(107 days)
No
The document describes a biological indicator and auto-readers for steam sterilization monitoring. The technology involves incubation and fluorescent reading, with no mention of AI or ML for data analysis or decision-making.
No
The device is described as a challenge pack for monitoring sterilization processes and an auto-reader for biological indicators. Its intended use is to verify the effectiveness of sterilization, not to treat or diagnose patients.
No
This device is used to monitor, qualify, and check the effectiveness of sterilization processes in healthcare facilities, rather than diagnose a medical condition in a patient.
No
The device description clearly outlines a physical challenge pack consisting of a plastic shell, tortuous channel, cavity, foil lid, biological indicator, and chemical integrator. While it interacts with auto-readers that likely contain software, the device itself is a physical product used in sterilization processes.
Based on the provided information, the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD) is not an In Vitro Diagnostic (IVD) device.
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 a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device contains a biological indicator (BI) and a chemical integrator (CI). The BI uses bacterial spores to assess the effectiveness of the sterilization process, and the CI verifies critical parameters of the cycle. These components are used to evaluate the performance of the sterilizer, not to analyze a patient sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Providing information for the diagnosis, treatment, or prevention of a disease or condition in a patient.
- Using reagents or assays to detect specific analytes in a sample.
The device is clearly designed for monitoring and validating sterilization processes in a healthcare setting, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD):
Use the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD in conjunction with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes |
3M™ Attest™ Auto-reader (490):
The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Auto-reader (490H):
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Mini Auto-reader (490M):
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD is designed to qualify and monitor dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities.
The 1492PCD Challenge Pack consists of a clear plastic shell, and a tortuous channel allowing for air removal and sterilant penetration. The channel connects to a cavity containing the monitoring products and all are covered by a foil lid. The 1492PCD is a single-use device.
Each 1492PCD Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1492V (brown cap) and a 3M™ Attest™ Steam Chemical Integrator (CI). The CI verifies that the stated values for the three critical parameters of exposure time, temperature, and steam saturation have been achieved. Upon exposure to steam a dark color visible through a window migrates along the indicator strip and offers an ACCEPT or REJECT reading. The 1492V Biological Indicator (BI) is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490, a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1492V BI in the 490, 490H or 490M Auto-reader indicates a steam sterilization process failure. A chemical process indicator is present on the brown cap of the 1492V BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink 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)
Tests Performed:
-
Resistance of 1492PCD Challenge Pack compared to AAMI 16 Towel PCD in claimed cycles
- Purpose: Demonstrate the performance of the 1492PCD Challenge Pack is equivalent to the performance of the AAMI 16 Towel PCD in the claimed cycles.
- Acceptance Criteria: Indicators contained in the 1492PCD 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.
-
Resistance of 1492PCD Challenge Pack compared to standalone indicators in claimed cycles
- Purpose: Demonstrate the 1492PCD Challenge Pack provides a greater challenge than the standalone indicators in the claimed cycles.
- Acceptance Criteria: Indicators contained in the 1492PCD Challenge Pack must demonstrate greater resistance compared to the standalone indicators in the claimed cycles.
- Results: Acceptance criteria met.
-
1492PCD Peel Force
- Purpose: Demonstrate acceptable peel force of Clear Challenge Pack 1492PCD heat seal foil lid from plastic shell.
- Acceptance Criteria: ≥4.25lbF and ≤16lbF.
- Results: Acceptance criteria met.
-
1492PCD Peel Force (pre and post sterilization)
- Purpose: Demonstrate acceptable peel force of Clear Challenge Pack 1492PCD heat seal foil lid from plastic shell, pre and post sterilization.
- Acceptance Criteria: ≥4.25lbF and ≤16lbF.
- Results: Acceptance criteria met.
Summary:
Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, containing three lots of 1492V BIs and three lots of 1243R Cls, were tested side by side with standalone indicators 1492V BIs and 1243R CIs. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007.
Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, containing three lots of 1492V BIs and three lots of 1243R CIs, were tested side by side with the AAMI 16 Towel PCD containing 1492V BIs and 1243R CIs. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007, and ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested for peel force of the heat seal foil lid from the plastic shell. The validated method used to perform the testing is based on ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids.
Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested for peel force of the heat seal foil lid from the plastic shell, pre and post sterilization. The validated method used to perform the testing is based on ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 18, 2024
3M Company Michelle Larsen Principal RA Specialist 3M Center 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144
Re: K241959
Trade/Device Name: 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3MTM Attest™ Auto-reader (490); 3MTM Attest™ Auto-reader (490H); 3MTM Attest™ Mini Auto-reader (490M) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: September 19, 2024 Received: September 19, 2024
Dear Michelle Larsen:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
PAULO LARANJEIRA -S
Digitally signed by PAULO LARANJEIRA -S Date: 2024.10.18 11:49:41 -04'00'
for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD):
3M™ Attest™ Auto-reader (490);
3M™ Attest™ Auto-reader (490H);
3M™ Attest™ Mini Auto-reader (490M)
Indications for Use (Describe)
3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD):
Use the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD in conjunction with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cvcles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes |
3M™ Attest™ Auto-reader (490):
The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Auto-reader (490H):
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Mini Auto-reader (490M):
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
Image /page/4/Picture/1 description: The image shows the 3M logo. The logo is red and features the number 3 followed by the letter M. The 3 and M are connected, and the logo is simple and recognizable.
510(k) Summary for 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M K241959
Sponsor Information:
3M Company 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Michelle M. Larsen Principal RA Specialist Phone Number: (651) 467-3991 Fax Number: (651) 737-5320 Email: mmlarsen@solventum.com
Date of Summary: 09 October 2024
1. Device Name and Classification:
Biological Indicator (BI) Challenge Pack Common or Usual Name:
5
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3MTM Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
| Proprietary Name: | 3M™ Attest™ Super Rapid Steam Clear Challenge Pack
1492PCD,
3M™ Attest™ Auto-reader 490,
3M™ Attest™ Auto-reader 490H,
3M™ Attest™ Mini Auto-reader 490M |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Indicator, Biological Sterilization Process |
| Device Classification: | Class II, 21 CFR 880.2800(a) |
| Product Code: | FRC |
2. Predicate Device:
3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, K193154
3. Description of Device:
The 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD is designed to qualify and monitor dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities.
The 1492PCD Challenge Pack consists of a clear plastic shell, and a tortuous channel allowing for air removal and sterilant penetration. The channel connects to a cavity containing the monitoring products and all are covered by a foil lid. The 1492PCD is a single-use device.
Each 1492PCD Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1492V (brown cap) and a 3M™ Attest™ Steam Chemical Integrator (CI). The CI verifies that the stated values for the three critical parameters of exposure time, temperature, and steam saturation have been achieved. Upon exposure to steam a dark color visible through a window migrates along the indicator strip and offers an ACCEPT or REJECT reading. The 1492V Biological Indicator (BI) is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490, a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1492V BI in the 490, 490H or 490M Auto-reader indicates a steam sterilization process failure. A chemical process indicator is present on the brown cap of the 1492V BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink
6
to light brown or darker upon exposure to steam. The process indicator is used by the customer to verify that the challenge pack was exposed to steam.
4. Indications for Use
3MTM Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD):
Use the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD in conjunction with the 3MTM Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | Exposure
Temperature | Exposure Time |
|-------------------------------------------|-------------------------|---------------|
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes |
3MTM AttestTM Auto-reader (490):
The 3MIMAttest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3MTM Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.
3MTM Attest™ Auto-reader (490H):
The 3MTM Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.
3MTM Attest™ Mini Auto-reader (490M):
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.
The submission device, the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, has the same intended use as the predicate device, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V. Both the submission device and the predicate device are Single Use biological indicator process challenge devices that are intended to be used in healthcare facilities to accompany products being sterilized and to monitor adequacy of the sterilization process.
7
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3MTM Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
Both the submission and predicate test packs are indicated for use in conjunction with the 3M™ Attest™ Auto-readers 490 and 490H, and 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal steam sterilization cycles. The predicate device is indicated for use in dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C). The submission device covers an additional cycle ((4 minutes at 273°F (134°C)) compared to the predicate device. The differences in Indications for Use do not alter the fundamental Intended Use of these products as biological indicator process challenge devices and do not raise new questions of safety and effectiveness.
5. Comparison of Technological Characteristics with the Predicate Device
Both the submission and predicate challenge packs are designed to increase resistance beyond that measured with a standalone BI and both represent a challenge to the sterilization process equivalent to the AAMI reference PCD. The 3M™ Attest™ Super Rapid Steam Clear Challenge Pack consists of a clear plastic shell and a tortuous channel connected to a cavity in the shell containing the monitoring products, all heat sealed with a foil lid whereas the predicate challenge pack consists of layers of medical index cards, some of which are diecut to contain indicators, overwrapped and secured with a label. Both the submission and predicate challenge pack utilize the same Biological Indicator, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V and the same Chemical Integrator, the 3M™ Attest™ Steam Chemical Integrator. The process indicator on the predicate challenge pack is present on the outer label of the overwrapped challenge pack whereas the process indicator on the submission device is present on the cap of the 1492V BI which is visible through the clear challenge pack. Both the submission and predicate challenge packs contain a visible process indicator that changes color upon steam exposure that is used by the customer to distinguish processed and unprocessed challenge packs. The accessories (Auto-readers) are the same for both the submission and predicate device and the readout time or the time to a result is the same for both the submission and predicate device.
The differences in technological characteristics between the submission and predicate challenge pack are illustrated in the Device Comparison Table (Table 1).
8
| Feature | Submission Device:
(K241959)
3MTM AttestTM
Super Rapid Steam Clear
Challenge Pack 1492PCD
and
3MTM AttestTM Auto-
reader 490 and 490H and
3MTM AttestTM Mini Auto-
reader 490M | Predicate Device:
(K193154)
3MTM AttestTM Super
Rapid 5 Steam-Plus
Challenge Pack 41482V | 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 Clear
Challenge Pack 1492PCD
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 Min Auto-reader
490M to qualify or monitor
dynamic-air-removal (pre-
vacuum and SFPP) steam
sterilization cycles of:
4 minutes at 270°F (132°C),4 minutes at 273°F (134°C), and3 minutes at 275°F (135°C) | Use the 3MTM AttestTM
Super Rapid 5 Steam-Plus
Challenge Pack 41482V in
conjunction with the 3MTM
AttestTM Auto-reader 490 or
3MTM AttestTM Auto-reader
490H having software
version 4.0.0 or greater to
qualify or monitor dynamic-
air-removal steam
sterilization cycles of:
4 minutes at 270°F (132°C), and3 minutes at 275°F (135°C). | Both the submission
and predicate test
packs are used to
qualify or monitor
dynamic-air-removal
steam sterilization
cycles. The submission
device is indicated for
an additional
sterilization cycle of 4
minutes at 273°F
(134°C).
Both the submission
and predicate test
packs utilize the same
Biological Indicator
(BI) and Chemical
Integrator (CI).
The 1492V BI is
indicated for use in
270°F (132°C) and
275°F (135°C)
dynamic-air-removal
steam sterilization
cycles (per K173437).
510(k) (K241710) is
pending clearance to
expand the Indications
for Use for the 1492V
BI to also include the
273°F (134°C) steam
sterilization cycle.
The 1243R CI is |
| Feature | Submission Device:
(K241959)
3MTM AttestTM
Super Rapid Steam Clear
Challenge Pack 1492PCD
and
3MTM AttestTM Auto-
reader 490 and 490H and
3MTM AttestTM Mini Auto-
reader 490M | Predicate Device:
(K193154)
3MTM AttestTM Super
Rapid 5 Steam-Plus
Challenge Pack 41482V | Comparison |
| | | | 270°F (132°C), 273°F
(134°C) and 275°F
(135°C) dynamic-air-
removal steam
sterilization cycles (per
K220942).
The 1492V BI
contained in both the
predicate and
submission test packs
are intended to be used
in conjunction with the
3MTM AttestTM Auto-
reader 490 or the
3MTM AttestTM Auto-
reader 490H having
software version 4.0.0
or greater to qualify or
monitor dynamic-air
removal steam
sterilization cycles.
The 1492V BI was
cleared for use with the
3MTM AttestTM Mini
Auto-reader 490M per
K200092. |
| 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. | 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 challenge
to the sterilization
process equivalent to
the AAMI reference
PCD. |
| Biological Indicator | 3MTM AttestTM Super Rapid
Readout Biological
Indicator 1492V with ≥ 1 x | 3MTM AttestTM Super Rapid
Readout Biological
Indicator 1492V with ≥ 1 x | Identical |
| | Submission Device:
(K241959) | Predicate Device:
(K193154) | |
| Feature | 3MTM Attest™
Super Rapid Steam Clear
Challenge Pack 1492PCD
and
3MTM Attest™ Auto-
reader 490 and 490H and
3MTM AttestTM Mini Auto-
reader 490M | 3MTM Attest™ Super
Rapid 5 Steam-Plus
Challenge Pack 41482V | Comparison |
| Biological Indicator
Incubation temperature | 106 Geobacillus
stearothermophilus spores
60 ± 2°C | 106 Geobacillus
stearothermophilus spores
60 ± 2°C | Identical |
| 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. | 24 minute final fluorescent
result in both the 490 and
490H Auto-readers having
software versions 4.0.0 or
greater.
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 or 490H Auto-
readers. | The 1492V BI
contained in both the
predicate and
submission test packs
are intended to be used
in conjunction with the
3MTM Attest™ Auto-
reader 490 or the
3MTM Attest™ Auto-
reader 490H having
software version 4.0.0
or greater to qualify or
monitor dynamic-air
removal steam
sterilization cycles.
The 1492V BI was
cleared for use with the
3MTM Attest™ Mini
Auto-reader 490M per
K200092. |
| 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. | 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. | Identical |
| | Submission Device:
(K241959) | Predicate Device:
(K193154) | |
| Feature | 3MTM Attest™
Super Rapid Steam Clear
Challenge Pack 1492PCD
and
3MTM Attest™ Auto-
reader 490 and 490H and
3MTM Attest™ Mini Auto-
reader 490M | 3MTM Attest™ Super
Rapid 5 Steam-Plus
Challenge Pack 41482V | Comparison |
| Biological Indicator
Resistance
Characteristics
• D-value
• Survival/Kill
Window | D-value ≥ 10 seconds at
132°C
D-value ≥ 8 seconds at
134°C
D-value ≥ 8 seconds at
135°C
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 | D-value ≥ 10 seconds at
132°C
D-value ≥ 8 seconds at
135°C
Survival Time = Calculated
survival time* or 1 minute
at 132°C and 40 seconds at
135°C, whichever is longer
Kill Time = Calculated kill
time* at 132°C and at
135°C | Both the submission
and predicate test
packs utilize the same
BI (1492V). The BI is
indicated for use in
270°F (132°C) and
275°F (135°C)
dynamic-air-removal
steam sterilization
cycles (per K173437).
510(k) (K241710) is
pending clearance to
expand the Indications
for Use for the 1492V
BI to also include the
273°F (134°C) steam
sterilization cycle. The
Resistance
Characteristics (D-
Value, Survival/Kill
Window) of the 1492V
BI have been updated
to include the
monitoring of steam
sterilization cycles at
273°F (134°C). |
| Biological Indicator
Culture Conditions | 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 Integrator | 3MTM Attest™ Steam
Chemical Integrator | 3MTM Attest™ Steam
Chemical Integrator | Identical |
| 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 |
| Feature | Submission Device:
(K241959)
3MTM AttestTM
Super Rapid Steam Clear
Challenge Pack 1492PCD
and
3MTM AttestTM Auto-
reader 490 and 490H and
3MTM AttestTM Mini Auto-
reader 490M | Predicate Device:
(K193154)
3MTM AttestTM Super
Rapid 5 Steam-Plus
Challenge Pack 41482V | 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. | External Chemical Process
Indicator turns from yellow
to brown or darker upon
steam exposure. | Both the submission
and predicate device
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 | 21 months | 21 months | Identical |
| Accessories
(Auto-readers) | 3MTM AttestTM Auto-reader
490 or the 3MTM AttestTM
Auto-reader 490H or the
3MTM AttestTM Mini Auto-
reader | 3MTM AttestTM Auto-reader
490 or the 3MTM AttestTM
Auto-reader 490H | The 1492V BI
contained in both the
predicate and
submission test packs
are intended to be used
in conjunction with the
3MTM AttestTM Auto-
reader 490 or the
3MTM AttestTM Auto-
reader 490H having
software version 4.0.0
or greater to qualify or
monitor dynamic-air-
removal steam
sterilization cycles.
The 1492V BI was
cleared for use with the
3MTM AttestTM Mini
Auto-reader 490M per
K200092 |
Table 1: Device Comparison Table
9
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
10
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M
11
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M
12
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M
13
6. Nonclinical Comparison to the Predicate Device
The differences between the submission and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD.
Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, containing three lots of 1492V BIs and three lots of 1243R Cls, were tested side by side with standalone indicators 1492V BIs and 1243R CIs. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007.
Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, containing three lots of 1492V BIs and three lots of 1243R CIs, were tested side by side with the AAMI 16 Towel PCD containing 1492V BIs and 1243R CIs. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007, and ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested for peel force of the heat seal foil lid from the plastic shell. The validated method used to perform the testing is based on ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids.
Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested for peel force of the heat seal foil lid from the plastic shell, pre and post sterilization. The validated method used to perform the testing is based on ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids.
| Test
Performed | Device
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
|------------------------------------------------------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Resistance
of 1492PCD
Challenge
Pack
compared to
AAMI 16
Towel PCD
in claimed
cycles | 1492PCD
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 1492PCD
Challenge Pack
is equivalent to
the performance
of the AAMI 16
Towel PCD in
the claimed
cycles | Indicators
contained in the
1492PCD
Challenge Pack
must
demonstrate
equivalent
resistance as
compared to the
indicators
contained in the | Acceptance
criteria met |
| Test
Performed | Device
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
| | | | | AAMI 16
Towel PCD in
the claimed
cycles | |
| Resistance
of 1492PCD
Challenge
Pack
compared to
standalone
indicators in
claimed
cycles | 1492PCD
Challenge Pack | FDA Guidance¹ | Demonstrate
the 1492PCD
Challenge Pack
provides a
greater
challenge than
the standalone
indicators in the
claimed cycles | Indicators
contained in the
1492PCD
Challenge Pack
must
demonstrate
greater
resistance
compared to the
standalone
indicators in the
claimed cycles | Acceptance
criteria met |
| 1492PCD
Peel Force | 1492PCD
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
1492PCD heat
seal foil lid
from plastic
shell | ≥4.25lbF and
≤16lbF | Acceptance
criteria met |
| 1492PCD
Peel Force | 1492PCD
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
1492PCD heat
seal foil lid
from plastic
shell, pre and
post
sterilization | ≥4.25lbF and
≤16lbF | Acceptance
criteria met |
Performance of the 1492PCD challenge pack was verified through the following tests:
14
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
1 FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification (510(k)] Submissions, October 4, 2007
15
7. Clinical Comparison to the Predicate Device
Clinical testing was not required or completed for the submission device.
8. Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the submission device, the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD, the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H, and the 3M™ Attest™ Mini Auto-reader 490M, are as safe and as effective as the legally marketed predicate device, the 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V for use with the 3M™ Attest™ Auto-reader 490, and the 3MTM Attest™ Autoreader 490H (cleared per K193154), and the 3M™ Attest™ Mini Auto-reader 490M (cleared per K200092) Class II (21 CFR 880.2800), product code FRC.