3M Comply Hydrogen Peroxide Indicator Tape

K183209 · 3M Company · JOJ · Feb 15, 2019 · General Hospital

Device Facts

• Record ID: K183209
• Device Name: 3M Comply Hydrogen Peroxide Indicator Tape
• Applicant: 3M Company
• Product Code: JOJ · General Hospital
• Decision Date: Feb 15, 2019
• 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® 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), and AMSCO® V-PRO® 60 Low Temperature Sterilization System (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.

Device Story

Chemical indicator tape; non-cellulosic plastic backing with pressure-sensitive adhesive; indicator stripes change color from blue to pink upon exposure to vaporized hydrogen peroxide. Used by healthcare personnel to secure sterilization packs and visually differentiate processed from unprocessed items. Provides immediate visual confirmation of exposure to sterilization process; does not indicate sterility. Operates via chemical reaction to hydrogen peroxide vapor. No electronic components or software.

Clinical Evidence

Bench testing only. Performance verified via color change, minimum exposure parameters, and endpoint color stability testing in the newly claimed sterilizer cycles (AMSCO V-PRO 60, STERRAD NX/100NX with ALLClear).

Technological Characteristics

Non-cellulosic plastic substrate; pressure-sensitive adhesive; chemical indicator stripes (blue-to-pink color change). Passive chemical indicator; no energy source; no software; no electronic connectivity. Shelf life: 18 months; endpoint stability: 12 months.

Indications for Use

Indicated for use as an external pack process indicator to differentiate unprocessed items from items processed in specific vaporized hydrogen peroxide sterilizers. 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™ Hydrogen Peroxide Indicator Tape 1228 (K170563)

Submission Summary (Full Text)

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February 15, 2019

3M Company Nadia Battah Senior Regulatory Affairs Associate 3m Center, Building 275-5w-06 St. Paul, Minnesota 55144

Re: K183209

Trade/Device Name: 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1228 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: January 22, 2019 Received: January 24, 2019

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 mav, 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 avare 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting 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) K183209

#### 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® 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), and AMSCO® V-PRO® 60 Low Temperature Sterilization System (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.

| 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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# 510(k) Summary for 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 K183209

### Sponsor Information:

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

Contact: Nadia Battah Senior Regulatory Affairs Associate Phone Number: [phone] Fax Number: [phone]

Date of Summary: February 13, 2019

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### TRADITIONAL 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™ Comply™ Hydrogen Peroxide Chemical Indicator<br>1228 |
| Classification Name: | Indicator, physical/chemical sterilization process |
| Device Classification: | Class II, 21 CFR § 880.2800 |
| Product Code: | JOJ |

### 2. Predicate Device:

K170563 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 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.

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## TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228

# 5. Technological Characteristic Comparison Table

| Feature | Submission Device (K183209):<br>3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 | Predicate Device (K170563):<br>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), 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. | 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. |
| Sterilizers and Sterilization Cycles | STERRAD® 100<br>STERRAD® 100S<br>STERRAD® NX (Standard and Advanced cycles)<br>STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles)<br>STERRAD® 100NX (Standard, Flex, Express, and Duo cycles)<br>STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express, and Duo cycles)<br>AMSCO® V-PRO™ 1 (Lumen cycle)<br>AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles)<br>AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)<br>AMSCO® V-PRO™ 60 (Lumen, Non Lumen and Flexible cycles) | STERRAD® 100<br>STERRAD® 100S<br>STERRAD® NX (Standard and Advanced cycles)<br>STERRAD® 100NX (Standard, Flex, Express, and Duo cycles)<br>AMSCO® V-PRO™ 1 (Lumen cycle)<br>AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles)<br>AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) |
| Substrate | Non-cellulosic plastic | Identical |
| Biocompatibility | The exposure to health care professional 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<br>endpoint reaction | Twelve (12) months | Identical |
| Shelf life | Eighteen (18) months | Identical |

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### 6. Summary of Non-Clinical Testing

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 (K170563). As no change has been made to the device materials, performance specifications, or fundamental technology, the biocompatibility and nonclinical testing provided in K170563 was referenced in this submission to support performance of the device in the claimed sterilizers.

To demonstrate performance in the newly claimed sterilizers 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™ 60 Low Temperature Sterilization System (Lumen. Non-Lumen and Flexible cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex and Express cycles) sterilizer.

#### Table 6.1 Summary of Nonclinical Testing

| Test | Result |
|----------------------------------------------------------------------------------------------------|--------|
| Color Change in Health Care Facility Cycle | Pass |
| Minimum Exposure Parameters to Affect the Change of the Indicator in<br>Health Care Facility Cycle | Pass |
| End Point Color Stability | Pass |

#### 7. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the 3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228 is as safe, as effective, and performs as well as or better than the legally marketed device, 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 cleared under K170568, Class II (21 CFR 880.2800), product code JOJ.