3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)

K241959 · 3M Company · FRC · Oct 18, 2024 · General Hospital

Device Facts

• Record ID: K241959
• Device Name: 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Oct 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD in conjunction with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles: Dynamic-air-removal (pre-vacuum and SFPP) 270°F (132°C) 4 minutes; Dynamic-air-removal (pre-vacuum and SFPP) 273°F (134°C) 4 minutes; Dynamic-air-removal (pre-vacuum and SFPP) 275°F (135°C) 3 minutes.

Device Story

The 3M™ Attest™ 1492PCD is a single-use biological indicator process challenge device (PCD) used in healthcare facilities to monitor steam sterilization efficacy. It consists of a clear plastic shell with a tortuous channel and foil lid, containing a 3M™ Attest™ 1492V Biological Indicator (BI) and a 3M™ Attest™ Steam Chemical Integrator (CI). The device is placed in the sterilizer; the CI provides immediate visual feedback (ACCEPT/REJECT) via color migration. The BI is incubated in a 3M™ Attest™ Auto-reader (490, 490H, or 490M) at 60°C. The reader detects fluorescence from enzymatic hydrolysis of a substrate within the BI; fluorescence indicates sterilization failure. The system provides a final result in 24 minutes. The PCD design increases resistance compared to a standalone BI, mimicking the AAMI 16-towel PCD challenge. Healthcare personnel use the output to verify sterilization adequacy before releasing processed items for patient use, ensuring patient safety by preventing the use of non-sterile instruments.

Clinical Evidence

No clinical data was required or completed for this submission. Performance was verified through bench testing, including resistance comparison to AAMI 16-towel PCDs and standalone indicators, and seal strength testing per ASTM F88/F88M-15 and ASTM F2824-10.

Technological Characteristics

Single-use PCD with clear plastic shell, tortuous channel, and foil lid. Contains 1492V BI (Geobacillus stearothermophilus spores, 10^6) and 1243R CI. Sensing principle: enzymatic fluorescence detection (BI) and color migration (CI). Connectivity: Auto-readers (490, 490H, 490M) for incubation and automated readout. Seal strength testing per ASTM F88/F88M-15 and ASTM F2824-10.

Indications for Use

Indicated for healthcare facilities to qualify or monitor dynamic-air-removal (pre-vacuum and SFPP) steam sterilization cycles at 270°F, 273°F, and 275°F using the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD in conjunction with specified 3M™ Attest™ Auto-readers.

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™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V (K193154)

Reference Devices

• 3M™ Attest™ Rapid Readout Biological Indicators 1295 (K200092)
• 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 (K200092)
• 3M™ Attest™ Super Rapid Readout Biological Indicators 1592 (K200092)
• 3M™ Attest™ Steam Chemical Integrator 1243R (K220942)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 18, 2024

3M Company Michelle Larsen Principal RA Specialist 3M Center 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144

Re: K241959

Trade/Device Name: 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3MTM Attest™ Auto-reader (490); 3MTM Attest™ Auto-reader (490H); 3MTM Attest™ Mini Auto-reader (490M) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: September 19, 2024 Received: September 19, 2024

Dear Michelle Larsen:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

{2}------------------------------------------------

assistance/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,

PAULO LARANJEIRA -S

Digitally signed by PAULO LARANJEIRA -S Date: 2024.10.18 11:49:41 -04'00'

for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

Submission Number (if known)

K241959

Device Name

3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD):

3M™ Attest™ Auto-reader (490);

3M™ Attest™ Auto-reader (490H);

3M™ Attest™ Mini Auto-reader (490M)

Indications for Use (Describe)

3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD):

Use the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD in conjunction with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cvcles:

| Cycle Type | Exposure Temperature | Exposure Time |
|-------------------------------------------|----------------------|---------------|
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes |

3M™ Attest™ Auto-reader (490):

The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.

3M™ Attest™ Auto-reader (490H):

The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.

3M™ Attest™ Mini Auto-reader (490M):

The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the 3M logo. The logo is red and features the number 3 followed by the letter M. The 3 and M are connected, and the logo is simple and recognizable.

# 510(k) Summary for 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M K241959

#### Sponsor Information:

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

Contact: Michelle M. Larsen Principal RA Specialist Phone Number: [phone] Fax Number: [phone] Email: [e-mail]

Date of Summary: 09 October 2024

#### 1. Device Name and Classification:

Biological Indicator (BI) Challenge Pack Common or Usual Name:

{5}------------------------------------------------

#### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3MTM Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M

| Proprietary Name: | 3M™ Attest™ Super Rapid Steam Clear Challenge Pack<br>1492PCD,<br>3M™ Attest™ Auto-reader 490,<br>3M™ Attest™ Auto-reader 490H,<br>3M™ Attest™ Mini Auto-reader 490M |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Indicator, Biological Sterilization Process |
| Device Classification: | Class II, 21 CFR 880.2800(a) |
| Product Code: | FRC |

# 2. Predicate Device:

3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, K193154

# 3. Description of Device:

The 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD is designed to qualify and monitor dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities.

The 1492PCD Challenge Pack consists of a clear plastic shell, and a tortuous channel allowing for air removal and sterilant penetration. The channel connects to a cavity containing the monitoring products and all are covered by a foil lid. The 1492PCD is a single-use device.

Each 1492PCD Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1492V (brown cap) and a 3M™ Attest™ Steam Chemical Integrator (CI). The CI verifies that the stated values for the three critical parameters of exposure time, temperature, and steam saturation have been achieved. Upon exposure to steam a dark color visible through a window migrates along the indicator strip and offers an ACCEPT or REJECT reading. The 1492V Biological Indicator (BI) is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490, a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1492V BI in the 490, 490H or 490M Auto-reader indicates a steam sterilization process failure. A chemical process indicator is present on the brown cap of the 1492V BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink

{6}------------------------------------------------

to light brown or darker upon exposure to steam. The process indicator is used by the customer to verify that the challenge pack was exposed to steam.

# 4. Indications for Use

3MTM Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD):

Use the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD in conjunction with the 3MTM Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:

| Cycle Type | Exposure<br>Temperature | Exposure Time |
|-------------------------------------------|-------------------------|---------------|
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes |

## 3MTM AttestTM Auto-reader (490):

The 3MIMAttest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3MTM Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.

# 3MTM Attest™ Auto-reader (490H):

The 3MTM Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.

# 3MTM Attest™ Mini Auto-reader (490M):

The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.

The submission device, the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, has the same intended use as the predicate device, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V. Both the submission device and the predicate device are Single Use biological indicator process challenge devices that are intended to be used in healthcare facilities to accompany products being sterilized and to monitor adequacy of the sterilization process.

{7}------------------------------------------------

#### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3MTM Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M

Both the submission and predicate test packs are indicated for use in conjunction with the 3M™ Attest™ Auto-readers 490 and 490H, and 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal steam sterilization cycles. The predicate device is indicated for use in dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C). The submission device covers an additional cycle ((4 minutes at 273°F (134°C)) compared to the predicate device. The differences in Indications for Use do not alter the fundamental Intended Use of these products as biological indicator process challenge devices and do not raise new questions of safety and effectiveness.

# 5. Comparison of Technological Characteristics with the Predicate Device

Both the submission and predicate challenge packs are designed to increase resistance beyond that measured with a standalone BI and both represent a challenge to the sterilization process equivalent to the AAMI reference PCD. The 3M™ Attest™ Super Rapid Steam Clear Challenge Pack consists of a clear plastic shell and a tortuous channel connected to a cavity in the shell containing the monitoring products, all heat sealed with a foil lid whereas the predicate challenge pack consists of layers of medical index cards, some of which are diecut to contain indicators, overwrapped and secured with a label. Both the submission and predicate challenge pack utilize the same Biological Indicator, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V and the same Chemical Integrator, the 3M™ Attest™ Steam Chemical Integrator. The process indicator on the predicate challenge pack is present on the outer label of the overwrapped challenge pack whereas the process indicator on the submission device is present on the cap of the 1492V BI which is visible through the clear challenge pack. Both the submission and predicate challenge packs contain a visible process indicator that changes color upon steam exposure that is used by the customer to distinguish processed and unprocessed challenge packs. The accessories (Auto-readers) are the same for both the submission and predicate device and the readout time or the time to a result is the same for both the submission and predicate device.

The differences in technological characteristics between the submission and predicate challenge pack are illustrated in the Device Comparison Table (Table 1).

{8}------------------------------------------------

| Feature | Submission Device:<br>(K241959)<br>3MTM AttestTM<br>Super Rapid Steam Clear<br>Challenge Pack 1492PCD<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H and<br>3MTM AttestTM Mini Auto-<br>reader 490M | Predicate Device:<br>(K193154)<br>3MTM AttestTM Super<br>Rapid 5 Steam-Plus<br>Challenge Pack 41482V | Comparison |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Single Use biological<br>indicator process challenge<br>device | Single Use biological<br>indicator process challenge<br>device | Identical |
| Indications for use | Use the 3MTM AttestTM<br>Super Rapid Steam Clear<br>Challenge Pack 1492PCD<br>in conjunction with the<br>3MTM AttestTM Auto-reader<br>490, the 3MTM AttestTM<br>Auto-reader 490H having<br>software version 4.0.0 or<br>greater, or the 3MTM<br>AttestTM Min Auto-reader<br>490M to qualify or monitor<br>dynamic-air-removal (pre-<br>vacuum and SFPP) steam<br>sterilization cycles of:<br>4 minutes at 270°F (132°C),4 minutes at 273°F (134°C), and3 minutes at 275°F (135°C) | Use the 3MTM AttestTM<br>Super Rapid 5 Steam-Plus<br>Challenge Pack 41482V in<br>conjunction with the 3MTM<br>AttestTM Auto-reader 490 or<br>3MTM AttestTM Auto-reader<br>490H having software<br>version 4.0.0 or greater to<br>qualify or monitor dynamic-<br>air-removal steam<br>sterilization cycles of:<br>4 minutes at 270°F (132°C), and3 minutes at 275°F (135°C). | Both the submission<br>and predicate test<br>packs are used to<br>qualify or monitor<br>dynamic-air-removal<br>steam sterilization<br>cycles. The submission<br>device is indicated for<br>an additional<br>sterilization cycle of 4<br>minutes at 273°F<br>(134°C).<br>Both the submission<br>and predicate test<br>packs utilize the same<br>Biological Indicator<br>(BI) and Chemical<br>Integrator (CI).<br>The 1492V BI is<br>indicated for use in<br>270°F (132°C) and<br>275°F (135°C)<br>dynamic-air-removal<br>steam sterilization<br>cycles (per K173437).<br>510(k) (K241710) is<br>pending clearance to<br>expand the Indications<br>for Use for the 1492V<br>BI to also include the<br>273°F (134°C) steam<br>sterilization cycle.<br>The 1243R CI is |
| Feature | Submission Device:<br>(K241959)<br>3MTM AttestTM<br>Super Rapid Steam Clear<br>Challenge Pack 1492PCD<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H and<br>3MTM AttestTM Mini Auto-<br>reader 490M | Predicate Device:<br>(K193154)<br>3MTM AttestTM Super<br>Rapid 5 Steam-Plus<br>Challenge Pack 41482V | Comparison |
| | | | 270°F (132°C), 273°F<br>(134°C) and 275°F<br>(135°C) dynamic-air-<br>removal steam<br>sterilization cycles (per<br>K220942).<br>The 1492V BI<br>contained in both the<br>predicate and<br>submission test packs<br>are intended to be used<br>in conjunction with the<br>3MTM AttestTM Auto-<br>reader 490 or the<br>3MTM AttestTM Auto-<br>reader 490H having<br>software version 4.0.0<br>or greater to qualify or<br>monitor dynamic-air<br>removal steam<br>sterilization cycles.<br>The 1492V BI was<br>cleared for use with the<br>3MTM AttestTM Mini<br>Auto-reader 490M per<br>K200092. |
| General<br>Design/Construction | Clear plastic tray with a<br>tortuous channel to the<br>cavity containing the<br>indicators, acting as a<br>challenge to limit air<br>removal and steam<br>penetration, sealed with a<br>foil lid. | Layers of medical index<br>cards, some of which are<br>die-cut to contain indicators,<br>overwrapped and secured<br>with a label. | Both the submission<br>and predicate<br>challenge packs are<br>designed to increase<br>resistance beyond that<br>measured with a<br>standalone BI and both<br>represent a challenge<br>to the sterilization<br>process equivalent to<br>the AAMI reference<br>PCD. |
| Biological Indicator | 3MTM AttestTM Super Rapid<br>Readout Biological<br>Indicator 1492V with ≥ 1 x | 3MTM AttestTM Super Rapid<br>Readout Biological<br>Indicator 1492V with ≥ 1 x | Identical |
| | Submission Device:<br>(K241959) | Predicate Device:<br>(K193154) | |
| Feature | 3MTM Attest™<br>Super Rapid Steam Clear<br>Challenge Pack 1492PCD<br>and<br>3MTM Attest™ Auto-<br>reader 490 and 490H and<br>3MTM AttestTM Mini Auto-<br>reader 490M | 3MTM Attest™ Super<br>Rapid 5 Steam-Plus<br>Challenge Pack 41482V | Comparison |
| Biological Indicator<br>Incubation temperature | 106 Geobacillus<br>stearothermophilus spores<br>60 ± 2°C | 106 Geobacillus<br>stearothermophilus spores<br>60 ± 2°C | Identical |
| Biological Indicator<br>Readout time | 24 minute final fluorescent<br>result in both the 490 and<br>490H Auto-readers having<br>software version 4.0.0 or<br>greater or in a 490M Auto-<br>reader.<br>1 hour final fluorescent<br>result in 490 Auto-readers<br>having software versions<br>less than 4.0.0.<br>Optional visual pH color<br>change result in 48 hours<br>for 490, 490H or 490M<br>Auto-readers. | 24 minute final fluorescent<br>result in both the 490 and<br>490H Auto-readers having<br>software versions 4.0.0 or<br>greater.<br>1 hour final fluorescent<br>result in 490 Auto-readers<br>having software versions<br>less than 4.0.0.<br>Optional visual pH color<br>change result in 48 hours<br>for 490 or 490H Auto-<br>readers. | The 1492V BI<br>contained in both the<br>predicate and<br>submission test packs<br>are intended to be used<br>in conjunction with the<br>3MTM Attest™ Auto-<br>reader 490 or the<br>3MTM Attest™ Auto-<br>reader 490H having<br>software version 4.0.0<br>or greater to qualify or<br>monitor dynamic-air<br>removal steam<br>sterilization cycles.<br>The 1492V BI was<br>cleared for use with the<br>3MTM Attest™ Mini<br>Auto-reader 490M per<br>K200092. |
| Biological Indicator<br>Mechanism of Action | When the enzyme that is<br>naturally occurring in the<br>spore is in its active state, it<br>is detected by measuring the<br>fluorescence produced by<br>the enzymatic hydrolysis of<br>a non-fluorescent substrate.<br>The resultant fluorescent<br>by-product is detected by<br>the Auto-reader. The<br>presence of fluorescence<br>upon incubation in the<br>Auto-reader indicates a<br>sterilization process failure.<br>There is an optional visual<br>pH color change which<br>indicates a steam<br>sterilization process failure. | When the enzyme that is<br>naturally occurring in the<br>spore is in its active state, it<br>is detected by measuring the<br>fluorescence produced by<br>the enzymatic hydrolysis of<br>a non-fluorescent substrate.<br>The resultant fluorescent<br>by-product is detected by<br>the Auto-reader. The<br>presence of fluorescence<br>upon incubation in the<br>Auto-reader indicates a<br>sterilization process failure.<br>There is an optional visual<br>pH color change which<br>indicates a steam<br>sterilization process failure. | Identical |
| | Submission Device:<br>(K241959) | Predicate Device:<br>(K193154) | |
| Feature | 3MTM Attest™<br>Super Rapid Steam Clear<br>Challenge Pack 1492PCD<br>and<br>3MTM Attest™ Auto-<br>reader 490 and 490H and<br>3MTM Attest™ Mini Auto-<br>reader 490M | 3MTM Attest™ Super<br>Rapid 5 Steam-Plus<br>Challenge Pack 41482V | Comparison |
| Biological Indicator<br>Resistance<br>Characteristics<br>• D-value<br>• Survival/Kill<br>Window | D-value ≥ 10 seconds at<br>132°C<br>D-value ≥ 8 seconds at<br>134°C<br>D-value ≥ 8 seconds at<br>135°C<br>Survival Time = Calculated<br>survival time* or 1 minute<br>at 132°C and 40 seconds at<br>134°C and 135°C,<br>whichever is longer<br>Kill Time = Calculated kill<br>time* at 132°C, 134°C and<br>at 135°C | D-value ≥ 10 seconds at<br>132°C<br>D-value ≥ 8 seconds at<br>135°C<br>Survival Time = Calculated<br>survival time* or 1 minute<br>at 132°C and 40 seconds at<br>135°C, whichever is longer<br>Kill Time = Calculated kill<br>time* at 132°C and at<br>135°C | Both the submission<br>and predicate test<br>packs utilize the same<br>BI (1492V). The BI is<br>indicated for use in<br>270°F (132°C) and<br>275°F (135°C)<br>dynamic-air-removal<br>steam sterilization<br>cycles (per K173437).<br>510(k) (K241710) is<br>pending clearance to<br>expand the Indications<br>for Use for the 1492V<br>BI to also include the<br>273°F (134°C) steam<br>sterilization cycle. The<br>Resistance<br>Characteristics (D-<br>Value, Survival/Kill<br>Window) of the 1492V<br>BI have been updated<br>to include the<br>monitoring of steam<br>sterilization cycles at<br>273°F (134°C). |
| Biological Indicator<br>Culture Conditions | Crushable glass ampoule<br>containing a growth media<br>and a fluorescence indicator<br>which is correlated to an<br>optional use pH indicator. | Crushable glass ampoule<br>containing a growth media<br>and a fluorescence indicator<br>which is correlated to an<br>optional use pH indicator. | Identical |
| Chemical Integrator | 3MTM Attest™ Steam<br>Chemical Integrator | 3MTM Attest™ Steam<br>Chemical Integrator | Identical |
| Chemical Integrator<br>Endpoint Specifications<br>(Minimum Stated<br>Values) | 250°F/121°C: 16.5 minutes<br>270°F/132°C: 2.0 minutes<br>273°F/134°C: 1.4 minutes<br>275°F/135°C: 1.2 minutes | 250°F/121°C: 16.5 minutes<br>270°F/132°C: 2.0 minutes<br>273°F/134°C: 1.4 minutes<br>275°F/135°C: 1.2 minutes | Identical |
| Chemical Integrator<br>Color Change | Dark color migrates along<br>strip visible through a green<br>window (ACCEPT) or red<br>window (REJECT) | Dark color migrates along<br>strip visible through a green<br>window (ACCEPT) or red<br>window (REJECT) | Identical |
| Feature | Submission Device:<br>(K241959)<br>3MTM AttestTM<br>Super Rapid Steam Clear<br>Challenge Pack 1492PCD<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H and<br>3MTM AttestTM Mini Auto-<br>reader 490M | Predicate Device:<br>(K193154)<br>3MTM AttestTM Super<br>Rapid 5 Steam-Plus<br>Challenge Pack 41482V | Comparison |
| Mechanism to<br>distinguish processed<br>and unprocessed<br>challenge pack | Process indicator present on<br>1492V BI cap is visible<br>through PCD and turns<br>color from pink to light<br>brown or darker upon steam<br>exposure. | External Chemical Process<br>Indicator turns from yellow<br>to brown or darker upon<br>steam exposure. | Both the submission<br>and predicate device<br>contain a process<br>indicator that changes<br>color upon steam<br>exposure that is used<br>by the customer to<br>verify that the<br>challenge pack was<br>exposed to steam. |
| Resistance Comparison<br>to the AAMI ST79 16<br>Towel PCD | Equivalent in resistance to<br>the AAMI ST79 16 Towel<br>PCD | Equivalent in resistance to<br>the AAMI ST79 16 Towel<br>PCD | Identical |
| Shelf Life | 21 months | 21 months | Identical |
| Accessories<br>(Auto-readers) | 3MTM AttestTM Auto-reader<br>490 or the 3MTM AttestTM<br>Auto-reader 490H or the<br>3MTM AttestTM Mini Auto-<br>reader | 3MTM AttestTM Auto-reader<br>490 or the 3MTM AttestTM<br>Auto-reader 490H | The 1492V BI<br>contained in both the<br>predicate and<br>submission test packs<br>are intended to be used<br>in conjunction with the<br>3MTM AttestTM Auto-<br>reader 490 or the<br>3MTM AttestTM Auto-<br>reader 490H having<br>software version 4.0.0<br>or greater to qualify or<br>monitor dynamic-air-<br>removal steam<br>sterilization cycles.<br>The 1492V BI was<br>cleared for use with the<br>3MTM AttestTM Mini<br>Auto-reader 490M per<br>K200092 |

## Table 1: Device Comparison Table

{9}------------------------------------------------

### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M

{10}------------------------------------------------

## TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M

{11}------------------------------------------------

## TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M

{12}------------------------------------------------

## TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M

{13}------------------------------------------------

### 6. Nonclinical Comparison to the Predicate Device

The differences between the submission and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD.

Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, containing three lots of 1492V BIs and three lots of 1243R Cls, were tested side by side with standalone indicators 1492V BIs and 1243R CIs. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007.

Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, containing three lots of 1492V BIs and three lots of 1243R CIs, were tested side by side with the AAMI 16 Towel PCD containing 1492V BIs and 1243R CIs. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007, and ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested for peel force of the heat seal foil lid from the plastic shell. The validated method used to perform the testing is based on ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids.

Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested for peel force of the heat seal foil lid from the plastic shell, pre and post sterilization. The validated method used to perform the testing is based on ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids.

| Test<br>Performed | Device<br>Description | Applicable<br>Standards | Purpose | Acceptance<br>Criteria | Results |
|------------------------------------------------------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Resistance<br>of 1492PCD<br>Challenge<br>Pack<br>compared to<br>AAMI 16<br>Towel PCD<br>in claimed<br>cycles | 1492PCD<br>Challenge Pack | FDA Guidance1 and<br>ANSI/AAMI<br>ST79:2017,<br>Comprehensive<br>guide to steam<br>sterilization and<br>sterility<br>assurance in health<br>care facilities | Demonstrate<br>the performance<br>of the 1492PCD<br>Challenge Pack<br>is equivalent to<br>the performance<br>of the AAMI 16<br>Towel PCD in<br>the claimed<br>cycles | Indicators<br>contained in the<br>1492PCD<br>Challenge Pack<br>must<br>demonstrate<br>equivalent<br>resistance as<br>compared to the<br>indicators<br>contained in the | Acceptance<br>criteria met |
| Test<br>Performed | Device<br>Description | Applicable<br>Standards | Purpose | Acceptance<br>Criteria | Results |
| | | | | AAMI 16<br>Towel PCD in<br>the claimed<br>cycles | |
| Resistance<br>of 1492PCD<br>Challenge<br>Pack<br>compared to<br>standalone<br>indicators in<br>claimed<br>cycles | 1492PCD<br>Challenge Pack | FDA Guidance¹ | Demonstrate<br>the 1492PCD<br>Challenge Pack<br>provides a<br>greater<br>challenge than<br>the standalone<br>indicators in the<br>claimed cycles | Indicators<br>contained in the<br>1492PCD<br>Challenge Pack<br>must<br>demonstrate<br>greater<br>resistance<br>compared to the<br>standalone<br>indicators in the<br>claimed cycles | Acceptance<br>criteria met |
| 1492PCD<br>Peel Force | 1492PCD<br>Challenge Pack | ASTM F88 / F88M-<br>15: Standard Test<br>Method for Seal<br>Strength of Flexible<br>Barrier and<br>ASTM F2824 – 10:<br>Standard Test<br>Method for<br>Mechanical Seal<br>Strength Testing for<br>Round Cups and<br>Bowl Containers<br>with Flexible<br>Peelable Lids | Demonstrate<br>acceptable peel<br>force of Clear<br>Challenge Pack<br>1492PCD heat<br>seal foil lid<br>from plastic<br>shell | ≥4.25lbF and<br>≤16lbF | Acceptance<br>criteria met |
| 1492PCD<br>Peel Force | 1492PCD<br>Challenge Pack | ASTM F88 / F88M-<br>15: Standard Test<br>Method for Seal<br>Strength of Flexible<br>Barrier and<br>ASTM F2824 - 10:<br>Standard Test<br>Method for<br>Mechanical Seal<br>Strength Testing for<br>Round Cups and<br>Bowl Containers<br>with Flexible<br>Peelable Lids | Demonstrate<br>acceptable peel<br>force of Clear<br>Challenge Pack<br>1492PCD heat<br>seal foil lid<br>from plastic<br>shell, pre and<br>post<br>sterilization | ≥4.25lbF and<br>≤16lbF | Acceptance<br>criteria met |

Performance of the 1492PCD challenge pack was verified through the following tests:

{14}------------------------------------------------

### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M

1 FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification (510(k)] Submissions, October 4, 2007

{15}------------------------------------------------

# 7. Clinical Comparison to the Predicate Device

Clinical testing was not required or completed for the submission device.

## 8. Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the submission device, the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H, and the 3M™ Attest™ Mini Auto-reader 490M, are as safe and as effective as the legally marketed predicate device, the 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V for use with the 3M™ Attest™ Auto-reader 490, and the 3MTM Attest™ Autoreader 490H (cleared per K193154), and the 3M™ Attest™ Mini Auto-reader 490M (cleared per K200092) Class II (21 CFR 880.2800), product code FRC.