3M Comply Hydrogen Peroxide Indicator Tape 1228

K150694 · 3M Company · JOJ · Oct 1, 2015 · General Hospital

Device Facts

• Record ID: K150694
• Device Name: 3M Comply Hydrogen Peroxide Indicator Tape 1228
• Applicant: 3M Company
• Product Code: JOJ · General Hospital
• Decision Date: Oct 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended 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. 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.

Device Story

Device is a chemical indicator tape used to secure sterilization packs and provide visual confirmation of exposure to vaporized hydrogen peroxide. Consists of non-cellulosic plastic backing with pressure-sensitive adhesive and chemical indicator stripes (alkali blue 6B dye). Used in healthcare facilities to differentiate processed from unprocessed items. Upon exposure to hydrogen peroxide vapor in specified STERRAD® cycles, indicator stripes undergo a color change from blue to pink. Healthcare personnel apply tape to external surfaces of wraps or pouches; visual inspection of color change post-sterilization confirms exposure to the process. Benefits include simple, reliable verification of sterilization cycle exposure for medical instruments.

Clinical Evidence

No clinical data included. Effectiveness demonstrated via bench testing, including verification of color change and post-sterilization adhesion across six lots in STERRAD® NX® and 100NX® cycles, and assessment of endpoint color stability for 12 months.

Technological Characteristics

Non-cellulosic plastic backing; pressure-sensitive adhesive; alkali blue 6B dye indicator ink. Color change: blue to pink. Shelf life: 18 months. Endpoint stability: 12 months. Sterilization process: vaporized hydrogen peroxide.

Indications for Use

Indicated for use as an external pack process indicator to differentiate processed from unprocessed items in STERRAD® 100, 100S, NX®, and 100NX® sterilization cycles. Suitable for use on non-woven disposable wraps and peel pouches in healthcare settings.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• 3M™ Comply™ 1228 Gas Plasma Indicator Tape (K020589)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 1, 2015

3M Health Care Ms. Hilary B. Hovde Regulatory Affairs Associate 3M Center, Bldg. 275-5W-06 St. Paul. MN 55144

Re: K150694

> Trade/Device Name: 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: August 19, 2015 Received: August 21, 2015

Dear Ms. Hovde,

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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Page 2 - Ms. Hovde

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 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 [phone] or [phone] 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 [phone] or [phone] 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

Enclosure

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# Indications for Use

510(k) Number (if known) K150694

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. 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) | <table border="0"><tr><td><table border="0"><tr><td>☐</td><td>Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act)</td></tr></table></td><td><table border="0"><tr><td>☑</td><td>Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act)</td></tr></table></td></tr></table> | <table border="0"><tr><td>☐</td><td>Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act)</td></tr></table> | ☐ | Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act) | <table border="0"><tr><td>☑</td><td>Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act)</td></tr></table> | ☑ | Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act) |
|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---|--------------------------------------------------------------------|
| <table border="0"><tr><td>☐</td><td>Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act)</td></tr></table> | ☐ | Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act) | <table border="0"><tr><td>☑</td><td>Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act)</td></tr></table> | ☑ | Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act) | | |
| ☐ | Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act) | | | | | | |
| ☑ | Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act) | | | | | | |

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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## Premarket Notification [510(k)] Summary

Image /page/3/Picture/1 description: The image shows the 3M logo. The logo consists of the number "3" followed by the letter "M", both in a bold, sans-serif font. The color of the text is red, and the background is white.

### Sponsor Information:

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

Contact Person: Hilary B. Hovde Regulatory Affairs Phone Number: [phone] FAX Number: [phone]

### Date of Summary: September 28, 2015

### 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 §<br>880.2800) |
| Device Classification: | Class II |
| Product Code: | JOJ |

### Predicate Device:

- 3M™ Comply™ 1228 Gas Plasma Indicator Tape (K020589) .
### 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.

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### Nonclinical Comparison to the Predicate Device

The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is similar in design to the previously cleared device of the same model number (the predicate) which is sold under the tradename 3M™ Comply™ 1228 Gas Plasma Indicator Tape (K020589). After the original clearance, but prior to product launch and commercialization in 2002, the adhesive was changed to improve adhesion. The change was managed according to 3M quality system design controls. The intent of this submission is to expand the indications for use to include use in the STERRAD® NX® and STERRAD® 100NX® 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. 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.

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# Comparison to Predicate Device

| Feature | Submission Device:<br>3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 | Predicate Device (K020589):<br>3M™ Comply™ 1228 Gas Plasma<br>Indicator Tape |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape<br>1228 to secure packs and as an external pack process indicator to<br>differentiate unprocessed items from items processed in the<br>STERRAD® 100, 100S, NX® (Standard and Advanced cycles)<br>and 100NX® (Standard, Flex, Express and Duo cycles)<br>sterilization processes. The tape is suitable for use on non-woven<br>disposable wraps and peel pouches. The chemical indicator<br>stripes turn from blue to pink after exposure to vaporized<br>hydrogen peroxide. | The 3M™ Comply™ 1228 Gas Plasma<br>Indicator Tape is indicated for use to secure<br>packs as an external pack indicator to<br>differentiate processed from unprocessed<br>items when exposed to vapor hydrogen<br>peroxide in the STERRAD® sterilization<br>processes (100, 100S, 50). The Comply 1228<br>is suitable for use on non-woven disposable<br>wraps and peel pouches. The diagonal stripes<br>of chemical indicator ink turn from blue to<br>pink after exposure to vapor hydrogen<br>peroxide in these sterilization processes. |
| Sterilizers and<br>Cycles | STERRAD® 100<br>STERRAD® 100S<br>STERRAD® NX® (Standard and Advanced cycles)<br>STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) | STERRAD® 100<br>STERRAD® 100S<br>STERRAD® 50 |
| Indicator Agent | Alkali blue 6B dye | Identical |
| Cycle Conditions<br>for Color Change<br>in STERRAD®<br>100 | Testing verified that the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 samples turned from blue to<br>pink when exposed to the STERRAD® 100 Sterilization cycle and the minimum time required for all indicator tape<br>samples to indicate a "pass" in relation to the color match was found.<br>Demonstrated per original submission K020589. | |
| Cycle Conditions<br>for Color Change<br>in STERRAD®<br>100S | Testing verified that the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 samples turned from blue to<br>pink when exposed to the STERRAD® 100S Sterilization cycle and the minimum time required for all indicator<br>tape samples to indicate a "pass" in relation to the color match was found.<br>Demonstrated per original submission K020589. | |
| Cycle Conditions<br>for Color Change<br>in STERRAD®<br>50 | Not Applicable. | Testing verified that the 3M™ Comply™<br>Hydrogen Peroxide Indicator Tape 1228<br>samples turned from blue to pink when<br>exposed to the STERRAD® 50 Sterilization<br>cycle and the minimum time required for all<br>indicator tape samples to indicate a "pass" in<br>relation to the color match was found.<br>Demonstrated per original submission<br>K020589. |
| Cycle Conditions<br>for Color Change<br>in STERRAD®<br>NX® | Testing verified that the 3M™ Comply™ Hydrogen Peroxide<br>Indicator Tape 1228 samples turned from blue to pink and the<br>minimum time required for all indicator tape samples to indicate<br>a "pass" in relation to the color specification was found when<br>exposed to the following STERRAD® NX® Sterilization Cycles:<br>Standard<br>Advanced | |
| Cycle Conditions<br>for Color Change<br>in STERRAD®<br>100NX® | Testing verified that the 3M™ Comply™ Hydrogen Peroxide<br>Indicator Tape 1228 samples turned from blue to pink and the<br>minimum time required for all indicator tape samples to indicate<br>a "pass" in relation to the color specification was found when<br>exposed to the following STERRAD® 100NX® Sterilization<br>Cycles:<br>Standard<br>Flex<br>Express<br>Duo | |
| Stability of the<br>endpoint reaction | Twelve (12) months | |
| Shelf life | Eighteen (18) months | Identical |

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### 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 exposure to medical instruments with the ink, nor to the patient.

### Effectiveness

The effectiveness of the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is demonstrated by the following tests:

- Performance in a Health Care Facility Cycle Samples from six different lots were verified to meet the requirements for detectable color change and poststerilization adhesion in the STERRAD® NX® (Standard and Advanced cycles) and the STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) sterilizers.
- Minimum Exposure Parameters to Affect the Change of the Indicator in a 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 STERRAD NX® (Standard and Advanced cycles) and the STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) sterilizers.
- End Point Color Stability Samples from four 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.

## Conclusion

Testing was conducted to confirm performance of the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 with the STERRAD® NX® and STERRAD® 100NX® per FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators; Guidance for Industry and FDA Staff, December 19, 2003.

The 3M™ Comply" Hydrogen Peroxide Indicator Tape 1228 is substantially equivalent to the predicate device. There are no new questions of safety or effectiveness.