(390 days)
Not Found
No
The document describes a biological indicator and an auto-reader for monitoring sterilization processes. There is no mention of AI or ML in the intended use, device description, or performance studies. The detection of sterilization failure is based on fluorescence, a standard biological indicator method.
No.
This device is designed to monitor sterilization processes, not to treat a medical condition or disease.
No
The device is a biological indicator used for routine monitoring of sterilization processes, specifically to confirm that sterilization has occurred. It does not diagnose any medical condition in a patient.
No
The device description clearly outlines a physical biological indicator (BI) composed of a plastic sleeve, spore carrier, media ampoule, and cap. While it is used in conjunction with an auto-reader which likely contains software, the device itself is a physical component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "routine monitoring of vaporized hydrogen peroxide sterilization processes." This is a quality control process for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device is a biological indicator containing spores and media, designed to detect sterilization failure by indicating the survival of microorganisms. It does not analyze biological samples from a patient.
- Anatomical Site and Patient Age Range: These are listed as "Not Applicable," further indicating that the device is not used on or for a patient.
- Intended User / Care Setting: The intended use is in "healthcare settings" for monitoring sterilization processes, not for patient diagnosis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
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:
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)
Product codes
FRC
Device Description
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.
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).
Test Name: Full Cycle Performance
Purpose: Verify performance in each of the full cycles in the STERIZONE® VP4 Sterilizer (Cycle 1).
Acceptance Criteria: All biological indicators display a negative fluorescent and negative visual response.
Result: Pass
Test Name: Fractional Cycle Performance
Purpose: Verify performance in fractional cycles for each of the cycles within the STERIZONE® VP4 Sterilizer (Cycle 1).
Acceptance Criteria: All biological indicators display a negative fluorescent and negative visual response.
Result: Pass
Test Name: Chemical Indicator (CI) Color Change
Purpose: Demonstrate the color change of the CI when exposed to the STERIZONE® VP4 Sterilizer (Cycle 1).
Acceptance Criteria: Color change from blue toward pink.
Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
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
1
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
2
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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3
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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
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:
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) |
5
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, and |
| Fast Non Lumen cycles) |
| V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast |
| cycles) |
| STERIZONE® VP4 Sterilizer (Cycle 1) |
Technological Characteristic Comparison Table
| Feature | Submission Device:
3M™ Attest™ Rapid Readout
Biological Indicator 1295 | Predicate Device (K210277):
3M™ Attest™ Rapid Readout
Biological Indicator 1295 | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| 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)
V-PRO® 60 Low Temperature
Sterilization System (Lumen,
Non Lumen and Flexible cycles) | 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)
V-PRO® 60 Low Temperature
Sterilization System (Lumen,
Non Lumen and Flexible cycles) | Addition of
the
STERIZONE®
VP4 Sterilizer
(Cycle 1) |
6
| Feature | Submission Device:
3MTM Attest™ Rapid Readout
Biological Indicator 1295 | Predicate Device (K210277)
3MTM Attest™ Rapid Readout
Biological Indicator 1295 |
|---------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | V-PRO® maX 2 Low
Temperature Sterilization
System (Lumen, Non Lumen,
Flexible, and Fast Non Lumen | V-PRO® maX 2 Low
Temperature Sterilization
System (Lumen, Non Lumen,
Flexible, and Fast Non Lumen |
| Feature | Submission Device:
3MTM Attest™ Rapid Readout
Biological Indicator 1295 | Predicate Device (K210277):
3MTM Attest™ Rapid Readout
Biological Indicator 1295 | Comparison |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------|
| | V-PRO® maX 2 Low
Temperature Sterilization
System (Lumen, Non Lumen,
Flexible, and Fast Non Lumen
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) | V-PRO® s2 Low Temperature
Sterilization System (Lumen,
Non Lumen, Flexible, and Fast
cycles) | |
| | STERIZONE® VP4 Sterilizer
(Cycle 1) | | |
| Organism | Geobacillus stearothermophilus
traceable to ATCCTM 7953 | Geobacillus stearothermophilus
traceable to ATCCTM 7953 | Identical |
| Viable spore
population | ≥1x106 | ≥1x106 | Identical |
| Resistance
characteristics | (Tested at 10 mg/L vaporized
hydrogen peroxide) | (Tested at 10 mg/L vaporized
hydrogen peroxide) | |
| • D-value | D10 mg/L ≥ 1 second | D10 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 |
| Readout time | 24 minute fluorescence result read | 24 minute fluorescence result read | Identical |
| 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. 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).
7
PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| 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 |
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.