(150 days)
No
The device is a chemical indicator tape that changes color based on exposure to hydrogen peroxide, a purely chemical reaction with no mention of AI/ML.
No
The device is used as a process indicator to differentiate processed items from unprocessed items in sterilization processes. It does not treat or diagnose any medical condition.
No
The device is an indicator tape used to differentiate unprocessed from processed items in sterilization, not to diagnose a condition or disease.
No
The device description clearly states it is a physical tape with a plastic backing, adhesive, and chemical indicator stripes, which are hardware components.
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 processes using vaporized hydrogen peroxide. This is a quality control measure for sterilization equipment and processes, not a diagnostic test performed on biological samples.
- Device Description: The device is a tape with chemical indicator stripes that change color based on exposure to hydrogen peroxide. This mechanism is related to monitoring a physical/chemical process, not detecting substances in a biological sample.
- Lack of Biological Sample Interaction: There is no mention of the device interacting with or analyzing any biological samples (blood, urine, tissue, etc.). IVDs are designed to test such samples.
- Focus on Sterilization Process: The entire description revolves around the use of the tape within sterilization cycles and its ability to indicate successful exposure to the sterilant.
Therefore, the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is a sterilization process indicator, not an in vitro diagnostic device.
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, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes and AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ max 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 to 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 non-cellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side.
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)
Nonclinical testing was performed.
- Color Change in Health Care Facility Cycle Samples from six different lots were verified to meet the requirements for detectable color change in the AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizer.
- Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle - Samples from six different lots were evaluated to determine the minimum time required for the color change of the indicator when used in the AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles).
- End Point Color Stability Samples from six different lots were verified to be stable to storage under typical office lighting conditions for at least twelve months post-exposure in a Hydrogen Peroxide Health Care Facility 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.
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.
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2017
3M Company Nadia Battah Regulatory Affairs Associate 3m Center, Building 275-5w-06 St. Paul, Minnesota 55144
Re: K170563
Trade/Device Name: 3M Comply Hydrogen Peroxide Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: July 10, 2017 Received: July 10, 2017
Dear Nadia Battah:
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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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.
Tara A. Ryan -S
for Lori Wiggins, MPT,CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K170563
Device Name
3MTM 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, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes and AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ max 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 to 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
Premarket Notification [510(k)] Summary K170563
Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is 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: Nadia Battah Regulatory Affairs Phone Number: (651) 733-0929 FAX Number: (651) 737-5320
Date of Summary: July 26, 2017
Device Name and Classification:
| Common or Usual Name: | Chemical Indicator |
|---|---|
| Proprietary Name: | 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 |
| Classification Name: | Indicator, physical/chemical sterilization process (21 CFR § |
| 880.2800) | |
| Device Classification: | Class II |
| Product Code: | JOJ |
Predicate Device:
- 3MTM Comply™ Hydrogen Peroxide Indicator Tape 1228 (K150694) .
Description of Device:
The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a non-cellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side.
4
Nonclinical Comparison to the Predicate Device
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 (K150694). There has been no change to the device's materials, performance specifications, or fundamental scientific technology. The intent of this submission is to expand the indications for use to include use in the AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers.
Summary of Clinical Testing
No clinical data was included in this premarket application submission.
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, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes and AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX 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 to pink after exposure to vaporized hydrogen peroxide.
5
Comparison to Predicate Device
| Feature | Submission Device:
3MTM Comply™ Hydrogen Peroxide
Indicator 1228 | Predicate Device (K150694):
3M™ Comply™ Hydrogen Peroxide
Indicator Tape 1228 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Use the 3MTM 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, 100S, NX® (Standard and
Advanced cycles) and 100NX® (Standard, Flex,
Express and Duo cycles) sterilization processes
and AMSCO® V-PROTM 1 (Lumen cycle),
AMSCO® V-PROTM 1 Plus (Lumen and Non
Lumen cycles), and AMSCO® V-PROT™ maX
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 to pink after exposure to
vaporized hydrogen peroxide. | Use the 3MTM 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, 100S, NX® (Standard and Advanced
cycles) and 100NX® (Standard, Flex,
Express and Duo cycles) sterilization
processes. The tape is suitable for use on
non-woven disposable wraps and peel
pouches. The chemical indicator from blue
to pink after exposure to vaporized
hydrogen peroxide. |
| Sterilizers | STERRAD® 100
STERRAD® 100S
STERRAD® NX (Standard and Advanced
cycles)
STERRAD® 100NX (Standard, Flex, Express,
and Duo cycles)
AMSCO® V-PROTM 1 (Lumen cycle)
AMSCO® V-PROTM 1 Plus (Lumen and Non
Lumen cycles)
AMSCO® V-PROTM maX Low Temperature
Sterilization System (Lumen, Non Lumen and
Flexible cycles) | STERRAD® 100
STERRAD® 100S
STERRAD® NX (Standard and Advanced
cycles)
STERRAD® 100NX (Standard, Flex,
Express, and Duo cycles) |
| Indicator Agent | Alkali blue 6B dye | Identical |
| Cycle Conditions
for Color Change in
STERRAD® 100 | Testing verified that the 3MTM Complyтм Hydrogen Peroxide Indicator Tape 1228 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.
Demonstrated per submission K020589. | |
| Cycle Conditions
for Color Change in
STERRAD® 100S | Testing verified that the 3MTM Complyтм Hydrogen Peroxide Indicator Tape 1228 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.
Demonstrated per submission K020589. | |
| Cycle Conditions
for Color Change in
STERRAD® NX
(Standard and
Advanced cycles) | Testing verified that the 3MTM Complyтм Hydrogen Peroxide Indicator Tape 1228 samples
turned from blue to pink and the minimum time required for all indicator tape samples to
indicate a "pass" in relation to the color specification was found when exposed to the following
STERRAD® NX® Sterilization Cycles:
Standard
Advanced
Demonstrated per submission K150694. | |
| Cycle Conditions
for Color Change in
STERRAD®
100NX (Standard,
Flex Express and
Duo cycles) | Testing verified that the 3M™ Complyт™ Hydrogen Peroxide Indicator Tape 1228 samples
turned from blue to pink and the minimum time required for all indicator tape samples to
indicate a "pass" in relation to the color specification was found when exposed to the following
STERRAD® 100NX® Sterilization Cycles:
Standard | |
| Express
Duo
Demonstrated per submission K150694. | | |
| Cycle Conditions
for Color Change in
AMSCO® V-
PRO™ 1 (Lumen
cycle), AMSCO®
V-PRO™ 1 Plus
(Lumen and Non
Lumen cycles), and
AMSCO® V-
PRO™ maX Low
Temperature
Sterilization System
(Lumen, Non
Lumen, and
Flexible cycles)
sterilizers | Testing verified that the 3M™ Comply™
Hydrogen Peroxide Indicator Tape 1228 turned
from blue to pink and the minimum time
required for all indicator tape samples to indicate
a “pass” in relation to the color specification was
found when exposed to the following AMSCO®
V-PRO™ maX Low Temperature Sterilization
System Cycles:
Lumen
Non Lumen
Flexible | |
| Stability of the
endpoint reaction | Twelve (12) months | Identical |
| Shelf life | Eighteen (18) months | Identical |
6
Biocompatibility
The components of the indicator ink used on the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 are all of low general toxicity. The exposure to the health care professional is minimal and well below any identified toxic thresholds for the compounds. There is no anticipated direct exposure to medical instruments with the ink, nor the patient.
Summary of Non-Clinical Testing
The non-clinical testing of the 3MIM ComplyTM Hydrogen Peroxide Indicator Tape 1228 is demonstrated by the following tests:
- Color Change in Health Care Facility Cycle Samples from six different lots were verified to meet the requirements for detectable color change in the AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizer.
- Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle - Samples from six different lots were evaluated to determine the minimum time required for the color change of the indicator when used in the AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles).
- End Point Color Stability Samples from six different lots were verified to be stable to storage under typical office lighting conditions for at least twelve months post-exposure in a Hydrogen Peroxide Health Care Facility Cycle.
7
Conclusion
The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is substantially equivalent to the predicate device.