Color Stability," the ground truth is whether the color change remained stable for 6 months after exposure.
8. The Sample Size for the Training Set:
- This information is not applicable and not provided. This device is a physical/chemical indicator, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable as there is no "training set" for this device.
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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 GasConcentration | ExposureTime | Temperature | RelativeHumidity % |
|---|---|---|---|
| 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 EthyleneOxide IndicatorTape | |||||
|---|---|---|---|---|---|
| The tape is designed to secure packs wrapped with untreatedwoven (i.e., reusable 100% cotton and cotton/poly blends) anddisposable non-woven, paper, paper/plastic, and spunbondpolyolefin/plastic wraps.United StatesUse the EO indicator tape to demonstrate that packs have beenexposed to one of the EO sterilization processes in the table belowand to distinguish between processed and unprocessed packs. | Use the EOindicator tape todemonstrate thatpacks have beenexposed to thesterilizationprocess and todistinguishbetween processedand unprocessedpacks. The tape isdesigned to securepacks wrappedwith treated anduntreated woven,with treated anduntreated non-woven, paper,paper/plastic, andTyvek®/plasticwraps. | ||||
| Indicationsfor use | EO GasConcentration | ExposureTime | Temperature | RelativeHumidity % | |
| 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% | ||
| IndicatorAgent | Phenol red | 1,8-dihydroxyanthroquinone | |||
| Minimumexposure tocriticalparametersfor colorchange | Designed to meet ISO 11140-1 Class 1 EO process indicatorrequirements | 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 chemicalsterilants (e.g., hydrogen peroxide). | ||
|---|---|---|
| Stability oftheendpointreaction | 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.
§ 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).