(239 days)
No
The document describes a biological indicator and an auto-reader that detects fluorescence. There is no mention of AI or ML in the intended use, device description, or performance studies. The detection method is based on a direct biological and chemical reaction, not algorithmic learning.
No.
This device is a biological indicator used to monitor the effectiveness of sterilization processes, not to treat or diagnose patients.
No
The device is a biological indicator used for routine monitoring of sterilization processes, not for diagnosing medical conditions in patients.
No
The device description clearly states it is a "self-contained biological indicator" which is a physical, single-use device composed of a plastic sleeve, spore carrier, media ampoule, and cap. It is used in conjunction with hardware (Auto-readers).
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "routine monitoring of vaporized hydrogen peroxide sterilization processes". This involves testing a process (sterilization) to determine its effectiveness, which falls under the scope of in vitro diagnostics.
- Device Description: The device description details a "self-contained biological indicator" that detects "sterilization failure" through the "detection of fluorescence upon incubation". This is a classic description of a biological indicator used to assess the efficacy of a sterilization process, which is an in vitro test.
- Performance Studies: The performance studies mention testing in accordance with FDA guidance for "Biological Indicator (BI) Premarket Notification [510(k)] Submissions" and "ANSI/AAMI/ISO 11138-1:2017 Sterilization of health care products- Biological Indicators". These standards and guidance documents are specifically related to devices used for monitoring sterilization processes, which are considered IVDs.
While the text doesn't explicitly use the term "in vitro diagnostic," the function and regulatory context described strongly indicate that this device is intended for in vitro diagnostic use. It's used to test a process (sterilization) outside of the human body to provide information about the effectiveness of that process.
N/A
Intended Use / Indications for Use
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: AMSCO® V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen, Non Lumen, and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo cycles).
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The 3MTM AttestTM 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical 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).
Study Type: Full Cycle Performance, Fractional Cycle Performance, Chemical Indicator (CI) Color Change.
Sample Size: Not specified.
Key Results:
- Full Cycle Performance: All biological indicators display a negative fluorescent and negative growth response. (Pass)
- Fractional Cycle Performance: All biological indicators display a negative fluorescent and negative growth response. (Pass)
- Chemical Indicator (CI) Color Change: Color change from blue toward pink. (Pass)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
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December 11, 2020
3M Company Mary Fretland Senior Regulatory Affairs Associate 3M Center. Building 275-5W-06 St.Paul, Minnesota 55144
Re: K200996
Trade/Device Name: 3M™ Attest™ Rapid Readout Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 13, 2020 Received: November 16, 2020
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
1
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 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 (OS) 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. Acting 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
2
Indications for Use
510(k) Number (if known) K200996
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: AMSCO® V-PRO® I Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, and Flexible cycles) and in STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo cycles),
| 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)
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3
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510(k) Summary for 3MTM Attest™ Rapid Readout Biological Indicator 1295 K200996
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Mary Fretland Senior Regulatory Affairs Associate Phone Number: (651) 737-2296 Fax Number: (651) 737-5320
Date of Summary: December 09, 2020
510(k) Reference: K200996
4
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:
K173435 3M™ Attest™ Rapid Readout Biological Indicator 1295
3. Description of Device:
The 3MTM AttestTM 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: AMSCO® V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen, Non Lumen, and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo cycles).
5
PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295
| | Submission Device:
3MTM AttestTM Rapid Readout
Biological Indicator 1295 | Predicate Device (K173435):
3MTM AttestTM Rapid Readout
Biological Indicator 1295 | Comparison |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Use the 3MTM 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:
AMSCO® V-PRO® 1 Low
Temperature Sterilization System
(Lumen cycle), AMSCO® V-
PRO® 1 Plus Low Temperature
Sterilization System (Lumen and
Non Lumen cycles), AMSCO® V-
PRO® maX Low Temperature
Sterilization System (Lumen, Non
Lumen, and Flexible cycles),
AMSCO® V-PRO® 60 Low
Temperature Sterilization System
(Lumen, Non Lumen and Flexible
cycles), STERIS® V-PRO® maX 2
Low Temperature Sterilization
System (Fast Non Lumen, Lumen,
Non Lumen, and Flexible cycles)
and in STERRAD® 100S,
STERRAD® NX (Standard and
Advanced cycles), STERRAD®
100NX (Standard, Flex, Express
and Duo cycles) systems,
STERRAD® NX with AllClearTM
Technology (Standard and
Advanced cycles) and STERRAD®
100NX with AllClearTM
Technology (Standard, Flex,
Express and Duo cycles). | Use the 3MTM Attest™ Rapid
Readout Biological Indicator 1295
in conjunction with the 3MTM
Attest™ Auto reader 490H as a
standard method of routine
monitoring of vaporized hydrogen
peroxide sterilization processes in
the following systems: AMSCO®
V-PROTM 1 Low Temperature
Sterilization System (Lumen cycle),
AMSCO® V-PROTM 1 Plus Low
Temperature Sterilization System
(Lumen and Non Lumen cycles),
AMSCO® V-PROTM maX Low
Temperature Sterilization System
(Lumen, Non Lumen, and Flexible
cycles), AMSCO® V-PROTм 60
Low Temperature Sterilization
System (Lumen, Non Lumen and
Flexible cycles) and in STERRAD®
100S, STERRAD® NX (Standard
and Advanced cycles), STERRAD®
100NX (Standard, Flex, Express
and Duo cycles) systems,
STERRAD® NX with ALLClearTM
Technology (Standard and
Advanced cycles) and STERRAD®
100NX with ALLClear™
Technology (Standard, Flex,
Express and Duo cycles). | Addition of
the 490 and
490M Auto-
readers
and
Addition of
the
STERIS®
V-PRO®
max 2 Low
Temperature
Sterilization
System
(Fast Non
Lumen,
Lumen, Non
Lumen, and
Flexible
cycles)
sterilizer |
| Indications for use | | | |
| Organism | Geobacillus stearothermophilus
traceable to ATCCTM 7953 | Geobacillus stearothermophilus
traceable to ATCCTM 7953 | Identical |
| Viable spore
population | $≥1x10^6$ | $≥1x10^6$ | Identical |
| Resistance
characteristics | (Tested at 10 mg/L vaporized
hydrogen peroxide) | (Tested at 10 mg/L vaporized
hydrogen peroxide) | |
| • D-value | $D_{10 mg/L} ≥ 1 second$ | $D_{10 mg/L} ≥ 1 second$ | Identical |
| • Survival/Kill
Window | Survival Time ≥ 5 seconds
Kill Time = 7 minutes | Survival Time ≥ 5 seconds
Kill Time = 7 minutes | |
| Carrier material | Polyethylene terephthalate | Polyethylene terephthalate | Identical |
| Incubation
temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Feature | Submission Device:
3MTM AttestTM Rapid Readout
Biological Indicator 1295 | Predicate Device (K173435):
3MTM AttestTM Rapid Readout
Biological Indicator 1295 | Comparison |
| Chemical
indicator | H2O2 sensitive ink; changes from
blue towards pink | H2O2 sensitive ink; changes from
blue towards pink | Identical |
| Shelf life | Two (2) years | Two (2) years | Identical |
5. Technological Characteristic Comparison Table
6
PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Rapid Readout Biological Indicator 1295
6. 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 K173435.
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 6.1 for testing completed in AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Full Cycle | |||
| Performance | Verify performance in each of the | ||
| full cycles in the AMSCO® V- | |||
| PRO™ maX 2 Low Temperature | |||
| Sterilization System (Lumen, Non- | |||
| Lumen, Flexible, and Fast Non- | |||
| Lumen cycles) sterilizer. | 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 AMSCO® V-PRO™ | |||
| maX 2 Low Temperature | |||
| Sterilization System (Lumen, Non- | |||
| Lumen, Flexible, and Fast Non- | |||
| Lumen cycles). | 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 | |||
| AMSCO® V-PRO™ maX 2 Low | |||
| Temperature Sterilization System | |||
| (Lumen, Non-Lumen, Flexible, | |||
| and Fast Non-Lumen cycles). | Color change from blue toward | ||
| pink. | Pass |
Table 6.1 Summary of Nonclinical Testing
- Addition of 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or ● greater per K173437 and K173584.
- Addition of 3MTM Attest™ Mini Auto-reader 490M per K200092. ●
7
7. 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 K173435, Class II (21 CFR 880.2800), product code FRC.