3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228

K222152 · 3M Company · JOJ · Sep 23, 2022 · General Hospital

Device Facts

• Record ID: K222152
• Device Name: 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228
• Applicant: 3M Company
• Product Code: JOJ · General Hospital
• Decision Date: Sep 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed 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.

Device Story

Device is non-cellulosic plastic tape with pressure-sensitive adhesive; features chemical indicator stripes. Used by healthcare professionals to secure sterilization packs and provide visual confirmation of exposure to vaporized hydrogen peroxide. Stripes change color from blue to pink upon exposure. Serves as Type 1 (Category e1) process indicator per ISO 11140-1:2014. Provides immediate visual feedback to clinicians to distinguish processed from unprocessed items, preventing accidental use of non-sterile equipment.

Clinical Evidence

Bench testing only. Testing conducted per ISO 11140-1:2014 standards for Type 1 process indicators. Results confirmed device requires vaporized hydrogen peroxide for endpoint color change, meets specific time/concentration requirements (7 seconds and 6 minutes at 50°C, 2.3 mg/l), and shows no ink transference.

Technological Characteristics

Non-cellulosic plastic backing; pressure-sensitive adhesive; chemical indicator stripes (blue to pink). Type 1 (e1) process indicator per ISO 11140-1:2014. No electronic components or software.

Indications for Use

Indicated for use as an external pack process indicator to differentiate unprocessed items from processed items in specified vaporized hydrogen peroxide sterilization systems. Suitable for use on non-woven disposable wraps and peel pouches.

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 (K212081)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

September 23, 2022

3M Company Yumi Wackerfuss Senior Regulatory Affairs Associate 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul, Minnesota 55144-1000

Re: K222152

Trade/Device Name: 3MTM Attest™ Hydrogen Peroxide Indicator Tape 1228 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: July 14, 2022 Received: July 20, 2022

Dear Yumi Wackerfuss:

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

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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/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K222152

Device Name

3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228

Indications for Use (Describe)

Use the 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed 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)

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

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The font is bold and sans-serif. The logo is simple and recognizable.

Image /page/3/Picture/3 description: The image shows the 3M logo, which is a well-known brand. The logo consists of the number "3" and the letter "M" in a bold, sans-serif font. The color of the logo is a vibrant red, and it is set against a white background. The logo is simple, yet recognizable.

# 510(k) Summary for 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 K222152

### Sponsor Information:

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

Contact: Yumi Wackerfuss Senior Regulatory Affairs Associate Phone Number: [phone] Fax Number: [phone]

Date of Summary: July 14th, 2022

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Image /page/4/Picture/0 description: The image shows the 3M logo. The logo is red and features the number "3" stacked on top of the letter "M". The font is bold and sans-serif.

#### 1. Device Name and Classification:

| Common or Usual Name | Chemical Indicator |
|-----------------------|-------------------------------------------------------|
| Proprietary Name | 3M™ Attest™ 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:

K212081, 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228

#### 3. Description of Device:

The 3M™ Attest™ 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. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide. 3MTM Attest™ Hydrogen Peroxide Indicator Tape 1228 is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014.

#### 4. Indications for Use

Use the 3M™ Attest™ 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 | | Submission Device: K222152 | Predicate Device (K212081) | Comparison |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| STERRAD 100S® Sterilization System | Feature | 3MTM AttestTM Hydrogen Peroxide<br>Indicator Tape 1228 | 3MTM ComplyTM Hydrogen Peroxide<br>Indicator Tape 1228 | |
| STERRAD NX® Sterilization System (Standard and Advanced cycles) | | Use the 3MTM AttestTM Hydrogen Peroxide<br>Indicator Tape 1228 to secure packs and as an<br>external pack process indicator to differentiate<br>unprocessed items from items processed in the<br>following sterilizers: | Use the 3MTM ComplyTM Hydrogen Peroxide<br>Indicator Tape 1228 to secure packs and as an<br>external pack process indicator to differentiate<br>unprocessed items from items processed in the<br>following sterilizers: | Similar. Product brand<br>name is changed from<br>ComplyTM to AttestTM. |
| STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) | | STERRAD 100® Sterilization System | STERRAD 100® Sterilization System | |
| STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) | | STERRAD 100S® Sterilization System | STERRAD 100S® Sterilization System | |
| STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) | | STERRAD NX® Sterilization System<br>(Standard and Advanced cycles) | STERRAD NX® Sterilization System<br>(Standard and Advanced cycles) | |
| V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) | | STERRAD 100NX® Sterilization System<br>(Standard, Flex, Express and Duo cycles) | STERRAD 100NX® Sterilization System<br>(Standard, Flex, Express and Duo cycles) | |
| V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) | | STERRAD NX® with ALLClear®<br>Technology Sterilization System (Standard<br>and Advanced cycles) | STERRAD NX® with ALLClear®<br>Technology Sterilization System (Standard<br>and Advanced cycles) | |
| V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) | | STERRAD 100NX® with ALLClear®<br>Technology Sterilization System (Standard,<br>Flex, Express and Duo cycles) | STERRAD 100NX® with ALLClear®<br>Technology Sterilization System (Standard,<br>Flex, Express and Duo cycles) | |
| V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) | | V-PRO® 1 Low Temperature Sterilization<br>System (Lumen cycle) | V-PRO® 1 Low Temperature Sterilization<br>System (Lumen cycle) | |
| V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) | | V-PRO® 1 Plus Low Temperature<br>Sterilization System (Lumen and Non<br>Lumen cycles) | V-PRO® 1 Plus Low Temperature<br>Sterilization System (Lumen and Non<br>Lumen cycles) | |
| V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) | | V-PRO® maX Low Temperature<br>Sterilization System (Lumen, Non Lumen,<br>and Flexible cycles) | V-PRO® maX Low Temperature<br>Sterilization System (Lumen, Non Lumen,<br>and Flexible cycles) | |
| V-PRO® 60 Low Temperature Sterilization<br>System (Lumen, Non Lumen and Flexible<br>cycles) | | V-PRO® 60 Low Temperature Sterilization<br>System (Lumen, Non Lumen and Flexible<br>cycles) | | |
| Indications for<br>use | | | | |
| | Submission Device: K222152 | Predicate Device (K212081) | Comparison | |
| Feature | 3M™ Attest™ Hydrogen Peroxide | 3M™ Comply™ Hydrogen Peroxide | | |
| | Indicator Tape 1228 | Indicator Tape 1228 | | |
| | V-PRO® maX 2 Low Temperature | V-PRO® maX 2 Low Temperature | | |
| | Sterilization System (Lumen, Non Lumen, | Sterilization System (Lumen, Non Lumen, | | |
| | Flexible, and Fast Non Lumen cycles) | Flexible, and Fast Non Lumen cycles) | | |
| | V-PRO® s2 Low Temperature Sterilization | V-PRO® s2 Low Temperature Sterilization | | |
| | System (Lumen, Non Lumen, Flexible, and | System (Lumen, Non Lumen, Flexible, and | | |
| | Fast cycles) | Fast cycles) | | |
| | STERIZONE® VP4 Sterilizer (Cycle 1) | STERIZONE® VP4 Sterilizer (Cycle 1) | | |
| | The tape is suitable for use on non-woven | The tape is suitable for use on non-woven | | |
| | disposable wraps and peel pouches. The | disposable wraps and peel pouches. The | | |
| | chemical indicator stripes turn from blue | chemical indicator stripes turn from blue | | |
| | toward pink after exposure to vaporized | toward pink after exposure to vaporized | | |
| | hydrogen peroxide. | hydrogen peroxide. | | |
| Substrate | Non-cellulosic plastic | Non-cellulosic plastic | Same | |
| Type of | Type 1 process indicator | No claim for indicator type | New claim for Type 1<br>process indicator | |
| | The exposure to health care professionals is | The exposure to health care professionals is | Same | |
| Biocompatibility | minimal and well below any identified toxic | minimal and well below any identified toxic | | |
| | thresholds for the compounds. | thresholds for the compounds. | | |
| Color Change | Blue toward pink | Blue toward pink | Same | |
| Detection | Hydrogen Peroxide | Hydrogen Peroxide | Same | |
| Stability of the | | | Same | |
| endpoint | Six (6) months | Six (6) months | | |
| reaction | | | | |
| Shelf life | Eighteen (18) months | Eighteen (18) months | Same | |

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.

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Image /page/5/Picture/0 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.

## 5. Summary of Technological Characteristics compared to Predicate Device

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Image /page/6/Picture/1 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The font is bold and sans-serif. The logo is simple and recognizable.

The 3M™ Attest™ 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 (K212081). No changes have been made to the device materials or fundamental technology.

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Image /page/7/Picture/0 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The logo is simple and recognizable, and it is often used on 3M products and marketing materials. The logo is bold and eye-catching.

### 6. Nonclinical Comparison to the Predicate Device

3M conducted nonclinical testing to support the product performance in accordance with :

- FDA Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for ● Chemical Indicators, issued December 19, 2003
- . ISO 11140-1:2014 Sterilization of healthcare products-Chemical Indicators-Part 1: General requirements for Type 1 (e1) Process Indicators.

Reference Table 6.1 for summary of nonclinical testing.

There is no change for the subject device from predicate device regarding the type 1 process indicator claim.

| Test Name | Purpose | Acceptance Criteria | | Result |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------|
| Absence of hydrogen<br>peroxide<br>(ISO 11140-1:2014<br>Type 1) | Verify device<br>requires the<br>presence of<br>vaporized<br>hydrogen<br>peroxide to reach<br>endpoint. | 45 Min at 50°C | Device does<br>not reach<br>endpoint color. | Pass |
| Hydrogen peroxide<br>(ISO 11140-1:2014<br>Type 1) | Confirm device<br>meets the Type 1<br>process indicator<br>for vaporized<br>hydrogen<br>peroxide<br>requirements. | 7 Sec at 50°C and gas<br>concentration of 2.3<br>mg/l<br>6 Min at 50°C and gas<br>concentration of 2.3<br>mg/l | Device does<br>not reach<br>endpoint color.<br>Device reaches<br>endpoint color. | Pass |
| Off-set/transference<br>(ISO 11140-1:2014) | Confirm device<br>meets the Type 1<br>process indicator<br>requirements. | After exposure to 6 Min<br>at 50°C and gas<br>concentration of 2.3<br>mg/l | Ink does not<br>transfer to<br>another<br>surface. | Pass |

### Table 6.1 Summary of Nonclinical Testing

### 7. Conclusion

The conclusions drawn from the nonclinical testing demonstrate that the subject device, the 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 cleared under K212081, Class II (21 CFR 880.2800), product code JOJ.