(32 days)
Not Found
No
The device is a chemical indicator tape that changes color based on exposure to hydrogen peroxide, a purely chemical reaction. There is no mention of any computational analysis, learning, or decision-making processes.
No.
The device is an indicator tape used to differentiate between processed and unprocessed medical items in a sterilizer, not for therapeutic use on patients.
No
This device is a chemical indicator used to differentiate processed items from unprocessed items in a hydrogen peroxide sterilization process. It does not diagnose any medical condition or disease.
No
The device is a physical tape with chemical indicator stripes, 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 packs and act as an external process indicator for sterilization cycles. It indicates whether an item has been exposed to vaporized hydrogen peroxide, not to diagnose a condition or analyze a biological sample.
- Device Description: The device is a tape with a chemical indicator that changes color based on exposure to a sterilization agent. It does not interact with biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any interaction with human or animal specimens, analysis of biological markers, or use in the diagnosis, treatment, or prevention of disease.
This device falls under the category of a chemical indicator used in sterilization processes, which is a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO® 1 (Lumen cycle), AMSCO® V-PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX, Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles), and AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen and Flexible, and Fast Non Lumen cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a noncellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
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)
To demonstrate performance in the newly claimed sterilizer and cycles, nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003.
Key results:
- Color Change in Health Care Facility Cycle: Pass - Color change from blue toward pink.
- Minimum Exposure Parameters: Pass - Determination of the minimum time for color to change from blue toward pink.
- End Point Color Stability: Pass - No significant color change after exposure to fluorescent light for a minimum of twelve (12) months.
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.
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 28, 2019
3M Company Mary Fretland Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K192673
Trade/Device Name: 3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 25, 2019 Received: September 30, 2019
Dear Mary Fretland:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192673
Device Name
3M™ ComplyTM Hydrogen Peroxide Indicator Tape 1228
Indications for Use (Describe)
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO® 1 (Lumen cycle), AMSCO® V-PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX, Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles), and AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen and Flexible, and Fast Non Lumen cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
| Type of Use (Select one or both, as applicable) | |
|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary for 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
K192673
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Mary Fretland Senior Regulatory Affairs Associate Phone Number: (651) 737-2296 Fax Number: (651) 737-5320
Date of Summary: October 26, 2019
4
PREMARKET NOTIFICATION [510(k)] 3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228
1. Device Name and Classification:
| Common or Usual Name: | Chemical Indicator |
|---|---|
| Proprietary Name: | 3M TM Comply TM Hydrogen Peroxide Chemical Indicator |
| 1228 | |
| Classification Name: | Indicator, physical/chemical sterilization process |
| Device Classification: | Class II, 21 CFR § 880.2800 |
| Product Code: | JOJ |
2. Predicate Device:
K183209 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
3. Description of Device:
The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a noncellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
4. Indications for Use
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO® 1 (Lumen cycle), AMSCO® V-PRO® 1 Plus (Lumen and Non-Lumen cycles), AMSCO® V-PRO® maX, Low Temperature Sterilization System (Lumen, Non-Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), and AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
5
| Submission Device (K192673): | Predicate Device (K183209): | |
|---|---|---|
| Feature | 3M™ Comply™ Hydrogen Peroxide | |
| Indicator Tape 1228 | 3M™ Comply™ Hydrogen Peroxide | |
| Indicator Tape 1228 | ||
| Indications for use | Use the 3M™ Comply™ Hydrogen | |
| Peroxide Indicator Tape 1228 to secure | ||
| packs and as an external pack process | ||
| indicator to differentiate unprocessed items | ||
| from items processed in the STERRAD® | ||
| 100, STERRAD® 100S, STERRAD® NX | ||
| (Standard and Advanced cycles), | ||
| STERRAD® 100NX (Standard, Flex, | ||
| Express and Duo cycles), STERRAD® NX | ||
| with ALLClear™ Technology (Standard | ||
| and Advanced cycles), STERRAD® | ||
| 100NX with ALLClear™ Technology | ||
| (Standard, Flex, Express and Duo cycles), | ||
| AMSCO® V-PRO® 1 (Lumen cycle), | ||
| AMSCO® V-PRO® 1 Plus (Lumen and | ||
| Non-Lumen cycles), AMSCO® V-PRO® | ||
| maX, Low Temperature Sterilization | ||
| System (Lumen, Non-Lumen, and Flexible | ||
| cycles), AMSCO® V-PRO® 60 Low | ||
| Temperature Sterilization System (Lumen, | ||
| Non-Lumen and Flexible cycles), and | ||
| AMSCO® V-PRO™ maX 2 Low | ||
| Temperature Sterilization System (Lumen, | ||
| Non-Lumen, Flexible, and Fast Non-Lumen | ||
| cycles) sterilizers. The tape is suitable for | ||
| use on non-woven disposable wraps and | ||
| peel pouches. The chemical indicator stripes | ||
| turn from blue toward pink after exposure to | ||
| vaporized hydrogen peroxide. | Use the 3M™ Comply™ Hydrogen | |
| Peroxide Indicator Tape 1228 to secure | ||
| packs and as an external pack process | ||
| indicator to differentiate unprocessed items | ||
| from items processed in the STERRAD® | ||
| 100, STERRAD® 100S, STERRAD® NX | ||
| (Standard and Advanced cycles), | ||
| STERRAD® 100NX (Standard, Flex, | ||
| Express and Duo cycles), STERRAD® NX | ||
| with ALLClear™ Technology (Standard and | ||
| Advanced cycles), STERRAD® 100NX | ||
| with ALLClear™ Technology (Standard, | ||
| Flex, Express and Duo cycles), AMSCO® | ||
| V-PRO® 1 (Lumen cycle), AMSCO® V- | ||
| PRO® 1 Plus (Lumen and Non-Lumen | ||
| cycles), AMSCO® V-PRO® maX Low | ||
| Temperature Sterilization System (Lumen, | ||
| Non-Lumen, and Flexible cycles), and | ||
| AMSCO® V-PRO® 60 Low Temperature | ||
| Sterilization System (Lumen, Non-Lumen | ||
| and Flexible cycles) sterilizers. The tape is | ||
| suitable for use on non-woven disposable | ||
| wraps and peel pouches. The chemical | ||
| indicator stripes turn from blue toward pink | ||
| after exposure to vaporized hydrogen | ||
| peroxide. | ||
| Sterilizers and | ||
| Sterilization | ||
| Cycles | STERRAD® 100 | |
| STERRAD® 100S | ||
| STERRAD® NX (Standard and Advanced | ||
| cycles) | ||
| STERRAD® NX with ALLClear™ | ||
| Technology (Standard and Advanced | ||
| cycles) | ||
| STERRAD® 100NX (Standard, Flex, | ||
| Express, and Duo cycles) | ||
| STERRAD® 100NX with ALLClear™ | ||
| Technology (Standard, Flex, Express, and | ||
| Duo cycles) | ||
| AMSCO® V-PRO™ 1 (Lumen cycle) | ||
| AMSCO® V-PRO™ 1 Plus (Lumen and | ||
| Non-Lumen cycles) | ||
| AMSCO® V-PRO™ maX Low | ||
| Temperature Sterilization System (Lumen, | ||
| Non-Lumen and Flexible cycles) | STERRAD® 100 | |
| STERRAD® 100S | ||
| STERRAD® NX (Standard and Advanced | ||
| cycles) | ||
| STERRAD® NX with ALLClear™ | ||
| Technology (Standard and Advanced cycles) | ||
| STERRAD® 100NX (Standard, Flex, | ||
| Express, and Duo cycles) | ||
| STERRAD® 100NX with ALLClear™ | ||
| Technology (Standard, Flex, Express, and | ||
| Duo cycles) | ||
| AMSCO® V-PRO™ 1 (Lumen cycle) | ||
| AMSCO® V-PRO™ 1 Plus (Lumen and | ||
| Non-Lumen cycles) | ||
| AMSCO® V-PRO™ maX Low Temperature | ||
| Sterilization System (Lumen, Non-Lumen | ||
| and Flexible cycles) | ||
| Feature | Submission Device (K192673): | |
| 3M™ Comply™ Hydrogen Peroxide | ||
| Indicator Tape 1228 | Predicate Device (K183209): | |
| 3M™ Comply™ Hydrogen Peroxide | ||
| Indicator Tape 1228 | ||
| AMSCO® V-PRO™ 60 (Lumen, Non- | ||
| Lumen and Flexible cycles) | ||
| AMSCO® V-PRO™ maX 2 Low | ||
| Temperature Sterilization System (Lumen, | ||
| Non-Lumen, Flexible, and Fast Non-Lumen | ||
| cycles) | ||
| Substrate | Non-cellulosic plastic | Identical |
| Biocompatibility | The exposure to health care professionals is | |
| minimal and well below any identified toxic | ||
| thresholds for the compounds. | Identical | |
| Color Change | Blue toward pink | Identical |
| Detection | Hydrogen Peroxide | Identical |
| Stability of the | ||
| endpoint reaction | Twelve (12) months | Identical |
| Shelf life | Eighteen (18) months | Identical |
5. Technological Characteristic Comparison Table
6
PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Indicator Tape 1228
The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is the same design as the previously cleared device of the same model number (the predicate) which is sold under the tradename 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 (K183209). No changes have been made to the device materials or fundamental technology.
6. Summary of Non-clinical Testing
To demonstrate performance in the newly claimed sterilizer and cycles, nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003. Reference Table 6.1 for testing completed in the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Color Change in | |||
| Health Care | |||
| Facility Cycle | To demonstrate the color change of | ||
| the device when used in the | |||
| AMSCO® V-PRO™ maX 2 Low | |||
| Temperature Sterilization System | Color change from blue toward | ||
| pink | Pass | ||
| Minimum | |||
| Exposure | |||
| Parameters | To determine the minimum time | ||
| required for the color change of the | |||
| device when used in the AMSCO® | |||
| V-PRO™ maX 2 Low Temperature | |||
| Sterilization System | Determination of the minimum | ||
| time for color to change from | |||
| blue toward pink | Pass | ||
| End Point Color | |||
| Stability | To demonstrate the post- | ||
| sterilization color stability of the | |||
| device after use in the AMSCO® V- | |||
| PRO™ maX 2 Low Temperature | |||
| Sterilization System | No significant color change | ||
| after exposure to fluorescent | |||
| light for a minimum of twelve | |||
| (12) months. | Pass |
Table 6.1 Summary of Nonclinical Testing
7
7. Conclusion
Based on the non-clinical performance data, the 3MTM Comply™ Hydrogen Peroxide Indicator Tape 1228 is as safe, as effective, and performs as well as or better than the legally marketed predicate, 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 cleared under K183209, Class II (21 CFR 880.2800), product code JOJ.