Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a biological indicator system that uses fluorescence detection and chemical indicators to determine sterilization effectiveness. There is no mention of AI or ML in the intended use, device description, or performance studies. The auto-readers perform automated incubation and reading, but this is based on detecting fluorescence, not complex pattern recognition or learning algorithms.

Therapeutic

No

This device is designed to monitor and qualify steam sterilization processes, not to treat or diagnose patients. Its function is to detect sterilization failures by indicating the presence of fluorescence, which points to microbial growth, not to provide therapy.

Diagnostic

No

Explanation: This device is a biological indicator and associated auto-readers used to monitor the effectiveness of steam sterilization processes in healthcare facilities. It assesses whether sterilization cycles have successfully killed microorganisms, indicating the sterility of medical instruments, rather than diagnosing a patient's condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a plastic vial, spore carrier, media ampoule, color-coded cap, and chemical process indicator for the biological indicator, and a clear plastic shell, foil lid, and chemical integrator for the challenge pack. While software is mentioned for the auto-readers, the core medical device being described includes significant hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, these devices are not In Vitro Diagnostics (IVDs).

Here's why:

Intended Use: The intended use of these devices is to "qualify or monitor" steam sterilization cycles in healthcare facilities. This is a quality control function for a sterilization process, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
Device Description: The device descriptions clearly state that the biological indicators are used to assess the effectiveness of steam sterilization by detecting the presence of viable spores after the sterilization process. The auto-readers are used to incubate and read the results of these biological indicators. This aligns with sterilization monitoring, not in vitro diagnostic testing.
Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition in a patient.

These devices fall under the category of sterilization process indicators, which are used to verify the effectiveness of sterilization equipment and procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

3M™ Attest™ Super Rapid Readout Biological Indicator 1493:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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 Temperature	Exposure Time
Gravity Displacement	250°F (121°C)	30 minutes
Dynamic-air-removal (pre-vacuum and SFPP)	250°F (121°C)	15, 20, 30, or 35 minutes

3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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:

	Exposure	Exposure
Cycle Type	Temperature	Time
Gravity Displacement	250°F (121°C)	30 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 1493 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, and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 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 1493, at 60°C for a final fluorescent result at 24 minutes.

Product codes (comma separated list FDA assigned to the subject device)

FRC

Device Description

The 3MTM Attest™ Super Rapid Readout Biological Indicator (BI) 1493 is a self-contained biological indicator specifically designed for rapid and reliable qualification testing and routine monitoring of 121°C (250°F) dynamic-air-removal and gravity-displacement steam sterilization processes in healthcare facilities. The 1493 BI is used in conjunction with a 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M.

The 1493 BI is a single-use device composed of a plastic vial containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1493 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490 Autoreader, the 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure.

The 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG is specifically designed to qualify and monitor gravity steam sterilization processes at 250°F (121°C) in healthcare facilities.

The 1493PCDG Challenge Pack consists of a clear plastic shell with an opening to the cavity containing the monitoring products, all covered by a foil lid. The 1493PCDG is a single-use device. Each 1493PCDG Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1493 and a 3M™ Attest™ Steam Chemical Integrator (CI) (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Steam Chemical Integrator offers an immediate ACCEPT or REJECT reading. A chemical process indicator is present on the cap of the 1493 BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink to light brown or darker upon exposure to steam. 3M™ Attest™ 1493 BI controls are provided with the Challenge Pack.

The 1493 BI is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization process when used in conjunction with the 3MM Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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 1493 BI in the 490. 490H or 490M Auto-reader indicates a steam sterilization process failure.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biological Indicator
The differences between the submission and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Readout Biological Indicator 1493.

Population: Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were tested for minimum spore Population. Testing was completed per the Guidance for Industry and FDA Staff. Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, and ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements.
Positive Control, D-Value, Z-value, Survival, Kill, and Component Inhibition Studies: Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were tested for Positive Control, D-Value, Z-value, Survival, Kill, and Component Inhibition Studies. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.
Holding Time Assessment: Two lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 was tested for a Holding Time Assessment. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.
Reduced Incubation Time: Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were tested for Reduced Incubation Time. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-8:2021 Sterilization of health care products -Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator.
Simulated Use Testing: Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were evaluated for simulated use testing in the claimed cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007.
Auto-reader Performance: One lot of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were evaluated for performance in the 3MTM Attest™ Auto-reader 490 and 3MTM Attest™ Mini Auto-reader 490M. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, and ISO 11138-1:2017 Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements.

Challenge Pack
The differences between the submission and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG.

Resistance of 1493PCDG Challenge Pack compared to AAMI 16 Towel PCD: Three lots of 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, containing three lots of 1493 BIs and three lots of 1243R Cls, were tested side by side with the AAMI 16 Towel PCD containing 1493 Bls 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.
Resistance of 1493PCDG Challenge Pack compared to standalone indicators: Three lots of 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, containing three lots of 1493 BIs and three lots of 1243R CIs, were tested side by side with standalone indicators 1493 Bls and 1243R Cls. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007.
1493PCDG Peel Force: Three lots of 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG 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.
1493PCDG Peel Force (pre and post sterilization): Three lots of 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG 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.

Key Results: All tests for both the biological indicator and the challenge pack met the acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K213809

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).

Summary

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 25, 2024

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

Re: K242538

Trade/Device Name: 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3MTM Attest™ Auto-reader 490; 3MTM Attest™ Auto-reader 490H; 3MTM Attest™ Mini Autoreader 490M Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: August 26, 2024

Dear Michelle Larsen:

Received: August 26, 2024

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/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.

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 (OS) 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 (QS) 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 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-regulatory

2

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Stephen A. Digitally signed by
Stephen A. Anisko -S
Anisko -S Date: 2024.11.25
11:20:05 -05'00'

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)

K242538

Device Name

3M™ Attest™ Super Rapid Readout Biological Indicator 1493;

3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG;

3M™ Attest™ Auto-reader 490;

3M™ Attest™ Auto-reader 490H;

3M™ Attest™ Mini Auto-reader 490M

Indications for Use (Describe)

3M™ Attest™ Super Rapid Readout Biological Indicator 1493:

Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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
Temperature | Exposure
Time |
|-------------------------------------------|-------------------------|---------------------------|
| Gravity Displacement | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15, 20, 30, or 35 minutes |

3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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:

	Exposure	Exposure
Cycle Type	Temperature	Time
Gravity Displacement	250°F (121°C)	30 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 1493 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, and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 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 1493, 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)

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510(k) Summary for 3MTM Attest™ Super Rapid Readout Biological Indicator 1493, 3MTM Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG. 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M K242538

Sponsor Information:

3M Company 3M Center 2510 Conway Ave., Bldg. 275-5W-06 St. Paul, MN 55144-1000, USA

Contact: Michelle M. Larsen, Principal RA Specialist Phone Number: (651) 467-3991 Fax Number: (651) 737-5320 Email: mmlarsen@solventum.com

Date of Summary: 19 November 2024

K242538

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1. Device Name and Classification:

Common or Usual Name:	Biological Indicator (BI)
Proprietary Name:	3MTM AttestTM Super Rapid Readout Biological Indicator
1493,
	3MTM AttestTM Super Rapid Steam Gravity Clear Challenge
Pack 1493PCDG,
	3MTM AttestTM Auto-reader 490,
	3MTM AttestTM Auto-reader 490H,
	3MTM AttestTM 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:

3M™ Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3M™ Attest™ Auto-reader 490H, and 3MTM Attest™ Mini- Auto-reader 490M, K213809

3. Description of Device:

The 3MTM Attest™ Super Rapid Readout Biological Indicator (BI) 1493 is a self-contained biological indicator specifically designed for rapid and reliable qualification testing and routine monitoring of 121°C (250°F) dynamic-air-removal and gravity-displacement steam sterilization processes in healthcare facilities. The 1493 BI is used in conjunction with a 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M.

The 1493 BI is a single-use device composed of a plastic vial containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1493 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490 Autoreader, the 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure.

7

The 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG is specifically designed to qualify and monitor gravity steam sterilization processes at 250°F (121°C) in healthcare facilities.

The 1493PCDG Challenge Pack consists of a clear plastic shell with an opening to the cavity containing the monitoring products, all covered by a foil lid. The 1493PCDG is a single-use device. Each 1493PCDG Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1493 and a 3M™ Attest™ Steam Chemical Integrator (CI) (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Steam Chemical Integrator offers an immediate ACCEPT or REJECT reading. A chemical process indicator is present on the cap of the 1493 BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink to light brown or darker upon exposure to steam. 3M™ Attest™ 1493 BI controls are provided with the Challenge Pack.

The 1493 BI is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization process when used in conjunction with the 3MM Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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 1493 BI in the 490. 490H or 490M Auto-reader indicates a steam sterilization process failure.

4. Indications for Use

3MTM Attest™ Super Rapid Readout Biological Indicator 1493:

Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3MTM 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 Temperature	Exposure Time
Gravity Displacement	250°F (121°C)	30 minutes
Dynamic-air-removal
(pre-vacuum and SFPP)	250°F (121°C)	15, 20, 30, or 35 minutes

3MTM Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or

8

greater, 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 |
|----------------------|-------------------------|---------------|
| Gravity Displacement | 250°F (121°C) | 30 minutes |

3MTM AttestTM 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 1493 at 60°C for a final fluorescent result at 24 minutes.

3MTM Attest™ Auto-reader 490H:

The 3M™ Attest™ Auto-reader 490H 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 1493 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 1493, at 60°C for a final fluorescent result at 24 minutes.

The submission device, the 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1493, has the same intended use as the predicate device, the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592. Both the submission device and the predicate device are Single Use biological sterilization indicators that are intended to be used in healthcare facilities to accompany products being sterilized and to monitor adequacy of the sterilization process. Both the submission and predicate BIs are intended to be used in conjunction with a 3MTM Attest™ Auto-reader 490, a 3MTM Attest™ Auto-reader 490H, or a 3MTM Attest™ Mini Auto-reader 490M to qualify or monitor gravity displacement and dynamic-air-removal (pre-vacuum and steam-flush pressure-pulse (SFPP)) steam sterilization cycles at 250°F (121°C). The predicate BI covers additional dynamic-air-removal steam sterilization cycles (270°F/132°C, 273°F/134°C and 275°F/135°C) compared to the submission BI. The differences in Indications for Use do not alter the fundamental Intended Use of these products as sterilization process monitors and do not raise new questions of safety and effectiveness.

K242538

9

The submission device, the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, has the same intended use as the predicate device, the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582. 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. Both the submission and predicate challenge packs are intended to be used in conjunction with a 3M™ Attest™ Auto-reader 490, a 3M™ Attest™ Auto-reader 490H, or a 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor gravity displacement steam sterilization cycles at 250°F (121°C). The predicate challenge pack also covers dynamic-air-removal (pre-vacuum and steam-flush pressure-pulse (SFPP)) steam sterilization cycles (250°F/121°C, 270°F/132°C, 273°F/134°C and 275°F/135°C') compared to the submission challenge pack. 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

Biological Indicator

The submission device, 3M™ Attest™ Super Rapid Readout Biological Indicator 1493, is the same design, materials, and construction as the previously cleared predicate device, 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 (cleared per K213809). The only difference is the 1493 BI is claiming use with fewer cycles compared to the 1592 BI. Both the submission device and the predicate device utilize the same spores to accomplish their intended use as biological sterilization indicators. The submission and predicate device are intended to qualify or monitor gravity displacement and dynamic-air-removal (pre-vacuum and steam-flush pressure-pulse (SFPP)) steam sterilization cycles at 250°F (121°C) while the predicate device covers additional dynamic-air-removal steam sterilization cvcles at 270°F (132°C), 273°F (134°C) and 275°F (135°C). The Resistance Characteristics (D-Value, Survival/Kill Window) of the submission device and the predicate device both cover the monitoring of steam sterilization cycles at 250°F (121°C). The predicate device was cleared per K213809 for use with the 3M™ Attest™ Auto-reader 490, the 3MTM Attest™ Autoreader 490H, and the 3M™ Attest™ Mini-Auto-reader 490M. The accessories (Autoreaders) 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.

10

The differences in technological characteristics between the submission and predicate biological indicators are illustrated in the Device Technological Characteristics Comparison Table - Biological Indicator (Table 1).

| Feature | Submission Device:
(K242538)
3MTM AttestTM Super
Rapid Readout
Biological Indicator
1493, 3MTM AttestTM
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device:
(K213809)
3MTM AttestTM Super
Rapid Steam Biological
Indicator 1592, 3MTM
AttestTM Super Rapid
Steam Challenge Pack
51582
and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Comparison |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Single Use sterilization
process indicator | Single Use sterilization
process indicator | Identical |
| Indications for use | Use the 3MTM AttestTM
Super Rapid Readout
Biological Indicator 1493
in conjunction with the
3MTM AttestTM Auto-
reader 490 having
software version 4.0.0 or
greater, the 3MTM
AttestTM Auto-reader
490H having software
version 4.0.0 or greater,
or the 3MTM AttestTM
Mini Auto-reader 490M
to qualify or monitor the
following steam
sterilization cycles:
• Gravity
Displacement, 250°F
(121°C),
30 minutes
and Dynamic-air-removal | Use the 3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592
in conjunction with the
3MTM AttestTM Auto-
reader 490 having
software version 4.0.0 or
greater, the 3MTM
AttestTM Auto-reader
490H having software
version 4.0.0 or greater,
or the 3MTM AttestTM
Mini Auto-reader 490M
to qualify or monitor the
following steam
sterilization cycles:
• Gravity
Displacement, 250°F
(121°C),
30 minutes
and Dynamic-air-removal | Both the predicate
and submission BIs
are indicated for
qualifying and
monitoring gravity
displacement and
dynamic-air-removal
steam sterilization
cycles at 250°F
(121°C). The
predicate BI is
indicated for
qualifying and
monitoring
additional dynamic-
air-removal steam
sterilization cycles
(270°F/132°C,
273°F/134°C and
275°F/135°C). |

		Table 1: Device Technological Characteristics Comparison Table - Biological Indicator

11

| Feature | Submission Device:
(K242538)
3MTM AttestTM Super
Rapid Readout
Biological Indicator
1493, 3MTM AttestTM
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device:
(K213809)
3MTM AttestTM Super
Rapid Steam Biological
Indicator 1592, 3MTM
AttestTM Super Rapid
Steam Challenge Pack
51582
and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Comparison |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (pre-vacuum and
SFPP), 250°F
(121°C),
15, 20, 30, or 35
minutes | (pre-vacuum and
SFPP), 250°F
(121°C),
15, 20, 30, or 35
minutes
• Dynamic-air-removal
(pre-vacuum and
SFPP), 270°F
(132°C),
3, 3.5, 4, 5.5, or 6
minutes
• Dynamic-air-removal
(pre-vacuum and
SFPP), 273°F
(134°C),
3 or 4 minutes
• Dynamic-air-removal
(pre-vacuum and
SFPP), 275°F
(135°C), 3, 3.5, or 10
minutes | Both the predicate
and submission BIs
are intended to be
used in conjunction
with the same auto-
readers. |
| General
Design/Construction | Plastic vial containing a
spore carrier and media
ampoule, enclosed with a
color-coded cap with
chemical process | Plastic vial containing a
spore carrier and media
ampoule, enclosed with a
color-coded cap with
chemical process | Identical |
| Feature | Submission Device:
(K242538)
3MTM AttestTM Super
Rapid Readout
Biological Indicator
1493, 3MTM AttestTM
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device:
(K213809)
3MTM AttestTM Super
Rapid Steam Biological
Indicator 1592, 3MTM
AttestTM Super Rapid
Steam Challenge Pack
51582
and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Comparison |
| | indicator located on top
of cap. | indicator located on top
of cap. | |
| Carrier Material | Plastic | Plastic | Identical |
| Media Ampoule | Crushable glass ampoule
containing a growth
media and a fluorescence
indicator which is
correlated to an optional
use pH indicator. | Crushable glass ampoule
containing a growth
media and a fluorescence
indicator which is
correlated to an optional
use pH indicator. | Identical |
| Chemical indicator | Turns from pink to light
brown or darker upon
steam exposure | Turns from pink to light
brown or darker upon
steam exposure | Identical |
| Indicator Organism | Geobacillus
stearothermophilus
traceable to ATCCTM
7953 | Geobacillus
stearothermophilus
traceable to ATCCTM
7953 | Identical |
| Viable spore
population | ≥ 1 x 106 | ≥ 1 x 106 | Identical |
| Mechanism of Action | When the enzyme that is
naturally occurring in the
spore is in its active state,
it is detected by
measuring the
fluorescence produced by
the enzymatic hydrolysis
of a non-fluorescent
substrate. The resultant
fluorescent by-product is
detected by the Auto- | When the enzyme that is
naturally occurring in the
spore is in its active state,
it is detected by
measuring the
fluorescence produced by
the enzymatic hydrolysis
of a non-fluorescent
substrate. The resultant
fluorescent by-product is
detected by the Auto- | Identical |
| Feature | Submission Device:
(K242538)
3MTM AttestTM Super
Rapid Readout
Biological Indicator
1493, 3MTM AttestTM
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device:
(K213809)
3MTM AttestTM Super
Rapid Steam Biological
Indicator 1592, 3MTM
AttestTM Super Rapid
Steam Challenge Pack
51582
and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Comparison |
| | fluorescence upon
incubation in the Auto-
reader indicates a
sterilization process
failure. | fluorescence upon
incubation in the Auto-
reader indicates a
sterilization process
failure. | |
| • D-value | D-Value ≥ 1.5 min at
121°C | D-Value ≥ 1.5 min at
121°C
D-value ≥ 10 seconds at
132°C
D-value ≥ 8 seconds at
134°C, 135°C | Both the predicate
and submission BIs
are indicated for
qualifying and
monitoring gravity
displacement and
dynamic-air-removal
steam sterilization
cycles at 250°F
(121°C). The
predicate BI is
indicated for
qualifying and
monitoring
additional dynamic-
air-removal steam
sterilization cycles
(270°F/132°C,
273°F/134°C and
275°F/135°C). |
| Survival Time | Meets the longer of FDA
and ISO 11138-1 and ISO
11138-3 requirements | Meets the longer of FDA
and ISO 11138-1 and ISO
11138-3 requirements | Identical |
| Kill Time | Meets the ISO 11138-1 and
ISO 11138-3 requirements | Meets the ISO 11138-1 and
ISO 11138-3 requirements | Identical |
| Feature | Submission Device:
(K242538)
3MTM AttestTM Super
Rapid Readout
Biological Indicator
1493, 3MTM AttestTM
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device:
(K213809)
3MTM AttestTM Super
Rapid Steam Biological
Indicator 1592, 3MTM
AttestTM Super Rapid
Steam Challenge Pack
51582
and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Comparison |
| Incubation temperature | 60 $\pm$ 2°C | 60 $\pm$ 2°C | Identical |
| Readout time | 24 minute final
fluorescent result in:
The 490 Auto-reader
having software
version 4.0.0 or
greater or The 490H Auto-
reader having
software version
4.0.0 or greater or The 490M Mini
Auto-reader
Optional visual pH color
change result in 7 days. | 24 minute final
fluorescent result in:
The 490 Auto-reader
having software
version 4.0.0 or
greater or The 490H Auto-
reader having
software version
4.0.0 or greater or The 490M Mini
Auto-reader
Optional visual pH color
change result in 7 days. | Identical |
| Shelf Life | 24 months | 24 months | Identical |
| Accessories
(Auto-readers) | 3MTM AttestTM Auto-
reader 490 having
software version 4.0.0 or
greater, 3MTM AttestTM
Auto-reader, or 490H
having software version
4.0.0 or greater, or 3MTM
AttestTM Mini Auto-
reader 490M | 3MTM AttestTM Auto-
reader 490 having
software version 4.0.0 or
greater, 3MTM AttestTM
Auto-reader, or 490H
having software version
4.0.0 or greater, or 3MTM
AttestTM Mini Auto-
reader 490M | Identical |

12

13

14

15

Challenge Pack

The submission device, the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, consists of a clear plastic shell with a cavity opening in the shell to the monitoring products, all heat sealed with a foil lid. The predicate device, the 3MIM Attest™ Super Rapid Steam Challenge Pack 51582, consists of layers of medical index cards, some of which are die-cut to contain indicators, overwrapped and secured with a label. Both the submission and predicate device are designed to increase the resistance beyond that measured with a standalone biological indicator and both represent a challenge to the sterilization process equivalent to the AAMI reference PCD. The predicate device utilizes the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 that was cleared per K213809. The submission device utilizes the 3M™ Attest Super Rapid Readout Biological Indicator 1493 which is the subject biological indicator of this submission. The submission BI (1493) is the same design, materials, and construction as the previously cleared predicate BI (1592). The only difference is the 1493 BI is claiming use with fewer cycles compared to the 1592 BI. Both the submission and predicate device utilize the same Chemical Integrator (CI), the 3M™ Attest™ Steam Chemical Integrator (cleared per K220942). The process indicator dot on the predicate device is present on the outer label of the overwrapped device whereas the process indicator on the submission device is present on the cap of the 1493 BI which is visible through the clear challenge pack. Both the submission and predicate device 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 packs are illustrated in the Device Technological Characteristics Comparison Table - Challenge Pack (Table 2).

16

| Feature | Submission Device:
(242538)
3M™ Attest™ Super
Rapid Readout
Biological Indicator
1493, 3M™ Attest™
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Predicate Device:
(K213809)
3M™ Attest™ Super
Rapid Steam Biological
Indicator 1592, 3M™
Attest™ Super Rapid
Steam Challenge Pack
51582
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Comparison | |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use | Single Use biological
indicator process
challenge device | Single Use biological
indicator process
challenge device | Identical | |
| Indications for use | Use the 3M™ Attest™
Super Rapid Steam
Gravity Clear Challenge
Pack 1493PCDG in
conjunction with the
3M™ Attest™ Auto-
reader 490 having
software version 4.0.0 or
greater, 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:
• Gravity
Displacement, 250°F
(121°C),
30 minutes | Use the 3M™ Attest™
Super Rapid Steam
Challenge Pack 51582 in
conjunction with the
3M™ Attest™ Auto-
reader 490 having
software version 4.0.0 or
greater, 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:
• Gravity
Displacement, 250°F
(121°C),
30 minutes
• Dynamic-air-removal
(pre-vacuum and
SFPP),
250°F (121°C),
30 minutes | Both the submission
and predicate
challenge packs are
indicated for
qualifying and
monitoring gravity
displacement steam
sterilization cycles at
250°F (121°C). The
predicate challenge
pack is also
indicated for
qualifying and
monitoring dynamic-
air-removal steam
sterilization cycles
(250°F/121°C,
270°F/132°C,
273°F/134°C, and
275°F/135°C).
The submission BI
(1493) that is
contained in the
submission PCD is | |
| Feature | Submission Device:
(242538)

3M™ Attest™ Super
Rapid Readout
Biological Indicator
1493, 3M™ Attest™
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Predicate Device:
(K213809)

3M™ Attest™ Super
Rapid Steam Biological
Indicator 1592, 3M™
Attest™ Super Rapid
Steam Challenge Pack
51582
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Comparison | |
| | | 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 | the same design,
materials, and
construction as the
predicate BI (1592)
that is contained in
the predicate PCD
(51582). Both the
predicate and
submission BIs are
indicated for
qualifying and
monitoring gravity
displacement and
dynamic-air-removal
steam sterilization
cycles at 250°F
(121°C). The
predicate BI is
indicated for
qualifying and
monitoring
additional dynamic-
air-removal steam
sterilization cycles
(270°F/132°C,
273°F/134°C and
275°F/135°C).

Both the submission
and predicate | |
| Feature | Submission Device:
(242538)
3M™ Attest™ Super
Rapid Readout
Biological Indicator
1493, 3M™ Attest™
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Predicate Device:
(K213809)
3M™ Attest™ Super
Rapid Steam Biological
Indicator 1592, 3M™
Attest™ Super Rapid
Steam Challenge Pack
51582
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Comparison | |
| | | | challenge packs
utilize the same
Chemical Integrator
(CI). The 1243R CI
is indicated for use
in 250°F (121°C)
gravity and 250°F
(121°C), 270°F
(132°C), 273°F
(134°C) and 275°F
(135°C) dynamic-
air-removal steam
sterilization cycles
(per K220942).
Both the predicate
and submission
challenge packs are
intended to be used
in conjunction with
the same auto-
readers. | |
| General
Design/Construction | Clear plastic tray with a
cavity opening in the
shell to the indicators,
acting as a challenge to
limit air removal and
steam penetration, sealed
with a foil lid. | Layers of medical index
cards, some of which are
die-cut to contain
indicators, overwrapped
and secured with a label. | Both the submission
and predicate
challenge packs are
designed to increase
resistance beyond
that measured with a
standalone BI and
both represent a | |
| Feature | Submission Device:
(242538)
3M™ Attest™ Super
Rapid Readout
Biological Indicator
1493, 3M™ Attest™
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Predicate Device:
(K213809)
3M™ Attest™ Super
Rapid Steam Biological
Indicator 1592, 3M™
Attest™ Super Rapid
Steam Challenge Pack
51582
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Comparison | |
| | | | challenge to the
sterilization process
equivalent to the
AAMI reference
PCD. | |
| Biological Indicator | 3M™ Attest™ Super
Rapid Readout Biological
Indicator 1493 | 3M™ Attest™ Super
Rapid Steam Biological
Indicator 1592 | The predicate BI and
the submission BI
are the same design,
materials, and
construction. | |
| Biological Indicator
Incubation
temperature | 60 ± 2°C | 60 ± 2°C | Identical | |
| Biological Indicator
Readout time | 24 minute final
fluorescent result in:
• The 490 Auto-reader
having software
version 4.0.0 or
greater
or
• The 490H Auto-
reader having
software version
4.0.0 or greater
or
• The 490M Mini
Auto-reader | 24 minute final
fluorescent result in:
• The 490 Auto-reader
having software
version 4.0.0 or
greater
or
• The 490H Auto-
reader having
software version
4.0.0 or greater
or
• The 490M Mini
Auto-reader | Identical | |
| Chemical Integrator | 3M™ Attest™ Steam
Chemical Integrator | 3M™ Attest™ Steam
Chemical Integrator | Identical | |
| Feature | Submission Device:
(242538)
3MTM Attest™ Super
Rapid Readout
Biological Indicator
1493, 3MTM Attest™
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Predicate Device:
(K213809)
3MTM Attest™ Super
Rapid Steam Biological
Indicator 1592, 3MTM
Attest™ Super Rapid
Steam Challenge Pack
51582
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3MTM Attest™
Mini Auto-reader 490M | Comparison | |
| Chemical Integrator
Endpoint
Specifications
(Minimum Stated
Values) | 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 | 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 | Identical | |
| Chemical Integrator
Color Change | Dark color migrates
along strip visible
through a green window
(ACCEPT) or red
window (REJECT) | Dark color migrates
along strip visible
through a green window
(ACCEPT) or red
window (REJECT) | Identical | |
| Mechanism to
distinguish processed
and unprocessed
challenge pack | Process indicator present
on 1493 BI cap is visible
through PCD and turns
color from pink to light
brown or darker upon
steam exposure. | External Chemical
Process Indicator turns
from yellow to brown or
darker upon steam
exposure. | Both the submission
and predicate
challenge pack
contain a process
indicator that
changes color upon
steam exposure that
is used by the
customer to verify
that the challenge
pack was exposed to
steam. | |
| Resistance
Comparison to the
AAMI ST79 16 Towel
PCD | Equivalent in resistance
to the AAMI ST79 16
Towel PCD | Equivalent in resistance
to the AAMI ST79 16
Towel PCD | Identical | |
| Shelf Life | 24 months | 24 months | Identical | |
| Feature | Submission Device:
(242538)
3M™ Attest™ Super
Rapid Readout
Biological Indicator
1493, 3M™ Attest™
Super Rapid Steam
Gravity Clear
Challenge Pack
1493PCDG
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Predicate Device:
(K213809)
3M™ Attest™ Super
Rapid Steam Biological
Indicator 1592, 3M™
Attest™ Super Rapid
Steam Challenge Pack
51582
and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Comparison | |
| Accessories
(Auto-readers) | 3M™ Attest™ Auto-
reader 490 having
software version 4.0.0 or
greater, 3M™ Attest™
Auto-reader, or 490H
having software version
4.0.0 or greater, or 3M™
Attest™ Mini Auto-
reader 490M | 3M™ Attest™ Auto-
reader 490 having
software version 4.0.0 or
greater, 3M™ Attest™
Auto-reader, or 490H
having software version
4.0.0 or greater, or 3M™
Attest™ Mini Auto-
reader 490M | Identical | |

Table 2: Device Technological Characteristics Comparison Table – Challenge Pack

17

18

19

20

21

6. Nonclinical Comparison to the Predicate Device

Biological Indicator

The differences between the submission and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Readout Biological Indicator 1493.

Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were tested for minimum spore Population. Testing was completed per the Guidance for Industry and FDA Staff. Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, and ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements.

Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were tested for Positive Control, D-Value, Z-value, Survival, Kill, and Component Inhibition Studies. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements,

22

and ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.

Two lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 was tested for a Holding Time Assessment. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.

Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were tested for Reduced Incubation Time. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-8:2021 Sterilization of health care products -Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator.

Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were evaluated for simulated use testing in the claimed cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007.

One lot of 3M™ Attest™ Super Rapid Readout Biological Indicators 1493 were evaluated for performance in the 3MTM Attest™ Auto-reader 490 and 3MTM Attest™ Mini Auto-reader 490M. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, and ISO 11138-1:2017 Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements.

| Test
Performed | Device
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
|-----------------------------------------------------------------|-----------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Population | 1493 BI | FDA Guidance1,
ISO 11138-1:20172 | To evaluate the
total viable
spore count | $\geq$ 106 spores | Acceptance
criteria met |
| Positive
Control Test | 1493 BI | FDA Guidance1,
ISO 11138-1:20172
and ISO 11138-
3:20173 | To evaluate
performance of
BI without
steam exposure | All BIs must be
fluorescent
positive at 24
minutes and
visual pH color
change positive
(yellow) at 168
hours | Acceptance
criteria met |
| Test
Performed | Device
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
| D-value for
121°C
(250°F)
cycles | 1493 BI | FDA Guidance¹,
ISO 11138-1:2017²
and ISO 11138-
3:2017³ | To evaluate the
resistance
characteristics
of the BI | D-value must
be ≥ 1.5
minutes | Acceptance
criteria met |
| Z-value for
121°C
(250°F)
cycles | 1493 BI | FDA Guidance¹,
ISO 11138-1:2017²
and ISO 11138-
3:2017³ | | Z-value must be
≥ 10°C | Acceptance
criteria met |
| Survival for
121C°
(250°F)
cycles | 1493 BI | FDA Guidance¹,
ISO 11138-1:2017²
and ISO 11138-
3:2017³ | To evaluate the
resistance
characteristics
of the BI | Meets the
requirements
for Calculated
survival time*
or 5 minutes,
whichever is
longer

ISO 11138-
1:2017 | Acceptance
criteria met |
| Kill for
121C°
(250°F)
cycles | 1493 BI | FDA Guidance¹,
ISO 11138-1:2017²
and ISO 11138-
3:2017³ | | Meets the
requirements
for Calculated
kill time*
ISO 11138-
1:2017 | Acceptance
criteria met |
| Component
Inhibition
Studies | 1493 BI | FDA Guidance¹,
ISO 11138-1:2017²
and ISO 11138-
3:2017³ | To evaluate the
effects of
carrier and
packaging
materials on the
resistance
characteristics
of the BI | Components
have no impact
on the recovery
of 10-100
organisms | Acceptance
criteria met |
| Holding
Time
Assessment
for 121°C
(250°F)
cycles | 1493 BI | FDA Guidance¹,
ISO 11138-1:2017²
and ISO 11138-
3:2017³ | To evaluate the
effect of the
labeled holding
time on the D-
value | D-value must
be within +/-
20% of the
initial D-value
calculated per
ISO 11138-
1:2017 | Acceptance
criteria met |
| Reduced
Incubation
Time for
121°C
(250°F)
cycles | 1493 BI | FDA Guidance¹,
ISO 11138-1:2017²
and ISO 11138-
8:2021⁴ | To validate the
reduction in
incubation time
from 7 days
(visual color
change) to 24
minutes
(fluorescent
readout) | Meets FDA's
requirements
for Reduced
Incubation
Time with ≥
97% alignment
with the
conventional
incubation time | Acceptance
criteria met |
| Test
Performed | Device
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
| Attest 1493
Simulated
Use | 1493 BI | FDA Guidance1 | Verification of
performance in
claimed cycles | the following
readout times:
• Fluorescent
result in 24
minutes | Acceptance
criteria met |
| 490 and
490M Auto-
reader
Performance | 1493 BI | FDA Guidance1,
ISO 11138-1:20172 | Verify
equivalent
performance of
the 1493BI
with the 3MTM
Attest 490 and
490M Auto-
readers | BIs must be
fluorescent
positive in 24
minutes and
visual pH color
change
(growth)
positive at 168
hours | Acceptance
criteria met |

Performance of the 1493 Biological Indicator (BI) was verified through the following tests:

23

24

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

2 ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General Requirements

3 ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

4 ISO 11138-8:2021 Sterilization of health care products – Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator

Challenge Pack

The differences between the submission and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG.

Three lots of 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, containing three lots of 1493 BIs and three lots of 1243R Cls, were tested side by side with the AAMI 16 Towel PCD containing 1493 Bls 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 Gravity Clear Challenge Pack 1493PCDG, containing three lots of 1493 BIs and three lots of 1243R CIs, were tested side by side with standalone indicators 1493 Bls and 1243R Cls. 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 Gravity Clear Challenge Pack 1493PCDG 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

25

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 Gravity Clear Challenge Pack 1493PCDG 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	Device	Applicable	Acceptance
Performed	Description	Standards	Criteria
Resistance
of
1493PCDG
Challenge
Pack
compared to
AAMI 16
Towel PCD
in claimed
cycle	1493PCDG
Challenge Pack	FDA Guidance1 and
ANSI/AAMI
ST79:2017,
Comprehensive
guide to steam
sterilization and
sterility assurance in
health care facilities	Demonstrate
the performance
of the
1493PCDG
Challenge Pack
is equivalent to
the performance
of the AAMI 16
Towel PCD in
the claimed
cycle	Indicators
contained in the
1493PCDG
Challenge Pack
must
demonstrate
equivalent
resistance as
compared to the
indicators
contained in the
AAMI 16
Towel PCD in
the claimed
cycle	Acceptance
criteria met
Resistance
of
1493PCDG
Challenge
Pack
compared to
standalone
indicators in
claimed
cycle	1493PCDG
Challenge Pack	FDA Guidance1	Demonstrate
the 1493PCDG
Challenge Pack
provides a
greater
challenge than
the standalone
indicators in the
claimed cycle	Indicators
contained in the
1493PCDG
Challenge Pack
must
demonstrate
greater
resistance
compared to the
standalone
indicators in the
claimed cycle	Acceptance
criteria met
1493PCDG
Peel Force	1493PCDG
Challenge Pack	ASTM F88 / F88M-
15: Standard Test
Method for Seal
Strength of Flexible
Barrier and ASTM
F2824 - 10:
Standard Test
Method for	Demonstrate
acceptable peel
force of Clear
Challenge Pack
1493PCDG
heat seal foil lid
from plastic
shell	≥2.75lbF and
≤10lbF	Acceptance
criteria met

Performance of the 1493PCDG challenge pack was verified through the following tests:

26

| Test
Performed | Device
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
|------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------------|
| | | Mechanical Seal
Strength Testing for
Round Cups and
Bowl Containers
with Flexible
Peelable Lids | | | |
| 1493PCDG
Peel Force | 1493PCDG
Challenge Pack | 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 | Demonstrate
acceptable peel
force of Clear
Challenge Pack
1493PCDG
heat seal foil lid
from plastic
shell, pre and
post
sterilization | ≥2.75lbF and
≤10lbF | Acceptance
criteria met |

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

27

7. Clinical Comparison to the Predicate Device

Clinical testing was not required or completed for the submission biological indicator or submission challenge pack.

8. Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the submission device, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493, the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, the 3MTM Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H, and the 3MTM Attest™ Mini Auto-reader 490M, is as safe, as effective and performs as well or better than the legally marketed predicate device, the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, the 3MTM Attest™ Autoreader 490, the 3M™ Attest™ Auto-reader 490H, and the 3MTM Attest™ Mini Auto-reader 490M (cleared per K213809) Class II (21 CFR 880.2800), product code FRC.