(77 days)
No
The summary describes a biological indicator and auto-readers that detect fluorescence. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is designed to qualify and monitor steam sterilization processes in healthcare facilities, not to provide therapy to patients.
No
Explanation: The device is used to qualify or monitor steam sterilization cycles by detecting process failures, not to diagnose medical conditions in patients. It assesses the effectiveness of a sterilization process.
No
The device description clearly details physical components like a plastic shell, tortuous channel, cavity, foil lid, biological indicator, and chemical integrator. While it interacts with auto-readers that have software, the device itself is a physical challenge pack.
Based on the provided information, the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE and its associated auto-readers are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is to "qualify or monitor" steam sterilization cycles in healthcare facilities. This is a quality control process for sterilization equipment, not a diagnostic test performed on biological samples from a patient.
- Device Description: The device contains a biological indicator (BI) and a chemical integrator (CI) to assess the effectiveness of a sterilization process. The auto-readers incubate and read the BI to determine if viable spores remain after sterilization. This is a test of the sterilization process itself, not a test on a patient sample.
- Lack of IVD Characteristics: The description does not mention analyzing human biological specimens (blood, urine, tissue, etc.) for the purpose of diagnosing disease or other conditions.
Therefore, these devices fall under the category of sterilization process indicators or quality control devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE: Use the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE in conjunction with the 3M™ Attest™ Auto-reader 490, the 3MM 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 cycle:
Cycle Type: Dynamic-air-removal, Exposure Temperature: 270°F (132°C), Exposure Time: 10 minutes
3MTM AttestTM Auto-reader 490:
The 3MTMAttest™ 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 AttestTM 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, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes.
3MTM AttestTM Mini Auto-reader 490M:
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MTM 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 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE is designed to qualify and monitor extended dynamic-air-removal steam sterilization processes at 270°F (132°C) in healthcare facilities.
The 1492PCDE Challenge Pack consists of a clear plastic shell, with 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 1492PCDE is a single-use device.
Each 1492PCDE 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 3MTM 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 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.
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)
Nonclinical Comparison to the Predicate Device
The differences between the submission and predicate device have been evaluated through performance tests for the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE.
Three lots of 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, containing three lots of 1492V BIs and three lots of 1243R CIs, 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 Extended Cycle Clear Challenge Pack 1492PCDE, 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 Extended Cycle Clear Challenge Pack 1492PCDE 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.
Performance of the 1492PCDE challenge pack was verified through the following tests:
-
Test Performed: Resistance of 1492PCDE Challenge Pack compared to AAMI 16 Towel PCD in claimed cycles
- Device Description: 1492PCDE Challenge Pack
- Applicable Standards: FDA Guidance and ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- Purpose: Demonstrate the performance of the 1492PCDE Challenge Pack is equivalent to the performance of the AAMI 16 Towel PCD in the claimed cycles
- Acceptance Criteria: Indicators contained in the 1492PCDE Challenge Pack must demonstrate equivalent resistance as compared to the indicators contained in the AAMI 16 Towel PCD in the claimed cycles
- Results: Acceptance criteria met
-
Test Performed: Resistance of 1492PCDE Challenge Pack compared to standalone indicators in claimed cycles
- Device Description: 1492PCDE Challenge Pack
- Applicable Standards: FDA Guidance
- Purpose: Demonstrate the 1492PCDE Challenge Pack provides a greater challenge than the standalone indicators in the claimed cycles
- Acceptance Criteria: Indicators contained in the 1492PCDE Challenge Pack must demonstrate greater resistance compared to the standalone indicators in the claimed cycles
- Results: Acceptance criteria met
-
Test Performed: 1492PCDE Peel Force
- Device Description: 1492PCDE Challenge Pack
- Applicable Standards: 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
- Purpose: Demonstrate acceptable peel force of Clear Challenge Pack 1492PCDE heat seal foil lid from plastic shell
- Acceptance Criteria: >=30.2 lbf
- Results: Acceptance criteria met
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 28, 2025
3M Company Michelle Larsen Principal RA Specialist 3M Center 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144
Re: K243501
Trade/Device Name: 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ 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: November 11, 2024 Received: November 12, 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/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 Anisko -S
Digitally signed by Ste Date: 2025.01.28 14:11:26
for: Christopher K. 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
510(k) Number (if known) K243501
Device Name
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE: 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 Extended Cycle Clear Challenge Pack 1492PCDE: Use the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE in conjunction with the 3M™ Attest™ Auto-reader 490, the 3MM 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 cycle:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal | 270°F (132°C) | 10 minutes |
3MTM AttestTM Auto-reader 490:
The 3MTMAttest™ 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 AttestTM 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, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes.
3MTM AttestTM Mini Auto-reader 490M:
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MTM 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image shows the 3M logo. The logo is red and consists of the number "3" and the letter "M" in a bold, sans-serif font. The number "3" is on the left, and the letter "M" is on the right.
510(k) Summary for 3MTM Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M K243501
Sponsor Information:
3M Company 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Michelle M. Larsen Principal RA Specialist Phone Number: (651) 394-8173 Fax Number: (651) 737-5320 Email: mmlarsen@solventum.com
Date of Summary: 14 January 2025
1. Device Name and Classification:
Common or Usual Name: Biological Indicator (BI) Challenge Pack
5
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 3MTM Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
| Proprietary Name: | 3MTM AttestTM Super Rapid Steam Extended Cycle Clear
Challenge Pack 1492PCDE,
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:
VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly, K182931
3. Description of Device:
The 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE is designed to qualify and monitor extended dynamic-air-removal steam sterilization processes at 270°F (132°C) in healthcare facilities.
The 1492PCDE Challenge Pack consists of a clear plastic shell, with 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 1492PCDE is a single-use device.
Each 1492PCDE 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 3MTM 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 Extended Cycle Clear Challenge Pack 1492PCDE: Use the 3MTM Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 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 3MTM Attest™ Mini Autoreader 490M to qualify or monitor the following steam sterilization cycle:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal | 270°F (132°C) | 10 minutes |
3MTM AttestTM Auto-reader 490:
The 3MTMAttest™ 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 luorescent result at 24 minutes.
3MTM AttestTM Auto-reader 490H:
The 3MTM Attest™ Auto-reader 490H is designed to incubate and automatically read 3MTM Attest™ Rapid Readout Biological Indicators 1295. 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™ Mini Auto-reader 490M:
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MTM 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 luorescent result at 24 minutes.
he submission device, the 3MTM Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, has the same intended use as the predicate device, the VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity™ Xtend 10 Assembly. Both he submission device and the predicate device are Single Use biological indicator process allenge devices that are intended to be used in healthcare facilities to accompany products being sterilized and to monitor adequacy of the sterilization process.
oth the submission and the predicate challenge packs are indicated to monitor 10-minute 270°F (132°C) dynamic-air-removal steam sterilization cycles. The submission challenge back is intended to be used in conjunction with the 3M™ Attest™ Auto-readers 490 and 0H, and 3M™ Attest™ Mini Auto-reader 490M. The 1492V Biological Indicator that is tained in the submission challenge pack was cleared for use with the Auto-readers per
7
K241710. 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
The submission 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. The predicate challenge pack consists of a reusable aluminum tube with a removable aluminum plug to allow loading of a single use assembly, containing the indicators, and a tortuous path challenge for air removal and steam penetration at the other sealed end. Both the submission and predicate challenge pack 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. Both the submission challenge pack and the predicate challenge pack contain a Biological Indicator (BI) that has been verified to qualify or monitor dynamic-air-removal steam sterilization cycles and both utilize a fluorescent result to indicate a steam sterilization process failure. Both the submission challenge pack and the predicate challenge pack contain a Chemical Indicator (CT) that are able to independently monitor and react to all critical parameters of the intended steam sterilization cycles. The process indicator present on the cap of the BI is visible through the clear plastic shell of the submission challenge pack whereas the chemical indicator is visible through the clear plastic sleeve assembly of the predicate challenge pack. Both the submission and predicate challenge pack contain a visible indicator that changes color upon steam exposure that is used by the customer to distinguish processed and unprocessed challenge packs. Both the submission challenge pack and the predicate challenge pack utilize a Biological Indicator which is intended to be used in conjunction with an incubator/reader to indicate a steam sterilization process failure.
The differences in technological characteristics between the submission and predicate challenge pack are illustrated in the Device Technological Characteristics Comparison Table (Table 1).
8
| Feature | Submission Device:
(K243501)
3MTM AttestTM
Super Rapid Steam
Extended Cycle Clear
Challenge Pack
1492PCDE and
3MTM AttestTM Auto-
reader 490 and 490H and
3MTM AttestTM Mini
Auto-reader 490M | Predicate Device:
(K182931)
VERIFY All-In-One
STEAM Reusable Test
Pack employing the
Celerity™ Xtend 10
Assembly | Comparison |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Single Use biological
indicator process challenge
device | Single Use biological
indicator process challenge
device | Identical |
| Indications for use | Use the 3MTM AttestTM
Super Rapid Steam
Extended Cycle Clear
Challenge Pack
1492PCDE in conjunction
with the 3MTM AttestTM
Auto-reader 490, 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 cycle:
• Dynamic-air-
removal, 270°F
(132°C), 10
minutes | The VERIFY All-In-One
STEAM Reusable Test
Pack employing the
Celerity Xtend 10
Assembly with a Celerity
20 STEAM Biological
Indicator and a Celerity 10
STEAM Chemical
Indicator can be used for
routine monitoring of 10-
minute 270°F/132°C
dynamic air removal steam
sterilization cycles. The
sleeve assembly is intended
to be used only with the
VERIFY All-In-One
STEAM Reusable Test
Pack. | The Indications for Use are
similar in that the subject
device and predicate device
are used to monitor 10-
minute 270°F/132°C
dynamic-air-removal steam
sterilization cycles.
The subject challenge pack
is intended to be used in
conjunction with the 3MTM
AttestTM Auto-readers 490
and 490H and the 3MTM
AttestTM Mini Auto-reader
490M. The 1492V BI
contained in the subject
challenge pack was cleared
for use with the Auto-
readers per K241710. |
| General
Design/Construction | Clear plastic tray with a
tortuous channel to the
cavity containing the
indicators, acting as a
challenge to limit air
removal and steam
penetration, sealed with a
foil lid. | The VERIFY All-in-One
STEAM Reusable Test
Pack consists of a reusable
aluminum tube with a
removable aluminum plug
to allow loading of the
Celerity Xtend 10
Assembly, containing the
indicators, and a tortuous
path challenge for air
removal and steam
penetration at the other
sealed end. | Both the subject challenge
pack and the predicate
challenge pack consist of a
BI and CI and are designed
and constructed with a
tortuous path to challenge
air removal and steam
penetration.
The subject challenge pack
is a single-use test pack. |
| Biological Indicator | 3MTM AttestTM Super
Rapid Readout Biological
Indicator 1492V with ≥ 1 | Celerity 20 STEAM
Biological Indicator with
1.0 – 4.0 x 106 Geobacillus
stearothermophilus spores | Both the subject device and
the predicate device utilize
Self-Contained Biological
Indicators with ≥106 |
| Feature | Submission Device:
(K243501)
3MTM AttestTM
Super Rapid Steam
Extended Cycle Clear
Challenge Pack
1492PCDE and
3MTM AttestTM Auto-
reader 490 and 490H and
3MTM AttestTM Mini
Auto-reader 490M | Predicate Device:
(K182931)
VERIFY All-In-One
STEAM Reusable Test
Pack employing the
CelerityTM Xtend 10
Assembly | Comparison |
| | x 106 Geobacillus
stearothermophilus spores | | Geobacillus
stearothermophilus spores |
| Biological Indicator -
Resistance
Characteristics
• D value | D-value ≥ 10 seconds at
132°C
D-value ≥ 8 seconds at
134°C
D-value ≥ 8 seconds at
135°C | D121≥ 1.5 min
D132 ≥ 10s
D135 ≥ 8s | Similar, both BIs are
characterized with
Resistance Characteristics
(D-value and Survival/Kill)
that meet FDA and ISO
requirements. |
| Biological Indicator -
Resistance
Characteristics
• Survival/Kill | Survival Time =
Calculated survival time*
or 1 minute at 132°C and
40 seconds at 134°C and
135°C, whichever is
longer
Kill Time = Calculated kill
time* at 132°C, 134°C and
at 135°C | Survival Time – Meets the
longer of FDA and ISO
11138-3 requirements
Kill Time – Meets the
shorter of FDA and ISO
11138-3 requirements | |
| Biological Indicator
Incubation
temperature | 60 ± 2°C | 55-60°C | Similar, both the subject
device and the predicate
device contain a BI that has |
| Biological Indicator -
Readout time | 24 minute final fluorescent
result in both the 490 and
490H Auto-readers having
software version 4.0.0 or
greater or in a 490M Auto-
reader.
1 hour final fluorescent
result in 490 Auto-readers
having software versions
less than 4.0.0.
Optional visual pH color
change result in 48 hours
for 490, 490H or 490M
Auto-readers. | 20 minute final fluorescent
result in CelerityTM Steam
Incubator. | been verified to qualify or
monitor dynamic-air-
removal steam sterilization
cycles.
The subject device has
different readout times than
the predicate device. |
| Feature | Submission Device:
(K243501)
3MTM Attest™
Super Rapid Steam
Extended Cycle Clear
Challenge Pack
1492PCDE and
3MTM Attest™ Auto-reader 490 and 490H and
3MTM Attest™ Mini Auto-reader 490M | Predicate Device:
(K182931)
VERIFY All-In-One
STEAM Reusable Test
Pack employing the
Celerity™ Xtend 10
Assembly | Comparison |
| Biological Indicator - 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-reader. The presence of fluorescence upon incubation in the Auto-reader indicates a sterilization process failure. There is an optional visual pH color change which indicates a steam sterilization process failure. | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety | Similar, both the subject device and the predicate device utilize a fluorescent result. The subject device also utilizes an optional visual pH color change. |
| Chemical Indicator | 3MTM Attest™ Steam Chemical Integrator | Celerity 10 STEAM Chemical Indicator | The chemical indicators in the subject challenge pack |
| Chemical Indicator - Color Change | Dark color migrates along strip visible through a green window (ACCEPT) or red window (REJECT) | The Celerity 10 STEAM Chemical Indicator indicates a pass by a color change of yellow to blue/purple or a fail indicated by no color change or an incomplete color change. | and predicate challenge pack are able to independently monitor and react to all critical parameters of the intended sterilization cycle.
The CI in the subject device is a Type 5 moving front integrator whereas the CI in the predicate device is a Type 6 emulating indicator. |
| 3M™ Attest™ Mini Auto-reader 490M | | | |
| | Submission Device:
(K243501) | Predicate Device:
(K182931) | |
| Feature | 3M™ Attest™
Super Rapid Steam
Extended Cycle Clear
Challenge Pack
1492PCDE and
3M™ Attest™ Auto-
reader 490 and 490H and
3M™ Attest™ Mini
Auto-reader 490M | VERIFY All-In-One
STEAM Reusable Test
Pack employing the
Celerity™ Xtend 10
Assembly | Comparison |
| Mechanism to
distinguish processed and
unprocessed challenge
pack | Process indicator present
on 1492V BI cap is
visible through PCD and
turns color from pink to
light brown or darker
upon steam exposure. | The Celerity 10 STEAM
Chemical Indicator can be
evaluated for a pass or fail
prior to opening the assembly.
A change in color from
yellow to blue/purple
indicates a pass. | Both the subject and
predicate device contain an
indicator that changes color
upon exposure to steam that
is used by the customer to
verify the challenge pack
was exposed to steam. |
| Accessories | 3M™ Attest™ Auto-
reader 490 or the
3M™Attest™ Auto-
reader 490H or the 3M™
Attest™ Mini Auto-reader | Celerity STEAM
Incubator/reader | Similar, both the subject
device and the predicate
device utilize a BI which is
intended to be used in
conjunction with an
incubator/reader |
Table 1: Device Technological Characteristics Comparison Table
9
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 3M™ Attest™ Auto-readers 490 and 490H
3MTM Attest™ Mini Auto-reader 490M
10
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
11
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
- per ISO 11138-1:2017, Annex E
12
6. Nonclinical Comparison to the Predicate Device
The differences between the submission and predicate device have been evaluated through performance tests for the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE.
Three lots of 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, 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 Extended Cycle Clear Challenge Pack 1492PCDE, containing three lots of 1492V BIs and three lots of 1243R Cls, were tested side by side with the AAMI 16 Towel PCD containing 1492V BIs 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, 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 Extended Cycle Clear Challenge Pack 1492PCDE 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.
| Test
Performed | Device
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
|---------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Resistance of
1492PCDE
Challenge
Pack
compared to
AAMI 16
Towel PCD
in claimed
cycles | 1492PCDE
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
1492PCDE
Challenge
Pack is
equivalent to
the
performance
of the AAMI
16 Towel PCD
in the claimed
cycles | Indicators
contained in the
1492PCDE
Challenge Pack
must
demonstrate
equivalent
resistance as
compared to the
indicators
contained in the
AAMI 16 Towel
PCD in the
claimed cycles | Acceptance
criteria met |
| Resistance of
1492PCDE
Challenge | 1492PCDE
Challenge Pack | FDA Guidance¹ | Demonstrate
the 1492PCDE
Challenge | Indicators
contained in the
1492PCDE | Acceptance
criteria met |
Performance of the 1492PCDE challenge pack was verified through the following tests:
13
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
| Test
Performed | Device
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
|-------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Pack
compared to
standalone
indicators in
claimed
cycles | | | Pack provides
a greater
challenge than
the standalone
indicators in
the claimed
cycles | Challenge Pack
must
demonstrate
greater resistance
compared to the
standalone
indicators in the
claimed cycles | |
| 1492PCDE
Peel Force | 1492PCDE
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
1492PCDE
heat seal foil
lid from plastic
shell | ≥30.2 lbf | Acceptance
criteria met |
1 FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007
14
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 Extended Cycle Clear Challenge Pack 1492PCDE, the 3M™ Attest™ Auto-reader 490, the 3MTM Attest™ Autoreader 490H, and the 3MTM Attest™ Mini Auto-reader 490M, is as safe, as effective and performs as well as or better than the legally marketed predicate device, the VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly (cleared per K182931) Class II (21 CFR 880.2800), product code FRC.