3M™ Attest™ Steam Chemical Integrators

K191236 · 3M Company · JOJ · Nov 22, 2019 · General Hospital

Device Facts

• Record ID: K191236
• Device Name: 3M™ Attest™ Steam Chemical Integrators
• Applicant: 3M Company
• Product Code: JOJ · General Hospital
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The 3M™ Attest™ Steam Chemical Integrators are designed to all critical parameters over a specified range of steam sterilization cycles. The integrating intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity 250°F/121°C 30 minutes; Gravity 270°F/132°C 3, 4, 10, 15, 25 minutes; Gravity 275°F/135°C 3, 10 minutes; Dynamic Air Removal 250°F/121°C 30 minutes; Dynamic Air Removal 270°F/132°C 4, 10 minutes; Dynamic Air Removal 273°F/134°C 3, 4 minutes; Dynamic Air Removal 275°F/135°C 3 minutes.

Device Story

Chemical indicator for steam sterilization monitoring; consists of paper wick and steam/temperature-sensitive chemical pellet inside paper/film/foil laminate. Pellet melts and migrates as dark color along wick upon exposure to steam, time, and temperature. User observes migration through window marked ACCEPT or REJECT. Placed in sterilization packs/trays by healthcare personnel. Provides visual confirmation of sterilization cycle parameters; assists in clinical decision-making regarding sterility of processed items. Benefits patient by ensuring medical devices used in procedures have undergone validated sterilization conditions.

Clinical Evidence

Bench testing only. Performance validated per ANSI/AAMI/ISO 11140-1:2014. Testing included Stated Value (SV) verification in saturated steam resistometers, simulated healthcare facility use testing, dry heat resistance, side-by-side comparison with biological indicators, and endpoint color stability. All tests passed.

Technological Characteristics

Chemical indicator; paper wick and proprietary chemical pellet in paper/film/foil laminate. Sensing principle: chemical pellet melting/migration dependent on steam, time, and temperature. Dimensions/form factor: strip. Connectivity: none. Sterilization: N/A (used to monitor sterilization).

Indications for Use

Indicated for use as an independent monitor of critical parameters in steam sterilization cycles (Gravity and Dynamic Air Removal) across specified temperatures (121°C–135°C) and exposure times. Intended for placement inside packs, pouches, containers, or trays.

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™ SteriGage™ Chemical Integrator for Steam (K101249)

Submission Summary (Full Text)

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November 22, 2019

3M Company Mary Fretland Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144

Re: K191236

Trade/Device Name: 3MTM Attest™ Steam Chemical Integrators Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: October 22, 2019 Received: October 23, 2019

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

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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 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 (QS) 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 medical devices and radiation-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,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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) K191236

### Device Name

3MTM Attest™ Steam Chemical Integrators

### Indications for Use (Describe)

The 3M™ Attest™ Steam Chemical Integrators are designed to all critical parameters over a specified range of steam sterilization cycles. The integrating intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

| Cycle Type | Temperature | Exposure Time |
|---------------------|-------------|--------------------------|
| Gravity | 250°F/121°C | 30 minutes |
| Gravity | 270°F/132°C | 3, 4, 10, 15, 25 minutes |
| Gravity | 275°F/135°C | 3, 10 minutes |
| Dynamic Air Removal | 250°F/121°C | 30 minutes |
| Dynamic Air Removal | 270°F/132°C | 4, 10 minutes |
| Dynamic Air Removal | 273°F/134°C | 3, 4 minutes |
| Dynamic Air Removal | 275°F/135°C | 3 minutes |

Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer: 250°F / 121°C: 16.5 minutes 270°F/ 132°C: 2.0 minutes 273°F/ 134°C: 1.4 minutes 275°F/ 135°C: 1.2 minutes

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 3MTM Attest™ Steam Chemical Integrators

### Sponsor Information:

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

Contact: Mary Fretland Senior Regulatory Affairs Associate Phone Number: [phone] Fax Number: [phone] Email: [e-mail]

Date of Summary: November 21, 2019

Submission Number: K191236

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#### 1. Device Name and Classification:

| Common or Usual Name: | Chemical Indicators |
|------------------------|----------------------------------------------------|
| Trade Name: | 3MTM AttestTM Steam Chemical Integrators |
| Classification Name: | Physical/chemical sterilization process indicators |
| Device Classification: | Class II, 21 CFR § 880.2800(b) |
| Product Code: | JOJ |

#### 2. Predicate Device:

3MTM ComplyTM SteriGage™ Chemical Integrator for Steam (K101249)

#### 3. Description of Device:

3M™ Attest™ Steam Chemical Integrators are chemical indicators consisting of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked ACCEPT or window marked REJECT; the extent of migration depends on steam, time, and temperature.

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#### 4. Indications for Use

The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

| Cycle Type | Temperature | Exposure Time |
|---------------------|-------------|---------------|
| Gravity | 250°F/121°C | 30 minutes |
| Gravity | 270°F/132°C | 3 minutes |
| Gravity | 270°F/132°C | 4 minutes |
| Gravity | 270°F/132°C | 10 minutes |
| Gravity | 270°F/132°C | 15 minutes |
| Gravity | 270°F/132°C | 25 minutes |
| Gravity | 275°F/135°C | 3 minutes |
| Gravity | 275°F/135°C | 10 minutes |
| Dynamic Air Removal | 250°F/121°C | 30 minutes |
| Dynamic Air Removal | 270°F/132°C | 4 minutes |
| Dynamic Air Removal | 270°F/132°C | 10 minutes |
| Dynamic Air Removal | 273°F/134°C | 3 minutes |
| Dynamic Air Removal | 273°F/134°C | 4 minutes |
| Dynamic Air Removal | 275°F/135°C | 3 minutes |

Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer:

| 250°F/121°C | 270°F/132°C | 273°F/134°C | 275°F/135°C |
|--------------|-------------|-------------|-------------|
| 16.5 Minutes | 2.0 Minutes | 1.4 Minutes | 1.2 Minutes |

#### 5. Nonclinical Comparison to the Predicate Device

The design, fundamental technology and performance specifications for 3M™ Attest™ Steam Chemical Integrators are similar to the previously cleared device which is sold under the tradename 3MTM ComplyTM SteriGage™ Chemical Integrator for Steam (K101249).

There has been no change to the device's performance specifications or fundamental scientific technology. The intent of this submission is to expand the indications for use. re-brand the device, and modify the materials used to construct the device.

The differences between 3M™ Attest™ Steam Chemical Integrator and the predicate do not raise any new questions of safety and effectiveness as demonstrated by the performance testing and biocompatibility assessment.

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#### 6. Technical Characteristics

### Technological Characteristics Comparison Between Subject and Predicate Device:

| Feature | Submission Device:<br>3MTM AttestTM Steam Chemical Integrators | Predicate Device (K101249):<br>3MTM ComplyTM SteriGageTM Chemical<br>Integrators for Steam |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Device Models | 1243RE and 1243RES | 1243RE |
| Device Design | 3MTM AttestTM Steam Chemical Integrators are<br>chemical indicators consisting of a paper wick and<br>steam and temperature sensitive chemical pellet<br>contained in a paper/film/foil laminate. The<br>chemical pellet melts and migrates as a dark color<br>along the paper wick. The migration is visible<br>through a window marked ACCEPT or window<br>marked REJECT; the extent of migration depends<br>on steam, time, and temperature. | Identical. |
| Indicator Agent | Proprietary formulation. | Identical. |
| Sterilization<br>method and cycles | Steam sterilization processes 250°F to 275°F<br>(121°C to 135°C) | Identical. |
| Shelf-life | One (1) year | Three (3) years |

## Indications for Use Comparison:

| Cycle Type | Temperature | Submission Device:<br>3MTM AttestTM Steam Chemical<br>Integrators<br>Exposure Time | Predicate Device (K101249):<br>3MTM Comply™ SteriGage™ Chemical<br>Integrators for Steam<br>Exposure Time |
|------------------------|-------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Gravity | 250°F/121°C | 30 minutes | ≥ 30 minutes |
| Gravity | 270°F/132°C | 3 minutes<br>4 minutes<br>10 minutes<br>15 minutes<br>25 minutes | ≥ 3 minutes (unwrapped) |
| Gravity | 275°F/135°C | 3 minutes<br>10 minutes | Not present. |
| Dynamic Air<br>Removal | 250°F/121°C | 30 minutes | Not present. |
| Dynamic Air<br>Removal | 270°F/132°C | 4 minutes<br>10 minutes | ≥ 3 minutes (unwrapped)<br>≥ 4 minutes (wrapped) |
| Dynamic Air<br>Removal | 273°F/134°C | 3 minutes<br>4 minutes | ≥ 3.5 minutes (unwrapped)<br>≥ 4 minutes (wrapped) |
| Dynamic Air<br>Removal | 275°F/135°C | 3 minutes | ≥ 3 minutes |

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| Feature | Submission Device:<br>3MTM Attest™ Steam Chemical Integrators | | | | Predicate Device (K101249):<br>3MTM Comply™ SteriGage™ Chemical<br>Integrators for Steam | | | |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------|-----------------|
| Endpoint<br>Specifications<br>(Minimum Stated<br>Values) | The minimum stated values for the 3MTM Attest™ Steam Chemical Integrators as determined using a resistometer are provided in the table below. | | | | The minimum stated values for the 3MTM Comply™ SteriGage™ Chemical Integrators for Steam as determined using a resistometer are provided in the table below. | | | |
| | Minimum Stated Values for 3MTM Attest™ Steam Chemical Integrators | | | | Minimum Stated Values for 3M™ ComplyTM SteriGage™ Steam Chemical Integrators | | | |
| | 250°F/<br>121°C | 270°F/<br>132°C | 273°F/<br>134°C | 275°F/<br>135°C | 250°F/<br>121°C | 270°F/<br>132°C | 273°F/<br>134°C | 275°F/<br>135°C |
| | 16.5<br>Minutes | 2.0<br>Minutes | 1.4<br>Minutes | 1.2<br>Minutes | 16.5<br>Minutes | 2.0<br>Minutes | 1.4<br>Minutes | 1.1<br>Minutes |

#### 7. Summary of Nonclinical Testing

Nonclinical testing of the 3M™ Attest™ Steam Chemical Integrators was conducted in accordance with the FDA Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003 as well as ANSI/AAM/ISO 11140-1:2014.

The effectiveness of the 3MTM Attest™ Steam Chemical Integrator was demonstrated in the following tests:

| Test Name | Purpose | Acceptance Criteria | Results |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Stated Value (SV)<br>Testing | To identify the critical parameters<br>required to achieve a stated inactivation,<br>by referring to a stated test organism<br>with stated D and z values. The<br>integrator must turn to "ACCEPT" end<br>point at the stated value time and must<br>also remain "REJECT" when exposed to<br>conditions of -1°C/-15% set point of the<br>SV time. All testing is completed in a<br>saturated steam resistometer. Integrator<br>temperature coefficient and correlation<br>coefficient are calculated to confirm<br>alignment to biological indicator<br>performance. | SV at 121°C $\geq$ 16.5 minutes<br>SV at 132°C $\geq$ 2.0 minutes<br>SV at 134°C $\geq$ 1.4 minutes<br>SV at 135°C $\geq$ 1.2 minutes<br>Integrator<br>temperature<br>coefficient 10 - 27°C<br>Correlation<br>coefficient $\geq$ 0.9 | PASS |
| Health Care<br>Facility Simulated<br>Use Testing | Confirm integrators provide acceptable<br>performance in cleared customer use<br>sterilization cycles. | Device reaches "ACCEPT"<br>endpoint reaction when<br>exposed to customer use<br>cycles.<br>Device does not reach<br>endpoint ("REJECT") when<br>exposed to failing conditions<br>in customer use cycles. | PASS |

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| Test Name | Purpose | Acceptance Criteria | Results |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------|
| Dry Heat Testing | Verify device requires the presence of saturated steam to turn to reach endpoint. | Endpoint must not be met following dry heat exposure at 140°C for 30 min. | PASS |
| Side-by-Side<br>Testing with<br>Biological<br>Indicator | Confirm integrators are parallel in performance to biological indicators (BI). | Chemical integrator parallels performance of BI and does not reach endpoint before BI is inactivated. | PASS |
| Endpoint Color<br>Stability | Confirm endpoint color stability for samples exposed to passing and failing conditions in a steam resistometer. | Endpoint decision must remain unchanged after 6 months. | PASS |

The results of performance testing on 3M™ Attest™ Steam Chemical Integrator demonstrate the device performs as intended in the claimed steam sterilization cycles.

#### 8. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the 3MTM AttestTM Steam Chemical Integrator is as safe, as effective and performs as well as or better than the legally marketed predicate, 3M™ Comply™ SteriGage™ Chemical Integrator for Steam cleared under K101249, Class II (CFR 880.2800, product code JOJ).