3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248

K222508 · 3M Company · JOJ · Nov 1, 2022 · General Hospital

Device Facts

• Record ID: K222508
• Device Name: 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
• Applicant: 3M Company
• Product Code: JOJ · General Hospital
• Decision Date: Nov 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles: 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 chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

Device Story

Chemical indicator strip; white plastic substrate with indicator ink bar. Used as internal pack process indicator to verify exposure to vaporized hydrogen peroxide. Upon exposure to hydrogen peroxide, ink bar changes color from blue to pink. Used in clinical settings by healthcare personnel during sterilization cycles. Provides visual confirmation of exposure to sterilization process; aids in distinguishing processed from unprocessed packs. No electronic components or software.

Clinical Evidence

No clinical data. Bench testing only. Testing included color development verification, light stability, and ISO 11140-1:2014 Type 1 compliance (absence of hydrogen peroxide, hydrogen peroxide exposure, and off-set/transference) for the STERIZONE VP4 Sterilizer (Cycle 1).

Technological Characteristics

Polyethylene substrate; chemical indicator ink bar; color change from blue to pink; Type 1 (Category e1) Process Indicator per ISO 11140-1:2014; shelf life 2 years; endpoint stability 4 weeks.

Indications for Use

Indicated for use as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in specified STERRAD, V-PRO, and STERIZONE sterilization systems.

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 Chemical Indicator 1248 (K203458)

Submission Summary (Full Text)

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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2022

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

Re: K222508

Trade/Device Name: 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: August 17, 2022 Received: August 18, 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

510(k) Number (if known) K222508

Device Name

3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248

Indications for Use (Describe)

Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:

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 chemical indicator bar turns 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) | <div> <span> ☒ </span> </div> |

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Image /page/3/Picture/0 description: The image shows the 3M logo. The logo is red and consists of the number 3 followed by the letter M. The logo is simple and recognizable.

# 510(k) Summary for 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248 K222508

#### 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 Preparation: Oct 20th, 2022

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Image /page/4/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.

# PREMARKET NOTIFICATION [510(k)] 4 ComplyTM Hydrogen Peroxide Chemical Indicator 1248 510(k) Summary - K222508

#### 1. Device Name and Classification:

| Common Name: | Chemical Indicators |
|------------------------|---------------------------------------------------------|
| Proprietary Name: | 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 |
| Classification Name: | Physical/chemical sterilization process indicators |
| Device Classification: | Class II, 21 CFR 880.2800(b) |
| Product Code: | JOJ |

#### 2. Predicate Device:

K203458, 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248

#### 3. Description of Device:

The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 has an indicator ink bar printed on a white plastic strip. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide. 3M™ Comply™ Hydrogen Peroxide Indicator 1248 is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014.

#### 4. Indications for Use

Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:

| 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 chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

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# 3M

#### 5. Technological Characteristic Comparison Table

| Feature | Submission Device (K222508):<br>3M™ Comply™ Hydrogen Peroxide Chemical<br>Indicator 1248 | Predicate Device (K203458):<br>3M™ Comply™ Hydrogen Peroxide Chemical<br>Indicator 1248 | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:<br>STERRAD® 100 Sterilization System<br>STERRAD® 100SSterilization System<br>STERRAD® NX Sterilization System<br>(Standard and Advanced cycles)<br>STERRAD® 100NX Sterilization System<br>(Standard, Flex, Express, and Duo cycles)<br>STERRAD® NX with ALLClear® Technology<br>Sterilization System (Standard and Advanced cycles)<br>STERRAD® 100NX with ALLClear®<br>Technology Sterilization System (Standard,<br>Flex, Express, and Duo cycles)<br>V-PRO® 1 Low Temperature Sterilization<br>System (Lumen cycle)<br>V-PRO® 1 Plus Low Temperature Sterilization<br>System (Lumen and Non Lumen cycles)<br>V-PRO® maX Low Temperature Sterilization<br>System (Lumen, Non Lumen, and Flexible<br>cycles)<br>V-PRO® 60 Low Temperature Sterilization<br>System (Lumen, Non Lumen, and Flexible<br>cycles)<br>V-PRO® maX 2 Low Temperature Sterilization<br>System (Lumen, Non Lumen, Flexible, and<br>Fast Non Lumen cycles) | Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:<br>STERRAD® 100 Sterilization System<br>STERRAD® 100SSterilization System<br>STERRAD® NX Sterilization System<br>(Standard and Advanced cycles)<br>STERRAD® 100NX Sterilization System<br>(Standard, Flex, Express, and Duo cycles)<br>STERRAD® NX with ALLClear® Technology<br>Sterilization System (Standard and Advanced cycles)<br>STERRAD® 100NX with ALLClear®<br>Technology Sterilization System (Standard,<br>Flex, Express, and Duo cycles)<br>V-PRO® 1 Low Temperature Sterilization<br>System (Lumen cycle)<br>V-PRO® 1 Plus Low Temperature Sterilization<br>System (Lumen and Non Lumen cycles)<br>V-PRO® maX Low Temperature Sterilization<br>System (Lumen, Non Lumen, and Flexible<br>cycles)<br>V-PRO® 60 Low Temperature Sterilization<br>System (Lumen, Non Lumen, and Flexible<br>cycles)<br>V-PRO® maX 2 Low Temperature Sterilization<br>System (Lumen, Non Lumen, Flexible, and<br>Fast Non Lumen cycles) | Similar. The submission<br>device adds the<br>STERIZONE® VP4<br>Sterilizer (Cycle 1) to<br>the Indications for Use. |
| Feature | Submission Device (K222508):<br>3M™ Comply™ Hydrogen Peroxide Chemical<br>Indicator 1248 | Predicate Device (K203458):<br>3M™ Comply™ Hydrogen Peroxide Chemical<br>Indicator 1248 | Comparison |
| | V-PRO® s2 Low Temperature Sterilization<br>System (Lumen, Non Lumen, Flexible, and<br>Fast cycles)<br>STERIZONE® VP4 Sterilizer (Cycle 1)<br>The chemical indicator bar turns from blue toward<br>pink after exposure to vaporized hydrogen<br>peroxide. | V-PRO® s2 Low Temperature Sterilization<br>System (Lumen, Non Lumen, Flexible, and<br>Fast cycles)<br>The chemical indicator bar turns from blue toward<br>pink after exposure to vaporized hydrogen<br>peroxide. | |
| Substrate | Polyethylene | Polyethylene | Same |
| Biocompatibility | The exposure to health care professionals is<br>minimal and well below any identified toxic<br>thresholds for the compounds. | The exposure to health care professionals is<br>minimal and well below any identified toxic<br>thresholds for the compounds. | Same |
| Color Change | Blue toward pink | Blue toward pink | Same |
| Detection | Hydrogen Peroxide | Hydrogen Peroxide | Same |
| Stability of the<br>endpoint reaction | At least one month<br>(4 weeks) | At least one month<br>(4 weeks) | Same |
| Shelf life | Two (2) years | Two (2) years | Same |
| Indicator Type | Type 1 Process Indicator | Not claimed | New claim for Type 1<br>process indicator |

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Image /page/6/Picture/0 description: The image shows the title of a document, which is a premarket notification for a 3M product. The product is the 3M Comply Hydrogen Peroxide Chemical Indicator 1248. The document is a 510(k) summary with the identifier K222508.

The 3MM Comply ™ Hydrogen Peroxide Chemical Indicator 1248 is the same design as the previously cleared device of same model number (predicate device: K203458) which is sold under the same tradename 3M™ Comply™ Hydrogen Peroxide Indicator 1248. No change has been made to the device materials, performance specifications, or fundamental technology.

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Image /page/7/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, and it is often used on 3M products and marketing materials. The logo is bold and eye-catching.

# PREMARKET NOTIFICATION [510(k)] 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 510(k) Summary - K222508

#### 6. Summary of Non-clinical Testing

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.

Reference Table 6.1 for testing completed in the used for STERIZONE® VP4 Sterilizer (Cycle 1) and Type 1 Process Indicator claim.

| Test | Purpose | Acceptance Criteria | Result | |
|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------|
| STERIZONE®<br>VP4 Sterilizer<br>(Cycle 1) Color<br>Development | To demonstrate the color<br>change of the device and<br>determine the minimum<br>exposure time for end point<br>color change when used in the<br>STERIZONE® VP4 Sterilizer<br>(Cycle 1) | Complete Cycle: Color change<br>from blue toward pink<br>7 second exposure: Color<br>change is not as pink (bluer)<br>than color reference match.<br>Determination of the minimum<br>time for color to change from<br>blue toward pink. | Pass | |
| STERIZONE®<br>VP4 Sterilizer<br>(Cycle 1) End<br>Point Color<br>(Post-<br>Sterilization)<br>Light Stability | To demonstrate the end point<br>color change stability of the<br>device following exposure to<br>STERIZONE® VP4 Sterilizer<br>(Cycle 1) | No significant change in the<br>endpoint color after exposure<br>to light during storage. | Pass | |
| ISO 11140-<br>1:2014 Type 1<br>Absence of<br>hydrogen<br>peroxide | Verify device requires the<br>presence of vaporized hydrogen<br>peroxide to reach endpoint. | 45 Min at<br>50°C | Device does<br>not reach<br>endpoint<br>color. | Pass |
| ISO 11140-<br>1:2014 Type 1<br>Hydrogen<br>peroxide | Confirm device meets the Type<br>1 process indicator for<br>vaporized hydrogen peroxide<br>requirements. | 7 Sec at 50°C<br>and gas<br>concentration<br>of 2.3 mg/l<br>6 Min at 50°C<br>and gas<br>concentration<br>of 2.3 mg/l | Device does<br>not reach<br>endpoint<br>color.<br>Device<br>reaches<br>endpoint<br>color. | Pass |
| ISO 11140-<br>1:2014 Off-<br>set/transference | Confirm device meets the Type<br>1 process indicator<br>requirements. | After<br>exposure to 6<br>Min at 50°C<br>and gas<br>concentration<br>of 2.3 mg/l | Ink does not<br>transfer to<br>another<br>surface. | Pass |

#### Table 6.1 Summary of Nonclinical Testing

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Image /page/8/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.

# PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248 510(k) Summary - K222508

### 7. Conclusion

The conclusions drawn from the non-clinical testing demonstrate that the subject device, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 cleared under K203458, Class II (21 CFR 880.2800), product code JOJ.