(65 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 or algorithmic processing.
No
The device is described as an indicator tape used to differentiate unprocessed items from sterilized items, not to treat a condition or disease.
No
Explanation: This device is an external pack process indicator used to differentiate processed from unprocessed items in sterilizers. It does not diagnose any medical condition or disease.
No
The device is a physical tape with chemical indicator stripes, not a software program.
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. It indicates whether an item has been exposed to vaporized hydrogen peroxide during a sterilization cycle.
- Mechanism: The device works by a chemical indicator changing color based on exposure to a sterilizing agent. It does not analyze biological samples or provide diagnostic information about a patient's health.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other biological specimens to diagnose, monitor, or screen for diseases or conditions.
This device falls under the category of a sterilization process indicator, which is a different type of medical device than an IVD.
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 following sterilizers:
STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)
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 3MTM 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. Reference Table 6.1 for testing completed in the STERIZONE® VP4 Sterilizer (Cycle 1).
Test: Color Change in Health Care Facility Cycle
Purpose: To demonstrate the color change of the device when used in the STERIZONE® VP4 Sterilizer (Cycle 1)
Acceptance Criteria: Color change from blue toward pink
Result: Pass
Test: Minimum Exposure Parameters
Purpose: To determine the minimum time required for the color change of the device when used in the STERIZONE® VP4 Sterilizer (Cycle 1)
Acceptance Criteria: Determination of the minimum time for color to change from blue toward pink
Result: Pass
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 5, 2021
3M Company Mary Fretland Regulatory Affairs Specialist 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K212081
Trade/Device Name: 3M1M Comply 100 Hydrogen Peroxide Indicator Tape 1228 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: August 6, 2021 Received: August 9, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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 Clarence W. Murray, III, PhD Assistant Director 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)
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 following sterilizers:
STERRAD 100® Sterilization System STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles) V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1)
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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is in red and consists of the number "3" followed by the letter "M". The logo is simple and recognizable.
510(k) Summary for 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
K212081
Sponsor Information:
3M Company 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Mary Fretland Regulatory Affairs Specialist Phone Number: (651) 737-2296 Fax Number: (651) 737-5320
Date of Summary: August 02, 2021
4
PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Indicator Tape 1228
1. 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 |
| Device Classification: | Class II, 21 CFR § 880.2800 |
| Product Code: | JOJ |
2. Predicate Device:
K203285 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
3. Description of Device:
The 3MTM 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 following sterilizers:
| STERRAD 100® Sterilization System |
|---|
| STERRAD 100S® Sterilization System |
| STERRAD NX® Sterilization System (Standard and Advanced cycles) |
| STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) |
| STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) |
| STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) |
| V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) |
| V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) |
| V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) |
| V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) |
| V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) |
| V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) |
| STERIZONE® VP4 Sterilizer (Cycle 1) |
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
5. Technological Characteristic Comparison Table
| Feature | Submission Device:
3MTM Comply™ Hydrogen
Peroxide Indicator Tape 1228 | Predicate Device (K203285):
3MTM ComplyTM Hydrogen
Peroxide Indicator Tape 1228 | Comparison |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Use the 3M™ ComplyTM
Hydrogen Peroxide Indicator Tape
1228 to secure packs and as an
external pack process indicator to
differentiate unprocessed items
from items processed in the
following sterilizers:
STERRAD 100® Sterilization
System
STERRAD 100S® Sterilization
System
STERRAD NX® Sterilization
System (Standard and
Advanced cycles)
STERRAD 100NX®
Sterilization System (Standard,
Flex, Express and Duo cycles)
STERRAD NX® with
ALLClear® Technology
Sterilization System (Standard
and Advanced cycles)
STERRAD 100NX® with
ALLClear® Technology
Sterilization System (Standard,
Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature
Sterilization System (Lumen
cycle)
V-PRO® 1 Plus Low
Temperature Sterilization
System (Lumen and Non
Lumen cycles)
V-PRO® maX Low
Temperature Sterilization
System (Lumen, Non Lumen,
and Flexible cycles)
V-PRO® 60 Low Temperature
Sterilization System (Lumen,
Non Lumen and Flexible
cycles)
V-PRO® maX 2 Low
Temperature Sterilization
System (Lumen, Non Lumen,
Flexible, and Fast Non Lumen
cycles)
V-PRO® s2 Low Temperature
Sterilization System (Lumen,
Non Lumen, Flexible, and Fast
cycles) | Use the 3M™ ComplyTM
Hydrogen Peroxide Indicator Tape
1228 to secure packs and as an
external pack process indicator to
differentiate unprocessed items
from items processed in the
following sterilizers:
STERRAD 100® Sterilization
System
STERRAD 100S® Sterilization
System
STERRAD NX® Sterilization
System (Standard and
Advanced cycles)
STERRAD 100NX®
Sterilization System (Standard,
Flex, Express and Duo cycles)
STERRAD NX® with
ALLClear® Technology
Sterilization System (Standard
and Advanced cycles)
STERRAD 100NX® with
ALLClear® Technology
Sterilization System (Standard,
Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature
Sterilization System (Lumen
cycle)
V-PRO® 1 Plus Low
Temperature Sterilization
System (Lumen and Non
Lumen cycles)
V-PRO® maX Low
Temperature Sterilization
System (Lumen, Non Lumen,
and Flexible cycles)
V-PRO® 60 Low Temperature
Sterilization System (Lumen,
Non Lumen and Flexible
cycles)
V-PRO® maX 2 Low
Temperature Sterilization
System (Lumen, Non Lumen,
Flexible, and Fast Non Lumen
cycles)
V-PRO® s2 Low Temperature
Sterilization System (Lumen,
Non Lumen, Flexible, and Fast
cycles) | Similar. The
submission
device adds the
STERIZONE®
VP4 Sterilizer
(Cycle 1) to the
Indications for
Use. |
| Feature | Submission Device:
3M™ Comply™ Hydrogen
Peroxide Indicator Tape 1228 | Predicate Device (K203285):
3M™ Comply™ Hydrogen
Peroxide Indicator Tape 1228 | Comparison |
| | STERIZONE® VP4 Sterilizer
(Cycle 1)
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. | 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. | |
| 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 | Six (6) months | Twelve (12) months | Alignment of
claim with
similar 3M
products. |
| Shelf life | Eighteen (18) months | Identical | |
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 (K203285). 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 STERIZONE® VP4 Sterilizer (Cycle 1).
Table 6.1 Summary of Nonclinical Testing
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Color Change in | |||
| Health Care | |||
| Facility Cycle | To demonstrate the color change of | ||
| the device when used in the | |||
| STERIZONE® VP4 Sterilizer | |||
| (Cycle 1) | 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 | |||
| STERIZONE® VP4 Sterilizer | |||
| (Cycle 1) | Determination of the minimum | ||
| time for color to change from | |||
| blue toward pink | Pass |
7
7. Conclusion
Based on the non-clinical performance data, the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 cleared under K203285, Class II (21 CFR 880.2800), product code JOJ.