(107 days)
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.
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.
The provided text describes the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD) and associated Auto-readers (490, 490H, 490M). This is a biological indicator system used to monitor steam sterilization processes, not an AI-based medical image analysis device. Therefore, many of the requested criteria (e.g., sample size for test set/training set, number of experts for ground truth, MRMC study, human-in-the-loop performance) are not applicable to this type of device and the information provided in the 510(k) summary.
However, I can extract the acceptance criteria and performance study details that are relevant to this biological indicator system, as described in the "Nonclinical Comparison to the Predicate Device" section.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance of 1492PCD Challenge Pack compared to AAMI 16 Towel PCD in claimed cycles | 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. | Acceptance criteria met |
| Resistance of 1492PCD Challenge Pack compared to standalone indicators in 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 (unsterilized) | ≥4.25 lbF and ≤16 lbF | Acceptance criteria met |
| 1492PCD Peel Force (pre and post sterilization) | ≥4.25 lbF and ≤16 lbF | Acceptance criteria met |
2. Sample Size Used for the Test Set and Data Provenance
For the resistance testing:
- Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested.
- These contained three lots of 1492V BIs and three lots of 1243R CIs.
- They were tested side by side with standalone indicators (1492V BIs and 1243R CIs) and with the AAMI 16 Towel PCD also containing 1492V BIs and 1243R CIs.
The exact number of individual devices or runs per lot is not specified, but for biological indicator testing, a standard number of replicates (e.g., 10-20) per test condition is typically used. - Data Provenance: The study appears to be a prospective laboratory-based performance study, conducted by the manufacturer (3M Company) in the U.S. (based on company location and FDA submission).
For the peel force testing:
- Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested.
The exact number of units per lot is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable. For biological indicator systems, "ground truth" is established by the known biological response of the indicator (e.g., spore kill/growth) under defined sterilization conditions, rather than human expert interpretation of images. The performance is objectively measured in a laboratory setting.
4. Adjudication Method for the Test Set
- This information is not applicable, as there is no human interpretation or subjective assessment to adjudicate. The fluorescence readings from the Auto-reader are objective, and chemical indicator endpoints are also designed for clear visual determination.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable, as the device is a biological indicator system, not an AI-based medical image analysis device involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not directly applicable in the AI sense. However, the performance of the "algorithm" (the biological indicator system and auto-reader) is inherently standalone in its function of detecting biological indicator results (fluorescence). The results of the Auto-readers are objective and do not require human interpretation.
7. The Type of Ground Truth Used
- The ground truth for biological indicators is the presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions. This is determined by the biological response of the indicator (showing growth/fluorescence for live spores, no growth/no fluorescence for killed spores) under controlled laboratory conditions, correlated with known sterilization efficacy.
8. The Sample Size for the Training Set
- This is not applicable, as this is not an AI/ML device that requires a training set. The device's performance is based on its physical/chemical/biological design and validated through non-clinical laboratory testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
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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.
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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
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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
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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.
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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:
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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 Pack1492PCD,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
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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 | ExposureTemperature | 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.
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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).
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| Feature | Submission Device:(K241959)3MTM AttestTMSuper Rapid Steam ClearChallenge Pack 1492PCDand3MTM AttestTM Auto-reader 490 and 490H and3MTM AttestTM Mini Auto-reader 490M | Predicate Device:(K193154)3MTM AttestTM SuperRapid 5 Steam-PlusChallenge Pack 41482V | Comparison |
|---|---|---|---|
| Intended Use | Single Use biologicalindicator process challengedevice | Single Use biologicalindicator process challengedevice | Identical |
| Indications for use | Use the 3MTM AttestTMSuper Rapid Steam ClearChallenge Pack 1492PCDin conjunction with the3MTM AttestTM Auto-reader490, the 3MTM AttestTMAuto-reader 490H havingsoftware version 4.0.0 orgreater, or the 3MTMAttestTM Min Auto-reader490M to qualify or monitordynamic-air-removal (pre-vacuum and SFPP) steamsterilization 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 AttestTMSuper Rapid 5 Steam-PlusChallenge Pack 41482V inconjunction with the 3MTMAttestTM Auto-reader 490 or3MTM AttestTM Auto-reader490H having softwareversion 4.0.0 or greater toqualify or monitor dynamic-air-removal steamsterilization cycles of:4 minutes at 270°F (132°C), and3 minutes at 275°F (135°C). | Both the submissionand predicate testpacks are used toqualify or monitordynamic-air-removalsteam sterilizationcycles. The submissiondevice is indicated foran additionalsterilization cycle of 4minutes at 273°F(134°C).Both the submissionand predicate testpacks utilize the sameBiological Indicator(BI) and ChemicalIntegrator (CI).The 1492V BI isindicated for use in270°F (132°C) and275°F (135°C)dynamic-air-removalsteam sterilizationcycles (per K173437).510(k) (K241710) ispending clearance toexpand the Indicationsfor Use for the 1492VBI to also include the273°F (134°C) steamsterilization cycle.The 1243R CI is |
| Feature | Submission Device:(K241959)3MTM AttestTMSuper Rapid Steam ClearChallenge Pack 1492PCDand3MTM AttestTM Auto-reader 490 and 490H and3MTM AttestTM Mini Auto-reader 490M | Predicate Device:(K193154)3MTM AttestTM SuperRapid 5 Steam-PlusChallenge Pack 41482V | Comparison |
| 270°F (132°C), 273°F(134°C) and 275°F(135°C) dynamic-air-removal steamsterilization cycles (perK220942).The 1492V BIcontained in both thepredicate andsubmission test packsare intended to be usedin conjunction with the3MTM AttestTM Auto-reader 490 or the3MTM AttestTM Auto-reader 490H havingsoftware version 4.0.0or greater to qualify ormonitor dynamic-airremoval steamsterilization cycles.The 1492V BI wascleared for use with the3MTM AttestTM MiniAuto-reader 490M perK200092. | |||
| GeneralDesign/Construction | Clear plastic tray with atortuous channel to thecavity containing theindicators, acting as achallenge to limit airremoval and steampenetration, sealed with afoil lid. | Layers of medical indexcards, some of which aredie-cut to contain indicators,overwrapped and securedwith a label. | Both the submissionand predicatechallenge packs aredesigned to increaseresistance beyond thatmeasured with astandalone BI and bothrepresent a challengeto the sterilizationprocess equivalent tothe AAMI referencePCD. |
| Biological Indicator | 3MTM AttestTM Super RapidReadout BiologicalIndicator 1492V with ≥ 1 x | 3MTM AttestTM Super RapidReadout BiologicalIndicator 1492V with ≥ 1 x | Identical |
| Submission Device:(K241959) | Predicate Device:(K193154) | ||
| Feature | 3MTM Attest™Super Rapid Steam ClearChallenge Pack 1492PCDand3MTM Attest™ Auto-reader 490 and 490H and3MTM AttestTM Mini Auto-reader 490M | 3MTM Attest™ SuperRapid 5 Steam-PlusChallenge Pack 41482V | Comparison |
| Biological IndicatorIncubation temperature | 106 Geobacillusstearothermophilus spores60 ± 2°C | 106 Geobacillusstearothermophilus spores60 ± 2°C | Identical |
| Biological IndicatorReadout time | 24 minute final fluorescentresult in both the 490 and490H Auto-readers havingsoftware version 4.0.0 orgreater or in a 490M Auto-reader.1 hour final fluorescentresult in 490 Auto-readershaving software versionsless than 4.0.0.Optional visual pH colorchange result in 48 hoursfor 490, 490H or 490MAuto-readers. | 24 minute final fluorescentresult in both the 490 and490H Auto-readers havingsoftware versions 4.0.0 orgreater.1 hour final fluorescentresult in 490 Auto-readershaving software versionsless than 4.0.0.Optional visual pH colorchange result in 48 hoursfor 490 or 490H Auto-readers. | The 1492V BIcontained in both thepredicate andsubmission test packsare intended to be usedin conjunction with the3MTM Attest™ Auto-reader 490 or the3MTM Attest™ Auto-reader 490H havingsoftware version 4.0.0or greater to qualify ormonitor dynamic-airremoval steamsterilization cycles.The 1492V BI wascleared for use with the3MTM Attest™ MiniAuto-reader 490M perK200092. |
| Biological IndicatorMechanism of Action | When the enzyme that isnaturally occurring in thespore is in its active state, itis detected by measuring thefluorescence produced bythe enzymatic hydrolysis ofa non-fluorescent substrate.The resultant fluorescentby-product is detected bythe Auto-reader. Thepresence of fluorescenceupon incubation in theAuto-reader indicates asterilization process failure.There is an optional visualpH color change whichindicates a steamsterilization process failure. | When the enzyme that isnaturally occurring in thespore is in its active state, itis detected by measuring thefluorescence produced bythe enzymatic hydrolysis ofa non-fluorescent substrate.The resultant fluorescentby-product is detected bythe Auto-reader. Thepresence of fluorescenceupon incubation in theAuto-reader indicates asterilization process failure.There is an optional visualpH color change whichindicates a steamsterilization process failure. | Identical |
| Submission Device:(K241959) | Predicate Device:(K193154) | ||
| Feature | 3MTM Attest™Super Rapid Steam ClearChallenge Pack 1492PCDand3MTM Attest™ Auto-reader 490 and 490H and3MTM Attest™ Mini Auto-reader 490M | 3MTM Attest™ SuperRapid 5 Steam-PlusChallenge Pack 41482V | Comparison |
| Biological IndicatorResistanceCharacteristics• D-value• Survival/KillWindow | D-value ≥ 10 seconds at132°CD-value ≥ 8 seconds at134°CD-value ≥ 8 seconds at135°CSurvival Time = Calculatedsurvival time* or 1 minuteat 132°C and 40 seconds at134°C and 135°C,whichever is longerKill Time = Calculated killtime* at 132°C, 134°C andat 135°C | D-value ≥ 10 seconds at132°CD-value ≥ 8 seconds at135°CSurvival Time = Calculatedsurvival time* or 1 minuteat 132°C and 40 seconds at135°C, whichever is longerKill Time = Calculated killtime* at 132°C and at135°C | Both the submissionand predicate testpacks utilize the sameBI (1492V). The BI isindicated for use in270°F (132°C) and275°F (135°C)dynamic-air-removalsteam sterilizationcycles (per K173437).510(k) (K241710) ispending clearance toexpand the Indicationsfor Use for the 1492VBI to also include the273°F (134°C) steamsterilization cycle. TheResistanceCharacteristics (D-Value, Survival/KillWindow) of the 1492VBI have been updatedto include themonitoring of steamsterilization cycles at273°F (134°C). |
| Biological IndicatorCulture Conditions | Crushable glass ampoulecontaining a growth mediaand a fluorescence indicatorwhich is correlated to anoptional use pH indicator. | Crushable glass ampoulecontaining a growth mediaand a fluorescence indicatorwhich is correlated to anoptional use pH indicator. | Identical |
| Chemical Integrator | 3MTM Attest™ SteamChemical Integrator | 3MTM Attest™ SteamChemical Integrator | Identical |
| Chemical IntegratorEndpoint Specifications(Minimum StatedValues) | 250°F/121°C: 16.5 minutes270°F/132°C: 2.0 minutes273°F/134°C: 1.4 minutes275°F/135°C: 1.2 minutes | 250°F/121°C: 16.5 minutes270°F/132°C: 2.0 minutes273°F/134°C: 1.4 minutes275°F/135°C: 1.2 minutes | Identical |
| Chemical IntegratorColor Change | Dark color migrates alongstrip visible through a greenwindow (ACCEPT) or redwindow (REJECT) | Dark color migrates alongstrip visible through a greenwindow (ACCEPT) or redwindow (REJECT) | Identical |
| Feature | Submission Device:(K241959)3MTM AttestTMSuper Rapid Steam ClearChallenge Pack 1492PCDand3MTM AttestTM Auto-reader 490 and 490H and3MTM AttestTM Mini Auto-reader 490M | Predicate Device:(K193154)3MTM AttestTM SuperRapid 5 Steam-PlusChallenge Pack 41482V | Comparison |
| Mechanism todistinguish processedand unprocessedchallenge pack | Process indicator present on1492V BI cap is visiblethrough PCD and turnscolor from pink to lightbrown or darker upon steamexposure. | External Chemical ProcessIndicator turns from yellowto brown or darker uponsteam exposure. | Both the submissionand predicate devicecontain a processindicator that changescolor upon steamexposure that is usedby the customer toverify that thechallenge pack wasexposed to steam. |
| Resistance Comparisonto the AAMI ST79 16Towel PCD | Equivalent in resistance tothe AAMI ST79 16 TowelPCD | Equivalent in resistance tothe AAMI ST79 16 TowelPCD | Identical |
| Shelf Life | 21 months | 21 months | Identical |
| Accessories(Auto-readers) | 3MTM AttestTM Auto-reader490 or the 3MTM AttestTMAuto-reader 490H or the3MTM AttestTM Mini Auto-reader | 3MTM AttestTM Auto-reader490 or the 3MTM AttestTMAuto-reader 490H | The 1492V BIcontained in both thepredicate andsubmission test packsare intended to be usedin conjunction with the3MTM AttestTM Auto-reader 490 or the3MTM AttestTM Auto-reader 490H havingsoftware version 4.0.0or greater to qualify ormonitor dynamic-air-removal steamsterilization cycles.The 1492V BI wascleared for use with the3MTM AttestTM MiniAuto-reader 490M perK200092 |
Table 1: Device Comparison Table
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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
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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
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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
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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
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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.
| TestPerformed | DeviceDescription | ApplicableStandards | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|---|
| Resistanceof 1492PCDChallengePackcompared toAAMI 16Towel PCDin claimedcycles | 1492PCDChallenge Pack | FDA Guidance1 andANSI/AAMIST79:2017,Comprehensiveguide to steamsterilization andsterilityassurance in healthcare facilities | Demonstratethe performanceof the 1492PCDChallenge Packis equivalent tothe performanceof the AAMI 16Towel PCD inthe claimedcycles | Indicatorscontained in the1492PCDChallenge Packmustdemonstrateequivalentresistance ascompared to theindicatorscontained in the | Acceptancecriteria met |
| TestPerformed | DeviceDescription | ApplicableStandards | Purpose | AcceptanceCriteria | Results |
| AAMI 16Towel PCD inthe claimedcycles | |||||
| Resistanceof 1492PCDChallengePackcompared tostandaloneindicators inclaimedcycles | 1492PCDChallenge Pack | FDA Guidance¹ | Demonstratethe 1492PCDChallenge Packprovides agreaterchallenge thanthe standaloneindicators in theclaimed cycles | Indicatorscontained in the1492PCDChallenge Packmustdemonstrategreaterresistancecompared to thestandaloneindicators in theclaimed cycles | Acceptancecriteria met |
| 1492PCDPeel Force | 1492PCDChallenge Pack | ASTM F88 / F88M-15: Standard TestMethod for SealStrength of FlexibleBarrier andASTM F2824 – 10:Standard TestMethod forMechanical SealStrength Testing forRound Cups andBowl Containerswith FlexiblePeelable Lids | Demonstrateacceptable peelforce of ClearChallenge Pack1492PCD heatseal foil lidfrom plasticshell | ≥4.25lbF and≤16lbF | Acceptancecriteria met |
| 1492PCDPeel Force | 1492PCDChallenge Pack | ASTM F88 / F88M-15: Standard TestMethod for SealStrength of FlexibleBarrier andASTM F2824 - 10:Standard TestMethod forMechanical SealStrength Testing forRound Cups andBowl Containerswith FlexiblePeelable Lids | Demonstrateacceptable peelforce of ClearChallenge Pack1492PCD heatseal foil lidfrom plasticshell, pre andpoststerilization | ≥4.25lbF and≤16lbF | Acceptancecriteria met |
Performance of the 1492PCD challenge pack was verified through the following tests:
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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
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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.
§ 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).