(104 days)
Use the 3M TM Attest TM Rapid Readout Biological Indicator 1295 in conjunction with the 3M TM Attest TM Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cvcles) V-PRO® &2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1) SteroScope® Sterilization System
Use the 3M IM Attest TM Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maXLow Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles) V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1) SteroScope® Sterilization System
3M™ Attest™ Rapid Readout Biological Indicator 1295: The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490H or the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3MTM Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure.
3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E: The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate. There has been no change to the product construction compared to the predicate submission, K212022. The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber. Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and concentration of vaporized hydrogen peroxide.
The provided text describes premarket notification for two devices: 3M™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E. The key new information in this submission is the addition of the "SteroScope® Sterilization System" to the indications for use for both devices. The acceptance criteria and the study performance for this new indication are detailed.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Device: 3M™ Attest™ Rapid Readout Biological Indicator 1295 (for SteroScope® Sterilization System)
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Full Cycle Performance | Verify performance in each of the full cycles in the SteroScope® Sterilization System. | All biological indicators display a negative fluorescent and negative growth response. | Pass |
| Fractional Cycle Performance | Verify performance in fractional cycles for each of the cycles within the SteroScope® Sterilization System. | All biological indicators display a negative fluorescent and negative growth response. | Pass |
| Chemical Indicator (CI) Color Change | Demonstrate the color change of the CI when exposed to the SteroScope® Sterilization System. | Color change from blue toward pink. | Pass (implicitly, as part of the BI unit) |
Device: 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (for SteroScope® Sterilization System)
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Complete (Full) Cycle Performance | Verify performance in the complete (full) cycle of a loaded SteroScope® Sterilization System. | Visual assessment of the chemical indicator yields an ACCEPT result with ≥ 95% accuracy. At least 80% of the population of indicators tested has a measured color change value corresponding to an ACCEPT result. | Pass, 100% accuracy Pass, >99.9% population |
| Fractional Cycle Performance | Verify performance in an incomplete cycle of a loaded SteroScope® Sterilization System. | Visual assessment of the chemical indicator yields a REJECT result with ≥ 95% accuracy. At least 80% of the population of indicators tested has a measured color change value corresponding to a REJECT result. | Pass, 100% accuracy Pass, >99.9% population |
Study Details
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific numerical sample sizes for the test sets (e.g., number of BIs or CIs tested in each condition). Instead, it uses qualitative statements like "All biological indicators" and quantitative statements related to percentages of the population of indicators.
- Data Provenance: The testing was "performed in a health care facility" (for the Chemical Indicator) and implicitly in a laboratory/testing environment for the Biological Indicator. The data is prospective, as it was generated specifically to demonstrate performance for the expanded indications. The country of origin is not specified, but given the FDA submission, it's likely U.S.-based or compliant with U.S. regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts or their qualifications for establishing ground truth. The ground truth for these types of devices (Biological and Chemical Indicators) is typically established through precisely controlled sterilization cycles using calibrated equipment and defined parameters (e.g., successful sterilization leading to no growth for BIs, or specific chemical changes for CIs). The "Visual assessment" mentioned for the CI implies human observation, but it doesn't specify if these were expert readers or how many.
4. Adjudication method for the test set
The document does not specify any formal adjudication method (e.g., 2+1, 3+1). For the chemical indicator, it mentions "Visual assessment," but no details on multiple readers or adjudication are provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI devices, where human perception and interpretation are key variables. For sterilization indicators, the evaluation focuses on the device's intrinsic performance against defined physical/chemical/biological criteria rather than how human readers' diagnostic accuracy is improved with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of these specific devices. The Biological Indicator's readout is automated by an "Auto-reader," which itself performs the "algorithm" (fluorescence detection). The Chemical Indicator's performance is determined by a visual color change. There isn't an "AI algorithm" in the typical sense (e.g., for image analysis) being evaluated here. The "standalone" performance is essentially the performance of the indicators themselves, which is what the non-clinical tests evaluate.
7. The type of ground truth used
- For the 3M™ Attest™ Rapid Readout Biological Indicator 1295:
- Biological Ground Truth: Absence or presence of fluorescent and/or microbial growth, indicating kill or survival of Geobacillus stearothermophilus spores after exposure to sterilization cycles. This is established by standard microbiological methods and incubation in the auto-reader.
- For the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E:
- Physical/Chemical Ground Truth: The successful achievement of specified exposure time, temperature, and vaporized hydrogen peroxide concentration (ACCEPT result) or failure to achieve these conditions (REJECT result). This is confirmed by the color change progression of the indicator and validated against the known conditions of the sterilization cycles (i.e., "complete/full cycle" vs. "fractional/incomplete cycle"). The "Visual assessment" is against this physical/chemical ground truth.
8. The sample size for the training set
The document does not provide information on a "training set" or its sample size. These devices are physical/chemical/biological indicators, not AI/machine learning models that typically require training data. The testing described is verification and validation, not model training.
9. How the ground truth for the training set was established
As there is no mention of a "training set" or AI/ML model for these devices, this question is not applicable to the provided information.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
June 27, 2024
3M Company Heidi Wallis Regulatory Affairs Senior Associate 3M Center 2510 Conway Avenue, Building 275-5W-06 St. Paul, Minnesota 55144-1000
Re: K240717
Trade/Device Name: 3M™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC, QKM Dated: May 14, 2024 Received: May 29, 2024
Dear Heidi Wallis:
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.
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"
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(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 OS 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.
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-regulatoryassistance/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.
Christopher K. Dugard -S
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
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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
510(k) Number (if known) K240717
Device Name
3M TM Attest TM Rapid Readout Biological Indicator 1295
Indications for Use (Describe) Use the 3M TM Attest TM Rapid Readout Biological Indicator 1295 in conjunction with the 3M TM Attest TM Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cvcles) V-PRO® &2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1) SteroScope® Sterilization System
| 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
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Indications for Use
510(k) Number (if known) K240717
Device Name
3M TM Attest TM Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Indications for Use (Describe) Use the 3M IM Attest TM Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maXLow Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles) V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1) SteroScope® Sterilization System
| 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."
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Image /page/5/Picture/1 description: The image shows the 3M logo. The logo is red and consists of the number "3" and the letter "M" next to each other. The number "3" is on the left and the letter "M" is on the right. The logo is simple and recognizable.
510(k) Summary for
3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Heidi Wallis Regulatory Affairs Senior Associate
Date of Summary: June 24, 2024
510(k) Reference: K240717
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3M™ Attest™ Rapid Readout Biological Indicator 1295 and
MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
1. Device Name and Classification:
| Common or Usual Name: | Biological Indicator |
|---|---|
| Proprietary Name: | 3MTM AttestTM Rapid Readout Biological Indicator 1295 |
| Classification Name: | Indicator, biological sterilization process |
| Device Classification: | Class II, 21 CFR § 880.2800(a) |
| Product Code: | FRC |
| Common or Usual Name: | Chemical Indicator |
|---|---|
| Proprietary Name: | 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-MetricChemical Indicator 1348/1348E |
| Classification Name: | Indicator, physical/chemical sterilization process |
| Device Classification: | Class II, 21 CFR § 880.2800 |
| Product Code: | QKM |
2. Predicate Device:
K211705, 3M™ Attest™ Rapid Readout Biological Indicator 1295
K212022, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
3. Description of Device:
3MTM Attest™ Rapid Readout Biological Indicator 1295:
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490H or the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3MTM Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure.
3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E: The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate. There has been no change to the product construction compared to the predicate submission, K212022.
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3M™ Attest™ Rapid Readout Biological Indicator 1295 and
3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.
Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and concentration of vaporized hydrogen peroxide.
4. Indications for Use
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems:
| STERRAD 100S® Sterilization System |
|---|
| STERRAD NX® Sterilization System (Standard and Advanced cycles) |
| STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) |
| STERRAD NX® with ALLClear® Technology Sterilization System (Standard andAdvanced cycles) |
| STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex,Express and Duo cycles) |
| V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) |
| V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) |
| V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexiblecycles) |
| V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexiblecycles) |
| V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible,and Fast Non Lumen cycles) |
| V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, andFast cycles) |
| STERIZONE® VP4 Sterilizer (Cycle 1) |
| SteroScope® Sterilization System |
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PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Use the 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles:
| STERRAD 100S® Sterilization System |
|---|
| STERRAD NX® Sterilization System (Standard and Advanced cycles) |
| STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles) |
| STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) |
| STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles) |
| V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) |
| V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) |
| V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) |
| V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) |
| V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) |
| V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) |
| STERIZONE® VP4 Sterilizer (Cycle 1) |
| SteroScope® Sterilization System |
Technological Characteristic Comparison Table
| Feature | Submission Device:3MTM Attest™ Rapid ReadoutBiological Indicator | Predicate Device (K211705):3MTM Attest™ Rapid ReadoutBiological Indicator | Comparison |
|---|---|---|---|
| Device Models | 1295 | 1295 | Identical |
| Indications for use | Use the 3M™ Attest™ RapidReadout Biological Indicator 1295in conjunction with the 3MTMAttest™ Auto-reader 490H or 490Auto-reader having softwareversion 4.0.0 or greater or 490MAuto-reader as a standard methodof routine monitoring of vaporizedhydrogen peroxide sterilizationprocesses in the following systems:STERRAD 100S® SterilizationSystem | Use the 3M™ Attest™ RapidReadout Biological Indicator 1295in conjunction with the 3MTMAttest™ Auto-reader 490H or 490Auto-reader having software version4.0.0 or greater or 490M Auto-reader as a standard method ofroutine monitoring of vaporizedhydrogen peroxide sterilizationprocesses in the following systems:STERRAD 100S® SterilizationSystem | Addition ofSteroScope®SterilizationSystem |
| Submission Device:3MTM Attest™ Rapid ReadoutBiological Indicator | Predicate Device (K211705):3MTM Attest™ Rapid ReadoutBiological Indicator | Comparison | |
| Feature | STERRAD NX® SterilizationSystem (Standard andAdvanced cycles) | STERRAD NX® SterilizationSystem (Standard and Advancedcycles) | |
| STERRAD 100NX®Sterilization System (Standard,Flex, Express and Duo cycles) | STERRAD 100NX®Sterilization System (Standard,Flex, Express and Duo cycles) | ||
| STERRAD NX® withALLClear® TechnologySterilization System (Standardand Advanced cycles) | STERRAD NX® withALLClear® TechnologySterilization System (Standardand Advanced cycles) | ||
| STERRAD 100NX® withALLClear® TechnologySterilization System (Standard,Flex, Express and Duo cycles) | STERRAD 100NX® withALLClear® TechnologySterilization System (Standard,Flex, Express and Duo cycles) | ||
| V-PRO® 1 Low TemperatureSterilization System (Lumencycle) | V-PRO® 1 Low TemperatureSterilization System (Lumencycle) | ||
| V-PRO® 1 Plus LowTemperature SterilizationSystem (Lumen and NonLumen cycles) | V-PRO® 1 Plus LowTemperature SterilizationSystem (Lumen and Non Lumencycles) | ||
| V-PRO® maX LowTemperature SterilizationSystem (Lumen, Non Lumen,and Flexible cycles) | V-PRO® maX Low TemperatureSterilization System (Lumen,Non Lumen, and Flexiblecycles) | ||
| V-PRO® 60 Low TemperatureSterilization System (Lumen,Non Lumen and Flexiblecycles) | V-PRO® 60 Low TemperatureSterilization System (Lumen,Non Lumen and Flexible cycles) | ||
| V-PRO® maX 2 LowTemperature SterilizationSystem (Lumen, Non Lumen,Flexible, and Fast Non Lumencycles) | V-PRO® maX 2 LowTemperature SterilizationSystem (Lumen, Non Lumen,Flexible, and Fast Non Lumencycles) | ||
| V-PRO® s2 Low TemperatureSterilization System (Lumen,Non Lumen, Flexible, and Fastcycles) | V-PRO® s2 Low TemperatureSterilization System (Lumen,Non Lumen, Flexible, and Fastcycles) | ||
| STERIZONE® VP4 Sterilizer(Cycle 1) | STERIZONE® VP4 Sterilizer(Cycle 1) | ||
| SteroScope® SterilizationSystem | |||
| Organism | Geobacillus stearothermophilustraceable to ATCC™ 7953 | Geobacillus stearothermophilustraceable to ATCC™ 7953 | Identical |
| Viable sporepopulation | $\ge$ 1x106 | >1x106 | Identical |
| Resistancecharacteristics | (Tested at 10 mg/L vaporizedhydrogen peroxide) | (Tested at 10 mg/L vaporizedhydrogen peroxide) | |
| • D-value | D10 mg/L $\ge$ 1 second | D10 mg/L $\ge$ 1 second | Identical |
| • Survival/KillWindow | Survival Time $\ge$ 5 secondsKill Time = 7 minutes | Survival Time $\ge$ 5 secondsKill Time = 7 minutes | |
| Feature | Submission Device:3MTM Attest™ Rapid ReadoutBiological Indicator | Predicate Device (K211705):3MTM Attest™ Rapid ReadoutBiological Indicator | Comparison |
| Incubationtemperature | 60 ± 2℃ | 60 ± 2℃ | Identical |
| Readout time | 24 minute fluorescence result read | 24 minute fluorescence result read | Identical |
| Chemicalindicator | H2O2 sensitive ink; changes fromblue towards pink | H2O2 sensitive ink; changes fromblue towards pink | Identical |
| Shelf life | Two (2) years | Two (2) years | Identical |
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3M™ Attest™ Rapid Readout Biological Indicator 1295 and
3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
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PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Rapid Readout Biological Indicator 1295 and
| 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E |
|---|
| Feature | Submission Device:3M™ Attest™ Vaporized HydrogenPeroxide Tri-Metric ChemicalIndicator | Predicate Device:3M™ Attest™ Vaporized HydrogenPeroxide Tri-Metric ChemicalIndicator (K212022) | Comparison |
|---|---|---|---|
| DeviceModels | 1348, 1348E | 1348, 1348E | Identical |
| Indicationsfor Use | Use the 3M™ Attest™ VaporizedHydrogen Peroxide Tri-Metric ChemicalIndicator 1348/1348E for pack controlmonitoring of the following hydrogencycles:STERRAD 100S® SterilizationSystemSTERRAD NX® SterilizationSystem (Standard and Advancedcycles)STERRAD 100NX®Sterilization System (Standard,Flex, Express and Duo cycles)STERRAD NX® withALLClear® TechnologySterilization System (Standardand Advanced cycles)STERRAD 100NX® withALLClear® TechnologySterilization System (Standard,Flex, Express and Duo cycles)V-PRO® 1 Low TemperatureSterilization System (Lumencycle)V-PRO® 1 Plus LowTemperature SterilizationSystem (Lumen and Non Lumencycles)V-PRO® maX Low TemperatureSterilization System (Lumen,Non Lumen, and Flexiblecycles) | Use the 3M™ Attest™ VaporizedHydrogen Peroxide Tri-Metric ChemicalIndicator 1348/1348E for pack controlmonitoring of the following hydrogenperoxide sterilization sterilizers andcycles:STERRAD 100S® SterilizationSystemSTERRAD NX® SterilizationSystem (Standard and Advancedcycles)STERRAD 100NX®Sterilization System (Standard,Flex, Express and Duo cycles)STERRAD NX® withALLClear® TechnologySterilization System (Standardand Advanced cycles)STERRAD 100NX® withALLClear® TechnologySterilization System (Standard,Flex, Express and Duo cycles)V-PRO® 1 Low TemperatureSterilization System (Lumencycle)V-PRO® 1 Plus LowTemperature SterilizationSystem (Lumen and Non Lumencycles)V-PRO® maX Low TemperatureSterilization System (Lumen,Non Lumen, and Flexiblecycles) | AdditionofSteroScope®Sterilization System |
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3M™ Attest™ Rapid Readout Biological Indicator 1295 and
| Feature | Submission Device:3MTM Attest™ Vaporized HydrogenPeroxide Tri-Metric ChemicalIndicator | Predicate Device:3MTM Attest™ Vaporized HydrogenPeroxide Tri-Metric ChemicalIndicator (K212022) | Comparison |
|---|---|---|---|
| V-PRO® 60 Low TemperatureSterilization System (Lumen,Non Lumen and Flexible cycles)V-PRO® maX 2 LowTemperature SterilizationSystem (Lumen, Non Lumen,Flexible, and Fast Non Lumencycles)V-PRO® s2 Low TemperatureSterilization System (Lumen,Non Lumen, Flexible, and Fastcycles)STERIZONE® VP4 Sterilizer(Cycle 1)SteroScope® SterilizationSystem | V-PRO® 60 Low TemperatureSterilization System (Lumen,Non Lumen and Flexible cycles)V-PRO® maX 2 LowTemperature SterilizationSystem (Lumen, Non Lumen,Flexible, and Fast Non Lumencycles)V-PRO® s2 Low TemperatureSterilization System (Lumen,Non Lumen, Flexible, and Fastcycles)STERIZONE® VP4 Sterilizer(Cycle 1) | ||
| IndicatorAgent | Proprietary | Proprietary | Identical |
| Stability oftheendpointreaction | At least six months | At least six months | Identical |
| Shelf life | 24 months | 15 months | Similar,shelf-lifeextendedto 24months |
| EndpointSpecifications(MinimumStatedValues) | VH2O2Concentration5.1 mg/L | VH2O2Concentration5.1 mg/L | Identical |
| Exposure Time1 | Exposure Time1 | ||
| Temperature50 degrees | Temperature50 degrees |
3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
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5. Nonclinical Comparison to the Predicate Device
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 has identical design, fundamental technology, and performance specifications to the predicate device under the same name. The key difference between the submission device and the predicate device is that the submission device adds an indication for pack control monitoring of the SteroScope® Sterilization System (last cleared under K211705)
To demonstrate performance in the newly claimed sterilizer and cycles, nonclinical testing was performed in accordance with the FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, issued October 04, 2007, and ANSI/AAMI/ISO 11138-1:2017 Sterilization of health care products- Biological Indicators-Part 1: General requirements (FDA Recognition Number 14-502).
Reference Table 5.1 and 5.2 for testing completed in SteroScope® Sterilization System.
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Full CyclePerformance | Verify performance in each of thefull cycles in the SteroScope®Sterilization System. | All biological indicators display anegative fluorescent and negativegrowth response. | Pass |
| Fractional CyclePerformance | Verify performance in fractionalcycles for each of the cycleswithin the SteroScope®Sterilization System. | All biological indicators display anegative fluorescent and negativegrowth response. | Pass |
| ChemicalIndicator (CI)Color Change | Demonstrate the color change ofthe CI when exposed to theSteroScope® Sterilization System. | Color change from blue towardpink. | Pass |
Table 5.1 Summary of Biological Indicator Nonclinical Testing
3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, has identical design, fundamental technology, and performance specifications to the predicate device under the same name. The key difference between the submission device and the predicate device is that the submission device adds an indication for pack control monitoring of the SteroScope® Sterilization System (last cleared under K212022).
Given the addition of this indication for the SteroScope® Sterilization System, nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003. Testing was conducted via simulated use testing of the SteroScope® Sterilization System.in a health care facility and all tests conducted passed.
Table 5.1 Summary of Tri-Metric Chemical Indicator Nonclinical Testing
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Complete (Full)CyclePerformance | Verify performance in thecomplete (full) cycle of a | Visual assessment of the chemicalindicator yields an ACCEPT resultwith ≥ 95% accuracy | Pass,100%accuracy |
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PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295 and
| loaded SteroScope®Sterilization System. | At least 80% of the population ofindicators tested has a measuredcolor change value correspondingto an ACCEPT result. | Pass,>99.9%population | |
|---|---|---|---|
| Fractional CyclePerformance | Verify performance in anincomplete cycle of aloaded SteroScope®Sterilization System. | Visual assessment of the chemicalindicator yields a REJECT resultwith ≥ 95% accuracy | Pass,100%accuracy |
| At least 80% of the population ofindicators tested has a measuredcolor change value correspondingto a REJECT result. | Pass,>99.9%population |
| 3M Attest Rapid Readout Biological Indicator 1295 and |
|---|
| 3MTM AttestTM Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348 |
6. Conclusion
Based on the non-clinical performance data, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is as safe, as effective, and performs as well as the legally marketed predicate, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 cleared under K211705, Class II (21 CFR 880.2800), product code FRC and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E cleared under K212022, Class II (21 CFR 880.2800), product code QKM.
§ 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).