(390 days)
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 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, Non 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)
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 3M™ Attest™ Auto-reader 490H or the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ 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.
The FDA 510(k) summary for the 3M™ Attest™ Rapid Readout Biological Indicator 1295 (K211705) describes the acceptance criteria and the study that proves the device meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Full Cycle Performance | Verify performance in each of the full cycles in the STERIZONE® VP4 Sterilizer (Cycle 1). | All biological indicators display a negative fluorescent and negative visual response. | Pass |
| Fractional Cycle Performance | Verify performance in fractional cycles for each of the cycles within the STERIZONE® VP4 Sterilizer (Cycle 1). | All biological indicators display a negative fluorescent and negative visual response. | Pass |
| Chemical Indicator (CI) Color Change | Demonstrate the color change of the CI when exposed to the STERIZONE® VP4 Sterilizer (Cycle 1). | Color change from blue toward pink. | Pass |
Note: The above table specifically refers to the nonclinical testing performed to demonstrate performance in the newly claimed sterilizer and cycles (STERIZONE® VP4 Sterilizer, Cycle 1), which is the primary reason for this new 510(k) submission as the device itself is identical to a previously cleared predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample size for the test set used in the full, fractional, and chemical indicator performance tests. It states that "nonclinical testing was performed."
- Sample Size: Not explicitly quantified in the provided text.
- Data Provenance: The testing was nonclinical, performed in a laboratory setting to evaluate the device's performance with the newly included STERIZONE® VP4 Sterilizer (Cycle 1). The country of origin is not specified but implicitly linked to the sponsor, 3M Health Care, based in St. Paul, MN, USA. The study is prospective in nature as it is a validation of the device's performance under specific conditions to support regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is generally not applicable to biological indicator performance studies. The ground truth for such studies is established through objective, predefined physical and biological measurements rather than expert human interpretation.
Therefore:
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1 used in clinical imaging studies) is not applicable here because the "readout" of a biological indicator (fluorescent and visual response) is a direct, objective measurement rather than a subjective interpretation requiring consensus among multiple readers.
Therefore:
- Adjudication Method: Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices involving human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on human performance. Biological indicators like the 3M™ Attest™ are designed for objective, automated readout and do not involve human diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the studies described are essentially "standalone" in nature, focusing on the biological indicator's performance based on its inherent characteristics and interaction with the auto-reader and sterilizer. The device functions independently in terms of its biological response to sterilization conditions, and the auto-reader provides an objective "readout" (fluorescent or visual response) without human intervention in the interpretation of the core sterilization effectiveness.
7. The Type of Ground Truth Used
The ground truth for biological indicator performance studies is based on:
- Biological Activity: The viability of Geobacillus stearothermophilus spores.
- Physical Parameters: The exposure of the BI to specific sterilant concentrations (vaporized hydrogen peroxide at 10 mg/L) and time.
- Negative Fluorescent/Visual Response: The absence of growth (negative fluorescent and negative visual response) for sterilized indicators and presence of growth for unsterile/fractionally treated indicators.
- Material Science: The color change of the chemical indicator based on chemical reaction with hydrogen peroxide.
Essentially, it relies on objective biological and chemical principles, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an AI/machine learning algorithm. For biological indicators, performance is established through empirical testing against predefined standards (e.g., FDA Guidance, ANSI/AAMI/ISO 11138-1:2017) rather than training models. The document refers to "nonclinical testing" to demonstrate performance.
Therefore:
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML algorithm:
- How Ground Truth for Training Set Was Established: Not applicable. Instead, the performance of the biological indicator (including its stated D-value and Survival/Kill Window) is established through rigorous testing methods defined by recognized standards for biological indicators.
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June 28, 2022
3M Company Mary Fretland Regulatory Affairs Specialist 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K211705
Trade/Device Name: 3M Attest Rapid Readout Biological Indicator, 1295 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: June 7, 2022 Received: June 8, 2022
Dear Mary Fretland:
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 (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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery 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
510(k) Number (if known) K211705
Device Name
3M™ Attest™ Rapid Readout Biological Indicator 1295
Indications for Use (Describe)
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM 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 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, Non 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)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K211705 510(k) Summary for 3M™ Attest™ Rapid Readout Biological Indicator 1295
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Mary Fretland Regulatory Affairs Specialist Phone Number: (651) 737-2296
Date of Summary: June 08, 2022
510(k) Reference: K211705
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PREMARKET NOTIFICATION [510(k) 3MTM Attest™ Rapid Readout Biological Indicator 1295
1. Device Name and Classification:
| Common or Usual Name: | Biological Indicator |
|---|---|
| Proprietary Name: | 3M™ Attest™ Rapid Readout Biological Indicator 1295 |
| Classification Name: | Indicator, biological sterilization process |
| Device Classification: | Class II, 21 CFR § 880.2800(a) |
| Product Code: | FRC |
2. Predicate Device:
K210277 3MTM Attest™ Rapid Readout Biological Indicator 1295
3. Description of Device:
The 3MTM 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 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ 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.
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 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) |
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PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295
| 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, andFast Non Lumen cycles) |
| V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fastcycles) |
| STERIZONE® VP4 Sterilizer (Cycle 1) |
Technological Characteristic Comparison Table
| Feature | Submission Device:3M™ Attest™ Rapid ReadoutBiological Indicator 1295 | Predicate Device (K210277):3M™ Attest™ Rapid ReadoutBiological Indicator 1295 | Comparison |
|---|---|---|---|
| Indications foruse | Use the 3M™ Attest™ RapidReadout Biological Indicator 1295in conjunction with the 3M™Attest™ Auto-reader 490H or 490Auto-reader having softwareversion 4.0.0 or greater or 490MAuto-reader as a standard method ofroutine monitoring of vaporizedhydrogen peroxide sterilizationprocesses in the following systems: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)V-PRO® 60 Low TemperatureSterilization System (Lumen,Non Lumen and Flexible cycles) | Use the 3M™ Attest™ RapidReadout Biological Indicator 1295in conjunction with the 3M™Attest™ Auto-reader 490H or 490Auto-reader having softwareversion 4.0.0 or greater or 490MAuto-reader as a standard method ofroutine monitoring of vaporizedhydrogen peroxide sterilizationprocesses in the following systems: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)V-PRO® 60 Low TemperatureSterilization System (Lumen,Non Lumen and Flexible cycles) | Addition oftheSTERIZONE®VP4 Sterilizer(Cycle 1) |
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| Feature | Submission Device:3MTM Attest™ Rapid ReadoutBiological Indicator 1295 | Predicate Device (K210277)3MTM Attest™ Rapid ReadoutBiological Indicator 1295 |
|---|---|---|
| V-PRO® maX 2 LowTemperature SterilizationSystem (Lumen, Non Lumen,Flexible, and Fast Non Lumen | V-PRO® maX 2 LowTemperature SterilizationSystem (Lumen, Non Lumen,Flexible, and Fast Non Lumen |
| Feature | Submission Device:3MTM Attest™ Rapid ReadoutBiological Indicator 1295 | Predicate Device (K210277):3MTM Attest™ Rapid ReadoutBiological Indicator 1295 | Comparison |
|---|---|---|---|
| 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) | |||
| Organism | Geobacillus stearothermophilustraceable to ATCCTM 7953 | Geobacillus stearothermophilustraceable to ATCCTM 7953 | Identical |
| Viable sporepopulation | ≥1x106 | ≥1x106 | Identical |
| Resistancecharacteristics | (Tested at 10 mg/L vaporizedhydrogen peroxide) | (Tested at 10 mg/L vaporizedhydrogen peroxide) | |
| • D-value | D10 mg/L ≥ 1 second | D10 mg/L ≥ 1 second | Identical |
| • Survival/KillWindow | Survival Time ≥ 5 secondsKill Time = 7 minutes | Survival Time ≥ 5 secondsKill Time = 7 minutes | |
| Carrier material | Polyethylene terephthalate | Polyethylene terephthalate | Identical |
| Incubationtemperature | 60 ± 2°C | 60 ± 2°C | 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 |
5. Nonclinical Comparison to the Predicate Device
The 3MTM Attest™ Rapid Readout Biological Indicator 1295 is identical to the previously cleared device of the same model number (the predicate) which is sold under the same tradename and cleared via K210277.
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, 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 for testing completed in the STERIZONE® VP4 Sterilizer (Cycle 1).
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PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Full CyclePerformance | Verify performance in each of thefull cycles in the STERIZONE®VP4 Sterilizer (Cycle 1). | All biological indicators display anegative fluorescent and negativevisual response. | Pass |
| Fractional CyclePerformance | Verify performance in fractionalcycles for each of the cycleswithin the STERIZONE® VP4Sterilizer (Cycle 1). | All biological indicators display anegative fluorescent and negativevisual response. | Pass |
| ChemicalIndicator (CI)Color Change | Demonstrate the color change ofthe CI when exposed to theSTERIZONE® VP4 Sterilizer(Cycle 1). | Color change from blue towardpink. | Pass |
Table 5.1 Summary of Nonclinical Testing
6. Conclusion
Based on the non-clinical performance data, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 is as safe, as effective, and performs as well as or better than the legally marketed predicate, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 cleared under K210277, 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).